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Ocular Diseases Drug Discovery

2018-04-192018-02-062017-11-20
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KEYNOTE SPEAKERS
Jerry Cagle

Jerry Cagle
Independent Pharmaceuticals Professional
Former VP, R&D, Alcon
Jerry Cagle
Independent Pharmaceuticals Professional
Former VP, R&D, Alcon
 
About Speaker:

Dr. Cagle is a longtime ophthalmic industry executive with a broad range of scientific and operational experience gained over the past four decades.  After completng graduate studies, Dr. Cagle joined the Faculty at The Ohio State University.  Three years later, in 1976, he moved to Alcon Laboratories as Secton Head,  R&D Microbiology.  He led development of the first proprietary product at Alcon, an antibiotic.  In turn, he took on additional responsibilities as Vice President(VP)  of Clinical Research, VP Regulatory Affairs and then VP Product Development.  In 1996, he was named Alcon's Senior Vice President for Global R&D.  Since leaving Alcon in 2009, Dr. Cagle has served as a Director for Aerie Pharmaceuticals, Clearside Biomedical, GrayBug Vision, AC Immune, Novaliq and Nacuity.  He has also given time to Foundation Fighting Blindness to help establish the organization's clinical development capability.  

Cristina Kenney

Cristina Kenney
Professor & Director, Ophthalmology Research
UC Irvine, Gavin Herbert Eye Institute
Cristina Kenney
Professor & Director, Ophthalmology Research
UC Irvine, Gavin Herbert Eye Institute
 
About Speaker:

Dr. Kenney is currently Professor, Gavin Herbert Eye Institute, and Department of Pathology/Laboratory Medicine, University of California, Irvine. She received her Ph.D. from University of Arizona, Tucson, AZ and her M.D. degree from University of California, Los Angeles.

Dr. Kenney’s research interests are to (a) use the transmitochondrial cybrid (cytoplasmic hybrid) model (cell lines with identical nuclei but mitochondria from different individuals) to characterize retrograde signaling (mitochondria to nucleus) that regulates major pathways associated with human diseases; (b) identify the molecular and genetics changes in mitochondria associated with the dry form of age-related macular degeneration (AMD); (c) identify drugs that target and protect the AMD mitochondria so cellular longevity is prolonged; and (d) examine the influence of mtDNA variants from different racial/ethnic populations upon the behavior and gene expression of retinal cells.

Carl Romano

Carl Romano
Executive Director and Head, Ophthalmology Research
Regeneron
Carl Romano
Executive Director and Head, Ophthalmology Research
Regeneron
 
About Speaker:

Carl Romano, Ph.D., was trained in Neuropharmacology and has been working in Ophthalmic Pharmacology since 1990. He was on the faculties of Ophthalmology and Neurobiology at Washington University from 1990-2004, when he left to lead the Retina Discovery Group at Alcon. Since 2013 he has been at Regeneron.

Linda Zangwill

Linda Zangwill
Professor, Ophthalmology
UC San Diego
Linda Zangwill
Professor, Ophthalmology
UC San Diego
 
About Speaker:

Linda Zangwill, Ph.D., Professor of Ophthalmology at the University of California San Diego, serves as Director of Clinical Research of the Hamilton Glaucoma Center, and Director of the Imaging Data Evaluation and Analysis (IDEA) Reading Center.  Dr. Zangwill completed her BS from UC Berkeley, MS from the Harvard School of Public Health, and PhD in Epidemiology from Ben-Gurion University of the Negev, Beer-Sheva, Israel. Dr. Zangwill has published over 275 manuscripts in peer-reviewed journals. She is an elected member of the Glaucoma Research Society, and serves on the editorial board of the Journal of Glaucoma, and International Glaucoma Reviews and is an Association for Research in Vision and Ophthalmology Gold Fellow.

Dr. Zangwill’s National Eye Institute and industry funded research focuses on improving our understanding of the complex relationship between structural and functional change over time in the aging and glaucoma eye, developing computational, machine learning and statistical techniques to improve glaucomatous change detection, and identifying risk factors that can predict rapidly progressing glaucoma.

DISTINGUISHED SPEAKERS
Matthias Birkhoff

Matthias Birkhoff
Vice President, Marketing
Aptar Pharma
Matthias Birkhoff
Vice President, Marketing
Aptar Pharma
 
About Speaker:

Matthias Birkhoff is Vice President, Marketing, of Aptar Pharma. In this role Matthias is responsible for Aptar Pharma’s Eye Care program and coordinates research and development activities, microbiological assessment and commercial strategies. Matthias started his career in pharmaceutical sales in a major multinational pharmaco before joining Aptar sixteen years ago.

