Working with a CDMO – How Consultants Play a Key Role
Once key issues have been addressed, the consultant will help to assess resource requirements necessary to manage the CDMO as well as work on the budget, capacity and timelines.
“For a client that has never worked with a CDMO before it is important to understand the optimal relationship and outcome or other options that may become necessary. Previous experience plays a clear, critical role in our recommendation of a partnering organization,” says Leininger.
As with most business relationships, there must be a collaborative effort between the client, the CDMO and the consultant if a successful outcome is to be realized. That means the relationship must be particularly close and flexible for the sake of the client. Having an individual at the CDMO as a single point of contact is critical.
“From the beginning, it is important to provide both the consultant and client with the information they need such as company history and experience, process costs and timelines, technical capability as well as regulatory and quality issues,” says Earnshaw. “There must be productive interaction between all involved parties.”
Most often, a three-way CDA is arranged that may require the consultant simplifying the processes to help their client understand the service portfolio and processes of the CDMO. Regular communication and documentation of meetings and what the action items are is essential.
“Because consultants already have a great deal of the know-how that clients may lack, it is often easier for the CDMO to work directly with a consultant in order to bring about a positive outcome for everyone,” says Earnshaw.
In regards to quality, the consultant must be able to troubleshoot along with the outsourcing partner in a collaborative and highly inclusive manner to make the client more comfortable in doing repeat business with a given CDMO. “As a consultant, we act as an extension of the client,” says Lin. “Likewise, the CDMO should also be thought of as an extension of the client if we are going to meet our goals.
Providing assistance in navigating complex global requirements as it pertains to the manufacturing strategy and plan with a CDMO is critical to the success of a client’s project.”
Through their work, consultants are in a unique position of dealing with a variety of companies, both large and small, and in a variety of projects. This affords them the opportunity to stay abreast of regulatory and quality requirements, emerging trends in technology and other key issues which may affect their clients.
“First and foremost, we must remain current on the technology, regulatory and quality side of the business,” says Leininger. “We see many different ways and approaches to doing things. And, there is always more than one way. For this reason, we need to be current and knowledgeable in how the business is working.”
For the client, consultant and CDMO alike, the ultimate success from a technical point of view is, of course, product approval. Given the high risk of drug development, however, such outcomes are quite limited.
Thus, unexperienced clients not utilizing the services of a consultant may well be taking a risk. “Start-ups not taking advantage of the experience and knowledge a consultant can bring to the selection of a business partner may well be missing out on critical expertise since most consultants have worked with a variety of CDMO’s,” says Earnshaw.
Whether a client decides to utilize the services of a consultant across the entire product life cycle is dependent upon the compound being developed. Most often, however, it is best to engage a consultant in early preclinical before any filing or regulatory applications have been submitted.
In this way, the consultant can help set the landscape of what needs to be achieved and help the client understand the development path into a GMP manufacturing environment.
This article was first published on contractpharma.com
About the authors:
Wendy Lin, CMC and Regulatory Affairs Consultant, has twenty years of professional, multidisciplinary biotech and pharmaceutical experience, focusing on regulatory affairs, quality, process development and manufacturing. She has successfully led and designed global development strategies for regulatory, clinical, CMC and companion devices.
Lizzie Leininger, PhD, Regulatory Affairs and Quality Consultant, has been involved in various pharma and biotech organizations throughout her twenty-five years in the industry. Her work history includes operational positions as vice president regulatory affairs, quality assurance and clinical operations at StemCell, Inc. as well as senior scientist at the FDA. Since 2008 Lizzie works as an independent consultant.
Paul Earnshaw, clinical business development manager, Vetter Pharma International USA Inc., has worked in the biotech and pharmaceutical industry for the past twenty-two years. After 9 years at Genentech serving in both manufacturing and quality roles, he transitioned into business development for Eppendorf. Since 2016 he has supported Vetter’s clinical manufacturing service.