6 Medical Affairs Principles to Bridge R&D and Business

Bridging-the-GapThe 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,

Senior Manager for Medical and Regulatory Projects, Takeda


Why Medical Advisors and MSLs Need Selling Skills – Is There a Paradox?

Winking smileyWhy Medical Advisors and MSLs Need Selling Skills – Is There a Paradox?

Obviously, the bar is high for Medical Affairs talent. They need to collaborate with R&D colleagues and deeply understand the science that underpins their work; they must understand the rules and regulations governing the industry almost as well as their compliance and legal department colleagues. Though when recruiting Medical Advisors or MSLs pharmaceutical HR and Medical Affairs managers may focus mostly on peer-to-peer scientific dialouge maintanace skills or clinical research background rather than basic customer interaction skills that possess colleages from Sales. As for background in Sales – it is often considered to be irrelevant and even destructive for future career in Medical Affairs. The reason why there is prejustce against sales background is strict functional borderline between Medical Affairs and Sales department and lack of clear understanding of MSL/Advisor credentials in Sales. So probably any chance of confusing the roles or having wrong insight about Medical Affairs is considered to bring severe risks (e.g. оff-label promotion). Though probably it’s not that black and white as good selling skills plus Medical Affairs intelligence do not potentially threat, but ensure powerful competency combination for customer oriented approach. Let’s summarize the features of successful integration of selling skills to Medical Affairs professional toolkit.

1. Become the number one solution for your customer’s clinical and therapeutic problems.
Many thought leaders are not just open for new data, but out there looking for solution to their problems. Becoming a problem solver for external stakeholders can be your competitive advantage.
2. Create opportunities for your Marketing and Sales partners based on medical community unmet needs.
Helping your internal stakeholders understand how you add value to their business and what other services you offer will create more new ways to collaborate. Instead of judging your internal customers as being difficult or demanding try to see the situation as an opportunity to apply your scientific intelligence.
3. Be a good negotiator with ability to persuade people.
While some people are natural communicators, the majority of individuals can learn these skills to succeed. Fortunately, with some training, MSL can be a better communicator and use the new-found skills in work.
4. Build and maintain your customer network.
Your customer network and relationships is also your competitive advantage. Thus if you focus on long-term medical community partnership you are building a win-win relationship that will serve you in the future.
5. Be able to craft and deliver a good “elevator pitch”.
Science oriented Medical Affairs colleagues rarely able to condense their proposals to a pitch size. Though if you are able to quickly and simply explain what is your project about and what is its value for the customer, you will exceedingly broaden the scope of your influence and will be perceived as a true partner.

Medical Affairs is a customer oriented organization and sometimes there is a temptation to become what your customers expect you to be. Such reactive approach is not always good for business, as it eventually turns MSLs and Medical Advisors to “order takers” who can compromise corporate compliance. When scientific and compliance intelligence is balanced with selling skills Medical Affairs colleagues acquire their own voice in the organization and become valuable partners of business and KOLs.

Dr. Alexander Tolmachev,

Senior Manager for Medical and Regulatory Projects, Takeda


What Medical Advisors Should Know About Pilot Studies

111Medical Affairs as normally responsible for managing Investigator Initiated Trials and support of Global Company Sponsored research often are expected to take ownership for local registration trial design and following medical overview. This is not a rutine job for a Medical Advisors who often are not qualified for cinical design development and research management. At the same time clinical trial managers will not be assigned to do that because of their project dedicated and unflexible roles. Outsourcing clinical trial design intellingence is not a good idea as anyway manufaturer representatives will have to bridge the gap between stakeholder expectations and clinical project. Thus Medical Advisors are most suitable experts for local trial design development. The critical step before finilizing a study design is planning a pilot study. Pilot studies receive little or no attention in scientific research training or textbooks, that is why these considerations addressing Medical Advisors responsible for local trial design might be useful.

1. Identify the full scale trial objectives and procedures before designing a pilot study.

After you will clearly understand what steps you want to take place in the main study, you will be able identify what exactly to test in the pilot study. You may want to preliminary assess time, budget, recruitment or retention rates, etc. Also you may assess potential human and data optimization problems such as personnel and data management issues.

2. Be very clear about why do you need to conduct the pilot research.

Whether or not a study is a pilot, depends on its objectives. A pilot study should only be conducted if the results will be informative for the main study. Studies conducted for the false reasons may result in findings of limited utility, which would be a waste of the researchers’ and participants’ efforts. Among the false reasons there may be the folowing
– I have funding for 10 patients only;
– I have limited funding;
– My boss told me to do it as a pilot.
Besides quite often the emphasis is wrongly placed on statistical significance, not on feasibility – which in fact is the main focus of the pilot study.

3. Avoid using pilot trials to estimate treatment effects.

This can be dangerous as such estimates may be unrealistic or biased because of the limited sample sizes. Therefore if not used cautiously, results of pilot studies can potentially mislead sample size or power calculations, particularly if the pilot study was done to see if there is likely to be a treatment effect in the main study.

4. Establish the criteria for success of a pilot study.

The criteria should be based on the primary feasibility objective. These will provide the basis for interpreting the results of the pilot study and determining whether it is feasible to proceed to the main study. In general, the outcomes of a pilot study can be one of the following:
– main study not feasible – then stop;
– feasible with modifications – then continue, but modify protocol;
– feasible with close monitoring – then continue without modifications, but monitor closely;
– feasible as is – then continue without modifications.
For each of these scenarios you will have to create clear success criteria based on the feasibility outcomes – such as recruitment rates, consent rates, completion rates, variance estimates, etc.

