Effective June 2, 2017, Cote Orphan LLC has been purchased and is now wholly owned by QuintilesIMS. All Cote Orphan personnel (including Dr Tim Cote) are being carried forward as employees now of "Cote Orphan, a QuintilesIMS Company". We are delighted to continue serving hundreds of orphan drug innovators with the absolute best in both orphan designations and review division regulatory affairs. 


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.

Download the OrphanDB Today!

OrphanDB, an orphan drug database brought to you by Coté Orphan, LLC, allows users to access orphan drug designation information with both the Food & Drug Administration (FDA) and the European Medicines Agency (EMA). 

-Access and search the EMA and FDA databases of orphan drugs in a user-friendly manner to check for designation status
-Search for orphan drugs matching criteria such as country, active substance, trade or generic name, sponsor company, and the app will even auto-suggest on partial entries
-Receive push notifications twice daily for any results you've followed
-Join Coté Orphan's mailing list

Our Leadership Team

 
Timothy Coté

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

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.

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JOSEPH KISZKA, MBA
VICE PRESIDENT OF BUSINESS DEVELOPMENT

Joseph Kiszka has experience in business development and strategy in both the medical device and biotech markets. In previous roles, Kiszka has worked closely with medical device executives and physicians on market development, product development, as well as medical education and training. In his current role at Coté Orphan combined with his previous achievements in earlier roles at Coté Orphan, Kiszka develops and drives overall business development strategy and long-term sales initiatives for a team of Business Development Managers and Associates covering national and international markets.  He earned his Master’s in Business Administration from Mount St. Mary's University, his Undergraduate Bachelor’s Degree in Science from George Washington University, and Six Sigma Lean and Green Belt from Villanova. Additionally, Joseph has recently started work to achieve a Ph.D. Prior to joining Coté Orphan Kiszka served 11 years in the U.S. Navy.

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Robert Anderson, PhD
Director of Regulatory Affairs Science

Robert Anderson has experience in translational science, regulatory affairs and program management. At Coté Orphan he is Director of Regulatory Affairs Science and his major responsibilities include coaching and mentoring clients and internal teams of regulatory scientists on submission strategy, product development planning and Chemistry, Manufacturing and Control (CMC) challenges. He has a extensive expertise in vaccines, and biotherapeutics, including cellular and gene transfer products. Prior to joining Coté Orphan, Anderson served as Senior Principal Regulatory Affairs Scientist at Leidos, Inc. Previously, Anderson was a Product  Reviewer (CMC) and Regulatory Project Manager at CBER/FDA. His portfolio of projects included novel viral vectors, cell therapies, cytokines and monoclonal antibodies and immunoglobulin like molecules. Anderson earned a B.Sc. in Biology/Microbiology from University of the Sciences in Philadelphia (USP; nee PCPS), a Ph.D. in Microbiology from the Pennsylvania State University College of Medicine, and completed doctoral and post-doctoral research in viral immunology and antigen processing.  Anderson also completed post-doctoral work at Yale University School of Medicine.


Our Staff


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Our Services

 

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.

RMAT Designation →

    - Our regulatory staff are well-versed in the unwritten rules of the FDA, and have had great success helping our client’s products achieve breakthrough status, among other designations

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.

    - 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:

  1. Seven years of marketing exclusivity
  2. Tax credits
  3. PDUFA Fee exemption
  4. Regulatory support from the Office of Orphan Product Development (OOPD)
  5. Extraordinary interest from the investment community in developing orphan drug products 
  6. 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.

 

Contact Us


 
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Coté Orphan, LLC

8630 Fenton Street, Suite 724
Silver Spring, MD 20910
202.779.9599

 

COTÉ ORPHAN, LLC

Cambridge Innovation Center (CIC)
1 Broadway
Cambridge, MA 02141