Coté Orphan is a boutique full-service regulatory group with a laser focus on Orphan Drugs. From the lab to the market, we take 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).
November 7-9, 2016
November 11, 2016
November 16 & 17th
The Coté Advantage
- As director of the OOPD at the FDA, Dr. Tim Coté personally signed off on 1,400 orphan designation applications, awarding designations to 800 and withholding approval of 600.
- Oversaw the progress to full marketing approval of 150+ orphan drugs from 2007-2011.
- Team of 25 professionals of whom >70% are doctoral-level trained.
- Regulatory scientists have 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.
Our Leadership Team
Timothy R. Coté, MD, MPH
Principal & Chief executive officer
Dr. Timothy R. Coté is a leading national regulatory expert in orphan drug development. With 23 years of Federal service at the FDA, NIH, and CDC, Dr. Coté recently served as the Director of the FDA Office of Orphan Products Development (OOPD) from Sept 2007 – May 2011. In this role he implemented the Orphan Drug Act and personally signed decisions on 1400+ orphan drug designation applications. An anatomic pathologist and medical epidemiologist, he has published 80 peer-reviewed articles on areas as diverse as HIV/AIDS-related malignancies, typhoid fever epidemics, and the impact of bicycle helmet laws on injury statistics. Dr. Coté is founder and CEO at Cote Orphan; he directs and trains staff to create compelling regulatory submissions that are finely tuned to each client's business strategy and to the unwritten rules within the FDA.
Dr. Coté received a bachelor's degree from Syracuse University, a medical doctorate from the Howard University College of Medicine and a master's degree in Public Health from Harvard School of Public Health.
Erin Lawless Miller, JD
Chief Operating Officer
Erin Lawless Miller has experience in law, finance, and operations management. In her current role as a member of the Senior Leadership Team, Lawless Miller functions as the Chief Operating Officer and is responsible for the operations of Human Resources, Finance, Marketing, and Strategic Planning. She was a member of the government and regulatory practices at Venable, LLP and the boutique FDA law firm of Buc & Beardsley, LLP, both in Washington, DC. As a contributing editor at the New York State Science and Technology Law Center, Lawless Miller wrote numerous articles on regulatory issues affecting patent, intellectual property, and technology transfer law for journal publication.
Lawless Miller has a law degree from Syracuse University College of Law and graduated Magna Cum Laude from Syracuse University’s prestigious S.I. Newhouse School of Public Communications. She holds certificates in contract negotiation and finance from Harvard Law School’s Program on Negotiations and the National Labor College. She earned a Black Belt in Lean Six Sigma. Lawless Miller is a 2009 recipient of the Hermes Award for outstanding contribution in the area of communications law and policy.
James LaFlamme, MS, RPH, FACHE
Executive Vice President
James LaFlamme has more than 30 years of health care operational experience and has held a variety of senior positions—including CEO, Chief Operations Officer, Vice President of Clinical Services, and Administrative Director—at several hospitals and health systems. In his current role as a member of the Senior Leadership Team, LaFlamme is responsible for leading all operations for both the Regulatory Affairs and Business Development divisions. This role encompasses overseeing the development and delivery of all advisory opinions and client deliverables as well as a full complement of Business Development and client-facing related activities on a global basis.
Prior to joining Coté, LaFlamme was Vice President for Accreditation and Recognition Operations at the National Committee for Quality Assurance (NCQA). Previously LaFlamme was the Director of the Healthcare Advisory Public Sector Practice at PricewaterhouseCoopers (PwC). At PwC, his primary focus was improving clinical and business operations for key healthcare clients.
LaFlamme earned a BS degree in Pharmacy from the University of Connecticut School of Pharmacy and a MS degree in Management from Indiana Wesleyan University. He serves on the Deans Advisory Board at the UCONN School of Pharmacy and is a Fellow of the American College of Healthcare Executives.
FDA Orphan Designation →
- The Coté team offers unparalleled expertise and efficiency in constructing the Orphan Drug designation application. We write the entire application, including the epidemiology and scientific rationale sections. A first draft takes our team two to three weeks to prepare. Most applications are submitted within three weeks of our team initiating work.
EMA Orphan Designation →
- We partner with our clients to decide whether an optional pre-submission meeting will optimize their likelihood of success. Additionally, we write the entire EMA Orphan Designation application and submit on the designated submission date. Our team will handle the management of the extensive translations required by EMA for submission. Because Coté has a European entity we are able to submit on behalf of those clients who do not possess such an entity.
Strategic Reviews →
- Our regulatory experts suggest to the client a product development strategy, while taking the current regulatory environment into consideration, to optimize an orphan drug development pathway. We perform an in-depth analysis of the epidemiology and the therapeutic area. Our strategic reviews provide a feasibility assessment of a specific molecule and disease state or a review of the client’s entire pipeline to discover and pursue all “orphanable” pathways.
Meeting Request & Briefing Package →
- We lead FDA Type A/B/C meetings, meetings with the OOPD, as well as Scientific Advice in the EU. Our expert team has direct experience with all FDA review divisions, with valuable knowledge of how to develop successful proposals to regulators.
Breakthrough Therapy Designation →
- Our team has had great success in writing breakthrough therapy designations. Our depth of knowledge and experience in working with each review division informs the strategy of each application.
Priority Review Voucher →
- We are the largest submitter of priority review designation applications. We understand the challenge of these applications, and in particular, the level of scrutiny given to the epidemiology section.
IND Filings →
- We prepare, submit and maintain INDs. We work with many clients to streamline their strategy and work towards Orphan Designations, Pre-IND meetings, and IND submissions. Our team has a unique skill set that can generate successful submissions, in a rapid and expert manner.
NDA, BLA, and MAA Filings →
- We stay with our clients from the lab to the market. We have strong experience in preparing marketing applications, as well as participating on the review of applications from inside the FDA.
What is an Orphan Drug?
Orphan drugs are medicinal products intended for diagnosis, prevention, or treatment of rare diseases or disorders. A “rare” disease is defined as a condition that affects fewer than 200,000 people in the U.S. (5 per 10,000 in Europe) or the prevalence is greater but the drug manufacturer is not expected to recover the costs of developing and marketing the treatment.
Why Apply for an Orphan Drug Designation?
Obtaining orphan designations is one of the first and most fundamental steps in developing a drug that treats a rare disease. Benefits include:
- Seven years of marketing exclusivity
- Tax credits
- PDUFA Fee exemption
- Regulatory support from the Office of Orphan Product Development (OOPD)
- Extraordinary interest from the investment community in developing orphan drug products
- Access to the OOPD grants program
Obtaining orphan designation greatly strengthens the business case and investment thesis for early stage drugs, providing the momentum to enter the clinic.
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