Medical Science Liaison (MSL): Understanding, Engaging and Interacting. Gill Logan Regional Medical Affairs Manager Takeda UK

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1 Medical Science Liaison (MSL): Understanding, Engaging and Interacting Gill Logan Regional Medical Affairs Manager Takeda UK Date of upload, October 2011

2 Disclosures Takeda UK employee Member of the MSLA Committee

3 The emerging MSL role in pharma Though still small, the number of MSLs has increased steadily, totalling 1,970 in 2008, up 48% from 1,335 in 2003, according to data for 12 major pharmaceutical and biotech companies. Research shows an average increase of 76 percent of MSL team sizes since Wall Street Journal Cutting Edge Information

4 The next 45 mins Understanding Who? What? A day in the life Engaging Comparison of roles Understanding challenges Tips for working with MSLs Interacting Case Study The Takeda UK experience

5 Understanding

6 What s in a name? Medical Science Liaison universally understood terminology LOTS of other titles Medical Liaison Manager Regional Medical Advisor Medical Science Managers Clinical Science Liaisons Regional Scientific Managers Any others? Range from fully field based through to hybrid office based roles with field responsibilities

7 Have you: Q..? Ever heard of the MSL role? Ever worked at the same company as an MSL team? Ever interacted with an MSL team? Ever been part of an MSL team?

8 MSLs are a field-based medical/scientific expert whose mission is to foster collaborative relationships with opinion leaders and to facilitate the exchange of unbiased scientific information between the medical community and the company 1 catalysts of collaboration between pharmaceutical companies and opinion leaders. MSLs are essential conduits to the quality and success of transmission of timely information, research resources, and business intelligence. All role descriptions for MSLs are non-promotional most commonly reporting to medical (or clinical)- MSLs are not super-reps and do not replace need for sales teams for marketed brands 1. Albert E et al. The Medical Science Liaison: An A to Z Guide, Jane Chin. The MSL Institute:

9 Typical background of an MSL Physician, Pharmacist, PhD, Nurse Practitioner, other HCP, Science Degree Experience in the relevant therapy area Pharma, clinical or science Previous Industry Experience Previous MSL role Medical Information or Medical Affairs Clinical Other? Direct from academia or NHS Experience working with KOLs and HCPs at all levels Clinical trials experience and good understand of trial design

10 Skills Required Self starter Strong communication skills Ability to engage with highly technical scientific audiences Therapeutic area expertise Ability to train/teach Ability to learn at a rapid rate Ability to travel (>50% in some cases) Ability to collaborate, persuade and motivate Excellent working knowledge of ABPI Code Good I.T skills Ability to network and matrix manage

11 What do they do? Core MSL Activities Scientific Exchange with Opinion Leaders/HCPs Coverage at Scientific and Medical Congress Support Central and investigator led research Medical support to Internal Partners

12 Scientific Exchange

13 Responding to unsolicited requests for information... Enquiries can be submitted to the MSL team: Via medical information Via sales representatives Direct to the MSL during interactions Genuinely unsolicited and HCP should have specifically requested or agreed to a face to face interaction Commonly received requests Overview of clinical evidence supporting product (formulary) Comparative evidence with competitors Congress Updates New data Molecules in development Off label/ unlicensed information Resources and materials (e.g. slidesets) developed to respond to requests

14 Value of MSL Opinion Leader (OL) Interactions Building company advocacy Collating OL feedback and insights in line with company product strategy to inform brand plans and communications Input into Product Lifecycle Plans through feedback to central medical teams including Phase IIIb and Phase 4 study designs and initiatives Identification of potential speakers, authors, investigator sites Speaker briefings for corporate symposia or local med ed meetings Facilitation of joint working and mutually beneficial collaborative projects Cross Functional Working and Two Way communication with Brand/Product Planning and MSL team is key to successful Opinion Leader working

15 Key Congress Activities

16 Key Congress Activities Support internal briefings to highlight key sessions and key topics of interest Attend relevant scientific sessions (therapy, products, pipeline and competitor) Give context on scientific data by providing feedback from OL and HCP interactions Collate reports on sessions/posters/orals and competitor activity for wider organisation Conduct external round table discussion meetings or advisory boards with OL s attending conference Supporting Medical Affairs Booths

17 Supporting Central and Investigator led research

18 Supporting Research Arguably most evolving aspect of the MSL role currently Identification of sites for central research programmes Liaison with investigators Establishing company contact from early in development versus CRO alone Facilitation of OL input into life cycle plans and supplementary clinical trials Management of investigator sponsored research proposals and processes

19 Support to Internal Partners

20 Support to internal partners Sales Medical Information Marketing Market Access Clinical

21 9am A day (or 3) in the life (example) Tuesday Wednesday Thursday MSL Team TC and Journal Club Travel to head office 10am Medical Team Meeting OL 1:1 regarding recent safety issue 11am 12pm 1:1 investigator meeting ISR proposal discussion with HCP 1pm Hospital presentation (unsolicited request) 2pm Formulary review Conference Planning Meeting (Brand Team) 3pm 4pm 5pm Preparation for Thu appointment with OL (TC with MIPV to discuss above) Travel Home Sales Training

22 Q? Are there other activities I have not mentioned that your MSLs are involved with at your companies? Are there any activities I have mentioned that your MSLs do not carry out?