Before getting involved in Business Development and Marketing, Matthias was in charge of sales in the AsiaPacific region. Matthias studied medicine at the University of Dusseldorf, Germany and holds a nursing degree.

Matthias has recently spoken at international events, such as NDD (Nasal Drug Delivery), London/UK, PMP (Pharmaceutical Plastics), Copenhagen/Denmark, Interphex, Tokyo/Japan, CPHI, Pharmapack, AAPS, or the IPA conference in Mumbai/India.

Balbir Brar

Balbir Brar
VP, Research & Development
Aciont
Balbir Brar
VP, Research & Development
Aciont
 
About Speaker:

Dr. Brar has over 25 years of experience for drug and device development and world vide registration of 8 major drugs including Botox. His experiences include working with major pharmaceutical companies i.e. Lederle /Wyeth (NYSE: WYE) where he developed Azmacort for asthma and topical Aristocort for atopic dermatitis, both multimillion dollar Drugs and at SmithKline & Beckman (NYSE: GSK/AGN) as Senior Director of Drug Safety, participated in the development of Tazarotene for Psoriasis and Acne.

At Allergan Inc. (NYSE: AGN) as Vice President Drug Safety/Clinical/non clinical PK, Toxicology, Pathology, Life sciences, he made major contributions towards the development and Regulatory submission of 50 IND's/510K's 505(b) 2 and worldwide approval of 8 NDA's which became very successful drugs currently on the market. This included Botox for the treatment of (Cervical dystonia, Cerebral palsy, migraine headache, post stroke dystonia, urinary incontinence, excessive sweating, blephrospasm and strabismus as, medical and Cosmetic), Betagan, Alphagan, Lumigan, Restasis (Dry Eye) Combigan, Ofloxacin, Azelex acne and Avage (Retinoid for wrinkles).

For the past 12 years he has played a leadership role in helping start up Biotechnology Companies where he has held positions of Board member, President, Executive VP R&D, Chief Technology Officer in the field of Diabetic Nephropathy, Oncology, Ophthalmology , Dermatology, and Cardiovascular drugs for plaque reversibility and stabilization. His responsibilities have included participation in fund raising, selection of CRO's for GMP chemical synthesis of API, Drug Product development, manufacture of clinical/non-clinical supplies, stability testing, Non-clinical Studies, Clinical studies, Phase I, II and III, IND and 505(b)2 filing for Virtual companies. Strong contacts with CRO's and experience of working with FDA and Regulatory Agencies worldwide.

Dr. Brar has a Ph.D. in Toxicology/Pathology from Rutgers University and D.V.M. from India with finance training from Harvard Business School. Dr.Brar is a recipient of numerous achievements awards for excellence, belongs to a number of scientific organizations and is the author/coauthor of over 55 scientific publications.

Ronald Buggage

Ronald Buggage
CMO
Eyevensys
Ronald Buggage
CMO
Eyevensys
 
About Speaker:

Dr. Ronald R. Buggage is the Chief Medical Officer of Eyevensys, a clinical stage biotech company developing its proprietary EyeCET platform, the first non-viral gene expression technology that enables the safe, local, sustained production of therapeutic proteins in the eye to address a wide range of ophthalmic diseases. Dr Buggage brings more than 14 years experience from both large pharma and biotech companies having worked in senior development positions in the US and Europe, overseeing clinical development programs for a broad range of ophthalmic indications.

Dr Buggage was most recently Division Medical Officer at Sanofi Ophthalmology Unit, responsible for its ophthalmology portfolio including development programs for ocular gene therapy. He also served as Chief Scientific Officer of Novagali Pharma, where he was responsible for the global clinical and regulatory strategy; Novagali Pharma was successfully acquired by Santen. Prior to moving to France, Dr Buggage held various positions of increasing clinical development responsibility at Novartis and Pfizer. Dr Buggage obtained his MD at UCLA School of Medicine, specializing in ocular pathology and ophthalmology at Emory, and completed his training in ocular immunology and uveitis at the National Eye Institute of the National Institutes of Health (NIH).

