Sep
16

5 Ways To Optimize Organizational Culture in Medical Affairs

by Dr. Alexander Tolmachev

The success and competing power of organizations including Medical Affairs depend on the commitment of their members, supporting their individual developments, ensure their participations, creating an organizational culture and make it stable for a period that all of the members in the organization share the common values and norms and these can be achieved with a leader who has good communication skills, high charisma and able to be source of inspiration and intellectual. Definitely universally efficient organizational culture of Medical Affairs cannot exist because the business environment in operating companies is always unique and changing, the goals and heritage are never the same and national cultures are different. The variability of influencing factors will always create special work-spirit and understanding of team mission. The role of Medical Affairs Manager/Director will be aimed on building of the organizational culture which on one side will originate from general corporate culture and on other side will support the mission of the department. 5 considerations below probably may be helpful in this process.

1. Engage Medical Affairs colleagues.
Numerous studies and organizational examples highlight the relationship between a highly engaged workforce and company performance. Highly engaged staff improve customer service, generate more innovation, advocate more for their organization, deliver higher quality, have lower rates of absenteeism and stay with employers longer. Furthermore in contrast to the marketing and sales departments Medical Affairs do not have motivating bonuses on the basis of sales plan fulfillment. The lack of link between the performance and the monetary reward, creates a special significance of non-material motivation. Based on the analysis performed by consulting agency Leadership IQ, there can be identified five factors of engagement applicable to organizational culture of Medical Affairs:

– Ensure that job candidates have the right personality. People who make up the team must initially demonstrate a creative approach to work and life, enterprise, and a desire to provide intangible value, as it is known that the work in Medical Affairs does not fit everyone.
– Continuous professional excellence in the team. Medical Affairs Managers should encourage with own example development of their employees and continuously look for talented people who could potentially fill up the team.
– Managers should hold employees accountable for their performance. Setting goals and monitoring progress may be delegated to staff where possible.
– Mentoring spirit is crucial. Managers should do the mentoring function where needed, give professional feedback and support their team. Rough criticism of the staff should be excluded from management.
– Exclusion of finger-pointing. Creative spirit in the team inevitably will sometimes lead to errors. It is extremely important to eliminate the habit of looking at colleagues mistakes and blame them, demonstrating instead that the error is only a new lesson for the team.

2. Ensure ‘ad hocratic’ values
With its responsibility for the access to scientific information Medical Affairs makes a great contribution to introduction of innovative pharmaceutical products and services to the rapidly renewing scientific community. Thus organization culture in Medical Affairs should strengthen innovation and should not interfere with this process. These conditions require Medical Affairs colleagues’ flexibility, creativity, entrepreneurship spirit, openness, risk taking (’ad hocracy’ features). It was found that product innovation is positively associated to ‘ad hocracy’ cultures and has a negative relation with hierarchical cultures. Hierarchical cultures’ features are stability, internal orientation, which favors decision making by authority, high formalization, emphasis on internal processes, and which would be negatively related to innovation. Since Medical Affairs culture is always a combination of both approaches, managers should probably continuously work on development of ‘ad hocratic’ pole, encouraging such qualities as flexibility, creativity, entrepreneurship, openness, and minimize the damage from the hierarchical pole, without excluding it totally.

3. Switch from compliance to Integrity
Attempting to overcome possible ‘moral silence’ of Medical Affairs employees when faced with issues that violate corporate values requires switch from compliance-oriented culture toward a culture based on integrity. Formal codes and other internal formal regulations that emphasize compliance are necessary, although informal mechanisms that are based on relationship-building are more likely to achieve moral excellence. Genuine dialogues and appropriate managers’ ethical decision-making practice can deepen the understanding in the team and create a mindful awareness of ethical values and induce trust that embrace both complying with rules and regulations, as well as inciting creative ‘ethical innovation’ with respect to human interaction in Medical Affairs. To establish a culture of ethical business practices it is probably beneficial for the head of Medical Affairs to operate in three key areas:

– Create a clear picture of a new future and explain why Medical Affairs need to be an example of ethical business behaviors in the company.
– Develop and structure business processes that will contribute to the desired behaviors.
– Consistently demonstrate the desired behaviors by own example.

