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PA IN THE MEDIA

Creating a customized approach for pharma launches

This article first appeared in Life Science Leader

Pharma launches are becoming increasingly complex. Not only do you need to engage with more stakeholders than ever before, but also the ways to engage them are rapidly multiplying.

Patients, providers, and payers are demanding increasingly customized and personalized engagement and often “beyond-the-pill” digital or service components. Many companies are also launching more often. Rather than a blockbuster launch every few years, there are multiple launches each year in specialized therapy areas for small patient populations or for new indications. Companies should, of course, build on their past launch experiences, but each launch requires different capabilities. Here, we consider four types of launches and show why you need a customized approach.

Oncology product launches

An individual oncology product will usually launch multiple times — and more frequently — over its life cycle, as it secures approvals in additional subpopulations within a given tumor type or in new tumor types altogether. Advances in understanding of cancer biology are driving more frequent launches, including:

  • new options in previously underserved tumor types with lower incidence
  • new lines of therapy in both early- and late-stage disease
  • new combination regimens
  • new routes of administration
  • new immunotherapies
  • more drugs with breakthrough designation, so faster route to market.

So commercial decision makers need to undertake strategic planning that encompasses the entire product life cycle (i.e., considering all anticipated new indication and new regimen launches for a product) so that they can understand the trade-offs associated with prioritizing different indications. As well as planning and managing their own new launches, they also need to stay aware of a string of competitive launches.

Oncology commercial organizations must therefore be constantly launch ready. They must develop efficient systems for tracking the rapidly evolving situation, develop and adjust commercial strategic plans in an agile way, engage with partners, and execute multiple launches. Launch teams must be well-integrated, cross-functional, and equipped with the right tools and processes.

On top of this, in oncology, companies must engage with increasingly diverse and sophisticated stakeholder groups such as oncologists, nurses, practice managers, key opinion leaders, managed care organizations, advocacy groups, IDNs (integrated delivery networks), clinical pathway organizations, and others. A prescriber will not only be an oncologist, but depending on the type of cancer, could, for example, also be a urologist or gynecologist. Add to that the fact that these groups are often overloaded with complex information and data on many tumor types, biomarkers, lines of therapy, regimens, and combinations.

Oncology marketing teams must ensure that they segment prescribers and other stakeholders based on their needs and desired outcomes. For each segment, they can then deliver the exact information each needs, provide the right resources, engage with them in the most effective way, and establish a dialogue that helps them achieve the best patient outcomes.

For example, for a company preparing for multiple oncology launches, we helped develop a single HCP (health care professional) segmentation that was aligned across the portfolio. We identified common attitudes and behaviors of HCP segments across tumor types, disciplines, and settings. The new segmentation enabled the client to implement a customer-centric, omnichannel strategy.

Digital Health product launches

There has been an explosion in the number of digital health products, including digital therapeutics (e.g., for depression, insomnia, obesity) as well as digital support throughout the patient journey for diagnosis, disease management, symptom management, and adherence. Complex drug/device/digital systems are creating a need for a flexible and iterative approach to launch planning, including collaborations among pharmaceutical, medical device, and software solutions companies.

Digital solutions typically drive frequent and complex launches, because of the speed of development, broadening of the product portfolio and the pure mathematics of possible combinations of new developments and updates of devices, digital, and data solutions. The ability to continuously learn and adapt, supporting the launch process with a modular and/or digital approach, will increase the likelihood of market success.

Digitally connected health solutions can move the business closer to the end user and to play a key role in the universe around patients, enabling them to lead better lives. To ensure launch differentiation is sustained in the actual patient experience, launch teams can benefit from bringing in new patient-focused capabilities and connecting to the wider customer-facing organization, which will support the products after launch. A targeted customer experience relies on being able to adjust the product and related services continuously as, for example, new customer demands, partnerships, digital services, and channels emerge. To be able to respond quickly enough, think about how to modularize components of the launch process and continuously incorporate the lessons from previous launches.

