The market momentum of novel therapies targeting unmet needs is creating a new landscape for pharmaceutical drug manufacturers. As the focus on these smaller patient pools grows, so does the complexity of drug development.
Companies must understand how the molecules filling today’s pipeline are changing our business, as they are causing a dramatic shift in how we plan for and execute drug development and manufacturing. As a CDMO, our customers’ needs give us a unique perspective on the evolution of the industry and how it is shaping today’s market. By passing this insight on to you, we at Patheon, part of Thermo Fisher Scientific, hope it gives you a better idea of industry trends in drug development.
The market impact of increased competition and CDMO growth
A deeper understanding of diseases and the science needed to treat them is helping replace the old model of blockbuster and “me too” drugs with one that focuses on disruptive innovations that can offer better value and benefits to its patients. Outsourcing has allowed these entrepreneurs to leverage the facilities and expertise of a strategic partner rather than invest too much of their own capital before they know the future of their drug. This reflects the critical role of CDMOs in supporting the development of clinical candidates as well as the registration of these products, marketing authorization, and manufacturing for global markets.
Smaller companies utilizing CDMO resources and companies facing increased competition must find ways to stand out and, more importantly, get ahead. This has led to an exploration of new territories in drug development, such as new mechanisms of action including targeted therapy, which is transforming the make-up of today’s drug development outlook.
The challenges of treating rare disease
The potential orphan drugs have for treating rare disease has not gone unnoticed. The molecules that make up these orphan drugs are not only complex, but they are also highly potent. High-potency active pharmaceutical ingredients (HPAPIs) require specific infrastructure and capabilities. These include but are not limited to containment procedures, engineering controls, and personnel handling during development and manufacturing at both clinical and commercial scale. A facility manufacturing HPAPIs must also:
- meet regulatory and environmental requirements
- be segregated from other facilities producing pharmaceutical products
- comply with occupational exposure limits for handling potentially hazardous compounds
Unfortunately, securing these measures requires a significant capital investment and several years to get a compliant facility up and running. Even if a company already possesses some of these capabilities, they could potentially be outdated. The equipment and engineering techniques used for highly potent compounds 5 to 10 years ago are now more sophisticated. Any company, including a CDMO, that invests in containment procedures and capabilities to handle these types of compounds will be better positioned to support the industry.
Finding a CDMO that is prepared for the future of pharma
Selecting the right CDMO for your project is critical. From discovery to commercialization, the drug development process can take many years, so you must choose one that can support a long-term relationship. This requires specific capabilities to support the clinical and/or commercial development of your drug substance or product in order to bring it through the regulatory approval stages and, ultimately, to the patient. The criteria a sponsor — no matter what size — should use to evaluate a partner include technical capability, capacity, experience, quality, client management, reputation, and financial stability. In addition, continuity of development and clinical manufacturing services at a single CDMO ensures a thorough understanding of deliverables, the ability to avoid delays, and a much smoother project management. Multiple tech transfers and changes of an outsourced partner at various stages of development often leads to the loss of knowledge and trade secrets, which is why it is beneficial to retain the knowhow and experience within one organization. Overall, the strength of a company’s personnel as well as the organization itself brings stability to the development and clinical programs they offer. Partnering with a qualified CDMO can not only help prepare you for the future of the industry, but, more importantly, it can also facilitate the delivery of safe and effective medicines to patients in a timely manner.