Jonca Bull

Jonca Bull
VP, Regulatory Consulting; Ophthalmology Therapeutic Area Director
PPD
Jonca Bull
VP, Regulatory Consulting; Ophthalmology Therapeutic Area Director
PPD
 
About Speaker:

Jonca Bull, M.D., serves as vice president of PPD® Regulatory Consulting within Global Product Development. In that role, she works to advance clinical development programs to ensure that new medical therapies are made available to patients in a rapid and cost efficient manner. As a regulatory affairs authority with therapeutic expertise in ophthalmology, she guides therapeutic, protocol and safety reporting training to internal teams at startup and to sites at investigator meetings.

Based in PPD’s Washington, D.C., area office, Dr. Bull joined PPD in 2017 following a career with the U.S. Food and Drug Administration (FDA) and in the pharmaceutical industry. In addition to ophthalmology, she has significant therapeutic experience in clinical regulatory development consulting for biopharmaceutical products in the areas of diabetes and sub-population disparities, non-opioid pain management in osteoarthritis, and sickle cell anemia. She is a subject matter expert in bioethical considerations in clinical trials and patient centricity and patient voice. Prior to joining PPD, Dr. Bull served as assistant commissioner at FDA with a focus on diverse populations and clinical trials; vice president for U.S./North American regulatory policy for Novartis Pharmaceuticals; and director of clinical regulatory policy for Genentech. From 1994 to 2005, Dr. Bull held various senior leadership roles with the FDA across various disease areas and programs. From 1982 to 1994 she cared for patients at a medical/surgical practice in the Washington metro area. She is a diplomat of both the American Board of Ophthalmology and the National Board of Medical Examiners. 

Dr. Bull holds an undergraduate degree from Princeton University, a medical degree from Duke University, and she completed residencies in general medicine and ophthalmology at George Washington University Hospital in Washington, D.C., where she also serves as an assistant clinical professor.  She is a recipient of a 2017 Year of Women Award in recognition of great accomplishment to the field of ophthalmology by Women in Ophthalmology.

David Culp

David Culp
Director, Research
Powered Research
David Culp
Director, Research
Powered Research
 
About Speaker:

W. David Culp, Jr., Ph.D. is the Director of Research for Powered Research, LLC. In this role he is responsible for management and oversight of all studies including model development. His training includes modeling and analyzing neovascularization, with specific training in analyzing choroidal neovascularization complexes from the Biological Imaging Core Facility in the Division of Intramural Research at the National Eye Institute (NEI). Furthermore, as a postdoctoral fellow at the University of North Carolina, he evaluated compounds and interfering RNAs in rat models of oxygen-induced retinopathy (OIR). He has significant surgical and microdissection experience and can image, analyze, and interpret data. Prior to joining Powered Research, Dr. Culp worked as a Senior Scientist at Affinergy, LLC, identifying novel peptides using phage display. Dr. Culp has also worked in the Laboratory of Cellular and Molecular Immunology at the National Institutes of Allergy and Infectious Disease developing anti-tumor vaccines. He has authored research articles, intellectual property documents, and has raised over 7 million dollars through the NIH Small Business Innovative Research (SBIR) program. Dr. Culp holds a B.S. in biology from Hampden-Sydney College, and a Ph.D. in experimental oncology from the Karolinska Institute.

Emmett Cunningham

Emmett Cunningham
Partner
Clarus Ventures
Emmett Cunningham
Partner
Clarus Ventures
 
About Speaker:

Dr. Cunningham joined Clarus in 2006 with extensive experience in the biomedical and biopharmaceutical sectors. Prior to joining Clarus, Dr. Cunningham was the Senior Vice President, Medical Strategy at Eyetech Pharmaceuticals, Inc. (NASDAQ:EYET), where he helped build and lead the team that developed and commercialized Macugen, a first-in-class product for the treatment of age-related macular degeneration. Prior to Eyetech, Dr. Cunningham was at Pfizer, Inc (NYSE: PFE), where he was responsible for the clinical development of early phase central nervous system compounds and the in-licensing of early and late-stage therapeutic candidates in ophthalmology.

Dr. Cunningham is an internationally recognized specialist in infectious and inflammatory eye disease with over 350 publications.  He is Adjunct Clinical Professor of Ophthalmology at Stanford University School of Medicine, was Clinical Professor and Director of the Uveitis service at NYU from 2002 to 2005, and was Director of both the Uveitis Service and the Kimura Ocular Immunology Laboratory at the University of California at San Francisco (UCSF) from 1995 to 2001.   Dr. Cunningham received an MD and MPH in epidemiology and statistics from Johns Hopkins University and a PhD in neuroscience from the University of California at San Diego (UCSD) for work done at The Salk Institute.  He completed both a residency in ophthalmology and fellowship training in Corneal Disease and Uveitis at UCSF and The Francis I. Proctor Foundation, a medical retina and uveitis fellowship at Moorfields Eye Hospital in London, and a fellowship in public health ophthalmology at the Wilmer Eye Institute in Baltimore.

