Guest Column | December 15, 2020

CDMO Selection: Can We Eliminate The On-Site Audit?

By Ray Sison

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General consensus within the outsourcing community is that conducting on-site audits is a critical activity in CDMO selection. In June 2019 I wrote about the nuts and bolts of performing on-site capabilities audits in my article "How to Ace Your Next CDMO Capabilities Audit." In that article I strongly advocated for preparing for and making the effort to get out to meet top candidates in person, and readers agreed. However, during this pandemic, in-person meetings are currently not possible. As the only alternative, many of my colleagues complain about the virtual audit experience and what is being lost. Whatever we're doing now isn't working. I say, let's get through a few virtual audits and figure out ways to make them better. If we are successful, it will change the way audits are done from now on. In part 1 of this article, I will focus on the trade-offs, challenges, and opportunities in virtual vs. on-site capability audits, but the same approach is applicable for quality audits.

On-site capability assessments are an indispensable part of the CDMO selection process. But, due to travel restrictions brought about by the ongoing pandemic, supply chain professionals, as well as development and clinical stage biotech companies that outsource, have no choice but to rethink and re-evaluate this step of the CDMO selection process. To accept this reality, we must revisit why on-site visits are important in the first place. Quite simply, the objectives are to assess and evaluate each CDMO's operational capabilities (OC), scientific approach (SA), and key personnel (KP).

  1. Operational capabilities: At any CDMO, multiple dosage forms, unit operations, and packaging options are often available at a given site. To best utilize time, the on-site visit allows sponsors to evaluate the facility and equipment specific to their project and hone in on strengths and weaknesses based on project requirements. Based on experience, sponsors can also evaluate CDMO processes that may differ from current practices to identify potential risks, e.g., materials handling, process flow, product storage, etc.
     
  2. Scientific approach, philosophy, and execution strategy: Proposal reviews are common during site visits where direct communication with scientists and engineers can bring context to the scope of work (SOW) outlined. These discussions permit debate and can refine or alter strategy based on stakeholder needs outside the immediate SOW. Outside stakeholders can define commercial constraints, regulatory strategy, and clinical requirements. Further, the on-site visit is part of the contract negotiation because of the dependency of timeline and budget on the SOW.
     
  3. Key personnel from the top down: During the site tour and the proposal discussion, participants have the opportunity to meet in person, interact, and to simply talk. Ideally this interaction seeds the professional relationships between the two companies and will strengthen communication moving forward. It is well understood that communication occurs beyond the spoken or written word. Everything from the overt to subliminal can make impressions that guide decisions in the selection process.

With these key objectives of on-site visits established, let's challenge assumptions. They fall into two categories; the first is objective and the second is subjective:

  1. You can't adequately assess a facility without actually being there.
  2. Without being in the same room, the opportunity to establish trust and relationships is lost.

The on-site capabilities audit is the best opportunity to evaluate the operation. For virtual audits to be a viable alternative, we have to address the trade-offs and shortfalls. In doing so, we can look not only to technology but also at the behavior modification. Stakeholders will have to collaborate closely to identify and solve problems together and create best practices. During these challenging times, those willing to make the effort can create a point of differentiation and there is an opportunity to shift the paradigm.

So, what can we do? It's a wide-open question, but here's one approach: Break down every element of the on-site meeting activity, map it to a virtual meeting, identify the trade-offs and challenges, and then solve the specific problems. In the process, bookmark opportunities that could raise the whole experience to another level. In my approach, here are my typical audit activities. Map your process using this as an example.

Table 1: Typical Audit Activities

Audit Activity

On-site

Virtual

Objectives

OC: Evaluate the facility and equipment specific to their project.

SA: Bring context to the scope of work.

KP: Seed professional relationships.

Objectives are the same.

Attendance

1 to 3 team members as budget and scheduling allow.

Up to 5 or more as agreed to by both parties.

Preparation

Objective and agenda driven, travel logistics.

Objective and agenda driven, technology logistics.

Time Commitment

1 to 2 days; 3 to 6 hrs. on-site.

2 to 3 hrs.; supplemental materials available offline.

Audit Meeting

Traditional verbal/nonverbal communication, formal/informal interactions, group activity.

Technology-driven communication, social media, group activity.

Audit Tour

Guided walk-through with open discussion. In person/first person.

Multimedia, customizable, virtual tours with segments available offline.

Debrief/Scoring

Immediately after call.

Can be extended, meeting can be recorded, comments and notes can be consolidated from online meeting tools.

Trade-offs, Challenges, And Opportunities

The most obvious trade-off works in favor of virtual meetings, specifically, travel logistics and cost. Virtual meetings are more flexible, time efficient, and cost effective. While many have argued that the cost of site visits is insignificant compared to the contract deal and the risk of making the wrong decision, if the audit objectives are met, informed decisions can be made without travelling on-site.

The other major trade-off can be described as the quality of the experience. Conventional wisdom is that nothing can replace the first-person on-site audit. As CDMOs scramble to beta test different approaches and technologies, the conventional wisdom has so far proven to be true. This can be expected. For virtual meetings to be viable replacements for on-site audits, CDMOs have to learn to optimize technology. Project sponsors have to demand more from CDMOs on this front. However, they must also be willing to participate in the process by being clear about expectations going in, engaging fully during the audit, and being willing to provide constructive feedback that can drive improvements after the audit.

Not only does technology need optimization, but behaviors will have to change. The subjective part of the on-site meeting is to provide an opportunity for participants to develop professional relationships that can enhance communication. To replace this, audit attendees will have to make the effort to actively use social media and one-on-one and group activities online. While this may make some uncomfortable, think of it this way: Expanding professional networks is never a poor use of time, has value beyond the transactional, and drives careers forward over time.

The opportunities presented by these trade-offs and challenges are that sponsors who effectively adapt their outsourcing practices will select better partners, potentially avoid downstream issues, and have a higher likelihood of success. CDMOs that improve the customer experience will have an edge over their competitors and will win more projects.

But let's be honest. We're not there yet. If you've hosted or attended a virtual site visit this year, you will agree that there is a lot of room for improvement. For example, live streaming video has gotten off to a rough start. Walking through a facility with an outstretched iPhone is a sure-fire way to give watchers vertigo — or worse. CDMOs can learn from other platforms online (e.g., streaming podcasts, documentaries, professional social media videos) and see that we haven’t even begun to optimize the online experience. Moreover, while we aren’t meeting participants in person, there are now other avenues in online group activities and social media that could facilitate interaction. Some online group activities, such as Zoom happy hours, are already widely accepted among weary professionals. Variations on social activities and novel events are opportunities for hosts to create unique experiences for their audience.

In part 2 of this article, I will discuss specific areas where technology can be optimized for the task and what behaviors and expectations must be changed to raise the virtual audit experience to a higher level.

About The Author:

Ray Sison is VP of pharmaceutical outsourcing and tech transfer at xCell Strategic Consulting and principal consultant at Vinco Pharma Solutions. He began consulting in 2011 after recognizing a need for expertise in pharmaceutical outsourcing among the discovery- and clinical-stage pharma companies he served as a business development representative for Patheon and MDS Pharma Services. Based on his experience, Sison provides insight to the CDMO’s business and operations, helping his clients negotiate and achieve better outcomes. Additionally, he has developed sound processes and templates to streamline CMO procurement to save time and cost. You can reach him at rsison@xcellstrategicconsulting.com or connect with him on LinkedIn.