Nov
15

The Rising Demand for Medical Science Liaisons

shutterstock_127896038The Medical Affairs Director needed me to find the right kind of talent for a specialized field medical role; Medical Science Liaison (MSL). A key phrase he repeatedly used has since come up in the subsequent discussions I’ve had with Medical Affairs professionals looking for great talent for their teams; “scientific credibility”.
Of course, scientific credibility has always been an important aspect of the interactions between pharmaceutical company employees and Healthcare Providers (HCPs). However, the reason why we have heard this term so much recently, one industry expert commented, is because companies are now operating in an environment where the promotion code is being interpreted very strictly, not only in terms of financial disclosure (ref: the “Sunshine Laws”) but also quite specifically on how, and by whom, information can be shared.
The evolving needs of HCPs have been a main driver in creating this new environment. As one Medical Science Liaison Manager explained to me, HCPs nowadays are dealing with more and more niche therapies, and have access to a lot of product information (e.g. through improvements in information technology), so the information and guidance they require from manufacturers is becoming increasingly specialized. With this, they expect the company to provide “partners”, with whom they can interact on more of a peer-level, discussing diseases and drugs. As Medical Representatives (MRs) find their interactions with Key Opinion Leaders (KOLs) more limited, especially in terms of the information they are allowed to share, this is where the MSL brings value. An MSL, with a medical license or doctorate degree, can bring the required level of scientific credibility to partner effectively with an HCP.
It’s clear why companies need strong MSLs, but where to find the right people? The challenge that every hiring manager faces is that they need someone with the requisite scientific credibility, but who also has the “soft skills” of a commercially-minded professional. I remember hearing the concern from one hiring manager that the young lady I’d introduced may be too academic. As he explained, it’s no use having an MSL with excellent scientific credentials if they can’t communicate effectively with HCPs, drive the business forward, and understand the importance of customer service.
In terms of mid-career MSL recruitment, we’ve seen a lot of hiring from competitors this year. Hiring managers have also been exploring other avenues to find or mold people with the right balance of skills. Some companies have explored academia, bearing in mind that these professionals will need subsequent development, and may not transition smoothly into the business world. Other hiring managers have found talent within their existing employees; e.g., MRs or marketing professionals with an MSc or PhD.
However, these alone cannot represent a sustainable, long-term strategy. A number of senior figures with whom I have spoken, highlighted the need to promote the MSL as a career choice within the industry, academia, and even amongst undergraduate and post-graduate students. One Medical Doctor suggested that Japan lacks the specifically designed courses balancing scientific education with a strong vocational element, which you find in other countries. If courses like this were offered, then future generations of MDs and PhDs may view the MSL role as a natural career choice.
One senior executive stated that he could see the pharmaceutical industry moving towards a more physician-led, or at least physician-inclusive, future. This would bring closer collaboration between HPCs and companies, based on sound principles of scientific evidence, leading to greater patient benefit. The role of the MSL is an essential link in this model. To achieve this, the scientists and physicians of tomorrow need to be shown that a career in industry is open to them, and is one of the most valid ways to make a great contribution to society.
Article By Philip Carrigan
Oct
10

The time is now for Medical Affairs

bigstock-Medicine-Doctor-Hand-Working-W-44541469On September 30th, 2013, a panel of Japan’s Health and Welfare Ministry issued an interim report on the manipulation of clinical research data on Diovan, a blood pressure-lowering drug, for Novartis Pharma. Aftershocks of the recent Diovan scandal have reverberated around Japan’s pharmaceutical industry. Quite expectedly, medical affairs (MA) will require strict compliance in medical and sales and marketing activities.

The environment on evidence generation through investigator-initiated trials (IITs) is fast changing. In the past, companies supported large-scale and local IITs by providing them with financial and administrative support. A senior Medical Director that we spoke to warned, “that the local studies may be the most dangerous as they are not always conducted according to GCP and are more related to commercial objectives, aligned with the importance of the centers or the power of the principal investigator. This practice used to exist everywhere and has long stopped in Europe. It still exists with some companies but I believe that it will stop in the near future”.

Medical affairs will need to lead initiatives to allay concerns of the industry by ensuring the independence of study organizations from funders and improving the quality of clinical studies through compliance with ICH-GCP. IITs will require adherence to standards of good clinical practice (GCP) set by the International Conference on Harmonization (ICH). Furthermore, companies will increase focus on programs with high transparency.

Most companies have two types of scientific teams: one for development and another for medical affairs. Development defines the scientific direction and early-stage development, as well as includes clinical trial runs, whereas medical affairs provide scientific support for late-stage development and post market support. In small companies, the same team may be responsible for both types of activities.

