Building Strong Cross functional Medical Affairs Teams A FirstWord Dossier ExpertViews Report

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1 Building Strong Cross functional A FirstWord Dossier ExpertViews Report

2 Published Copyright 2015 Doctor s Guide Publishing Limited All rights reserved. No part of this publication may be reproduced or used in any form or by any means graphic, electronic or mechanical, including photocopying, recording, taping or storage in information retrieval systems without the express permission of the publisher. This report contains information from numerous sources that Doctor s Guide Publishing Limited believes to be reliable but for which accuracy cannot be guaranteed. Doctor s Guide Publishing Limited does not accept responsibility for any loss incurred by any person who acts or who fails to act as a result of information published in this document. Any views and opinions expressed by third parties and reproduced in this document are not necessarily the views and opinions of Doctor s Guide Publishing Limited. Any views and opinions expressed by individuals and reproduced in this document are not necessarily the views and opinions of their employers. Cover image: everythingpossible - Fotolia.com

3 Contents Executive summary... 1 Methodology and objectives...2 Contributors...3 Medical affairs structure and organisation...4 Case study: Medical affairs structure and organisation at Company A...6 Therapeutic areas and strategic medical operations... 7 An integrated structure...9 Case study: The changing structure of medical affairs at Company B...10 Changes to the field medical teams...10 Geographic medical affairs organisation Franchise-based medical affairs structure...13 Cross-functional responsibilities...14 Operational support from global business services...15 Case study: Medical affairs structure and organisation at Company C...16 Case study: US medical affairs team structure and organisation at Company D...18 Case study: A vision for medical affairs in a small company...20 The diversity of medical affairs functions...24 Communication and education...25 Medical information Engaging external medical experts Health economics and outcomes research...29 Data generation and dissemination post-approval...32 i

4 Building strong cross-functional teams...34 Case study: Cross-functional development of an integrated strategy for each molecule...36 Medical affairs has a key role in cross-functional strategy teams...36 Medical affairs involvement on R&D project teams Case study: Strategic involvement of medical affairs from proof of concept...39 Early involvement as part of a therapeutic area cross-functional team...39 Medical affairs involvement increases once clinical studies begin...40 Cross-functional team dynamics change but key members remain Effective communication is vital within a cross-functional team Case study: Increased participation in cross-functional teams from Phase II to Phase III Strategic planning from Phase II...43 Medical affairs involvement increases from Phase III...44 The level of involvement of teams changes through the lifecycle...45 Regular interaction with sales & marketing is important...45 Sharing a physical location is helpful...46 Case study: Field medical affairs is less involved from pre-launch to Phase IV The field medical team has limited involvement pre-launch Cross-functional interaction is limited to three or four meetings per year Field medical involvement increases from Phase IV...48 Information flow and the importance of the internal firewall...49 ii

5 Challenges for medical affairs and the main drivers for change...52 Internal challenges in a cross-functional team environment...52 Increasingly complex external demands...55 The rising importance of payers...56 Transparency Compliance...58 Better disease understanding...59 Smarter use of digital technology for data storage and communication...59 Key Findings...62 iii

6 Executive summary The healthcare environment is constantly changing and pharmaceutical companies are being forced to adapt to an increasingly regulated climate where stakeholders demand value. Evolving as a direct result of changing market conditions, medical affairs departments are now uniquely positioned to provide cross-functional teams with valuable scientific and market knowledge at every stage of a product lifecycle. In a fiercely competitive marketplace where blockbusters are few and far between and R&D costs are rising, it is more important than ever for pharmaceutical companies to develop the right medicines. As such, companies are becoming more focused on their core strengths and organising their business units around key therapeutic areas. Within this overall strategy, medical affairs teams are increasingly being organised by therapy area or franchise, with alignment from global to country level. Taking this a stage further, some companies are moving operational and administrative duties out of these therapy teams and into specialist support units, enabling therapy teams to retain strategic focus. In order to effectively tackle challenges such as how best to address unmet medical need and which products should be developed, cross-functional collaboration is being fostered between R&D, medical affairs, regulatory, health economics and outcomes research (HEOR) and market access, and sales and marketing teams, typically by therapy area. In this new working environment, it is clear that input from medical affairs is becoming more valued at a strategic level earlier in the product development process. In some companies this input is sought as early as the proof of concept stage, although for most there is still greater involvement from Phase III and beyond. The structure and organisation of medical affairs and how this is changing to align with corporate needs varies between individual companies and is illustrated through case studies. A discussion of cross-functional collaboration follows, from the perspective of medical affairs professionals, as well as some of the challenges faced by medical affairs teams and the drivers for change in an increasingly complex operating environment. 1

