Event: FDA Regulatory Strategies and CMC Considerations

March 21st, 2018
5:00 pm to 7:00 pm
6828 Nancy Ridge Drive, Suite 100, San Diego, CA 92121

Are you interested in resurrecting shelved projects from big pharma R&D pipelines? Are you working on drug re-purposing and would like to know how to obtain market exclusivity or extend patent lives? Have you anticipated the impact of FDA guidance documents on your drug development program? Then, come to meet industry veterans at IRISYS on March 21st to hear valuable insights and participate in sizzling discussions on these and more hot topics that keep the San Diego biotech community buzzing.

IRISYS is kicking off the new year with an educational seminar. Click here to register early to reserve a seat and to mingle with like-minded drug discovery and development gurus. Registration will be open starting at 4:30PM. Presentations will start at 5:00PM. Appetizers and non-alcoholic drinks will be served.

The event will wrap-up with a tour of our cGMP manufacturing facility for clinical supply and commercial drug products for those who are interested.

Agenda:

4:30PM                 Registration

5:00PM                 FDA Regulatory Pathways and Strategies – Gerald Yakatan, Ph.D., CEO, IRISYS

5:30PM                 Impact of 1997 SUPAC Guidance on Development, Testing and Manufacturing of an Anti-parasitic Semisolid Topical Dosage Form – Richard Kenley, Ph.D., Founder, PLADD Consulting

6:00PM                 Q&A and open discussions

6:30PM                 cGMP facility tour – Robert Giannini, Ph.D., VP and Chief Technology Officer, IRISYS

Speaker Bios:

Gerald Yakatan, Ph.D., CEO, IRISYS

Dr. Yakatan has served as Chairman & CEO of IRISYS since founding the Company in 1996. In addition to his leadership and oversight of IRISYS’ operations, Dr. Yakatan personally heads our Strategic Consulting services. He plans and engages in FDA meetings with U.S. and international clients, and interacts with high-level FDA personnel on their behalf.

Dr. Yakatan has decades of pharmaceutical development, clinical trial strategy and design, and regulatory affairs experience. Prior to founding IRISYS, he was President & CEO of Avanir Pharmaceuticals, where he was responsible for the development, regulatory approval and commercialization of Abreva®, and he led development efforts resulting in the NDA submission for Nuedexta®.  Dr. Yakatan has also served as Pharmaceutics Chair at the University of Texas at Austin; Vice President for Product Development Worldwide at Warner Lambert/Parke Davis; and Founder and CEO at Tanabe Research Labs, USA.  Dr. Yakatan has a long-standing commitment to community service and has been a member of the Boards of Directors for numerous not-for-profit organizations.

Dr. Yakatan received his B.S. in Pharmacy and M.S. in Pharmaceutical Chemistry from Temple University in Philadelphia, Pennsylvania. His Ph.D. was earned in Pharmaceutical Sciences from the University of Florida, in Gainesville, Florida. Dr. Yakatan has received distinguished alumnus awards from Temple University and from the University of Florida.

Rich Kenley, Ph.D., Founder, PLADD Consulting

Expert consultant in Chemistry, Manufacturing and Controls (CMC) aspects of pharmaceutical and biotechnology products. Seasoned scientist, entrepreneur, business executive and expert consultant with over 35 years of experience in the pharmaceutical and biotechnology industries.

Dr. Kenley founded Cabrillo Laboratories (a pharmaceutical services provider) in 1998 (subsequently sold to Magellan Laboratories and then to Cardinal Health).  At Cardinal Health, he was President of Pharmaceutical Sciences group.  In 2008 he founded Advantar Laboratories (subsequently sold to Eurofins).  Prior to 1998, Dr. Kenley was VP of product development for Amylin Pharmaceuticals and held senior leadership positions at Genetics Institute, Baxter Healthcare, Syntex, and SRI International.

Dr. Kenley received his B.Sc. degree in Chemistry from the University of Illinois and his Ph.D. in chemistry from the University of California, San Diego.  He is a Fellow of the American Academy of Pharmaceutical Sciences.

Robert Giannini, Ph.D., VP & Chief Technology Officer, IRISYS

Dr. Giannini has more than 30 years of pharmaceutical industry experience. His breadth of knowledge includes development of a wide range of dosage forms such as controlled/extended release solids, oral liquids, and injectables. He has been responsible for all aspects of dosage form development and manufacture: pre-formulation, formulation development, analytical methodology, stability, process validation, regulatory compliance/submissions, and day- to-day production for currently marketed products. Dr. Giannini joined IRISYS in 2004 and has been the primary author and principal investigator on most of the Company’s proposals that resulted in the awarding of numerous NIH development and manufacturing contracts.

From 1981 to 1985 Dr. Giannini served as a Senior Scientist – Solid Dosage Forms, and then as Unit Supervisor – Novel Drug Delivery Systems at Wyeth Laboratories. In 1985 he joined Key/Schering Plough as Section Head – Solid Dosage Form Development. This was followed by a position as Vice President – Pharmaceutical Research and Development at a small venture capital funded firm called Himedics. In 1991, he joined Watson Laboratories as Director of Product Development where he was responsible for the development of generic products from formulation to ANDA submission.

Dr. Giannini was awarded a Ph.D. in Industrial Pharmacy from the University of Maryland at Baltimore for research in the area of solid dosage form design.