B2B series webinar:
Regulatory Considerations
On-demand Event
(on-demand access for the webinar series)
This webinar is part of a series of three educational events hosted in advance of the 2021 ARVO Bench to Bedside (B2B) Meeting. The other webinars included in the series are:
Series cost: Free for members
(on-demand access for all three webinars)
Description
It is important for bench scientists who innovate to learn how and when to communicate with stakeholders who can potentially help translate laboratory discoveries into marketable products, drugs, and remedies that treat visual disorders.
This webinar will help innovators and new companies determine how to establish an early and productive dialogue with the FDA to gain valuable insights that could boost their chances of success and produce cost-effective clinical development strategies in drugs, devices, biologics and generics.
Moderators
Michael S. Berlin, MD, MSc
Director and Founder of the Glaucoma Institute of Beverly Hills
Professor of Clinical Ophthalmology, UCLA Jules Stein Eye Institute
Michael S. Berlin, MD, MSc is the founder and director of the Glaucoma Institute of Beverly Hills and Professor of Clinical Ophthalmology at the UCLA Jules Stein Eye Institute. He is a board-certified glaucoma specialist with 40+ years of experience in glaucoma and cataract diagnoses and treatments. His special interests are in laser technologies and surgeries, and applied pharmaceutical research. He is a pioneer of future treatments, holds multiple patents in glaucoma therapeutics, and had worked extensively with Professor Theo Seiler in Germany in the development of excimer lasers for ophthalmology, both refractive and for the treatment of glaucoma, developing ELT the first concept of what is now called MIGS. Dr. Berlin is a member of the American Glaucoma Society, the American Society for Laser Medicine and Surgery, the American Society of Cataract and Refractive Surgery, and the American Academy of Ophthalmology. He has been granted the AAO's Honor and Senior Achievement Awards. He also remains active on the ANSI Z-136.3 (laser safety) and ANSI Z-80.27 (glaucoma devices) committees. Dr. Berlin received his Bachelor of Sciences degree Cum Laude, Masters of Science in Ophthalmology and Medical Doctorate degrees from the University of Michigan where he also completed Ophthalmology residency followed by Glaucoma Fellowship Training at the Mount Sinai Medical Center in New York where, at that time, Timolol was being studied as a potential treatment for glaucoma. His student, Carl Camras, later developed latanoprost.
Barbara Wirostko, MD, FARVO
Adjunct Clinical Professor in the Depts of Ophthalmology and Biomedical Engineering, University of Utah
Barbara Wirostko, a serial entrepreneur, is the CMO and co-founder of Qlaris Bio. Wirostko is a board-certified practicing glaucoma specialist holding a clinical adjunct professor position at the University of Utah, in Ophthalmology at Moran Eye Center and in the Dept. of Biomedical Engineering. She was previously the CMO of EyeGate Pharmaceuticals following its acquisition of Jade Therapeutics where Wirostko was co-founder and CSO, spearheading clinical development of its unique hyaluronic acid Ocular Bandage Gel (OBG) for human use. For Jade Therapeutics, Wirostko, as PI, received $3M in SBIR funding for the OBG polymer from the DOD and NSF. In 2006 to 2010, she held leadership positions at Pfizer, NY, in Ophthalmology, overseeing global medical responsibilities for the Xalatan franchise as senior medical director. She sits on various editorial boards including Ophthalmology Glaucoma and Journal of Glaucoma. She has also published hundreds of peer-reviewed papers, books, serves on numerous advisory boards, grant review committees and holds fellowship positions with ARVO and AAO. She lectures globally on her area of clinical research expertise, exfoliation glaucoma. Wirostko received her MD and completed her residency at Columbia University, College of Physicians and Surgeons, NY, and holds a BA with distinction in microbiology from Cornell University.
Speakers
Darby Kozak, PhD
Acting Deputy Director
Division of Therapeutic Performance, Office of Research and Standards
Office of Generic Drugs, Center for Drug Evaluation and Research
U.S. Food & Drug Administration (FDA)
Darby Kozak is acting deputy director of the Division of Therapeutic Performance in the FDA’s Office of Generic Drugs. Kozak leads a team of interdisciplinary scientists on the development of new analytical methods and equivalence evaluation methodologies for complex parenteral, ophthalmic and optic drug products. Prior to joining the FDA, Kozak was chief scientist at Izon Science, research fellow at the Australian Institute for Bioengineering and Nanotechnology and lecturer at the University of Queensland. Kozak has a BSc in Chemical Engineering from the University of Washington and a PhD in Physical Chemistry from the University of Bristol.
