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OUR TEAM
Howard L. Levine, Ph.D., Founder, President, and Principal Consultant
Howard L. Levine, Ph.D. has over 30 years of experience in successful product companies and as founder of BioProcess Technology Consultants, Inc., the leading CMC consulting group in the biopharmaceutical industry. Prior to founding BioProcess Technology Consultants, Dr. Levine was Vice President of Manufacturing Operations at Repligen Corporation. There he was responsible for all process development and manufacturing activities, including production of therapeutic proteins, monoclonal antibodies and recombinant Protein A. Dr. Levine was previously Director, Pilot Plant Operations at Xoma Corporation where he was responsible for the development and manufacture of monoclonal antibody products for clinical trial. He has also held positions of in process development and manufacturing at Genentech and Amgen. Throughout his career, Dr. Levine has assisted in the development of over 20 different biological products and the successful commercialization of 3 of these products. Dr. Levine is currently a member of the Editorial Advisory Boards of BioPharm Magazine and Bio/Pharmaceutical Outsourcing Report, a member of the Scientific Advisory Boards of Pall Corporation and Biologics Process Development, Inc., and a member of the Board of Directors of Protein Sciences Corporation. Dr. Levine has been an invited lecturer on manufacturing strategy, downstream processing, and commercialization of biotechnology products. Dr. Levine holds a Ph.D. in chemistry from the University of Chicago and completed a post-doctoral fellowship at Harvard University.
Susan Dana Jones, Ph.D., has more than 20 years of discovery, product development, and strategic planning experience in biotechnology. She co-founded two biotechnology companies and has managed discovery and product development programs in multiple organizations and for multiple disease areas. She currently manages several outsourced biopharmaceutical process development and manufacturing programs for client products, assists and advises clients and vendors regarding applicable cGMP regulatory guidelines, performs regulatory compliance audits, prepares CMC sections of client regulatory submissions to FDA, EMEA, and other competent authorities, and performs due diligence of manufacturing and analytical operations for investors or clients considering acquiring products in development. In addition, Dr. Jones serves as a guest lecturer at Northeastern University, as a member of the Board of Directors of Virginia-based start up company Gene Solutions, and as a member of the Editorial Advisory Board of BioProcess International. Prior to joining BioProcess Technology Consultants, Dr. Jones was Senior Vice President of Corporate Development at Serenex, Inc, where she worked with other senior managers to complete a $15M Series B financing. She was previously Vice President of Product Development at Waratah Pharmaceuticals, where her responsibilities included management of outsourced product development and manufacturing activities for a combination protein and peptide therapeutic. Before Waratah, Dr. Jones held development and management positions of increasing responsibility at Peptimed Inc., Virus Research Institute (now Celldex Immunotherapeutics), IntraImmune Therapies Inc., and Dyax Corp. Dr. Jones received her Bachelor's degree from Harvard University, her Ph.D. from the University of California, San Francisco, and performed post-doctoral research at the Dana-Farber Cancer Institute of Harvard Medical School.
Dr. Blackwell is the Past President of the Greater Boston Chapter of ISPE, a society for pharmaceutical manufacturing professionals,and currently leads its Process and Product Development Community of Practice at the society’s international level. He is also on the Editorial Review Board for Pharmaceutical Processing. Dr. Blackwell holds Bachelor’s and Master’s degrees in Chemical Engineering and Microbiology, respectively, from The Ohio State University and a Ph.D in Chemical Engineering from Northeastern University. He also received dual Master’s degrees in Business Administration and Technology Management from the University of Maryland.
David F. Broad, Ph.D. has over 30 years experience in process development and manufacturing of biopharmaceuticals, as well as considerable executive experience. Most recently, Dr. Broad was General Manager and Vice President of Genentech’s Oceanside Manufacturing campus. There he was responsible for the successful start up, licensure and operation of their 6 x 16,000L cell culture production facility. He was previously Vice President of West Coast Manufacturing at IDEC (now Biogen IDEC) where he was responsible for the clinical and commercial manufacturing. Following the merger of IDEC with Biogen, this facility was sold to Genentech, and Dr. Broad led the integration of that facility and staff into Genentech. He has also held positions in process development and manufacturing at Cell Genesys, Celltech Biologics (now Lonza), and Beecham Pharmaceuticals (now GSK). Throughout his career, Dr. Broad has contributed to the development of over 30 different biologic products and the successful commercialization of eight of these. He served on the Board of California Manufacturing Technology. Dr. Broad has a B.Sc. and Ph.D. in Microbiology awarded by University of London; he also undertook Postdoctoral studies at University College London, Dept. of Biochemical Engineering. He has authored numerous papers and presentations.
Francisco (Frank) Castillo, Ph.D. has over 30 years of experience in research and process development of biologics. For the last 12 years he held positions as Chairman of the Scientific Leadership Team, Scientific Director, and Head of Fermentation and Cell Culture Development at Berlex Biosciences, a subsidiary of Schering AG. Previously he spent 10 years at Xoma Corporation as Director of Cell Culture and Fermentation Development. He was also a Visiting Scholar at U.C. Berkeley and Founder and Head of the Fermentation Laboratory at the Venezuelan Institute of Scientific Research. Dr. Castillo’s professional activities have ranged from basic research in microbiology and virology to process development for the GMP production of monoclonal antibodies, recombinant proteins, vectors for gene therapy, and cells for cell-based therapies. He has been involved in the development of multiple biologics and was responsible for the CMC sections of numerous regulatory filings and has interacted with the FDA, EMEA, and other international, national and local regulatory agencies worldwide.
