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Infectious Diseases Summit 2017

2018-04-202017-06-132017-05-13
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Day 1 - Thursday, July 13, 2017
7:00
Continental Breakfast & Registration
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7:50
Welcome & Opening Remarks
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10:00
Human Noroviruses Contain Multiple and Diverse Antiviral Targets
 
Brent Korba
Brent Korba
Professor
Georgetown University
About Speaker: Dr. Korba has been a faculty member of the Department of Microbiology and Immunology in the Georgetown University Medical center since 1984. His expertise lies in the field of early stage pre-clinical drug discovery, utilizing enzymatic and tissue cu... Read Full Bio 
 
 
Brent Korba
Brent Korba
Professor
Georgetown University
 
About Speaker:

Dr. Korba has been a faculty member of the Department of Microbiology and Immunology in the Georgetown University Medical center since 1984. His expertise lies in the field of early stage pre-clinical drug discovery, utilizing enzymatic and tissue culture-based assays, as well as pre-clinical animal models. He has conducted antiviral testing contracts for the NIAID, NIH since 1990. His specific areas of focus are Hepatitis B and Noroviruses (current), as well as Hepatitis C. Dr. Korba has published over 115 peer-reviewed papers, 18 book chapters and 63 conference abstracts. He also holds several patents for the use of antiviral compounds. Dr. Korba is an active consultant in the pharmaceutical field, and has been a member of several scientific advisory boards for various companies. He is an ad-hoc reviewer and has been an editorial board member for a number of scientific journals, as well as grant study sections for the NIH and American Cancer Society.

 
Abstract: Noroviruses (NoV) are the leading cau...Read More 

Noroviruses (NoV) are the leading cause of nonbacterial, acute gastroenteritis worldwide and pose a significant financial burden (>$5B) on U.S. healthcare systems. In the U.S., noroviruses are responsible for more than 50% of all cases of food-borne illness, over 20 million infections, and 70,000 hospitalizations annually. The NoV replication cycle presents a number of potentially accessible antiviral targets. The viral polymerase (RdRp) contains at least 2 sites for binding of allosteric inhibitors. The nucleoside analogue 2’C-methylcytidine has been shown to be an effective inhibitor of human NoV replication in cell culture and murine norovirus (MNV) in infected animals. The NoV chymotrypsin-like cysteine protease has been shown to be inhibited by a divergent series of molecules. The NoV VPg protein covalently linked to the 5’-end of the viral genome is required for both the initiation of translation as well as priming for RNA replication, creating a novel, potential, intervention target. Enzymatic and cell culture-based assays are available to evaluate potential inhibitors, and structures for all three viral proteins are available to aid in computer-assisted drug design. Antiviral development for NoV infections is in its infancy providing an especially significant opportunity for the development of therapeutic agents.

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10:25
Morning Networking Break
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Antiviral Drugs Research & Development 2017
Respiratory Viral Infections: Current Landscape and Emerging Drugs
Moderator: Sreerupa Challa, Spring Bank Pharmaceuticals
10:55
Antiviral Activity of an Innate Immune Modulator Against Respiratory Viruses
 
Santanu Bose
Santanu Bose
Professor
Washington State University
About Speaker: Dr. Bose is currently a faculty member in the Washington State University College of Veterinary Medicine. Before moving to Washington State in 2014, Dr. Bose was a faculty member of the Department of Microbiology and Immunology in the University of T... Read Full Bio 
 
 
Santanu Bose
Santanu Bose
Professor
Washington State University
 
About Speaker:

Dr. Bose is currently a faculty member in the Washington State University College of Veterinary Medicine. Before moving to Washington State in 2014, Dr. Bose was a faculty member of the Department of Microbiology and Immunology in the University of Texas Health Science Center Medical School. His research is focused on understanding various aspect of innate immune response against respiratory viruses like human respiratory syncytial virus (RSV), influenza A virus and parainfluenza viruses. Particularly he is interested in elucidating the mechanism regulating innate antiviral and inflammatory response, which play a critical role in host defense against respiratory viruses. Dr. Bose has published widely in top quality research journals and holds US patents. Dr. Bose is in the editorial board and serves as an academic editor for numerous per-reviewed research journals and more recently served as a regular member of NIH study section.

 
Abstract: ...Read More 

Respiratory syncytial virus (RSV) is a lung tropic virus that causes severe airway infection (pneumonia and bronchiolitis) among infants, children, immune-compromised and elderly. Currently, there is no vaccine and/or effective antiviral therapeutics to combat RSV infection. Therefore, there is an urgent need for developing anti-RSV agents. SB 9200 is a first-in-class oral innate immune modulator with potent antiviral activity against HBV, HCV and Norovirus. Our studies have identified SB 9200 as an anti-RSV therapeutic agent. Studies performed with human lung epithelial A549 cells revealed antiviral activity of SB 9200 against RSV. Anti-RSV activity of SB 9200 was further evident from our studies performed with RSV mouse model that mimics RSV- induced human disease. SB 9200 administration to the airway resulted in – a) reduced RSV burden in the respiratory tract; and b) diminished airway inflammation, and lung disease severity. Mechanism of action studies in vitro revealed the ability of SB 9200 to activate interferon regulatory factor 3 (IRF3) which resulted in production of antiviral cytokine interferon-beta (IFN-beta) from epithelial cells. IFN-beta was also detected in the lung of SB 9200 treated mice. Furthermore, knockdown of two pattern recognition receptors (PRRs) RIGI and Nod2 abrogated IFN-beta production from SB 9200 cells. In addition, we observed direct interaction of SB 9200 with RIG-I. Thus, we have identified SB 9200 as an anti-RSV agent. Mechanistically, our studies suggest that interaction of SB 9200 with PRRs like RIG-I and Nod2 results in production of antiviral cytokine IFN-beta which play a critical role in inhibiting RSV infection.

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Anti-Infectives Partnering & Deal-Making 2017
Non-Traditional Approaches and Technologies in Anti-Infectives
Moderator: Mark Albrecht, BARDA, HHS
10:55
Discovery and Development of Anti-Infective Immunotherapy Using Human Monoclonal Antibodies
 
Vu Truong
Vu Truong
Founder & Chief Executive Officer
Aridis Pharmaceuticals
About Speaker: Founder, Chief Executive Officer, and Director Dr. Truong is a founder of Aridis and recently elected to the CEO position in 2014 after having served as the company's Chief Scientific Officer for the past 9 years. He has over 18 years of experience... Read Full Bio 
 
 
Vu Truong
Vu Truong
Founder & Chief Executive Officer
Aridis Pharmaceuticals
 
About Speaker:

Founder, Chief Executive Officer, and Director
Dr. Truong is a founder of Aridis and recently elected to the CEO position in 2014 after having served as the company's Chief Scientific Officer for the past 9 years. He has over 18 years of experience in biopharmaceutical drug development, having held positions of increasing responsibilities in companies which were eventually acquired by larger entities, including Gene Medicine (sold to Megabios), Aviron (sold to Medimmune), and Medimmune (sold to Astra Zeneca). He has a life-long interest and research experience in infectious diseases, focusing on the development of innovative human monoclonal antibodies and vaccines designed to address life threatening infections. His product development experience includes FluMist™, Synagis™ mAb, and a number of other monoclonal antibody based therapeutics. Dr. Truong is the principal architect of the Aridis technologies, which includes a range of anti-infective products and pharmaceutical processing technologies. He received his Ph.D. in Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine.

 
Abstract: Aridis has a discovery platform techn...Read More 

Aridis has a discovery platform technology that allows for rapid discovery and manufacture of fully human monoclonal antibodies from patients, and are developing several anti-bacterial antibodies as adjunctive immunotherapy to standard of care antibiotics. Several antibodies addressing this need are currently in clinical studies, some with preliminary signs of safety and efficacy. Among the advantages of adjunctive antibody therapy that is combined with standard-of-care antibiotic therapy are the excellent safety profiles, long serum half-life, little impact on normal human flora, a new mode of action and a low risk of emergence of resistance. Key elements of our antibody discovery platform will be presented, as well the clinical data on Aridis’ mAb programs. The presentation will introduce attractive facets of the anti-infective immunotherapy approach of using human monoclonal antibody (mAb) and discuss future directions.

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11:20
A Host-Directed Antiviral Approach for Treatment of Influenza
 
Kelly  Warfield
Kelly Warfield
Senior Director, Antiviral Research and Development
Emergent BioSolutions
About Speaker: Dr. Kelly Lyn Warfield received her college degree from Loyola University, Maryland and Ph.D. degree in molecular virology from Baylor College of Medicine in Houston, Texas studying immune responses, pathogenesis and adverse events related to rotavir... Read Full Bio 
 
 
Kelly  Warfield
Kelly Warfield
Senior Director, Antiviral Research and Development
Emergent BioSolutions
 
About Speaker:

Dr. Kelly Lyn Warfield received her college degree from Loyola University, Maryland and Ph.D. degree in molecular virology from Baylor College of Medicine in Houston, Texas studying immune responses, pathogenesis and adverse events related to rotavirus vaccination and infection. During a National Research Council postdoctoral fellowship at the USAMRIID, Dr. Warfield developed animal models, vaccines and therapeutics for filoviruses. Dr. Warfield co-founded the start-up company Integrated Biotherapeutics, Inc. and was the Vice President of Vaccine Development for 6 years with a focus on development of antivirals and vaccines for Ebola and Marburg viruses. Currently, she is the Senior Director of Antiviral Research at Emergent BioSolutions with responsibility for the development activities for broad-spectrum antiviral and antibacterial compounds.

 

 
Abstract: ...Read More 

Iminosugars are glucomimetics that target host α glucosidases I and II, enzymes that contribute to glycosylation and folding of proteins in the endoplasmic reticulum (ER). Blockade of host ER α glucosidase activity results in improperly glycosylated and misfolded viral envelope glycoproteins causing reduced virus production and infectivity.

The iminosugar UV-4B has in vitro activity against a diverse set of glycosylated, enveloped RNA and DNA viruses including dengue, influenza, Ebola, and vaccinia and promotes survival in lethal dengue and influenza mouse models. The antiviral activity of UV-4B against a variety of influenza viruses has been thoroughly characterized in immortalized MDCK cells, primary differentiated normal human bronchial epithelial cells, and mouse models.

An important benefit of host-targeted antivirals is reduced selection for resistant viruses since targeting a host enzyme does not expose the virus to direct selective pressure, but rather denies the virus a critical substrate for which there is no biochemical or viral gene-encoded alternative and minimizes selection of resistance. Serial passage of influenza viruses in the presence of UV-4B in mice did not cause emergence of drug-resistant viruses as characterized by efficacy studies and progeny viruses were deep sequenced to assess changes in the viral genomes.

UV-4B is currently in Phase 1 clinical trials where it has been found to be well-tolerated as single oral doses in healthy volunteers. Future clinical trials will determine whether targeting host ER α glucosidases with an iminosugar is a promising therapeutic approach for treatment of influenza infections.

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11:20
Microbiome Directed Therapeutics for Combating Antibiotic Resistant Organisms
 
Marina Santiago
Marina Santiago
Research Scientist & Infectious Disease Lead
Finch Therapeutics
About Speaker: Marina Santiago joined Finch Therapeutics in July 2016 to help drive Finch's programs targeting drug resistant infections. For the last 10 years, Dr. Santiago has worked on different aspects of antibiotic resistance, from natural product discovery an... Read Full Bio 
 
 
Marina Santiago
Marina Santiago
Research Scientist & Infectious Disease Lead
Finch Therapeutics
 
About Speaker:

Marina Santiago joined Finch Therapeutics in July 2016 to help drive Finch's programs targeting drug resistant infections. For the last 10 years, Dr. Santiago has worked on different aspects of antibiotic resistance, from natural product discovery and isolation, to developing genomics techniques for identifying new resistance factors. She received her BS in Molecular Biophysics and Biochemistry from Yale University, and her PhD in Chemical Biology at Harvard Medical School.

 
Abstract: The intact gut microbiome offers cons...Read More 

The intact gut microbiome offers considerable intrinsic colonization resistance against enteric antibiotic resistant bacteria (ARB). At Finch Therapeutics, we are leveraging these features to develop microbial therapeutics that eliminate ARB and re-establish colonization resistance without selecting for further resistance. Indeed, microbiome-directed therapies offer an alternative evolutionary paradigm to traditional antimicrobials, selecting against resistance carriage, rather than promoting resistance. Finch is developing both naturally derived products (FIN-403) and synthetic ecologies (FIN-721) to combat ARBs. FIN-403, our lead product candidate has 88% efficacy against recurrent C. difficile infections and is entering a Phase 2 randomized controlled trial in the second half of 2017. FIN-721 is a cocktail of cultured organisms under development to prevent VRE, CRE and ESBL infections by decolonizing high-risk carriers.

In this talk, you will learn about:
1. The principles behind microbiome-directed antimicrobials
2. Naturally derived product strategies
3. Synthetically designed product strategies
4. The competitive landscape in microbiome-based therapies

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11:45
Mechanism of Action of Small Molecule Inhibitors of the RSV Polymerase
 
Rachel Fearns
Rachel Fearns
Associate Professor, Microbiology
Boston University
About Speaker: Dr. Fearns obtained her Ph.D. at the University of St Andrews, UK and performed post-doctoral training at the National Institutes of Health, USA studying factors that affect respiratory syncytial virus (RSV) transcription and genome replication. As a... Read Full Bio 
 
 
Rachel Fearns
Rachel Fearns
Associate Professor, Microbiology
Boston University
 
About Speaker:

Dr. Fearns obtained her Ph.D. at the University of St Andrews, UK and performed post-doctoral training at the National Institutes of Health, USA studying factors that affect respiratory syncytial virus (RSV) transcription and genome replication. As a principal investigator, Dr. Fearns has worked to understand the molecular mechanisms by which the RSV polymerase functions, using a combination of cell-based and in vitro assays, and to determine the mechanisms of action of viral polymerase inhibitors.

 
Abstract: Respiratory syncytial virus (RSV) is ...Read More 

Respiratory syncytial virus (RSV) is the major cause of hospitalization of infants. It is also a significant cause of disease in the elderly and immunocompromised. As yet, there is no vaccine or effective antiviral treatment to control the virus. RSV has an RNA genome, which is transcribed to produce capped and polyadenylated mRNAs, and replicated to generate progeny genomes. RSV transcription and genome replication are performed by a multi-functional viral RNA dependent RNA polymerase, which has three enzymatic domains to catalyze RNA polymerization, cap addition and cap methylation. My group has developed cell-based and in vitro assays to monitor different aspects of transcription and replication. These have been used to investigate the mechanisms of action of small molecule inhibitors that target the RSV polymerase. In this presentation, I will present data for three small molecule inhibitors of the RSV polymerase, AZ-27, BI-D, and GS-5734, which have different mechanisms of inhibition. AZ-27 inhibits RNA synthesis initiation at the promoter, BI-D prevents the polymerase from recognizing an RNA release signal required for transcription, whereas the triphosphate form of GS-5734 is an unusual chain terminator. This presentation will provide information to convey the impact of RSV on public health, describe the current RSV inhibitor landscape, enable the audience to understand the processes the RSV polymerase performs, relate small molecule inhibition mechanisms to what is known regarding RSV polymerase structure and function, and showcase assays that are available for RSV polymerase study.

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11:45
Dengue Vaccine Development: What Have We Learned and Re-learned?
 