Dr. Cunningham founded and is the Chairman of the Ophthalmology Innovation Summit, a well-attended symposium held in conjunction with the annual meetings of the American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgery and the American Society of Retinal Surgeons. The OIS brings together leading companies, clinicians, academics and investors in the ophthalmology space.

Dr. Cunningham represents Clarus on the Board of Directors of Annexon BiosciencesGraybug VisionRestoration Robotics, and SFJ Pharmaceuticals Group. He is a Board observer for Lumos Pharma and is on the Scientific Advisory Board of Aerie Pharmaceuticals (NASDAQ: AERI).

Previous Directorships include Neomend (acquired by Bard) and SARcode Biosciences (acquired by Shire). Additionally, he was Board Observer for AvillionFerrokin (acquired by Shire), Ophthotech (NASDAQ: OPHT), Pearl Therapeutics (acquired by AstraZeneca), and was a member of the Scientific Advisory Board for ESBATech (acquired by Alcon).  

Iain Duncan

Iain Duncan
CEO
NeuMedics Inc.
Iain Duncan
CEO
NeuMedics Inc.
 
About Speaker:

Mr. Duncan is a co-founder and serves as the Chief Executive Officer of NeuMedics Inc. During the last 18 years he has worked exclusively in startups with the responsibility of executing the preclinical/clinical development, analytical chemistry and cGMP's for drug manufacturing and has successfully filed three NDA's and one MMA for both orphan products and products for unmet medical needs. All of which are which are currently commercially available. Prior to working in biotechnology, Mr. Duncan was involved with the manufacturing of industrial chemicals and was frequently re-assigned to manage mergers and new entity integrations. Mr. Duncan has co-authored five patents that include new chemical entities and drug formulations.

Mala Dutta

Mala Dutta
Lead, Office of Translational Research
NEI, NIH
Mala Dutta
Lead, Office of Translational Research
NEI, NIH
 
About Speaker: Mala Dutta completed her graduate studies in Immunology and T-cell signaling from the National Human Genome Research Institute (NHGRI), NIH, under the NIH-GWU Partnership Program. After brief post-doctoral research, she joined the Technology Transfer and Intellectual Property Office (TTIPO) at the National Institute of Allergy and Infectious Diseases (NIAID) as a Technology Development Specialist. She came on board the National Eye Institute’s Office of Translational Research as a Presidential Management Fellow and now leads the office in its technology development, collaboration, translational and inter-agency initiatives.
Rafal Farjo

Rafal Farjo
Chief Executive Officer
EyeCRO LLC
Rafal Farjo
Chief Executive Officer
EyeCRO LLC
 
About Speaker:

Rafal Farjo, Ph.D. is Chief Executive Officer for EyeCRO. He has been involved in ophthalmic research for over 20 years and received his bachelor's degree in Cell and Molecular Biology from the University of Michigan and his Ph.D. in Cell Biology from the University of Oklahoma. During his time at the University of Michigan, Dr. Farjo established a genomics core facility with a special emphasis on discovering genes and pathways associated with Age-Related Macular Degeneration and Diabetic Retinopathy. At the University of Oklahoma, Dr. Farjo's research focused on the characterization of preclinical retinal disease models and the development of new treatment modalities. During this tenure, he published the first study demonstrating the feasibility of using non-viral DNA nanoparticles as a method for gene therapy to ocular cells. He is an author of multiple patents relating to ophthalmic drug delivery and has also published in several prestigious journals, including The Journal of Cell Biology, Genome Biology, Molecular and Cellular Biology, and Investigative Ophthalmology and Visual Sciences.

John Freshley

John Freshley
President & CEO
ONL Therapeutics, Inc.
John Freshley
President & CEO
ONL Therapeutics, Inc.
 
About Speaker:

John Freshley has 20+ years in leadership roles of start-up companies. His expertise spans the assembly of multi-disciplinary leadership teams, product and business strategy development, partnership development, and fundraising. John joined ONL Therapeutics in 2013 after serving the company as a mentor-in-residence through the technology transfer office at the University of Michigan. Prior to ONL, John was chief business officer of Compendia Bioscience through its acquisition by Life Technologies in 2012. He launched the company in 2006 with co-founders from the University of Michigan and served as its interim chief executive officer. In this role, he assembled the management team, secured early funding and the company’s initial round of customers. Previously, John had been president and chief executive officer of Genetics Squared (now Everist Health).

