November 02
12:00 pm - 1:00 pm EDT

LOCAL TIME

Scaling up a gene therapy manufacturing facility

Scaling up a gene therapy manufacturing facility is extremely complex and challenging. In this webinar, co-sponsored by Precision ADVANCE and Project Farma, a panel of industry experts discuss the strategies and challenges faced when building a cutting-edge gene therapy facility from the planning stages to build-out to operational readiness. They will also share key insights into their company’s approach to building these facilities and for mitigating risk under accelerated timelines.

JOIN THIS WEBINAR TO:
  • Hear from industry leaders on their unique experience and approach to building a gene therapy manufacturing facility
  • Learn whether a facility is right for your organization by utilizing a “make vs. buy” business case analysis
  • Learn about flexible manufacturing including modular and single-use technology
  • Set up your facility build for success by creating proper project workstreams, infrastructure, and quality systems
  • Learn about phased implementation, commissioning and qualification strategies, and regulatory challenges

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Sarah Stoll

Sarah Stoll

Director, Project Farma

Sarah Stoll is a Director at Project Farma. She has over 10 years of experience in capital projects, operational strategy and execution in the Pharmaceuticals, Biotechnology, and Cell & Gene Therapy Industry. In her role, Sarah applies expert knowledge, industry experience, and relentless energy to resolve potential roadblocks and produce solutions. She has led diverse, cross-functional teams of up to 25 throughout the entire project lifecycle including project initiation/funding requests, business case development, conceptual design, basis of design, detailed design, construction, commissioning and qualification, validation, project close-out/purchase order closure. She has a degree in B.S in Chemical and Biological Engineering from the University of Colorado at Boulder.

Ricardo Jimenez

Ricardo Jimenez

VP, Technical Operations, Neurogene

Ricardo Jimenez serves as the Vice-President of Technical Operations for Neurogene Inc., a company focused on gene therapy for rare neurological disorders. Mr. Jimenez has spent more than 20 years in the pharmaceutical and biotechnology industry, with >15 of those years in the gene therapy field. Prior to Neurogene, Mr. Jimenez was the site head of the Lonza Houston manufacturing facility and played a leadership role in establishing Lonza as a major contract cellular and gene therapy manufacturer, including designing and managing the construction of the flagship cell and gene therapy facility in Pearland, TX. He started in gene therapy in 2005 at Introgen Therapeutics, where he was responsible for the validation activities for adenoviral-based products and served as Head of Quality in what became in 2009 Vivante GMP Solutions, a contract manufacturing organization acquired by Lonza. Mr. Jimenez holds a B.S. in biomedical science from Texas A&M University.

Greg Gara

Greg Gara

SVP, Manufacturing, Taysha Gene Therapies

Greg R. Gara has over 25 years of experience in the biotechnology field specializing in designing, constructing, and starting up large- and small-scale manufacturing facilities throughout the world. Greg is currently the SVP of Manufacturing for Taysha Gene Therapies. Prior to joining Taysha he was the VP of Pharmaceutical Engineering at Sarepta. Before Sarepta, he designed, constructed, and started up the facility located in North Chicago for AveXis, a Novartis company, led the team for the facility expansion in North Carolina, in addition to renovating the recently acquired Colorado site. Greg and his team were responsible for the design, construction, startup, and commissioning of the new facilities being constructed in Research Triangle Park and Colorado. Prior to AveXis, he led the facilities and engineering organization at Hospira prior to the Pfizer acquisition. Before joining Hospira, Greg spent 15 years working for Amgen and was part of the Cork Ireland construction project.

Brian Winstead

Brian Winstead

Director, Pharmaceutical Engineering, Sarepta

Brian Winstead has over 25 years of experience in the pharmaceutical industry leading small and large scale GMP facility builds. As Director of Facilities and Engineering at Sarepta, he is currently responsible for the operation and maintenance of Sarepta’s five facilities including environmental health and safety and managing capital projects.

Prior to Sarepta, Brian was a program manager leading a large $500MM facility build for CSL Behring’s cardiovascular drug and launch of CSL’s gene therapy acquisition, integration and facility build in Pasadena, California. Prior to joining CSL, Brian held multiple leadership roles in project and program management with Novartis, Pfizer Global Engineering, King Pharmaceuticals Global Engineering and Wyeth. In these roles, he led capital project programs ranging from $1Mto $200MM encompassing GMP facility builds for new drug launches, technologies in aseptic processing, oral solid dose, and cell and gene therapy. Brian’s education includes a Bachelor’s in Mechanical Engineering from North Carolina State University and Project Management Professional Certification. He is an active member in healthcare organizations including the Project Management Institute, International Society of Pharmaceutical Engineers, American Society of Mechanical Engineers and others.

Tony Khoury

Tony Khoury

EVP, Project Farma

Tony Khoury is an experienced industry leader in life sciences, specifically, biologics and advanced therapies. As a member of the Project Farma leadership team, Tony has spearheaded the firm’s growth in the biologics and most recently next generation medicines. Tony has extensive experience with small and large molecules including biologics, biosimilars, and cell and gene therapies and has worked with small and large life science organizations including startups, academic centers, financial institutions and CMOs/CROs.

Tony is a subject matter expert with Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focused on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring cell or gene therapies to market.

Anshul Mangal
moderator

Anshul Mangal

President, Project Farma & Precision ADVANCE

Anshul is the President of Project Farma (PF) and Precision ADVANCE. He founded and grew PF into a leading global biologics and advanced therapy engineering consulting firm. In addition, Anshul has served as general counsel and managed all corporate legal transactions. Under Anshul's leadership, PF pioneered the industrialization of advanced therapies including two notable, commercially approved cell and gene therapies and created PF's Advanced Therapy Manufacturing Playbook. This playbook helped develop the largest cell and gene therapy manufacturing footprint in the world. To date, PF has led 20+ facility builds with over $1BB in capital spend, selected and managed 60+ CDMO engagements and partnered with over 40+ advanced therapy organizations.

Project Farma was acquired by Precision Medicine Group in 2020 to be the cornerstone of Precision ADVANCE. ADVANCE is a collection of Precision's interconnected services and complementary teams that uniquely focuses on the complexities of clinical, regulatory, manufacturing and commercial needs to successfully bring a cell or gene therapy to market. Anshul is also dedicated to advancing next-generation medicines through his philanthropic efforts at the Institute for Life Changing Medicines, various patient-advocacy organizations and the Alliance for Regenerative Medicine.