Responsible for evidence generation, medical education, publications, and medical communications, medical affairs is essential for the biopharmaceutical industry. In part one of this roundtable discussion, Inizio experts predict the 2024 trends in the medical affairs market and discuss the challenges and opportunities for biotech companies. You can read part two, focusing on data & AI here, and part three focusing on omnichannel engagement here.
Medical affairs play a crucial role in bridging the gap between the development of investigational products and their eventual commercialization. What factors will influence how medical affairs will facilitate this process in 2024?
Sam Falsetti, Global Chief Biotechnology & Innovative Solutions Officer, Inizio Medical:
For pre-approval companies, the stage of the clinical program and current capitalization status will have a big impact on medical affairs. I expect companies with lead assets in pre-clinical through to phase two to face continued fundraising headwinds, which may impact the scope of early-stage investments in medical affairs. This will challenge CMOs and medical affairs leads in these companies to accomplish their goals with a potentially leaner internal team and overall budget. Similarly, for companies in phase three, it may be critical to quickly assess gaps and develop a plan for rapid catch-up due to delayed investments in earlier phases. Ultimately, medical affairs is essential for both pipeline success and, particularly, late-stage clinical development and launch preparedness.
Regardless of the stage of the asset, it will remain critical for biotechs to continue to invest in medical affairs to maximize asset strategy and the overall clinical program success. Medical affairs manages and collaborates on multiple critical workstreams such as evidence generation, KOL external engagement, medical education, publications and patient advocacy. So investment is necessary in medical affairs, what varies will be scope, timing, and specific activities.
For biotechs with approved assets, modernizing medical affairs as well as developing advanced KPI measures is essential to demonstrate the value of specific, as well as overall, medical affairs investments. The modernization of medical affairs covers a broad range of topics, including AI integration, omnichannel and analytics/impact assessment. This is a key area in which both existing and new medical organizations can benefit from external support to assess, plan and operationalize.
Medical affairs has a central role in shaping an organization’s strategy, alongside research and development. What key factors will businesses need to take into consideration as part of their strategic positioning in 2024?
Brandon Boland, Vice President, Biotechnology Portfolio Lead, MEDiSTRAVA, an Inizio Company:
Medical affairs does not operate in a silo to the other communications flag-bearers. In our view, medical affairs should serve as a central hub for other cross-functional communications stakeholders to not only ensure consistency of communications efforts but to avoid duplicative efforts and drive internal consensus. This was readily apparent in 2023 when our most successful biotech clients embraced this resource-sparing and efficient approach to both hedge against financial headwinds and optimize the value of their efforts.
Inizio Medical has been at the forefront of helping organizations transform their medical affairs initiatives. We don’t take anything for granted, and unless a tactic or initiative adds value to your company, we will advise against it. We don’t view ourselves as executors of a predefined strategy but rather as true and trusted partners whose primary success metric is the success of our clients. In this regard, if medical affairs is doing something without internal cross-functional alignment it puts the entire initiative at a disadvantage from the start. This is particularly true at biotechnology companies where a leaner operating model can create headwinds to carving out the time necessary for internal alignment building. We believe it is critical for any partner agency to understand the operating environment within a client company and to act as an extension of the internal team to foster consensus and ensure strategic alignment across communications activities.
Luis Perez, Senior Commercial Director, Nucleus Global, an Inizio Company:
Medical affairs should champion the development of strategic imperatives, messaging and narrative to support product positioning, alongside other critical functions such as R&D, Market Access, and Commercial. Organizational goals can be driven by Medical, with activities and content tailored to support functional objectives. Ultimately, embracing a more integrated approach maximize the smaller, more agile organizational model typical of biotechnology firms.
In 2024, various external factors could potentially disrupt the medical affairs and biotech market, including ongoing economic uncertainties in the global economy caused by inflation and supply chain disruptions. What external factors and market trends will affect biotech and medical affairs?
Sam Falsetti:
All of these are, to some extent, a continuation of trends we observed in 2023. We anticipate some recovery in 2024 but the fundraising and public offerings of 2019 to 2021 are unlikely to return. Analyzing market cap recovery from trough levels in we see consistent recovery in the cohort of companies with phase 3 assets and a lack of cohort market cap recovery for biotechs with pre-clinical and phase 1 assets. The most variability is in the cohort of companies with phase 2 assets.
We anticipate that biotechs with assets in phase 3 will continue to outperform earlier-stage peers in fundraising and this discrepancy will continue to shift the role of medical affairs towards more effort expenditure later in the clinical stage than is ideal. This creates a challenge for earlier-stage companies bringing medical affairs insights to corporate, asset, approval and launch planning without an ideal internal infrastructure. For those companies with a lead asset in phase 2 development they will have to carefully consider how to guide investments in medical affairs to maximize value early and enable phase 3 and commercial success.
For later-stage companies, it means that new medical affairs professionals are hired closer to launch and must transition and scale rapidly while driving peri-launch decision-making. Alternatively, and often more frequently, bringing in a partner agency and contract staffing for medical information and field medical, which Inizio supplies, can help de-risk investments and preserve organizational flexibility.
Another key factor will be the continued technology advancements in omnichannel and artificial intelligence. For established biotechs and pharmas, with existing medical affairs infrastructure, this will mean organizational change management as they seek to modernize medical affairs through improved technology integration. Today we see many medical affairs leads with goals to action corporate-level technology integration activities with respect to AI and omnichannel in 2024. This will mean building out a technology stack as well as driving organizational change, operational deployment, and integration across the global and regional medical affairs teams.
We have been at the forefront of modernization activities both with respect to our clients and internally for some time. We have made large investments in both our staff and technology stack with respect to AI, omnichannel, analytics and real world evidence. We have been engaging with these activities at an industry level through associations and thought leadership as well as at a client level through strategic and operational support since the inception of these disciplines. For us this change, while disruptive to long established ways of working, is very exciting and represents a culmination of multiple trend lines in medical affairs and in biopharma.
As the medical affairs landscape continues to evolve in 2024, a proactive approach can help to overcome challenges, provide innovative healthcare communications and enhance patient outcomes. External partners can bring the expertise and support required to deliver innovative medical affairs and support medical affairs build-out in all stages of company lifecycle. To find out how Inizio can support your medical affairs, get in contact.
