– Dr. Yakatan to Direct a Discussion with FDA CDER Leaders –
San Diego, February 6, 2017 – IRISYS, LLC, a San Diego-based provider of contract pharmaceutical product development and manufacturing services, today announced that Gerald Yakatan, Ph.D., Chairman, CEO and founder of IRISYS, will be will be moderating the “FDA Panel Discussion and Q&A” session at The International Conference on Drug Development (ICD2) in Austin, Texas on February 13, 2017. The panelists include a former U.S. Food and Drug Administration (FDA) Commissioner and six Directors currently associated with the FDA’s Center for Drug Evaluation and Research (CDER). Dr. Yakatan is also a member of the ICD2 Conference Organizing Committee.
“The ICD2 meeting is vital for anyone who works in regulatory affairs in drug development,” said Gerald Yakatan, Ph.D., IRISYS Chairman, CEO and founder. “In particular, the FDA panel session provides conference participants a unique opportunity to hear from, as well as to direct questions and comments to, a distinguished panel of FDA leaders.”
The FDA panel discussion and Q&A moderated by Dr. Yakatan is expected to be especially valuable for conference attendees. Proposed topics include: (1) Digital Technologies – Ability of the FDA to assess effectiveness and safety of emerging technologies; (2) Emerging manufacturing technology regulation to support new clinical development programs; (3) Emerging Technologies – e.g., Bioelectronics and implants; and (4) Role of FDA in the “Moonshot” initiative.
Dr. Yakatan personally heads IRISYS’ 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. Regulatory activities performed by IRISYS include pre-IND meeting management and follow-up; preparation and submission of IND and ANDA filings; and regulatory strategic planning based on the client’s specific product and proposed application.
ICD2 is known for bringing together national and international scientists from academia, the pharmaceutical industry, the biotechnology industry and regulatory agencies for the opportunity to learn of and discuss new initiatives for finding a better way to develop new drugs and improve the quality of existing drug products.
The 57th annual ICD2 conference is presented by The University of Texas at Austin College of Pharmacy Division of Pharmaceutics. ICD2 is intended for leaders in Academia, the Pharmaceutical and Biotechnology Industry (PhRMA, BIO, GPhA), contract research organizations, API manufacturers, and domestic and international regulatory agencies in positions to affect the science and regulation of drug discovery and development, who wish to stay abreast on the national and international initiatives affecting the development of safe and effective pharmaceutical drug products.
About IRISYS, LLC
IRISYS was founded in 1996 to provide contract pharmaceutical product development and manufacturing services, specializing in formulation development, cGMP manufacturing of clinical trial materials and commercial pharmaceutical products, and strategic consulting related to the drug development process. IRISYS’ custom approach to drug development is supported by the Company’s scientific and regulatory experience in moving more than 100 drug products from discovery to clinical development and commercialization.
About The International Conference on Drug Development (https://sites.utexas.edu/cpe-icdd/)
The International Conference on Drug Development (ICD2), formerly known as the International Industrial Pharmacy Conference (IIPC), continues over half a century of tradition offering an informal forum for the exchange of ideas concerning the drug discovery and drug development process. This conference has been referred to as the Gordon Conference on Drug Development and is proudly presented by The University of Texas at Austin College of Pharmacy.
The goal of ICD2 is to update participants on the national and international initiatives affecting the development of safe and effective pharmaceutical drug products. By the end of the program, the attendees will develop an appreciation and in-depth understanding of the continuous scientific and regulatory efforts to improve the quality of pharmaceutical products and their impact on pharmaceutical care.
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