MEDICAL SCIENCE LIAISON: EMERGING ROLES 2009

David M. Shearer, MD: CMO/ VP of Clinical Operations: ICTS, LLC

INTRODUCTION

An integrated model is now required to better demonstrate and depict the emerging roles of the Medical Science Liaison (MSL) and the wide variety of associated responsibilities. Although there are increasing and diverse possibilities for incorporation of the MSL into the field, an education, information and awareness gap currently exists between the industry and the medical community which may be effectively bridged by expanding the utilization of the MSL.

The MSL is a healthcare consulting professional, who is qualified by training (PhD, Pharm D, MD) and represents pharmaceutical, biotechnology, medical device, and managed care companies. In providing representation as an extension of the respective industry into the medical healthcare community, the MSL of today is quite different from the past.

The responsibilities of the MSL have emerged as a comprehensive, complex and highly interactive role which has evolved significantly since inception by the Upjohn Company in 19671. In days past, the MSL was limited in outreach to the medical community, secondary to high-tech tools and processes which did not exist at that time, and currently avail a more dynamic and real time communication potential. The industry has also transformed into a highly diverse, yet regulated system mandating accurate information sharing to ensure compliance and safety. Currently, the MSL is able to transcend limitations of the past and discuss high level science to achieve better education, messaging, new ideas, further research, enhanced medications, improved safety and compliance. Ultimately, further empowerment of the MSL would satisfy an idealistic vision whereby daily MSL activities are uplifted into a realm of increased awareness within the medical community resulting in optimal treatment options and quality of patient care.

 

Scientific discussions and unique possibilities for research and development (R&D), as well as important feedback from the medical community are often lost or not captured at all. Therefore, in order to satisfy this void, there is a need for a well developed, systematic approach to obtain this critical information. The solution exists in an enhanced communication and tracking model which allows for the progression of the roles and responsibilities of the MSL and furthers the efforts of the sponsor to expand R&D possibilities. Therefore, it is necessary to capture MSL metrics and communication to better evaluate the MSL program and proactively adjust MSL activities to ensure sponsor goals and objectives. The fast paced, goal oriented, and global demands of the industry create a need for an MSL program which is able to capture metrics in “real time” and create reports which satisfy compliance and regulatory guidelines.

A communication structure can be established which promotes the capture of physician information relayed to the MSL with interaction to and from the sponsor. Effective communication between the MSL and the prescribing physician and key opinion leaders (doctor to doctor relationship) is an essential component of organizational success whether it is based on interpersonal, intergroup, intragroup, organizational, or external levels2.The physician and sponsor may be operating and functioning at different levels due to the intricacy of their respective professions, and therefore, the thoughts and potentials of each may not be fully recognized, resulting in valuable information being lost forever. Perhaps we should rename Dr. John Gray’s book to “Physicians are from Mars, Sponsors are from Venus” in order to better portray the need for both sides to be recognized and heard. Yet, it is a must for the MSL and physician to talk to one another in order to effectively represent and honor the advancement of the science behind new therapies and novel uses for existing compounds.

Education has an immense impact on the human society. One can safely assume that a person is not in the proper sense, nor has awareness matured until he is educated3.  It is through enhancing the educational process via the incorporation of the MSL, that knowledge and information can be effectively delivered worldwide. Therefore, the dissemination of direct to consumer (DTC) materials, in addition to physician aiding materials such as pamphlets, DVDs, memory sticks and websites enhance the educational process in addition to safety and compliance by the physician and most importantly the patient. Better means of assessing DTC information is a necessity in these changing times and incorporation of international programs by the pharmaceutical industry.

In addition, as pharmaceutical companies continue to expand their programs to conform to a global market, MSL teams will need to be flexible and able to adapt their international relationships to satisfy the demands of the industry.

Today, MSLs are evolving into a more independent, targeted and highly strategic role and responsibility. In recognition of this growth, few realize the annual MSL appreciation day, each November 3rd which started in Fishers, IN in 2006 by Pharm, LLC4. MSLs are now presenting and interacting with key opinion leaders (KOLs) throughout the medical community to actively share insights and achieve corporate goals ranging from educational presentations to new scientific ideas for research and development.  In order to ensure proper messaging, the industry depends on the MSLs’ scientific expertise to provide and support education, training, safety, compliance, research, and clinical initiatives. Therefore, choosing the right MSL program is a rather selective and detailed process but ultimately can result in an invaluable service. These topics are further described below.

 

INTERACTION WITH HEALTHCARE PROFESSIONALS

The MSL typically functions as the intermediary between the pharmaceutical sponsor and the physician, serving roles in both the transmission of beneficial compound information and the gathering of in-field medical intelligence. Both roles are critical in establishing peer relationships which result in obtaining the necessary feedback from the physician and providing it to the sponsor. This information provides insight as to how patients and physicians like or dislike particular medications, reimbursements, pricing strategies, physician initiated trials, clinical trial possibilities, educational platform development, safety, and compliance.

