Start Too Early… Before It’s Too Late

by Susan Nemetz, July 2021

Try this: Hold up one hand to signal “stop” while using the other hand to indicate “come forward.” I used to work with someone who mimed this all the time as a way of commenting on the mixed, often conflicting messages we sometimes receive in our industry (and lives).

We often discuss this “go fast, but wait” phenomenon with our early- and mid-stage clients in the commercialization space. Everyone wants to ensure they will be commercially successful when they reach the market. But everyone also wants to hold off on significant investment until there is more certainty around the data, the financing, and the company vision.

Fortunately, in the commercial function, the New Product Planning (NPP) role has emerged over the past many years to pay attention early — to inform the program team, to ensure that market insights are gathered and shared with the clinical team when trials are defined, and to provide competitive insights on the changing market dynamics of both pipeline and approved products. This shift has made a huge difference in informing development plans and eventual commercial viability.

So how does the “go fast, but wait” phenomenon apply to another key area of commercialization — Medical Affairs?

To answer this question, I would like to introduce Ray Mankoski, MD, PhD. We have been so fortunate to have Ray on The NemetzGroup team since the early part of the year; he has already made a significant impact on the Medical Affairs thinking for these young companies.

Ray comes to us with deep and broad medical and research credentials, experience in large pharma, as well as in two small companies where he led the build of the Medical Affairs function from the ground up. Ray has seen what is needed and experienced the impact of not addressing some key areas in the pre-Medical Affairs phase of a company.

Three Questions

I asked Ray Mankoski, MD, PhD, three questions in preparation for this month’s e-conversation.

#1. What role does Medical Affairs play in helping patients and companies?

Medical Affairs is uniquely positioned within the “symphony” of the drug development and commercialization ensemble. It is staffed by clinicians and scientists who can speak the language of a broad array of stakeholders, from patients to payers, not to mention lending their own professional interpretations as researchers and physicians.

Prior to approval, these professionals bring deep, complex insights from the “outside” and engage in real-world evidence generation, all of which can inform development plans, support the approval process, and ensure successful launches while providing an important link between the internal clinical and commercial teams.

After approval, Medical Affairs provides an objective, non-promotional translation of the science and the data of a disease and its treatments to HCPs and other stakeholders. This supports the successful adoption of new therapies for patients with unmet needs and ensures safe and effective use of and access to approved products.

Medical Affairs is also responsible for a broad array of additional evidence-generating activities to support a product’s ongoing lifecycle, including registries, Phase 4 research, continuing medical education, and independent investigator research.

#2. What is the most significant change you have seen in the Medical Affairs discipline over the last 3–5 years?

Where do I begin?! It’s really across the board:

  • There is a greater awareness of the importance of the function and its potential to lead critical activities well before a product’s approval. You can see this by the degree to which Medical Affairs is being leveraged in organizations of all sizes and continues to mature holistically as a discipline, with multiple professional societies, growing in size within organizations, and having a global impact in an increasingly connected healthcare world.
  • Medical Affairs is becoming engaged increasingly earlier, supporting clinical development and pipeline programs. This is partly due to a heightened need to generate real-world evidence, especially in rare disease and precision oncology, to support regulatory approvals and early payer conversations, and to bring in “on-the-ground” insights to development programs, particularly in highly competitive spaces.
  • There is a recognition that peer-to-peer dialogue that informs the patient experience is essential to achieving the vision of a patient-centered company. Today, even small, nascent patient organizations bring a depth of clinical and scientific acumen and are looking for the same level of scientific exchange as the KOLs.

#3. What should an early-stage company be thinking about in the broad Medical Affairs arena when it is still premature to build that capability?

Understand the stakeholder universe.

The key word here is “universe.” Because while many companies may focus initially on only the “top” KOLs and academic centers — those who conduct research, publish, and speak on a topic — they need to broaden that view to build relationships with the non-academic leaders who may be shaping standards of care within their referral base and in large practice networks.

Medical Science Liaisons are often a great resource for identifying these hidden practice leaders, but often the “top” academic KOLs can be quite helpful in connecting companies with clinicians who have deep therapeutic expertise and highly practical insights because they focus almost exclusively on patient care.

Beyond clinician and patient opinion leaders, there are many others with deep expertise who are integral to the scientific exchange. This can include patient advocacy groups and their scientific leadership, professional societies, health economic and outcomes leaders, and healthcare systems. Understanding how these audiences view a changing disease landscape early in a therapy’s development is crucial.

Align the scientific (and future clinical) narrative.

Even before it is known for certain whether a therapy will work or whether there will be data to support its use, there needs to be a common narrative around “how it functions“ (the mechanism of action) and “why it’s needed in the first place.” Creating a cross-functionally aligned scientific platform, even if it is skeletal, is critical.

Use of the scientific platform must be pervasive and consistent at every level of the company, from conversations with investors, to investigator meetings, to disease education. This harmonized way of discussing the science ensures that the full spectrum of stakeholders — both internal and external — hears the same message and feels confident that the company knows what it has in hand.

Plan early for longer-term lifecycle management

Consider taking calculated risks on early investments to bolster data outputs in the peri-launch period (e.g., natural history studies or investigator-initiated research). New data breathes even more life into a product a year or two after launch and can be leveraged by field teams, in publications, and through external education. If started early, data-generation activities can anticipate important questions at launch. And data from “indication-adjacent” studies, where there is an unmet medical need but no dedicated company-sponsored program, may also provide an early read on potential indication-expansion activities as well as support inclusion into professional guidelines.

Conclusion

I am so grateful to Ray for his insights on this important subject. I know we could have talked for many more hours, and I feel this is far from our last discussion on the topic.

Overall, it is vital that early- and mid-stage companies understand and align on a definition of commercialization as a mindset — one in which the entire company is focused not just on patients but on what it will take to get the therapy to market.

“Go fast, but wait” is a limiting and often confusing posture. Starting early within the scope of Medical Affairs — before all the questions are answered and unknowns are clarified — is a more constructive approach to getting to market effectively and providing the essential medical information clinicians need to care for their patients.


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