Stephen Thomas
Stephen Thomas
Chief, Division of Infectious Diseases
State University of New York, Upstate Medical University
About Speaker: Stephen J. Thomas, MD is an Infectious Diseases physician and Professor of Medicine who recently joined the State University of New York (SUNY) Upstate Medical University in Syracuse, NY. Prior to joining SUNY Upstate he retired as a Colonel (COL) in... Read Full Bio 
 
 
Stephen Thomas
Stephen Thomas
Chief, Division of Infectious Diseases
State University of New York, Upstate Medical University
 
About Speaker:

Stephen J. Thomas, MD is an Infectious Diseases physician and Professor of Medicine who recently joined the State University of New York (SUNY) Upstate Medical University in Syracuse, NY. Prior to joining SUNY Upstate he retired as a Colonel (COL) in the U.S. Army Medical Corps. Dr. Thomas’s last position in the Army was as the Deputy Commander for Operations (Chief Operating Officer) at the Walter Reed Army Institute of Research (2014-2016). During his military career Dr. Thomas spent more than 5 years living and working in Southeast Asia coordinating field and vaccine research. He spent much of his early career working on dengue and other arboviruses and recently has had key involvement in Ebola, MERS-CoV, and Zika vaccine development efforts. Dr. Thomas has authored and more than 74 manuscripts and 7 book chapters. He routinely speaks on infectious diseases and research and development issues at national and international scientific events and sits on expert scientific committees, working groups, and advisory boards for the Department of Defense, the U.S. NIH, non-governmental organizations, foreign nation regulatory agencies, and numerous pharmaceutical companies exploring issues related to infectious diseases. He earned his Bachelor of Arts with Honors in Biomedical Ethics from Brown University, his Medical Degree from the Albany Medical College, and completed his internship and residency in Internal Medicine and Infectious Diseases fellowship at the Walter Reed Army Medical Center. Dr. Thomas is board certified in both specialties, holds a certification in Tropical Medicine and Traveler’s Health from the America Society of Tropical Medicine and Hygiene (ASTMH), and is a Fellow in the American College of Physicians, Infectious Diseases Society of American, and the ASTMH.

 
Abstract: Dengue is a persistent and growing gl...Read More 

Dengue is a persistent and growing global public health problem and tropical and subtropical regions devote extensive resources trying to control dengue outbreaks and caring for those who develop dengue disease. Despite decades of exploration and experimentation the immunopathologic mechanisms of dengue disease remains incompletely understood. There are currently no licensed anti-viral prophylactic or therapeutic agents to prevent or treat dengue and after more than 70 years of development efforts a single dengue vaccine has been licensed in over 10 endemic countries. Unfortunately, the vaccine’s performance in phase 2b and 3 efficacy trials indicate it will not meet the needs of all populations potentially requiring protection from dengue. Two additional vaccines are in advanced clinical development in disease end-point trials and there are numerous other candidates in early clinical and pre-clinical development. As vaccine candidates advance and additional data is generated the conversations about what constitutes a protective immune profile for dengue becomes increasingly more complex and interesting. Durable, vaccine induced immunity and its association with enduring efficacy and/or risk of disease or severe disease is also extremely relevant in light of the tens of thousands of people being exposed to licensed and experimental dengue vaccines.     

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11:45
Arsanis, Inc. Targeted Monoclonal Antibody Immunotherapeutics for Infectious Diseases
 
Aaron  Pelta
Aaron Pelta
Vice President, Business Development & Commercial Strategy
Arsanis, Inc.
About Speaker: Aaron Pelta has been Vice President, Business Development & Commercial Strategy at Arsanis, Inc since 2016. Prior to Arsanis, Aaron served in a variety of Business Development and Commercial roles in over 10 years at Cubist Pharmaceuticals, Aaron... Read Full Bio 
 
 
Aaron  Pelta
Aaron Pelta
Vice President, Business Development & Commercial Strategy
Arsanis, Inc.
 
About Speaker:

Aaron Pelta has been Vice President, Business Development & Commercial Strategy at Arsanis, Inc since 2016. Prior to Arsanis, Aaron served in a variety of Business Development and Commercial roles in over 10 years at Cubist Pharmaceuticals, Aaron led the execution of several anti-infective deals during his time at Cubist, including the acquisitions of Optimer and Calixa. Aaron also worked in Business Development roles at Shire and AMAG.

 
Abstract: Arsanis, Inc. is a clinical-stage bio...Read More 

Arsanis, Inc. is a clinical-stage biopharmaceutical company developing targeted monoclonal antibodies (mAbs) for pre-emptive and post-infection treatment of serious infectious diseases. Our current monoclonal antibody programs address specific pathogens by selectively targeting their pathogenic processes, rather than broadly killing bacteria, potentially allowing Arsanis to combat critical infections without contributing to antibiotic resistance or damaging the patient’s microbiome. While mAbs have been successfully applied in many therapeutic areas, they have yet to be fully leveraged for acute bacterial infections, where they hold the potential to address critical unmet medical needs and to change the course of antibiotic resistance. Advances in our knowledge of bacterial pathogenesis have now opened new possibilities of expanding the use of mAbs to acute bacterial infections. Arsanis’ lead program, ASN100, is currently in a Phase 2 study for the prevention of S. aureus pneumonia in high-risk mechanically ventilated patients. Pipeline programs target MDR Gram-negative pathogens including E. coli and K. pneumoniae.

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12:10
Memory CD4 T Cell Regulation of Innate Lymphoid Cells During Protective Responses Against Influenza A Virus
 
Tara  Strutt
Tara Strutt
Assistant Professor
University of Central Florida
About Speaker: Tara Strutt, Ph.D. is an Assistant Professor in the Immunity and Pathogenesis Division of the Burnett School of Biomedical Sciences at the University of Central Florida. Her research is centered on understanding how the adaptive immune system con... Read Full Bio 
 
 
Tara  Strutt
Tara Strutt
Assistant Professor
University of Central Florida
 
About Speaker:

Tara Strutt, Ph.D. is an Assistant Professor in the Immunity and Pathogenesis Division of the Burnett School of Biomedical Sciences at the University of Central Florida. Her research is centered on understanding how the adaptive immune system controls innate inflammatory responses.

 
Abstract: The primary goal of vaccination is to...Read More 

The primary goal of vaccination is to protect individuals from the morbidity and mortality of pathogen exposure by generating immunological memory. Our current understanding is that memory CD4 T cells, commonly regarded as the regulators of memory cytotoxic CD8 T cells and/or antibody-producing B cells, provide protection by hastening pathogen clearance through ‘faster, bigger, and better’ immune responses. It is now clear, however, that many different subsets of CD4 T cells, many with specialized functions other than providing ‘help’, are generated during immune responses against pathogens. In studies designed to ascertain the full functional potential of memory CD4 T cells responding against influenza A virus (IAV), we found that virus induced TH1-like, as well as in vitro polarized TH1 or TH17 memory CD4 T cells, enhance early innate inflammatory responses that correlate with better and earlier control of IAV in infected lungs. In further studies, we found innate lymphoid cells (ILC), which are not normally associated with anti-viral responses but rather associated with healing and wound repair, are also mobilized by memory CD4 T cells during the early stage of the response against IAV. Unexpectedly, the protection afforded by memory CD4 T cells against lethal IAV challenge is significantly compromised when ILCs are depleted. These findings reveal a previously unappreciated beneficial role of memory CD4 T cells in regulating tissue homeostasis during recall responses against pathogens through the regulation of ILC subsets.

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12:10
Development of Efficacious Pertussis Vaccines
 
Rajendar Deora
Rajendar Deora
Assistant Professor, Microbiology & Immunology
Wake Forest School of Medicine
About Speaker: Dr. Deora received a M.Sc. degree in Biochemistry from the University of Calcutta. He graduated from the University of Illinois at Chicago in with a Ph.D. in Microbiology. Dr. Deora joined WFUHS as an Assistant professor in 2003 and was promoted to A... Read Full Bio 
 
 
Rajendar Deora
Rajendar Deora
Assistant Professor, Microbiology & Immunology
Wake Forest School of Medicine
 
About Speaker:

Dr. Deora received a M.Sc. degree in Biochemistry from the University of Calcutta. He graduated from the University of Illinois at Chicago in with a Ph.D. in Microbiology. Dr. Deora joined WFUHS as an Assistant professor in 2003 and was promoted to Associate Professor in 2010.
His areas of interest are: Virulence mechanisms of Bacterial pathogens; Molecular determinants of pathogenesis and Biofilm development; Host pathogen interactions, Effectiveness of small molecules on the colonization of and biofilm formation in the murine respiratory tract, Vaccine Development.

 
Abstract: Bordetella pertussis is a gr...Read More 

Bordetella pertussis is a gram negative bacterium that causes whooping cough or pertussis. Despite high vaccine coverage, the incidence of pertussis is increasing in the USA, Europe and other countries. The current acellular pertussis vaccines (aPV) are only partly effective, compared to the discontinued whole cell vaccines.  Although the mechanisms that have led to pertussis reemergence are likely multi-factorial, lower vaccine efficacy and poor short-lived vaccine-induced immunity are some explanations. All currently used aPVs are formulated with alum as the adjuvant, which induces primarily IgG1 antibody responses and Th2-type CD4+ T cells. We have identified an outer membrane protein, Bordetella Colonization Factor A (BcfA).  We show that BcfA has adjuvant activity and enhances antibody responses to protein antigens. BcfA elicits Th1/17 skewed pertussis-specific immune responses, and remodels the Th2-biased immune responses elicited by alum.  In an intranasal murine model of B. pertussis infection, addition of BcfA to the aPV reduces bacterial numbers in the respiratory tract. Our results suggest that this combination adjuvant platform is a good candidate for development for non-human primate and human clinical trials. Additionally, this adjuvant combination may be applicable to other diseases where Th1 type immunity is important for protection.

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12:10
DARPA’s Efforts to Address the Threat of Emerging Infectious Diseases
 
Matthew  Hepburn
Matthew Hepburn
Program Manager, Biological Technologies Office
DARPA
About Speaker: COL Matthew Hepburn, MC, USA joined DARPA as a program manager in 2013. He aims to address the dynamic threats of emerging infectious diseases with potential impact on national security. Prior to joining DARPA, COL Hepburn served as the Director of ... Read Full Bio 
 
 
Matthew  Hepburn
Matthew Hepburn
Program Manager, Biological Technologies Office
DARPA
 
About Speaker:

COL Matthew Hepburn, MC, USA joined DARPA as a program manager in 2013. He aims to address the dynamic threats of emerging infectious diseases with potential impact on national security.

Prior to joining DARPA, COL Hepburn served as the Director of Medical Preparedness on the White House National Security Staff. Additional previous assignments include: Chief Medical Officer at a Level II medical facility in Iraq, clinical research director at the US Army Medical Research Institute for Infectious Diseases, exchange officer to the United Kingdom and internal medicine chief of residents at Brooke Army Medical Center at Fort Sam Houston, Texas. 

COL Hepburn completed internal medicine residency and infectious diseases fellowship programs at Brooke Army Medical Center. He holds Doctor of Medicine and Bachelor of Science in biomedical engineering degrees from Duke University.

 
Abstract: DARPA’s mission is to create an...Read More 

DARPA’s mission is to create and prevent strategic technological surprise by funding the development of breakthrough technologies for national security. My portfolio of programs at DARPA addresses the threats that infectious diseases pose to national security, and my presentation will walk through examples of those programs, highlighting how we design ambitious goals that address capability gaps in infectious disease response. I intend to explain DARPA’s vision for connecting infectious disease forecasting, diagnostics, prognostics, and the development of effective interventions to realize a future in which highly capable platforms in these areas enable rapid and effective response to infectious disease threats.

Benefits:

-The audience will gain a better appreciation of how DARPA compliments overall U.S. Government approaches to addressing threats from infectious diseases.
-The audience will learn about promising technologies and platforms that exemplify progress in responding to outbreaks.

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12:35
Lunch on Your Own
12:35
Parallel Pathways for Generating Protective Lung-Resident Memory CD4 T Cells in the Lung
 
Kai  McKinstry
Kai McKinstry
Assistant Professor
University of Central Florida
About Speaker: Kai McKinstry received his PhD from the University of Saskatchewan (Canada) in 2005. He then undertook postdoctoral studies at the Trudeau Institute in the Adirondack Mountains of New York State focusing on understanding how memory T cells form an... Read Full Bio 
 
 
Kai  McKinstry
Kai McKinstry
Assistant Professor
University of Central Florida
 
About Speaker:
  1. Kai McKinstry received his PhD from the University of Saskatchewan (Canada) in 2005. He then undertook postdoctoral studies at the Trudeau Institute in the Adirondack Mountains of New York State focusing on understanding how memory T cells form and how their responses upon rechallenge differ from those of naïve T cells. Dr. McKinstry joined the Faculty of the Department of Pathology at the University of Massachusetts Medical School in 2005. Here he continued to research how protective memory T cells contribute to successful immune responses, and how specialized populations of memory T cells with different functions form. In 2015 Dr. McKinstry joined the Division of Immunity and Pathogenesis in the Burnett School of Biomedical Sciences at the University of Central Florida where his research is focused on understanding how memory T cells that reside at sites of infection are generated following infection and vaccination.
 
Abstract: ...Read More 

Studies in animal models and clinical observations point toward key roles for tissue-resident memory T cells (TRM) during protective recall responses against a variety of pathogens. TRM that persist at sites of infection may be especially important for clearing microbes that can mutate to avoid protective antibodies, such as influenza A virus (IAV). Here, we show that the formation of CD4+ TRM following IAV priming of mice can occur through both an interleukin-2-dependent, and an interleukin-2-independent, interleukin-15-dependent pathway. These subsets share a prototypical TRM phenotype and expression of a core gene signature that is common across several different TRM described at diverse tissue sites. The TRM are highly functional, and are better able to elicit innate inflammatory cytokine responses than are circulating memory CD4 T cells of the same specificity. Importantly, adoptive transfer of the TRM can protect otherwise naïve mice against a lethal challenge of IAV. These studies, highlight the potential for vaccine-induced CD4 TRM in contributing to viral clearance upon IAV challenge, and indicate that the generation of the subset is likely dependent on factors that are distinct from those that are needed to generate circulating CD4 T cell memory.

Benefits:
Attendees will gain insight into the heterogeneity of CD4 T cell memory populations.
Attendees will learn about the protective functions of memory CD4 T cells.
Attendees will learn about cytokine signals that control the memory fate of CD4 T cells.
Attendees will gain perspective on how vaccines that target local development of T cell memory can improve protection against viral pathogens.

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1:00
Lunch on Your Own
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Antiviral Drugs Research & Development 2017
Blood Borne Pathogens: New Frontiers in Research and Drug Development
Moderator: Tara Strutt, University of Central Florida
2:15
Allosteric HIV-1 Integrase Inhibitors
 
Mamuka Kvaratskhelia
Mamuka Kvaratskhelia
Professor
Ohio State University
About Speaker: Originally from the country of Georgia, Dr. Kvaratskhelia trained at Moscow State University, Russia; John Innes Center, England; University of Dundee, Scotland; and with Dr. Stuart Le Grice at Drug Resistance Program, NCI-Frederick, USA before start... Read Full Bio 
 
 
Mamuka Kvaratskhelia
Mamuka Kvaratskhelia
Professor
Ohio State University
 
About Speaker:

Originally from the country of Georgia, Dr. Kvaratskhelia trained at Moscow State University, Russia; John Innes Center, England; University of Dundee, Scotland; and with Dr. Stuart Le Grice at Drug Resistance Program, NCI-Frederick, USA before starting his own program at the Ohio State University. Through his PhD and postdoctoral years Dr. Kvaratskhelia has been trained as a biochemist with a strong emphasis on studying protein-protein and protein-nucleic acid interactions. Since the beginning of his independent research career at the Ohio State University in 2003, his primary research focus has been to better understand the structure and function of HIV-1 integrase as a therapeutic target. He has developed extensive expertise in understanding retroviral integrases: their catalytic role in the virus life cycle, integration site selection in host cell chromosomes, and interactions with cognate cellular cofactors such as LEDGF/p75 and BET proteins (Sharma et al, 2013, PNAS). Particularly noteworthy is the recent discovery of a novel, non-catalytic function of integrase in HIV-1 biology as it binds the viral RNA genome to promote virion morphogenesis (Kessl et al, 2016, Cell). Another major area of focus of Dr. Kvaratskhelia’s research is the development of allosteric integrase inhibitors (ALLINIs). Toward this goal, his research team and collaborators have made critical contributions by elucidating the mechanism of action of currently available ALLINIs (Jurado et al, 2013, PNAS; Sharma et al, 2014, PLoS Pathog.), which are now in clinical trials. His current efforts are focused on developing novel, improved ALLINIs with entirely new scaffolds for their potential clinical application in treating AIDS patients.