7 Methodology and objectives This FirstWord Dossier ExpertViews report provides insights into the evolving structure and organisation of medical affairs teams as internal partners and key participants in cross-functional teams. The information for this report was gathered from multiple sources, including primary research from in-depth telephone interviews with senior medical affairs professionals from within the pharmaceutical industry, and supported by secondary research, mainly from publically available sources of information. Research objectives: To understand the structure and organisation of medical affairs teams, particularly at the global level; To understand the diversity of functions within the medical affairs team, with a particular focus on the strategic functions at the global medical affairs level; To understand which other teams the medical affairs team interacts with on a regular basis, including research and development (R&D), market access and sales & marketing, either as part of a specific cross-functional team or a less formalised partnership; To understand at what stage medical affairs strategic involvement in a project begins and which teams are involved at various stages during the lifecycle of a product; To gain insight into the flow of information between teams and how this is monitored; To gain insight into some of the challenges faced by medical affairs teams, both internally and in response to wider changes in the healthcare environment. 2

8 Contributors The contributors were selected on the basis of their knowledge, experience and expertise in medical affairs. Interviews were conducted with the following individuals from a cross-section of large, medium and small pharmaceutical companies: Head of Regional Medical Affairs Vice President, US Medical Affairs Associate Director, Field Medical Affairs Executive Medical Director, Medical Affairs Franchise Head, Medical Communications Global Medical Affairs Director Vice President of Medical and Scientific Affairs Head of Strategic Global Medical Affairs Operations 3

9 Medical affairs structure and organisation Historically, medical affairs emerged in response to increasing internal and external pressure to split the medical and commercial functions within pharmaceutical companies. Internally, R&D departments were asked to focus on generating and developing new products rather than managing products post-approval. At the same time, increasing regulatory pressures have pushed a number of activities to medical affairs that were formerly undertaken by sales and marketing. 1 The challenge for medical affairs today is evolution from a fairly undefined catch-all department into a cohesive team that plays a vital role in data generation and the communication of accurate and timely scientific information to internal and external stakeholders, and then to educate stakeholders on the value of those data. 2 It is, therefore, unsurprising that the structure and organisation of medical affairs departments differs between companies, and different terminologies may be used for what are essentially similar functions. All pharmaceutical companies work differently. Companies use different terminologies for the same things, so visualising this and digesting it is difficult. Global Medical Affairs Director In some companies, medical affairs is structured as a standalone function, while in others it forms part of the research and development (R&D) organisation. Large companies tend to have a number of teams within the medical affairs organisation, such as global, regional and country level teams, with different operational functions. Whereas the global team tends to operate at the strategic level, the country team is likely to include the medical science liaisons (MSLs) that work on the ground, directly interacting with physicians on a more regular basis. In this scenario, the global team will typically provide support and training to the country teams, ensuring a consistent message throughout the company. 1 Crowley-Nowick, P and Smith, J. (April 2013). The Role of Medical Affairs in Moving from R&D to Commercialization. Retrieved from 2 FirstWord (August 2014). Reshaping Medical Affairs: delivering value to KOLs and payers. Retrieved from 4

10 If you look at companies across the globe, in some, medical affairs reports into R&D, in others it s separate from R&D, but both report into the Chief Medical Officer. I think that, in general, companies are moving towards ensuring that their medical teams, whether they be medical affairs or research and development, are reporting into the scientific side of the company and not the commercial side. Head of Regional Medical Affairs At Bristol-Myers Squibb (BMS) for example, Global Development and Medical Affairs (GDMA) forms part of the overall R&D organisation. The company states that the GDMA organisation develops innovative medicines and communicates the value of these medicines to society, as well as providing information of their safe and appropriate use. GDMA is seen to play a critical role in the R&D process by understanding unmet medical needs and developing a clinical development programme that generates high quality data to support product approval, the product label and economic value discussions. This process allows BMS to focus on the compounds that will potentially provide the most value to patients. 3 In order to show the diversity and similarities in the structure of medical affairs teams, this section of the report is organised into case studies focusing on how medical affairs is currently structured in three different companies, as well as a vision for the future of medical affairs in a transforming clinical development company where the medical affairs function is evolving as the company moves towards commercialisation of its first product. 3 Bristol-Myers Squibb (2015). Global Development and Medical Affairs. Retrieved from 5

