By Sue Wollowitz, Ph.D., president, Wollowitz Associates LLC
Disclaimer: I am a CMC (chemistry, manufacturing, and controls) consultant. Everything I write here is biased.
Outsourcing is typically for laboratory and manufacturing activities. But small companies outsource expertise in the form of consultants for similar reasons: They provide skills and expertise a sponsor does not have in-house on a full-time basis.
Sponsors want one of two things from their consultants: to give expert advice to an internal team that manages specific activities, or to be the person managing the activities. In a virtual company, the latter role pretty much comes down to managing other outsourced providers, i.e., CDMOs and CROs.
As to managing outsourced activities, whether in-house or with the aid of a consultant, it is important to have a knowledgeable person working with the CMO. There are multiple reasons: (1) they provide additional expertise in technical problem solving, (2) they can translate between sponsor needs and technical requirements to find the right balance of tactical and strategic solutions, (3) CMOs are experts in GMP activities but not necessarily in CMC regulatory strategies that can shape their work, and (4) most projects require several CMOs, and shepherding knowledge and materials among them makes a project run smoothly. A consultant expert serving as sponsor representative can provide all this. However, the three-way relationship between a sponsor, consultant, and CMO adds challenges and benefits for all parties.
The Consultant-CMO Interface
Consultants working on many projects work with many CMOs and can develop long-term relationships with business development, project management, and technical personnel. Knowing the company’s capabilities, facilities, procedures, and project management makes it easier to determine if they are the appropriate fit for the sponsor. Project start-up is faster, communication can be more effective, and problems may be more quickly resolved. Conversely, a CMO failing to meet the needs of a project will inevitably influence recommendations by the consultant for future projects.
The Consultant As Expert Advisor And Representative
Despite the above, the consultant’s client is not the familiar CMO, but rather the sponsor company that they sometimes barely know. Consultants should recommend facilities that are appropriate for the client. The consultant should be attentive to the client’s needs and priorities, whether they are timing, cost, location, or quality of output.
A consultant cannot provide the best service without complete knowledge of the project history and an understanding of why certain decisions have been made. Sponsors often don’t want to pay for the consultant to participate in team meetings or question project strategies, yet one always provides a better answer when they understand why a question is being asked. Likewise, absence of strategic insight into a company makes it very difficult for the consultant to use their experience and influence to act as a representative of the sponsor. They may be unknowingly negotiating something with a CMO that is in conflict with what the client thinks is in their own best interest. Or, they may make tactical decisions to meet requested timelines that the company internally recognizes as untenable. Admittedly, these challenges also exist within a company, but they are exacerbated with additional communication barriers to consultants.
When technical issues arise at the CMO, there are always differences of opinion on what should warrant a change of scope, what responsibility is shared or not, what the commitment is, etc. When the consultant and client themselves have different opinions, it is difficult for the consultant to act as the representative.
The consultant is not always the principal interface with the CMO but may share the role with a sponsor’s technical expert or project manager. This simplifies things considerably, but as in any multiple party discussion, those on the same side of the table should also be on the same page before coming to the meetings. It can be frustrating for the CMO to hear disparate opinions or if substantial decisions between the consultant and sponsor overtake project meetings.
There are also the seemingly mundane but important role decisions, which should be ironed out between a sponsor and the consultant early on. What decisions can be made without sponsor review, and who signs as technical or QA reviewer for various CMO documents? Who should be copied on what communications with the CMO, and who is responsible for getting documents into the client knowledge base?
Consultant Conflict Of Interest
Potential conflicts of interest for a consultant are: (1) not giving a client the same quality of expertise because of their relationship with another client, and (2) trading CMO negotiations among clients. Consultants cannot always predict their time demands, but they should give each client the quality of work they committed to or be honest about their limitations. The second situation can arise when a consultant has two clients working with the same CMO. The consultant cannot formally or informally negotiate tradeoffs between the projects or sacrifice one program to benefit the other. Using influence capital, asking for favors, or playing bad cop on one project that limits the second project is not fairly representing all clients.
Expert consultants are integral members of the small pharma community. As with all outsourced providers, a better understanding of their abilities and limitations makes for a better relationship and more successful program.
About The Author:
Sue Wollowitz, Ph.D., is a pharmaceutical development consultant and educator. She is interested in CMC tactics and strategies in small companies that increase operational quality and best support project goals. Wollowitz has led pharmaceutical operations at Medivation, Inc. and held various positions at Cerus Corp. and Dow Chemical Corp. She is the holder of 32 patents and author of over 20 publications. Wollowitz has a Ph.D. in organic chemistry from the University of Wisconsin-Madison and had further training at CNRS in France and at the University of Chicago. She can be contacted at email@example.com or on LinkedIn.