The MSL Society is proud to be recognizing excellence within the MSL profession during our 6th Annual Conference. During the Awards Night Celebration, on September 5th at the Aria Hotel in Las Vegas, we will honor the finalists and as well as the winner of each category.
We will have awards in 6 categories:
MSL of The Year (US)
MSL of The Year (outside the US)
MSL Rookie of The Year (US)
MSL Rookie of The Year (outside the US)
MSL Manager of The Year (US)
MSL Manager of The Year (outside the US)
Join us in the celebration!
Judges
Arthur Chan, PhD, MBA – Executive Director, Head of MSL Capabilities, Novartis
Ralph Rewers, PharmD – US Medical Science Liaison Head, Abbvie
Linda Traylor, PhD – VP, Clinical Development & Medical Affairs, Biodesix
Avery Ince, MD, PhD – US Scientific and Medical Affairs Strategy Lead – Janssen
Davida White, MD – Head Medical Excellence, Indivior
Donna Holder, PharmD – Director, Field Medical Center of Excellence, Merck
First, I think it goes back to how we built the team. We always strive for collaboration and the personal connection when looking at an MSL candidate, if we expect a team to connect with our most influential key opinion leaders, then we would expect that our communication internally in stellar first. With that said, we function as team, but allow MSLs to do what they do best. We have regular team meetings, events, virtual and live. We thrive on the success of our individual team members and our collective efforts which move the whole medical affairs department forward. We stay positive, we solve problems together, and we are accountable to each other.
They know what the expectations will be. There are no surprises, because there are enough curve balls in the field, in the market etc. Here, our team is solid, the bar is set high, but it doesn’t change. That stability allows for success in the role, it allows for less burnout.
Emotional intelligence, relatability—a personal connection. This coupled with scientific rigor, makes for a great combination. It’s important to read cues, to know not only what to say but when to say it, this is something that is key to relationship building.
Practice, but connections within the team itself. You have to manage up, down and sideways, so its practice and more practice. With that said, we also make sure we give the team the tools they need to refine their skills. At our team meetings, we will often bring in some breakouts to help develop these tools.
Copyright 2013-2018 The Medical Science Liaison Society. All rights reserved. The information contained in this article may not be published, broadcast or otherwise distributed without prior written authorization. The MSL Society is a 501(c)(3) Non-Profit Organization dedicated to advancing the global MSL career.
How do you define “KOL” needs?
Defining KOL needs may seem initially and superficially that it may be simple. However, it is multifactorial and more involved than one would initially assume. A facet can be that KOL needs are aspects of their practicing medicine that require them to feel connected to a resource of free flowing, timely and accurate information that helps them gain a deeper understanding or clarification of the product, treatment paradigm is or therapeutic area being addressed, to the end that the HCP can stay on the forefront of medicine and remain well-informed.
How do you ensure strong KOL relationships?
As with any relationship, this needs to be continually developed and can many times be strung on a thin cobweb and be unpredictable. Thus some main qualities surrounding strong KOL relationships can be ensured by always acting as an ethical, comprehensive and timely resource. The MSL should never over or under state importance of data, impinge unnecessarily on a KOLs time or provide false or misleading information.
How do the needs of the KOL needs change according to the leader you are engaging with?
KOL needs, depending on how it is defined for that particular KOL , can be quite fluid. At times, the needs of the KOL can change depending on the institution or practice setting they are operating within (i.e., academic, private practice, or trial site) or the reason the MSL is providing resources to the KOL (i.e., speaker programs, clinical trials, independent research projects or patient counseling).
What skills are required for understanding your KOL?
Overall, the MSL must have a comprehensive understanding of the therapeutic area in which they are interacting to interpret and anticipate the needs of their KOL. In general, the MSL must listen to understand and be receptive to alternative viewpoints. In this regard, the MSL should try to avoid entering into KOL dialogue with a pre-defined agenda.
Copyright 2013-2018 The Medical Science Liaison Society. All rights reserved. The information contained in this article may not be published, broadcast or otherwise distributed without prior written authorization. The MSL Society is a 501(c)(3) Non-Profit Organization dedicated to advancing the global MSL career.
I want to first thank the MSL Society for giving me the opportunity to answer a few regulatory questions. These questions are timely as I just attended a legal round-table in Washington D.C in which we reviewed and discussed a few pharmaceutical and medical device issues surrounding the industry. Of course, the first issue that was presented which directly impacts the MSL is off-label promotion. In regard to change, this topic is changing by gaining more attention in the legal arena. Companies and individuals are consulting outside counsel with more frequency on guidance on the topic of off-label promotion. One change that must be made is to promote awareness and increase “knowledge” on this subject matter. Though the majority of off-label promotion cases have transpired from rather limited causes such as poor communication and inadequate corporate training programs, more than a few categories of off-label marketing complaints were observed during a legal analysis during the round-table event. These included expansions to unapproved diseases, unapproved disease subtypes, and unapproved drug doses.
In recent times, off-label marketing of medical devices and pharmaceuticals has remained a prime focus for government investigation. The issues surrounding off-label promotion are twofold: first, it is an illegal activity that violates federal law; second, it places individual employees and the corporation in jeopardy. Infractions for off-label promotion can include incarceration and heavy fines for individuals and corporations. As a byproduct, off-label communication may also impose ethical dilemmas on innocent bystanders when these types of known communications occur. Because this activity is illegal, any person contemplating reporting such acts may well shoulder a heavy personal and professional burden – they also may confront the thoughts and threats of retaliation. It is indeed imperative that employees know what off-label promotion is, and what the indications for use are in the case of the specific device or drug they are promoting. Training employees to avoid not only engaging in off-label promotion, but also reporting its occurrence to management, is tantamount to taking that first fundamental step towards an effective off-label compliance effort. Reports have indicated that some leaders may not want to bring attention to their own internal practices of labeling, or lack thereof.