Judy Gordon

Judy Gordon
Founder & President
ClinReg Consulting Services, Inc
Judy Gordon
Founder & President
ClinReg Consulting Services, Inc
 
About Speaker:

Dr. Gordon is president of ClinReg Consulting Services, a clinical and regulatory consulting practice, and has taken multiple NDAs and PMAs through the FDA review process. She has been involved in conducting clinical trials and obtaining FDA approval for a broad range of drugs, biologics and devices including the first intravitreal sustained release drug delivery system (Vitrasert), intravitreal drugs/biologics for AMD and DME, drug delivery systems for glaucoma drugs, prostate cancer and other oncology drugs, combination products, injectable polymers for tissue bulking in GERD and urinary incontinence, drug-eluting sinus stents, CAD systems for tumor detection, coils and polymers for aneurysm treatment, intracranial stents for stroke prevention, breast biopsy devices, femtosecond lasers for LASIK and cataract surgery, phakic and accommodating phakic IOLs, excimer lasers, and other novel products.

Dr. Gordon has been active in chairing several industry-FDA working groups on guidance documents and has served as the industry representative to FDA’s Ophthalmic Devices Advisory Panel and the CDRH Dispute Mediation Panel

Glen Gum

Glen Gum
Associate Director, Ophthalmology
Absorption Systems
Glen Gum
Associate Director, Ophthalmology
Absorption Systems
 
About Speaker:

Glenwood Gum, M.S., Ph.D. is Associate Director of Ophthalmology at Absorption Systems California, based in the San Diego. Absorption Systems California is an advanced research facility, accredited by the Association of Accreditation and Assessment of Laboratory Animal Care International (AAALAC), registered as a research facility with the United States Department of Agriculture (USDA), assured with NIH’s Office of Laboratory Animal Welfare (OLAW) and home to a team of scientists and experts who have many years of combined experience in rodent, rabbit, canine, porcine and ovine research.  Dr. Gum leads the preclinical ophthalmology team whose expertise and experience includes translating models across species, as well as developing new disease and surgical models to assess the efficacy, safety and distribution of therapeutics (small molecules and biologics), devices, stem cells and gene therapy.  Dr. Gum has many years of in vivo experience, in ophthalmic drug discovery, drug development, and toxicology.  Prior to joining Absorption Systems, Dr. Gum was Senior Manager/Principal Scientist at the Biological Test Center (BTC), a division of B. Braun Medical Inc., where he led teams of scientists and technicians performing preclinical in vivo tests of the pharmacokinetics, efficacy, and safety of drugs and ocular medical devices. At Johnson & Johnson IOLAB, in the department of Pharmacology and Toxicology, he was involved in the developed of glaucoma and anti-inflammatory drugs.  Dr. Gum had previously been on the faculty at the College of Veterinary Medicine of the University of Florida for seven years. Over the course of his long career, Dr. Gum has developed or co-developed many of the preclinical models of glaucoma, corneal anomalies, age-related macular degeneration (AMD), retinoblastoma, uveitis, dry eye, and diabetes that are used all over the world for drug testing. He has authored or co-authored more than 120 publications and several book chapters.

John Higuchi

John Higuchi
CEO
Aciont
John Higuchi
CEO
Aciont
 
About Speaker:

John Higuchi is CEO of Aciont. Higuchi is a former VP of Business Development and Corporate Treasurer for Lipocine (Nasdaq: LPCN) and currently serves on its Board. Lipocine is a late clinical staged, oral drug delivery company that has filed an NDA for the first oral drug to treat hypogonadism in men and it has an oral drug for the prevention of pre-term birth entering late stage clinical development. Higuchi also is a co-founder and Board member of Spriaso, LLC, which has an FDA approved combination drug product for respiratory therapy and has other primary care products under development. He received his BS degree in Chemistry at Hope College and his MBA and MS in Information Systems from The George Washington University.

Brian Levy

Brian Levy
Chief Executive Officer
Ocunexus Therapeutics
Brian Levy
Chief Executive Officer
Ocunexus Therapeutics
 
About Speaker:

Dr. Levy is currently CEO of Ocunexus Therapeutics a Biopharm company developing novel and differentiated products in ophthalmology targeting Gap Junction Channel Modulation. Prior to Ocunexus he was Chief Medical Officer at Aerie Pharmaceuticals developing Rho Kinase Inhibitors for the lowering of IOP in patients with Glaucoma.