Medical affairs and medical liaison function alongside marketing to provide technical support to both internal teams and external customers. Medical liaison teams include field-based medical information specialists who provide in-depth drug and disease information to health providers. Both medical affairs and medical liaison teams provide information services to educate department employees and thus ensure that consumer questions are addressed, as well as disseminate data to health care providers in the community. Medical affairs teams also formulate publications plans and report key trial results to the PMDA, in scientific meetings, and through journal articles.

Social pressure to ensure research independence and publication of relevant data that benefit patients has increased. The goals are to increase the number of publications and improve the standard of medical science in Japan. Ultimately, the strength and performance of medical affairs departments will have a direct correlation to the number and quality of highly ethical scientific publications.

The crisis initiated by the Diovan scandal may prove to be the catalyst to improve the quality of educational and promotional materials (medical affairs teams prepare scientific information for marketing purposes) and to deepen relationships with professional associations, patient support groups, and advocacy groups.

The race to attract top medical affairs and medical liaison talents has intensified. More important, the pressure has increased on medical affairs and medical liaison to ensure that pre-promotion, off-label promotion of products are and not carried out and along with any unscientific bias promotion or prescription inducible clinical trial and that outside speakers do not act as a company’s operative or champion.

MA is playing a more critical role than ever; a leading European MA Director explained that “Medical Affairs should really function as the emergency brake for the shuttle that runs between the commercial organization and the R&D organization. Some companies have the MA organization residing in either one of these larger functional areas in either a matrix organization or adjacent functional area. The “brake” function comes into play, when the commercial organization in ostensibly “innovative” proposal is running a high risk of inflicting grievous harm to the reputation of a company in the post marketing space or the R&D organization is pursuing non-value added activities that have little or no commercial POS (probability of success), then MA needs to step in and speak to the science and provide supportive data to bolster their position or assessment. They are critical to prevent nefarious activities in both the development space as well as the post marketing space and hence prevent either loss of value (EPS) and subsequently investors’ confidence or loss of trust (from a tarnished reputation) due to unethical behavior”.

One of Asia’s leading Clinical Directors prophesied, “the future is bright for MA to become the star in the data generation, data recognition, data interpretation and analytics, arena as they pursue and the only real metric that matters in this industry, “speed to market” of high quality, safe and effective medicines. The future beckons with opportunity and the company which can capitalize on this will reap fortunes even for niche market and unmet medical needs drugs, that usually only come with blockbuster drugs. The formula is simple DATA → Information → Knowledge → Wisdom. The real commercial differential for success is not in Pharma knowledge but in Pharma wisdom. MA can become the star in this role rather than the cameo appearance it currently makes in this arena”.

The successful MA teams will be able to find the proverbial needle (data) in the hay stack while being in compliance with GCP guidelines. No one can predict the future but one thing is clear, MA is becoming one of the most critical functions at pharmaceutical companies.

Article By Philip Carrigan

Sep
10

How to persuade an academic KOL?

загруженноеMSL organization is the interface between corporate functions and external medical and scientific environment. MSLs normally are not directly linked with the goals of commercial organizations, but some expectations of internal stakeholders still influence the MSL’s work. The major company’s expectation from its MSLs is to keep the KOLs engaged and developed. The range of brand/company advocacy that a KOL delivers is normally described as negative, neutral or positive. Since MSL is the KOL’s key point of contact with the company, it is the MSL who can directly influence a KOL to shift from one advocacy level to another. When the newly hired MSL gets face-to-face to an experienced academic KOL it is mostly good communication and influence skills that mean the difference between a successful meeting and a missed opportunity.

1. Don’t just push your own arguments
People who know how to persuade and influence also know that strongly advocating an idea with persistence will get you nowhere. Certainly, you have to be able to articulate your position in a convincing way, but that is only half of the way. You have to actively listen when you want to persuade. You need to listen to assess how receptive KOL is to your point of view as well as to capture KOL specific objections, which you will have to resolve. Also listen for moments of agreement so you can capitalize on consensus with KOL. One of the keys to effective persuasion is to know the other side of the argument.

2. Clarity of your communication is the key.
When you can’t explain your concept or idea in simple words, such that a student could explain it with sufficient clarity to another adult, it’s probably too complicated. The art of persuasion of a KOL lies in simplifying something down to its core, and communicating it. Avoid use of scientific buzz words or jargon that you or KOL may not understand properly. Academic KOLs are very keen on learning new things, so if you give your KOL such an opportunity without confusing, you will obtain interest and trust in return.

