The MassBio Annual Meeting focuses on the timeliest and critical challenges facing the Massachusetts life sciences industry. The meeting program is designed by a steering committee of industry leaders and the agenda encompasses keynote presentations, panel discussions, interactive working sessions and extensive networking opportunities.
The Redefining Early Stage Investments (RESI) Conference is an ongoing conference series that will be establishing a global circuit for early stage life sciences companies to source investors, create relationships, and eventually, get funding.
Coté Orphan is a boutique full-service regulatory group with a laser focus on Orphan Drugs. From the lab to the market, we take you and your idea to the FDA and EMA for approval. With over 300 innovative biotechnology and pharmaceutical clients, Team Coté is led by Dr. Tim Coté, the former Director of the FDA’s Office of Orphan Products Development (OOPD).
The Coté Advantage
- As director of the OOPD at the FDA, Dr. Tim Coté personally signed off on 1,400 orphan designation applications, awarding 800 designations.
- Oversaw the progress to full marketing approval of 150+ orphan drugs from 2007-2011.
- Team of 25 professionals of whom more than 70% are doctoral-level trained.
- Regulatory scientists with deep knowledge and experience in the “unwritten rules” of the FDA regarding orphan drugs.
- Coté Orphan is the largest submitter of FDA and EMA orphan designations worldwide.
- Coté Orphan is dedicated to providing tangible deliverables that measurably enhance our clients’ assets. We do not merely opine—we do the work of creating quality regulatory filings.