Before entering the startup world he was Corporate Vice President R&D and Chief Medical Officer at Bausch & Lomb for 15 years. At Bausch & Lomb he was responsible for 3 NDA’s for pharmaceuticals (Retisert, Zylet, Besivance) all FDA approved and currently in the market. On the device side of the business he was responsible for 4 PMA’s and multiple 510K’s.   Devices included Phaco Emulsification Equipment and Intra Ocular Lenses for cataract surgery, Refractive Lasers and Microkeratomes for surgical correction of refractive errors and Contact Lenses and Care Systems for non surgical correction of refractive errors. Prior to Bausch & Lomb he was Associate Professor, Department of Ophthalmology at California Pacific Medical Center in San Francisco and prior to that in private practice in Toronto and a clinical investigator and consultant to the ophthalmic industry. He received a Doctor of Optometry degree from the University of California at Berkeley and a Master of Science in comparative anatomy and physiology of the eye at U of Waterloo in Canada.

Brian Mansfield

Brian Mansfield
Senior Vice President, Research
Foundation Fighting Blindness
Brian Mansfield
Senior Vice President, Research
Foundation Fighting Blindness
 
About Speaker:

Dr. Mansfield joined the Foundation Fighting Blindness as the Deputy Chief Research Officer in 2011. He ensures implementation of the Foundation’s scientific research strategic plan, and leads scientific assessments of new technologies, treatments and therapies for retinal degenerative diseases. He also leads the patient registry team and the Foundations genetic testing program.

Prior to joining the Foundation, Dr Mansfield was the Chief Scientist and Vice President for Research and Development for Correlogic Systems Inc., a start-up biotechnology company developing serum-based systems for the early detection and diagnosis of cancer. Prior to that he spent 5 years as a Senior Scientist in Protein Development at Human Genome Sciences Inc. leading a mammalian expression group and as project lead for Lead Optimization. Prior to this, Dr Mansfield spent 12 years as a tenured Professor of Eukaryotic Genetics at Massey University, New Zealand and 3 years as a Visiting Professor at Georgetown University, Washington D.C.. Dr Mansfield’s academic research focused the biochemistry and genetics of early developmental genes. Since 1992, Dr Mansfield has also held the position of Adjunct Scientist with the NICHD, NIH, collaborating with Dr Janice Chou on the molecular genetics of Glycogen Storage Disease Type I (GSD-I) and the development of a gene therapy.

Dr Mansfield received an Honors degree in Physical Chemistry from Canterbury University, a Ph.D. in Biochemistry from the University of Otago, New Zealand and completed his post-doctoral training in molecular genetics at the Johns Hopkins University School of Medicine, Baltimore, with Professor Daniel Nathans.

Charlie McDermott

Charlie McDermott
President & Chief Business Officer
Impact Biomedicines, Inc.
Charlie McDermott
President & Chief Business Officer
Impact Biomedicines, Inc.
 
About Speaker:

Charlie McDermott serves as President and Chief Business Officer of Impact Biomedicines and has over 22 years of operating experience in the biotech industry. Most recently he served as the President and Chief Business Officer of Kala Pharmaceuticals, Inc.. Since joining Kala Mr. McDermott helped take two programs from discovery though phase 3 trials in 4 years and raised over $200 million dollars, including the July 2017 IPO. Prior to joining Kala, Mr. McDermott was Vice President of Business Development at Allergan, where he completed a variety of transactions and global partnerships that ranged from novel platforms to commercial products (such as Abicipar, RESTASIS MultiDose™, Acuvail™, Lastacaft™, and Latisse™). Mr. McDermott obtained an MBA from the University of San Diego, a M.A. in molecular, cellular and developmental biology from the University of California, Santa Barbara, and a B.S. in biochemistry and molecular biology from the University of California, Santa Cruz.

Michael Naimark

Michael Naimark
Director, Business Development
CBSET
Michael Naimark
Director, Business Development
CBSET
 
About Speaker:

Michael is the Director of Business Development at CBSET Inc., a not-for-profit GLP-compliant preclinical research organization based in Lexington MA. Michael holds an MS degree in Human Anatomy & Neurobiology from the University of Tennessee Medical Center and professional certifications in Medical Device Regulatory Affairs, Biologics Regulatory Affairs, and Project Management. Michael has worked in the preclinical research field for 15 years as a study director and study surgeon and most recently served as Project Manager at the Neural Stem Cell Institute (NSCI), where he oversaw the development of a cell-based therapy for macular degeneration under a 4-year award from the New York Stem Cell Foundation. Since joining CBSET Michael has focused on client-centered outreach and the development of new programs and capabilities to expand CBSET's translational research services.