4. Provide clear and meaningful mission to the team
Medical Affairs managers should clearly explain the employees that their contribution is crucial for saving or improving lives and letting people remake the future. They are no more just providing access to medical data, but they are the leaders that are able to change the world through innovative products and information services. Medical Affairs is known as a very credible organization in Pharma industry, so it may make an honor to belong there. If the conversation is real and manager serves as example of her/his own words the team will get most clear understanding of WHY Medical Affairs is contributing. Also probably it is important to consider that clearly defined and agreed tactical objectives can make all the difference between a year of collaboration or contentiousness, productivity or discontent.

5. Introduce culture of service for stakeholders
In Medical Affairs that are serving for internal and external stakeholders it becomes a challenge to simultaneously remain a leader and to do your service function according to expectations and needs. Is it ever possible to serve and lead at the same time? Hopefully yes. According to my understanding Medical Affairs leadership is an ability to come with “third alternative” proposals to both groups of stakeholders based on their needs and contribute for the long-term future of the company remaining the trusted partner. Thus basic requirement from Medical Affairs is keeping focus on stakeholders’ needs. The only way how managers can drive change in the direction of service culture is to continuously lead by own example.

Reference
1. B. Smith. The Future of Pharma. 2011.
2. M. Sandhya Sridevi. Employee Engagement: The Key to Improving Performance. International Journal of Business and Management Vol. 5, No. 12; December 2010
3. J. Naranjo Valencia. Organizational culture as determinant of product innovation. European Journal of Innovation Management Vol. 13 No. 4, 2010, pp. 466-480
4. Creating an Ethical Culture: A CEO’s Checklist. www.pharmacompliancemonitor.com

Sep
09

8 Things That Comprise Success Of Investigator Initiated Trial

by Dr. Alexander Tolmachev

Along with industry initiated trials in collaboration between pharmaceutical industry and academic community investigator initiated trials (IIT) play significant role. Industry initiated trials are not, and cannot be, designed to determine all the potential uses for a medication. In turn IITs expand product knowledge, including safety. Physician researchers often identify new ways of using existing treatments, thus improving the health of numerous other patients. And there is always greater weight attached to non-industry sources of data. This is the reason why companies need more IIT and continue procedural excellence for the best performance it this area. Below are some considerations that may be helpful in approval and running the IIT.

1. Consider why your company supports (or wants to support) IIT. There are several reasons why your company may want to support investigator-initiated research. The research could provide important benefits to your company in the form of new ideas and valuable clinical data. The research also may advance medical and scientific knowledge of a disease state or an otherwise under-studied patient population. Your company should understand these reasons because they will help the company to define its priorities for investigator-initiated research projects.

2. Remember that the parties involved in the research have mutual goals. Although industry may support investigator-initiated research for a variety of reasons, all parties involved – investigators, clinical sites, and your company – should establish several mutual goals for the research. These goals should include generating quality research that results in publications and high quality data, good partnerships and continuing relationships, and, of course, protecting human subjects and ensuring regulatory compliance. Investigator-initiated research can often complement a company’s R&D goals, and in some specialties, a substantial portion of innovation may result from investigator-initiated research projects. As with your company’s reasons for supporting the research, these goals should underpin how the research should be structured and conducted.

3. Establish pre-defined criteria for the review and approval of the research. An important part of standardizing company review of and support for investigator-initiated research is defining in advance the types of research a company will support. For example, research may focus on a therapeutic area, disease state, patient population, or other factors. Your company should require written proposals from investigators demonstrating that the proposed research fits within the company’s established criteria.

