MA CRO/CMO: Contract Manufacturing of Drug Substance & Finished Dosage Forms
Friday, January 18 2013
8:00 am – 10:00 am
Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA
This event features an interactive panel discussion with the Boston area's leading experts who will share their impressions of best practices when faced with outsourcing decisions for drug substance/drug product development and manufacturing. The session will address both small and large molecules. The audience is encouraged to engage the panel regarding their challenges with technology transfer, cGMP manufacturing, project management, analytical testing/support, and the impact of an evolving regulatory environment. This event presents a special opportunity for those involved with pharmaceutical production outsourcing decisions to benefit from the collective experience of the Boston biopharma community. Mark your calendar!
- Dave Dlesk, COO, Avaxia Biologics
- Parrish M. Galliher, Founder & CTO, Xcellerex, Inc
- Dr. Sean Johnston, VP Operations, Paratek Pharmaceuticals
- Dr. Tom Wagler, Sr. Director, CMC Operations, Infinity Pharmaceuticals
Dave Dlesk is currently the COO of Avaxia Biologics, a leader in gut-targeted therapeutics, where he is responsible for process development, manufacturing, clinical operations, quality, finance and human resources. Avaxia is bringing its first product, AVX-470 an oral anti-TNF antibody developed to treat Inflammatory Bowel Disease, into the clinic in early 2013. He has held key leadership positions in large and small life science companies including CEO in four start-ups, corporate officer in charge of Operations at Biogen and President of a $200 million subsidiary of Terumo, a global medical device company.
Parrish M. Galliher earned his BA in Biology at Boston University (1975) and then joined the Biofuels Laboratories of Dynatech R/D Corporation where he built and studied the performance of biomethanation stirred tank fermenters to convert coal syn-gas, kelp seaweed, freshwater algae and municipal solid waste to methane. Mr. Galliher then earned his MS degree in Biochemical Engineering at MIT (1981). He then joined Biogen, Inc. in 1981 where bioprocess development he was responsible for design, commissioning and management of Biogen’s and biomanufacturing facilities for both E.coli and mammalian cell manufacturing. As Director of Process Engineering, he led the team responsible for the development of the commercial upstream process and the startup, initial validation and commissioning of Biogen’s Avonex® manufacturing facility, later licensed by the FDA in 1996. Mr. Galliher joined Alpha-Beta Technology (ABT) in 1994 as Director of Manufacturing Development and led the technology transfer, startup, validation, and commissioning of ABT’s commercial biopharmaceutical manufacturing plant in Smithfield, RI at which he became Vice President of Operations and General Manager in 1997. Mr. Galliher joined LeukoSite, Inc. in 1999 as Vice President of Biologics Manufacturing and continued in that role after Millennium Pharmaceuticals acquired LeukoSite. At Millennium, Mr. Galliher led the CMC Team that contributed to FDA and EU licensure of CAMPATH® monoclonal antibody in 2001. He also created and led the Biologics manufacturing “Factory of the Future” Program which enabled high speed development of Millennium’s monoclonal antibodies for clinical trials. In December 2002, Mr. Galliher became Founder, President and CEO of Xcellerex, an advanced single use biomanufacturing services/technology company, where he led the creation of the high throughput robotic PDMax™ optimization technology, single use XDR™ bioreactor, XDM™ mixing systems and the turnkey single use modular FlexFactory® biomanufacturing platform. In December 2004, Mr. Galliher transitioned to Founder and Chief Technology Officer of Xcellerex, Inc.. As Principal Investigator, Mr. Galliher led Xcellerex's $19M US Gov't DoD DARPA/DTRA contract for the "Accelerated Manufacture of Pharmaceuticals Program" (AMP), awarded in 2007 and continued through completion of Phase 2 Swine flu Live Fire Test in 2009. In 2012 GE Healthcare acquired Xcellerex Inc. and Mr. Galliher continued in his position as Chief Technology Officer for Xcellerex, a GE Healthcare Life Sciences Company. Mr. Galliher is the recipient of Bioprocess International’s 2012 “Thought Leader of the Decade” award and is committed to the potential of biotechnology to transform human health. He is co-inventor on numerous patents in the field of advanced high efficiency biomanufacturing.
Dr. Sean Johnston has over 30 years of experience in the pharmaceutical industry focusing on process development, manufacturing and operations. He began his career as a Process Manager for Bristol Myers-Squibb. Prior to joining Paratek, Dr. Johnston served as the Senior Vice President of Operations for Genaera Corporation. At Genaera and other start-up organizations he managed development, manufacture and analytical activities associated with a range of drug product candidates, including small molecules and biologics in multiple product formulations. He has made regulatory submissions in the U.S., Canada and Europe, and has hosted pre-approval inspections and general inspections by the FDA and other regulatory authorities. Dr. Johnston has also worked with pharmaceutical contract manufacturers, including Lonza and Siegfried Chemicals, where he was responsible for all aspects of commercial and clinical manufacturing, process improvement, technology transfer and facilities expansion. Dr. Johnston received his MBA and Ph.D. from the National University of Ireland.
Tom Wagler is currently Sr. Director of Chemistry, Manufacturing and Controls (CMC) development and supply operations at Infinity Pharmaceuticals (Cambridge). Previously, Tom was with Biogen Idec heading their global small molecule contract manufacturing operations focusing on external development and manufacture of API’s, DP and package/labeling finished goods. Prior to joining Biogen, Tom was with Sepracor Pharmaceuticals (now Sunovion Pharmaceuticals) as executive director of Chemical Process Research and Development. Tom has had various other Pharmaceutical Research and Development roles including Bristol Myers Squibb and FMC Corporation. Tom holds a Ph.D. in Organic Chemistry from SUNY Stony Brook and a MBA in Operations from Rutgers Business School.