Issue link: https://www.e-digitaleditions.com/i/1450659
22 Pharmaceutical Technology Europe BIO/PHARMA OUTSOURCING INNOVATION eBOOK 2022 P h a r mTe c h . c o m Additionally, proprietary nonclinical models that test for- mulations for effectiveness at early stages continue to be an asset to the company's client base. For example, MedPharm's reconstructed human nasal epithelia model is a living repre- sentation of the nasal membrane, and allows formulations that are targeted for the different regions of the nose (local, sys- temic, or brain) be tested to evaluate formulation parameters such as delivery, irritancy, mucoadhesion, and effectiveness. Growth areas PTE: What type of formulation work is more commonly out- sourced currently? Allen (MedPharm): There is continued growth in product development by specialty and virtual pharmaceutical com- panies. As large pharma looks for investments in late-stage assets, start-up companies that effectively deliver well-devel- oped products with effective clinical data are highly sought out for licensing and acquisition deals. Consequently, start-up companies require formulation expertise at the earliest stages of development and often do not have extensive research labs to perform critical assess- ments such as screening multiple APIs. Outsourcing of these early research activities continues to grow, and MedPharm continues to invest in these services to support both early start-up and specialty pharma companies. Biggest challenges PTE: What are the biggest challenges for outsourcing partners when working on a formulation project? Allen (MedPharm): In the fast-paced environment of drug de- velopment, it can be challenging to ensure that all stakeholder needs are being articulated at the start of formulation activ- ities and continue through the development process. When sponsors have not conveyed all needs or if they are not pre- pared to make decisions on formulation priorities when chal- lenges arise during development, it can often mean repeating activities or delaying timelines. PTE: How do outsourcing pa r t ners overcome t hese challenges? Allen (MedPharm): One key aspect that must be stressed at the start of any programme is the necessity of a well-defined tar- get product profile. The key attributes of what the formulation should achieve and, particularly in the topical space, how it should feel when applied or how it should be packaged and used by the patient are critical considerations of development. Internal expertise is also critical which includes programme management, development, or regulatory resources. Benefits of broad experience PTE: What are the key benefits of outsourcing formulation development? Allen (MedPharm): When formulation development is not an internal strength or if the delivery route is outside of in-house formulation expertise, the broad experience of a service provider dedicated to these services can save time, money, and avoid the pitfalls of an ineffective, poorly developed formulation. CROs [contract research organi- zations] and contract development and manufacturing organizations, particularly those focused on niche markets like MedPharm, have broad experience and can pull from decades of experience and current real-time learnings to guide development activities in the constantly changing reg u lator y env i ron ment. Ser v ice prov iders ca n a lso offer more dedicated resources when companies need to prioritize critical programmes. Reference 1. Mordor Intelligence, Formulation Development Outsourcing Market—Growth, Trends, COVID-19 Impact, and Forecasts (2021–2026), Market Report (May 2021). PTE Over the years and in light of various industry trends, the demands for out- sourced services have increased and evolved. In this interview, Pharma- ceutical Technology Europe discusses how process development demands have changed for service providers with Xiaoyong Fu, PhD, chief technology officer and head of API Business, WuXi STA. Trends impacting process development services PTE: How have process development demands evolved over the years for outsourcing partners? Fu (WuXi STA): Molecules are getting more complex, pipelines more diverse, and at the same time, increasing numbers of targets are on accelerated pathways. Put these factors together and there is a need for contract development and manufacturing organizations (CDMOs) that can handle integrated and accelerated pathways with a full suite of technologies from biocatalysis and flow chemistry through to crystallization and spray drying. Integrated models provide much greater flexibility and enable API and formulation teams to work side by side. Phase-appropriate development is also often asked of many CDMOs, and this usually means running pathways sequentially. Another way timelines can be accelerated is by developing an 'end-in-mind' process strategy to seamlessly connect discovery, development, and commercial API needs from milligram to metric ton scale. But the CDMOs will need a large R&D team with the right expertise and a broad technology platform to ensure the most appropriate chemistry at every scale. The final trend that is being seen and, in some ways is linked to the challenges of the pandemic, is the requirement of a partner who can ensure supply chain stability with a robust continuity business plan including multiple facilities available, technologies to avoid or minimize the use of scarce material, or even the ability to manufacture them in the event of shortages. This means forward- looking innovators are seeking backing by a contract partner that has a solid network of vetted vendors and a large chemistry organization and a diverse manufacturing and technology platform that can react and adapt quickly. —Felicity Thomas Evolving Demands of Process Development Services Development