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Strategies for building a cell therapy manufacturing facility

Building an advanced therapeutic manufacturing facility is complex and highly customized. In this webinar co-sponsored by Precision ADVANCE and Project Farma, a panel of industry experts discuss the challenges faced when building a cutting-edge cell therapy manufacturing facility from build-out to operational readiness and share key insights into their company’s approach to mitigating risk under accelerated timelines.

Join this webinar to:
  • Hear from industry leaders on their unique experiences and specific approach to building an innovative cell therapy manufacturing facility
  • Understand the site selection process including a “make vs. buy” business case analysis utilizing modular and single-use technology
  • Set up your build for success by creating proper project workstreams
  • Gain key insights into building out infrastructure and quality systems
  • Learn about phased implementation, commissioning, and qualification strategies, change management, and regulatory challenges
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John Khoury

John Khoury

EVP, Project Farma

John Khoury is a 20+ year veteran and leader in the biotech/pharmaceutical industry. As a member of the Project Farma Leadership Committee, John has spearheaded Project Farma’s growth in the gene and cell therapy space. He has led and provided strategy on key partner initiatives including make vs. buy analysis, site and vendor selection, tech transfer execution strategies, and facility start-ups. In addition to his experience in advanced therapies, John has extensive experience with small and large molecules including biologics and biosimilars. Over the past four years, he has led facility builds totaling over $500MM. During this time, he has worked with small and large biotech and pharmaceutical companies including gene and cell therapy startups and CMOs/CROs.

John 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.

Scott Bertch

Scott Bertch

ED, Clinical Site Head, Tenaya Therapeutics

Scott Bertch is Executive Director, Clinical Site Head at Tenaya Therapeutics, a company with a mission to discover, develop, and deliver curative therapies that target the underlying causes of heart disease. Scott has 25 years of experience in the pharmaceutical. And biotechnology field specializing in the design, construction, automation and validation of production. Facilities. Scott has developed and maintained programs for engineering project delivery, equipment acquisition, and commissioning & qualification. Prior to joining Tenaya, Scott served as Senior Director of Technical Operations at Novartis Gene Therapies where he executed major capital projects to design and construct manufacturing, laboratories, warehousing and office complexes for cutting-edge gene therapy manufacturing technologies and modular facility design. Scott's areas of expertise include applying engineering, validation, and. Automated solutions to complex processes in the biotech and gene therapy space.

Sumit Verma

Sumit Verma

SVP, Commercial Manufacturing, Iovance

Sumit Verma currently serves as Senior Vice President of Commercial Manufacturing for Iovance Biotherapeutics – A San Francisco based Immuno-Oncology company dedicated to providing novel products for curing cancer. He has executive responsibilities for building a new cell therapy manufacturing facility and commercial manufacturing organization that will be involved in providing life-saving cancer therapies across North America and Europe.

He has had multiple leadership roles at Merck, Covidien, Mallinckrodt and prior to Iovance, served as the Chief Operating Officer for Curium Pharmaceuticals. He has successfully led his respective teams in four new FDA-approved drug approval and launches over the past 10 years in Biologics, Vaccines, Nuclear Medicine and Radionuclide Oncology.

Sumit received his Bachelor of Science in Chemical Engineering from Lafayette College and Master’s in Engineering Management from Washington University in St. Louis and is fluent in 4 languages. He is a certified PMP® professional, has a Six Sigma Black belt and holds 13 U.S patents in pharmaceutical technology and drug development.

Alexis Melendez

Alexis Melendez

Director, Facilities & Engineering, Kite Pharma

Alexis Melendez is Director of Facilities & Engineering for Kite Pharma where he is responsible for the design, construction and start-up of a greenfield high volume cell therapy manufacturing facility. Alexis was the second employee hired for the Frederick, MD facility with plans to grow the site to 300+ staff over the coming years.

Prior to joining Kite, Alexis spent 7 years at the AztraZeneca Biologics Frederick, MD site where he led the Site portfolio, Site Master Planning and Capital Management teams. During this time, he led major infrastructure, utility and process equipment projects as well as Enterprise software deployments with global network impact. Preceding AstraZeneca, Alexis spent 15 years at Johnson & Johnson where he held numerous positions of increasing responsibility including Maintenance Engineer, Process Engineer and Capital Portfolio Manager with an average annual budget of $35MM. Alexis was also part of the leadership team for a $220MM greenfield facility expansion.

Alexis holds a bachelor’s in Industrial Engineering from University of Puerto Rico. In his 20+ years in the industry, he has gained experience in small molecule, large molecule and now cell therapy manufacturing.

Faraz Siddiqui

Faraz Siddiqui

VP, Process Development & Manufacturing Operations, Instil Bio, Inc.

Faraz Siddiqui is responsible for process development, supply chain and manufacturing operations in US and UK, at Instil Bio. Along with CMC development for ITIL-168 and ITIL-306, Faraz’s team is currently focused on bringing both clinical and commercial capacity online to meet the US, UK and EU demand. He has over 23 years of biotech experience with manufacturing, facility startup, technology transfers, operational excellence and well-rounded process and technology development. Passionate for operations, innovation and leadership, Faraz has been recognized for excellence, impactful change management and key contributions throughout his career.

Prior to Instil Bio, he was a Sr Director, Technology Excellence at Kite, a Gilead Company, responsible for Technology Development, Materials Sciences, Technology Transfers and PD Business Operations. Faraz’s team was focused on pioneering the development of the next generation of automation technology to drive higher quality, reduce processing time and bring the COGS lower for cell therapy industry. In addition, his team was responsible for screening latest processing materials and transferring Kite products in various phases to multiple locations in the manufacturing and partner network. Prior to Kite, Faraz was a global head of biologics tech transfers at Genentech/Roche where his team lead more than 50 biologics tech transfers.

Faraz holds an executive MBA with Honors from Saint Mary’s College and BS in Biochemistry from University of California, Davis.

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 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.