Markham C. Luke, MD, PhD
Director & Supervisory Physician
Division of Therapeutic Performance, Office of Research and Standards
Office of Generic Drugs, Center for Drug Evaluation and Research (CDER)
U.S. Food & Drug Administration (FDA)
Markham C. Luke serves as director and supervisory physician for the Division of Therapeutic Performance (DTP) in the FDA's Office of Generic Drugs. DTP is responsible for facilitating pre-application development of generic drugs by conducting and promoting regulatory science research to establish standards ensuring drug therapeutic equivalence. Markham is a dermatologist with a MD and PhD (pharmacology) from Johns Hopkins University. With the FDA since 1998, he has served in various roles, including lead medical officer for dermatology drugs in CDER, chief medical officer and deputy director for the Office of Device Evaluation in the Center for Devices and Radiological Health and acting director for cosmetics, Center for Food Safety and Applied Nutrition.
Tieuvi Nguyen, PhD
Director
Division of Health Technology (Ophthalmic Devices)
Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH)
U.S. Food & Drug Administration (FDA)
Tieuvi Nguyen joined FDA in 2011 and currently serves as director of the Division of Ophthalmic Devices in CDRH. In this role, she oversees various scientific and regulatory policies related to the premarket approval, postmarket performance and surveillance, and compliance and enforcement of ophthalmic devices. Prior to joining the FDA, Nguyen held numerous positions in the pharmaceutical and finance industries.
Organizer
Cheryl Rowe-Rendleman, PhD
CEO and Managing Consultant, Omar Consulting Group LLC
Cheryl Rowe-Rendleman is a clinical research and development professional, serving as CEO and Managing Consultant of Omar Consulting Group, LLC (Princeton NJ ǀ Durham, NC). Omar (ophthalmic management and research) is a practice that specializes in regulatory and clinical consulting for drugs and devices in the US, Europe and China. Rowe-Rendleman attended public school in Baltimore, Md., and graduated from Princeton University where she studied chemical engineering and biology with a focus in neuroscience. She completed two postdoctoral training fellowships in developmental and degenerative eye diseases at the University of Texas and the University of San Francisco Medical Schools respectively. Rowe-Rendleman worked in industry for 13 years where she was responsible for driving research and development for different types of drugs and devices that treat diseases, including those that cause blindness. She was named co-inventor on three US patents in ophthalmic drug delivery, has been involved in over 50 clinical trials and has published numerous manuscripts and books.
Michael S. Berlin, MD, MSc is the founder and director of the Glaucoma Institute of Beverly Hills and Professor of Clinical Ophthalmology at the UCLA Jules Stein Eye Institute. He is a board-certified glaucoma specialist with 40+ years of experience in glaucoma and cataract diagnoses and treatments. His special interests are in laser technologies and surgeries, and applied pharmaceutical research. He is a pioneer of future treatments, holds multiple patents in glaucoma therapeutics, and had worked extensively with Professor Theo Seiler in Germany in the development of excimer lasers for ophthalmology, both refractive and for the treatment of glaucoma, developing ELT the first concept of what is now called MIGS. Dr. Berlin is a member of the American Glaucoma Society, the American Society for Laser Medicine and Surgery, the American Society of Cataract and Refractive Surgery, and the American Academy of Ophthalmology. He has been granted the AAO’s Honor and Senior Achievement Awards. He also remains active on the ANSI Z-136.3 (laser safety) and ANSI Z-80.27 (glaucoma devices) committees. Dr. Berlin received his Bachelor of Sciences degree Cum Laude, Masters of Science in Ophthalmology and Medical Doctorate degrees from the University of Michigan where he also completed Ophthalmology residency followed by Glaucoma Fellowship Training at the Mount Sinai Medical Center in New York where, at that time, Timolol was being studied as a potential treatment for glaucoma. His student, Carl Camras, later developed latanoprost.