11 Case study: Medical affairs structure and organisation at Company A Medical affairs at Company A is organised both geographically and by therapy area. The way we operate here is that we have global medical affairs, regional medical affairs, clusters medical affairs and country medical affairs. These are all based on the strategic areas and they re all aligned in the reporting structure, so country reports to the cluster, cluster reports to the region, region reports to the global. That s by therapeutic area, [for example] immunology, oncology, haematology. The therapeutic areas have strong alignments and a strong connection from the global level all the way down to the country. Figure 1: Company A Geographic Medical Affairs Reporting Structure Head of Strategic Global Medical Affairs Operations Global Medical Affairs Regional Medical Affairs Cluster Medical Affairs Cluster Medical Affairs Country Medical Affairs Country Medical Affairs Source: FirstWord research Across the organisation, there are around 300 people working in medical affairs. The size of the various teams within the overall organisation varies significantly, however, depending on the therapy area and the lifecycle stage of the product on which they are working. 6

12 Your flagship products or therapeutic areas tend to have a lot more people, so it varies quite a bit. It could range from a product that is being launched two years from now that may only have 10 people [working] on it, to a product on the market in a key therapeutic area that may have 80 people on it. Head of Strategic Global Medical Affairs Operations Therapeutic areas and strategic medical operations Put simply, the medical affairs organisation at Company A is split into therapeutic areas and strategic medical operations, which provides operational support. Each therapeutic area has medical directors, therapeutic directors and therapeutic managers. Under strategic medical operations, there are a number of centres of excellence (COEs), including: Medical communications; Medical information; Advertising and promotional review, known is some companies as medical legal regulatory review (MLR); Project management; Operations development; Medical events and vendor management; Medical strategic planning and launch excellence; Research grants and Independent Medical Education (IME); Budget and contracts. These COEs partner with each of the therapeutic areas across the organisation. You can almost look at this [strategic medical operations] as the foundation of our organisation. These resources [COEs, such as] ad/prom [advertising/ promotion] or events or strategic planning and launch excellence or contracts, or budgets, are shared across the therapeutic areas. Head of Strategic Global Medical Affairs Operations 7

13 The reason for this organisational structure is that the company wanted scientists to focus on therapeutic franchise areas, brand strategy and interactions with healthcare providers, rather than on operational activities. In addition, there are other groups within medical affairs, including benefit risk management, global field medical team management, and knowledge management and literature services. All of these are defined as shared services as they partner and collaborate with the therapeutic franchise areas. Figure 2: Company A Strategic Medical Operations areas Therapeutic Medical communications Budgets & contracts areas areas Therapeutic Therapeutic Medical strategic planning & launch excellence Operations development Medical events & vendor management Centres of Excellence Research grants & independent medical education Project management Medical information, knowledge management, & literature services Advertising & promotional review* Therapeutic Therapeutic areas Therapeutic areas *Also known as medical legal review (MLR) Source: FirstWord research The main aim of this central operational support group is to provide services to enable personnel in the therapeutic areas to operate more effectively. In terms of numbers, operational support is ideally outnumbered by around two-to-one in favour of the therapeutic area teams. 8

