Biotech medical affairs roundtable: Self-commercialization in oncology

In our latest roundtable, our experts discuss the challenges and opportunities biotech firms face when it comes to commercializing their oncology therapies – and the vital role medical affairs plays. 

Why is oncology such an attractive area for biotech firms to focus on?

Christopher Jones, SVP, Scientific Services, ApotheCom, an Inizio Company:

Oncology remains an area of high unmet need. Despite recent advances and headlines generated by successful studies, clinical endpoints are often based on the time to failure of an intervention.

Oncology is an example of how discoveries in the academic setting can be rapidly converted to entrepreneurial opportunities via university spinouts or partnerships with existing biotechs. Also, pathways to launch can be shorter via breakthrough therapy designation and accelerated approval.

It’s important to note that in the US, conditions for accelerated approval have become tougher with the FDA seeking clear evidence of ongoing confirmatory trials and timelines for completion.

What advantages do biotech firms have over larger pharma companies in oncology?

Zachary Lentz, Global Chief Growth, Inizio Medical, an Inizio Company:

Biotech firms excel in prioritizing patient-centric approaches due to their flexible operating model. They can swiftly adapt strategies to put patients first, fostering direct connections with patients and advocacy groups, ensuring their voices guide decisions. This focus on patient-centricity empowers biotechs to develop therapies not only targeting the disease but also enhancing the overall quality of life for cancer patients.

How important is it to have a portfolio / pipeline of assets for commercialization?

Sally Alexandroff, Partner, Specialized Services, MEDiSTRAVA, an Inizio Company:

Oncology drug development is rapid and while the regulatory environment is evolving, opportunities remain for expedited approvals. Generally, this acceleration depends on how well you can optimize your clinical trial site selection, recruitment, and execution.

Having a strong external network within a particular indication, gained from multiple assets or pipeline, can increase the speed of clinical development, build confidence, and improve opportunities for effective evidence generation.

However, a biotech with only one highly efficacious drug (with a clear direction and no unexpected safety concerns) can still build the necessary external relationships and deliver effective, strategic medical affairs activities to support successful self-commercialization.

What can smaller biotechs do to navigate the challenging self-commercialization journey?

Zachary Lentz:

Hiring a highly experienced team with extensive oncology commercialization experience is the first and most crucial step. Pair that with best-in-class external partners who work as an extension of your team strategically and operationally and you’ll have a strong foundation for commercial success.

Also, don’t underestimate the value of early relationship building across key stakeholders in the drug-development journey. Oncology is arguably the most complex therapeutic area and ensuring you’re collaborating with the right academic physicians and institutions is critical to the success of your program.

On the other side of the coin, the oncology community has highly engaged patient advocacy groups that can help to ground your innovation in the real-world needs and challenges patients face.

Sally Alexandroff:

Successful self-commercialization depends on multiple factors including early identification of a robust target product profile, an understanding of the size and robustness of the intended market, an assessment of current and future competitive landscape trends, and effective use of medical affairs.

Oncology is extremely competitive, with companies vying for ever smaller segments of specific populations. With multiple ongoing clinical trials and drugs in development in many indications, medical affairs teams are essential for gathering feedback and providing education on key aspects of your developing drug. They can also identify and address any potential barriers to care.

At what stage should companies be investing in medical affairs?

Christopher Jones:

As early as possible and you should ring-fence staff and financial resources. Sometimes medical affairs is just another hat worn by a contract manufacturing organization, but what often happens is that it then gets deprioritized in favor of addressing emergent needs in the clinical development program. You have to be careful.

Sally Alexandroff:

HCPs are under increasing pressure to remain up to date on new clinical trials and approvals so they can give patients optimum care. Due to this complexity, medical affairs should be involved at earlier phases of development in oncology than in other therapeutic areas.

With some drugs receiving approval at phase 2, it’s important to plan early and effectively to ensure HCPs have the knowledge and information to confidently use the new medication with the right patients at the right time.

What are some of the other advantages of having a dedicated medical affairs team?

Christopher Jones:

A strong medical affairs team will own and adapt your asset’s medical plan as it evolves towards launch, from defining the clinical opportunity and creating disease state awareness, through to clinical data dissemination using consistent and aligned communications.

In resource-constrained organizations, medical affairs teams can add value by creating modular content for multiple environments to drive internal, HCP, and patient engagement.

How can medical affairs work with other areas to help companies scale and achieve drug approval and commercialization?

Sally Alexandroff:

Early cross-functional interactions are key. For medical affairs to adequately prepare the external environment for any new drug, they will a solid understanding of the clinical trial development program, the proposed indications, and the potential requirement for a companion diagnostic.