The Medical Affairs (MA) role is evolving from its traditional support role to becoming a strategic force in the pharma community.
Indeed, MA teams hold the position as the conduit of medical knowledge and communication among multiple stakeholders. The role of Medical Affairs is now to communicate information about evidence-based medicine within fragmented healthcare systems, write Kurt Conger and Ming Shen at Deloitte.
In this post, we explore how MA teams can fulfill this more strategic role of optimizing the product life cycle by combining scientific knowledge, hard evidence, and data management.
Take the Holistic Viewpoint of Drug Development
While getting a drug to market is a monumental task, the potential for significant gains is undeniable. It’s high risk with a strong likelihood of failure, writes Stig Johan Wiklund, Chief Scientific Officer at software product firm Captario. The best approach, he argues, is holistic drug development.
Wiklund says pharma teams should move away from the prevailing approach of segmented development and instead approach planning, designing, and decision-making in an integrated manner. A holistic development model considers the whole life cycle of drug development, including post-launch marketing and sales, as one process.
In a Medical Affairs Professional Society (MAPS) white paper, authors Matthew McLoughlin, Marieke Jonkman, and Milana Zivkov note that MA teams generally agree that a holistic approach better preserves data integrity and generates more useful insights — yet a consistent set of best practices regarding holistic approaches in MA has yet to emerge. One way to develop this consistency may be the use of eTMF and similar software to standardize MA teams’ efforts and share them across the organization.
MA Teams Must Champion Data Use
McLoughlin, Jonkman, and Zivkov also note that MA teams have a strategic role to play in product life cycle optimization. Teams can make their mark during early research and development and continue all the way through to commercialization.
To seize these opportunities, MA teams need to become the champions of data. They should find out how real-world evidence (RWE) can plug gaps in data and how data can inform strategy. Data must be converted into accessible and customized content that is relevant to particular stakeholder audiences.
Being the stewards of data will also mean that Medical Affairs teams can lead evidence generation. Specifically, they will be able to deliver “rapid-cycle, integrated evidence generation across health economics and outcomes research (HEOR), RWE, Phase IIIb/IV studies,” note Matthias Evers, Brindan Suresh, Ann Westra, and Alexandra Zemp in a McKinsey report.
With a deep level of data insight, the authors write that MA personnel will be able to combine their science knowledge, data prowess and stakeholder engagement to provide the best evidence to support the entire life cycle of a medical product. The result will be improved patient outcomes.
But data is only the beginning. It’s up to Medical Affairs teams to create a meaningful narrative of what that data means and why it’s relevant. Digital platforms can be used to share the medical story that resonates with healthcare providers and the value story that connects with payers.
Long-Term Focus Begins With the Product Pre-Launch
There is much to do and lots of excitement involved when launching a product. But it’s important that Medical Affairs teams don’t lose sight of the long-term goals and strategy, notes Gemma Pfister, at healthcare industry management consulting firm Vynamic.
A short-term focus can lead to increased risk by not identifying potential and probable events and how they might affect the launch. Part of the problem is focusing too much internally and not paying attention to changes in the market such as regulations, policy, and technology which might impact patients’ ability to access treatment. Pfsiter says MA teams should focus on scenario planning to enable long-term agility, helping to ensure successful product launches.
Medical Affairs teams should be involved in product development as long as five years before launch, according to Anna Walz, founder and CEO of biopharmaceutical industry strategy advisory MedEvoke. The knowledge that MA teams have — current care standards, product attributes, and how customers perceive the market and product — means they can build an accurate target product profile to enable better clinical research efforts.
The Medical Science Liaison role, part of the Medical Affairs team, can make an impact on early product development. By gathering feedback about a new product, the MSL can communicate the resultant insights to the pharma company, key opinion leaders and external and internal stakeholders, explains the team at Arx Research.
This degree of influence can have significant consequences on the success of a product life cycle. By accessing early feedback, MSLs can help drug manufacturers understand whether the medical community is ready to accept the product or additional time is needed for patients and doctors to find out more.
Medical Affairs teams should also be ready to respond to requests for feedback from external stakeholders and be able to write an effective medical information letter.
Product Life Cycles and Patents
Several strategies need to align to improve the life cycle of a medical product. These include R&D, marketing and regulatory, along with technological upgrades to facilitate the overall process, writes Ambikanandan Misra, a Professor of Pharmacy at Maharaja Sayajirao University of Baroda.
One area of focus is managing the period of the product life cycle after the patent expires. Misra says pharma companies can look to repurpose drugs using a number of “processes or resources including knowledge mining of existing scientific databases, in-silico approaches, in vitro and in vivo experiments, clinical observations, epidemiology and post-hoc analysis.”
Finding new ways to extend the product life cycle through repurposing the drug can be effective but certain requirements need to be met. For instance, the reformulated product must offer patients more than the original purpose of the drug. Meeting the requirements will potentially lead to a larger patient demographic that has access to the drug, Misra adds. Plus the approach will result in faster and less expensive drug development.
MA Teams Can Support Rare Disease Patients
Patients with rare diseases need support from pharma companies. This support should be extended to those patients’ caregivers, say George A. Chressanthis and Animesh Arun at The Medicine Maker. This means that Medical Affairs teams can find out what both patients and caregivers need during their medical journey.
Medical Affairs teams should be able to identify common challenges, such as access to treatment. Arun and Chressanthis advise that this information — the geography and target markets of patients — can inform design and sales of products to serve patients’ needs.
When MA teams are able to identify these patient needs, they will be better placed to strategize for the product’s commercialization and coordinate a united approach to the scientific, clinical, pre-launch, launch and post-launch phases of a product’s life cycle. While not limited to rare disease patients, amplifying the patient voice is a key role of MA teams. Teams can better advocate for the patient’s voice by engaging with patient advocacy groups.
Taking a holistic view of Medical Affairs that encompasses patient needs can benefit patients as well, write Evelyn I. Rojas, Niurka M. Dupotey, and Hans De Loof in a 2023 article in Pharmacy. For example, comprehensive medication management services both improve patient care and generate higher-quality data for use in clinical trials and by MA teams.
The patient voice can be used to inform the drug development strategy, neurologist Frank Wiegand et al. write at Drug Discovery Today. The Medical Affairs team can also help direct patients to early access or compassionate-use programs — so patients gain access to treatment even before the drug has been launched commercially.
Big-Picture Management of Regulatory Information
To ensure proper management of regulatory information throughout the product life cycle, Medical Affairs will need to maximize the use of data. Erick J. Gaussens, who spent 21 years as Chief Scientific Officer at the consulting and outsourcing partner company, ProductLife Group, says managing data from multiple databases is key.
Regulatory information requires compilation of all of the product data, which has to be managed to high levels of quality for easy access. The main reason for this is for regulatory authorities to gain better insights about product data, but pharma companies can benefit too, Gaussens explains. After all, they will be able to access any product data from any time of the product’s life cycle.
In a data-intensive regulatory landscape, MA teams must prioritize compliance and use this data to enhance stakeholder understanding of its significance, demonstrating how it can benefit both pharmaceutical companies and regulators.
Data management is increasingly becoming a major tool in the Medical Affairs toolkit. It helps them to inform broader product development strategies. But it also enables MA teams to have more meaningful engagement with stakeholders. By taking a long-term view of product development and getting involved early on in the process, Medical Affairs teams can ensure the life cycle is optimized while also driving home their value as a strategic function.
Post updated 11/7/2023.
Originally published 3/10/2020.
Images used under license by Shutterstock.com.