Plasmid DNA Insights: Expanded focus on CMC in gene & cell therapy development

Gene and cell therapy developers are contending with the implications of the evolving regulatory environment while trying to progress programs as quickly as possible to address unmet needs and secure first-mover advantage in competitive indications. Regulators are facilitating efforts to truncate development timelines through a series of designations that can expedite programs while also making efforts to implement standardization.

Our expert panel will discuss the key quality areas that are gaining more scrutiny from regulators, and the reasons and thinking behind it.

  • Construct design elements—eliminating extraneous sequences while optimizing yield and expression.
  • Changes in the field and current efforts underway to drive a reduction of time from start to finish for producing high-quality product at a commercial scale.
  • Evaluation of key in-process and standardized release testing with validation glidepath.
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Anthony Davies

Dr. Anthony Davies

Executive Chairman, Dark Horse Consulting

Anthony founded Dark Horse Consulting in 2014, bringing 20+ years of leadership experience in product, process and manufacturing development to cell and gene therapy companies in need. Anthony has a proven track record in managing pharmaceutical pipelines, is a skilled liaison with international regulatory agencies, and has an intense familiarity with a wide range of biologics, and cell and gene therapies. He is a highly sought-after keynote speaker and chair of national and international conferences and seminars, noted for his provocative, thoughtful and sometimes contrarian presentations.

Ken Bonnell

Ken Bonnell

SVP of Quality and Regulatory, Aldevron

Ken Bonnell is an accomplished quality, operations, and regulatory compliance expert with more than two decades of experience in the biosciences, biotech, and pharmaceutical industries. He joined Aldevron as Senior Vice President of Quality and Regulatory Affairs in July of 2020 and is a member of the company’s executive team. He is responsible for all quality and regulatory compliance, and for supervising standards across all Aldevron’s sites. Before Aldevron, Bonnell served as the Vice President and Global Head of Quality for Teligent Pharma, a multi-million dollar global pharmaceutical company, where he was responsible for returning the organization to a state of compliance following an FDA warning letter. He also spent five years at Merck, where he served as Director of Quality Assurance, and six years at PCI Pharma, where he served as Executive Director of QA, and later as Global Vice President of Quality and Regulatory Affairs.

Bonnell graduated with a B.S. degree in Biology from Mary Washington University, Fredericksburg, VA; and an M.B.A. in Business Management from Montgomery University, Meridian, MS; and a Master of Science in Biology from the University of Nebraska, Kearney, NE.

Biswarup DasGupta

Biswarup DasGupta

Director of Quality Assurance, Sarepta

Biswarup DasGupta (Bis) is a Quality and Compliance leader with more than 20 years of experience leading cross-functional teams in Manufacturing, Quality Control, and Quality Assurance. He has successfully lead Consent Decree (CD) Verification, Certification Inspection by FDA, and Audit Phase of the CD during this period. His professional strengths are Development, Remediation, and Implementation of Quality Systems, validation of the Isolator, Aseptic Processing, Contamination Control and Compliance with CGMP, Training and mentorship, Pre-Approval Inspection (PAI) Preparation, Internal Audits, Method and Equipment Validation, Project Management, and Quality Risk Management. He has experience in both large and small molecules (both pharma and biotech including Gene therapy) drugs. Bis is actively involved with PDA, co-authored PDA TR 13-2, and currently leading the new TR on Contamination Control. He joined Sarepta Therapeutics as Director of Quality Assurance in July of 2019. Before Sarepta, Bis worked as a Quality leader for Sanofi for over 10 years and GKS Biologics for 2 years prior to joining Sanofi.

Bis graduated with a B.S. degree in Chemistry, Microbiology, and Zoology from Bangalore University, India, and a Master of Science in Microbiology from the University of Mysore, India.

Frank Bonnelly

Frank Bonnelly

Director of Supply Chain, Encoded

Frank Bonnelly is an accomplished, customer service focused and results-driven leader with 17+ years of professional experience in alliance and strategic partnership management, CMO management, supply chain, external manufacturing, continuous improvement, change management, supply planning, new product launch, and S&OP. Frank joined Encoded Therapeutics in September 2021 as Director of Supply Chain and Alliance Management. Prior to joining Encoded, Frank spent more than four years at AveXis where he led the supply chain and sourcing efforts for critical raw materials (plasmids, HEK cell line, PEI, and more.) as well a critical manufacturing equipment. Frank also led Alliance Management for critical external partnerships including viral vector CMOs. Prior to AveXis, Frank spent nine years at Hospira, primarily in supply chain focused roles.

Frank graduated with a Bachelor of Science in Industrial and Systems Engineering from the Georgia Institute of Technology, Atlanta.

Arsalan Arif

arsalan arif

Founder & Publisher, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.