In prior articles, we have discussed the critical role played by pharmaceutical companies’ Medical Affairs departments, particularly related to product launch preparations and execution. Now we’ll examine the growing importance of project management within Medical Affairs departments.
The great separation
As prior articles have noted, the pharma industry became increasingly focused on innovating new products about 25 years ago. This created the risk that commercial interests would start driving pharma’s clinical innovations. In response, regulators advised companies to sequester their medical and commercial aspects. The establishment of Medical Affairs departments was a notable result of these events.
From the start, Medical Affairs played a key role, generating and managing clinical data and safety data, while ensuring that the information was not improperly used from a regulatory perspective. And, while commercial departments do what they can within the limits of the medication’s label to market their products, Medical Affairs was designed to focus on using clinical data to help patients receive the maximum benefit from product use.
The evolution of Medical Affairs
Given their strong understanding of regulatory requirements, Medical Affairs departments were tasked early on with helping manage collaborative relationships between themselves and Commercial teams. In some companies, Medical Affairs was also responsible for aligning science and clinical data with brand team strategic imperatives and assisting with medical message development, exposing Medical Affairs staffs directly to products’ marketing interests. While doing their best to work behind a “marketing proof” firewall, many Medical Affairs departments began acknowledging and even aligning their perspectives with those of Commercial departments.
Over time, tensions emerged between maintaining strict regulatory requirements and honoring commercial interests. Guidance from regulators is not always clear, and the interpretation of regulations varies from company to company. Some companies have nudged medical affairs departments toward activities that benefit commercial outcomes. While Medical Affairs typically doesn’t directly engage in product marketing, it has evolved in ways that may be blurring regulators’ original intent.
Primary roles of Medical Affairs
Today, while most Medical Affairs departments remain highly conscious of their regulatory obligations, the roles played by these departments have become inextricably linked to the success of many brands. For example, they are often deeply involved in helping craft the medical “story” for a brand. This work often begins when a product’s initial data starts to surface, well in advance of launch.
Medical Affairs also is key to researching and detailing the product’s patient journey. In this role, these departments often act as patient advocates, helping to ensure that physicians use the product to maximum effect and patients receive optimal outcomes.
Modern Medical Affairs departments carry a heavy load, with those efforts only representing a portion of the typical portfolio. Medical Affairs also:
- Synthesizes and summarizes the data to help create the product’s communications action plan, which is then executed at specific intervals prior to and following approval
- Trains the Commercial team on various aspects of clinical and safety data
- Trains medical science liaisons (MSLs), enabling pro-active discussions with key opinion leaders (KOLs) and other clinicians
- Helps recognize advocates and detractors within the medical community, particularly among KOLs.
- Conducts advisory boards to detect additional product-related information that might be useful and identify opportunities for publications, including clinical papers, posters, abstracts, presentations at conferences, etc.
Medical Affairs is also responsible for health economics and outcomes research (HEOR) functions that provide the real world evidence payers demand for formulary decision-making. Medical Affairs supplies data that helps payers position the product, for example, helping them decide if the product can be adopted as first line therapy.
Medical Affairs work streams include: medical operations, budget management, field medical (MSLs and training leads), medical account (payer) management, HEOR, clinical development, medical communications, publications, medical education (including congress activities, convention booths, and industry therapeutic updates, such as symposia). They also generate medical information to respond to inquiries from healthcare professionals.
As if this weren’t enough, as noted in our previous article, over the years Medical Affairs has actually been charged with directly supporting some marketing activities. These include:
- Aligning medical objectives, strategies, and tactics to the organization’s commercial goals
- Providing selected medical insights to Commercial to support post-launch activities
- In collaboration with Commercial, partnering with KOLs at leading medical and academic institutions on ways to improve patient outcomes and control healthcare costs
Project management: Responding to a growing need
With this large and still-evolving set of responsibilities, Medical Affairs teams’ overall scope and size has increased dramatically since the function was first conceived. That has led directly to the need for program and project management expertise within these departments.
How crucial is project management to the effectiveness of Medical Affairs? Here is a partial list of tasks Medical Affairs project managers typically address:
- Detailed planning of the various phases of product development
- Planning the implementation of tactical activities to support product strategies
- Executing tactics including data generation, advisory boards, publications, symposia, conference presentations and information booths and other medical meeting-related activities
- Managing the development of annual plans including strategy, goals, tactics, and budgets aligned with the organization’s yearly business planning process
- Facilitating ongoing 3-5 year strategic planning with Medical Operations, Finance, and other key teams
- Tracking and reporting tactical implementation and measures across each work stream/product to ensure alignment with company strategies and goals
- Helping develop new program and portfolio strategies to align with the product management lifecycles
- Providing tools that connect Medical Affairs with each program within the department’s portfolio(s), while maintaining regulatory discipline
- Applying business knowledge to develop solutions for Medical Affairs teams
- Providing insight and guidance to navigate the regulatory landscape and help provide effective and efficient tools to manage expectations across internal and external stakeholders
- Provide vendor management and oversight, potentially including management of contracting, as well as partnering with Legal and Contracts teams
Medical Affairs project managers also must effectively manage a range of documentation, assess risks, ensure team-based efficiencies, interact with a variety of stakeholders, and monitor timelines and budgets.
And the list goes on … and on.
Why project management is vital
While it may have started with a predominantly clinical focus, Medical Affairs has evolved and is now a strategic partner in the overall success of many brands. However, while the strategic imperatives should be the same for Medical Affairs as they are for the Commercial team, Medical Affairs does not generate revenue directly. Its focus should be, and typically is, on the patients, with a goal of differentiating the product clinically for providers and payers to improve patients’ lives.
This responsibility is far from easy and Medical Affairs project managers are pivotal to effectively making it happen on a daily basis.
In our next post, we will see why, when Medical Affairs is managing projects well, the benefits are visible. And we will explore why project management, done poorly, can directly affect product success.
Gain the benefits of top quality project management
It’s fairly simple—effectiveness leads to success. That’s true throughout the business world and it is certainly true in pharma. That’s why so many leading organizations come to CMK Select to support their project management functions. We know how to keep things on track, keep things moving, keep teams focused. Whether you use our expertise or bring in our staff, contacting CMK Select can provide a big boost to your success.