Scott Burger on finding the right strategic partner

By Brian Caine

Advanced Cell & Gene Therapy MD Scott Burger gave attendees of Cell Therapy Bioprocessing & Commercialization a detailed overview of the roles, responsibilities and importance of teaming up with the right strategic partners, CMOs, CROs Suppliers and other contract providers.

“While it takes a village to raise a child, it also takes a village to successfully bring a product to market,” he said.

He also outlined the five historical problems with working with CMOs:

1. Insufficient cell therapy experience and expertise
2. Inadequate capacity
3. Lack of commitment to the project
4. Differing expectations for roles and responsibilities
5. Inadequate/ineffective communication between client and CMO

Burger provided examples of differences between a biological and a CT CMO and reinforced the critical need to vet each CMO candidate to ensure their “capabilities, capacity, availability match your needs and expectations”.

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How to rescue a clinical trial

At ClinPage, they recently posted an article about the keys to resuming a clinical trial if you've taken over it midway through the process. So what should you do if you're asked to resume a project after everything's been started?

They suggest:
1) Assess and plan
2) No rushing
3) Create trust
4) Initial Visits
5) Ongoing oversight

For an in-depth look at the steps, read the article here.

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