Panel: Optimizing Technical Operations: Best Practices for Manufacturing Next-Gen Medicines
  • Current trends and manufacturing strategies for next-generation medicines
  • Best in class practices for facility planning, CQV, operational readiness and startup
  • New innovative technologies on the horizon

Anshul Mangal
Project Farma

Anshul Mangal is President of Project FARMA and Precision ADVANCE. Anshul founded and grew PF into a leading global biologics and advanced therapy engineering consulting firm. Under Anshul’s leadership, PF has partnered with over 100+ therapeutic innovators, developed state-of-art manufacturing facilities for complex biologics and pioneered the industrialization of advanced therapies including many commercially approved cell and gene therapies. PF was acquired by Precision Medicine Group in 2020 to be the cornerstone of Precision ADVANCE. ADVANCE is a collection of Precision’s services uniquely focused on the complexities of research and clinical development, regulatory, manufacturing, and commercial needs to successfully bring an advanced therapy to market.  In addition, Anshul is an investor, board member and advisor at several biotech organizations.  Prior to PF, Anshul was a patent litigator at Jones Day and a consultant at Morgan Stanley & Discover Financial Services.

Flemming Dahl
Senior Vice President, Fill & Finish Expansions Management
Novo Nordisk

Flemming Dahl is Senior Vice President at Novo Nordisk heading up the area Fill & Finish Expansions which is responsible for all major fill & finish expansion projects across Novo Nordisk globally. A key focus area in Mr. Dahl’s role is a focused drive to professionalize and standardize fill & finish facilities via a modular approach to aseptic production, finished production, intralogistics and quality control while designing the facilities for flexibility, automation and compliance. Mr. Dahl runs a double-digit billion DKK portfolio of expansion projects spanning multiple time zones. He has been with Novo Nordisk since 1994 and held several senior leadership positions, including Senior Vice President for the global Quality organisation covering all units in Novo Nordisk and has headed up the company’s biopharmaceutical production also as Senior Vice President. Mr. Dahl holds a Master Degree in Chemical Engineering from the Technical University of Denmark.

Ciaran Brady
Vice President MS&T
Vertex Therapeutics

Ciaran joined Vertex in 2021 and is the Vice President of MSAT, which provides technical leadership within the commercial manufacturing organization. This includes partnering with the R&D teams to develop and implement robust and scalable processes that are capable of reliably supplying patients with high quality medicines. The team also directly support the manufacturing sites to resolve complex technical issues and implement new technologies and technical agendas to drive continuous improvement.

Ciaran previously worked at Human Genome Sciences, Eli Lilly and Co. and Bristol-Myers Squibb in roles of increasing responsibility and has over 20 years of industry experience in manufacturing and process development, primarily for biologic medicines. During his career, he has directly contributed to the successful approvals, launches and supply of medicines such as Benlysta, Trulicity, Taltz, Opdivo and Orencia.

Ciaran is a native of Ireland and earned bachelor’s and Ph.D. degrees in Biotechnology from Dublin City University in Ireland. He subsequently moved to the U.S. to undertake a post-doctoral program in vaccine process development at the National Institutes of Health in Bethesda, MD.

Jason Politi
Chief Technology Officer
Verve Therapeutics

Jason Politi is the chief technical operations officer at Verve Therapeutics. Jason brings over 25 years of industry experience in development, manufacturing, and project management. Jason previously served as senior vice president of technical operations at Verve since 2021. Prior to joining Verve, he served as senior vice president, technical operations at Prevail Therapeutics, where he helped to build and lead the chemistry, manufacturing and controls (CMC) team and managed the company’s AAV gene therapy programs. He was instrumental in the approval of Prevail’s first three investigational new drug applications with the FDA and the supply for Prevail’s clinical trials prior to the company’s acquisition by Eli Lilly in 2021. Before Prevail, Jason served as senior director, clinical manufacturing at Alexion. Earlier in his career, he held leadership roles at various biotechnology and pharmaceutical companies, including Dyax, Biogen and AbbVie.

Jason holds a B.S. in Chemical Engineering from the Massachusetts’s Institute of Technology and an MBA from Boston College.

Project Farma is an industry leader in providing project management, validation, engineering and consulting services with a proven track record in gene and cell therapy. We partner with gene and cell therapy organizations in addition to healthcare, pharmaceutical, bio-pharmaceutical companies to support finding ground-breaking treatments and solutions. Our gene and cell therapy clients include early stage startups, establish cell and gene therapy companies and CMOs / CROs. We are committed to helping advance cutting-edge medicines by leveraging our deep knowledge and broad experience in cell and gene therapy to meet any new challenges.