Regulatory Blog: Strategic Considerations for Biotechs

Commercial and Regulatory Strategy Considerations for Biotech

BY Alberto Grignolo, Corporate Vice President, Parexel, Sheela Hegde, Partner and Managing Director in Parexel’s Health Advances subsidiary and Leslie DeVos, VP, Regulatory Consulting, Parexel - 12.18.19 -

Many critical and innovative new therapies today, including those for rare and untreated diseases, are in the biotech pipeline. In fact, today biotech represents more than 80 percent of the drugs currently in development.  However, careful planning at the earliest stages of development is required to ensure that these life-changing innovations have the best chance of success and reach the patients that need them.  In this blog, Parexel regulatory and strategy experts Alberto Grignolo, Sheela Hegde and Leslie DeVos tackle the question of how we can ensure that worthy innovations in the biotech pipeline make it to patients sooner, and how companies can optimize their plans earlier to mitigate risks of delay or failure along the journey to patients.

Alberto: Let's get started with your backgrounds.  I'd like to know what brought you into this field and how you became interested in drug development, and in biotech in particular.

Leslie: My interest in helping people started when I was a young teenager and I had a relative who had a childhood cancer who lived with me. Watching her go through chemotherapy and the radiation treatments at a young age had a huge impact on me.  I also lost a grandparent to lung cancer and it affected me deeply.

I chose the path of Nursing initially and specialized as an oncology clinical specialist.  I had the opportunity to work in several oncology inpatient units and in an oncology critical care unit where I administered Phase I therapies.  During that time, I became interested in the drug development process and transitioned into industry, working for both biotech and large pharma companies before joining Parexel and leading the global regulatory team, based in Bethesda, MD.

Sheela: I had always been interested in medicine as a kid. I volunteered at hospitals, and I really wanted to work with patients. In college, I decided that the field of medicine was not ultimately a fit for me, but I still wanted to be in a career that had an impact on patients. Working in hospitals, I developed a fascination with the technology aspects of healthcare and that brought me to the life sciences industry.

I first worked at Novartis, and then moved to Health Advances, where I advise biotech and medtech companies on how to optimize their investments so that they can successfully bring new advances to patients. I love what I do, and I feel that we do make day-to-day impact on patients through our work.

The Current State of Biotech

Alberto: You both work with biotech companies every day.  Can you tell me what you are seeing in the market today? And what is the current climate for biotech?

Sheela: The good news is that we are in a favorable investment climate for biotech today.  From a financing, M&A and IPO perspective, we are seeing a very strong market and it looks like that will continue for the foreseeable future.

What that means is that we have many well-capitalized biotech companies that have the "gunpowder" to run the studies they need to advance novel therapies, to investigate their mechanisms and their platforms, and to evaluate multiple indications.  All of this is really good news for the industry and for patients.

Leslie: From a regulatory perspective, it's been a common sentiment in the biotech industry that over the past decade regulatory authorities have come a long way in reducing the barriers to market entry.

We're seeing, especially in the US and Europe, that we now have well-defined regulatory pathways for products such as biosimilars and cell therapies. We’ve certainly seen an opening up of the regulators with respect to accommodating the innovations in drug development, and that is encouraging.

Alberto: Biotech companies are usually in a big hurry, aren't they?

Leslie: Well, in my observation, I'd say biotech companies are really close to patients and that’s why they are in a hurry.  You often find, when you're working with a biotech company that there's a personal connection from someone in the company, for example the founder or the chief scientist, with a particular disease, and they're passionate about it.

They understand the urgency because they've watched friends or relatives suffer.  They understand the urgency of getting drugs to patients in a way that meets their needs, which is aligned with our mission at Parexel.

Sheela: I think there's definitely urgency to get new medicines to patients and, coming from the corporate advisory side, companies are under pressure to generate data that proves their approach is safe and effective.  They need to show their investors that their science is going to work in clinical reality, which is critical to getting the funds they need to get their treatments all the way to market.

Focusing on the Patient

Alberto: You both mentioned the focus on the patient, which certainly has become much more intense in recent years.  I traveled recently to Japan and spoke to a number of companies there.  There's great interest in virtual trials, and generally in making clinical research more convenient for patients.  Are you seeing this as a shift globally?

Sheela: I think it's in everyone's interest to make that happen.  Making trials easier for patients would get them enrolled faster, would help get to readouts faster, get to approvals faster, and get to markets faster.  Economist Intelligence Unit research commissioned by Parexel indicates that trials that have a strong patient focus are much faster to enroll, and even lead to a higher probability of launch and reimbursement, which I think is very provocative, and something that we should help more companies achieve.

Alberto: Leslie, you've had so much experience dealing directly with patients in hospital settings, what are your views about involving patients early in the drug development process?

