The pharmaceutical landscape has transformed over the years to include a greater number of biopharma firms and smaller virtual companies with a diverse pipeline of assets. With increasingly complex drug products, sponsors are engaging CDMOs earlier in the development process. In turn, CDMOs have had to create and develop the advanced technologies and capabilities needed to address the challenges that complex compounds present in drug formulation, development, and manufacturing. Furthermore, in today’s market, improved efficacy via drug delivery and patient compliance have become an essential layer in the development process. Elliott Berger, Vice President, Marketing and Strategy, Catalent shares his insights on the past 20 years and what we can anticipate for the future of the industry and outsourcing.  –KB

Contract Pharma: What are some of the major pharma/biopharma industry changes that have impacted contract service providers?

Elliott Berger: Probably the most obvious change for contract service providers is in the mix of customers and their needs. Whereas 20 years ago, drug development was dominated by the top 20 or 30 ‘big pharma’ companies, currently around 75% of the development pipeline comes from small and mid-sized companies. These companies often lack the resources and assets of large pharma, and look to an experienced outsourcing partner to assist at all stages of development.

Similarly, drugs and therapies have changed from being small molecule dominated to now include biopharmaceuticals and cell and gene therapies. Development and manufacturing partners have evolved and invested in these technologies to meet the differing needs of biologically-derived medicines.

CP: What are some changes you anticipate for the future of the industry and outsourcing?

EB: Drug molecules are becoming increasingly complex, and the challenges of bringing a successful drug to market are increasing while timescales for projects, and patient populations decrease. One specific area where innovators are looking to development partners such as Catalent for guidance is in dose design and thinking earlier on in the development process about decisions that will impact important patient-related factors such as patient adherence and ultimately, outcomes.

A drug will only be successful if the active molecule is efficacious, and it is formulated into an optimal dose form that can be taken easily and as prescribed.

CP: How have service offerings and operations for CDMOs evolved over the years?

EB: CDMOs have had to evolve and become more flexible, and investments have been made by many of the larger companies to widen service provision and capacity in specific areas where the industry can benefit. This may be in new areas as research grows, such as cell and gene therapy, or increasing access to manufacturing technologies such as spray drying, where historically there was insufficient capacity to meet increasing global demand for a means of overcoming solubility issues.

For innovators, choosing the correct outsourcing partner for specific projects can be pivotal, and can make the difference between a product being successful, and one that achieves little success because it demonstrates only a small incremental benefit in patients’ lives.

CP: What global market changes have had the greatest impact on the industry and CDMO services?

EB: The decline in “blockbuster” drugs and rise of smaller, niche therapies have been matched by a rise in the number of smaller/virtual companies that now feature more in the development pipeline. This change has seen service models change from a fee-for-service “contract manufacturing” basis, to a far more collaborative approach. The smaller companies that lack expertise and resource are more reliant on outsourcing, and look to choose a CDMO development partner by its experience with ‘their type of molecule’, technology offerings, intellectual property and access to specialized dose forms rather than solely capacity or cost.