Statements relating to off-label promotion occur when discussions drift away from the indication. This is one of the most common issues relating to off-label promotion. Frequently, statements made by MSLs or sales representatives to customers result in off-labeling problems for device or pharmaceutical companies. Additionally, it must be noted that manufacturers can engage in off-label promotion through various other promotional mediums and marketing materials, such as; Web sites, sales brochures, direct-to-consumer advertising, and press releases.
The FDA and other government agencies may also look at and evaluate the following information sources to determine whether off-label promotion has occurred:
Business Practices can also create off-label risk for a company. These practices include:
I have highlighted several internal issues that can be faced relating to off-labeling. I will add that external issues can also pose threats as well. One such example surrounds questions posed by physicians. Inquiries from physicians must be unsolicited requests for a company to respond to off-label uses. The response to any such unsolicited inquiry must be balanced—or include information about both the risks and benefits of the off-label use—and be commensurate with the scope of the question. A few companies may direct their MSL to answer the question with the aforementioned in mind. The answer would also be directed to the one who is asking the question. Any inquiry must genuinely originate with the physician in order for the company to respond legally, as this is from the guidance document. Companies should implement compliance strategies aimed at preventing off-label activities that could lead to heavy fines and worse.
Yes, I would first like to bring to your attention that the first drafted guidelines will be released at the MSL Conference in Las Vegas. We have formatted a notice and comment section that resembles a legislative framework that led to the final draft. While there are off-label regulations and codes of practice in all countries, there are no black and white interpretations for MSLs. The drafted guidelines can be a reference and used by companies in a multitude of ways. The drafted guidelines set the stage to assist the MSL – it can be seen as the algorithm that may be followed by the MSL. We hope to see you in Las Vegas and join us on the release of the MSL guidelines. A special thank you to those who assisted in the construction and body of the drafted guidelines.
This information is for educational purposes only and should not be construed as legal advice or a legal opinion from the author. This information is my own opinion and not that of past or present employers.
Copyright 2013-2018 The Medical Science Liaison Society. All rights reserved. The information contained in this article may not be published, broadcast or otherwise distributed without prior written authorization. The MSL Society is a 501(c)(3) Non-Profit Organization dedicated to advancing the global MSL career.
The biggest challenge, before I even hired the MSLs, was to learn what previous experience internal colleagues had with MSLs (if any) and what expectations existed regarding the role of the MSL. Educating internal partners about the role of the MSL and level-setting expectations (as well as development of compliance guidelines and SOPs, etc,) was the focus of my work for the first 5-6 months.
There are the usual necessary training activities with any MSL group such as disease state and product-specific education/training. Development of a new MSL group requires some additional training related to corporate culture, and the interaction of the MSLs with our internal colleagues. In addition, guidelines and policies regarding interactions with KOLs need to be clearly communicated.
Building a new team allows one to create the culture for the MSL group from the very start. We were able to create a non-competitive culture of trust, collaboration and a focus on common goals by being very clear in the interviewing process about the environment we intended to create. I hired field managers who shared my vision for the team, and together we hired MSLs with that vision in mind. Having taken over management of an existing team in the past, I realize that is an opportunity you don’t always have.
Whether hiring a new MSL for an existing team or building an entirely new team, it is important to hire carefully, first of all. After that, I think it is important to convey to the new person that you have confidence in their ability to do the job, to make your expectations for training and execution in the field clear, and establish a line of communication so that the MSL feels that they can call with questions or clarification. I think it is also important to provide a mentor to the new MSL from the existing team. Beyond that, I try my best to provide what they need and get out of their way.
Good MSLs are uncovering and hearing KOL insights constantly in the field. A single 1-hour discussion with a KOL can uncover real-world insights on product development paths and timing, on clinical trial conduct and protocol development and product marketing ideas as well as competitive intelligence. If those insights are communicated in a timely fashion, they can be used by our internal colleagues in clinical development, marketing etc. to make informed decisions. Too often KOL insights get left in the field, while internal colleagues are making decisions based on incomplete or inaccurate information. That is a shame, in my opinion.
Over the years I have worked with MSLs and field managers to develop methods of getting KOL insights to internal colleagues quickly and accurately. The methods are not perfect, but they get the job done. We use two different methods: one for KOL field insights and one for communications with our clinical trial sites. Both involve the use of shared documents software, such as Sharepoint. Field KOL insights are logged on a shared document continuously and compiled and sent to internal colleagues monthly. Occasionally insights are particularly time-sensitive and are communicated immediately. For insights from our clinical trial sites, we have developed a continuous feedback loop between the MSL, the company’s Clinical Project Manager and the Clinical Research Organizations Project Manager. Insights gained from the clinical trial sites are logged on a shared document and are shared continuously with the project managers. Weekly calls involving a representative from the MSL team with the project managers insures proper follow-up and issue resolution with the study sites.
As we’ve all heard, one of the most important aspects to include when communicating anything is the “So what?”. Whether communicating insights to scientific or non-scientific colleagues, it is important to make clear why this insight is important, if it is not intuitive. What impact might this have on our development program? How does might this impact our marketing plan now and in the future? We also group our KOL insights into topic areas that may be of interest to various internal stakeholders, to save them time and allow them to focus on items of most interest or importance to them.
Copyright 2013-2018 The Medical Science Liaison Society. All rights reserved. The information contained in this article may not be published, broadcast or otherwise distributed without prior written authorization. The MSL Society is a 501(c)(3) Non-Profit Organization dedicated to advancing the global MSL career.
