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B2B series webinar:

Regulatory Considerations

Virtual event
Nov. 18
2 - 3pm EDT

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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, $15 nonmembers
(registration includes all three webinars, plus on-demand access if unable to attend a live presentation)

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.

Attendees will be able to submit questions in advance and during the session. 

Speakers

image of Darby KozakDarby 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.

image of Markham LukeMarkham 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.  

image of Tieuvi NguyenTieuvi 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.  

image of Yan WangYan Wang, PhD
Acting Team Lead for Complex Drug Substances & Formulation
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)

Yan Wang is the acting team lead for Complex Drug Substances & Formulation Team in the Division of Therapeutic Performance, Office of Research and Standards in the FDA's Office of Generic Drugs. In her current role, she leads a group of interdisciplinary scientists developing product specific guidances, addressing controlled correspondences, pre-ANDA meeting requests, citizen petitions and internal consults in the areas of complex drug substances and complex formulations for various routes of administration and dosage forms. Wang also manages research projects on developing new analytical methods, in vitro characterization and drug release testing methodologies for complex drug products. She specializes in complex parenteral, ophthalmic, otic, intravaginal, and intrauterine formulations. Wang received a PhD in Pharmaceutical Sciences from the University of Connecticut.  

Organizer

image of Cheryl Rowe-RendlemanCheryl Rowe-Rendleman, PhD
CEO and Managing Consultant, Omar Consulting Group LLC

 

Dr. 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.  Cheryl attended public school in Baltimore, Maryland and graduated from Princeton University  where she studied chemical engineering and biology with a focus in neuroscience. Cheryl completed 2 postdoctoral training fellowships in developmental and degenerative eye diseases at respectively, the University of Texas and the University of San Francisco Medical Schools. She 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 3 US patents in ophthalmic drug delivery, has been involved in over 50 clinical trials, and published numerous manuscripts and books.

 

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