The journey to develop a product and move it toward health authority approval and eventual commercial success can be long and difficult. Obstacles along the path can slow this journey and risk a product development team’s ability to reach their destination. This is particularly true of small, early-stage teams working within tight budgets and timelines. One major issue can distract the team, exhaust the budget, and obstruct progress.
Viewing product development as a journey highlights the vital role CMC Specialists play in early-stage activities. Whether you are conducting toxicology, ADME, or clinical studies, all must start with an active pharmaceutical ingredient (API), often referred to as ‘the active.’ The CMC Specialist evaluates and characterizes the active and devises the formulation. In this foundational role, they are essentially paving the way for the product development team to start their journey. At this critical early stage, they are also removing obstacles that might slow the team’s pace or completely stop progress.
Armed with a Target Product Profile (TPP) and a Development Plan as their guide, cross-functional R&D teams embark on their development journey. These teams are frequently looking for ways to reduce costs, mitigate risks, and increase speed along the way. They must move quickly and operate efficiently. Planning for this trip is essential.
The CMC Specialist initially translates the TPP into an actual product by defining attributes like the formulation and dosage form. They manage the documentation and maintenance of this detailed information for regulatory applications required by health authorities. The road pavement has begun.
CMC Specialists work with contract manufacturing organizations (CMO) to determine the manufacturing process, packaging requirements, product testing strategy, specifications, and product stability. This necessary liaison role safeguards against manufacturing issues arising on the critical path. Experienced CMC Specialists execute strategies to ensure that appropriate formulations and packaging configurations are available to support clinical trials. With strong CMC expertise, product development teams can stay focused and avoid product supply issues. Obstacles in the road are avoided.
Input from a CMC Specialist will also be advantageous as the team plans for required pediatric trials. The look, taste, and mouthfeel of medicines influence the palatability of a final product for children, and ultimately if they will swallow it or not. CMC Specialists can assess formulation, dosage, and packaging options and make recommendations that support pediatric research. Upcoming bumps in the road are smoothed.
The guidance of a CMC Specialist is not limited to product-specific CMC strategy. As a company grows, CMC expertise can also help to shape and build the CMC organization. Experienced CMC Specialists may advise leadership teams on required capabilities, skill sets, and emerging technologies to improve operations. CMC Specialists that have worked with small and large firms also understand the benefits and risks of operational strategies such as outsourcing or partnering. This experience can help teams make informed decisions and implement the right approach.
CMC Specialists help pave the road for product development teams to help reach their destinations sooner.
NGT Biopharma Consultants has attracted some of the industry’s top CMC talent. Our experience can be your asset. Contact Us to learn more about how we can pave the road ahead, using our exceptional CMC expertise to bring new drugs through development to market.