DDR has put together a world-class team of development and commercialization experts to help make your drug development and launch processes as efficient as possible. In addition to the personnel listed below, DDR has access to an extensive network of professionals who can further enhance and complement your team on a short- or long-term basis.To contact any of the consultants below, please e-mail firstname.lastname@example.org.
Jerry Boudreault is the President and Founder of DDR. With over 20 years’ experience in the healthcare industry, Jerry has an impressive track record of successfully bringing biopharmaceutical products to market. Prior to founding DDR, Jerry was Director of Supply Operations at Transkaryotic Therapies, Inc., where he was responsible for managing external manufacturing and distribution capacity for all clinical and commercial biologic products as well as industrializing the operations of TKT in preparation for the launch of Replagal®. Previous to that, he spent 12 years at Biogen, Inc. where he held management positions in the operations planning, Avonex® supply chain, outsourcing and clinical and commercial manufacturing groups.
Jerry graduated magna cum laude with a BS in Operations Management and Economics from the University of Massachusetts, Boston, with distinction in Economics. Jerry is currently serving a 2-year term as President of the New England PDA (Parenteral Drug Association).
Carolyn Green, Ph.D., MBA, has been a Vice President at DDR since 2006. Focusing on Regulatory Affairs, Analytical Development and Project Management, Carolyn brings expertise in development and post-approval activities, business processes for Quality Control groups in data management systems and contract development, and in CMC Regulatory Affairs with filings for NDA, IND, amendments and supplements to the FDA, EU, Canada and other international markets. Prior to DDR, Carolyn held senior scientific positions at Momenta Pharmaceuticals, Inc. and Millennium Pharmaceuticals, Inc., where she gained invaluable experience in GMP facility compliance, authoring regulatory filings, developing and validating analytical characterization methods, collaborating with external analytical laboratories, setting specifications for CMC team for starting materials, intermediates, API and DP, and working with Quality Control to evaluate drug impurities.
Carolyn holds a BA in Chemistry from Albion College in Michigan, a Ph.D. in Chemistry from the University of Iowa, Iowa City, and an MBA from the University of Massachusetts, Boston
Antonio L Mercado, MS, has been a Senior Consultant at DDR since 2013. With over 25 years' in drug development, he has hands on experience in Regulatory Affairs CMC (Health Authorities meetings, CMC regulatory strategy and life cycle management in the US, EU, Canada and other international markets including Brazil and China), Analytical Development, QC and QA activities including auditing and management of Contract Manufacturing Organizations (CMOs).
Prior to DDR, Antonio held analytical laboratories management positions at Janssen Pharmaceutica in Puerto Rico and New Jersey, and Purepac Pharmaceuticals (now Actavis) in New Jersey. He later held CMC Regulatory Affairs positions at Sanofi-Aventis in Pennsylvania and more recently at Millennium Pharmaceuticals, Inc. (Takeda) in Cambridge, MA.
Antonio holds a BS in Chemistry from Interamerican University in Puerto Rico, a Master in Quality Assurance/Regulatory Affairs and a Post Master Certificate in Regulatory Affairs from Temple University School of Pharmacy in Philadelphia, and is currently pursuing an MBA at Northeastern University in Boston, MA. He is currently a member of RAPS and DIA.