4. Investigate the structure and requirements of internal multi-disciplinary group that will review the proposal. Knowing it will help you to pre-review the proposal and to get prepared better. Usually the companies ensure that research proposals are funneled into a common repository. For example, many companies are implementing an integrated on-line submission system. The research proposals are then reviewed by an internal committee. Most often, this committee will be comprised of medical/R&D personnel. Sales and marketing personnel never can influence the committee’s operations.

5. Establish your company’s role in and oversight of the research. Your company should think about the role it wants to have in investigator-initiated research. For example, does the company want to comment on the protocol? Require the investigator to submit certain research reports or report adverse events to the company? License the research data? Be able to audit or monitor the research? Review research publications? Train the investigator and others? Although your company’s level of participation may vary by the particular research project, the company should think about what level of participation and oversight it wants to have. At the same time, these activities must be balanced with the limitations on regulated industry’s interactions with health care professionals and with preserving the investigator’s regulatory status as sponsor.

6. Have a written agreement. Quite simply, your company should enter into a written agreement for investigator-initiated research before the research begins. This agreement serves several important purposes, including:
– establishing the elements of the company’s participation – such as protocol review/comment, research-reporting obligations, ownership of research data, company auditing and monitoring rights;
– setting forth provisions to protect the company, the investigator, and the research site in case something goes wrong;
– helping to ensure the confidentiality of information a company may provide to an investigator. The agreement also memorializes the key distinction between investigator-initiated research and sponsored research: in investigator-initiated research, the investigator is the regulatory sponsor of the research and must comply with all associated regulatory obligations.

7. Remember the written agreement is different from other clinical research agreements. Your company should be aware that as a general rule, the provisions of an agreement for investigator-initiated research tend to differ from the provisions of industry-sponsored research agreements. For example, investigators often will own the data in investigator-initiated research, whereas in industry-sponsored research, the industry sponsor nearly always requires data ownership.

8. Follow procedures to standardize your company’s support of investigator-initiated research. A manufacturer’s compliance policies and procedures should include a standard mechanism for tracking review and support of investigator-initiated research.

Reference
1. Top Ten Considerations for Industry Support of Investigator-Initiated Research. http://www.ebglaw.com/shownewsletter.aspx?Show=12025

Aug
30

12 Tips for Medical Science Liaisons’ Success

by Dr. Alexander Tolmachev

Despite a great range in functional specter of Medical Affairs people related to size and profile of the company, region, culture and many more factors – the basic philosophy of this organization remains more or less unchanged. This is an effort to summarize managerial tips for Medical Science Liaisons leading to success.

1. Specify concrete goals of your work. Unclear job objectives will lead to confusion. Make sure that your goals are reflected in your half-year performance agreement and you understand how to track your progress. Think about what you would like to do in 5 years and what steps will you have to undertake to get there.

2. Identify your key stakeholders within the company and investigate their expectations and values. Your cooperation with the national/global Medical Adviser and the business teams is an asset. Make sure that you treat your supervisor as your ‘customer’ as well.
3. Always keep in mind the total amount of your external stakeholders, as well as the number of your customers with whom you are collaborating most actively.
4. Develop and track an individual engagement plan for each of your external stakeholder, including the rationale, timelines, budget, responsible persons. This document will serve as the main evidence of your work. Besides you may use is as a ’contract’ with the thought leaders declaring your intents and commitments for the future.
5. One of the best ways to win the favor of the thought leaders – is to be engaged in social activities. To do so, always take part in scientific events, help carry out research activities, support the large-scale public initiatives of the thought leaders.
6. You can influence only when you are trusted. So build trust with your stakeholders. Medical Affairs people are known to be more credible than business for the medical society, this highlights the importance of earning trust every day. Be a good listener and be tolerant to criticism always trying to understand true motives and needs of people behind any communication.
7. Develop / participate in the development of your performance metrics. Metrics should be few, but very relevant. It’s a challenge to measure the intangible, still it is possible. On one side the metrics should reflect your real contribution to business and level of external stakeholders engagement, on the other they will help you to track your own development goals.
8. Regularly review and discuss the dynamics of your metrics with your supervisor. If you know that a planned value of the metric is unattainable, ask for advice from the medical affairs manager / medical advisor.
9. Respect the borderline with business. Despite common external customers and activities with marketing and sales, consider that you have different objectives and metrics for success. Moreover you are functionally different in off-label communication: business cannot disseminate it. You can do it upon unsolicited request.
10. Remember the difference between medical information queries, given at the initiative of the doctor (unsolicited request) and requests specified after the “tip” of the employee (solicited request). The second case can be regarded as an indirect promotion of the product. This is most important if the request is related to off-label data.
11. Continuously learn. This is not only about your therapeutic area where you are a definite internal expert. Take every day as an opportunity to learn something new that will help you to achieve your goals. Conflicts and errors are just our study material that makes us more professional.
12. Do not forget that your professionalism is growing not so much due to your wins, but more due to your failures. Try to appreciate every failure and mistake, take your lessons to become more professional.
Aug
27