14 Another way of looking at the operations and therapeutic area is that the therapeutic area is customer facing, while operations is more back office. We are very conscious of making sure that we have more people in our front office than our back office. You don t want to have an excellent back office where the operation is fantastic, but you don t have enough people to actually meet with your customers, educate, [work on] advisory boards, symposia, etc. Our ideal proportion is 60 to 70 percent in the therapeutic area, 30 to 40 percent in the back office. An integrated structure Head of Strategic Global Medical Affairs Operations So how do they all work together? The therapeutic area team defines the medical strategy and medical objectives. Depending on these, a lot of the execution will fall to the specialities within the strategic medical operations group. For example, if the therapeutic area decides to have symposia at a medical conference, or run advisory boards, the team will work with the relevant COE. If they want to run events, the medical events team will be involved, taking on the logistics. When it comes to budgeting, the budget team will advise on prioritising the funds available to the therapeutic area. Each COE is involved in partnering the therapeutic areas depending on their needs at a given time. It s a very integrated and intertwined structure. For example, the TA [therapeutic area] decides they want to have symposia at a medical conference. The medical communication team are the experts in putting up symposia in conferences so they partner with the TAs and start building on, what s the objective of the conference? What do we want to accomplish? What are the unmet needs that we need to educate the physicians on? What s the purpose of this objective? They decide what the agenda should be based on the overall objectives, who should be the chair, who should be the speaker. That s one example of collaboration. It could be similar with advisory boards. If you want to do advisory boards then medical communications gets involved with that. If it is related to advertising, promotional review (or medical legal review) would get involved with the review of the materials - maybe it is for the launch, maybe it has to do with existing products, maybe the contents are changing and the [strategic] team gets involved. Head of Strategic Global Medical Affairs Operations 9

15 Case study: The changing structure of medical affairs at Company B Since the end of 2013, Company B has engaged in a series of transactions to focus on a small number of core business segments, one of which is innovative pharmaceuticals. To this end, the company has recently completed a number of strategic acquisitions and divestitures. Within this transforming company, the medical affairs structure has evolved over the last several years into a standalone function that sits between R&D and commercial. At the same time, the global medical affairs structure has become more focused on specific franchises, where previously it provided a more general supporting role to all of the different franchises. About seven or eight years ago, medical affairs was basically a sub-function of development [R&D], responsible for clinical development and medical affairs (CDMA). Within that function, we had global scientific operations, which was setting up and leading the MSL organisation. It was new at that time; it came over from the US, was implemented in Europe, and the global scientific operations unit grew quickly with more MSLs being allocated to functions like medical affairs. Changes to the field medical teams Global Medical Affairs Director As it became clear that the global scientific operations function was unable to fulfil the demands from senior management, a decision was taken to focus the MSL organisation more on capabilities and skills. A new organisation was put in place, called Field Medical Excellence. As a result of the change in structure, the responsibility for scientific operations and for the MSLs was placed with the global medical affairs teams. Under the new organisation, the reporting structure for MSLs has moved towards therapy area franchises and matrix management, although this change is not without its limitations. Enhancing capabilities is very important. There is a focus on capability building for MSLs, [such as] how can we ensure that they become more effective, more 10

16 knowledgeable and how can we ensure they have the right tools? The other area is capability-building in global [medical affairs], explaining what the MSL role is and how it works in a country pharmaceutical organisation. Geographic medical affairs organisation Global Medical Affairs Director Geographically, the global medical affairs team is split approximately 70:30 between the company s European headquarters and international sites, mainly the US. In addition, each country pharmaceutical organisation has it own medical team, which may run local clinical or real world studies. The country pharmaceutical organisation is also where the medical science liaison (MSL) force for each country is based. In general, probably 70 percent of global people [at Company B] are based in Europe, at headquarters. But I would say of the other 30 percent, probably 25 percent of them are based in the US [at a site that] is not a global site, [but] it s a US headquarters and a large number of the people at that site have global positions. That s probably true for many companies that have European global headquarters, that they still have a lot of global people based in the US headquarters as well. Executive Medical Director, Medical Affairs The global [medical affairs] team is spread out: basically, we are divided between Europe and the US, but each local country organisation has its own medical team that may run local studies for medical affairs within the country. Franchise Head, Medical Communications While global and country teams are essentially organised separately, the global medical affairs team interacts with MSLs, providing standard training materials and non-product related skills training. The global team may provide product specific training, therapy area training as well as functional skills, non-product related training, people skills training; anything from presentation skills, understanding the compliance regulations around MSL interactions with healthcare providers [to] soft skills training; things 11

17 that are general in nature and not necessarily related to a specific product. [For example] things like Sunshine [the Physician Payments Sunshine Act] and the equivalent for Europe, the EFPIA regulations; the implications of those types of things that are relevant to everybody, but not related to a product are the types of things that we would get involved with. Franchise Head, Medical Communications Figure 3: Geographic Medical Affairs Organisation at Company B Global Medical Affairs Regional Medical Affairs Country Medical Teams Medical Directors MSLs Medical Communications Medical Information Provision of content-specific, therapy area and skills training Source: FirstWord research 12

