The Cell and Gene Therapy Revolution

September 24, 2020

A conversation with Klein Hersh’s Hillary Kaplan

Even as the global biopharma industry urgently focuses on combatting COVID-19, the cell/gene therapy sector marches onward, experiencing strong growth and expansion.

The sector has continued its rapid progression into one of the industry’s hottest markets, spurred on by robust venture capital investment in new company formation and ongoing strategic acquisitions by big pharma. Analysts forecast that this growth will result in a healthy R&D climate, with hundreds of therapies moving through drug manufacturers’ pipelines in the coming years.

In a recent roundtable hosted by Fierce Pharma, industry experts from Novartis, Kite, BioMarin, and Astellas’ Audentes Therapeutics subsidiary took a deep dive into the critical role of manufacturing in cell and gene therapy. A key takeaway from the discussion was the need to solve the manufacturing process and scalability challenges which could make or break the success of many novel cell and gene therapies.  

To share her insights and discuss the talent acquisition impact of the cell and gene therapy revolution, we sat down with our own Hillary Kaplan, Senior Director, Bioprocess CMC / Manufacturing. Hillary has been on the frontlines of this field, recruiting top operational and scientific executives for companies developing emerging technologies in the fields of cell and gene therapy, regenerative medicine, and stem cells.

Advances in cell and gene therapies have the potential to transform medicine and potentially cure many life-threatening diseases. In recent years, medical breakthroughs, such as chimeric antigen receptor T cell therapy (CAR-T), have been proven clinically to be life-saving therapies for several cancers and offer further promise for additional conditions and solid tumors.

Scientific research and clinical development are thriving in the field. Former FDA Commissioner Scott Gottlieb previously estimated that the agency could approve between 10 and 20 cell and gene therapies a year through 2025.

Solving the manufacturing challenge

The explosive growth of the cell and gene therapy sector comes with a caveat: companies must address unique manufacturing process challenges in order to achieve sustainable market success.

Since each patient requires personalized treatment, the manufacturing and logistics of cell and gene therapies is daunting. CAR-T therapies, for example, require the extraction, genetic modification, expansion, and re-administration of each individual patient’s cells – including transport from hospital to manufacturing facility, and all under stringent quality control standards.

Manufacturers are also challenged to produce a consistently safe product from starting material that is different every time – a uniquely different scenario than a production run from a well-defined cell line.

The bottom line is that the cell and gene therapy arena is a dynamic and rapidly evolving area of science and medicine. As a result, reliable strategies to scale up production are still developing. With hundreds of clinical trials underway, and all companies competing for limited production capacity and manufacturing facilities, overcoming the scalability challenge is arguably the most pressing dilemma cell and gene therapy companies face moving forward.

Top talent is critical

Working closely with my Klein Hersh colleague Todd Rosengarten, I am proud to partner with a wide array of innovative companies in the cell and gene therapy market. Our focus is on integrating our subject matter expertise and deep engagement in the life sciences arena with the ability to tap into the industry’s broadest talent network to help our clients recruit and hire proven leaders in process development and manufacturing.

Through our experience we have gained a number of valuable lessons and honed best practices that we emphasize with our cell and gene therapy client. First and foremost, we encourage our clients to place an emphasis on manufacturing early on in development, even during the pre-clinical stage. By hiring a proven manufacturing professional early in the R&D cycle, companies will be better prepared to establish required GMP processes and plan ahead for production challenges as new therapies move through clinical development and on to commercialization.

We also advise our clients to also be open minded in their approach to hiring. Cell and gene therapy are emerging, albeit growing scientific fields. Competition for top talent is immense. It can be a long hiring cycle for a company to find a manufacturing or process leader with 100% of the skills they are looking for. It’s really important, therefore, for companies to be creative in their approach to talent. It’s a high bar to find a manufacturing professional who can transform an organization from day one. We have had success helping clients recruit manufacturing professionals with late stage GMP experience in life sciences and then augmenting their team with scientific or technical talent in cell and gene therapy knowledge.

Last, but certainly not least, is the importance of cultural fit. This is universal best practice emphasized by all of our practice groups at Klein Hersh. Our message to clients is to find leaders who will not only deliver the essential skills and expertise you require but will also thrive in your company’s unique culture.

Authored by
Hillary Kaplan
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About the Author
Hillary Kaplan is a client partner within the bioprocess CMC/manufacturing practice at Klein Hersh International. At Klein Hersh, Hillary works closely with clients developing emerging technologies in the fields of cell and gene therapy, regenerative medicine, and stem cells, as well as traditional products such as vaccines, monoclonal antibodies, and other therapeutic proteins. As a member of the bioprocess CMC/manufacturing ...