Covadonga Paneda

Covadonga Paneda
R&D Manager
Sylentis
Covadonga Paneda
R&D Manager
Sylentis
 
About Speaker:

Covadonga Pañeda has over fifteen years of industrial and academic experience; she is currently Sylentis’ R&D Manager. She received her M.Sc. in Biochemistry in 1998 and her Ph.D. in Biochemistry in 2001 both from Universidad Autónoma de Madrid. During her first post-doctoral fellowship at Hospital Niño Jesús, Spain she focused on the development of animal models of human disease and gene expression in the diseased state, she subsequently held a second post-doctoral fellowship at Scripps Research Institute, CA, USA where she extended her studies on gene expression in different disease models and was co-founder of the Mouse Behavioral Assessment Core. She thereafter shifted her career towards industry where she’s held the positions of Study Director and Head of Efficacy and Multidisciplinary Development at Vivotecnia, a non-clinical CRO. Her areas of expertise include ophthalmology, neuroscience, diabetes, aging, metabolic diseases, liver biology, rare diseases, RNA interference and biotechnology derived products. She is author of 32 scientific publications, 5 patents and she is ad hoc reviewer for Medicinal Research Reviews, Behavioral Neuroscience, Ophthalmology, International Journal of Molecular Studies and British Journal of Pharmacology. She is also an external expert evaluator for the H2020 program on Topics PHC 14 – 2015 and H2020-SC1-2017: “New therapies for rare diseases”.

Neil Poloso

Neil Poloso
Director, Biological Research
Allergan
Neil Poloso
Director, Biological Research
Allergan
 
About Speaker:

Neil Poloso received his B.S. in Biology from the University of Delaware (1997) and Ph.D. in Immunology from Emory University (2002). While at Emory University, he helped develop a method of deriving cancer vaccines from primary tumor tissue using protein transfer of lipid-linked immune-stimulatory molecules. Following graduate school, Dr. Poloso moved to the National Cancer Institute for a postdoc in the laboratory of Paul Roche studying protein trafficking in antigen presenting cells. While there, he published three papers on the association of MHC class II with lipid rafts. Following his time at the NCI, Dr. Poloso moved into the biotech industry, first with Alba Therapeutics, working on characterizing immune effects of their lead compounds for Celiac disease, and shortly thereafter moving to Allergan, Inc. (2008) in Irvine, CA. At Allergan, Dr. Poloso is currently a Director of Biological Research working to discovery of new therapeutics in the areas of prostaglandins and prostamides in inflammation, hair biology, and metabolic disease.

Firas Rahhal

Firas Rahhal
Partner
ExSight Ventures
Firas Rahhal
Partner
ExSight Ventures
 
About Speaker:

Dr. Rahhal is a partner at ExSight Ventures, a venture capital firm specializing in early-stage impact investments in innovative ophthalmic diagnostic and treatment solutions. He is a senior partner at Retina-Vitreous Associates Medical Group in Los Angeles, and is Associate Clinical Professor of Ophthalmology at the UCLA Geffen School of Medicine. He has published extensively in respected peer-reviewed ophthalmology journals and has been an investigator in over 100 ophthalmology clinical trials. Dr. Rahhal completed an Ophthalmology Residency at Cornell University Medical Center, followed by a Fellowship in Vitreoretinal Diseases / Surgery and Uveitis at UCSD Medical Center.

Christian Roesky

Christian Roesky
CEO & Managing Director
Novaliq
Christian Roesky
CEO & Managing Director
Novaliq
 
About Speaker:

Dr. Christian Roesky is CEO and Managing Director of Novaliq. Dr. Roesky has more than 15 years in eye care and extensive operational experience at multiple international healthcare companies. Previously he was general manager for Bausch + Lomb GmbH in Berlin; commercial director, Central Europe of Abbott’s Diagnostics Division; general manager and speaker of the German Country Management Board of Abbott GmbH & Co. KG in Wiesbaden; and, general manager of Alcon Germany & Austria (Novartis). Prior to this, Dr. Roesky worked as marketing manager, EURMEA for Alcon in the USA, Spain and Switzerland, focusing on strategy and market access to transform global and regional commercial activities. He studied chemistry and was awarded his Ph.D. with honors from the Technical University of Freiberg, Germany.