23 Engaging

24 Comparison of MSL and Med Info Role Activity MSL Medical Info Respond to unsolicited requests for med info (in the field) ( ) Provide medical and scientific support to internal teams Provide insights on topics of interest based on HCP enquiries and interactions to drive standard letter and resource development Input into development and approval of salesforce materials and briefs Conduct literature searches and write standard medical information response letters based on unsolicited enquiries Identify and interact with opinion leaders (OL s) and HCPs on a regular basis, developing long-term peer to peer relationships - Support with identification and liaison of potential and existing clinical trial sites - Facilitate Investigator Sponsored Research requests - Provide relevant medical education to HCPs in line with regional medical plans -

25 Comparison of MSL and Med Info Role Activity MSL Medical Info Respond to unsolicited requests for med info (in the field) ( ) Provide medical and scientific support to internal teams Provide insights on topics of interest based on HCP enquiries and interactions to drive standard letter and resource development Input into development and approval of salesforce materials and briefs Conduct literature searches and write standard medical information response letters based on unsolicited enquiries Identify and interact with opinion leaders (OL s) and HCPs on a regular basis, developing long-term peer to peer relationships - Support with identification and liaison of potential and existing clinical trial sites - Facilitate Investigator Sponsored Research requests - Provide relevant medical education to HCPs in line with regional medical plans -

26 Q? Is this overlap similar in your companies (where you have MSL-type roles?) Any other activities that overlap not mentioned?

27 Challenges of the MSL role 1. Keeping up to date with latest scientific information and trends! REMEMBER: MSLs are not restricted to information access like sales, as long as used in the correct, non-promotional manner MSL-HCP interactions are often highly topical and current, and may relate to current environment or future changes rather than product specific 2. Having time to conduct desk work as always on the move Getting from A to B and dealing with travel is a challenge Leaves limited time for desk work and trawling for information 3. Working remotely Limited time in the office can mean out of sight out of mind May miss out on important communications or briefs 4. Compliance and AE reporting MSL working often grey area as reasonably new role Knowledge of AE reporting processes is extremely important

28 MSL and Med Info Working in partnership Keeping up to date Time for desk work Working remotely Compliance and AE reporting Joint training plans Share info on common requests Consider MSL colleagues (visibility) ABPI Updates and current trends Current awareness and journal clubs Identify joint needs and resources Shared information Knowledge of AE reporting processes Alerts and useful websites Literature searches (Med Info are the experts!) Joint approach to medical info services

29 Interacting

30 Case Study Takeda UK Team and process alignment Awareness Shared Resources

31 Medical Department Takeda UK Regional Medical Affairs Manager UK RMA Team UK Medical Director Medical Managers and Advisors UK General Manager MIPV Manager MIPV Team NHS and Regulatory Affairs Director Compliance Department Market Access *Regional Medical Advisor is the Takeda UK terminology for MSL

32 Team and Process Alignment Team One MSL team member aligned to the MIPV team Attends regular (usually monthly) MIPV meetings Acts as the liaison between the MSL and MIPV team Share information, activities, priorities and discuss hot topics MIPV invited to MSL clinical discussions Processes All Medical Information processes are consistent across MIPV and MSL team- reflected in all relevant SOPs and guidance documents ALL MSL team enquiries are submitted to MIPV with documented evidence of request (MIRF or ) and recorded in the Medical Information database MIPV have triage system in place MIPV- Medical Information/ Pharmacovigilance MIRF- Medical Information Request Form

33 Joint Approach to Awareness Medical Information Services Brochure Contact Info on sales briefs

34 Shared Resources Through team alignment can identify and share info on hot topics and resources required Standard letters and Core Response Documents MSL internal training and understanding Support for developing slide resources e.g. ensuring all relevant data included Slide resources Usually for MSL use with external HCPs, with medical information support with development Resource library Shared document where MSL and MIPV can view which resources are available for each product, topics and current approval status

35 Case Study Takeda UK Team and process alignment Joint working and initiatives and optimise Awareness services and increase value to company Shared Resources

36 Conclusion MSLs are a reasonably recent addition to the pharma industry and growing in numbers over time The role is highly varied, but the core activities of the MSL are: Scientific exchange with HCPs and OL s Research support Conference coverage Medical support to internal partners Although distinct roles, the MSL and MI teams share similar responsibilities and activities The MSL and MI teams can work effectively together to optimise services and increase value to the company

37 MSLA Vision MSL Association (MSLA) To provide a common platform in the UK & ROI to drive compliance, value, credibility & sustainability of the MSL role Mission 1. To define & leverage standards of practice to ensure compliance and drive credibility 2. To demonstrate & grow the value of the MSL role within industry and with external stakeholders 3. A cross company common platform to share & drive best practice

38 You re not an MSL unless you have Been on a plane, train and car all in one day Arrived at your appointment at a hospital only to realise the consultant is at the satellite hospital which is the other side of town! Explained the difference between what a MSL does versus a drug rep one million times Had a company computer melt down right before a critical presentation Had to explain to an investigator (tactfully) why the company did not see value in their research proposal Explained to your family exactly what you do, repeatedly!!

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