 
Abstract: Evolution of HIV-1 strains resistant ...Read More 

Evolution of HIV-1 strains resistant to current therapies is a major clinical problem in the fight against AIDS. Therefore, new inhibitors with alternative mechanisms of action are needed. Allosteric HIV-1 integrase (IN) inhibitors (ALLINIs) have recently emerged as a promising class of antiretroviral agents and are currently in clinical trials. Our research has focused on dissecting the mode of action of these inhibitors. ALLINIs target the clinically unexploited dimer interface of HIV-1 IN and exhibit dual function in vitro: impairing IN binding to its cellular cofactor LEDGF/p75 and promoting IN aggregation. Unexpectedly, in infected cells ALLINIs were significantly more potent during virion maturation rather than integration. These inhibitors induced hyper-multimerization of IN in virions and yielded eccentric, non-infectious virus particles, where the ribonucleoprotein complexes (RNPs) were mislocalized outside the protective capsid core. While the essential catalytic role of IN during HIV-1 integration into the human genome is well established, our findings have prompted us to investigate the non-catalytic function of IN during virion maturation. We have found that IN binds the viral RNA genome and ensures the correct localization of RNPs within protective capsid core. ALLINIs inhibited IN binding to the viral RNA genome in virions of wild type but not the escape mutant virus. Collectively, these findings have uncovered a non-catalytic function of IN during virion maturation and elucidated the mode of action of ALLINIs. Our current efforts are focused on developing improved ALLINIs with novel scaffolds using crystallographic screening of fragments which bind to the catalytic core domain of IN followed by a fragment expansion approach to obtain potent inhibitors. The ultimate goal of these studies is to develop clinically useful ALLINIs.

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Vaccines Research & Development 2017
Next-Generation Vaccine Technologies
Moderator: Ken Rosenthal, Roseman University of Health Sciences
2:15
Self-Amplifying mRNA Vaccines to Facilitate a Rapid Response
 
Jeffrey Ulmer
Jeffrey Ulmer
Head, Preclinical R&D US
GSK Vaccines
About Speaker: Dr. Jeffrey Ulmer received his B.Sc. with honors from the Department of Chemistry at the University of Regina in 1978 and was the recipient of the Merit Award of the Society of Chemical Industry of Canada. He received his Ph.D. in biochemistry from M... Read Full Bio 
 
 
Jeffrey Ulmer
Jeffrey Ulmer
Head, Preclinical R&D US
GSK Vaccines
 
About Speaker:

Dr. Jeffrey Ulmer received his B.Sc. with honors from the Department of Chemistry at the University of Regina in 1978 and was the recipient of the Merit Award of the Society of Chemical Industry of Canada. He received his Ph.D. in biochemistry from McGill University in 1985 and completed his postdoctoral training in the laboratory of Nobel laureate Dr. George Palade in the Department of Cell Biology at Yale University School of Medicine. At Merck Research Laboratories, Chiron Corporation and Novartis Vaccines he conducted seminal studies on nucleic acid vaccines and novel vaccine adjuvants/delivery systems. He has published over 200 scientific articles, is on the editorial boards of Expert Opinion on Biological Therapy, Human Vaccines, and Expert Review of Vaccines. He is currently Head, Preclinical R&D, GSK Vaccines.

 
Abstract: ...Read More 

Recent advancements have demonstrated that vaccines based on self-amplifying mRNA have the potential to combine the positive attributes of other types of vaccines without their limitations. Although the mRNA vaccine field is in its infancy, the prospects are promising. The broad utility and rapid response potential of this novel vaccine technology may enable a new generation of vaccines able to address the health challenges of the 21st century, including rapid responses to newly emerging infectious diseases. A key enabler of success will be efficient delivery of the synthetic RNA payload.

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2:15
Antibacterial Monoclonal Antibodies: A Strategy to Prevent Serious Bacterial Infections
 
Christine  Tkaczyk
Christine Tkaczyk
Senior Scientist, Infectious Diseases
MedImmune
About Speaker: Christine Tkaczyk is currently a Senior Scientist at Medimmune. She developed several programs to identify specific human monoclonal antibodies as alternative therapies against bacterial infections especially Staphylococcus aureus. She earned a PhD i... Read Full Bio 
 
 
Christine  Tkaczyk
Christine Tkaczyk
Senior Scientist, Infectious Diseases
MedImmune
 
About Speaker:

Christine Tkaczyk is currently a Senior Scientist at Medimmune. She developed several programs to identify specific human monoclonal antibodies as alternative therapies against bacterial infections especially Staphylococcus aureus. She earned a PhD in immunology from Pasteur Institute, Paris. She completed her postdoctoral training at the National Institutes of Health, NIAID.

 
Abstract: Broad-spectrum antibiotic therapy has...Read More 

Broad-spectrum antibiotic therapy has fueled the current antibiotic resistance epidemic. Taken together with the recent understanding of the adverse effects of antibiotic therapy on the healthy microbiome, alternative strategies to combat serious bacterial infections are being considered. Antibacterial monoclonal antibodies (mAbs) are one alternative currently under clinical evaluation. We have developed multiple platforms to generate human monoclonal antibodies (mAbs) against bacterial virulence factors that when combined with robust in vitro assays and multiple animal models allow for the selection of potent antibacterial mAbs. MEDI4893 is a human anti-Staphylococcus aureus alpha toxin (AT) mAb engineered for extended ½-life (> 80 days) currently in phase IIb clinical testing for the prevention of S. aureus pneumonia in ICU patients. AT is a secreted pore-forming toxin shown to play a key role in S. aureus pathogenesis by inducing tissue damage, tight junction cleavage and immune system dysfunction. MEDI4893 prophylaxis and adjunctive therapy with standard-of-care antibiotics reduced disease severity in preclinical skin soft tissue infection and lethal pneumonia models. MEDI4893 acts by preventing AT-mediated tissue damage and immune dysregulation. MEDI4893 prophylaxis also demonstrated efficacy in a S. aureus + Gram-negative mixed lung infection model by limiting outgrowth of the co-infecting Gram-negative pathogen and decreasing lethality, indicating a role for AT in S. aureus. Together, these results indicate MEDI4893 holds promise as an alternative therapy for the prevention of S. aureus pneumonia.

Benefits
• The antibiotic resistance epidemic demands alternative antibacterial approaches
• Technology advances have enabled the development of novel antibacterial mAbs
• Alpha-toxin neutralizing mAb MEDI4893 protects against S. aureus pneumonia in prophylaxis and in adjunctive therapy with standard-of-care antibiotics
• MEDI4893 may reduce infection in patients co-infected with S. aureus and drug-resistant Gram-negative bacteria

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2:40
SB 9200, a Potent and Selective Oral Immuno-Modulator, for the Treatment of Chronic Hepatitis B Infection
 
Kris Iyer
Kris Iyer
Co-Founder, Chief Scientific Officer
Spring Bank Pharmaceuticals
About Speaker: R. P. Iyer, (Kris) is the co-founder and Chief Scientific Officer of Spring Bank Pharmaceuticals. He has more than 25 years’ experience in drug discovery in diverse therapeutic areas including antivirals, inflammation and immune-oncology. Kris is a... Read Full Bio 
 
 
Kris Iyer
Kris Iyer
Co-Founder, Chief Scientific Officer
Spring Bank Pharmaceuticals
 
About Speaker:

R. P. Iyer, (Kris) is the co-founder and Chief Scientific Officer of Spring Bank Pharmaceuticals. He has more than 25 years’ experience in drug discovery in diverse therapeutic areas including antivirals, inflammation and immune-oncology. Kris is an innovator in the fields of nucleic acid chemistry, bioorganic chemistry and pharmaceutical sciences with over 100 publications and 150 issued and filed US and international patents. Prior to Spring Bank, Kris was the co-founder and VP of Discovery of Origenix Technologies.

 
Abstract: Background: Over 350...Read More 

Background: Over 350 million people worldwide are infected with chronic hepatitis B (CHB). While life-long therapy with direct-acting nucleoside and nucleotide antivirals (DAAs) can effectively suppress viral replication, development of resistance and toxicity to DAAs remain a significant problem. Therefore, new antiviral agents are needed that can potently suppress viral replication, clear viral antigens and cccDNA to achieve a “functional cure” in CHB.

CHB is associated with defects and/or inadequate immune response against the virus since viral proteins interfere with the functions of cellular innate immune viral sensors such as RIG-I, NOD2, and MDA5 thereby disabling the innate and adaptive immune responses. Immunomodulatory agents that can induce innate immune responses, suppress viral replication, and additionally shape the adaptive immune response are needed. The immunomodulatory agents, when combined with DAAs, can potentially result in a durable control of infection through development of HBV antibodies that could lead to a functional cure of CHB within a defined duration of treatment.

SB 9200, an oral immunomodulator, is a novel synthetic dinucleotide prodrug that activates cellular viral sensors RIG-I and NOD2 and restore the cellular production of IFNs, ISGs and antiviral cytokines.  SB 9200 is being currently evaluated in global 12-week Phase II clinical trials.

Preclinical studies: SB 9200 has demonstrated potent antiviral activity against wild type-, and resistant variants of HBV in HBV-infected Hep.G2 cells and primary human hepatocytes with suppression of HBV DNA (EC50, 0.2 mM) and reductions in HBsAg and HBeAg. In addition, SB 9200 showed synergistic antiviral activity when combined with Tenofovir, and Entecavir.

In the HBV transgenic mouse model, in dose-ranging studies, once-daily oral administration of SB 9200 for 14 days resulted in potent suppression of liver HBV DNA. In chronically WHV-infected woodchucks, oral administration of SB 9200 for 12 weeks at 15 and 30 mg/kg/day resulted in significant dose-dependent reductions in serum and hepatic levels of viral DNA, RNA, and surface antigens. In addition, induction of IFNs, ISG15, and OAS-1 along with hepatic expression of RIG-I and NOD2 was observed consistent with the activation of host-immune responses by SB 9200.  In a sequential dosing study in WHV-infected woodchucks, oral administration of SB 9200 at 30 mg/kg/day for 12 weeks, followed by 4 weeks of oral Entecavir at 0.5 mg/kg/day, resulted in an average 6.4 log10 decline in serum viral DNA and 3.3 log10 decline in WHsAg.  Overall, the pharmacodynamic studies have demonstrated that SB 9200 can induce potent antiviral effects via the activation of the host immune response.

Conclusion: Preclinical studies coupled with ADME and pharmacokinetic studies, as well as, IND-enabling safety pharmacology and toxicology studies in rats and cynomolgus monkeys have enabled the launch of Phase II clinical trials in CHB.

Acknowledgements: The preclinical studies of SB 9200 were supported through NIAID grants UO1 AI058270 and RO1 AI094469 (RPI, PI).

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2:40
Accelerated Development of a T-Cell Based Vaccine for Q Fever
 
Mark Poznansky
Mark Poznansky
Director, Vaccine and Immunotherapy Center
Massachusetts General Hospital
About Speaker: Dr. Mark C. Poznansky, MD, PhD. Director, Vaccine and Immunotherapy Center, Massachusetts General Hospital. Dr. Poznansky is Associate Professor of Medicine at Harvard Medical School and Attending Physician in Infectious Diseases Medicine and Dir... Read Full Bio 
 
 
Mark Poznansky
Mark Poznansky
Director, Vaccine and Immunotherapy Center
Massachusetts General Hospital
 
About Speaker:

Dr. Mark C. Poznansky, MD, PhD.
Director, Vaccine and Immunotherapy Center, Massachusetts General Hospital.

Dr. Poznansky is Associate Professor of Medicine at Harvard Medical School and Attending Physician in Infectious Diseases Medicine and Director of the Vaccine and Immunotherapy Center (VIC) at MGH. He is the discoverer of fugetaxis, the principle of immuno-repulsion that forms the basis of the company’s products. His laboratory defines molecular mechanisms for novel immune processes and explores the relevance of these mechanisms to novel approaches to vaccines and immunotherapies for cancer, infectious diseases and diabetes.

Dr. Poznansky obtained his B.Sc. and his MD at the University of Edinburgh in the United Kingdom and his PhD from the Department of Medical Sciences at Cambridge University. He also served as a Resident in Clinical Immunology at the Addenbrooke’s Hospital in Cambridge, UK and a Captain in the Royal Army Medical Corps. Following post-doctoral research training in retrovirology at Harvard Medical School and the Dana Farber Cancer Institute, Dr. Poznansky did further residency training at St. Mary’s Hospital, Imperial College, London.. He then returned to Harvard Medical School as a Clinical Fellow in the Infectious Diseases Fellowship Training Program, and has been progressively promoted to his current position. He has been awarded a prestigious MGH Research Scholar Award, and was recognized in 2015 by the MGH Cancer Center One Hundred event for his contributions to the development of novel immunotherapies and vaccines for cancer.

In the years following his faculty appointment, Dr. Poznansky has gained very well deserved recognition as a leader in the field of leukocyte migration and the modulation of leukocyte trafficking and function for the purposes of the development of novel vaccines and immunotherapies for infectious diseases, cancer and type 1 diabetes. He has also gained a particular recognition for establishing a new model for translational research that accelerates the process by which basic biological discoveries move towards products and technologies that improve patient care and treatment. His work on novel cancer vaccines and immunotherapies are predominantly focused on treating mesothelioma and ovarian cancer – two very difficult to treat diseases. Dr. Poznansky’s team at VIC is currently developing both a small molecule modulator of the immune system and a fusion protein for this purpose in close collaboration with clinical scientists and industry experts. Dr. Poznansky also chairs the Boston Immunotherapy Initiative which is a deeply collaborative consortium of doctors and scientists from across academia in Boston who set as their mission the accelerated execution of trials of new immunotherapies for cancer including mesothelioma.

 
Abstract: Q fever, a disease caused by the smal...Read More 

Q fever, a disease caused by the small Gram-negative organism Coxiella burnetii, is highly infectious; a single inhaled organism can result in acute and chronic disease in humans which can be severe. Q fever outbreaks have been documented in several countries including Australia and the Netherlands, and most recently has been of concern to the US Department of Defense because of high seroconversion rates detected among military personnel serving in Iraq. C. burnetii infection, when identified clinically and serologically, can be treated with antibiotics including tetracycline but a vaccine is considered to be critical to the control of this disease in occupational and biodefense settings. The Q-VAX vaccine (CSL), developed for human use to prevent C. burnetii infection, was applied in Australia with limited success. Q-VAX has a significant side effect profile and is well known to be highly reactogenic. This has precluded the broader use of Q-VAX. There is thus a clear need for a less reactogenic and potentially more efficacious vaccine for occupational and biodefense purposes. In view of the finding that although neutralizing antibodies play a role in the control of C burnetii infection, CD4+ T cell immunity plays a critical role in protective immunity against the pathogen we are pursuing a T-cell based Q fever vaccine candidate. Scientific and operational strategies for accelerated discovery and development of such a candidate will be discussed.

