JLABS and MilliporeSigma Discussion Panel Event – Navigating technical and regulatory challenges with confidence
South San Francisco, CA
3:30pm - 6:30pm
It is critical to anticipate and overcome challenges rapidly when transitioning from pre-clinical POC studies into clinical studies in drug development. The earlier you consider the risks and long-term effects of raw materials, technologies and process performance, the higher your chances of succeeding in development.
Key considerations regarding raw materials, supply chain robustness, technology scalability and validation requirements are often underestimated. However, if one of these areas is not properly managed, it could lead to serious project delays and can potentially compromise the development and commercialization of pioneering drug therapies.
This presentation and subsequent panel discussion will:
- Bring to light the challenges encountered when going from animal testing to first-in-human studies
- Consider factors which can mitigate potential pitfalls
- Share ideas how to facilitate a seamless transition
Tom Beil | Vice President of Quality Assurance, MilliporeSigma read bio»
Elizabeth Goodrich | Director of Bioprocess Applications Engineering, MilliporeSigma read bio»
Vince Mecozzi | Scientist for Downstream Purification , Audentes Therapeutics read bio»
Jim Neville | Director of Technology Management – Americas, MilliporeSigma read bio»
Kathy Martin Remington | Principal Scientist, BioReliance read bio»
Jeff Shumway | Associate Director of Business Development, Formulation and Drug Delivery,MilliporeSigmaread bio»
3:00pm | Registration and Networking
3:30pm | Welcome and Introductions
3:45pm | Presentations: Start with the End in Mind
4:30pm | Panel Discussion
5:30pm | Networking reception
6:30pm | Program Close
Free | General Public
Tom Beil | Vice President of Quality Services, MilliporeSigma
Tom Beil is VP and Head of Quality Services for MilliporeSigma. He is responsible for leading the Customer Facing portion of our Life Sciences Quality and Regulatory team. Prior to his current role Tom was VP of Quality and Regulatory Affairs for Sigma-Aldrich. Responsible for leading corporate-wide quality assurance and regulatory programs, Tom re-joined Sigma-Aldrich from the Centocor division of Johnson & Johnson, where he was the Senior Director of Site Quality Assurance. Prior to working for Centocor, Tom worked as Associate Director of Quality Assurance for Wyeth. Prior to the acquisition, this was Tom’s second tenure with Sigma-Aldrich, having spent 13 years as Quality Systems Manager from 1986 to 1999, beginning as a Production Chemist, Procurement, Contract Manufacturing Manager and ending as Manager of Quality Assurance.
Tom’s wealth of knowledge and experience is helping build customer relations upon our industry-leading Quality and Regulatory compliance position. His uses his network of Industry Forums in Rx360 and BPOG to champion our position. His teams current focus is on helping support risk mitigation, quality and regulatory initiatives across product and service through sponsoring Clarity and Magenta programs. These programs will enhance our partnerships with customers to guide them through the challenges faced in procuring materials with the proper compliance profiles.
In addition to his in-depth knowledge of quality systems and the regulatory environment, Tom has experience in petrochemical chemistry, research biology, cell culture in Research, Manufacturing and Purchasing He received graduate and Masters degrees from Illinois State University, majoring in Biology and Chemistry.
Elizabeth Goodrich | Director of Bioprocess Applications Engineering, MilliporeSigma
Elizabeth Goodrich in accomplished biotech engineer with over 25 years of experience in protein purification process development and scale-up as well as system design and process automation. She currently leads the Global Biopharma Applications Engineering team for the Process Solutions business of MilliporeSigma, working to develop proof statements, best practices, and integrated processing solutions for the full range of products in the organization’s toolbox. Ms. Goodrich holds a Bachelor of Science degree in Chemical Engineering from the Massachusetts Institute of Technology.
Vince Mecozzi | Scientist for Downstream Purification , Audentes Therapeutics
Vince Mecozzi, PhD, is a Scientist for Downstream Purification at Audentes Therapeutics. He was the first scientist in the PD team for Audentes, and has been directly responsible for the development, scale-up, and implementation of Audentes downstream process to date. Prior to Audentes, he worked at various biotechnology companies in Cambridge, MA, including Biogen Idec. Vincent received his PhD from Brandeis University.
Jim Neville | Director of Technology Management – Americas, MilliporeSigma
Jim Neville is currently the Director of Technology Management – Americas at MilliporeSigma. This function oversees a team of scientists and engineers who deliver hands-on expertise and experienced consultation through all stages of Biopharmaceutical Development and Manufacturing. He received his B.S. in Chemistry from the State University of New York Oneonta, with additional Course work in Biochemistry. Jim has more than 33 years of experience at MilliporeSigma with previous positions in Chromatographic Media Research & Development, Manufacturing, as well as well as Technical Transfer Engineering and Application Engineering disciplines. He has been an active participant in the American Chemical Society BIOT program for many years through chairing sessions, presenting and as a Downstream Program Coordinator. He has recently been nominated and approved to be the Industrial Chair for the 2019 American Chemical Society BIOT Annual Program. He is an independent reviewer for Wiley Scientific Peer Review Purification Content. He has served as member of the International Scientific Committee for The Affinity Conference. He has presented at the 2014 BioProcessing Asia Conference, and during 2004-2007 was an instructor at the ASME Bio-Downstream Process Design and Economics training course.
Dr. Kathy Martin Remington | Principal Scientist, BioReliance
Dr. Kathryn Martin Remington is a member of BioReliance’s Field Development Services group and provides U.S.clients with technical and regulatory support. Kathy joined the organization in 2010 from Catalent Pharma Solutions where she established a viral clearance program and managed it for 7 years. Prior to that, Kathy was the Section Head of the Viral Validation group for Bayer Healthcare. During her nearly 20 years in viral clearance, she has authored a number of publications on the viral safety of biopharmaceuticals. Kathy earned her M.S. and Ph.D. degrees in Microbiology from the University of Montana
Jeff Shumway | Associate Director of Business Development, Formulation and Drug Delivery, MilliporeSigma
Jeff Shumway is currently the Associate Director of Business Development, Formulation and Drug Delivery, at MilliporeSigma, a business of Merck KGaA, Darmstadt, Germany, where he is responsible for managing a team of technical resources supporting the AMERICAS geography. In his 11 year tenure at MilliporeSigma, Jeff has held varied roles in the technology specialist and commercial sales organization with a dedicated focus on supporting both classic pharma and biopharmaceutical business partners from a process technology perspective.
Prior to working for MilliporeSigma, Jeff spent 10 years at Applied Biosystems (now part of Thermo Fisher) with roles in Research and Development, Quality Control, Quality Systems Management and Operations; with responsibilities related to the development and commercialization of novel chemiluminescent formulations and support technologies for platform screening and protein assay and analysis.
Jeff Shumway holds a Bachelor of Science degree in Biochemistry and Molecular Cellular Biology from the University of Massachusetts at Amherst.
Contact: Jim Viola
Contact Email: firstname.lastname@example.org
JLABS @ SSF
329 Oyster Point Blvd.
South San Francisco, CA