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  • 08 Nov 2013 9:04 AM | Deleted user

    The MSL Society is celebrating the success of its second successful global event of the year, the Paris 2013 Conference.  Held at the Hyatt Regency Paris Etoile, the action-packed conference brought together medical science liaisons and medical affairs professionals from nearly every corner of the globe and multiple life science industries, including pharmaceuticals, biotechnology, medical devices and diagnostics, and clinical research organizations.

    The event opened in customary MSL Society fashion, with a networking reception for the conference participants to get to know each other in a comfortable setting on the evening of October 28.  During the following two days of intense content-sharing, participants heard a range of experienced speakers deliver critical information on a broad-ranging set of topics that impact the daily professional lives of MSLs and the departments and companies they serve.  Topics discussed included the Evolving Role of the MSL, Building a Medical Affairs Department, MSL Training, and Building an MSL Team Structure in a Therapeutic Area.

    Speakers at the event included several leading lights in the global medical affairs community, including Elizabeth Kupferer of Sequenom (USA), Martin Obladen of Bayer Healthcare (Germany), Jennifer Williams of Bard Medical (USA), Ayse Olmez of Bayer Healthcare (Turkey), Elena Chukraeva of Janssen (Russia), Belinda Gist of Genzyme (USA), Yavuz Silay of Labiopharma (USA), Elly Grimaldi of GRS (USA), Maria Mabunay of Mundipharma (Singapore), and Gregory Fiore of the Medicines Company (USA).

    For Williams, one of the featured speakers at the event, the timing is right for the MSL Society to serve its members and help them attain the maximum benefits the global medical affairs community has to offer.  "There is no better time to engage in the development and leadership of the MSL,” Williams stated.  “The MSL Society has successfully launched this type of needed engagement around the globe, and success is certain through peer review and meetings such as the professional meeting in Paris.” 

    Kupferer concurred with Williams’ assessment. “The conference in Paris provided an invaluable networking and collaboration experience, the kind of experience that genuinely fosters the expansion and maturation of the MSL role throughout the world,” Kupferer explained.  “Given the diverse experiential and professional backgrounds of MSLs, from health care provider to bench researcher, these types of events are integral to the advancement of the MSL profession.  Indeed, all attendeesundefinedfrom tenured MSLs and directors to those wishing to enter into the MSL role for the first timeundefinedcan benefit from attending.”

    Belinda Gist of Genzyme praised the MSL Society for an event that already surpasses similar conferences staged in the healthcare space with regard to the level of interactivity among speakers, panelists, sponsors, and attendees:  "The Paris MSL Society conference was fantastic.  It was the single-most interactive event I have attended.  I thoroughly enjoyed the exchange with my peers and their willingness to share stories, successes, and challenges. I see the MSL Society as a key driver in shaping the future of the MSL profession, and I am tremendously excited to be a part of it."  

    The MSL Society extends its gratitude to the following sponsors and media partners who powered the organization’s second conference with both financial and strategic resource commitments:  Thought Leader Select, Global Prairie, Barrington James, FiercePharma, Elsevier, PM360, and inScience Training,

    According to MSL Society Chairman Samuel Dyer, the event reflected the best expression twin values of networking and education for the MSL community:  “The MSL Society’s Paris conference was a great success and a rare opportunity for attendees to engage with a diverse group of speakers representing MSL leadership from the U.S., Europe, Turkey, Russia and Asia.  It is very exciting to see the global MSL community come together to support the MSL Society while discussing important issues facing the MSL role such as MSL certification, on-board training, and MSL metrics. It was also a lot of fun to socialize with friends and establish new relationships during the evening networking events held overlooking the Eiffel Tower and the Louvre."

    Stay tuned to this space for announcements regarding 2014 MSL Society events.        

  • 21 Oct 2013 12:18 PM | Deleted user
    What is the Future of Medical Affairs?

