From The Editor | October 1, 2020

Hello From The Other Side: Advice On Drug Development Outsourcing

Louis_Photo_2019

By Louis Garguilo, Chief Editor, Outsourced Pharma

Corporate Guys communicating from distance

A number of your colleagues may have worked on both sides of the outsourcing equation – at CDMOs and now your biopharma organization.

Do you know who they are? Do you provide them opportunities to:

  • help bridge communication gaps with external partners;
  • offer guidance for enlightened vendor management;
  • or assist in improving overall outsourcing outcomes?

Perhaps it’s you with both CDMO and biotech experience. Hopefully, you aren’t feeling frustrated your experience is being overlooked.

The importance here is this:

Few at biotechs outside of “dual-track” employees fully recognize the opportunities and challenges that lie in wait at external partners.

“I spent the early part of my career at a CDMO,” says Ken Baker, Director, CMC Project Lead, Sage Therapeutics. “It was the greatest training ground possible for what I’m doing now.”

Baker’s glad he made the move to the drug-owner side.

“But certainly,” he admits, “at times I miss the buzz and hyper-activity at the CDMOs. I enjoyed that climate with my colleagues, all top notch.”

Likewise, Baker’s colleague at Sage, Steve Collier, Sr. Director, Process Development, worked at service providers previously.

Ken Baker, Director, CMC Project Lead, Sage Therapeutics
Ken Baker, Director, CMC Project Lead, Sage Therapeutics
“To be successful at a CDMO, you've got to be able to think on your feet, and be good at what you are doing,” he says.

“If you can build the right relationship with the right CDMO, it can be a great experience for all concerned. It can augment the capabilities you have – not just with ‘hands,’ but with technical and strategic inputs.”

Advice To The Wise

Baker and Collier say this of professionals with CDMO experience:

  • may lack some wider CMC experiences, but come from an environment where picking things up quickly is a vital attribute.
  • have an enhanced understanding of timing, and execution challenges.
  • command a solid knowledge of appropriate resource, and budget needs, for given activities.
  • tend to work well under pressure, excel at solving problems – especially when things go a bit awry.

Opportune times to leverage this experience include when performing risk-assessment activities, during due diligence/project kick offs, and site visits.

“These employees can pressure test situations for you,” says Baker. “They also know how to make the most of meetings to best position projects for success.”

Dueling Advocates

Steve Collier, Sr. Director, Process Development, Sage Therapeutics
Steve Collier, Sr. Director, Process Development, Sage Therapeutics
The advice above is derived from comments Baker and Collier made at our recent OP-Virtual, titled “Managing Your CDMOs: Advice From Professionals Who've Been On Both Sides Of Outsourcing.”

Because of past CDMO experience, says Baker, “Now as the people managing outsourcing for biotechs, we recognize we serve as liaison between our partners and internal stakeholders.”

“We must be able to communicate to outsourcing partners what our priorities are, what needs to get done, and what our real short-term and long-term goals are.

“Then we must work to communicate internally to our teams about how things are going. Are there any potential delays? Are we going to impact clinical trials or tox studies? We need to keep our internal teams informed.”

Baker says he’s had to advocate for the CDMO side at previous employers.  

“People can do a great job 99% of the time, but everybody remembers that 1% when things go wrong,” he says.

“Some in biopharma management are quick to want to move away from a CDMO, and try somebody else, once there's been an issue.

“But we’ve spent a long time building a relationship with that CDMO, and building that trust between the two organizations,” counters Baker.

“We don't want to just jump ship. Often, we're working through some of the issues together, and need to advise management: "We should continue this relationship. It's worth putting that effort into it."

And thus, says Baker, “A lot of our job is resolving ongoing issues with the programs we're managing.”

He also mentions the financial aspects to CDMO oversight.

“We're all working on those endless contracts,” he says with a barely hidden smile, “especially master service agreements.”

“CMC tends to be the second largest budget within a biotech organization at some points. We have to ensure we're proficient at tracking those budgets, and keeping within the spend. If we’re not, that needs to be communicated.”

The Makeup Of Success

“I spent years working at various CDMOs,” says Collier. “I came to believe there are certain pillars that make up a successful service provider.”

He lists them as:

  • strengths in process development and analytical development
  • manufacturing from the operational perspective
  • quality assurance (underpinning all GMP activities)
  • understanding the business side (overarching the whole project)
  • project management (weaving all of this together).

“Few CDMOs are strong in all areas,” he says. “Experience at CDMOs provides you with some unique insights into how these interplay, potential tensions, and how to mitigate.”

For example, he says, if an innovator feels a CDMO lacks a certain strength or capacity, or because of timelines in certain projects, “one strategy is to divide out work packages, and place them with more specialized providers.”

“You can use a secondary provider, and integrate the outputs of that work into your primary CDMO. Some examples are impurity ID and impurity synthesis, analytical method development and co-validation. Look at how you leverage a portfolio of these companies to get the right outcome for your project.”

Another area is manufacturing, where Collier says biotechs might not fully understand how scheduling works, and capacity is mapped.

“As an innovator, it's important to fully comprehend what capacity is available, how far CDMOs are booking out, and who controls that capacity,” he says.

“How many commercial projects do they have? These could be internal generic projects, or external innovative projects.

Collier also recognizes from experience that CDMOs can be driven by quarterly and yearend numbers. That can influence how they behave to realize revenue.

“If you understand that dynamic,” he says, “you can work with a company to try and come up with a mutually beneficial approach to scheduling and invoicing, for example.”

He concludes: “People with CDMO experience on your team can help you understand why certain decisions are made at CDMOs, and how to navigate these to get outcomes that work optimally for both sides.”

------------

The views expressed here are those of the individuals interviewed, and do not represent the opinions of any current or former employers. Some of the text here has been edited for purposes of readability.

Visit OP-Virtual for more content from outsourcing professionals.