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Register by
June 8, 2013 for a 10% Discount. Or Register 3
for the price of 2 with the coupon code RCDVB! |
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Day 1 - Monday, July 8, 2013 |
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| 7:00 |
Continental Breakfast and Registration |
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| 7:55 |
Welcome and Opening Remarks |
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Regulatory Guidance and Overcoming Challenges in Anti-infectives Development |
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| 8:00 |
Yuan-Hua Ding, Senior Director & Head of
External R&D Innovation - Asia, Pfizer Worldwide Research & Development,
Pfizer |
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| 8:25 |
Richard Bax, Senior Partner, Transcrip
Partners |
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| 8:50 |
Roger Echols, Principal Member, ID3C |
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Panel Discussion
Regulatory Guidance and Overcoming Challenges in Anti-infectives
Development |
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| 9:15 |
Panelist: Steven C. Gilman, Executive Vice
President, Research & Development; Chief Scientific Officer, Cubist
Pharmaceuticals |
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Panelist: Richard Bax, Senior Partner,
Transcrip Partners |
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| 10:05 |
Networking Break |
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Government Collaborations and Non-dilutive Funding |
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| 11:00 |
Enabling Anti-infective Drug Product Rfforts Across the Development Spectrum |
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Michael Kurilla, Director, Office of Biodefense Research Affairs; Associate
Director, Biodefense Product Development, National Institute of Allergy and
Infectious Diseases |
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| 11:25 |
Overview of Non-Dilutive Funding for Antibiotics |
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John M. Clerici, Principal, Tiber Creek
Partners |
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Biotechnology companies are increasingly
seeking to use non-dilutive capital from the U.S. Government, foreign
governments, and non-governmental organizations as part of their
commercialization objectives. Companies must have a full understanding of
funding and procurement opportunities and help communicate the advantages and
the state of development of its technology so that it resonates most effectively
with funding and purchasing decision-makers.
Private equity and venture capital firms are increasingly aware of the fact that
legislation and policies established in the US and the EU directly influence the
value of their investments. It is critical for companies undertake an effort in
identifying and analyzing global government procurement trends as well as
assessing the risks associated with investing in companies that receive U.S.
federal and state funding and government contracts.
In the specific area of antibiotics, this approach is more important than any
other area of biotechnology given the risks of development and the pricing
pressure on new antibiotics, not to mention their finite life span for efficacy
due to resistance. Thus, access to non-dilutive capital becomes critical. This
talk will explore the sources of such capital, the experience of past applicants
(both successful and unsuccessful) and prospects for future funding in this age
of government austerity. |
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| 11:50 |
Lunch on Your Own |
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Recent Advances in Anti-Infectives |
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| 2:00 |
Previously Unculturable Bacteria, the New Frontier in Antibacterial Drug
Discovery |
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Aram T. Salzman, CEO, NovoBiotic
Pharmaceuticals |
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| 2:25 |
Prabhavathi Fernandes, Ph.D., President and CEO,
Cempra Pharmaceuticals |
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| 2:50 |
Malcolm Kendall, President and Chief Executive
Officer, Indel Therapeutics |
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| 3:15 |
Networking Break |
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Panel Discussion
Current Trends and Future in Anti-infectives Development |
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| 4:00 |
Panelist: Joyce A. Sutcliffe, PhD, Senior Vice
President, Biology, Tetraphase Pharmaceuticals, Inc. |
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Panelist: Lew Barrett, LLBarrett
Biopharmaceutical Consulting, LLC |
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Panelist: Mike Birch, Chief Operating Officer,
F2G |
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Panelist: Glenn Tillotoson, Consultant,
GST Micro |
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Panelist: Berthold Hinzen, VP, Head of Business
Development & Licensing General Medicine, Bayer Pharma AG Berlin |
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Panel Discussion
Investment Opportunities with Venture Capitalists |
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Panel Moderator: Malcolm
Kendall, President and Chief Executive Officer, Indel Therapeutics |
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| 4:45 |
Panelists TBA |
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Short Presentations
Advances in Anti-infectives |
| 5:15 |
To be considered for a short presentation,
please submit an abstract
here by May
31, 2013. Selected presentations will be based on quality of abstract and
availability. Presentation slots fill up fast so please submit your abstract
ASAP. |
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| 5:30 |
Networking Reception and Poster Session |
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Day 2 - Tuesday, July 9, 2013 |
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7:30 |
Continental Breakfast |
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Panel Discussion
Finding the Middle Ground in Partnerships with Big Pharma and
Govt. |
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| 8:00 |
Panelist: Jennifer Giottonini Cayer, Chief
Operating Officer, Rempex Pharmaceuticals |
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Panelist: Kleem Chaudhary, Director Strategic
Alliances, Novartis |
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Other Panelists TBD |
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Recent Advances in Clostridium Difficile Infection |
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| 8:45 |
TBA |
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| 9:10 |
Oral Presentations from Exemplary Submitted Abstracts |
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To be considered for an oral presentation, please
submit an abstract
here by June 8, 2013. Selected presentations will be based on quality of
abstract and availability. Presentation slots fill up fast so please submit your
abstract ASAP. |
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Multi Drug Resistant Gram Negative Infections |
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| 9:40 |
Eravacycline: A Potent, Broad Spectrum Antibiotic That Is Efficacious in
Patients with MDR Gram-Negative Infections |
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Patrick Horn, Chief Medical Officer,
Tetraphase Pharmaceuticals |
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Methods: In a randomized, double-blind phase 2
trial, patients with cIAI were randomized (2:2:1) into one of 3 arms
[Eravacycline (Erav) 1.5 mg/kg IV QD: Erav 1.0 mg/kg IV BID: Ertapenem (Erta) 1g
IV QD], with treatment up to 14 days. Baseline intra-abdominal cultures were
obtained and susceptibility to study drugs and comparators was done. Clinical
outcome at the Test of Cure (TOC) visit (10-14 days after last dose) in the
microbiologically evaluable population (ME) was the primary efficacy endpoint.