    By Dr. Alexander Tolmachev

    According to McKinsey & Company report, back in 2007 medical leaders from across the pharmaceutical industry assembled to develop a common understanding of a ten-year vision for Medical Affairs. With five years now past, it is hardly surprising that significant change has occurred in the world in which the pharmaceutical industry operates, especially given the remarkable economic environment and the continued acceleration of technological change. While many of the trends predicted in 2007 will continue, the pace of change is expected to increase even more as we approach 2020. The report states that three new, stronger forces will emerge that will greatly alter the healthcare landscape:

    1. The definition of value will be much broader and will expand as the types of healthcare stakeholders who demand a demonstration of value increase. At the same time, there will be an increased focus on evidence and higher hurdles for proving product value.

    2. Interactions between pharmaceutical companies and various medical stakeholders will continue to evolve with the emergence of new decision makers and with greater public scrutiny of these relationships. The role of patients will also fundamentally change with the rise of consumerism in healthcare.

    3. The proliferation of data and demands for transparency we see today will accelerate as we head towards 2020. The number and types of users of medical data and information will continue to expand rapidly.

    Given the significant changes in the healthcare landscape, this is an appropriate time to reassess and redefine the vision for Medical Affairs developed five years ago. Over the past 12 months, McKinsey & Company worked with Medical Affairs executives across the industry to produce this updated 2020 Vision for Medical Affairs. If achieved, the four aspirations below would enable the Medical Affairs function to create significantly greater value for their companies, industry and society: 
    1. Enhance patient access to best use of optimal medical treatment by clearly demonstrating value to practitioners and payors throughout the lifecycle of each product.
    2. Embrace patient-centric healthcare by engaging and partnering with a broader range of healthcare stakeholders to more fully understand the different needs of patients and to be able to provide tangible value to patients.
    3. Facilitate coordination and integration of different medical data and types of knowledgein the company and achieve external recognition for providing credible and unbiased medical information.
    4. Acquire and develop the talent to cultivate and build a strong, multi-faceted Medical Affairs organization that encompasses the new set of competencies required to navigate the future healthcare landscape across the globe.

    Much work will be required to realize this vision to create value for individual companies and the industry overall. At the heart of this effort, improved patient care and outcomes must be the central motivation of the Medical Affairs leaders. To do that effectively, Medical Affairs must become an equal to the R&D and commercial functions in advocating the patient-centric view. Deep patient insights have to come from engagements with emerging medical stakeholders and mining of new data, such as real-world evidence. Medical Affairs will also need to build new capabilities to leverage these insights.

    Reference
    1. Pharma Medical Affairs 2020 and beyond - McKinsey & Company Report. www.mckinsey.com
  • 14 Oct 2013 10:44 AM | Deleted user
    9 Steps Towards a Valuable Pharmaceutical Advisory Board

    By Alexander Tolmachev

    Advisory boards offer pharmacuetical companies a wide range of advantages, including guidance on clinical development and trial protocols, marketing campaign assessments, and improved chances for product reimbursement. Successful Ad Boards create actionable deliverables and provide incalculable value via the relationships with medical professionals. Pharmaceutical Advisory boards can cost companies anywhere between $1,500 and $150,000 with influence of variety of factors, including location, size, logistics, length of meeting, venue costs, third-party management fees, and - to participants. Tighter budgets and regulatory restrictions increasingly influence advisory board organizers to do less for more. Reducing costs without compromising meeting quality is essential, as poorly planned advisory boards may fail to provide companies with fully developed opinions and valuable recommendations. It is reasonable to assume that there is a number of features common to valuable Ad Boards. Let's distill them to clear actions required to make an excellent Ad Board.

    1. Set up a clear purpose based on real needs of medical community.
    Investigate the professional needs of the physicians in your therapeutic area. Looking into participants needs and motivations will provide mutual beneficial experiences. Develop a bright agenda and put a meeting goal into a header of the handouts as it should be very clear for the advisors why they are here.

    2. Invite right experts.
    Recruit a representative group of advisors that captures the spectrum of opinions of your brand. This doesn't mean that the board will necessarily consist of only brand supporters, it some cases the best opportunities happen when you manage to get insights from collision of opinions. Understanding why physicians are non-supporters is vital in determining what is required to convert them to brand advocates.