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2:40
Nontraditional Products in Development to Treat or Prevent Bacterial Infections: As the Conventional Antibiotics Pipeline Remains Thin, Finding New Approaches is Critical
 
Joe  Thomas
Joe Thomas
Associate, Antibiotic Resistance Project
The Pew Charitable Trusts
About Speaker: Joe Thomas is an associate on the Pew Charitable Trusts’ antibiotic resistance project. Joe works on research and polices to help spur the discovery and development of urgently needed antibiotics. Prior to Pew, he worked at the London School of Eco... Read Full Bio 
 
 
Joe  Thomas
Joe Thomas
Associate, Antibiotic Resistance Project
The Pew Charitable Trusts
 
About Speaker:

Joe Thomas is an associate on the Pew Charitable Trusts’ antibiotic resistance project. Joe works on research and polices to help spur the discovery and development of urgently needed antibiotics. Prior to Pew, he worked at the London School of Economics and Political Science (LSE) on identifying barriers to development in the market for rapid diagnostic devices for bacterial infections. He has bachelor’s degrees in biology and political science from the University of Pittsburgh and an MSc from the London School of Economics and Political Science.

 
Abstract: While antibiotic discovery and develo...Read More 

While antibiotic discovery and development remain essential to combating the growing threat of antibiotic resistance, “outside-the-box” approaches to preventing and treating bacterial infections are also needed. Such nontraditional approaches encompass a variety of products, from well-known medical interventions, such as vaccines and immunotherapies, to entirely new types of therapies that have never been approved for use in human medicine, such as virulence inhibitors or lysins. Nontraditional products are unlikely to fully substitute or replace antibiotic use but could provide new treatment options for patients through combined use with antibiotics or as a means of preventing an infection from taking hold. Today, there are very few of these types of products on the market for use in patients, and questions remain regarding how nontraditional products should be tested for safety and efficacy, and how they could be used appropriately in the clinical setting. To shed light on the development of these types of products and evaluate potential public policies to spur innovation, The Pew Charitable Trusts conducted an assessment of nontraditional products for the treatment of systemic bacterial infection that are currently in clinical development for the U.S. market. Currently, the pipeline shows that 32 nontraditional products are in clinical development, but few have reached advanced phases of clinical testing. Harnessing the promise of “outside-the-box” approaches requires focused attention from a broad range of stakeholders, including scientists, clinicians, funders, and regulators to validate new technologies and establish guidelines for how to demonstrate the safety and efficacy of nontraditional products.

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3:05
Galidesivir, a Broad-Spectrum Adenosine Analog Direct-Acting Antiviral Drug, Abrogates Viremia in Rhesus Macaques Challenged with Zika Virus
 
James  Whitney
James Whitney
Assistant Professor
Beth Israel Deaconess Medical Center; Harvard University
About Speaker: Dr. James B. Whitney received his Ph.D. in Virology from McGill University in Montreal, Canada. He did his post-doctoral training at The Beth Israel Deaconess Medical Center and Harvard Medical School where he studied viral transmission and evolution... Read Full Bio 
 
 
James  Whitney
James Whitney
Assistant Professor
Beth Israel Deaconess Medical Center; Harvard University
 
About Speaker:

Dr. James B. Whitney received his Ph.D. in Virology from McGill University in Montreal, Canada. He did his post-doctoral training at The Beth Israel Deaconess Medical Center and Harvard Medical School where he studied viral transmission and evolutionary dynamics in the setting of T cell vaccination. He is the Principal Investigator of the Viral Dynamics laboratory at the Center for Virology and Vaccine Research at the BIDMC.

His laboratory focuses on viral dynamics, emerging viral diseases and eradication strategies for the the HIV-1/SIV viral reservoir. In collaboration with Industry partners, he is evaluating a number of pre-clinical therapeutic modalities to reduce the HIV-1 reservoir burden and impact Zika infection.

 
Abstract: BACKGROUND- Zika virus (ZIKV) was fir...Read More 

BACKGROUND- Zika virus (ZIKV) was first isolated from a sentinel rhesus monkey in 1947. ZIKV infection in humans is associated with serious neurological complications. Guillain-Barré syndrome and pediatric microcephaly have been reported to overlap with ZIKV endemicity in South America. No antivirals or protective vaccines are available. Galidesivir (BCX4430) an adenosine analogue is a potent viral RNA-dependent RNA polymerase inhibitor with demonstrated broad-spectrum antiviral activity.

METHODS- We have conducted a pre-clinical study in rhesus monkeys to assess the safety and efficacy of Galidesivir against ZIKV infection. Fifteen animals were subcutaneously challenged with 1×105 TCID50 of a Puerto Rican ZIKV isolate. Animals were distributed into 3 groups (n=5/group). Ninety minutes after challenge, group 1 received intramuscular (I.M.) doses of 100 mg/kg BCX4430 BID on Day 0 followed by 25mg/kg BID for 9 additional days. Group 2 received only 100 mg/kg BCX4430 IM BID on Day 0. Group 3 received vehicle only. We followed multiple endpoints, including ZIKV RNA levels in plasma, urine, saliva, and cerebrospinal fluid. Immune activation, complete blood counts, chemistries and BCX4430 pharmacokinetics were also monitored longitudinally throughout the study.

RESULTS- Galidesivir administration was well-tolerated. All control animals developed high-level viremia by day 2 post infection. Monkeys in group 1 did not develop any detectable plasma viremia. Monkeys in group 2 were partially protected; two animals from this group had detectable plasma ZIKV RNA, but the onset was delayed and magnitude reduced compared to controls. All control monkeys (group 3) had readily detectable ZIKV RNA in CSF, saliva and urine. Animals in groups 2 and 3, had sporadically detectable ZIKV in CSF, urine and saliva and viral shedding was markedly reduced compared to controls. ZIKV infection elicited immune responses in BCX4430-treated monkeys; these were diminished compared to controls.

CONCLUSIONS- Galidesivir dosing in rhesus monkeys was well-tolerated and offered significant protection against ZIKV challenge. These results warrant further study. Experiments on dose optimization and potential therapeutic regimens are planned.

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3:05
Development of Novel C Type Lectin Receptor Agonists as TH17-Inducing Adjuvants for Next Generation TB Vaccines
 
Alyson Smith
Alyson Smith
Assistant Research Professor; Director, Immunology
University of Montana; Inimmune Corp
About Speaker: Alyson Smith is an Assistant Research Professor at the University of Montana in the Division of Biological Sciences and also the Director of Immunology at the biotech startup Inimmune. She completed her PhD in molecular pharmacology at the Mayo Clini... Read Full Bio 
 
 
Alyson Smith
Alyson Smith
Assistant Research Professor; Director, Immunology
University of Montana; Inimmune Corp
 
About Speaker:

Alyson Smith is an Assistant Research Professor at the University of Montana in the Division of Biological Sciences and also the Director of Immunology at the biotech startup Inimmune. She completed her PhD in molecular pharmacology at the Mayo Clinic in Rochester MN. She went to do post doctoral fellowships at both Mayo Clinic and GlaxoSmithKline Vaccines where she worked on understanding the structure-function relationships and mechanism of action of several classes of innate stimulating agonists.

 
Abstract: Mycobacterium tuberculosis (Mtb), the...Read More 

Mycobacterium tuberculosis (Mtb), the causative pathogen of tuberculosis (TB), is a global pathogenic threat that is one of the leading causes of death among adults. Multi-drug resistant and extensively drug resistant TB is an emerging threat shown to be spreading as a result of transmission and as such could benefit greatly from the development of a new, effective vaccine. Mtb is structurally composed of many immunostimulatory elements, chief among them are a family of trehalose 6,6’-dimycolate (TDM) compounds. It has recently been shown that these cell wall lipids act to stimulate the immune system through engagement of the innate, C type lectin receptor Mincle. Because of their potent immune stimulating properties these compounds have recently come into focus as potential vaccine adjuvants, especially for many fungal and bacterial pathogens. However, naturally-derived TDM has proven to be too toxic for use in vaccines – inducing over-reactive immune responses. Therefore, we have been developing unique synthetic derivatives of this natural molecule with matched immunostimulatory activity but diminished toxicity. We created a library of synthetic trehalose-based compounds with varying structures and assessed their ability to modulate innate immunity in human and mouse immune cells. We optimized the acyl chain configuration for maximal immune stimulation in human cells and discovered divergent structure-activity-relationships between murine and human responses. We also assessed the ability of the variant compounds to induce a TH17-favorable cytokine profile from primary human cells, as vaccine-induced Th17 cells have recently been demonstrated to improve Mtb control in animal models. Finally, initial in vivo studies with aqueous formulations of the optimal in vitro determined compound demonstrated good TH17 activity and will be assessed further for their ability to boost immunity to a TB antigen. Our data demonstrates the species and structure-specific activity of our novel compounds and clearly highlights the necessity of multispecies structure-activity evaluation for potential therapeutic molecules even at the earliest stages of investigation. As well this study demonstrates the clear potential for Mincle agonist compounds for use as vaccine adjuvants.

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Anti-Infectives Partnering & Deal-Making 2017
Economic Drivers Moving Drug Development Forward
Moderator: David McAdams, Duke Fuqua School of Business
3:05
Economic Incentive Considerations for Development of Anti-Infectives
 
Kimberly Sciarretta
Kimberly Sciarretta
Interdisciplinary Scientist/Project Officer
BARDA, HHS
About Speaker: Kimberly Sciarretta is a Project Officer with the Anti-Infectives Program the in the Division of CBRN Countermeasures at the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and ... Read Full Bio 
 
 
Kimberly Sciarretta
Kimberly Sciarretta
Interdisciplinary Scientist/Project Officer
BARDA, HHS
 
About Speaker:

Kimberly Sciarretta is a Project Officer with the Anti-Infectives Program the in the Division of CBRN Countermeasures at the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Dr. Sciarretta joined BARDA in February 2015 as an Interdisciplinary Scientist and is a Project Officer for several therapeutic medical countermeasure programs. Prior to BARDA, Dr. Sciarretta consulted as a subject matter expert to several Federal Agencies.

 
Abstract: Development of medical countermeasure...Read More 

Development of medical countermeasures (MCM) for emerging infectious diseases (EID) and of anti-bacterials have unique and different economic challenges. Pharmaceutical companies entering MCM development for EIDs often have to balance internal business priorities with that of an urgent response to the EID. In addition, there is uncertainty around future market potential, sufficient return on investment, as well as potential challenges with regulatory development paths. Similarly, there had been a persistent decline in pharmaceutical companies developing anti-bacterials mainly due to limited commercial return. In the last two years, there has been a significant push from industry and external organizations to explore potential economic incentive models that could help invigorate future investment in anti-bacterials. Likewise, the US government response to recent outbreaks of EIDs including MERS, Ebola and Zika, has sparked exploration of potential economic models for consideration that could be used to strengthen pharmaceutical company investment for EIDs.

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3:30
RNAi in HBV, the Next Backbone Therapy for Use in Combinations?
 
Bruce Given
Bruce Given
COO, Head of R&D
Arrowhead Pharmaceuticals
About Speaker: Dr. Given has served as COO of Arrowhead Pharmaceuticals since 2011. Dr. Given retired as Chairman of the Board for ICON, plc in 2013 and served as President and Chief Executive Officer and as a member of the Board of Directors of Encysive Pharmaceut... Read Full Bio 
 
 
Bruce Given
Bruce Given
COO, Head of R&D
Arrowhead Pharmaceuticals
 
About Speaker:

Dr. Given has served as COO of Arrowhead Pharmaceuticals since 2011. Dr. Given retired as Chairman of the Board for ICON, plc in 2013 and served as President and Chief Executive Officer and as a member of the Board of Directors of Encysive Pharmaceuticals. Prior to joining Encysive, he was with Johnson & Johnson for 9 years, serving in several capacities including as President, International, Ortho-Clinical Diagnostics and as Head of U.S. Marketing & Sales and Research & Development for Janssen Pharmaceutica. Prior to entering the pharmaceutical industry, he was on the medical faculty at the University of Chicago. Dr. Given received his M.D. degree with honors from the University of Chicago, Pritzker School of Medicine and completed his medical training at the University of Chicago and at Brigham and Women’s Hospital, where he was Clinical Fellow at Harvard Medical School.

 
Abstract: With the breakthroughs in curative th...Read More 

With the breakthroughs in curative therapies for Hepatitis C, attention has now turned to Hepatitis B (HBV). Chronic HBV infects 250-400 million patients globally and accounts for as many as 1 million deaths annually due to hepatic failure or HCC. Current therapies, principally nucleot(s)ide inhibitors (NUCs), control the virus but rarely lead to functional cure (HBsAg loss), which is the aim of next generation therapies. In the last few years RNA interference (RNAi) has emerged as a likely candidate to join NUCs as core members in combination therapy studies aimed at restoring the host immune system leading to functional cure. This presentation will discuss the mechanism of action for RNAi drugs, discuss their effects in the clinic and explain why they are likely to be commonly used in emerging combination therapies.

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3:30
Translating Biodefense Responsiveness to Cancer Immuno Oncolgy-Vaccines on Demand
 
Annie  De Groot
Annie De Groot
Founder, CEO & CSO
Epivax, Inc.
About Speaker: Annie De Groot is a Smith College graduate and medical doctor trained at the University of Chicago Pritzker School of Medicine. She trained in Internal Medicine and Infectious Disease at New England Medical Center and was a research fellow at the Nat... Read Full Bio 
 
 
Annie  De Groot
Annie De Groot
Founder, CEO & CSO
Epivax, Inc.
 
About Speaker:

Annie De Groot is a Smith College graduate and medical doctor trained at the University of Chicago Pritzker School of Medicine. She trained in Internal Medicine and Infectious Disease at New England Medical Center and was a research fellow at the National Institutes of Health from 1986 to 1989. De Groot joined the faculty at Brown University in 1993, where she began to develop the cutting edge computational vaccine design tools for which she is well known.

De Groot is the co-founder and CEO/CSO of Epivax, Inc., a leading company in the field of immunoinformatics, working with a wide range of global clients and partners to improve the design of vaccines and biologics and improving human health everywhere. EpiVax will celebrate its 20th anniversary in 2018. De Groot also serves as director of the University of Rhode Island's Institute for Immunology and Informatics and was awarded $13M in funding from the NIH to develop "iCubed" as a center of excellence in computational vaccinology. She is the author more than 190 peer-reviewed publications in the fields of computational vaccinology, biodefense, personalized vaccines, and immunology.

De Groot is the founder and volunteer medical director of Clinica Esperanza/Hope Clinic, which provides free medical care and preventive health services to adults living in Rhode Island who do not have health insurance. She is also the founder and scientific director of the GAIA Vaccine Foundation, a non-profit organization that works to improve the health of children and families in West Africa. She has won numerous awards, including the Smith Medal in 2013, was recognized as one of the 50 most influential people in vaccinology in 2014, and named Biotech CEO of the Year at the 2016 Vaccine Industry Excellence (ViE) Awards.

 
Abstract: ...Read More 

Tumor-specific mutations discovered using whole-exomic sequencing of tumor-normal pairs can be harnessed to identify neo-epitopes capable of stimulating T cell-mediated processes leading to tumor regression. Neo-epitope prediction using computational tools rapidly identifies epitope candidates in the mutanome, but a large proportion of neo-epitopes is not immunogenic. One explanation is that some epitopes, particularly class II major histocompatibility complex (MHC) epitopes, activate regulatory T cells (Tregs) trained in the thymus on self-antigens, which reduces anti-tumor activity. To address this pitfall, we designed the JanusMatrix algorithm to identify tumor-specific sequences capable of Treg activation by parsing candidate sequences into MHC-facing and T cell receptor (TCR)-facing sequences. As epitopes with shared TCR-faces can cross-react with the same T cells, cancer epitopes that share TCR-faces with multiple human sequences may cross-react with thymic-derived Tregs and are thus counter-indicated for immunotherapy. Retrospective analysis of non-small lung cell cancer neo-epitopes showed up to ~30% of neo-epitopes in a single patient exceed the cutoff for significant TCR-face homology with human proteins. Based on prior validation of Treg activating epitope predictions in infectious disease studies, we expect application of JanusMatrix to the neo-epitope discovery pipeline will focus candidate selection on high-value sequences. Neo-epitopes with low Treg activation potential may then be used to support development of personalized therapies including vaccination and in vitro expansion of tumor infiltrating lymphocytes for adoptive cell transfer.