18 Franchise-based medical affairs structure The global medical affairs organisation covers all of the franchises, each of which has a Franchise Medical Head reporting to the Head of Global Medical Affairs. Medical affairs functions, such as medical communications and brand medical directors, work within franchise teams. Within medical affairs, there is also an overall head of medical information, and each medical affairs team has a medical information person. Likewise, each team will work with someone from the health economics group. While these functions have separate responsibilities, they work closely together within a cross-functional team. Within the organisational structure, franchise functions are directly related to supported products. Non-franchise functions, such as operations and compliance, also fall under medical affairs. Overall, around people are involved in medical affairs at Company B. Figure 4: Global Medical Affairs Reporting Structure at Company B Global Head of Medical Affairs Franchise Medical Head* Health Economics Team Medical Information Global Brand Medical Directors Franchise Head of Communications Non-franchise functions that also fall under medical affairs: Global Medical Affairs Directors Communication Leaders (brand specific) Operations Compliance * There is a Medical Head for each of five franchises. Source: FirstWord research 13

19 Global medical affairs is a single function, but we have franchise teams within the overall global function. I have the medical communications team for [a particular] franchise. We have medical information, and that is a separate group, although we work very closely with them. Within a given franchise or team we are a very cross-functional group; we don t work in isolation from each other. [For example] the medical information group would work very closely with the medical communications group as well as the medical directors in terms of developing content, checking and verifying content within guidance documents, or in answer to a medical query. So where the med info group may be accountable and responsible for ultimately providing it [the content], in terms of the actual doing it and putting it together, it very often could be a cross functional team with multiple stakeholders involved. Franchise Head, Medical Communications In the respiratory franchise, for example, there are three disease areas: asthma, chronic obstructive pulmonary disorder (COPD) and cystic fibrosis. Within this franchise, a number of global brand medical directors cover the major products and these all report to the medical franchise head. Cross-functional responsibilities While the franchise teams have a vertical reporting structure, team members also work in cross-functional teams where they have functional responsibility to the team leaders. There are both brand specific cross-functional teams and teams that have wider engagement across brands. We have cross-functional teams within medical affairs where the members of the team do not directly report to the team leader, but [they] have functional responsibility to them. Within a brand team, we would have regional medical directors and team members from medical communications, health economics and market access. They have their own reporting structure to their own management but also, for the team, they report into [the team leaders]. We also work in conjunction with other medical affairs teams. For example, we work closely on initiatives across the respiratory franchise, with our asthma and our CF [cystic fibrosis] colleagues. So for example, we re doing a series of independent 14

20 CME [continuing medical education] events that are going to be focused on both severe asthma and COPD. So for a project like that, we ll work with the [respiratory product] team to identify the right steering committee to set that up. Operational support from global business services Executive Medical Director, Medical Affairs Various operational functions that used to be part of the global medical affairs organisation and were outsourced to agencies have now been brought in-house to a team that provides global business services. This allows the medical affairs team to focus on its strategic role, while the global business services team takes care of the administrative tasks. Congress is a good example. We would select global speakers for a symposium, we would do the speaker briefing, and then global business services ensures that the contracts are in place, that potential slide support is done and arranges for everybody to attend on the same days. Global Medical Affairs Director 15

21 Case study: Medical affairs structure and organisation at Company C The medical affairs structure at Company C is both complex and in transition, which has resulted in different regions and countries being at different stages of this process. For some country-level medical affairs personnel, a legacy dual reporting structure remains. Our global medical affairs, medical affairs within the western hemisphere and Asia, as well as the regional offices throughout Asia and Europe, are all one organisation that reports into a single head of medical affairs, who then reports to the Chief Medical Officer. At the country level in Europe and Asia, medical affairs still has a dual reporting relationship to both the general manager of that country, as well as their respective regional medical affairs headquarters. Head of Regional Medical Affairs Figure 5: Geographic Medical Affairs Reporting Structure at Company C Chief Medical Officer Head of Medical Affairs Head of R&D Regional Medical Affairs Country Medical Affairs Source: FirstWord research 16