    3. Strive for expert synergy, not a conflict.
    Use your emotional intelligence in participant selection and keep in mind that an outstanding project may turn disaster when antagonistic advisors are comming together. Instead carefully select experts according to their mutual needs and personal sympathy.

    4. Have a great meeting moderator.
    One of the keys to achieving a valuable outcome is a moderator that keeps the group on task and moves discussion forward so that the meeting doesn’t get bogged down. It's a 'make or break' of your Ad Board. Having a respected and steady chairperson alters the dynamic of discussions and increases the chances that the end result of the meeting will be an effective and actionable finding.

    5. Make sure that moderator is aware of your expectations.
    Ensure that the moderator is on the same page with you. Brief the moderator about what you expect as the end result. The best case is to prepare the agenda together with the moderator considering her/his needs and interests. Leave a lot of freedom for her/him in the workflow of the meeting. Ask for advice and keep promises.

    6. Incorporate adult learning principles to shape the program.
    Reliance on didactic presentations fails to work due to the diversity of learning and group discussion styles. Try to engage different perception channels and prepare handouts with relevant data, slides or videos.

    7. Challenge participants to invest in the result and do their homework. The best approach is to meet all the participants personally and ask for their expert contribution at the meeting. You will have to specify what do you expect from them in the end and ask to do some preparation.

    8. Ensure that meeting results are converted to action steps. As well as there is a responsible who will follow up with the advisors. I case it's not you, make sure to have her/him at the meeting. Keep in mind that having the next steps is the real purpose of the meeting and you can never ignore this part.

    9. Communicate the outcome of the meeting internally. Make sure your internal stakeholders (marketing, sales) are aware of the meeting agenda, the participants, the next steps and the follow up responsible.



  • 08 Oct 2013 10:26 AM | Deleted user
    9 Rules for Off-label Communications in Medical Affairs

    By Dr. Alexander Tolmachev

    Drug companies will always seek to extend the markets for their products, and regulators will always be concerned that the promotion of these products is truthful. The challenge is to maintain a balance that best protects patients. Off-label communications are on the borderline of what is permitted to provide patient value. Off-label communication is a part of the product life cycle, and policies regarding off-label uses should consider that a larger process than only an obligatory task. Let's go through the most important considerations about communication of off-label data in Medical Affairs based on FDA draft guidance.

    1. Off-label data may be communicated by Medical Affairs only in reactive manner as a reply on a unsolicited (unprompted by company) query. A solicited request is one where direct or indirect references to off-label use are first mentioned by a company or a company representative.

    2. Solicited requests would render a company response to be illegal promotion.

    3. Medical Affairs has to respond privately to any person making an unsolicited “public” request for off-label use. A public response on a website or in a social media forum would provide off-label information to individuals who did not request such information and, therefore, may promote a product for the off- label use.

    4. This approach is different from approach to unsolicited requests in an in-person public forum, such as a meeting or a conference. In those settings, a response to an unsolicited question about off-label use may be made to the audience at large.

    5. Any responses to unsolicited requests must be truthful, balanced, accurate, and not misleading. In addition, the responses should be non-promotional and scientific or medical in nature, generated by medical personnel who are independent from sales and marketing departments, responsive only to the question asked, and provided only to the person making the inquiry.

    6. FDA states that unpublished data on file with the company may be disseminated and there are no restrictions on the types of data.

    7. FDA advises companies to keep a written record of the nature of the request and the name, address, and affiliation of requestor; the information provided; and any follow-up inquiries, questions, and responses.

    8. Disclaimers, disclosures, and attachments should accompany all off-label information, including:- A copy of required approved labeling.- A statement identifying the approved indications.
    - A statement that the information contains references to not approved uses.- All important safety/risk information.
    - A complete list of references, including journal articles that may provide negative information about off-label uses.9. Company policies and standard operational procedures related to medical information services and medical request resolution should be carefully considered by the responsible.