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3:30
Antimicrobial Development: Narrowing the ROI Gap
 
Adam  Woodrow
Adam Woodrow
Vice President & Chief Commercial Officer
Paratek
About Speaker: Adam Woodrow joined Paratek in October 2014 to lead the commercialization of Paratek’s product portfolio. Adam previously worked for Pfizer for five years in various strategic and operational commercial roles. While at Pfizer, Adam led the commerci... Read Full Bio 
 
 
Adam  Woodrow
Adam Woodrow
Vice President & Chief Commercial Officer
Paratek
 
About Speaker:

Adam Woodrow joined Paratek in October 2014 to lead the commercialization of Paratek’s product portfolio. Adam previously worked for Pfizer for five years in various strategic and operational commercial roles. While at Pfizer, Adam led the commercial development group in Pfizer's Specialty Care Business Unit, launching Xeljanz® for Rheumatoid Arthritis and Vyndaqel® for the treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP). In addition, Adam led the global strategic marketing teams for a variety of products in fields ranging from rare disease to acute hospital based infections; major products included Enbrel®, Zyvox®, ReFacto® and Benefix®. Adam joined Pfizer from Wyeth Pharmaceuticals, where he was Vice President and Global Business Manager for Enbrel leading all commercial aspects of Wyeth's inflammation portfolio, co-promotion, licensing, and product development. In his 10 years at Wyeth, Adam held senior marketing and sales positions in the US and in his native UK. During his career in the pharmaceutical industry, Adam has worked with several non-profit societies and organizations. Adam has a Bachelor of Science degree in Industrial Chemistry from the University of Wales College of Cardiff.

 
Abstract: On September 15th 2003 at ...Read More 

On September 15th 2003 at the 43rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy a packed audience of antimicrobial researchers, drug industry representatives and government officials attended a key scientific session entitled “Why is big pharma getting out of anti-infective drug discovery?” Members of the faculty outlined the challenges for antimicrobial developers at that time and voiced their concerns for the future of antimicrobial development and where this might lead in terms of our ability to treat infectious diseases.

Since that presentation almost every prediction, no matter how pessimistic has come true. We have witnessed the exodus of most major and mid-size pharma companies from antimicrobial drug development and with this we have also seen the slowest rates of new antimicrobial development on record. This is at a time when we are facing common infections even from the community that can be caused by pathogens resistant to almost every known treatment option.

Meanwhile a small but persistent group of Biotech’s who foresaw this likely outcome have continued their mission to bring forward new innovative therapies. This is despite the unfavorable investment environment and a challenging market place facing companies that are successful in bringing new solutions to market.

In this session, we will look at the key drivers and barriers for antimicrobial drug development and specifically discuss the economic incentives that exist today and how they affect investment activity. In addition, we will explore new policy-based economic incentives to continue to spur antimicrobial drug development and examine their likely success should they become a reality.

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3:55
Afternoon Networking Break
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4:25
The Woodchuck and Its Application in the Development of New Therapeutics Against Hepatitis B Virus
 
Stephan Menne
Stephan Menne
Associate Professor, Microbiology & Immunology
Georgetown University
About Speaker: Stephan Menne received his Ph.D. in Virology and Immunology at the University of Duisburg-Essen in Germany, where his research concentrated on the immunopathogenesis of hepatitis B virus (HBV) using woodchucks and woodchuck hepatitis virus as a surro... Read Full Bio 
 
 
Stephan Menne
Stephan Menne
Associate Professor, Microbiology & Immunology
Georgetown University
 
About Speaker:

Stephan Menne received his Ph.D. in Virology and Immunology at the University of Duisburg-Essen in Germany, where his research concentrated on the immunopathogenesis of hepatitis B virus (HBV) using woodchucks and woodchuck hepatitis virus as a surrogate animal model. He completed a postdoctoral fellowship at Cornell University (Ithaca, NY) and was appointed thereafter to Assistant Professor. During that time he extended his studies and became involved in the testing of the safety, efficacy and innate and adaptive immune responses mediated by experimental drugs against HBV in woodchucks. Following his appointment to Associate Professor at Georgetown University Medical Center (Washington, DC) in 2010, he is now responsible for the testing of new HBV therapeutics in woodchucks that is funded by the Division of Microbiology and Infectious Diseases (DMID) of NIAID/NIH. This program is attempting to improve the treatment of chronic HBV infection and associated liver diseases, and is accessible to pharmaceutical companies and academic groups. His research is further funded by R01 grants and research agreements/contracts with pharmaceutical companies. He has published 55 peer-reviewed papers, 4 book chapters, and numerous conference abstracts.

 
Abstract: An estimated 250 million people are c...Read More 

An estimated 250 million people are chronically infected with hepatitis B virus (HBV), and over one million people die each year due to HBV-associated liver diseases, including liver injury, cirrhosis and hepatocellular carcinoma (HCC). Current therapeutics for chronic HBV infection involve nucleos(t)ide analogs, but their use is limited due to the emergence of drug resistant variants during treatment, the risk of relapse upon treatment discontinuation, and unwanted side effects. Clearance of HBV surface antigen (HBsAg) and seroconversion to antibodies against HBsAg are rare events and only achieved in less than 10% of treated patients. Since HBV persistence is thought to be the result of an insufficient or functionally impaired immune response, interferon-alpha is also licensed for therapy of HBV, but the systemic administration is limited because of unwanted side effects and variability in treatment response. However, 25-30% of patients treated with interferon, alone or in combination with nucleos(t)ide analogs, achieve a sustained antiviral response, including the loss of HBsAg. Therefore, one main goal of current HBV therapy is to develop new therapeutics that can mimic the benefits of interferon, but induce suppression of HBV replication, clearance of HBsAg, and seroconversion in more than one-third of treated patients.

The Eastern woodchuck (Marmota monax) is naturally infected with the woodchuck hepatitis virus (WHV), a hepadnavirus closely related to human HBV. Neonatal WHV infection parallels the main route of human (vertical) transmission for chronic HBV infection and displays a disease course similar to that in HBV-infected patients. Thus, chronic WHV infection in woodchucks is a fully immunocompetent model for the preclinical evaluation of safety and antiviral efficacy of new anti-HBV compounds. Recent development of new immunotherapeutic strategies in this animal model will be presented, including: 1) SB 9200 (Spring Bank Pharmaceuticals), a dinucleotide that activates the viral sensor proteins RIG-I and NOD2; 2), AIC649 (Anti-Infective Cures), an immunostimulant based on inactivated parapoxvirus ovis virus particles; and 3) JVRS-100 (Juvaris BioTherapeutics), an immunostimulant based on cationic liposome-DNA complexes.

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4:25
A CMV Vaccine Based on Non-Replicating Lymphocytic Choriomeningitis Virus Vectors Expressing gB and pp65 is Safe and Immunogenic in Man
 
Anders Lilja
Anders Lilja
VP Technical Development
Hookipa Biotech
About Speaker: Dr. Anders Lilja is the VP of Technical Development at Hookipa Biotech AG and is responsible for developing promising product candidates from research to manufacturing. He led the preclinical characterization and manufacturing of Hookipa’s cytomega... Read Full Bio 
 
 
Anders Lilja
Anders Lilja
VP Technical Development
Hookipa Biotech
 
About Speaker:

Dr. Anders Lilja is the VP of Technical Development at Hookipa Biotech AG and is responsible for developing promising product candidates from research to manufacturing. He led the preclinical characterization and manufacturing of Hookipa’s cytomegalovirus vaccine candidate HB-101. Prior to joining Hookipa, he was a Research Investigator and Associate Research Project Leader at Novartis Vaccines. Dr. Lilja holds an MSc in chemical engineering from Chalmers University of Technology (Sweden), a PhD in biochemistry from University of Maryland, and did postdoctoral training in molecular virology at Princeton University. He has co-authored several publications characterizing key cytomegalovirus vaccine antigens.

 
Abstract: HB-101 is a CMV vaccine candidate bas...Read More 

HB-101 is a CMV vaccine candidate based on non-replicating lymphocytic choriomeningitis virus vectors expressing two human CMV antigens, the tegument protein pp65 and a truncated isoform of the fusion protein gB. The safety and immunogenicity of HB-101 were evaluated in a randomized, placebo-controlled, double-blind phase I dose-escalating trial (NCT02798692). Three cohorts of 18 subjects per cohort were enrolled. In each cohort, 14 subjects received the vaccine and four received placebo. Vaccine and placebo were administered on day 0, month 1, and month 3. Safety and reactogenicity data were collected and reviewed by an independent data and safety monitoring board. Immunogenicity readouts included humoral and cellular responses against gB, cellular responses against pp65, as well as humoral and cellular responses against the LCMV vector backbone. Overall, HB-101 was safe and elicited potent immune responses. Comprehensive, unblinded safety and immunogenicity data through month 4 of the study will be presented.

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Anti-Infectives Partnering & Deal-Making 2017
Regulatory Considerations for Drug Development
Moderator: Mark Goldberger, Mark Goldberger MD MPH LLC
4:25
Anti-Infective Development: New Tools - A Better Result?
 
Mark  Goldberger
Mark Goldberger
Independent Consultant
Mark Goldberger MD MPH LLC
About Speaker: Dr. Goldberger received his MD degree from the Columbia University College of Physicians and Surgeons in New York and his MPH from George Washington University in Washington, DC. He completed his postgraduate training at the Presbyterian Hospital in ... Read Full Bio 
 
 
Mark  Goldberger
Mark Goldberger
Independent Consultant
Mark Goldberger MD MPH LLC
 
About Speaker:

Dr. Goldberger received his MD degree from the Columbia University College of Physicians and Surgeons in New York and his MPH from George Washington University in Washington, DC. He completed his postgraduate training at the Presbyterian Hospital in New York and the Centers for Disease Control (CDC) in Atlanta. He is board certified in internal medicine and infectious disease and is a fellow of the Infectious Diseases Society of America. Dr. Goldberger was on the faculty of Columbia University for nine years.

Dr. Goldberger joined the Food and Drug Administration in 1989. At FDA he served as primary reviewer, medical team leader, Director of the Division of Special Pathogen and Immunologic Drug Products and Director of the Office of Antimicrobial Products within the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA). In addition to these positions he coordinated drug shortage activities within the CDER from 1990 - 2006. Dr. Goldberger also was the FDA lead in an assessment of the readiness of the Pharmaceutical Industry for Y2K. In 2000 he spent 8 months as acting Associate Center Director for Quality Assurance in CDER during which time he developed the concept of the Regulatory Briefing. In 2003-2004 he was Acting Deputy Center Director of CDER. In 2006 he became Medical Director for Emerging and Pandemic Threat Preparedness within the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration.

In October 2007 he joined Abbott as Divisional Vice President – Regulatory Policy and Intelligence. In this role he was involved in multiple areas of both product and policy development. He continued in this position when AbbVie separated from Abbott until May 2013 when he became VP Regulatory Affairs and Senior Advisor. In this position he provided regulatory and scientific input both into multiple development programs and in the preparation of marketing applications. In September 2014 he retired from AbbVie and opened his own consulting practice as Mark Goldberger MD MPH LLC.

While at Abbott and AbbVie he participated in PhRMA and efpia working groups on antibiotic resistance and twice presented on this subject to the European Medicines Agency as well as to the FDA. As a member of the FDA Alumni Association he has participated in several training sessions for staff from CDE/CFDA as well as for CDE/TFDA. He has presented multiple times at DIA China as well as at APEC 2012 and 2016 in Taiwan.

 
Abstract: In the last few years legislative inc...Read More 

In the last few years legislative incentives such as Qualified Infectious Disease Product Designation and the 21st Century Cures Act have become available to provide a range of tangible and potential benefits to expedite development. Equally important are the initiatives the FDA has undertaken through public meetings and guidance to provide more detail on approaches to expediting development and in some cases the contributions of third parties. All of these include both paths forward and potential caveats. In my talk I will review these recent initiatives and activities and highlight how the benefits and sticking points of this current environment can impact success.

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4:50
Modified Dendrimer Based Antiviral Inhibits Zika Virus Replication: Implications for Therapy
 
Donald Alcendor
Donald Alcendor
Associate Professor
Meharry Medical College
About Speaker: Donald Alcendor, PhD is an Associate Professor at Meharry Medical College and an Adjunct Associate Professor at Vanderbilt University Medical Center. Dr. Alcendor completed his graduate studies at University of California, Davis in Molecular Virology... Read Full Bio 
 
 
Donald Alcendor
Donald Alcendor
Associate Professor
Meharry Medical College
 
About Speaker:

Donald Alcendor, PhD is an Associate Professor at Meharry Medical College and an Adjunct Associate Professor at Vanderbilt University Medical Center. Dr. Alcendor completed his graduate studies at University of California, Davis in Molecular Virology.  He completed his post-graduate studies at the NIH and Johns Hopkins University, in Baltimore Maryland in departments of Molecular Virology and Viral Oncology respectively.  Dr. Alcendor is the first to investigate the infectivity of human retinal pericytes for HCMV and their potential role in viral dissemination in the inner blood retinal barrier (IBRB) and the concomitant implications for CMV-associated ocular disease. Dr. Alcendor’s lab utilizes a tri-cell culture model system of the neurovascular unit (NVU) within the IBRB developed with primary human cells that are separately cultivated in a single source medium and infected with low passaged clinical isolates of HCMV from newborns at low multiplicities of infection to mimic human physiological conditions. He finds that retinal pericytes within the IBRB are most permissive for HCMV infection when compared retinal endothelial cells and Müller cells and are involved in the production of proinflammatory and angiogenic cytokines.

There are similarities between Zika virus and Cytomegalovirus ocular pathology.  Dr. Alcendor has recently expanded his studies to develop a pathogenic model and therapeutic intervention for Zika virus induced ocular disease.  DWK-M1 is a novel antiviral that can effectively inhibit Zika virus replication and suppress Zika virus induced inflammation in vitro. DWK-M1 is a non-toxic compound, stable at room temperature that can penetrate target cells.  DWK-M1 has unique features of a therapeutic antiviral for ZIKV associated ocular disease. Currently there is no specific treatment or vaccine for Zika virus infection.  This addresses an urgent unmet medical need for efficacious therapeutics for Zika virus.

 
Abstract: Waldemar Popik, Atanu Khatua and D...Read More 

Waldemar Popik, Atanu Khatua and Donald J. Alcendor

 BACKGROUND: Zika virus (ZIKV) infection has been associated with a sporadic increase in the incidence of Guillain-Barré syndrome and microcephaly in infants.  Currently there is no treatment or vaccine for ZIKV infection.  Here we explore the use of dendrimer based technology targeting the nucleotide translation initiation complex site of ZIKV for antiviral development.

METHODS: The modified dendrimer DWK1 targeting the nucleotide translation initiation complex site of ZIKV was used in an infectivity assay at 10 uM for inhibition of ZIKV replication.   Inhibition of ZIKV infectivity in human glomerular podocytes treated with DWK1 was analyzed by quantitative real time polymerase chain reaction (qRT-PCR), western blot analysis, immunofluorescence, and fluorescent focus assay (FFA). We also examined proinflammatory cytokines induced in ZIKV infected podocytes pretreated with DWK1 treatment.

