Leading the Change to Continuous Manufacturing of Small Molecules

February 25, 2020 8:00 AM - 10:00 AM

Ragon Auditorium, 400 Tech Square, Cambridge, MA 02139

Add to Calendar 2/25/2020 8:00:00 AM 2/25/2020 10:00:00 AM Leading the Change to Continuous Manufacturing of Small Molecules

For more than a century, pharmaceuticals have been assembled through a systematic step-by-step process known as batch manufacturing. Continuous Manufacturing (CM) facilitates production of the final dosage form in a single nonstop process with no equipment downtime. Although different approaches are being taken, the goals are the same: promoting drug quality and improving the efficiency and yield of pharmaceutical manufacturing.

Today, with the support of CDER FDA, under the leadership of Janet Woodcock, MD, there are four companies manufacturing five FDA approved products using CM, treating diseases like cystic fibrosis, HIV-1 infections, breast cancer and leukemia. According to FDA, about 20 additional companies have engaged them to support their efforts to convert to CM.

Massachusetts has been at the forefront of this paradigm shift, with its home-grown companies and academic institutions developing and commercializing innovative continuous solutions. In this forum we’ll explore where we are and what’s next with Continuous Manufacturing of small molecules and what companies should be doing. We’ll also hear how CM has the potential to transform the entire discovery, development & manufacturing value chain from some visionary leaders.

This forum will focus on the following aspects of this ongoing industry transformation:

  • What are the advantages/disadvantages of adopting continuous manufacturing? What is the risk of being left behind?
  • What are the current barriers for implementation of continuous manufacturing?
  • What is the Emerging Technologies Team (ETT) at CDER, and their role in CM?
  • How should companies approach testing/adoption of this new platform? 
  • What is the role of supporting equipment, e.g., Process Analytical Technologies (PATs), and control systems?
  • End-to-end – when will this happen?
  • What is the larger vision for continuous flow technology and autonomous reaction platforms?

