Now more than ever before, Emerging biopharma companies (EBPs) are in a competitive environment with high-cost pressures and evolving hurdles from payers that are reducing the chances of product reimbursement. These companies span from precommercial, to having a few assets on the market, and usually spend less than $200 million in research and development. Furthermore, EBPs are changing how they elect to bring their products to market. An increasing number are opting to roll out their assets themselves (as opposed to partnering with someone else). Of the NASs originated by EBPs in 2021, three quarters (76%) were also launched by the EBP¹.

When an EBP’s focus shifts from asset development to commercialization it is often the case that many resources are already exhausted. These scenarios create cost-cutting efforts from leadership teams resulting in reactive last minute budget decisions that end up eliminating critical elements for a successful product launch. For example, the company may have overlooked the importance of defining an audience and articulating the economic value of the product early on, while asset development is still underway. Defining, and refining along the product lifecycle, the scientific value statements will actually reduce data development costs if a medical strategy and scientific communication platform is aligned to clinical development plans prior to early phase study launch and appropriately supplemented with real world data. The goal of any scientific narrative for the right audience should always include changing clinical practice behavior that improves patient outcomes.

Even with highly innovated (potentially disrupting) therapeutics, some EBPs struggle to achieve product launch success. Recent analysis from the IQVIA Institute report: Emerging Biopharma’s Contribution to Innovation shows that in more than 600 product launches, it was observed that failed launches were primarily due to missed alignment on patient profiles and physician audiences far enough in advance, missing their chance to gather supplemental data that speaks to those groups.

It is a costly mistake for EBP’s to engage physicians post-launch via field commercial teams only to find out that the patient profile is not well defined. With the support of the Medical Affairs leader(s), EBPs should start thinking early on about their physician audiences, patient profiles, payers, advocacy groups, and competitive landscape. This can help differentiate the product from both a scientific and commercial perspective, ensuring field medical and commercial alignment pre and post launch, and leading to clinically meaningful product adoption.

Here are some ways a Medical Affairs partner can be part of emerging biopharma companies’ early strategy for launch success.

Take a patient-centric approach

The patient is the end user. Patient perspectives should be considered. Medical Affairs partners can help identify the appropriate patient-generated data sources. This ensures that the appropriate patient populations are identified, including populations based on demographics, disease stage/progression, socioeconomics (e.g., for health equity and access programs), clinico-genomics, and other characteristics. This also ensures that data about patients is appropriate, including diagnosis and treatment history, concomitant medications, comorbidities, and more.

Often what the patient thinks is different than what their provider believes is the case. Medical Affairs partners can promote inclusiveness, diversity, and inclusion of the patient voice in strategic planning. This should be started well ahead of launch and continue to be an ongoing and evolving process post-launch.

Identify thought leaders as advocates

A Medical Affairs partner can use a nuanced data process, publication activities, and relationships within and across networks to understand their profiles and identify thought leaders. Thought leaders are the local, regional, and national influencers who have immense sway over clinical learning and product adoption in their provider networks.

They play a vital role in translating the scientific evidence that supports a product into clinical application. Once EBPs know who thought leaders are at the national and regional levels, they can engage them based on disease state education prior to launch, and product awareness at launch.

Adoption of the product can be 25% higher when biopharma companies properly engage thought leaders.

Discover the product’s place in the current treatment paradigm

Medical Affairs can help EBPs understand the treatment landscape and patient diagnosis and treatment journeys that their product will enter into, based on robust data about competitors, existing clinical need, and differentiation. With access to large patient level datasets including registrational data and real world data, Medical Affairs can discover what other studies have been done in the same space.

EBPs can use these insights to gain market access, articulate a compelling value proposition, offset any hurdles caused by the product use or mechanism of action, and figure out how to convert prescribers and patients from existing therapies if competition exists.

IQVIA can help you build a roadmap to launch success

EBPs should have an initial conversation about the three above topics as soon as they start to see efficacy data, if not before. A year or more ahead of launch, IQVIA’s Medical Affairs team has helped EBPs like yours develop a launch roadmap by:

• Identifying patient and physician profiles
• Setting up partnerships with advocacy organizations to educate patients and care partners, identify healthcare professional advocates, and understand the patient perspective
• Identifying thought leaders early, finding early adopters, and gaining an understanding of the educational need
• Launching unbranded patient and physician education strategies to jumpstart scientific dialogue
• Developing scientific value statements to shape educational messaging

Even if you already have similar activities underway, IQVIA can assess your current state and design a Medical Affairs engagement that’s tailored to your company and budget. This roadmap can be revisited and adapted close to the launch, or even after the launch.

Contact IQVIA your launch partner, here to reduce overwhelm, increase your chances of launch success, and improve patient outcomes once the product is in the market.

^{1_{Emerging Biopharma’s Contribution to Innovation” IQVIA Institute Report, June 2022}}