How Compatible Do a CDMO and Sponsor Need to Be?

7 questions to ask to ascertain compatibility

Posted: April 29, 2019

API Manufacturing and Pharmaceutical Manufacturing

There is no Match, eHarmony, Bumble or other dating site where sponsors can meet their ideal Contract Development and Manufacturing Organization (CDMO) partner.  It might be a good idea for a new business.  But until it becomes as easy as swiping left or right, sponsors looking for the most compatible CDMO to develop and manufacture their API have to go on some dates – and both sides need to do their homework.

As you know, dates can be deceiving. What appears appealing on the surface may not turn out to be what you’re looking for—or what you need. But the good news is that there is a method to finding the ideal mate to assure one of the most important requirements in a work relationship–compatibility.

This article will largely focus on the CDMO’s perspective. We too are looking for the ideal sponsor, one who will appreciate and benefit from what we bring to the table and from the close collaboration our teams will develop in the course of the project.

Why compatibility rates a Leadership Award

Compatibility is such an important factor in determining who to outsource drug development and manufacturing to that Life Science Leader gives a coveted Leadership Award for that category. At SEQENS North America, we are proud to be the recipients of that award, one of 12 Life Science Leadership Awards we received in 2019. As for compatibility, we have won awards in that category since the Leadership Awards were instituted in 2013.

So what makes us so compatible with sponsors that we keep winning top awards in that category? And why is it important to sponsors?

There are essentially two facets to a compatible sponsor-CDMO relationship. One is technical compatibility. The other is cultural compatibility.

Technical compatibility

When “dating” a CDMO, it’s important to determine whether the CDMO meets the following four requirements:

  • Experience
  • Capabilities
  • Expertise
  • Resources

All of these are necessary to develop new chemistry for an API that will soon become a viable treatment.  When we talk to prospective customers, we always look for a good technical fit.  We don’t pretend to be all things to all sponsors. If your project is outside our purview of small molecule chemistry or GMP foods or other GMP materials, we will tell you. On the other hand, people appreciate knowing when our wide technical capabilities are well suited for their project and are grateful for our detailed exploration to make sure there is a good technical fit.

Cultural compatibility

Once we’ve ascertained that the technical capabilities are aligned with the project needs, we turn to determining cultural compatibility. It’s just as important.  We spend a lot of time up front with our clients to understand their goals and objectives. We want to make sure their goals and ours are a good match too. 

Virtual companies whose goal is to turn a quick buck by developing its IP just enough to license it are typically not a good fit.  Because they often look to cut corners, which can compromise the product and the overall project.

Communication is one of our key hallmarks. We make every effort to make sure people understand how we view a good collaborative relationship. Because of the complexity of our business it’s important to us that sponsors we work with plan to come to us for process development, analytical chemistry and GMP manufacturing.  It avoids execution risk, because those who know the chemistry intimately have the best chance of completing the project most efficiently.

TECH TRANSFER

Why an award for compatibility?

I’m certain Life Science Leader recognizes the complexity entailed in a relationship between CDMO and sponsor. Compatibility lends itself to ensuring success to a great extent. Many CDMOs will tell you they can do everything for everyone. Consider that a red flag.  It doesn’t mean your company and project are necessarily compatible with the CDMO. You need to do your due diligence.

Checklist for assessing compatibility

Here are seven things the sponsor and CDMO should discuss:

  1. What will it take to synthesize this NCE (New Chemical Entity)?
  2. Does it fall within the CDMO’s area of expertise?
  3. What is the business model: does the sponsor plan to invest in the asset? Are the financial resources available to see the project through?
  4. Who will be on the respective teams, and how knowledgeable are they?
  5. How will decisions be made and who will make them quickly?
  6. Is the sponsor’s team available for the weekly meetings we insist on, and for calls in-between should an issue arise?
  7. Sponsors should ask: Who’s your ideal customer?

Despite our efforts on both sides, we can never absolutely assure compatibility, but with decades of experience of what’s gone right, what’s gone wrong and why, we have a pretty good idea.

Case example of good compatibility

We have worked with sponsor teams who are on site once a week, working with us on a regular basis. Every molecule that comes out of their lab comes directly to us. We send a proposal, they sign off. Having received good value on previous projects they come back again and again and trust that we will neither take advantage nor bill inappropriately.  In their experience they have found SEQENS NA very compatible, with everything under one roof. They also say they have the security of knowing we can quickly adapt if the project changes. We likewise enjoy the challenging projects they bring, and the close working relationship born of mutual respect.

We think that being open about what we look for in potential sponsors shows that we are careful with whom we partner. We don’t take on projects that aren’t a good fit or claim we have expertise we don’t have just to get a client. Our goal is the long-term success of our company, and that means we value the success of each project and that we ask questions to help determine whether or not we should take on the project. 

Give us a call at (978) 462-5555 or email us at info@seqens.com. We’re happy to talk and answer any questions you may have–just so long as you know that we just might ask you a few questions, too.

About the Author

Ed Price CEO of PCI Synthesis
Ed is President & CEO of SEQENS North America (formerly PCI Synthesis). He serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA)...

Do you have questions? Talk to Ed.