Senior Team
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 info@ddres.com.Jerry Boudreault
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
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
Mike Overton, MS
Mike Overton has been a Senior Consultant with DDR since 2007. With over 25 years’ experience in the life sciences industry, Mike brings expertise in manufacturing, contract manufacturing, technology transfer, supply chain management, manufacturing facility design, start-up and validation, mergers and acquisitions, global strategic partnering, and regulatory agency requirements. Prior to joining DDR, Mike was Vice President of Manufacturing and Plant Operations at Acambis and has held a variety of operations management positions at Wyeth Biotech, and Biogen, Inc., where his responsibilities included bioprocessing, bulk manufacturing, technical operations, facility security, cell culture, technology transfer, CMC authoring, M&A due diligence and CMO selection.
Mike received a BA in Biology from Boston University and a Master of Science in Administration from Central Michigan University.
Mark Staples, Ph.D.
Mark Staples, Ph.D. has been a Senior Consultant at DDR since 2007. For more than 20 years, Mark has helped transform scientifically interesting projects into commercial products. His expertise includes the development of proteins and peptides and project management of the CMC portions of regulatory submissions. From 1997 to 2007 he served at the Director or VP level at MicroCHIPS, Inc., GlycoGenesis, Inc., and Praecis Pharmaceuticals, Inc. At Biogen, Inc. from 1988 to 1997, he played critical roles in the development and launch of Avonex® and Angiomax®, and at Praecis, he led the CMC development team that achieved Plenaxis™ approval.
Mark received his BA and Ph.D. in Biochemistry from the University of Kansas and was also a Postdoctoral Fellow at Harvard Medical School. He has held volunteer leadership positions within the American Association of Pharmaceutical Scientists (AAPS), including Chair of the BIOTEC Section (2006). From 1993 to 2006, he held positions on the Board of the New England Chapter of the Parenteral Drug Association (PDA), was President of the Chapter in 2003-2004, and is a past recipient (2007) of the PDA Chapter Volunteer Award.