RESULTS: We show a 1438-fold or 99.9% reduction in ZIKV transcription by qRT-PCR in human glomerular podocytes and human retinal endothelial cells (REC) after a 24 h pretreatment with 10uM of DWK1 followed by 72h exposure to ZIKV in the absence of DWK1.  In addition, we demonstrate by immunoblot analysis a complete suppression of ZIKV protein expression in infected podocytes treated with DWK1. We also show highly reduced levels of ZIKV proteins expressed in infected podocytes treated with DWK-1 by immunofluorescence and fluorescent focus assays.  We observed a suppression of ZIKV induced proinflammatory cytokines namely RANTES (regulated on activation, normal T cell expressed and secreted), TNF-α (tumor necrosis factor-α), MIP-1α (macrophage inflammatory protein 1 alpha), and INFβ (interferon beta) in podocytes pre-treated with DWK1, compared to controls.

CONCLUSIONS: This study shows that the ZIKV specific modified dendrimer DWK1 is a novel antiviral that can effectively inhibit ZIKV replication and suppress ZIKV induced inflammation profile in vitro. DWK1 is a non-toxic compound, stable at room temperature that can penetrate target cells.  DWK1 has unique features of a potential therapeutic antiviral for ZIKV.

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4:50
Nano-Vaccine Delivery Platform for Personalized Cancer Vaccination
 
James Moon
James Moon
Assistant Professor, Biomedical Engineering; Co-Founder & Chief Science Officer
University of Michigan; EVOQ Therapeutics
About Speaker: Dr. James Moon is John Gideon Searle Assistant Professor in the Department of Pharmaceutical Sciences and Biomedical Engineering at the University of Michigan, Ann Arbor. Dr. Moon is also a co-founder and Chief Science Officer of EVOQ Therapeutics th... Read Full Bio 
 
 
James Moon
James Moon
Assistant Professor, Biomedical Engineering; Co-Founder & Chief Science Officer
University of Michigan; EVOQ Therapeutics
 
About Speaker:

Dr. James Moon is John Gideon Searle Assistant Professor in the Department of Pharmaceutical Sciences and Biomedical Engineering at the University of Michigan, Ann Arbor. Dr. Moon is also a co-founder and Chief Science Officer of EVOQ Therapeutics that works on cancer vaccine technologies. Dr. Moon’s translational research program aims to develop novel engineering tools for improving vaccines and immunotherapies. He has received numerous awards, including 2016 National Science Foundation CAREER Award, 2016 DOD-CDMRP Career Development Award, 2015 Melanoma Research Alliance Young Investigator Award, the 2012 NIAID Research Scholar Development Award, and the 2011 IEEE-EMBS Harvard Wyss Institute Award for Translational Research. Dr. Moon received his bachelor’s degree from the University of California, Berkeley, and his Ph.D. from Rice University, and he completed his postdoctoral training at MIT (HHMI).

 
Abstract: Recent innovations in DNA/RNA sequenc...Read More 

Recent innovations in DNA/RNA sequencing have allowed for the identification of patient-specific tumor neo-antigens, ushering in the new era of personalized cancer vaccines. Peptide vaccines in general may serve as an ideal platform for neo-antigen vaccines, but the therapeutic efficacy of peptide vaccines have been limited in clinical trials. Here we present an alternative strategy where preformed nanocarriers, with an established clinical manufacturing procedure and excellent safety profiles in humans, are readily formulated with adjuvants and antigen peptides, including neo-antigens, to produce personalized cancer vaccines. We show that lipid-based nanodiscs can efficiently co-deliver antigen and immunostimulatory molecules to draining lymph nodes and elicit potent CD8+ cytotoxic T lymphocyte responses directed against tumor antigens, leading to substantially enhanced anti-tumor efficacy in multiple murine tumor models. Owning to the facile production process, robust therapeutic efficacy, and good safety profiles, our novel nano-vaccine technology offers a powerful and convenient platform for patient-tailored cancer vaccination.

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4:50
Panel: Funding & Partnering with US Government Agencies
Mark Albrecht
Mark Albrecht
Project Officer, Anti-Bacterials Branch
BARDA, HHS
 
Mark Albrecht
Mark Albrecht
Project Officer, Anti-Bacterials Branch
BARDA, HHS
 
About Speaker:

Mark Albrecht, PhD joined the Biomedical Advanced Research and Development Authority (BARDA) in March 2012. As a BARDA project officer within the Anti-Bacterials Branch, he works across the PHEMCE to strengthen inter-agency collaborations, coordinate efforts to advance the development of bio-defense medical countermeasures, and ensure that agency portfolios are properly aligned. Dr. Albrecht leads multiple interdisciplinary teams focused on supporting the day-to-day advanced development and regulatory activities necessary to gain marketing approval of medical countermeasures addressing our nation’s bio-defense and public health needs. Prior to his arrival at BARDA, Dr. Albrecht was a Senior Staff Scientist at the Biological Defense Research Directorate (BDRD) within the Naval Medical Research Center (NMRC) were he was responsible for leading the Navy’s programs on passive immune-therapy against anthrax and the development of multi-valent/agent vaccination strategies against Bacillus anthracis and Yersinia pestis based on recombinant proteins and DNA. He also supported the Navy’s and DARPA’s Seven-Day Burkholderia Biodefense Research Program. In his roles at BARDA and BDRD Dr. Albrecht has facilitated and maintained numerous public-private partnerships between industry and Government organizations. Dr. Albrecht received his B.A. in Biology from the Whitman College, Walla Walla, WA. He went on to the University of California Riverside where he received his PhD in Microbiology while studying the properties of sensitivity and resistance of Pseudomonas aeruginosa and B. cepacia to antimicrobial peptides and the role of alginate lyase during P. aeruginosa biofilm formation.

Tina  Guina
Tina Guina
Program Officer, Division of Microbiology and Infectious Diseases
NIAID, NIH
 
Tina  Guina
Tina Guina
Program Officer, Division of Microbiology and Infectious Diseases
NIAID, NIH
 
About Speaker:

Tina Guina, PhD
Program Officer, Drug Development Section, Office of Biodefense, Research Resources and Translational Research
NIAID, NIH

Tina Guina manages a portfolio of contracts for development of new anti-infective therapeutics, and collaborates with other federal agencies within the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) on policy and response strategies to biodefense and other infectious disease emergencies. She is a principal investigator of interagency Working Group for qualification of animal model of pneumonic tularemia as a Drug Development Tool.

Dr. Guina has twenty-five years of experience in infectious disease research, and nine years of experience in development of vaccines, therapeutics and animal models. Prior to joining NIAID in 2012, Dr. Guina worked in biotech industry on development of vaccines for tuberculosis, anthrax and influenza, with focus on product development and regulatory strategies. During her academic appointment at the University of Washington in Seattle in 2002-2008, she led research studies that characterized bacterial virulence factors and regulatory networks using state-of the art systems biology approaches. Dr. Guina holds a PhD in molecular biology and biochemistry from Wesleyan University and BSc in molecular biology from University of Zagreb, Croatia.

Gregory  Davenport
Gregory Davenport
Vice President
The Conafay Group
 
Gregory  Davenport
Gregory Davenport
Vice President
The Conafay Group
 
About Speaker:

Gregory J. Davenport, Ph.D. is a VP with The Conafay Group (TCG) - professional services firm that assists life sciences companies and organizations in securing federal non-dilutive funding, congressional and agency relationship building, alliance development and policy lobbying. At TCG, Greg assist various clients with partnering and securing funding from organizations such as HHS, BARDA and the Department of Defense.

Greg has over 22 years of experience in medical product development and government contracting. Prior to TCG, Greg held various C-Level executive positions with both private biotech and publically traded life science companies where he secured more than $350 million in government funding.

Greg earned a B.S. from Dillard University in New Orleans, received his Ph.D. in molecular biology from Howard University, and performed post-doctoral studies at the University of Maryland Medical Center and George Washington University Medical Center. Greg currently serves on the board of LouisianaBio (LA state affiliate of Biotechnology Industry Association); on the advisory board of the Mount Saint Mary’s University Biotechnology and Management Program; and serves on the advisory council for the Mount Opportunities for Success in Science (MOSS), a National Science Foundation S-STEM funded program.

Tyler Merkeley
Tyler Merkeley
Program Manager, CARB-X
BARDA, HHS
 
Tyler Merkeley
Tyler Merkeley
Program Manager, CARB-X
BARDA, HHS
 
About Speaker:

Tyler Merkeley MS, MBA, PMP, is the co-founder of CARB-X and serves as the Biomedical Advanced Research and Development Authority’s (BARDA) CARB-X Program Manager. He joined BARDA in 2009 as a Health Scientist to accelerate the advanced research and development, procurement, stockpile and sustainment of medical countermeasures (MCM) against biological, chemical, radiological, and nuclear (CBRN) agents under Project BioShield.  During his tenure at BARDA he has led the smallpox antiviral procurement, BARDA’s Total Life Cycle Costs containment initiative, designed and launched HHS’s Combating Antibiotic Resistant Bacteria (CARB) Accelerator [CARB-X], managed BARDA’s 1st agreement using Other Transaction Authority (OTA) and served as the Acting Chief of Staff for BARDA.

Michael  Pucci
Michael Pucci
Executive Director, Early Drug Discovery
Spero Therapeutics
 
Michael  Pucci
Michael Pucci
Executive Director, Early Drug Discovery
Spero Therapeutics
 
About Speaker:

Michael J. Pucci, PhD, is Executive Director, Early Drug Discovery, at Spero Therapeutics in Cambridge, MA. He has more than 28 years of experience in antibacterial drug discovery and has previously held positions at Achillion Pharmaceuticals, Bristol-Myers Squibb Co., and in R&D at Microlife Technics/Unilever. At BMS, he worked on several cephalosporin projects providing penicillin-binding protein (PBP) binding data analyses for candidate compounds and leading one program through pre-clinical development. He also was involved with identifying novel antibacterial targets and developing high-throughput screens to identify inhibitors while leading the initial bacterial genomics effort at BMS.  At Achillion, he led novel topoisomerase inhibitor programs as well as a collaborative carbapenem project. Dr. Pucci is co-founder and currently employed at Spero Therapeutics, a biotech company whose goal is to develop novel therapies to treat antibiotic-resistant bacterial infections. He is a member of the American Society for Microbiology and serves on the Editorial Boards of Antimicrobial Agents and Chemotherapy, Microbial Drug Resistance, and the Annals of the New York Academy of Sciences. He has participated in numerous NIH review panels including the Drug Discovery and Resistance (DDR) Study Section. He is an author on more than 80 publications and 17 patents. Dr. Pucci received his B.S. in Biology from the University of Connecticut, his Ph.D. in Microbiology from Temple University, and had post-doctoral training at Virginia Commonwealth University.

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5:15
Networking Reception & Poster Session
5:15
Networking Reception & Poster Session
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5:40
Networking Reception & Poster Session
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Day 2 - Friday, July 14, 2017
 
7:15
Breakfast with Mentors
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8:30
Development of RNA Aptamers as Targeted Therapeutics for HIV-1 and Metastatic Cancers
 
John  Burnett
John Burnett
Assistant Professor, Molecular and Cellular Biology, Beckman Research Institute
City of Hope
About Speaker: John Burnett, Ph.D., is Assistant Professor in Molecular and Cellular Biology at Beckman Research Institute of City of Hope. The Burnett lab is focused on developing gene- and RNA-based therapies for human diseases.  Our recent work includes the dev... Read Full Bio 
 
 
John  Burnett
John Burnett
Assistant Professor, Molecular and Cellular Biology, Beckman Research Institute
City of Hope
 
About Speaker:

John Burnett, Ph.D., is Assistant Professor in Molecular and Cellular Biology at Beckman Research Institute of City of Hope. The Burnett lab is focused on developing gene- and RNA-based therapies for human diseases.  Our recent work includes the development of RNA aptamers as targeted therapeutics and diagnostics for HIV and cancer.  The lab also specializes in genome editing strategies for generating HIV-resistant immune cells.  Dr. Burnett received his doctoral degree in Chemical and Biomolecular Engineering from the University of California, Berkeley, where he was co-advised by Profs. David Schaffer and Adam Arkin.  He first joined the City of Hope as a postdoctoral fellow in Dr. John Rossi’s laboratory.

 
Abstract: Aptamers are single-stranded oligonuc...Read More 

Aptamers are single-stranded oligonucleotides that recognize and bind to target ligands (e.g., proteins) with high specificity and affinity, comparable to antibody:antigen interactions. The unique binding properties of aptamers result from their ability to assume stable three-dimensional conformations that facilitate stable interactions with a target. Additional properties, such as their small size and low immunogenicity, make aptamers potentially useful as imaging diagnostics and therapeutics for multiple human diseases. Our lab is interested in developing aptamers as diagnostics and therapeutics for cancer by selecting for aptamers that bind specifically to extracellular cancer biomarkers. Currently, we are focusing on the development of aptamers against G-protein-coupled receptors (GPCRs) that are aberrantly expressed in tumor growth and metastasis or required for HIV-1 infection, including several chemokine receptors. This presentation will describe our efforts to improve the existing selection methodology for aptamer selection against GPCRs and the potential applications of these aptamers as therapeutic delivery agents and diagnostics for metastatic cancers and HIV-1.

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8:30
Enhancing the Effector CD8 T Cell Response to Influenza: Effect of IL-2/IL-6 can be Reproduced by TLR3/TLR4 Agonists
 
Janet  McElhaney
Janet McElhaney
VP Research and Scientific Director
Health Sciences North Research Institute
About Speaker: Janet E. McElhaney, MD, FRCPC, FACP, is HSN Volunteer Association Chair in Healthy Aging, VP Research and Scientific Director, Health Sciences North Research Institute, and Professor, Northern Ontario School of Medicine. Her “Vaccine Initiati... Read Full Bio 
 
 
Janet  McElhaney
Janet McElhaney
VP Research and Scientific Director
Health Sciences North Research Institute
 
About Speaker:

Janet E. McElhaney, MD, FRCPC, FACP, is HSN Volunteer Association Chair in Healthy Aging, VP Research and Scientific Director, Health Sciences North Research Institute, and Professor, Northern Ontario School of Medicine.

Her “Vaccine Initiative to Add Life to Years” (VITALiTY), is an interdisciplinary approach using measures of frailty to reflect overall health status and risk factors for catastrophic disability; developing biomarkers of protection against influenza and herpes zoster and exploring the contribution of “inflammaging” in designing new vaccines for improved protection in older adults.

The overall goal is to promote healthy aging through vaccination and to address the challenges of multiple chronic conditions particularly in rural and remote communities in Canada, including Indigenous people and their communities.

 
Abstract: An age-related decline in cytolytic a...Read More 

An age-related decline in cytolytic activity has been described in CD8+ T cells, we have previously shown that the poor CD8+ effector T cell responses to influenza A/H3N2 challenge result from a decline in the proportion and function of these cytolytic T lymphocytes (CTL). We find that addition of exogenous IL-2 and IL-6 to influenza-stimulated PBMCs from older adults, enhances the generation of CTL by increasing the cell proliferative response and reducing the proportion of apoptotic effector CD8+ T cells to levels resembling those of younger adults. The combined effect of adding exogenous IL-2 and IL-6 results in greater differentiation into effector T cells including influenza M1 tetramer +ve T cells. Further, this effect of IL-2 and IL-6 can also be produced with the addition MPLA (TLR4 agonist) and poly I:C (TLR 3 agonist). These results suggest a mechanism that could be exploited to improve influenza vaccine efficacy in older adults by combining existing vaccines with adjuvants to more effectively stimulate IL-2 and IL-6 responses to vaccination. 

Benefits of presentation are the attendee will understand:
1. How the immune system weakens of with age
2. Interaction between persistent CMV infection and decline in CD8 T cell function
3. How age-related changes in CD8 T cells can be reversed
4. Targets for new influenza vaccine development and related correlates of protection.

