Expert Interview Series

Strategies for Success in Cell Therapy

Invetech asked several cell and advanced therapy (CAT) companies and industry insiders to share their perspectives on 3 key issues that can affect the growth and success of CAT companies—obtaining funding, regulatory considerations, and manufacturing scale-up planning.

We've compiled these interviews into a collection we hope will serve as a valuable resource to support the growth and success of CAT companies worldwide. 

Some of our favorite insights include...

"Into Phase 1 and definitely by Phase 2, CAT companies need to make definitive choices related to manufacturing. To be able to do so, they also need a clear view about their indication, the size of their target patient population, and the way the product will be used in the hospital environment."

Dr. Dieter HauwaertsDieter Hauwaerts
Director, Manufacturing

"The FDA clearly understands the issue of variability in autologous therapies. But that does not mean that CAT companies don’t have to address it. And if it’s not addressed by Phase 3 it may be very difficult to get to approval without a comparability study."

Renee BoernerRenee Boerner
Senior Director, Regulatory Affairs
Argos Therapeutics

"If the VC has not invested in your sector previously, it will be an uphill battle. To generate attention, especially in early financing, making a connection through a personal or business relationship is usually essential. They will also be interested in knowing more about your current investors and their pedigree. Knowing that reputable investors have already invested in your company is somehow de-risking their investment."

Jean-Jacques MondoloniJean-Jacques Mondoloni
Managing Partner
Wombat Capital

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For more than 30 years, Invetech has provided full-spectrum product realization services to create breakthrough products and custom automation systems for companies across the globe. Our experience spans a broad range of market sectors, including laboratory diagnostics, point of care diagnostics, cell therapy, life sciences, industrial and consumer products.

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