| About Us | Services | Experience | Our Team | Information | Contact Us | Home |
OUR TEAM
Howard L. Levine, Ph.D., Founder, President, and Principal Consultant
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 an Adjunct Assistant Professor of Pharmaceutical Sciences at the Massachusetts College of Pharmacy and Health Sciences, 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 Avant 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. Contact information. Complete CV.
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.
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.
Scott P. Fulton is a Senior Consultant with over 30 years experience in the biotechnology industry. Mr. Fulton’s professional interests include large-scale purification technology, biomolecule analysis, economic modeling of biopharmaceutical manufacturing, transgenic production and business strategies for the biotechnology marketplace. He spent 12 years at Amicon and eight years at PerSeptive Biosystems, as a senior manager in research, product development and marketing of tools and products for the biotechnology industry and life science research, and was responsible for the development and introduction of several dozen chromatography media, membrane, instrumentation and process system product lines. At Genzyme Transgenics (now GTC Biotherapeutics) for five and a half years as Vice President of Program Management, he oversaw development projects for biopharmaceutical protein production in transgenic dairy animals, as well as technologies for downstream processing. Since 2001, Mr. Fulton has worked as an independent consultant in technology and business strategy in the biotechnology industry, joining BioProcess Technology Consultants in 2008. Mr. Fulton is also founder and CEO of BioSystem Development LLC, which is producing a rapid, automated biomolecule analysis system targeted at the pharmaceutical development market. Mr. Fulton received B.S. degrees in physics and applied biology and an M.S. degree in biomedical engineering, all from MIT.
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 20 years of experience in research and 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 (particularly regarding the recently enacted EU CTD/QP legislation) 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.
Robert Conway, Ph.D., has over 25 years of experience in membrane filtration of biological and small molecule pharmaceuticals. Prior to joining BioProcess Technology Consultants, he held positions for eight years at 3M-Cuno, Inc. as Director of Marketing and Associate Director Scientific Applications Support Services. Prior to that, he held senior positions in Marketing and Technical Services at Pall Corporation spanning 18 years.
Dawn Ecker has over 14 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. Contact information. Complete CV.
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. Contact information. Complete CV.
©Copyright 2008 BioProcess Technology Consultants, Inc. |
|||