    Reference

    1. Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. DRAFT GUIDANCE. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf

    2. Kupchyk A. FDA’s draft guidance on social media and off-label communications. Nixon Peabody LLP. http://www.nixonpeabody.com/files/142219_FDA_Health_Alert_01_26_2012.pdf

    3. Kyle Sampson, J.D., and Brian J.Wesoloski, J.D. Off-Label and Pre-Approval Promotion. Hunton & Williams LLP. http://www.hunton.com/files/Publication/87a698ce-a24a-4913-bcec-71e7358dea10/Presentation/PublicationAttachment/b0b5ff9d-3de9-46ff-9624-8116942df128/ContractPharma_March_2012.pdf4. C. Lee Ventola. Off-Label Drug Information Regulation, Distribution, Evaluation, and Related Controversies. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2799128/pdf/ptj34_8p428.pdf
  • 30 Sep 2013 10:08 AM | Deleted user
    7 Easy Steps to Smart Engagement of Scientific Thought Leaders

    By Dr. Alexander Tolmachev

    Company experts and academic scientific leaders comprise the collective central nervous system of the pharmaceutical product. This is the reason why engaging external experts whose experience and skills are required to meet specific scientific, medical, and commercial needs is so important for pharmaceutical industry. These engagements help companies to guide new product development, generate data, refine strategy, and create relevant, credible, and persuasive medical and promotional content. Thus pharmaceutical companies have to broaden the network and take care of thought leaders. Below are some specific tips for smart engagement of external experts.

    1. Clearly define your goal.
    Make sure that all engagement activities, from field visits to physician medical education programs, are driven by specific scientific or commercial objectives. A well-orchestrated and objective-driven approach to thought leader engagement throughout the product’s lifecycle can be your critical competitive advantage.

    2. Come to ask for consultation not for engagement.
    You build relationships with external experts whose experience and skills are required to meet specific scientific, medical, and commercial needs of the company. Be transparent, share your goals and ask for advice. Open, clear and real discussions among company and non-company experts can significantly advance the development of product strategy and medical content.

    3. Listen carefully and read the real needs between the lines.
    Strive for a holistic understanding of your customers and their needs. Some of thought leader needs will be emotional rather than logical. The more you know your external partners, the better you become at anticipating their needs. Communicate regularly so that you are aware of problems or upcoming expectation. External experts "buy" solutions for their problems, so make your engagement story an solution efficiently matching the specific needs.

    4. Create new proposals through combining existing ideas, concepts and opportunities.
    Keep in mind that these engagements should allow scientific leaders and industry to pursue common aspirations: to advance medical science, meet unmet medical needs, and provide real value to patients. Try creating cross-functional expert work groups, welcome international networking, collaborate with your colleagues in other therapeutic areas, do benchmarking with other disengaged industries.

    5. Make any feedback your best friend.
    Encourage and welcome suggestions about how you could improve. Besides greater engagement with scientific leaders, rooted in meaningful, bi-directional dialogue, can drive high level drug development and commercialization, while enhancing the company’s status of partner of choice. Treat any feedback of thought leaders as a basis of improving engagement and quality. Capturing customer opinions and complaints will increase the volume, quality, and relevancy of recommendations that can reshape concepts, services, and messages.

    6. Do less, but most crucial things.
    Keep the link between thought leader engagement and your strategic goals, finding and focusing on 20% of activities that will provide you 80% of success. You may give your customer a voice and decrease your control and involvement. Allow the expert to set preferences by channel and even communication type. This will not only empower the thought leaders and build trust, but will provide a critical service to the organization by keeping your interaction compliant.