Leslie: There is so much we can be doing to involve patients in the process and while we have initiated this approach, as an industry I think we could do it more often, and we could do it better. 

Patients have so much to bring to the table with respect to understanding of their own disease, understanding their treatment decisions, how they decide to participate in the clinical study, how they report the experiences that they have, the adverse events, the experience of participating in a clinical study. This can help design studies that are targeted to make life more bearable for patients and also for their caregivers.

They're contributing a tremendous amount to the science related to their disease and to helping other patients.  I think it's incumbent upon those of us in the industry to learn as much as we can about patient experiences to help advance the development of new medicines. 

Regulatory agencies are also taking notice.  In the US, and also in many other regions, companies and health authorities are meeting with patients and patient advocacy groups. Patient input is extremely impactful and important for everyone who is part of the drug development process to hear.

Getting New Medicines to Market Faster

Alberto: Now to tackle the big question – how can companies ensure they are getting these much-needed medicines to the patients who need them?  What do biotech companies need to be thinking about even at the earliest stages of development?

Sheela: I think it's critical for biotech companies to plan as early as possible to optimize investments, to really think about what it's going to take to succeed commercially and to make those factors just as important as the scientific and regulatory ones.  Sometimes we'll see companies overly focused on the science and on the requirements to get from one phase to the next.  But where they can fall short is missing a key opportunity or not having the value proposition well thought out or not having the right story to attract investors.

We advise companies to step back, to really think about the end goal.  Where is the technology or the product that they're aiming to develop going to fit in the market in 10 or 15 years?  Who is the patient that they're hoping to get this product to?  In order to get to that patient, what evidence are they going to have to show not only to regulators but also to physicians, patients, and payers?

It may be challenging in the earliest stages to commit time and resources to this effort, but even in the preclinical stages, doing a high-level market analysis on different indications can help a company choose the right indications and really understand the market opportunity.  

Leslie: Speaking from a regulatory strategy perspective, I absolutely agree with Sheela that these events really need to be taking place in parallel.  What we often see is that the clinical strategy takes the priority position.  But we find that it's best to holistically consider the regulatory and commercial strategies early on so that we can understand the regulatory and commercial road map as we're building out the clinical development plan.

The first goal line is the regulatory authority approval for a marketing authorization, but you also need to know where you're going in the market place because you want to understand what the requirements are for each one of the targeted markets in advance of designing your clinical trial.  Marketing authorization does NOT equal market access.  However, if these strategies are paired together so that we may optimize how we will most successfully drive a product through its life cycle, we have a greater chance of seeing that therapy reach the patients who need it. It also drives more efficient development.

Alberto: Sheela, in cases where a new therapy represents a significant scientific innovation and there is great scientific promise, why is it still so important to focus on commercial strategy?

Sheela: Scientific innovation is so important, but we also need to be able to understand how the innovation is going to be different from or better than what patients have – not just today but in five or ten years?  And how is this scientific innovation going to justify the price of the treatment?  Will it make a marked impact on the disease? Will it make a marked impact on quality of life?  All of those things need to be well-understood and articulated beyond just the excitement of the science itself, and that should be done as part of early planning.

Alberto: Final question: we all know that drug development is fraught with difficulties, challenges, traps and failures. Based on your experience, what are the most common missteps biotechs make along the drug development journey, and how could they be avoided?

Leslie: Most of the pitfalls I see are in the early product development strategy that includes clinical, regulatory and commercial.  The absence of a plan and the lack of a product development road map leads to bumps in the road with respect to health authority approvals, and often requires additional work to be done before the product can progress.

We encourage companies to take advantage of the opportunity for early regulator meetings - the INTERACT meeting with CBER, for instance - to engage with the development process very early on and get early advice on a wide range of development topics.  Also, in biotech, many companies target orphan indications in limited patient populations in the pursuit of personalized treatments.

It becomes increasingly difficult to complete studies quickly, especially in a crowded research space, often requiring more clinical sites.  So, if you are focusing on some of those more orphan or unmet medical need indications, be prepared for these challenges and incorporate regulators’ feedback into early planning.

Sheela: I have seen biotech companies lack a clear story -- a story for investors about how their science or their technology will have a real impact in the market, and what will be the path to realize that impact. 

You must articulate a clear, tangible, addressable market opportunity, and how your technology will be differentiated five years from now or 10 years from now.  Not having your value proposition really fleshed out compromises the ability to convince investors in the early days, and later, the stakeholders that need to adopt and pay for that innovation and ultimately make the therapy accessible to patients.

At Parexel Biotech, we share biotech companies' drive to make life better for patients, to involve those patients in the process and to plan with the end in mind from the very earliest stages. This is critical to success. For more information on Parexel Biotech and insights from our experts, please visit


We are always available for a conversation.


We are always available for a conversation.


Communication Preference

Communication Preference