Understanding the true value of medical affairs – a new giant in need of a voice

Joseph Kohles PhD and David Thompson

Alligent Group

Joe Kohles and David Thompson discuss the growing importance of medical affairs departments in pharma.

The rising costs of drug development as well as heightened scrutiny of marketing practices evident over the past decade, are among a number of reasons leading to greater responsibility given to Medical Affairs departments, traditionally charged with shepherding clinical trials and publications. Medical Affairs has become the home of a far greater burden of responsibility across a wide range of segments, with a synchronous diminished authority in Marketing groups. The table below illustrates this point based on our observations across the industry.

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If you work in Medical Affairs or Marketing, you will probably recognize some or all of these trends. Responsibilities have shifted for good reason. The question becomes whether resources and budgets have kept pace and moved with them. Or are most Medical Affairs departments running on empty, over-burdened with these new or expanded responsibilities and struggling to keep up? And why is this?

The value medical affairs brings

A large part of the value that Medical Affairs brings beyond traditional outputs such as clinical trials and publications is what one may refer to as “continual access”. Access to key stakeholders, such as physicians, hospitals, and other institutions, while still a challenge, has become their domain, moving away from Marketing and Sales groups. This continual access recognizes that Medical Affairs is able to return value back to those key stakeholders, in the form of relevant medical and scientific information. Physicians are still looking for credible sources of information about the products they use and Medical Affairs can, in most cases, still provide this to them. Medical Affairs and field medical personnel return value to physicians by answering key questions, providing information about emerging products, engaging in knowledgeable discussion around current data and helping them solve reimbursement or clinical trial-related issues.

Recognizing value and the challenges this brings

The increased responsibility and budget (though often not enough when it comes to the latter) has brought with it new challenges. More and more Medical Affairs groups, in particular Medical Directors, are at the forefront of major company decisions from study designs and promotional reviews to compliance and legal matters. Being at the intersection of science and commercialization also puts Medical Affairs in a matrix management situation, driving communication and decision-making between groups such as R&amp,D, marketing, legal and regulatory. Increased budgets have also brought heightened scrutiny and pressure for Medical Affairs to demonstrate their value back to the organization.

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“Increased budgets have also brought heightened scrutiny and pressure for Medical Affairs to demonstrate their value back to the organization.”

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So it is clear that while corporate leadership recognizes the value that exists in the Medical Affairs group, much of the increase in responsibility has come without the necessary rigor in support, training or guidance.

Providing a voice for medical affairs

The most common issue we see in supporting Medical Affairs leaders is the perception that they are simply a pair of hands rather than true partners. Continually hounded for information and updates, rather than being in control of communication, they are seemingly always behind, playing catch-up to a timetable imposed rather than self-constructed.

Our guidance centers on the need to take control. Crucially, this is not achieved through avoiding other key stakeholders in the company who have a right to participate in decision-making, rather, via exerting more influence, and staying one step ahead of planning and communication issues.

The following recommendations have, in our experience, helped Medical Affairs leaders improve their position internally, both in obtaining commensurate resources in recognition of the value they provide, as well as providing a platform to communicate this value, thus avoiding constant and repetitive requests for information which can drain those very resources needed in the first instance.

1. Highlight the need for resource – cry for help at the right time

Ensure senior management is fully aware of the demands on your department’s time and the tradeoffs that need to be made. Build up year-on-year evidence of the increased responsibilities you face, and the limited personnel and resources you have to deliver. Be aware of the budget planning cycle and get way ahead of it.

2. Prioritize training

Those new to Medical Affairs need to know how to do their jobs effectively. MDs, PhDs or PharmDs are not experts in regulatory, clinical design, statistics, or HEOR, nor are they presenters or facilitators from day one. And yet they will be asked to do all of these things to varying degrees right from the start. Provide your people with the tools they need to develop, but also ensure this is balanced with an education program building communication skills, leading to increased confidence in dealing with other stakeholders within the company.

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“Those new to Medical Affairs need to know how to do their jobs effectively.”

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3. Voice your successes

Medical Affairs professionals frequently show a sense of humility that comes back to bite them. All too often, the news that an abstract or publication has been accepted, a clinical trial has completed, or a thought leader has endorsed a new piece of science, gets lost. Create a department news service, via an e-blast or regular stakeholder conference call, to put out updates and successes to all stakeholders, thereby avoiding countless responses to questions on a daily basis.

4. Exchange experiences and create best practices

More often than not Medical Affairs teams are structured around therapy areas or brands. But do new teams talk to experienced teams about successes and failures, what works and what doesn’t? Herein lies a wealth of information and evidence that can help new teams argue for budget and resource, as well as avoid frequently encountered pitfalls. Consider a regular experience exchange forum across different functions (e.g. medical directors, clinical operations, or medical information) to share group best practices.

5. Integrate teams across a brand and share goals

The increasingly observed trend of brand team integration appears to work well, with life cycle teams including medical, marketing and other stakeholders sharing joint goals for the year. Life cycle leaders are appointed based on their skills in managing a matrix, rather than on the department they reside in. This removes the “us and them” scenario and breeds teamwork, creating a louder voice within the company.

The value of Medical Affairs and the increased responsibilities this new giant has within Pharma is clear. We do not see a reversal and, quite possibly, we haven’t seen the end of this trend in our view. Getting the right resources in place to help meet this challenge is critical, but being smart about how to operate within the realm of this higher set of expectations internally, is where real efficiencies and productivity will be derived.

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About the authors:

Joseph Kohles, Ph.D.:

Our Partner and Managing Director, Joseph Kohles, PhD., is a dynamic leader with more than 20 years of research and industry-side pharmaceutical experience, both in medical marketing and clinical research. In addition to a broad range of experience across multiple therapeutic areas such as oncology, osteoporosis, pain and diabetes, Joseph has written and published more than 20 peer-reviewed manuscripts and over 60 abstracts and posters in areas such as basic research, preclinical, clinical, datamining, and pharmacoeconomic analysis.

Joseph’s most recent experience was in leading the oncology medical affairs team for a large Fortune 100 pharmaceutical company in the US. In this capacity, he guided the overall medical strategy and led the team in execution of clinical trials, data mining, publications plans, and overall commercial support.

David Thompson:

Our Partner and Managing Director, David Thompson, is a veteran of the medical communications industry, spending 17 years with Gardiner-Caldwell, now KnowledgePoint360 Group, in various leadership positions in Europe and the US. In 2002, David established the hugely successful US division of Gardiner-Caldwell, based in New Jersey. As Group President in KnowledgePoint360, David continued to run this arm of the company, as well as several other agencies across the US market, working closely with medical affairs and marketing clients from offices in New Jersey, Chicago, San Francisco and Pennsylvania. David spent his early career with PricewaterhouseCoopers and in education, before entering the medical communications field. David earned a Bachelor of Arts degree in Economics from the University of Newcastle-upon-Tyne and did postgraduate work in Education at the University of Manchester.

What do you see to be the value of Medical Affairs?