Managing raw and starting materials for viral vector manufacture: managing risk and staying flexible

Abstract

<div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/Eric Hacherlsq.jpg" data-image="1"></div><div class="author-det"> Eric Hacherl holds a PhD in Chemical Engineering from Rutgers University. As the Head of Manufacturing, he is responsible for Internal and External Manufacturing, Materials Management, Shipping &amp; Receiving and Manufacturing Science &amp; Technology. Eric joined Spark in September 2020 with over 20 years of experience in the pharmaceutical industry. His functional expertise lies in Operations, Supply Chain and Manufacturing Science &amp; Technology. His focus has been primarily on vaccines and large molecule manufacturing. Prior to joining Spark, he was the Site General Manager and VP of Operations for Catalent Gene Therapy in Baltimore, MD. </div></div></div><div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/Klem photo 200x200.jpg" data-image="1"></div><div class="author-det"> Christopher Klem is an experienced professional specializing in technical and logistical oversight of external/contract manufacturing operations in the emerging gene therapy space. Effectively managed external manufacturing projects for over 15 years, specializing in relationship building and execution of program deliverables. Current experience in oversight of all aspects of outsourced supply chain partnerships: drug substance, drug product, secondary packaging and specialty distribution of commercial and clinical gene therapy products. Also have managed and directed internal Primary and Secondary operations in both pharmaceutical and biopharmaceutical manufacturing, directing large multi-tiered teams to meet internal manufacturing objectives. </div></div></div><div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/Galbraith photo 200x200.jpg" data-image="1"></div><div class="author-det"> Mark Galbraith has worked in the biopharmaceutical industry for 20 years, where he has gained diverse experience and knowledge in all phases of product development from preclinical to commercial. Mark began his career at Merck &amp; Co, where he held positions of increasing responsibility in several functional areas related to vaccine clinical development and vaccine commercial manufacturing including analytical R&amp;D, regulatory sciences, commercial analytical support, and quality control operations. Mark continued to develop his career in quality control management and analytical development by directing the quality control activities at Celldex Therapeutics, Bristol Myers-Squibb, and Gilead Sciences. Mark has gained a broad knowledge of vaccines, biotechnology products, sterile pharmaceuticals, and now gene therapy. Mark is currently serving as Head of Quality Control and Analytical Sciences for Spark Therapeutics Inc. in Philadelphia, PA. Spark is a leader in the field of gene therapy, seeking to transform the lives of patients by developing potential one-time, life-altering treatments for debilitating genetic diseases. </div></div></div><div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/Ryan Bartock sq.jpg" data-image="1"></div><div class="author-det"> Ryan Bartock is Vice President and Head of Technical Strategy &amp; Operations at Spark Therapeutics, a fully integrated gene therapy company and member of the Roche family of companies. Ryan joined Spark Therapeutics as Head of Supply Chain and Network Strategy in 2017 where he established the Supply Chain function and launched the first ever FDA approved Gene therapy. His current responsibilities include leading the Supply Chain and CMC Program Management functions, as well as strategic initiatives across Research, Technical and Commercial organizations. He is also interim Head of Technical Development, overseeing Process and Analytical development, Automation and Pre-Clinical Operations. Ryan holds BSc in Engineering and Business from Drexel University. His 18 years of industry experience spans pre-clinical and clinical development, manufacturing operations, supply chain, CMC, corporate strategy and new product launches at both GSK and Merck. </div></div></div>