Q: Can we start with a brief history of PharmaLex, what are your key offerings into the industry?

A: PharmaLex was established 25 years ago with a vision to make a difference to how the industry interacts with regulatory authorities. Today, we support more than 600 clients worldwide with an expert approach to compliance. PharmaLex offers six solution areas that cover the entire product lifecycle: Post-Launch Outsourcing, Local Affiliate Services, Business and Portfolio Mergers and Acquisitions, Strategic and Scientific Consulting, Innovations to Market, and Integrated Product Development.

I’m a solution lead for our Integrated Product Development (IPD) area. A major part of that is strategic product development, which is about helping clients establish an understanding of what is needed to get their product through development and build a strong foundation for commercial success. It’s the centrepiece of what I do. We have experts in all major regions around the globe, including a team of eight here in the US. Our subject matter experts know what it takes to bring products to the patients who need them. They also have a strong working knowledge of the various functional activities that need to be integrated seamlessly in order to ensure the most time- and cost-efficient development program, with a high probability of success. We take a bench-to-bedside view across the product lifecycle, from designing a preclinical program that will meet regulatory approval to designing a global clinical/regulatory strategy and helping to guide commercial success. Given the complexity of development and the multi-year programs, a significant challenge for many companies is understanding what questions they should be asking or answering and when. That’s how we can help.

Q: We hear a lot about the need for integration in drug development – why is this important to the future of the industry, especially as it relates to small molecules?

A: It’s always been important, but now it’s even more so, because it helps to move drugs faster and more efficiently through the development process. It’s quite simple. Consider an activity such as preparing for a meeting with the Food and Drug Administration (FDA). If this activity is not well planned out, with all of the major contributors in alignment, the meeting may be delayed and critical feedback from the agency will not be available when needed to advance the program further into development. This could lead to a delay in the clinical program, for example, which would ultimately lead to a delay in product launch. For a product expected to return US$400 million in the first year of sales, each day the program is delayed would mean lost revenue of more than US$1 million.

All the functional activities needed to bring the product to the market are intricately interconnected. Understanding how the various puzzle pieces fit together is critical to efficient planning of the development phase.

When focusing on single activities or only on the next milestone, it’s common for development programs to go through fits and starts, for example having to repeat a study in a different geography because the input of regulators in various regions was not sought or incorporated into the development plans.

So, thinking from an integrated point of view, instead of just getting to the next milestone or the next dataset, taking a holistic view can prevent a lot of that rework and hassle that goes along with it. This is especially true for innovative small molecules, some of which are developed using artificial intelligence (AI) and/or machine learning (ML). The higher the quality of the data being fed into AI/ML, the greater the chance of success in hitting a druggable target with beneficial clinical outcomes.