The Road to Biologic IND

A Workshop on Navigating the FDA Approval Process

Hosted by Hershey Center for Applied Research

Whether your goal is to develop your pipeline through commercial launch, or partner as early as possible, submitting an IND is a critical early milestone. Even with big pharma and VC firms competing for the most promising compounds, the bar is still quite high and startups are expected to demonstrate a solid plan for achieving IND acceptance to be taken seriously.

Join us on Thursday, January 26 for a series of presentations followed by an interactive panel discussion exploring the basic requirements and considerations you must be aware of when planning for a successful IND submission.

Presentations will highlight the following:

Admission and lunch are compliments of HCAR. Colleagues, partners and prospective tenants are welcome. RSVP to Corr@hersheyresearch.com or call Caitlin at 717-566-8900.

Agenda

Speakers

Michiel Ultee, PhD, Chief Scientific Officer, Laureate BioPharma
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.

Robert Burford, PhD, VP Regulatory Affairs, Laureate BioPharma
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.