Mwango Kashoki: Senior Vice President & Global Head of Regulatory Strategy, Parexel Regulatory Consulting

Please introduce yourself and how your career path led you to Parexel?

I have been with Parexel in the Regulatory Consulting group for almost 5 years. I joined Parexel from the FDA’s Center for Drug Evaluation and Research (CDER), where I had been for over 16 years. At the FDA, I began as a Primary Medical Officer and then became a clinical team leader. In both roles, I helped to guide pharmaceutical companies on their drug development programs and performed technical review of investigational and marketing applications for new drugs to determine the safety and adequacy of the clinical trials. Additionally, I made recommendations on whether to approve drugs for marketing. My last role at the FDA was as the Associate Director for Safety in CDER’s Office of New Drugs (OND), heading the postmarket drug safety program. In addition to technical assessment of clinical data to determine strategies to monitor and manage drug risks, a significant component of this role was the development of regulatory policy and internal CDER procedures to implement drug safety legal requirements. Each of my FDA roles provided tremendous insights into drug development from the Regulator’s perspective, which sparked my interest in learning the process and considerations from the drug developer’s perspective. I believed that regulatory consulting would be a good way for me to apply both my knowledge and add to my experience. That is what led me join the Regulatory Consulting team at Parexel!

What does the VP-Technical on our Regulatory Consulting team do?

In a nutshell, the VP-Technical role is to advise drug companies on the most efficient regulatory pathways to get their drugs to market and keep them there, with the shared goal of bringing innovative, safe and effective drugs to patients who need them. In this way, the VP-Technical and other strategic consultants in our group serve a very similar function to reviewers and assessors in regulatory agencies such as the FDA and EMA. The VP-Technical must critically analyze and critique a company’s data and current drug development strategy to determine if they will be adequate to yield results that will achieve the goals and meet regulatory standards. When a company has a novel product or unique drug development strategy for which there is no precedent, the VP-Technical must also consider innovative ways in which the company’s goals can be met.

The exact work varies from client to client, and across the types of products and development programs. For example, a large, well-established pharmaceutical company might want advice on options for expanded uses of their existing products, while a smaller start-up biotech company might need end-to-end support with their new IND submission since they lack regulatory expertise in-house. That’s what makes the work so interesting here!

What does a typical day of the VP-Technical look like?

The VP-Technical has their own portfolio of clients, which grows over time as one is assigned to early engagements and contracted projects. Client work is based on one’s areas of technical and geographic region expertise. Thanks to my general medicine background, I cover a wide range of therapeutic areas, which was a real attraction of the VP-Technical role at Parexel. Due to my FDA experience, I support companies who are seeking US development and approval. Most of what I contribute is advisory or strategic.

Due to the cross-disciplinary nature of drug development, the VP-Technical will often work with in a team. We have a global, multidisciplinary team of Regulatory Consultant subject matter experts in CMC, nonclinical, clinical pharmacology, and clinical. We also collaborate closely with experts in other Parexel functional groups, such as epidemiology, biostatistics, and the physicians in our clinical trials group. Our Regulatory Consulting work is supported by a great team of project leaders and technical writers.

What one works on day-to-day will vary. There will be longer term projects, such as advising on and preparing for an NDA submission. Then there may be quick turn-around projects, such as when a company wants input on a specific issue or set of questions. Our clients seek our regulatory advice on a wide range of matters, across all phases of development. For example, how to design trials, seek orphan drug designation, or include complex data in a regulatory submission. That’s one of the exciting aspects of the VP-Technical role. One gets to influence a product’s development even from the earliest stages, sometimes profoundly.

What are important considerations for the VP-Technical role?

Every client has its own processes, every assignment its own issues, so you must be agile and able to take new ideas on board quickly that may challenge your previous thinking. I particularly enjoy advising clients who have an especially innovative product or prospective trial design. I’m broadening my technical horizons and I have to think very deeply about how we present and justify these innovations to Regulators. This can really stretch you, which, as a self-confessed ‘geek’, I love! As a VP-Technical, you need to be a diplomat, while still being objective about the company’s available data, science, and regulations.

How does Regulatory Consulting support clients?

Since most R&D and outsourcing for Regulatory Consulting services is done by small to mid-size companies, we work a lot with these types of companies. We primarily support companies who are developing drugs (small molecules and biologics), but we also work with device companies. Since we support the full range of product types, the companies we work with are varied and can scale from large pharma to start-ups pursuing their first commercial drug development. Start-ups can be very interesting, because often there’s a lot of innovation without much drug development experience and you’re their “go-to” regulatory expert. You gain new knowledge of an advancement in drug development, and frequently have to think of the most expeditious pathway to get to the next important milestone, since these programs typically have a sense of urgency.

How does Parexel support professional growth and team development?

I can relate to that. I’m a physician, and work closely with other clinicians, scientists, statisticians and so on; so, I’m constantly learning from them. Due to Parexel’s years as a CRO and in Regulatory Consulting, there’s a lot of knowledge to assimilate. As I’ve mentioned before, one is constantly learning from our clients.

At Parexel, “thought leadership” is a major component of our work, which is particularly true for the VPs in our Regulatory Consulting group. Our knowledge and expertise are what we offer to clients; and for them to consider us as their trusted advisor, it’s important that we provide them with informed and helpful insights. Accordingly, VPs are encouraged to publish and participate in professional conferences, and to maintain their credentials.

What would you say are a VP-Technical’s ‘must-have’ skills and characteristics?

I’d say a passion for contributing to the development of the next generation of drugs and devices for patients. You also must be open to new ideas and determined to keep up! There’s a lot of technical challenge too. I can’t imagine doing this job without a strong medical or scientific background. And you must love it!

What do you enjoy outside of work?

I prefer to spend my free time doing things that are arts-related and not to do with science. Prior to the pandemic, I did a lot of salsa dancing. We have quite a community of social salsa dancers in my area. It’s great exercise, I’ve made some good friends. I’m slowly getting back into that. Another gift of the pandemic is that it caused me to explore my local parks and trails. I often plan long walks over the weekends. In the summer, you’re sure to find me at an outdoor concert!