Unlike traditional drug development, cell therapy logistics require extremely close, integrated relationships with contract research (CRO) and manufacturing (CDMO) organizations. Due to the direct line from patient to manufacturing and back, these partners function as critical extensions of the core team to ensure timeliness and safety.

Successful MedTech innovation starts by identifying a pressing, real-world clinical problem and then developing a solution. This 'problem-first' approach is more effective than creating a technology and searching for an application, a common pitfall for founders with academic backgrounds.

Dr. Abelson’s career spans the transformation of clinical research from an endeavor led by a single physician-scientist to a complex industry with specialized companies for statistics, patient recruitment, and regulatory affairs. This specialization has enabled the current rapid pace of drug development.

Biotech companies create more value by focusing on de-risking molecules for clinical success, not engineering them from scratch. Specialized platforms can create molecules faster and more reliably, allowing developers to focus their core competency on advancing de-risked assets through the pipeline.

A crucial piece of advice for biotech founders is to interact with patients as early as possible. This 'patient first' approach helps uncover unmet needs in their treatment journey, providing a more powerful and differentiated perspective than focusing solely on the scientific or commercial landscape.

Responding to Wall Street pressure to de-risk, large pharmaceutical firms cut internal early-stage research. This led to an exodus of talent and the rise of contract research organizations (CROs), creating an infrastructure that, like cloud computing for tech, lowered the barrier for new biotech startups.

When seeking partnerships, biotechs should structure their narrative around three core questions pharma asks: What is the modality? How does the mechanism work? And most importantly, why is this the best differentiated approach to solve a specific clinical challenge and fit into the competitive landscape?

The most impactful medical advances come from 'clinical scientists' who both see patients and work in the lab. This dual perspective provides a deep understanding of disease mechanisms and how to translate research into treatments, a model that Dr. Abelson believes is now under threat due to economic pressures.

For smaller biotechs, the key to a successful CRO relationship is treating them as a genuine partner. This requires moving beyond a transactional, fear-based dynamic to one of open communication and mutual respect. Biotechs should actively solicit CRO feedback, as they possess valuable cross-industry insights and can identify sponsor-side behaviors that need to change.