Taking Your API to the Next Level: Three Steps to Consider Before Outsourcing

11月 19, 2020 By Laura Chamberlain (10 minute read)

Scientist in lab developing an API

With outsourcing API development becoming more common, we see a rise of multiple competing Contract Development Manufacturing Organizations (CDMOs) as potential development partners. This allows small/virtual companies the ability to take their concept to clinic at a much lower cost versus building, renting, or buying lab space at a facility.

More accessible drug development for small, emerging, and virtual companies should mean more opportunities for research and faster development/approvals for medicines to change the world. After researchers make it past preclinical toxicology, they often don’t know where to go and the idea of engaging with a large CDMO can be intimidating. Researchers have put their heart and soul into their small molecule API, and the thought of handing their “baby” off to a stranger opens a myriad of concerns and considerations.

If you and your team are thinking about outsourcing your API’s clinical development, it’s important to ask yourself:

Though these questions just scratch the surface of what capabilities the right CDMO should possess, they are the foundation of the criteria in selecting one. The right CDMO should be a partner who not only values your API, but one that guides you through the quoting and selection process—especially if it’s your first-time outsourcing.

The timing, prep, and process of engaging with a CDMO is often unclear, and the growing network of possible vendors can be daunting. A savvy CDMO should be able to provide flexible drug development to small, virtual companies, university spinouts, and bench-top chemists. Whether your molecule requires basic or complex synthesis, or containment, a CDMO should make you feel confident in their ability to deliver high yields, optimize synthetic routes, and mitigate risk in the manufacturing process.

To make an informed decision on a CDMO, consider these three steps:

Step One: Determining When to Engage

Determining the right time to engage a potential CDMO is the first step and is often a challenging decision. Many new and emerging biotech/pharma companies get stuck on timing and funding, which can make them hesitate in engaging with a potential CDMO.

Engage Earlier Than You Think

The time it takes to evaluate, select, and initiate activity with a CDMO can be a lot longer than you may think. It’s important to engage a potential CDMO earlier rather than later to discuss the development and/or manufacturing of your molecule. The average time to a select a CDMO—from first conversation to initiation—takes approximately three months. By engaging earlier, you give yourself ample time to get a better understanding of your own needs and what the right CDMO looks like for you and your molecule.

There Will Never Be a “Perfect Time” to Engage

For new and emerging biotech/pharma companies, funding is a typical roadblock and compiling a full RFP is time consuming. If you find yourself facing either of these challenges, it’s important to remember that early engagement is a balancing act, and you may never find yourself in the “sweet spot” with the required funding and a complete RFP for use in CDMO discussions. This makes having transparent conversations sooner rather than later even more critical, as you can use them to refine and make decisions faster in the future. When engaging with a CDMO in the early days, be sure to ask them:

The best information often comes through discussion and cannot be put into a technical package. Asking these questions up front can be used to craft a more thorough RFP.

Ask the Potential CDMO to Show and Tell

While many companies don’t require the assistance of a CDMO until they need GMP material, that does not necessarily mean they need to wait to engage a potential CDMO. As early as lead candidate selection, engage the potential CDMO for non-GMP material for late-stage toxicology studies. Utilizing a CDMO for late-stage tox material may cost you slightly more upfront than a CRO or non-GMP shop, but it’s worth it, because:

Step Two: Preparing for Conversations With a CDMO

It is helpful to a potential CDMO to have a formal RFP detailing your needs, goals, and the technical information your team has generated so far on the API. A common challenge for small and virtual pharma/biotech companies is they do not always have the workforce or bandwidth to compile an RFP. If compiling the “perfect” RFP is standing in the way of beginning your vendor search, the right CDMO will have a team who can review, discuss, and confirm the scope of your project to help move the process forward. The more you prepare for your conversations with prospective CDMOs, the more confident you’ll feel through the process. There are some key elements that are crucial to develop a proposal for your project. Gathering and sharing this information up front will allow for more detailed discussions as to how the potential CDMO fits into your specific program.

Step Three: Vendor Scorecard and Meaningful Conversations

Once you’ve outlined your goals and commercial aspirations, it’s important to develop selection criteria. Rank each criterion by level of importance and “score” each vendor as you move through the selection process. Common criteria include:

  1. Capability, technology, and expertise—does the CDMO possess the technological capabilities and scientific expertise to develop and optimize a robust and scalable API process?
  2. Capacity and timing—does the CDMO have the production resources to meet your timing and delivery needs?
  3. Regulatory history and quality—does the CDMO have a successful track record with local and global regulatory agencies and adhere to strict quality standards?
  4. Partnerships and relationships—does the CDMO have a vast network of esteemed partners who can vouch for their performance?
  5. Location and geographical reach—does the CDMO have a large geographical network of internal labs and support locations?
  6. Integrated offering—does the CDMO provide an end-to-end sourcing solution and can they work on multiple aspects of your drug development needs?
  7. Security of supply—does the CDMO’s vast network of partners include vendors who can continually provide the raw materials necessary for production?
  8. Financial security and business continuity—does the CDMO have a history of strong financial performance and internal processes/procedures to ensure business continuity?

Next Steps for Selection

Once you prepare for conversations and develop your vendor scorecard, it’s equally as important to come up with selection requirements. These are the actions you intend to take during the vendor screening process and prior to moving forward with a CDMO. This is where you really get to know a prospective CDMO. Potential CDMOs should show you: their facilities and how they work at the ground level, how they approach terms and their flexibility with things like licensing and contracts, and how they interact with your internal stakeholders. Some common considerations are explained, but only your team can determine what you need to know from a potential partner before moving forward.

Engaging in Purposeful and Meaningful Conversation

Developing all of this will ultimately prepare you for each conversation with a potential CDMO. The more you put into having purposeful and meaningful conversations, the more you’ll get out of them. As you engage in these types of conversations, be sure to:

Making the Most Informed Choice

By following these steps, your team will be able to make the most informed choice of which CDMO is best for you. The right CDMO should always take a consultative approach, but if your team is new to drug development, it is wise to engage a CMC consultant for additional support. A CDMO isn’t there to make decisions for you. They are there to be your partner who can help make recommendations on their experience, but also allow you to have the power and ownership to make final decisions regarding your program. The right CDMO will act as your commercial accelerator who can take your API to the next level.

For more information on the criticality of API CDMO selection, please download this case study.

Download Case Study »

Laura Chamberlain, Business Development Executive – API

Laura Chamberlain

Business Development Executive – API