Another benefit that can be realized through the launch of digital health products is to align with implementation of digital patient-engagement solutions. This could enable pharma companies to drive innovation based on patient data, drive efficiency through automated solutions such as self-service (where relevant), and drive an improved customer experience through personalization.

Development and launch are often performed in collaboration with partners, and a vital part of launch preparation is to get partnership agreements and SLAs (service-level agreements) and to ensure adaptability to each relevant market. You also should make sure these agreements are operationalized in the processes of support organizations, such as those providing customer service.

Also, internally, there is a need to engage with and evolve new types of capabilities in the launch process and “rewire” the processes. Think about how to build cross-functional agile launch teams that can cover all the relevant drug/device/digital capabilities end-to-end and also integrate the understanding of, for example, compliance, partnerships, and patient engagement.

Rare disease launches

A rare disease is any disease that affects a small percentage of the population. Most rare diseases are genetic, many appear early in life, and they are often chronic and life-threatening. Rare diseases include rare childhood cancers and conditions such as cystic fibrosis, Huntington’s disease, and hemophilia. On average, it takes more than four years to receive an accurate diagnosis of a rare disease.

Because rare diseases are often genetic, disproportionately affect children, and carry an extremely high burden for patients and their caregivers, having a patient-centric approach is core to the whole commercialization process. When launching a new therapy, companies usually provide extensive beyond-the-pill services to support patients and caregivers. In addition, targeted patient-finding initiatives are critical for any rare disease product launch.

Rare disease patients and caregivers are often active members of communities and support groups which share information and best practices for their condition. Ahead of a rare disease product launch, companies should build strong relationships with patients, patient advocacy groups (PAGs), and other key stakeholders. This is critical to understanding patients’ needs, defining new treatment paradigms, and gaining early-treatment access.

On the HCP side, there are typically very few experts in each rare disease, so being able to connect, communicate, and share knowledge is especially important. Companies launching rare disease products must help develop centers of excellence (COEs), identify and engage with experts, and help establish referral networks.

Companies, therefore, need to build partnerships that help get the right treatment to the right patient at the right time. This means using system network analysis to understand current patient pathways and working together with COEs and PAGs to shape future pathways. It also means finding ways to regularly include patient and PAG input in launch strategy. Leveraging data from diverse sources like registries, cohorts, online communities, and social platforms can provide powerful insights and help identify ways to provide support for patients and HCPs beyond-the-pill.

For example, we supported the design, European regulatory (EMA) submission, and creation of a rare disease registry. The registry design and operations were optimized to manage lifetime costs, while maintaining scientific robustness in collecting the required data. The data collected has generated deep insights into a poorly understood condition.

Vaccine launches

Vaccines are, of course, a critical component in prevention and even eradication of some diseases. Any vaccine launch will require robust planning and then agility to pivot quickly when the situation changes. This is even more crucial for vaccines when there is high unmet need and the launch is via national vaccination programs.

As we have seen during the current pandemic, time to launch for vaccines can be rapidly accelerated. The launch plan needs to consider changes in timings and in the competitive and regulatory environment in order to manage risk and appropriately commit resources pre-launch. You also need to uncover unmet needs beyond vaccine efficacy and effectiveness. Expanding the view to consider the needs and misconceptions of individuals and populations, as well as multiple stakeholders across the health ecosystem, enables you to connect with “heads, hearts, and hands” to drive behavior change during vaccine launch and rollout.

Across these various types of launches, there is still a need for structure and learning from experience. You also need to customize your launch preparations based on the specific needs of the customers and patients served by your brand. This means a change in mindset toward diversification and adaptability, and then ruthless prioritization of the key success factors for your specific launch, whether it is generating customer insights, using patient-centered design, developing partnerships and collaborations, or building organizational agility.

Roz Lawson and Johanne Olsen are life sciences experts at PA Consulting

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