Due to growing demand for specialized treatments and increasing regulations like EU ANNEX 1 on pharmaceutical processes, drug development companies face constant challenges of navigating through this regulatory environment, setting the right strategy or building the right partner network. This is where the partnership with pharmaceutical consultants becomes important. They will not only support to facilitate the identification of and collaboration with suitable Contract Development and Manufacturing Organizations (CDMOs) but will also make sure to streamline the whole drug development process, potentially avoiding costly or incorrect decisions along the way.

The Role of Consultants in CDMO Selection and Collaboration

Consultants in the pharmaceutical industry are experts in various areas of the overall drug development process, from biochemistry and manufacturing to regulatory compliance and quality control. A pharma consultant is typically an independent, senior-level professional with extensive experience and an outstanding network. They are usually entrepreneurs who have developed their own practice around a unique skill set, or past executives “keeping their hand in” with contract projects. They advise drug development companies, based on their expertise and prior experience, in the strategic decision making of building the right strategy and choosing the right service providers.

For small drug development companies and biotech start-ups that often lack the expertise and resources for the drug development process, consultants play a critical role before and after the selection of CDMOs. Even before the selection of partners, consultants support building the right strategy. Based on this strategy they can also support the screening and selection process of your specialized partners. Moreover, they can act as external experts for specialized operations - working with different CDMOs based on the drug asset's strategy and co-steering the development path. This often involves the creation and implementation of an outsourcing strategy based on the technical requirements and supply chain considerations.

Effective Collaboration Between Consultants, CDMOs and Clients

Consultants often play a critical role in the delivery of the project scope, which includes detailed budgeting, setting and accomplishing development goals, optimizing the supply chain, and careful timeline planning. The effective collaboration between the drug development companies, the CDMOs, and the consultants will result in successful operation.

Clear definition of work scopes and roles is important from the beginning of the engagement. While the level of a consultant's involvement may vary in different circumstances, clear definition of roles and scope of work between parties, are a must. When ramping up from preclinical to clinical development, more suppliers and different outsourced service providers are often needed for more complicated processes. The closer you get to commercialization; the more parties are generally involved. Open communication and clear distribution of responsibilities between drug development companies, CDMOs and consultants help define the path to success and propel drug assets closer to regulatory approvals.

Sharing information such as company history, experience, cost estimates, timelines, technical skills, regulatory and quality requirements is fundamental to a longstanding relationship that results in success for the customer, and in turn, the CDMO and consultant. Productive interaction and open communication among all parties can make or break this success. A three-way Confidential Disclosure Agreement (CDA) is needed. Consultants navigate between the partner simplifying processes for their clients to allow for a clear understanding of the CDMO's services. Regular communication, documented meetings, and precise action items are key components of this collaboration. In the grand scheme of things, the consultants and the CDMOs should be seen as an extension of the client’s team, sharing the same commitment to achieving common goals.

Due to their varied work exposures, consultants have perspectives that help CDMOs stay updated on changing regulations, emerging technology trends, and other critical factors that impact their clients' potential success. This further contributes to the know-hows within the three-way partnership, achieving a win-win for all parties.

Navigating the Drug Development Landscape

In the world of drug development, the measure of success is often the approval of a product as well as the commercial launch delivering first units to patients. This is where the cooperation with consultants plays a key role. Start-ups that don't take advantage of the experience and insights that consultants offer when choosing a business partner may miss out on vital expertise.

When a biotech is developing new molecules, they often look to very specialized partners for support. The CDMO team builds the solution concept for development and commercial manufacturing of the fill and finish process of the new drug product. Suddenly, it’s not just about the molecule: support is needed for many more activities and work streams - manufacturing, quality, process development, CMC, logistics, project management, clinical trials and all the regulatory and compliance requirements that go with them. Building all this expertise with hiring full-time employees is expensive. Moreover, a lot of companies compete for such talents. Many of those skills will only be needed for a short period of time, or to execute a specific project, to get from A to B, not to permanently expand the team.

What to Look for in a Consultant

When you decide to engage with a consultant, be sure to consider the following questions:

Domain expertise. Have they worked with a similar substance and project scope before? Does their experience allow them to know what’s needed not only for the short-term, but for long-term success? Many decisions made during early phases will determine success throughout phase III and commercial launch. Make sure the consultant has the same understanding. If they have taken a product to the clinical phase before, then they should know how to transition between preclinical and clinical development.

Personality. Will they work well with your team? You will work very closely with this person for a project that may last up to several years. You need to know whether they are a good fit to your team.

Network. Do they have the right relationships and access to the right partners? Ideally, they should have broad exposure to a wide variety of different organizations during their career. In the event of something outside of their expertise is required, they will be able to point you in the right direction or make referrals to other professionals.

Drug development companies can benefit greatly from collaborating with consultants who understand CDMOs and the strategic steps needed to bring innovative products to market. This partnership simplifies the process, advancing groundbreaking products to the forefront of the industry more efficiently.