MSL Society Paris 2013: Featured Speaker Elizabeth Kupferer

The MSL Society is proud once again to have an expert-packed speaker lineup for its Paris 2013 event in October.  Among the panel of speakers from the world of medical affairs is the dynamic director of medical affairs at SequenomDr. Elizabeth Kupferer.

Elizabeth holds a Doctor of Philosophy (Ph.D.) from the University of Texas at Austin in Women’s Health, with an additional interdisciplinary portfolio in Women’s and Gender Studies. She earned her undergraduate and graduate degrees from the University of Texas Medical Branch in Galveston.  In addition to her role at Sequenom, a life sciences leader in genetic analysis solutions, Elizabeth serves as Adjunct Assistant Clinical Professor of Nursing at the University of Texas at Austin.

During her 35-year career, Elizabeth has gained a vast amount of clinical experience in many areas of women’s health, beginning as a registered nurse in labor & delivery, with progressive management roles up to the director level. She practiced for eight years as a women’s health nurse practitioner (WHNP), and has taught at the graduate level.

Most recently, she has worked in the life sciences industry for 11 years in medical affairs. Elizabeth has been an author and co-author of peer-reviewed journal publications in the Women’s Health field and has presented clinical, medical, and scientific information to small and large groups at local, national, and international venues. .

The MSL Society Blog sat down with Dr. Kupferer to discuss her upcoming presentation at Paris 2013.

The MSL Society Blog: What topic will you be speaking about at Paris 2013?

Elizabeth Kupferer: I will be sharing about my professional experience with establishing a Medical Affairs department and MSL team in a Molecular Diagnostics Laboratory setting.

The MSL Society Blog: Why do you think this is important in the world of MSLs?

Elizabeth Kupferer: This topic is important is because it illustrates the value of the addition of a Medical Affairs Department and MSL team in an industry that is not highly-regulated. My department and MSL team was the first of its kind in the pre-natal diagnostics space and has now been replicated by our competitors. HCP education is integral in molecular diagnostics and genetic testing because of the rapid and continued advancement in diagnostic technologies that are literally driving changes to clinical practice. It is important for health care providers to understand how the technologies work and how they can be integrated into practice appropriately and ethically.

The MSL Society Blog:  What’s the single-most important trend you see on the horizon with regard to the role of MSLs?

Elizabeth Kupferer:  I believe the biggest impact on the MSL role is the increasing complexity of pharmaceuticals, devices and the advancement of personalized medicine and genomics.  This opens up more opportunities for highly-educated experts in each of these therapeutic areas.

The MSL Society Blog:  What’s the most important piece of advice you could give to a new MSL today?

Elizabeth Kupferer:  Stay curious and embrace change. Flexibility and adapting to change are integral to the MSL role.

Register now for MSL Society Paris 2013 at the event website, www.themsls.org/Paris-2013, for a great opportunity to learn from leading experts like Elizabeth Kupferer, along with plenty of opportunities to network with peers and executives across the global medical affairs community.