Break free from Quality Roadblocks

Sarah Thomas

Senior Vice President of Quality, REGENXBIO

Sarah Thomas is the Sr. Vice President of Quality at REGENXBIO, responsible for the Quality Assurance, Quality Control and Analytical Development organizations. She has over 30 years’ experience in pharmaceutical, biotech & gene therapy Quality. She has experience working with products at all phases of development, from early clinical phases to commercial distribution. She has led Quality teams through the transition from clinical to commercial operations, and through multiple product approvals. Ms. Thomas received an MBA from George Washington University and a BS in chemistry from Butler University.

Keith A. Lamb, Ph.D.

Executive Director, Lachman Consultant Services, Inc.

Keith A. Lamb, Ph.D. is an Executive Director at Lachman Consultants and a Quality and Chemistry Manufacturing and Controls (CMC) executive with a passion for innovation and delivery of novel medicines to patients. Committed to the combination of quality, science and a risk-based approach to ensure clear decision making and outcomes which benefit patients. Broad technical understanding and experience in biopharmaceuticals, small molecules, and cell and gene therapy (CGT). Inclusive leader of teams with demonstrated delivery across the product development lifecycle and commercialization. Extensive experience in design, implementation and operation of Pharmaceutical Quality Management Systems for current Good Manufacturing Practice (cGMP) and product quality, all whilst growing and developing organizations and inspiring people development. Detail oriented with business and strategic acumen demonstrated through experience presenting and reporting risks and performance summaries for a wide range of technical and corporate governance forums.

Susan McClatchey

Vice President, Quality, Eterna Therapeutics

Ms. McClatchey is a seasoned Quality professional with 29 years of experience in the biopharmaceutical and blood banking industries. For the last 18 years she has specialized in development and implementation of quality management systems, as well as commissioning and qualification of cleanrooms in support of pre-clinical and clinical stage product development and manufacturing. She is currently Vice President, Quality at Eterna Therapeutics. Prior to joining Eterna, she held positions at IDEC Pharmaceuticals, Cosmo Bioscience, and ViaCyte, among other companies. She began her career in the Quality Control laboratory performing environmental, raw material and product testing, analytical method development, and validation. Ms. McClatchey has a B.S. in Biology from California State University, San Marcos and a professional certificate in Clinical Trials Management from UCSD Extension.

Richard Dennett

Senior Director CMC & Regulatory Strategy, PPD

Richard has nearly 30 years biopharmaceutical industry experience and actively consults on wide ranging aspects of Regulatory Affairs CMC for client projects. He provides seasoned expertise, regulatory-technical guidance, and direction for ‘concept to commercial’ global regulatory CMC strategy. Richard further chairs PPD’s Regulatory Affairs Advanced Therapies Forum where he is instrumental across a wide array of cell and gene therapy (CGT) projects at all stages of clinical development. He has extensive and actual ‘hands-on’ experience across research/development and GMP manufacture of multiple biopharmaceutical products; able to readily bridge across essential technical and regulatory aspects and to provide focused strategic CMC input at all key stages.

Shardha Millington

Consultant, Citeline

Shardha is a consultant at Citeline (formerly Pharma Intelligence) who specializes in cell and gene therapy, working with Biotech and Pharmaceutical companies conducting competitive research and strategic market analysis. Shardha is also active in thought leadership creation, having published articles for Citeline's In Vivo publication, as well as quarterly reports on the Gene, Cell and RNA landscape published as part of a continuing partnership with the American Society of Gene and Cell Therapy.