Dr. Castillo holds a Ph.D. in microbiology from the College of Medicine and Dentistry of New Jersey and completed post-doctoral training at the Department of Biochemistry, University of Birmingham, U.K.  ALEX KANAREK, PH.D.Senior Consultant Alex Kanarek, Ph.D., has more than 30 years of experience in the biopharmaceutical industry with the Wellcome Foundation (now GlaxoSmithKline) and Connaught Laboratories (now Sanofi Pasteur). In 1993, he established an independent consulting practice specializing in regulatory compliance in drug development laboratories and manufacturing plants, technology transfer and biopharmaceutical product development. In 2006, Dr. Kanarek became affiliated with BioProcess Technology Consultants as a Senior Consultant, providing GMP compliance, regulatory, and auditing services. Dr. Kanarek has authored Guides to Good Manufacturing Practice, Good Laboratory Practice, Good Validation Practice, Good Clinical Practice, and Good Facility Design, as well as The Bioprocessing Industry Market Analysis Report for the Informa Group. He was contributing editor of Bioprocess News for the first 18 months of its existence and continued to write the Regulatory Notes column until the newsletter ceased publication. He is now on the editorial advisory board of the BioProcess International journal. Dr. Kanarek received his B.S. in Microbiology from Imperial College, University of London, and his Ph.D. from Cambridge University. Dr. Kanarek has also received Membership (MCIM) in international pharmaceutical business development from the UK Royal Chartered Institute of Marketing. Contact information. Complete CV.
Patricia Seymour has over 20 years of experience in the biotechnology industry. Her expertise spans the development and commercialization spectrum, including biologics and small molecule development and manufacturing, supply chain strategy and management and operations leadership. Her current activities include: developing overall CMC strategies for diverse product pipelines, developing and implementing outsourcing strategies, managing outsourced process development and manufacturing activities from drug substances through to distribution, steering clients through CMC regulatory requirements and overall CMC operations including project management and budgeting. Prior to joining BioProcess Technology Consultants, Ms. Seymour was Senior Director, Global Investigational Supply Operations at Millennium Pharmaceuticals, Inc., where she worked with other senior leaders to develop and implement CMC strategies including outsourcing. She was previously Director of Business Development at Covance Biotechnology Services (now Diosynth) where her responsibilities included negotiating contact manufacturing projects. As Senior Director, Corporate Development at Collaborative BioAlliance she was instrumental in launching the new contract manufacturing business unit. Before Collaborative, Ms. Seymour held research and development positions at ImmunoGen, Dana Farber and Sloan Kettering. Ms. Seymour received her B.S. from Villanova University and her M.B.A. from Boston University. Ms. Seymour is Certified Supply Chain Professional (APICS).
Dawn Ecker has over 16 years of experience in the biotechnology industry. Her experience ranges from drug discovery, in vitro and in vivo screening, in vivo model development, and pharmacokinetics as well as manufacturing and purification of recombinant products and biopolymers. Before joining BioProcess Technology Consultants, she was a Research Fellow at the University of Massachusetts in Amherst and managed the University’s Core Sequencing Facility, providing contract sequencing and RT-PCR services to the University community and several industrial clients. She also over saw the day to day operations of the research laboratory and aided in the incorporation of high throughput screening methods and equipment enabling expedited research activities. Prior to her position at UMASS, she maintained a biopharmaceutical clinical trials database, assisted in development and administration of client driven marketing surveys and generated client data via proprietary bio-economic models at BioPharm Services Inc. Ms. Ecker has been involved in managing a contract fermentation organization and held research and development positions in several other biotechnology organizations. Her current responsibilities at Bioprocess Technology Consultants focus on maintaining proprietary company databases and utilizing proprietary cost of good and supply chain management models. She holds a B.S. in Microbiology/Biotechnology from Quinnipiac University and a M.S. in Biology from Worcester Polytechnic Institute.
Rick Stock, Ph.D., has worked and consulted for the biopharmaceutical industry specializing in biomanufacturing for 7 years. Prior to joining BioProcess Technology Consultants, he was a specialist in computer modeling of biological and biomanufacturing systems at BioPharm Services, Inc. He has worked on a variety of bioprocesses including r-proteins and biopolymers. Dr. Stock has worked with early stage companies and large pharmaceutical companies such as Amgen, Centocor and Millennium. He was assistant director of a pilot manufacturing facility at Worcester Polytechnic Institute and provided contract development and manufacturing services to a variety of biotechnology clients. He has more than two years of experience instructing and advising graduate students in the Bioprocess Lab at Worcester Polytechnic Institute (WPI). Dr. Stock has also founded and sold his own company (Natural Biopolymers, LLC), which developed a process for producing a novel pharmaceutical grade biopolymer for drug delivery. He holds a B.S. from The Ohio State University, and an M.S. in Chemical Engineering and a Ph.D. in Biochemical Engineering from WPI.
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