BioNJ Breakfast Briefing
The Road to Biologic IND
April 4, 2012
7:30 a.m. to 11:15 a.m.
The Westin Princeton at Forrestal Village
201 Village Boulevard, Princeton, New Jersey
A key early milestone for any biopharmaceutical is filing and securing approval of an Investigational New Drug (IND) application to assess the new product in the clinic. The value of a new potential therapeutic skyrockets once clinical safety and efficacy are established. The route to the IND, however, requires in-depth technical, toxicological and regulatory expertise. Many discovery-based companies seek outside expert assistance in developing their discovery into a new biopharmaceutical suitable for evaluation in patients.
This presentation will focus on the key areas needed to move down the road from discovery to successful IND submission, including:
- Expression, Production, Purification, Analytics, Formulation, Fill/Finish
- Development of a robust manufacturing process and key components of the Chemistry/Manufacturing/Controls (CMC)
- Toxicological study design, species selection, material requirements, and timelines
- Differences in toxicological properties between small-molecule and protein therapeutics
- Regulatory filing, including electronic formatting (eCTD) and submission (ESG)
- Regulatory strategies to minimize costs and timelines while balancing risk
- Michiel E. Ultee, Ph.D. , has more than 25 years of experience in the biopharmaceutical industry and has worked with antibodies since 1975. He serves as Laureate Pharma’s scientific head and has been part of their biopharmaceutical operations team since 1987. His prior positions include Vice President of Process Sciences and Director of Manufacturing & Technical Operations. Dr. Ultee began his career in Research and Development, where he was part of the team that developed two licensed biopharmaceuticals. He holds four U.S. patents and has published numerous scientific articles. Prior experience includes postdoctoral research in immunology at NYU Medical School. He is a frequent speaker at biopharmaceutical conferences, and a member of the editorial advisory boards of Bioprocess International and Biopharm International. Dr. Ultee earned his graduate and undergraduate biochemistry degrees from Northwestern University and Dartmouth College.
- Dr. Thompson earned her PhD from the University of Arizona in Physiology and Toxicology and completed a postdoctoral fellowship at Reproductive Toxicology Division of the US Environmental Protection Agency. Thereafter, she joined the Drug Safety Evaluation department at Bristol-Myers Squibb Company, where she has been supporting nonclinical development of small molecules and biologic compounds since 2004.
- Dr. Burford joined Laureate Pharma in November 2010 with an impressive career in the pharmaceutical industry that has spanned the past 41 years. Dr. Burford holds a Ph.D. in pharmacology/toxicology from the University of Western Ontario, Canada, and has held various positions with innovator and emerging drug companies, as well as contract research firms. These positions included preclinical pharmacology and toxicology at Bio-Research Laboratories in Montreal, and 17 years at Searle Pharmaceuticals, where he held various positions including Director of Clinical Research, Medical Director of Life Sciences Division, and Director of Scientific Affairs. Thereafter, he was the Director of Clinical Research at Biovail Laboratories, V.P. of Product Development at Axonyx Inc, and V.P. of Preclinical and Regulatory Affairs at Sequoia Pharmaceuticals. For the past 16 years he has been President of the American Clinical Research Consultants Inc. where, as an industry consultant, he has offered expert advice and counsel in preclinical toxicology and early phase clinical development of new drug products and medical devices. He has represented both domestic and foreign clients before the FDA and HPB, being thoroughly familiar with the regulatory requirements of medical product approval in the U.S. and Canada. He is a past president of the Society of Toxicology, Canada, Secretary General of the International Union of Toxicology and a member of the American Society for Clinical Pharmacology and Therapeutics, among others.
7:30 – 8:15am – Registration & Networking Breakfast
8:15 – 10:15am – Program
10:15 – 11:15am - Tour of Laureate Biopharma Production Plant (Transportation will be provided.)