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8:55
Developing Novel and Effective Immune Adjuvants for Early Life
 
Naveen Surendran
Naveen Surendran
Research Scientist II
Rochester General Hospital Research Institute
About Speaker: Dr. Surendran’s research focuses on the human innate immune regulation of adaptive immunity against neonatal and pediatric infectious diseases. His doctorate was in Immunology and Microbiology with a specific focus on dendritic cell (DC) biology an... Read Full Bio 
 
 
Naveen Surendran
Naveen Surendran
Research Scientist II
Rochester General Hospital Research Institute
 
About Speaker:

Dr. Surendran’s research focuses on the human innate immune regulation of adaptive immunity against neonatal and pediatric infectious diseases. His doctorate was in Immunology and Microbiology with a specific focus on dendritic cell (DC) biology and vaccine development. During his post-doctoral fellowship at the Institute of Human Virology, University of Maryland he studied the three way interactions between dendritic cells, natural killer cells and γδ- T cells and DC mediated T-follicular helper cell generation and its critical role in inducing long term B cell memory responses. As a Research Scientist at RGHRI, Dr. Surendran is studying innate immunity and responses to vaccines in newborns and infants. Early immunization is required to protect infants but is limited by the immaturity of the immune system. In the short-term Dr. Surendran’s goal is to devise novel methods to safely improve the efficacy of poorly immunogenic vaccines by use of better adjuvants or TLR agonist combinations and in the long-term he focuses on delineating the basic mechanisms of innate regulation of adaptive immunity in neonates/infants to develop new vaccines against infectious diseases that lack (ex. RSV) effective vaccines. Dr. Surendran seeks to elucidate the exact nature of signals required to induce neonatal/infant APCs to effectively stimulate adaptive B and T cell responses.

 
Abstract: Early life is characterized by high s...Read More 

Early life is characterized by high susceptibility to infectious diseases. Nearly half of all neonatal and young infant (<6 months of age) deaths are due to vaccine preventable acute bacterial and viral diseases. However, vaccine mediated prevention of infections is limited due to immune adaptations in early life to maintain the balance between tolerance and pro-inflammatory responses. Neonatal immunity is Th2 biased. Many of the early life intracellular bacterial and viral pathogens require strong Th1 response for protecting neonates against infections. We recently identified a population of infants (6-12months old) as Low Vaccine Responders (LVR) who fail to respond or respond with suboptimal immunity to >50% of routine pediatric vaccines containing alum adjuvant that favor Th2 responses. This underlines the need to safely increase the immunogenicity of early life vaccines with novel adjuvants. It is increasingly clear that neonates are competent to generate fully mature adaptive immune responses as seen with BCG and whole cell pertussis vaccines. Over the last decade there is a tremendous interest in developing novel TLR agonists and adjuvants that induce Th1 response in neonates. Our work using cord blood show that robust APC costimulatory responses and Th1 polarizing IL12p70 and IFN-γ responses can be generated when stimulated with TLR agonist combinations that contain TLR7/8 agonist-R848. Using chemically detoxified pertussis toxoid as a model antigen we show that novel adjuvant combinations that elicit robust antibody and Th1 responses in neonates can be developed.

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8:30
Panel: Pushing and Pulling- What Incentives Help Spark Innovation in Antibiotic Drug Discovery and Development?
Kimberly Sciarretta
Kimberly Sciarretta
Interdisciplinary Scientist/Project Officer
BARDA, HHS
 
Kimberly Sciarretta
Kimberly Sciarretta
Interdisciplinary Scientist/Project Officer
BARDA, HHS
 
About Speaker:

Kimberly Sciarretta is a Project Officer with the Anti-Infectives Program the in the Division of CBRN Countermeasures at the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Dr. Sciarretta joined BARDA in February 2015 as an Interdisciplinary Scientist and is a Project Officer for several therapeutic medical countermeasure programs. Prior to BARDA, Dr. Sciarretta consulted as a subject matter expert to several Federal Agencies.

Danielle Peters
Danielle Peters
President
Magnet Strategy Group
 
Danielle Peters
Danielle Peters
President
Magnet Strategy Group
 
About Speaker:

Danielle Peters is President of Magnet Strategy Group, a public affairs consulting firm operating in the United States and Canada. Magnet maintains an extensive roster of specialized consultants and partners in both countries, to provide clients with a customized public affairs team focused on achieving results.

Prior to founding Magnet Strategy Group, Dani held senior roles with public affairs firms in Washington, D.C. and Ottawa, Ontario, concentrating on fields that include innovation, healthcare and life sciences. Over the past decade, Dani has worked closely with industry, not-for-profit and government on advocacy, public policy and funding strategies in the health sector. In addition to operating Magnet Strategy Group, Dani serves on the Industry Advisory Board for Bloom Burton & Co., a healthcare investment advisory firm in Toronto, Canada.

Gregory  Frank
Gregory Frank
Director, Infectious Disease Policy, Health Policy
Biotechnology Innovation Organization (BIO)
 
Gregory  Frank
Gregory Frank
Director, Infectious Disease Policy, Health Policy
Biotechnology Innovation Organization (BIO)
 
About Speaker:

Greg comes from a research background of viral immunology, where he trained at the University of Pittsburgh and pursued his postdoctoral training at the National Institutes of Allergy & Infectious Diseases (NIAID). Greg began his science policy career first at the Federation of American Societies for Experimental Biology (FASEB) before joining the Infectious Diseases Society of America (IDSA), where he lead science and diagnostic policy. Greg joined the Biotechnology Innovation Organization (BIO) in 2016 where he leads several infectious diseases policy issues, including antimicrobial resistance.

Jeffrey Stein
Jeffrey Stein
President and Chief Executive Officer
Cidara Therapeutics
 
Jeffrey Stein
Jeffrey Stein
President and Chief Executive Officer
Cidara Therapeutics
 
About Speaker:

Jeffrey Stein, Ph.D., has been the President and Chief Executive Officer of Cidara Therapeutics since 2014. Prior to joining Cidara, Dr. Stein was Chief Executive Officer of Trius Therapeutics from its founding in 2007 until its acquisition by Cubist Pharmaceuticals in September of 2013. Dr. Stein was also the founding Chairman and President of the Antibiotics Working Group. Previously, Dr. Stein was a Venture Partner and Kauffman Fellow with Sofinnova Ventures and opened the firm's San Diego office in 2005. Prior to joining Sofinnova, Dr. Stein was co-founder and Chief Scientific Officer of Quorex Pharmaceuticals which was acquired by Pfizer Pharmaceuticals in 2005. He has also served as a Principal Scientist with Diversa Corporation and the Agouron Institute. Dr. Stein conducted his postdoctoral research as an Alexander Hollaender Distinguished Postdoctoral Fellow at the California Institute of Technology and his graduate work as a NASA Graduate Student Researcher Fellow at UCSD.

David  McAdams
David McAdams
Professor, Business Administration & Economics
Duke Fuqua School of Business
 
David  McAdams
David McAdams
Professor, Business Administration & Economics
Duke Fuqua School of Business
 
About Speaker:

David McAdams is Professor of Business Administration at the Fuqua School of Business, Duke University. He is also Professor of Economics in the Economics Department at Duke. He earned a B.S. in Applied Mathematics at Harvard University, an M.S. in Statistics from Stanford University, and a Ph.D. in Business from the Stanford Graduate School of Business. Before joining the faculty at Duke, he was Associate Professor of Applied Economics at the MIT Sloan School of Management.

Professor McAdams' primary research interests are microeconomic theory and game theory. His work has been published in leading economics journals, on a range of topics including auctions, pricing, negotiations, and relationships. His most recent work develops the economic theory of infectious-disease diagnosis and management, with implications for antibiotic resistance and investment.

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9:20
Panel: New Approaches to Antiviral Development
Sreerupa Challa
Sreerupa Challa
Principal Scientist
Spring Bank Pharmaceuticals, Inc
 
Sreerupa Challa
Sreerupa Challa
Principal Scientist
Spring Bank Pharmaceuticals, Inc
 
About Speaker:

I am a team-orientated scientist with substantial experience in integrating inter-disciplinary knowledge to help advance drug development programs. My professional goals include a strong commitment to drug development through my diverse scientific background that includes oncology, immunology, immune signaling, molecular biology, virology and biochemistry. My experience spans from in vitro assays to in vivo modeling to support small molecule and biologic drug discovery development. Currently, I am a Principal Scientist at Spring Bank Pharmaceuticals successfully contributing to the progress of Anti-viral, Oncology and Inflammation programs at all stages. 

Donald Alcendor
Donald Alcendor
Associate Professor
Meharry Medical College
 
Donald Alcendor
Donald Alcendor
Associate Professor
Meharry Medical College
 
About Speaker:

Donald Alcendor, PhD is an Associate Professor at Meharry Medical College and an Adjunct Associate Professor at Vanderbilt University Medical Center. Dr. Alcendor completed his graduate studies at University of California, Davis in Molecular Virology.  He completed his post-graduate studies at the NIH and Johns Hopkins University, in Baltimore Maryland in departments of Molecular Virology and Viral Oncology respectively.  Dr. Alcendor is the first to investigate the infectivity of human retinal pericytes for HCMV and their potential role in viral dissemination in the inner blood retinal barrier (IBRB) and the concomitant implications for CMV-associated ocular disease. Dr. Alcendor’s lab utilizes a tri-cell culture model system of the neurovascular unit (NVU) within the IBRB developed with primary human cells that are separately cultivated in a single source medium and infected with low passaged clinical isolates of HCMV from newborns at low multiplicities of infection to mimic human physiological conditions. He finds that retinal pericytes within the IBRB are most permissive for HCMV infection when compared retinal endothelial cells and Müller cells and are involved in the production of proinflammatory and angiogenic cytokines.

There are similarities between Zika virus and Cytomegalovirus ocular pathology.  Dr. Alcendor has recently expanded his studies to develop a pathogenic model and therapeutic intervention for Zika virus induced ocular disease.  DWK-M1 is a novel antiviral that can effectively inhibit Zika virus replication and suppress Zika virus induced inflammation in vitro. DWK-M1 is a non-toxic compound, stable at room temperature that can penetrate target cells.  DWK-M1 has unique features of a therapeutic antiviral for ZIKV associated ocular disease. Currently there is no specific treatment or vaccine for Zika virus infection.  This addresses an urgent unmet medical need for efficacious therapeutics for Zika virus.

John  Burnett
John Burnett
Assistant Professor, Molecular and Cellular Biology, Beckman Research Institute
City of Hope
 
John  Burnett
John Burnett
Assistant Professor, Molecular and Cellular Biology, Beckman Research Institute
City of Hope
 
About Speaker:

John Burnett, Ph.D., is Assistant Professor in Molecular and Cellular Biology at Beckman Research Institute of City of Hope. The Burnett lab is focused on developing gene- and RNA-based therapies for human diseases.  Our recent work includes the development of RNA aptamers as targeted therapeutics and diagnostics for HIV and cancer.  The lab also specializes in genome editing strategies for generating HIV-resistant immune cells.  Dr. Burnett received his doctoral degree in Chemical and Biomolecular Engineering from the University of California, Berkeley, where he was co-advised by Profs. David Schaffer and Adam Arkin.  He first joined the City of Hope as a postdoctoral fellow in Dr. John Rossi’s laboratory.

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9:20
Panel: Clinical Trial Design during Epidemics
Robert  Walker
Robert Walker
Director, Division of Clinical Development
BARDA, HHS
 
Robert  Walker
Robert Walker
Director, Division of Clinical Development
BARDA, HHS
 
About Speaker:

Dr. Walker is the (Acting) Chief Medical Officer and Director of the Division of Clinical Development (DCD) in the Biomedical Advancement Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). The DCD manages the Clinical Studies Network and is responsible for oversight of the coordination, execution, and analysis of interventional clinical studies funded by BARDA. Dr. Walker joined BARDA in 2014, and oversees a diverse portfolio of projects. Prior to joining BARDA, Dr. Walker was chief medical officer at Nuron Biotech, vice president of clinical development at Aeras, and vice president of clinical development and medical and scientific affairs at MedImmune, Inc. Before working in biotech, Dr. Walker was a clinical investigator at the National Institute of Allergy and Infectious Diseases and an attending physician in Critical Care Medicine at the National Institutes of Health. 

Cheryl  Keech
Cheryl Keech
Executive Medical Director, Global Product Development
Pharmaceutical Product Development
 
Cheryl  Keech
Cheryl Keech
Executive Medical Director, Global Product Development
Pharmaceutical Product Development
 
About Speaker:

Dr. Keech is the Executive Medical Director for Infectious Diseases in the PPD Global Product Development group. Prior to working with PPD, Dr. Keech worked at PATH from 2012-2015. While at PATH, Dr. Keech served as global director of clinical and regulatory for the division of vaccine access and delivery (2015-2016) and global clinical lead for pneumococcal, influenza and respiratory syncytial virus programs (2012-2015). In her role as global director, she was responsible for the oversight of post licensure trials (PASS, phase IIIb/IV and real world effectiveness), disease surveillance activities, label extensions, pharmacovigilance, WHO prequalification submissions, health technology assessment, and risk evaluations and mitigation strategies. Dr. Keech also served as the Director/clinical lead for the Meningitis A Vaccine and clinical lead for the RTS,S Malaria Vaccine Initiative. Responsibilities of a clinical lead include establishing/optimizing the clinical development plan, trial design and protocol development, Trial execution, data analysis and reporting. During her time at PATH she was focused on programmes for Meningitis A, Malaria, Japanese Encephalitis, Pertussis, Rotavirus, Pneumoccoccus, RSV and influenza. Prior to PATH, Dr. Cheryl was the Sr. Director for R&D and Medical Affairs, GSK Australia Vaccine Unit, responsible for the oversight of phase I-IV trials (pediatric, adult and travelers) which included 16 licensed products and 6 products in various stages of development within the Australian Affliate. She has gained experience across the global (southeast Asia, Africa, EU, USA, Australia), across the phases of R&D (I-IV) and across all levels of World Bank defined country income (high, middle, low).  She has knowledge of national regulatory needs, global endorsement/recommendation processes (WHO prequalification, GAVCS recommendation) and the value proposition requirements for commercialization of new vaccine candidates (including national tendering and Minister of Health endorsement).  

Matthew Memoli
Matthew Memoli
Director, LID Clinical Studies Unit, Viral Pathogenesis and Evolution Section, Laboratory of Infectious Diseases
NIAID, NIH
 
Matthew Memoli
Matthew Memoli
Director, LID Clinical Studies Unit, Viral Pathogenesis and Evolution Section, Laboratory of Infectious Diseases
NIAID, NIH
 
About Speaker:

Dr. Memoli is a graduate of he College of William and Mary and he received his Masters Degree in Microbiology from Thomas Jefferson University in Philadelphia, PA.  He then received his MD from St George’s University School of Medicine.  He completed a residency in internal medicine at the Washington Hospital Center Georgetown University Internal Medicine Program in Washington, DC.    After completing an infectious disease fellowship in NIAID at the National Institutes of Health, Dr. Memoli developed a clinical/translational research program to study influenza and other respiratory viruses in the Laboratory of Infectious Diseases.  He now serves as the Director of the LID Clinical Studies Unit.

Dr. Memoli has taken part in the research response for multiple emerging infectious diseases including pandemic influenza, Ebola, and Zika. He has reinvigorated the healthy volunteer influenza challenge model in the US and it serves as his main research interest.   He also has undertaken the first clinical trial involving a mosquito saliva based vaccine, and is highly interested in novel and uniquely designed clinical trials.  Other interests include clinical pathogenesis of viral infections in immunocompromised patients and other special at risk populations, intrahost evolution of influenza, antiviral resistance, immune correlates of protection against respiratory viruses, modes of transmission, and molecular diagnostics.