Results: 143 patients were enrolled. A total of 212 pathogens were isolated from
119 patients in the micro-MITT population: Gram-negative aerobes (67.9%),
Gram-positive aerobes (23.5%), anaerobes (8.5%). In the Gram-negative aerobes,
25% (36/144) were extended-spectrum ?-lactamase producers (ESBL) and 11.1%
(16/144) were ertapenem-resistant.
Clinical outcomes (ME) at TOC were similar: (% cure, 95% CI); Erav 1.5 (92.9,
80.5-98.5); Erav 1.0 (100, 91.4-100); Erta (92.3, 74.9-99.1). The bases for
failure were persistent/recurrent intra-abdominal infection (Erav 1.5=1,
Erta=1), adverse event related (Erav 1.5=1, Erta=1) and remote site infection
(Erav 1.5=1). Eighteen of 20 patients (90%) with one or more ESBL-producing
baseline isolates who were treated with eravacycline had favorable outcomes.
There were no study-drug related SAEs. Overall AE, nausea, and vomiting rates
were low and not significantly different between the groups.
Conclusions: In this study, Erav demonstrated similar efficacy to Erta and was
safe and well tolerated, with low rates of GI side effects. These data support
continued development of Erav for the treatment of serious infections, including
those caused by multidrug-resistant gram-negative pathogens. |
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| 10:05 |
Networking Break |
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| 10:50 |
Les Tari, Vice President of Drug Discovery,
Trius Therapeutics |
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| 11:15 |
Glenn Tillotoson, Consultant, GST Micro |
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| 11:40 |
Marc Lemonnier, CEO, Antabio |
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| 12:05 |
Xenorhabdus & Photorhabdus: a Promising Bioresource for the Discovery of Novel
Antibiotics |
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Philippe Villain-Guillot, Chief Executive
Officer, Nosopharm SAS |
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Antibiotic resistance remains a high unmet
medical need. The situation is worsened by the scarcity of investigational new
drugs in the antibacterial pipeline. In that context, natural products based
drug discovery is widely acknowledged to be an interesting strategy to reach
novel antibacterial drug candidates. The bacterial genera Xenorhabdus and
Photorhabdus represent such a promising bioresource. They are symbiotic bacteria
of entomopathogenic nematodes with an original life-cycle that requires the
production of a great diversity of bioactive secondary metabolites. Nosopharm
has developed a unique expertise in the medicinal mining of Xenorhabdus and
Photorhabdus. This innovative know-how enables Nosopharm to discover and develop
novel antibiotic classes for the treatment of multiresistant bacterial
infections. Nosopharm’s pipeline includes NOSO-95, a novel first-in-class broad
spectrum antibacterial with activity against multiresistant clinical
Gram-negative pathogens.
Benefits of the talk include:
1. Overview of the drug discovery potential of Xenorhabdus and Photorhabdus
2. Overview of the Nosopharm expertise in the medicinal mining of Xenorhabdus
and Photorhabdus
3. Insights into the discovery of NOSO-95, a first-in-class antibacterial with
activity against MDR Gram-negative pathogens |
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| 12:30 |
GTC Sponsored Lunch |
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Panel Discussion
Licensing vs Co-development Partnerships |
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| 1:30 |
Ian Nicholson, Chief Executive Officer,
FG2 |
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Other Panelists TBD |
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| 3:25 |
Conference Concludes |
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