3. Doing your homework gives you an advantage.
Accurate preparation allows for effective persuasion. Your starting point should always be to know more about the KOL and situations around her or him. Ask your sales counterparts to share as much as they know about the KOL including communication style, interaction expectations and needs. Attend conferences to listen KOL speaking or read articles by her or him. Knowing this will give you spontaneous insights what to say or do and when to shut up.

4. Confidence and Certainty
Evidence based thinking makes academic KOLs sensitive to certainty in communication with pharmaceutical companies. Truly, there is no quality as compelling and attractive as certainty. If you really believe in what you say and you have enough clear arguments to prove that, you will always be able to persuade KOLs to do what’s right for them, while getting what you want in return.

5. Mind reciprocity

When you give something to someone, they will feel like they owe you. If KOL sees value in services you provide, you may not shy about suggesting some new opportunities for contribution – speaking at a conference, writing an article, moderating an Advisory Board. People feel bad about not reciprocating and will often agree to contribute. Don’t forget to maintain adherence to compliance in interaction with KOLs – expectation of them providing you a service in return for the scientific value you brought is inappropriate as it makes this service not unsolicited.

6. Be Purposeful
Most conversations with KOLs do not require trying to get someone to do or accept something. Aggressive pushers are a turn-off and will only put most KOLs on the defensive mode or will be ignored. It’s the MSL who rarely asks or argues that ultimately gets KOL’s consideration.

7. Offer Satisfaction
Choose being successful over being right. Smart persuaders know that they don’t have to win every little battle to win the war. They are more than willing to sacrifice if it helps the business. Often that is simply to give a KOL what she or he wants whenever possible.

8. Don’t try to persuade the unpersuadable
It’s OK that a KOL’s perspective is different from the company’s. Moreover, it’s an insightful opportunity to liaise with such an expert, broaden your scope and seek for more potential of the product. In long time run, solid relationship with a KOL who is currently is negative to your brand may provide you a lot more value than your current advocates.

You want to persuade KOLs more? – Argue and advocate less often.

Jul
05

7 Essential Considerations about Promotional Material Review and Approval

business-gear-to-success-20933774Promotional material review has become an important topic because of increasing scrutiny of pharmaceutical advertising by Regulatory Authorities, Public and Media across the world. Dissemination of promotional materials and engagement in activities that are promotional in nature is a part of business practice of pharmaceutical and biotechnology companies. Promotional materials target either consumers or health care professionals and are disseminated on different types of media. Surveillance and enforcement of prescription drug advertising is governed by country Regulatory Authorities (i.e. FDA in US, Federal Legislation in Russia, etc).

To ensure that promotional materials and activities comply with industry guidance and local regulations, pharmaceutical companies normally establish promotional review committees, which are cross-functional teams that take into account legal considerations and review medical consistency. The medical reviewer normally resides in Medical Affairs or Medical Information department. The basics of medical promotional review are more or less common among established and emerging countries since they are based on global corporate requirements. Below are the some most essential principles of promo-material review and approval in pharma and biotech manufacturers.

1. Promotional review committe has to be established and it’s work should be governed by a corporate procedure with clear distribution of responsibilities. Normally it’s representatives are from Regulatory, Legal, Marketing, Medical Information and Medical Affairs. Review and approval process may be virtually performed in a corporate on-line system with access for all assigned roles.

2. The prescription drug advertising and promotion regulations require promotional materials to be fair-balanced and not false or misleading in the communication of benefit and risk data. Promotional content must be consistent with the prescribing information as approved by local regulatory authorities.

3. Promotion and advertising of a product prior to marketing authorization (registration) is prohibited. Information on unapproved drugs and indications (off-label) may be given to physicians only by the Medical Affairs function and only upon unsolicited request from physician.

4. Promotional content must be substantiated by reference to prescribing information as approved by local regulatory authorities or by additional scientific evidence meeting the requirements of local regulatory authorities. Such additional evidence should be made available to physicians upon request.

5. Medical Information responsibles ensure scientific relevance, accuracy and completeness of clinical data, as well as that claims are adequately supported by data and materials are consistent with current approved label. The acceptability of references used to support claims should also be determined.

6. Medical literature quotations must not change the meaning intended by the author or the significance of the underlying work or study.

7. Normally pharmaceutical manufacturers require that promotional material should include:
– trade name and generic name of the product;
– name, logo and address of the company marketing the product;
– short statement with essential product characteristics including safety data;
– date of production and a unique identifier.

Reference

1. Bork L., et al. The role of pharmaceutical medical information in promotional review: three benchmarking review. Drug Information Journal, 2012; 46: 107-114.

Written by Dr. Alexander Tolmachev, alexander.tolmachev@gmail.com