    7. High level scientific content is everything.
    High level clinical and scientific data will make you a trusted partner playing on the side of medical communities. Your continuous excellence and expertise can be applied to form a shared understanding of a product’s strategy and content between a company and the thought leaders.
  • 22 Sep 2013 9:40 AM | Deleted user
    What is Medical Affairs Leadership?

    by Dr. Alexander Tolmachev

    Medical Affairs departments were initially formed to facilitate peer-to-peer scientific interactions between physicians and industry more that 40 years ago. Later alterations in the regulatory environment have resulted in a shift of activities perviously managed by Marketing to Medical Affairs. Between 2002 and 2008 there occurred a substantial organizational change with an increased share of Medical Affairs departments acquiring independence from Marketing. Now Medical Affairs is still tightly linked to Marketing projects and routine practices as an internal advisory department specialized in medical sciences and compliance. At the same time Medical Affairs is responsible for building long term relationship with scientific and medical communities. These two types of interactions are possible in condition of sustainable Medical Affairs Leadership. What is expected from Medical Affairs people remain the leaders?

    1. Inspire the vision of the future with your scientific insights. Your scientific and legal competence is the power allowing you to see the future success. Use your expertise to build up a new picture of collaboration of your company and medical communities, tell the stakeholders your story and be the change.

    2. Set high standards of healthcare ethics by own example. Business will always consider financial results a top priority despite the changes in regulatory requirements. Matrix environments provide great opportunities for Medical Affairs to contribute to potential risks mitigation in the teams and to be acknowledged as a ethical "gate keeper". Compliance with the procedures and integrity as a personal value of Medical Affairs people will serve as a landmark of business conduct for the internal partners.

    3. Prepare the long term success of your company. Indeed valuable contribution of Medical Affairs is mostly aimed to the company long term future. Remaining only reactive towards stakeholders' requests will decrease Medicals' influence on the future and turn them into a pure support function. Make patient health benefit your priority in interaction with external stakeholders (this obviously will not be achievable overnight).

    4. Earn trust with your stakeholders every day. Medical Affairs have an advantage over business in credibility with external stakeholders - Medicals are reported to be more trusted, even more trusted than physician peer speakers at speaker programs. Ability to carry out unsolicited peer-to-peer communications that include off-label, consideration of costs related to disease state, approaches to overall patient management and the potential benefits of appropriate care give Medical Affairs an opportunity to acquire trust in interaction with external stakeholders on daily basis. Besides your trust funds within the company will play the key role when your partners will decide whether they want to follow you.

    5. Influence through education. Investigate the knowledge gaps and needs and provide the useful data. Be the one who will convert sophisticated information to clear and intelligible messages and next time people will come again and ask for your help. If you are continuously educating your stakeholders, you are already influencing and leading them.

    6. Make your stakeholder needs serve a basis for your success. The only way to make your stakeholders buy-in is meet their expectations. Use any opportunity to investigate their needs, satisfy them, be open to feedback and that will make you a partner of choice.

    7. Consider the feedback and criticism your greatest opportunity. Obviously when you are a key partner of business, you need regular feedback to change and grow. The same is about external stakeholders. If you receive a complaint or a criticism shower this first of all means that your stakeholder is seeking dialog with you. Use that immediately as a chance to look into their real needs better. Who knows, often right approach to complaint management brings your relationship on a new level of trust.

    8. Invite other departments into your story. In matrix structures you have a lot of opportunities to practice internal leadership without people management functionality. Help your cross-functional colleagues to buy-in your projects. When you communicate them the picture of your common success they will probably get engaged quicker.

    9. Measure and communicate your contribution. It is hard to measure the intangible, but it is possible. Use both qualitative and quantitative metrics. Demonstrate the numbers and the dynamics linked with Medical Affairs contribution. Be flexible - sometimes there might be no need to dive too deep to pick up your pearl.
  • 16 Sep 2013 7:30 AM | Deleted user
    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
  • 09 Sep 2013 8:32 AM | Deleted user
    8 Things That Comprise Success Of Investigator Initiated Trial

    by 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
  • 30 Aug 2013 9:05 PM | Deleted user
    12 Tips for Medical Science Liaisons' Success

    by 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.

  • 27 Aug 2013 5:17 PM | Deleted user

    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 Sequenom, Dr. 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.

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