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9:20
Panel: Pricing and P&T Committee’s Role in Determining Novel Antibiotic Usage
Cristina Larkin
Cristina Larkin
Chief Commercial Officer
Spero Therapeutics
 
Cristina Larkin
Cristina Larkin
Chief Commercial Officer
Spero Therapeutics
 
About Speaker:

Cristina Larkin is the Chief Commercial Officer at Spero Therapeutics in Cambridge, MA. Ms. Larkin has over 22 years of experience developing strategic commercial insights for biopharmaceutical companies and their infectious disease products such as Avycaz, Dalvance, Teflaro, Levaquin and Floxin. Prior to joining Spero, she served as Assistant Vice President for Actavis, formerly Forest Laboratories. During that time, Ms. Larkin led the commercial hospital antibiotic franchise team and was responsible for the US launch and execution strategy for several antibiotics. Additionally, she was a member of the business assessments and business development team and played an integral role in the out-licensing of ceftaroline to AstraZeneca, the acquisition of Durata and more.

Ms. Larkin received a bachelor’s degree from Florida State University.

Andrew  Thorrens
Andrew Thorrens
‎Reimbursement & Market Access Executive
Allergan
 
Andrew  Thorrens
Andrew Thorrens
‎Reimbursement & Market Access Executive
Allergan
 
About Speaker:

Andrew Thorrens is the Head of Market Access and Reimbursement Strategy for Allergan. Andrew has a distinctive career with over 20 years of diversified leadership experience in the healthcare industry. His experience with claims adjudication management, employee benefits, pricing and reimbursement strategy in the biopharmaceutical industry brings well-rounded expertise in market access to the anti-infective commercial team at Allergan.

Andrew joined Allergan through the acquisition of Durata Therapeutics, Inc., where he also headed the market access and reimbursement for Dalvance in its initial launch. prior to Durata, Andrew led the health policy and reimbursement strategy for Takeda Pharmaceuticals and previous to that spent 18 years at Baxter International, Inc., where he managed the employee health and welfare plans and instituted a company wide reimbursement strategy and payor relations function.

Andrew has a deep understanding of the evolving payment methodologies and health policy initiatives stemming from the Affordable Care Act in the public and commercial payer sector including Medicare Part B drug reimbursement proposals. In his current role at Allergan he actively works at the intersection of health policy, health economics and reimbursement strategy, and, is a frequent speaker on these topics.

Jonathan  Kfoury
Jonathan Kfoury
Managing Director & Partner
L.E.K. Consulting
 
Jonathan  Kfoury
Jonathan Kfoury
Managing Director & Partner
L.E.K. Consulting
 
About Speaker:

Jonathan Kfoury is a Managing Director and Partner in L.E.K. Consulting’s San Francisco office, focused on biopharmaceuticals, medical technology, and life sciences. He joined the firm in 2006, and since that time has led an extensive set of engagements with global biopharmaceutical, medical technology, and diagnostic clients across human health, animal health, and agribusiness markets. Jonathan advises clients on commercial strategy and life-cycle management for in-line products, market access and commercialization planning for pipeline assets, and growth / partnering strategy. With an operating background in both Clinical and Business Development at specialty biopharmaceutical companies, Jonathan brings a hands-on understanding of internal decision-making needs to his advisory work with clients.

Jonathan has published and spoken-widely on the subject of antimicrobial resistance in human and animal health, including on key business issues and opportunities facing biopharmaceutical manufacturers and other stakeholders.

In addition to significant experience in immunology, oncology, men's/women's health, and CNS/pain management, Jonathan’s interests include growth strategy across infectious-diseases, biosimilars, and outcomes-driven digital health opportunities.

Prior to joining L.E.K., Jonathan was a Business Development executive for Acusphere and Purdue Pharma, and manager of global Clinical Development for Cubist Pharmaceuticals’ (now Merck) blockbuster antibiotic Cubicin® - the most successful IV antibiotic launched in US history. In addition to global management training at INSEAD, Jonathan earned an S.M. in Health Policy & Management from Harvard University, and graduated from Trinity College with a Bachelor of Science degree in Neuroscience.

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9:50
 
Joshua Speidel
Joshua Speidel
Managing Director, Commercial Practice
Latham BioPharm Group
About Speaker: Dr. Speidel leads the development and execution of a Commercial Practice at LBG that provides subject matter expertise and advisory services to mergers and acquisition, strategic business development, biological product development and due diligence ... Read Full Bio 
 
 
Joshua Speidel
Joshua Speidel
Managing Director, Commercial Practice
Latham BioPharm Group
 
About Speaker:

Dr. Speidel leads the development and execution of a Commercial Practice at LBG that provides subject matter expertise and advisory services to mergers and acquisition, strategic business development, biological product development and due diligence to clients. Dr. Speidel is a biotechnology product development professional with experience from pre-discovery to the lifecycle management of mature products destined for the HHS Pandemic Influenza Vaccine Stockpile. Dr Speidel provides program management, federal contract compliance support, and technical expertise to clients. He has led teams in the submission of proposals resulting in >$89M of awards. As a Health Scientist for the U.S. Department of Health and Human Services (HHS), Biomedical Research and Development Authority (BARDA), he led efforts to establish the core capabilities to support the licensure of medical countermeasures in the areas of manufacturing capacity, product development, clinical studies, and long-term stockpiling. At BARDA, Dr. Speidel was responsible for the post-licensure management of three pandemic influenza vaccine stockpile programs, one advanced development program for a licensed recombinant influenza vaccine, and the Clinical Studies Network program. The total contract values of these efforts were in excess of $17 billion. Earlier, while consulting to the U.S. Defense Advanced Research Projects Agency (DARPA), Dr. Speidel created programmatic concepts that were pitched to DARPA’s director and resulted in excess of $250M in contract awards, was the technical point of contact for two teams in the “Accelerated Manufacturing of Pharmaceuticals” program which pioneered efforts in recombinant vaccine production, and was the project manager for their $100M response to the H1N1 pandemic that built three tobacco based manufacturing facilities and advanced a pre-discovery stage vaccine candidate through a Phase 1 Clinical Trial, on time and on budget.

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10:10
Morning Networking Break
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10:40
Round Table Discussions
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10:40
Round Table Discussions
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10:40
Round Table Discussions
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12:00
Lunch Provided by GTCbio
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Anti-Infectives Partnering & Deal-Making 2017
General Session: Public/Private Partnerships in Support of Global Health
Moderator: Cheryl Keech, Pharmaceutical Product Development
1:00
CARB-X: What to Expect from CARB-X in our 2nd Year of “Xccelerating Global Antibacterial Innovation”
 
Tyler Merkeley
Tyler Merkeley
Program Manager, CARB-X
BARDA, HHS
About Speaker: Tyler Merkeley MS, MBA, PMP, is the co-founder of CARB-X and serves as the Biomedical Advanced Research and Development Authority’s (BARDA) CARB-X Program Manager. He joined BARDA in 2009 as a Health Scientist to accelerate the advanced research an... Read Full Bio 
 
 
Tyler Merkeley
Tyler Merkeley
Program Manager, CARB-X
BARDA, HHS
 
About Speaker:

Tyler Merkeley MS, MBA, PMP, is the co-founder of CARB-X and serves as the Biomedical Advanced Research and Development Authority’s (BARDA) CARB-X Program Manager. He joined BARDA in 2009 as a Health Scientist to accelerate the advanced research and development, procurement, stockpile and sustainment of medical countermeasures (MCM) against biological, chemical, radiological, and nuclear (CBRN) agents under Project BioShield.  During his tenure at BARDA he has led the smallpox antiviral procurement, BARDA’s Total Life Cycle Costs containment initiative, designed and launched HHS’s Combating Antibiotic Resistant Bacteria (CARB) Accelerator [CARB-X], managed BARDA’s 1st agreement using Other Transaction Authority (OTA) and served as the Acting Chief of Staff for BARDA.

 
Abstract: CARB-X is a global innovation fund to...Read More 

CARB-X is a global innovation fund to support antibacterial product development supported by the Biomedical Advanced Research and Development Authority (BARDA), National Institute of Allergy and Infectious Diseases and Wellcome Trust, the UK based a global charitable foundation dedicated to improving health. Co-Founder, Tyler Merkeley, will recap the first year of CARB-X and discuss their vision for Year #2 as they continue to build a Global Innovation Fund to accelerate global antibacterial innovation to address the threat of antibiotic resistant infections.

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1:25
GARDP, a PDP Contributing to Address AMR-Related Public Health Priorities
 
Jean-Pierre Paccaud
Jean-Pierre Paccaud
Director, Business Development
GARDP (Global Antibiotic R&D Partnership)
About Speaker: Dr Paccaud is responsible for the business development and corporate strategy of GARDP, an initiative he contributed to created within DNDi. Previously he was responsible since 2007 for DNDi’s business development activities, including opportunity ... Read Full Bio 
 
 
Jean-Pierre Paccaud
Jean-Pierre Paccaud
Director, Business Development
GARDP (Global Antibiotic R&D Partnership)
 
About Speaker:

Dr Paccaud is responsible for the business development and corporate strategy of GARDP, an initiative he contributed to created within DNDi. Previously he was responsible since 2007 for DNDi’s business development activities, including opportunity identification, contract structure and negotiations, and alliance management.

Dr Paccaud also notably founded and led Athelas SA, a startup company active in the field of anti-bacterial drug discovery, until its merger with Merlion Pharmaceuticals. Before taking on entrepreneurial challenges in industry, Dr Paccaud spent more than 15 years in academia, working in immunology, diabetes, and cell biology.

Trained as a molecular and cellular biologist, Jean-Pierre Paccaud completed his post-doctoral studies at the University of California at Berkeley, and earned his PhD at the University of Geneva School of Medicine.

 
Abstract: The Global Antibiotic Research and De...Read More 

The Global Antibiotic Research and Development Partnership (GARDP) is a not-for-profit research and development organization that addresses global public health needs in the field of bacterial infectious diseases by developing and delivering new antibiotic treatments, while endeavouring to ensure stewardship and affordable access to them. Initiated and incubated through close collaboration between WHO and Drugs for Neglected Diseases initiative (DNDi), GARDP is part of the implementation of the Global Action Plan on Antimicrobial Resistance that calls for new public-private partnerships for encouraging research and development of new antimicrobial agents and diagnostics. GARDP has received seed funding from the governments of the United Kingdom, Germany, the Netherlands, South Africa, and Switzerland, as well as from the medical humanitarian organization Médecins Sans Frontières. GARDP is a joint WHO/DNDi initiative being currently hosted within DNDi in its start-up phase.

GARDP’s mission is to work in partnership with the public and private sectors to develop and deliver new treatments for bacterial infections wherever drug resistance is present or emerging, or for which inadequate treatment exists, and where it is unlikely that they will be developed by the private sector.

GARDP will prioritize R&D projects by focusing on unaddressed global public health gaps, particularly for drug-resistant bacterial infections. Through partnerships, collaborations, and coordination, GARDP will ensure that new antibiotic treatments remain affordable subject to a global sustainable access agenda, including stewardship.

GARDP has, within its first 8 months, built up a team of 10 people with additional support staff from DNDi contributing directly to the GARDP programmes and is actively fund-raising to start projects by end of 2017.

Priority setting methodology and R&D interventions considered to date will be presented and discussed.

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1:50
The Importance of Public/Private Partnerships In Addressing Global Infectious Disease Threats
 
Kevin  Gilligan
Kevin Gilligan
Senior Scientific Advisor
ClinicalRM
About Speaker: Kevin J. Gilligan, Ph.D. is a virologist and emerging disease expert with over 30 years of experience in academia, government and industry developing vaccines, drugs and diagnostics to address public health issues related to global emerging disease. ... Read Full Bio 
 
 
Kevin  Gilligan
Kevin Gilligan
Senior Scientific Advisor
ClinicalRM
 
About Speaker:

Kevin J. Gilligan, Ph.D. is a virologist and emerging disease expert with over 30 years of experience in academia, government and industry developing vaccines, drugs and diagnostics to address public health issues related to global emerging disease.  Dr. Gilligan earned his Ph.D. in the Dept. pf Microbiology and Immunology at the University of North Carolina at Chapel Hill in 1990.  As a National Research Council Fellow working at Ft. Detrick, Dr. Gilligan was the first to demonstrate acquired immunity to Ebola virus via vaccination in a guinea pig animal model.  Dr. Gilligan recently left HHS/BARDA (U.S. Department of Health and Human Services/Biomedical Advanced Research and Development Authority), where he was Branch Chief for drugs and therapeutics in the Influenza division. Dr. Gilligan has since joined ClinicalRM as Senior Scientific Advisor.

 
Abstract: Nations and global organizations hopi...Read More 

Nations and global organizations hoping to prevent or mitigate emerging pandemic infectious disease episodes face daunting technical challenges. Amongst these challenges are the difficulty in anticipating which pathogen will emerge, where it will first present itself and how quickly it will spread.

There are three main countermeasures health professionals use in addressing these infectious disease episodes; 1) vaccines that match the pathogen of interest, 2) diagnostics to identify and track its spread and reveal its genetic character, and 3) anti-infective to treat those who get infected. Since many pathogens of pandemic potential do not normally present a significant public health threat, the private sector is often insufficiently responsive to developing these countermeasure tools, since the market for them between episodes is small compared to those pathogens that are endemic and whose circulation is predictable and constant. Nevertheless, the potential cost of a single global pandemic episode in both lives and economic activity can be catastrophic, and thus nations and global health institutions have an obligation to address potential risks before they occur. Some nations and institutions have created institutions that assist the private sector in developing the needed countermeasures, by providing money and expertise to drive technological innovation, and by creating a market for such products after approval by stockpiling them and assisting in supporting a warm base manufacturing infrastructure.

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2:15
BARDA’s Role in Product Development for Public Health Emergency Preparedness
 
Joseph Larsen
Joseph Larsen
Director (acting), CBRN Medical Countermeasures
BARDA, HHS
About Speaker: Dr. Larsen is acting Director of the Division of CBRN Medical Countermeasures within the Biomedical Advanced Research Development Authority (BARDA). In that role, he oversees a $2.8B fund for the development and procurement of medical products for us... Read Full Bio 
 
 
Joseph Larsen
Joseph Larsen
Director (acting), CBRN Medical Countermeasures
BARDA, HHS
 
About Speaker:

Dr. Larsen is acting Director of the Division of CBRN Medical Countermeasures within the Biomedical Advanced Research Development Authority (BARDA). In that role, he oversees a $2.8B fund for the development and procurement of medical products for use during public health emergencies.  He is also the BARDA lead for the BARDA’s work on combating antibiotic resistant bacteria and is an executive member of CARB-X, a novel $450M public private partnership focused on promoting innovation in antibacterial drug development.  Dr. Larsen has been actively involved in discussing potential reforms to the economic incentive structures for antibacterial drug development.  Previously Dr. Larsen served as Deputy Director of BARDA’s CBRN Division.  From 2010-2014, Joe served as Chief of the Broad Spectrum Antimicrobials program at BARDA.   The goal of BARDA’s Broad Spectrum Antimicrobials program is to develop additional antimicrobial treatment options needed to counter the growing threat of antimicrobial resistance. In that role, he oversaw a portfolio of approximately $1.2B in programs that support the development of novel antibacterial and antiviral drugs. Dr. Larsen also serves as the BARDA representative on the U.S. Transatlantic Task Force on Antimicrobial Resistance. Dr. Larsen received his PhD in Microbiology from the Uniformed Services University of the Health Sciences and his BA with honors from the University of Kansas. 

 
Abstract: BARDA provides a number of different ...Read More 

BARDA provides a number of different economic incentives to support the development of medical countermeasures (vaccines, therapeutics, and diagnostics).  This talk will focus on BARDA’s strategy, its major programs/initiatives, and will discuss current gaps in BARDA’s ability to incentivize industry to develop medical countermeasures for national defense, emerging infectious diseases, and antibiotic resistant bacteria.  

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2:40
Conference Concludes