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Manufacture Advanced Medicine, Contract Manufacturing Services, Business Practice, Trends & Forecasts

Cell Yourself

As a cell and gene therapy manufacturer, some of the most important decisions you’ll make revolve around selecting partners for clinical development and delivery, as well as commercial launch. If a supplier cannot meet your needs, you may face delayed trials or a slow commercial product rollout, which costs time and money. Careful consideration during the supplier evaluation phase is critical – and that includes asking the right questions.

Check out the experience and expertise

The cell and gene therapy industry is still young, but that doesn’t mean you have to settle for working with partners with little cell and gene therapy experience. Any potential partner should be able to prove in practice – not just in theory – that they’ve been successful in this environment before. 

  • As you evaluate partners, ask:Can you trust the teams assigned to deliver services to you? 
  • Do you have confidence they will move mountains to ensure your projects are delivered in the manner you expect? 
  • Does the partner have a proven track record of delivering on time and within budget? 
  • Are escalation pathways already set in such a manner that when things go wrong (which they will) solutions are developed and deployed quickly? 
  • How will you justify your partner selection to senior executives and your board of directors? What evidence supports your choice between a known reputation and brand name recognition vs. a partner offering innovative new approaches that you think may better service your business? choices between reputation vs. brand name vs. prior experience, and innovative new approaches

When assessing the answers, don’t just think about what you need today; picture where you are going so that you can select a partner who will meet your future needs too. 

Technical Challenges

An ideal partner will have at the ready a list of technical challenges you are likely to face. They should be upfront about which of those technical challenges they are well suited to handle, which should be managed by your organization, and which are best to outsource to a different partner. Be vigilant in evaluating whether their technical plan achieves the outcomes you need within your timelines and budget while complying with relevant regulatory and quality requirements. When navigating both domestic and international markets, this can represent a significant body of work and you need a well thought-through and supported plan. 

Recommended questions to ask: 

  • What types of issues or challenges have other clients experienced throughout their studies and commercial launches? What lessons learned can you share to help our organization avoid similar pitfalls? 
  • What qualification and validation data can you provide to support the quality and reliability of your core capabilities? 
  • As the utilization of our therapy grows, what mechanisms do you have in place to support scale? What barriers to scale exist today and what is on your technical roadmap to close those gaps? 
  • Where do you most often experience quality issues? What are your mitigation plans?

Can your partner be flexible? And at what cost?

Experience in a partner is important, which often drives companies to large, well-established partners. But you must also consider how flexible they can be. They may not be able to customize their processes to meet your needs. At the other end of the spectrum, a small startup may be able to offer exactly what you need, but may slow you down in other ways as they build out the fundamental elements of their product offering. Balance is important. Try asking:

  • How is the work we are proposing similar to and different from what you normally support?
  • What are the costs and timelines associated with adapting standard processes to meet our unique needs?   
  • What are your standards and methods for qualifying and validating customizations? 
  • What risks or unintended consequences do we introduce by customizing our service offering? 
  • How have your standard offerings accelerated progress for clients? Are there common areas where your processes can get bogged down and are challenged to meet the needs of your clients? What improvements do you have planned in the next 12 months? 

A matter of trust

Cell and gene therapy is a rapidly changing industry. There will be surprises along the way and bumps in the road, and you will need to pivot quickly at times. A partner should work with you to build creative solutions to overcome the challenges you encounter.

When assessing potential partners and listening to their responses to your questions, ask yourself:

  • Does this company’s mission align with our company’s mission?
  • Do I trust this team? And if the individuals I’m working with now leave the organization, can I expect the same level of quality and service?
  • Are incentives aligned to ensure this partner works as diligently as my own to achieve our key objectives? If not, how could we restructure agreements to drive mutually beneficial outcomes? 
  • Can I trust this company to partner closely in the most challenging of times so we can overcome obstacles and drive progress together? Successful partnerships in cell and gene therapy happen when all parties move beyond the traditional supplier relationship. Market changes, regulatory changes, and scientific advancements push sponsors and partners to continuously evolve to make improvements and navigate hurdles. Ultimately, when partners are aligned on shared goals, they can overcome the challenges together.
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About the Author
Molly Mjolsness

Director of Client Experience and Transformation, Be The Match BioTherapies, Minneapolis

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