The communication structure depicted in figure 1.1 below demonstrates the MSL serving as the conduit between the physician and the sponsor. The application of a communication structure into an integrated communication system provides the means for the uploading of physician comments containing valuable patient feedback to the MSL in addition to the downloading of supportive information from the sponsor’s safety, regulatory, and marketing departments. Likewise, similar methodology can be applied to facilitate the MSL role in the development, use, and interaction of patient registries within the medical community to enhance safety and compliance and the communication of vital patient information.   

 

 

Figure 1.1 : Communication Structure

The MSL / KOL interaction usually involves a specific therapeutic area treatment, procedure, medication, or device. University and leading national health and / or academic institutions are often preferred; as highly developed research and premiere physician / KOLs can be identified and engaged into the pharmaceutical process. In addition, the MSL may interact at a higher level with governing agencies associated with healthcare and pharmaceuticals, thereby, providing insight into political, moral and ethical views on the use of specific medications and the implications, goals, and objectives which must be addressed and overcome in order to satisfy product lifecycles. The MSL is responsible for successfully relaying information from the sponsor to the physician and therefore, must effectively align with clinical operations, medical affairs, marketing, and sales departments to ensure informational transfer from the field.

 

EDUCATION:

The MSL educational and training processes are vital to developing the information base that will ultimately facilitate patient safety and compliance. One main objective of the MSL is to establish relationships with key opinion leaders and provide them with the necessary information and resources to discuss and safely prescribe medication to their patients. The dissemination of educational materials is important to the standardization of messaging transmitted within the medical community.  Such educational information may include, but is not limited to, clinical trial results, safety and efficacy data, educational updates specific to a therapeutic area, continuing medical education, and speaking opportunities. An educational perspective allows for the development of important networks with KOLs and decision makers to ensure a healthy product lifecycle while enhancing conceptualization for further research and development. Interactions with the KOL also may include advisory board meetings, speaker training, workshops (e.g. lunch and learns), conferences, formulary submissions, and further educational material development.  In addition, the MSL is able to increase disease state awareness among KOLs in discussing the latest therapies and provide assistance in building knowledge specific to targeted disease pathways. Due to simple geography, the field based MSL is able to identify new and innovative medical findings in different regions which may result in the development of publications and providing unique data and insight to these respective regions. The growth and development of the MSL yields a more educated healthcare community, which results in a better educated and compliant patient.

 

CLINICAL TRIALS

Medical science liaisons can also play a role in clinical trial programs, particularly at the phase 2, 3, and post-marketing level. Through the establishment of solid and coherent relationships with physicians participating in clinical trials, local support from MSLs can aid in patient recruitment and retention, safety, and compliance. The MSL can also apply their expertise to the clinical trial site specific to how clinical trials are conducted, CFR/ ICH guidelines, and the assurance of high data quality and integrity. Often times, the MSL is underutilized in this capacity creating a missed opportunity for the sponsor to use a valuable resource in the research and development process. A high level KOL relationship with the MSL oftentimes results in further drug possibilities and scientific discussions resulting in new clinical trials and physician-initiated studies.

 

COMPLIANCE / SAFETY / REGULATORY

The utilization of an MSL program aids in optimizing Good Clinical Practice (GCP) to maximize proper and effective dosing and safe use of a medication. The sponsor and respective MSL take a leading role in improving patient safety, as emphasized by the Pharmaceutical Research and Manufacturers of America (PhRMA): safety is the highest priority and should be the top priority in any MSL program8. To assist in ensuring safety and compliance, the MSL is able to effectively communicate and distribute relevant educational materials, which enhance awareness within the healthcare community and prioritize the benefit for patients and aid in the enhancement of the practice of medicine. Emphasis is placed on existing data which supports the importance of establishing and maintaining national patient safety goals5. The Federal Food, Drug and Cosmetic Act emphasizes taking a leading role in improving patient safety and requires the accurate promotion of products as per product label6,7. The Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) has established guidelines for the basis of compliance programs and sets a standard of excellence to be withheld and respected by the pharmaceutical industry9. 

In recent studies, 59% of physicians surveyed indicate that their biggest complaint about patients is their failure to follow and adhere to the doctor’s prescribed treatment regimen, and only 50% of patients take their medication as directed by their physician.10,11 This translates into a non-compliance factor resulting in billions of dollars per year in lost sales to the pharmaceutical industry, not to mention causing 125,000 deaths annually in the U.S.12,13  In today’s litigious society, an MSL program can assist in risk mitigation by providing essential in-field treatment information, fine-tuning physician to patient communication models, and assessing off-label and outside safety parameter prescribing. 

