Transitioning from Benchtop Research to Manufacturing: Getting Past the Growing Pains

July 7, 2020 12:00 PM - 1:00 PM

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Add to Calendar 7/7/2020 12:00:00 PM 7/7/2020 1:00:00 PM Transitioning from Benchtop Research to Manufacturing: Getting Past the Growing Pains

Leading or working in a biopharma startup environment is an exciting venture, but it can also be stressful. As an emerging company matures, it must transition from conducting benchtop research and creating small quantities of its own product to CMC/Manufacturing at scale to achieve a clinical enabling regulatory filing and conduct early stage clinical studies. There are a lot of options to consider and decisions to make. It’s never too early to plan!

In general, a small company cannot do everything required and may experience sticker shock when looking at human resources, outsourcing / partners, supply chain, and funding requirements. Going from research to CMC/ Manufacturing requires a different skill set. Processes that work on a bench do not necessarily scale, and the tech transfer processes with technical partners can be tricky. This panel will go into different approaches small companies can take and how to execute them well. We’ll also talk about new local initiatives to assist early stage companies with manufacturing.

This forum will cover the following:

  • How to find the right partner to generate high quality GLP materials for tox studies
  • Considerations for scaling small versus large molecule products
  • How to set up quality clinical supply
  • How to get the right service as soft skills are often lacking in partnerships
Key Takeaways for Audience:
  • Getting to a clinical enabling regulatory filing is expensive
  • Plan ahead to enable manufacturing – personnel, partners, and funds
  • Going from research to development/CMC is a different skill set
  • Processes that work on a bench does not necessarily scale up

NOTE: MassBio makes every effort to accommodate our entire community at each of our events. Please let us know at least 3 days in advance of the event if you require special accommodations, such as captioning.

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  • Mark Bamforth
  • President & CEO, Arranta Bio
  • Mark Bamforth founded a new CDMO, Arranta Bio, in May 2019, focused on providing process development and clinical supplies to product pioneers in the microbiome space. Previously, Mark founded Brammer Bio in 2015, a best-in-class viral vector contract development and manufacturing organization (CDMO) supporting cell and gene therapies. Brammer’s team grew from 110 in 2016 with the addition of 100 from the acquisition of two Biogen commercial facilities, to over 600 at the time of its acquisition by Thermo Fisher Scientific in April 2019. In 2010, Mark founded a biologics CDMO, Gallus BioPharmaceuticals, and acquired a world-class facility and team of 160 from J&J with a commercial supply agreement. Gallus tripled through organic growth and merging with Laureate Biopharma. Gallus was sold to DPx Holdings B.V. in Sept. 2014. Mark previously spent 22 years in the UK and USA running a global manufacturing operation and a pharmaceutical CMO business for Genzyme and served as a corporate officer for 9 years. He began his career as a petroleum engineer exploring for North Sea oil with Britoil, then as a chemical engineer in the whisky industry with Whitbread. Mark serves on the boards of Avid Bioservices, MassBio, Wentworth Institute of Technology, and Entrepreneurial Scotland. He has a BS in Chemical Engineering from Strathclyde University and an MBA from Henley Management College.
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  • Celina Chang
  • Vice President Business Operations & Technology, LabCentral
  • Celina leads corporate operations pertaining to science, technology and strategic relationships (EHS, IT and business development) and is an advisor for onsite lab operations. She explores strategic expansion opportunities for LabCentral and plays a key role in the design, buildout activities and launch for expansion projects such as the Pagliuca Harvard Life Lab, MIT’s The Engine, LabCentral’s 700 Main Street expansion, LabCentral 610 and LabCentral 238. She began her career in process development working on pediatric viral vaccines with Wyeth Pharmaceuticals then shifted her focus to tissue engineering for both topical and implantable biological medical devices. Prior to joining LabCentral, she spent close to two years as a senior scientist at InVivo Therapeutics, a company developing groundbreaking technologies for the treatment of spinal cord injuries (SCI) and more than six years at Pervasis Therapeutics, a company advancing new therapies to improve dramatically the outcomes of common vascular interventions. She joined the company while it was still an early-stage biotech and was instrumental in advancing several of its products through clinical trials. Pervasis was acquired by Shire. Celina earned her bachelor’s degree in bioengineering from Cornell University.
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  • Spencer Fisk
  • Senior Vice President, Technical Operations, Rubius Therapeutics
  • Operations. Spencer brings to Rubius more than 25 years of experience in Manufacturing and CMC product development. Prior to joining Rubius, Spencer served as VP & Global Head of Cell & Gene Technical Development and Manufacturing at Novartis where led the CMC development and manufacturing organization to deliver the CAR-T portfolio. Under his leadership, the team successfully registered and launched the first CAR-T cellular therapy product, Kymriah, which has demonstrated transformative efficacy in patients with acute lymphoblastic leukemia. While at Novartis, Spencer also led the process development teams in support of the commercialization of Cosentyx® and the registration and approval of ErelziTM and Rixathon®. Prior to Novartis, he led manufacturing and CMC functions in support of Somavert®, Elonva®, Retavase® and Puregon® while at Merck, formerly Schering Plough, Organon and Covance. Prior to Merck, Spencer held various process development and manufacturing roles at Genentech, Genencor and Novo Nordisk.
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  • Parika “Pinky” Petaipimol
  • Associate Director, Program Management at Pandion Therapeutics
  • Parika “Pinky” Petaipimol leads the CMC activities for Pandion Therapeutics and has been with the company since 2018. Prior to Pandion, Pinky spent 14 years at Biogen, where she gained both technical depth and broad knowledge of the biotech/pharma industry in various roles. She also worked in Business Development and New Product Commercialization to round out her technical expertise. In addition to progressing the Biogen pipeline, Pinky grew two important employee resource networks within the company, the Women’s Innovation Network (WIN) and the Parent Networking Group (PNG), to solidify the company’s commitment to diversity and inclusion. Both groups have grown exponentially from their inception and are now integrated into the company’s culture. Pinky has a BS in Biomedical Engineering from Georgia Tech with a concentration in tissue engineering, a MS in Manufacturing Engineering, and an MBA from Boston University. While pursuing her MBA, she worked to spin out a company based on technology from BU. She has served on the External Advisory Board for the Georgia Tech Biomedical Engineering (BME) Department and as a Board Director for BME Career Alliance (which is now absorbed into the Biomedical Engineering Society). She sat on the Advisory Board for the Society for Participatory Medicine (SPM) and is a peer reviewer for the Journal of Medical Internet Research (JMIR). She is also a co-chair for the Drug Manufacturing/CMC/Supply Chain Forum through the Mass Biotech Council.
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