5. Get the statistician involved.

Whereas Medical Advisors are not qualified in medical statistics this probably is a make-or-break for good study proposal. Statistician will help you elaborate the statistical methods for the analysis of primary and secondary feasibility outcomes.

6. Mind the sample size calculation.

In many cases pilot studies are conducted to generate data for sample size calculations. It is important that the sample for a pilot is representative of the target study population. It should also be based on the same inclusion/exclusion criteria as the main study. A pilot study should be large enough to provide useful information about the aspects that are being assessed for feasibility. Though the obtained data should be used with caution, as results from pilot studies can potentially mislead sample size calculations. You have to consider supplementing the information with qualitative discussions with clinicians.

7. You will have to publish results of the pilot study.

Any attempt should be published to provide medical community with information about feasibility to save resources being unnecessarily spent on studies that may not be feasible. Further, having such information can help researchers to avoid duplication of efforts in assessing feasibility.

8. Learn the basics of pilot study design.

Actually this is the key recommendation that I can provide you with. Lack of specific knowledge often make Medical Advisors bog down in research projects for many months without any progress. Though you will agree that there is no rocket science in designing pilot research when you read the articles that I’m referring to below.


1. Altman et al. Why do a pilot study? 2006

2. Friedman. Commentary: Why we should report results from clinical trial pilot studies Trials 2013, 14:14

3. Lancaster et al. Design and analysis of pilot studies: recommendations for good practice. Journal of Evaluation in Clinical Practice, 10, 2, 307–312

4. Thabane et al. A tutorial on pilot studies: the what, why and how. BMC Medical Research Methodology 2010, 10:1


Dr. Alexander Tolmachev,

Senior Manager for Medical and Regulatory Projects, Takeda


7 Essential Features of Effective Interaction Between Medical Affairs and Health Care Compliance

Rubber stamp approvalToday the quality of compliance in pharmaceutical business operations has become an increasingly important issue reflecting significant changes in the regulatory environment almost worldwide. Pharmaceutical companies must conduct promotional activities accurately and within the scope of governmental approvals as well as corporate policies. Off-label and false or misleading promotion are strictly prohibited everywhere. Medical Affairs is normally involved in content approval of any promotional materials, and the appropriate employees must be trained to avoid improper promotional activities. The promotional review committee has to be familiar with the rules of promotion, including off-label promotion and false or misleading promotion. Such expertise in many cases is ensured by Medical Affairs, Compliance, Legal, Pharmacovigilance and Regulatory. Though some may be optional contributors, Medical Affairs and Compliance are mandatory. How to find a shortest path to compliant customer congruent services and avoid conflict of doing right things and doing things right? The solution might be in establishing a productive dialogue between Medical Affairs and Health Care Compliance. Below are some features that will help to ensure a win-win outcome.

1. Respect each other’s opinions.
It is necessary to openly discuss the opinion differences between the committee members in meetings. Medicals, Compliance, Regulatory, etc team members must learn to trust each other and rely on the expertise of the individual in whose discipline the controversy lies. No one should ever be attacked for his or her opinion. Try to fully understand why Marketing is producing this or that activity but at the same time be on the side of corporate policies. Preserving the constuctive balance of business orientation and compliance will help you to foster great achievements and reputation.

2. Have clear understanding of your roles and mutual expectations.
In most cases it is useful to formally review the responsibilities and expectations of committee members to prevent useless work and bogging down in future. Compliance specialists will be mostly focused on two risk areas such as inappropriate promotion (including off-label) or corrupted HCP interactions. So in collaboration with your Compliance Officer you’ll have to be ready to explain what, why and for whom are you doing. Besides be ready to explain to the compliance officer what is your mission and contribution to the outcome.

3. Conduct valuable committee meetings.
Make sure there is a clear purpose to meet together. If you can decide something just on the phone or e-mail, so its obviously no need to waste time. On the contrary, working excessively offline, between team meetings and on weekends, may as well signal a dysfunctional team. Responding to excessive e-mails and “copying all” is fatiguing and can disrupt the decision making process. Establish right balance between online and offline decisions.

4. Invest time in learning corporate policies and procedures.
This will let you save much more time and efforts in the future. Besides your dialogue with Compliance Officer will be well-founded and you will build trust based relationship.

5. Be transparent.
Take your time to explain to the compliance officer not only what is your activity or promo about, but primarily why you are investing efforts and budget to bring it up. Focus on the desired outcomes of your activities and make sure they are in line with the corporate code of conduct. Get ready for the questions and provide full and clear answers. All that will help you to earn trust of your Compliance Officer.

6. Be honest.
Making mistakes is OK, especially in environment of continuous change. Honesty requires us to overcome the fear of being judged by others, the fear of exposure and being seen as weak or incompetent and tell the truth. Honesty is the foundation of trust within your team and is probably most important quality for compliance related team work. In order to develop honesty in your team you have to refrain from judging each other or finger pointing.

7. Include additional personnel in team meetings if necessary.
Your meetings may slow down due to long discussions in the absence of important stakeholders who can bring light to the nature of the job. Such employees often from Marketing or Sales usually have the answers to questions – “How will this article reprint be distributed to the physicians?”, “Will this brochure be too complex for the prescribers to understand?”, etc.

Dr. Alexander Tolmachev,

Senior Manager for Medical and Regulatory Projects, Takeda