Bringing a new pharmaceutical product to market is a unique process based on a number of requirements for supporting a product launch. For a research and development (R&D) company, launching a product into market may seem to be an issue for someone else to handle in the far-distant future and at a much later time. But even at laboratory or early development stages, biotechnology companies should understand the language of pharmaceutical companies and know how that industry operates. Doing so helps biotech companies make early decisions regarding their investigational products that could lead to future success.

Here we focus on the role of medical affairs, a critical part of the pharmaceutical industry. In the past, there was no direct equivalent to medical affairs in biotechnology, yet it plays an ever-increasing and important role in that industry as well. It’s become a new and innovative way by which companies can use corporate partnerships to flexibly and efficiently maximize medical affairs support.

Background on the Role of Medical Affairs

The traditional bio-manufacturing model includes two main pillars: an R&D organization in charge of developing new products and a commercial organization in charge of marketing and selling those products. Pharmaceutical manufacturing has a similar split: a development group (responsible for getting FDA approval for drug products) and a commercial team (that markets and sells those products). One big difference, however, is that the bio pharmaceutical industry has lacked an additional group to act as a bridge between development and commercialization. This is the role of medical affairs.

Medical affairs originally emerged as a reaction to increasing pressures from regulators to separate medical and commercial functions. Companies were experiencing increasing internal demands to focus the role of development on generating and developing new products rather than on managing products after FDA approval. Over the past 25 years, continued regulatory pressure shifted a number of commercial activities to people with medical expertise, most often to medical affairs groups.

Thus, medical affairs has evolved into a separate medical organization that often sits within development organizations but primarily works on post-approval activities and has both the scientific and clinical expertise to support commercial products. Examples of medical affairs functions include:

• Managing key thought leader relationships

• Publishing data from corporate-sponsored trials

• Presenting educational information about a product or therapeutic landscape

• Answering questions from healthcare providers regarding product safety or efficacy that is not addressed in a product’s label

• Supporting research initiatives outside labeled indications for marketed products.

For a company whose product is years away from commercialization, the information above may be interesting, yet may seem irrelevant. It may be thought-provoking, but otherwise meaningless in the day-to-day operations of a typical biotechnology company that is involved more with drug discovery than with drug development and commercialization. Although gaining a deep understanding of medical affairs may not seem immediately relevant, understanding the overall purpose of it and the functions it performs becomes crucial as a product moves closer to commercialization. Medical affairs can sometimes be overlooked due to competing priorities such as establishing a commercial organization, ensuring a smooth path toward regulatory approval, and creating and validating a stable and reliable manufacturing supply chain. However, the role of key medical affairs functions becomes critical in the lead-up product launch. The foundation for such functions must be laid 12–24 months before launch for this important department to deliver maximum value to a company.

Core Competencies

To illustrate that point, we must review the three core medical affairs teams: medical communications/publications, medical science liaisons (MSLs), and medical information. We also discuss the ideal timing for implementing those efforts while preparing for a drug launch (defined as T0).

Medical communications/publications is a medical affairs group that directs and plans for all drug-related publications such as abstracts, posters, and manuscripts. Such communications are essential for product commercialization. The group is also responsible for developing a strategic plan that integrates and aligns the timing of clinical trial data locks with the release of key data points at scientific meetings. That plan outlines the timing of abstract submissions and defines when key manuscripts can and should be published in the years leading up to and following a launch. This includes publication of interim data (if available) for either early-stage or pivotal trials, which can occur months to years before drug approval (T – 24 to T – 12; or 24 to 12 months before launch).

Another key role for a medical communications group is developing clear and consistent language to describe clinical results for the organization as a whole. A publication plan is even more critical after drug approval when a new product faces a competitive environment and medical communities begin to incorporate it into their therapeutic programs. Each initiative must be planned and carefully coordinated to maximize the amount of exposure, recognition, and buzz for a new drug product.

Medical Science Liaisons (MSLs) traditionally hold two main roles: to support a range of educational and/or research goals. But their real value lies in scientific and clinical expertise that allows them to cultivate relationships with both external and internal parties. Externally, an MSL team is uniquely positioned as the “medical” face of the company in a way that is very distinct from its sales organization. It often has strong ties with both community and academic physicians and can be an effective conduit for a flow of information both out to a medical community and into a company itself. Internally, because of the bridge-like nature of medical affairs, an MSL team can use its strong relationships with other major corporate departments to help external parties understand and navigate internal waters. An MSL team is ideally formed sometime during the T – 24 to T – 12-time frame. That period provides time for mastering the disease state and therapeutic landscape, learning about all aspects of the drug, and — most important — establishing relationships with key external stakeholders (thought leaders, key organizations, and payers). It is essential for the success of a launch that those relationships already exist at T0.

Medical information experts are key resources within medical affairs for both MSL and commercial teams. A medical information group can address typical concerns about commercial drug products, including safety, efficacy, dosing, and administration. At the time of launch, medical information experts are often the primary recipients of questions from patients, healthcare providers, and other interested parties. So they must be equipped with fair and balanced, prewritten letters that accurately describe the information a company has available (or does not have) about each newly approved agent. In addition, medical information experts (or other representatives from medical affairs) play active roles in the development of commercial materials and/or sales training. Developing such materials is essential for preparing a commercial team for a product launch. The typical time frame for establishing a medical information group is the same as that of the other teams described herein (T – 24 to T – 12).

To maximize the value and effectiveness of medical affairs, this department should be formed about one to two years in advance of product launch. That period will allow a medical affairs team to become familiar with the product, understand related issues, and become experts in the group’s wide variety of roles and responsibilities. Understanding the capabilities and functions of medical affairs and the timing for when their functions are needed is a critical component of preparing for and executing a successful drug product launch.