 Ragon Auditorium, 400 Tech Square, Cambridge, MA 02139
  • Jennifer Baltz, Ph.D.
  • Co-Founder and COO, Zaiput Flow Technologies
  • Jennifer Baltz, Ph.D. is a scientist with expertise in fields ranging from biophysics to basic biology and an entrepreneur with extensive business experience. Dr Baltz holds a Bachelor of Science from Johns Hopkins University and a Ph.D. in Biochemistry from Harvard University. She has been involved in the fundraising, boot-strapping and operation of several start up companies at different levels. She has been collaborating for several years with one of the largest angel investment groups in the US and with multiple investment funds focused on innovative technologies. She brings to Zaiput a breadth of business expertise, scientific acumen and connections in the business arena and is currently coordinating Zaiput's financial and business strategy.
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  • Matthew M. Bio, Ph.D.
  • President and Chief Executive Officer, Snapdragon Chemistry
  • Matthew Bio brings substantial experience in process development to Snapdragon Chemistry and is driven by a passion for developing new technologies in organic synthesis; enabling safer, more efficient processes; and providing access to new chemical architectures. Matthew earned his Ph.D. in Chemistry from Columbia University and went on to work as a process development chemist at Merck Research Laboratories. In 2006, Matthew moved to Amgen, where he was promoted to Director of Process Development and led the development of both batch and continuous processes for clinical candidates. Throughout his career, Matthew has been involved in the development of more than 50 clinical candidates, the launch of three new drugs to the market, and is author or inventor on numerous regulatory filings and more than 30 peer-reviewed publications and patents.
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  • Ray Forslund, Ph.D.
  • Vice President, Head of CMC Development and Project Management, Syner-G- Pharma Consulting
  • Ray received his Ph.D. in Organic Chemistry from the University of Illinois at Chicago and completed his MBA from Babson College. Ray has over 13 years of experience in the Pharmaceutical industry working for both pharmaceutical and CRO/CMO companies. At Syner-G, Ray is a member of the Senior Leadership team having responsibility for leading the CMC and Project Management business units. His team is responsible for providing scientific solutions for drug development programs including identifying and managing CRO/CMO/CDMOs for Syner-G’s clients to support drug substance, drug product and analytical development activities. Ray’s scientific team is also tasked with providing strategic and Program Management oversite of development and clinical stage programs. Previously, Ray was part of the Senior Leadership team at Laurus Synthesis Inc. (LSI), a Boston based CRO/CMO where he led the Project Management group. He began his pharmaceutical career as a process chemist at Vertex Pharmaceuticals then moved on to Ironwood Pharmaceuticals holding several scientific positions of increasing responsibility leaving as a Senior Manager of Operations.
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  • Jana Spes, M.Sc., MBA
  • Head of Pharmaceutical Development & Manufacturing Sciences, Ironwood Pharmaceuticals
  • Jana Spes, Head of Pharmaceutical Development and Manufacturing Sciences at Ironwood, is a Technical leader with global experience in big and mid-size pharma companies in US, Canada and Europe focused on development, scale-up & launch of global products, implementation of new technologies and life cycle management initiatives An expert in product launch and life cycle management from API, early development/CMC, QbD based process scale-up and commercial technology transfer through innovative implementation of FDA and global regulatory guidance’s. In the current role, she provides strategic and operational leadership for drug product and analytical CMC development and manufacturing of clinical trial materials for Ironwood pipeline of small molecules. In previous roles as VP of TechOps, Apotex, Canada, she was responsible for technical life cycle management strategy of a large commercial portfolio. Prior to Apotex, she worked as Director, Process Development & Product Support at Ferring in Switzerland, a specialty bio-pharmaceutical company, where she spearheaded implementation of FDA Validation Guidance, participated in design of biotech processes according to ICH Q8-Q10 guidelines and lead a team working on biological and small molecules. She started her career with Pfizer and Johnson and Johnson in USA.
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  • Bayan Takizawa, MD, MBA
  • Co-Founder and Chief Business Officer, Continuus Pharmaceuticals
  • Bayan Takizawa is a co-founder and the Chief Business Officer at CONTINUUS Pharmaceuticals. Before joining CONTINUUS, he was a consultant with The Chartis Group, an advisory firm that provides strategic and operational support for hospitals and healthcare systems. Prior to Chartis, Bayan was a senior analyst at Actin Biomed, a healthcare venture capital firm. In addition, Bayan has worked at Sandoz Pharmaceuticals, where he studied the economic impact of a novel continuous chromatography technology. This work led to his Master’s Thesis, which was nominated for “Best Thesis Award” within the Leaders For Global Operations Program at MIT. Bayan has an MD from Yale, an MS in Engineering Systems and MBA from MIT, and a BS in Chemical Engineering from Cornell. He has multiple publications in peer-reviewed journals.
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  • Bernhardt L. Trout, Ph.D.
  • Prof. Chemical Engineering, MIT & Director of the Novartis-MIT Ctr. for Continuous Manufacturing
  • Bernhardt L. Trout is a Professor of Chemical Engineering at MIT. He is currently Director of the Novartis-MIT Center for Continuous Manufacturing and the Co-Chair of the Singapore-MIT Alliance Program on Chemical and Pharmaceutical Engineering. He received his S.B. and S.M. degrees from MIT and his Ph.D. from the University of California at Berkeley. In addition, he performed post-doctoral research at the Max-Planck Institute. Professor Trout’s research focuses on molecular engineering, specifically the development and application of both computational and experimental molecular-based methods to engineering pharmaceutical formulations and processes with unprecedented specificity. Since 1999, he has focused on molecular engineering for biopharmaceutical formulation, primarily liquid formulation, but also lyophilized formulation. A major aspect of his research focuses on developing both microscopic and macroscopic models to design stable formulations efficiently. In 2007, with several colleagues from MIT, he set up the Novartis-MIT Center for Continuous Manufacturing, a $85 million partnership with the objective of transforming pharmaceutical manufacturing. In addition to Novartis, he has worked with many other pharmaceutical companies in research or consulting. He has published over 150 papers and currently has 21 patent applications.
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