Seminar: Interested in Orphan Drugs? What You Need to Know About Regulatory Affairs

Scientists, clinicians, and entrepreneurs cogitate on mechanisms, patients, and money, respectively. The tie that binds them all is regulatory affairs. In this “edutainment session,” Dr. Dr. Tim Cote will share with scientists, clinicians, and entrepreneurs all they need to know to make FDA and EMA (and investors) smile. He will respond to questions relating to FDA and EMA orphan designations, the Pediatric Rare Disease Priority Review Voucher, Fast Track Designation, Breakthrough Therapy Designation, INTERACT, Pre-IND, and Type A, B, and C Meetings, IND submissions, all the way to NDA and BLA.

Contrary to popular opinion, regulatory affairs is more exciting than watching paint dry. It is the creative, strategic process by which dreams become tangible.

Join us in this highly engaging session!

Dr. Timothy Cote is the founder and CEO of Only Orphans Cote (OOC), a regulatory affairs consultancy with offices in Washington DC and Cambridge, MA.  As a physician, pathologist and epidemiologist, Dr. Cote has more than 30 years of experience in leadership positions at the National Institute of Health and the Center for Disease Control. As the former Director of the Office of Orphan Product Development (OOPD) at the U.S. Food and Drug Administration (FDA), Dr. Cote spearheaded the agency’s efforts to implement the Orphan Drug Act, signing decisions over 1,400 orphan drug designation applications, while advancing the relationships between the FDA and the European Medical Agency (EMA). Dr. Cote is also the founder and Chief Executive Officer of Cote Orphans Consulting, which was acquired by IQVIA, an American Fortune 500.  

In his current capacity as CEO, Dr. Cote’s focus is on orphan drugs for rare diseases with a track record of advising multinational pharmaceutical companies and start-ups on regulatory strategies, achieving market exclusivity among other related aspects to orphan drug designations.