Article updated April 2023
An ever-changing global outlook increasingly impacts drug and device launches. Traditionally, most pharmaceutical companies face challenges around the rising costs of research and development, the difficulty of enrolling patients in clinical studies, manufacturing issues, changing public opinion, and patent expiration, to name a few. Anticipating the problems that may arise from these challenges – and strategizing ways to confront and solve them – is a top concern for ensuring medical affairs launch excellence.
What are the top challenges impacting launch excellence?
Some of the current challenges facing the life science industry and potentially affecting product launches include:
Delayed clinical trials
While it’s possible some trial sponsors still feel the effects of clinical trials that were delayed, extended, or even canceled due to restrictions in 2020 and 2021, companies are now looking to technology to reduce the amount of face-to-face interaction during trials, which can help make up lost time and be used in case of future disruptions.
The cost of research and development
COVID-19 vaccines were developed quickly but at a high cost. These expensive measures were necessary due to the global health emergency, but there were knock-on effects. First, the vaccine push depleted capital. Second, the swiftness of the response set up consumer expectations that essential drugs can be developed and brought to market in months. Medical affairs teams must now do their part to save time during the drug development process and reduce spending.
Supply chain disruptions
Pharmaceutical companies suffered the same severe supply chain disruptions as other industries during the pandemic, with little relief well into 2022. Organizations are eager to find a medical strategy to head off future disruptions that could be caused by another pandemic, global conflict, or travel and transport disruptions due to climate change.
A cultural shift from cure to prevention
Consumers are more interested in special diets, exercise, and early screenings for common diseases, and some life science companies may see less demand for medication and a corresponding drop in funding.
Pursuing cures for so-called incurable diseases
Research into potential cures for diseases like Alzheimer’s, epilepsy, rare cancers, and other conditions has occurred over decades. As the years pass, funding sources may dry up, or other priorities may emerge and divert funds and awareness.
Medical affairs’ impact on product launches
The medical affairs role is critical to any product’s success. The organization’s role in product launches and in the healthcare landscape has generally evolved over the past few decades. Medical affairs teams have an essential role before, during, and after commercial launch – and as such, they sit at the center of regulatory, clinical, market access, and commercial activities.
Traditionally, the role of medical affairs consisted of:
- Providing feedback on protocols for investigational drugs or new indications of approved drugs
- Disseminating data and knowledge from clinical trials
- Developing relationships with external stakeholders, such as KOLs
According to the Medical Affairs Professional Society, these areas of influence still exist. However, the function of medical affairs organizations has changed from a support role to a strategic role, mainly in response to external stakeholders – including KOLs, HCPs, patients, caregivers, advocacy groups, payers, and policymakers – setting higher standards for the scientific evidence needed to support a product before launch.
[Medical affairs’ evolving role] has occurred largely because the days of successfully launching a new product based solely on making it available through regulatory approval and marketing efforts no longer exists. That approach is no longer feasible due to the increasing complexity of the changing healthcare landscape, considering key decision-maker needs and the evolving demands of patients, payers, and healthcare providers. – MAPS
Building a medical affairs launch excellence team
Medical affairs is typically part of a broader pharma launch excellence team within a life science organization. The team also includes:
- Patient advocacy
- Market access/HEOR
- Public and investor relations
- Manufacturing and supply chain
As experts with highly scientific and medical backgrounds, medical affairs organizations have key functional skills that support the goals of launch excellence. These skill areas include:
- Medical science liaisons
- Evidence generation
- Medical information
- Medical regulatory/promotional review
- Scientific expertise
- Health economics and outcomes research (HEOR)
- Medical/scientific communications
- Medical education
- External engagement
How medical affairs impacts key launch stakeholders
Medical affairs organizations have a strong strategic advantage in contributing to product launches because of the direct connections they build and nurture with key stakeholders. Here are some of the key groups medical affairs interacts with before, during, and after launch, and why they are essential.
Patients can offer critical information about how they respond to messaging and their experience of being diagnosed with or living with a specific condition. It’s important to get this information directly from patients – patient input that is filtered through a doctor’s experience is less impactful and ultimately less valuable. Here again, insights management technology can make it easier for product developers to engage with patients before launch and once a product is on the market.
Physicians are also consumers of pharmaceutical and medical device products in that they facilitate their eventual use and can be influential in their peer communities. To understand how physicians will respond to a product, life science teams can simply ask – and these days, those conversations are most easily had in a virtual venue.
KOLs are critical as you take a product to market. Experts recommend using virtual engagement – including produced web events – to create interactive opportunities for KOLs to share their opinions about different diseases, therapeutic areas, and new products.
Insights management technology and launch excellence
The pandemic changed how HCPs interact with pharma companies, likely for good; face-to-face meetings and a one-size-fits-all approach to engagement won’t work like they used to. What impact will this have on the role of medical affairs in a medical device or pharmaceutical new product launch? And beyond virtual interaction and collaboration, what technologies can help medical affairs teams streamline work and add value during launch?
With HCPs (and, for that matter, patients and other KOLs) opting for more and more virtual interactions, medical affairs teams are adding another channel to traditional insight-gathering. Medical affairs organizations need a way to conduct, organize, and analyze insight gathering across multiple virtual channels and in-person conversations, typically across different teams and geographies.
While email, messaging, and automatic transcripts can help the exchange of information move faster, these tools don’t provide organization or analysis. In fact, they may end up adding to the noise. Technology specific to life science teams and medical affairs is more appropriate for collating and sharing insights in the lead-up to a pharma product launch.
Many pharmaceutical and medical device companies are using an insights management platform to obtain, organize, and analyze insights and observations. Asynchronous discussions, social listening technology, network analytics, and natural language processing work together to reduce the amount of tedious analysis and shorten timelines during the launch process.
To learn more about insights management, read our blog series.