COMMERCIALISATION
as well as decisions on whether a company has the capability and capacity to effectively handle this internally, are all taken into consideration when planning for commercialisation.
What are the various development challenges during commercialisation? There are many challenges with respect to pharma development, but when I view it from a very high-level perspective, I have some key areas to consider. Pharma is dealing with ever-increasing, cost-sensitive pressures, and in the background, you need to meet robust regulatory and quality expectations, which are non-negotiables. As an industry, we’re facing increasingly aggressive timelines to address patient needs: when something looks promising for certain disease states, people are looking to achieve the final outcome as quickly as possible. The environment surrounding COVID-19 and the need for preventatives and treatments is a terrific example of that. We need to develop innovative products that are evaluated in clinic without necessarily having the ideal dosage forms, while still having a reasonable path to commercialisation at a global scale in a cost- effective way. Many things get in the way of that. Developing a product is complex, and you need very broad skills and knowledge while at the same time having the necessary specialised expertise. The dynamics of clinical development are ever-changing, operate on a global scale, and have inherent complex logistics. Our responses to these dynamics are often needed on a real-time basis. If you consider these, it should be obvious that these are more pressing for a small company with a smaller number of employees, and their need to work with partners is heightened. This all feeds into being able to make the right make-versus-buy decisions.
Can you explain what make-versus-buy fundamentals are in development programmes and what the key factors are that determine make-versus-buy decisions? Every industry has a need to really pay some focused attention to the ‘correct’ make-versus- buy decisions. I consider three different areas when it comes to helping organisations make make-versus-buy decisions. Primary is the core capability consideration – really understanding what your organisation and personnel bring to
the table that differentiates you from skilled outsourcing partners. What are the core capabilities you have versus those areas that you could effectively outsource? One thing I’ve seen with a big company like Pfizer is the importance of having a logical story behind make-versus-buy decisions and making sure everyone in the organisation understands and is aligned with that strategy. The next area is around quality and compliance aspects. We need to be able to perform global clinical trial conduct, and the suppliers we use need to have very clear quality systems that align with our industry’s data integrity and data-transparency expectations. Whether you make or buy, you need to assure you can support your deliverables with robust quality fundamentals.
The final aspect is around financials: what is it going to cost, whether you do the work yourself or rely on a partner? Having a good understanding of ‘total cost of ownership’ is vital to support sound make-versus-buy decision-making. Do you truly understand the cost of leveraging external capabilities versus building those internally?
Could you expand on how quality and compliance come into partnering decisions? Maybe one thing to further stress is the non-negotiable aspect of quality and regulatory compliance, and that goes from the early aspects as you start to apply good manufacturing practices (GMPs) in your Phase I supplies forward by making sure you have strong quality systems upfront. It’s very important to clarify and document who is responsible for what, and making sure there are no compliance gaps. This isn’t easy because it requires ongoing dialogue and monitoring of sometimes dynamic regulatory expectations, as well as performance
“We’re facing increasingly aggressive timelines to address patient needs. When something looks promising, people are looking to achieve the final outcome as quickly as possible.”
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