6 Medical Affairs Principles to Bridge R&D and Business

ИзображениеThe traditional pharmaceutical 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. Medical Affairs act as a bridge between development and commercialization. Now when companies continue experiencing increasing internal and external demands to focus on developing new products rather than on managing products after registration, enhancing collaboration between Medical Affairs, R&D and Business becomes crucial for future success. Many pharmaceutical companies are suffering from a crisis of collaboration. During the past several years lack of productive communication between leaders in Research, Clinical Development, and Sales and Marketing has in many cases led to waste of efforts and short-sighted decision-making. Late-stage failures still occur because the right information from the value chain doesn’t contribute to the decision-making process. Probable reason is that attempts to optimize corporate interaction are mainly structural. A culture developed in silos will not automatically transform just because the boundaries have been removed.

Principles of facilitation of cross-functional collaboration between R&D and Business.

1.  Increase the breadth and depth of customer engagement

A simple opportunity for synergy and bi-directional objectives is lost in the silo organizations. Despite value propositions and collaborating with customers, the sales person’s objective is to make a sale. The R&D people seek customer contact, but mainly to improve the value of study objectives and outcomes. The role of Medical Advisor/MSL is to help the company to achieve both goals — get essential customer input and indirectly advance the sale. The trick is to look across functions for the right value proposition to offer the external customer.

2. Make R&D walk a mile in Business’s shoes (and vice versa)

The R&D and Business functions often don’t understand each other — they have rarely needed to. Researchers, even at the highest levels, may produce compounds with little thought on how these compounds will be differentiated after registration. Similarly, on the Commercial side, very few people understand the tough decisions made in R&D. These are cultural gaps. Role of Medical Affairs is to help researchers to be exposed to what it is like to sell an undifferentiated product, and assist Sales and Marketing to experience what it is like to manage the uncertainty of a development pipeline. Periodic cross-functional training, supported prominently by senior leadership, can broaden the perspectives of each group. Case studies can allow each group to experience the real issues faced by their colleagues, giving them a better understanding of the responsibilities of other functions and improving their awareness of the whole organization.

3. Facilitate collaboration by getting full insight of R&D and Business roles

Medical affairs people have to be familiar with the entire commercialization process and with broader market changes so that they can deal with other business colleagues equally. At the same time,
they need to be able to position scientific and R&D activities appropriately to commercial colleagues.
Medical Affairs strategists need to engage in life-cycle planning with Business and R&D people.
Automated and streamlined processes with clearly defined roles and responsibilities can help accelerate time-lines and lower costs.

4. Clarify your responsibilities for R&D and Business

Due to work of Medical Affairs in ensuring compliance, handling medical information, and generating medical evidence is complex, it can easily look like a black box to those outside the function. Medical Affairs often finds itself at odds with R&D and Business. Furthermore, in recent years, Medical Affairs has undergone a transformation, driven by regulatory mandates and compliance concerns which make it difficult for the Medical organization to bring its scientific services to customers, internal and external.

5. Grow Business leadership competencies

Medical Affairs people have to be familiar with the entire commercialization process and with broader market changes so that they can deal with other business colleagues equally. At the same time,
they need to be able to position scientific and R&D activities appropriately to commercial colleagues.
Medical Affairs strategists need to engage in life-cycle planning with Business and R&D leaders.

6. Keep synced with the rest of the organization

This will prevent needless divisions, wasted effort, irrelevant trials, and missed opportunities. Medical Affairs people must be able to work effectively in matrix organizations by collaborating with cross-functional leaders and driving change without reporting structure.
R&D organizations are under pressure to increase productivity and deliver innovation. Looking ahead, R&D will increasingly focus on strategic partnerships and collaborations, from drug discovery to early- and late-stage development. As the industry evolves, Medical Affairs will have to take a stronger position as a central governance mechanism, linking relevant activities between R&D and Business while maintaining the focus on scientific credibility. Medical Affairs is well-positioned to become the liaison between external stakeholders and the R&D organization, providing direct customer contribution into the R&D process.


  1. Managing talent in the Medical Affairs function Creating value through a  strengths-based approach. McKinsey&Company. July 2013. www.mckinsey.com.
  2. Breaking down the walls Integrating clinical development with commercial operations. Deloite. www.deloitte.com.
  3. Peg Crowley-Nowick, Jodi Smith. The Role of Medical Affairs in Moving from R&D to Commercialization. April 2013. www.bioprocessintl.com

By Dr. Alexander Tolmachev


Originally published on MSL Society blog.

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