 

CHOOSING THE RIGHT MSL PROGRAM TO ENSURE ALIGNMENT


Aligning the MSL program to match sponsor objectives and also coincide with KOL and physician interaction can often be exhilarating as well as complex. The correct toolset inclusive of physician educational materials and DTC capability is vital to the success of the program. The active involvement and participation of the sponsor is important for the standardization and consistent messaging in the field. Once the strategy has been established, roll out can occur on a more locally defined and regionally specific territory. Safety, compliance and regulatory guidelines are addressed to further ensure the quality of the program and its integration with corporate and cultural philosophies alike.   The bottom line in any MSL program outsourcing is flexibility and both the willingness and ability of the MSL provider to custom design the right program to fit your needs.

 

THE MEDICAL SCIENCE LIAISON MODEL:

Figure 2.1 below best depicts the complexity of today’s MSL and summarizes the principles described above. Circular movement is depicted to emphasize the interaction and flow between the MSL and various components between the sponsor and the medical healthcare community. In the model shown below, the MSL is in the innermost core creating dimensionality and depth which results in the dynamics and strength of the surrounding elements. The core provides stability and provides the ability for movement and flexibility within the model as a continuum of the MSLs adaptability.

Figure 2.1: The Medical Science Liaison Model: Emerging Roles

Ultimately, via scientific knowledge exchange, product market intelligence, and alliance with the healthcare community, research and development efforts are enhanced by the communication and MSL relationships which provide further tools and knowledge to the physician and enhanced patient care.

 

CONCLUSION


Today, MSLs have metamorphized into a highly interactive, innovative, and strategic role. As shown in the model above, an integrated system is now required to better demonstrate and depict the wide variety of MSL responsibilities. However, an educational and awareness gap still exists between the industry and physician which could be filled via better utilization of the MSL and customer interaction.

MSL programs can offer a tremendous opportunity to achieve corporate goals and objectives while achieving high standards of education, obtaining necessary physician feedback, interacting within clinical trials and ensuring the satisfaction of proper compliance, safety and regulatory parameters. In addition, the opportunity for growth and development of the MSL, especially in global markets, is staggering when addressing the need for enhanced education in the field.

Pharmaceutical goals and objectives are best demonstrated and justified by initiating an MSL program which is able to capture metrics in “real time” and create metric reports which satisfy compliance and regulatory guidelines. An integrated communication system benefits the advancement of science while assisting the sponsor in evaluating drug interaction and other emerging long-term safety issues as well as providing essential feedback for mitigating actionable risk.

As information is collected, an effective MSL program is able to incorporate information and feedback from the field which can significantly impact corporate strategies. Those companies which identify the need for an innovative and creative MSL program, which shows flexibility and adaptability while leveraging KOL and high level scientific discussion, will ultimately benefit in effectively satisfying the demands of shareholders, executives, and the healthcare community.

Through it all, the patient should ultimately benefit, feeling more comfortable while having a high degree of confidence in the quality, effectiveness, and safety of their prescription medicines. It is in the non-biased, scientific representation of the industry that the MSL is able to discuss treatment options regarding a medication, therapy or device which ultimately aids the patient via optimizing knowledge, care, compliance, awareness, and understanding within the healthcare community.

About the Author:

David M. Shearer, MD, is Chief Medical Officer and Vice President of Clinical Operations for Integrated Clinical Trial Services (ICTS) which provides clinical trial sponsors, contract research organizations and site networks with a comprehensive resource for patient enrollment, site optimization, education and medical science liaison expertise. In his position, Dr. Shearer oversees the medical components of ICTS to aid in quality assurance in each of these areas. Dr. Shearer has established a turnkey, highly interactive and flexible medical science liaison program for purposes of educating the healthcare community about pharmaceuticals.

Dr. Shearer has 12 years of experience in the pharmaceutical industry and has performed more than 100 clinical trials at some of America’s largest pharmaceutical companies, in addition to conducting 6 years of in-hospital research at the Cleveland Clinic Foundation and Temple University Hospital, resulting in multiple publications.  This research included studies for Type I and II diabetes mellitus, obesity, myocardial infarction, stroke, gastroenterology, schizophrenia, Alzheimer’s, depression, sleep disorders, hypertension and hyperlipidemia. 

For more information, please email dshearer@integratedtrials.com

REFERENCES

  1. http://www.scientificadvantage.com/mslhistory.php
  2. http://web.cba.neu.edu/~ewertheim/interper/commun.htm
  3. http://searchwarp.com/swa230219.htm : Manu Goel, keydegree.com
  4. http://www.pr.com/press-release/20974
  5. www.jointcommission.org/sentinel/events/statistics/
  6. http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
  7. http://uscode.house.gov : (41 U.S.C. 51-58)
  8. http://www.phrma.org/safety/
  9. http://www.usdoj.gov/oig/
  10.  “Consumer Reports” as reported in “Product Management Today”, April, 2007.
  11. The Wall Street Journal, 10/21/03.
  12. Datamonitor, 7/1/07.
  13. American Pharmacy, February, 1989.

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