Paul Stone

Paul Stone
Associate Vice President, Regulatory Affairs
Allergan
Paul Stone
Associate Vice President, Regulatory Affairs
Allergan
 
About Speaker:

Paul is the Regulatory Therapeutic Area Head for Ophthalmology and Biosimilars at Allergan. He has overall responsibility for global regulatory strategy for all ophthalmology projects worldwide. In addition, Paul leads the global regulatory development of biosimilars for Allergan.

Paul has held various positions at Allergan. He started his career in Allergan in the UK where he was responsible for the Ophthalmology portfolio in Europe, Africa and Middle East. Since moving to the USA, Paul has been responsible for Global Regulatory Development for the Urology, Dermatology, Neurology & Pain therapeutic areas within the Allergan pharmaceutical portfolio.

Prior to joining Allergan, Paul worked in Regulatory Affairs and Medical Writing at Covance supporting development of a broad range of pharmaceutical products with a variety of pharmaceutical companies.

Paul gained his PhD in Biochemistry & Molecular Biology from the University of Leeds whilst working with Wellcome Biotech. He also has an MSc in Pharmaceutical Medicine from the University of Surrey and a BSc in Biochemistry & Biotechnology from the University of Birmingham, UK.

Derek Welsbie

Derek Welsbie
Assistant Professor, Department of Ophthalmology
University of California, San Diego
Derek Welsbie
Assistant Professor, Department of Ophthalmology
University of California, San Diego
 
About Speaker:

Derek S. Welsbie, M.D., Ph.D., is a board-certified ophthalmologist who has an active medical and surgical practice, specializing in adolescents and adults with all stages of glaucoma. An Assistant Professor of Ophthalmology at the Shiley Eye Institute, his laboratory studies the way in which glaucoma leads to optic nerve injury, neurodegeneration and, ultimately, vision loss. Specifically, he uses high-throughput genetic screening to comprehensively characterize the genes responsible for nerve cell death. His ultimate goal is to develop new medication- and gene therapy-based neuroprotective strategies to interfere with these deleterious genes, prevent nerve cell death and improve outcomes for patients with glaucoma.

Prior to joining UC San Diego Health, Dr. Welsbie was an Assistant Professor at the Johns Hopkins University Wilmer Eye Institute, where he won the Shafer Prize for innovative glaucoma research from the Glaucoma Research Foundation and was named Assistant Professor of the Year (2015). He also served as the Stephen J. Ryan Assistant Chief of Service and continues to have an interest in resident and medical student education. Dr. Welsbie completed a residency in Ophthalmology and fellowship training in Glaucoma at the Wilmer Eye Institute. He earned his medical degree and doctorate in molecular biology from the David Geffen School of Medicine at UCLA.

Daniel White

Daniel White
CEO
Clearside Biomedical
Daniel White
CEO
Clearside Biomedical
 
About Speaker:

Mr. White is a founder of Clearside Biomedical and has served as the President and Chief Executive Officer and as a member of our board of directors since our inception in May 2011. From 2008 to 2011, Mr. White served as Executive Director, Global Corporate Development, for Stiefel Laboratories, Inc., a dermatology pharmaceutical company acquired by GlaxoSmithKline in 2009. From 2007 to 2008, he co-founded and served as President and Chief Executive Officer of Percept BioScience, Inc., a biotechnology company. In 2003, Mr. White co-founded, and until 2007 served as Vice President of Finance and Corporate Development of Alimera Sciences, Inc., a biopharmaceutical company focused on ophthalmology. Previously he was Head of Business Development and Licensing for CIBA Vision, a Novartis company, and Director of Licensing and Business Development for AAIPharma. Mr. White holds an M.B.A. degree from Wake Forest University and a B.S. degree in molecular biology from Auburn University.

David Woodward

David Woodward
CTO, JeniVision
Senior Research Investigator, Imperial College London
David Woodward
CTO, JeniVision
Senior Research Investigator, Imperial College London
 
About Speaker:

David F Woodward is the author of almost 200 manuscripts and invited reviews and inventor of approximately 100 patents, including the patents on Lumigan and Latisse. A former GSK and Allergan employee, David F Woodward is now co-founder and CTO of JeniVision Inc. and holds a part-time academic position at Imperial College London, England.