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Achieving launch excellence in oncology

Any new drug launch must overcome numerous obstacles in the pursuit of success. Many of these challenges are exacerbated in oncology, where the treatment landscape rapidly evolves with novel mechanisms of actions (e.g., cell therapy, bi/tri-specific antibodies), where there are ever-changing regulatory requirements, the use of biomarkers, etc. Today’s oncology launch landscape is highly saturated and competitive, cumulatively presenting significant challenges, particularly for small and emerging companies to gain traction with medical and scientific communications that inform key stakeholders about their oncology therapies.

Cutting through the noise is critical, as the volume and complexity of information has become a barrier. The treatment landscape changes rapidly, and healthcare providers (HCPs) have limited time to comprehend these large volumes of new information. It is even more challenging for patients. HCPs, patients, and payers need clear, concise, and consistent information to ensure that they are providing patients the best possible care.

Strategic planning and early investments in HCP and patient education are critical success factors for small and emerging companies launching oncology products. This is not limited to medical oncologists, patients and caregivers are increasingly involved in their care decisions, and we need to do a better job of learning from the experience gained through the clinical trials to effectively educate the differing stakeholders. When engaging the community, consider:

  • Field teams, especially MSLs, need to understand practice-specific patient populations and treatment preferences to effectively engage in oncologist-specific scientific exchange. Correspondingly, resources need to be equipped with easy-to-navigate, concise communications that can be appropriately catered to the differing physician types.
  • Patient advocacy and engagement are becoming more important in the oncology landscape. Understanding how patients perceive and value differing treatment options will be critical to inform communications.

Given the complexity of the externally changing environment, often internal education and terminology are not aligned within emerging organisations. Yet, overlooking a coordinated effort in these areas can result in a disjointed and confusing communication plan. A lack of internal consistency about key product messages can translate into a lack of understanding by external stakeholders. These pitfalls are avoided by establishing a foundation, through a formal scientific platform and publication strategy, which allows for idea sharing and consistency.

Planning is critical

A number of core elements underly the need for deliberate and dynamic communications to consistently convey the product’s value and place in the treatment paradigm. Some of those are particularly challenging for emerging pharma, yet critical to a successful launch.

Integrated launch planning and management: This launch planning process needs to be grounded in strategic imperatives and integrated across the medical and commercial organisation. This enables the differing functions to collaboratively build upon what is planned and executed. The exercise should start with Medical Affairs in phase 2 to establish relationships with the community, followed closely by development of robust, integrated commercial plans.

Scenario planning: The plan needs to consider risk mitigation and differing outcomes in terms of the asset’s registrational path (e.g., positive, neutral, sub-par). Scenario plan around the differing outcomes, including the possibility of a change in course due to competitive data and/or regulatory decisions. This will enable the organisation to pivot quickly and appropriately, enabling control of the narrative.

Advantages and challenges for small and emerging biotech companies

Highlighted through the core elements detailed above, it is easy to see potential challenges for an emerging pharma company launching in the complex oncology landscape. Large companies may have an advantage with sophisticated organisations and financial resources to support a launch. However, there are numerous benefits to be found in being a small and emerging organisation preparing for a product launch in oncology.

One distinct advantage that smaller companies can leverage is focus and agility. With fewer decision-makers involved in approving changes, small and emerging companies can be nimbler than their large company counterparts.

Another asset for small and emerging companies is often the company culture. Emerging biotechs are commonly fuelled by a few committed and highly skilled individuals, often with a personal connection to the oncology space. Not only does this give biotech a clear and central purpose to motivate success from, but the smaller organisation size lends well to the company’s ability to pursue personal relationships with HCPs and patients starting at the leadership level.

It is important for small and emerging companies to identify what their version of success looks like early on. Success for a smaller company is likely to look quite different from success for a larger company with extensive access to funding and resources. To overcome resource limitations, these biotechs need to have focused strategies and plans alongside realistic objectives for what success looks like. This is where partnering with an established agency with experience working with small and emerging companies in oncology can be an asset.

Choosing the right agency partner

Launching a new cancer therapy is a collaborative effort. Small and emerging biotechs have limited resources, and engaging an established agency partner with knowledge and expertise across small, mid, and large pharma, can open doors to opportunities that would have been otherwise inaccessible.

This is where finding the right agency partner is critical. Assess fit, experience, and flexibility – and decide what balance is most appropriate for your launch. It is important that partners understand the dynamics a small company faces, which often include a rapidly changing market space, funding hurdles, and lifecycle development stage gates to manage.

Navigating the journey to launch excellence

The road to achieving launch excellence is not smooth or well-defined. There are numerous obstacles along the way that can threaten to upset even the most established strategies and plans.

Prepare for these challenges by thinking through the scenarios – what can happen and what will we do. This includes engaging the community in an appropriate manner, that clearly defines the benefit of the novel treatment to the differing audiences. Adapt to each change in the terrain by leveraging the flexibility and passion inherent within the small organisation and collaborating with the right partners. Each new therapy that enters the market opens more opportunities for patients to receive life-changing care and challenges scientific minds to reach a little further toward the goal of eradicating cancer.

About Envision Pharma Group

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Envision is a leading provider of evidence-based communication services and industry-leading technology solutions (iEnvision) that have applicability across many areas of medical affairs and related functional responsibility. Envision provides services and technology solutions to more than 90 companies, including all of the top 20 pharmaceutical companies. TwoLabs is an Envision company focused on providing integrated and customised product launch solutions for small pharma/biotech companies. We help chart the path from clinical and medical affairs to commercial for a new product launch and provide strategies for continued market viability for drugs on the market.

To find out more, visit www.envisionpharmagroup.com and www.twolabs.com.

About the authors

Angus Bromley, Two Labs

Angus has a strong healthcare-focused background with over 15 years of industry and management consulting experience. As a leader in Two Labs Strategic Consulting group, he has collaborated with clients to address strategic and operational challenges across medical and commercial organisations, including oncology focused new product planning, launch strategy and planning, and capability development. 

Rachel Shemer, Envision Pharma Group

Rachel Shemer is a SVP, Medical Strategy at Alligent Medical Affairs. Working with biotech and pharma, Rachel has over 20 years’ experience in marketing, brand planning, medical affairs, KOL development, and launch execution in the US and global markets. Her role serves to understand the client’s long-term goals and analyse the market landscape, clinical development programmes and risk mitigation whilst working with the team to develop a go-to market strategy that contains all the necessary ingredients to support a successful launch. 

 

Kimberly Cash, TwoLabs

Kimberly Cash is a general manager, Medical Affairs & Communications, at TwoLabs who works with BioTech/BioPharma companies to deliver strategic medical affairs tactics and impactful medical communications plans. Kimberly has led medical affairs strategy & development at small to large pharmaceutical companies for over 20 years. She has led several successful, multi-faceted product launches in the BioTech/BioPharma space and applies this expertise to guide clients through these unique challenges in the interest of improving the lives of patients.

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