22 In terms of employees, Company C has around 1,800 people working in medical affairs worldwide, although staffing varies significantly between regions, depending on the tasks undertaken internally and those that are outsourced. From a data generation standpoint in this region [the Americas] we rely on CROs [contract research organisations] to do a lot of our clinical operations work with our close management of the CRO, while in Europe this is managed by an internal clinical operations team. Head of Regional Medical Affairs Within medical affairs at Company C, senior roles, such as medical directors and scientists, are generally undertaken by physicians, while health economics and health outcomes (HEOR) scientists may be either physicians or have specialist HEOR qualifications. These are supported by various functions, both in-house and in the field. The best way to define it is, we have medical directors/scientists who are largely physicians. We have the health economics and health outcome scientists, some of whom are physicians and others who have an advanced degree in health economics and outcomes research. We then have the back office operational support, i.e., project managers, administrative assistants and those sorts of roles. We have in-house clinical project managers and data managers, and then outside of the main office we have our medical science liaisons [MSLs]. We have both clinical MSLs and we have health outcomes, health economics field based MSLs. Of the total organisation, they make up about percent. Also in house, we have our medical communications scientists and people who staff the call centre to answer unsolicited questions, or who work with physicians to write medical letters in response to unsolicited questions, etc. Head of Regional Medical Affairs 17

23 Case study: US medical affairs team structure and organisation at Company D In Company D, there is a global medical affairs team based at its headquarters in Europe, with country-based medical affairs teams affiliated to it. The teams are set up by brand, with supporting functions covering the whole franchise. The US medical team mirrors the global team and has around 55 people, including the MSLs. Each affiliate [country] has its own medical affairs function. The US, being the biggest, has a more significant team in medical affairs. The reporting structure has dotted lines to a global medical affairs function because they set the medical platforms and ensure consistency. We re set up by brand, so there is a global medical director for one brand and there is a global medical director for another brand. Support functions are set up differently. For example, medcom [medical communications and publications] is not by brand; it is covering the entire franchise. [Within] the franchise, we have several medicines covering different pathways. Then there are other molecules that are helping other pathways. So if we have to do some medical education, it s really at the franchise level, the disease state level. Vice President, US Medical Affairs Within the medical affairs team, there are various operational functions that cover the franchise. You have medical communication [and] medical education, which includes CME [continuing medical education] and speaker training [as well as] advisory board. Then you have the clinical operation function. There s somebody responsible for HEOR - they sit in medical - and then the field-based medical group. Vice President, US Medical Affairs 18

24 Figure 6: Company D Medical Affairs Reporting Structure Global Medical Affairs Brand Medical Directors Operational functions cover the whole franchise Medical communications HEOR Medical education Field-based medical group Source: FirstWord research The medical affairs team is strategically involved in a brand throughout its lifecycle and has a key role in the cross-functional brand teams and the lifecycle teams. The medical affairs director is one of the brand team directors [alongside] the brand director for marketing and the brand director for market access. This group directs the strategic plan for the company for a particular medicine, so they re directly responsible for the brand throughout its lifecycle. They re responsible for the brand performance. There is a member of my team that sits on the lifecycle team, which is part of the R&D team that is actually working on studies on the ground. So there is a strong connection between medical affairs and the R&D team through the lifecycle team. Strong involvement is really at the Phase III level. On the medical side, I only have one person [who is a] vital representative on the lifecycle team and is the single point of contact for medical and the other functions. Vice President, US Medical Affairs 19

25 Case study: A vision for medical affairs in a small company Company E is essentially transforming from an early-stage development company to a late-stage development company. The company has a lead compound in clinical development and up until recently, medical affairs functions were undertaken as required, but not in an organised way. As the company moves forward to registration-enabling clinical trials, the formation of a new medical and scientific affairs team has been initiated. The intention for the company is that clinical trials will meet the primary endpoints that will enable filing, and a commercial presence will become possible at some point in the future. Because of our broad and aggressive clinical development programme, the company was actually wise in starting a medical affairs team early to support the clinical development functions within the organisation, but also to anticipate building out some of the earlier functions that medical affairs traditionally does, such as medical liaisons, publication strategy, advisory boards, and other kinds of KOL engagement activities and tactics. Vice President of Medical and Scientific Affairs The VP of Medical and Scientific Affairs has been provided with an opportunity to build a new team to formally take on the medical affairs functions as the company moves forward. Among his first initiatives is stakeholder engagement, particularly at the strategic level. The first thing that we re doing is seeking to improve our engagements with the investigators we work with who, in most cases, are also key opinion leaders, to really strengthen this aspect of the company. This, he explains, is because there is currently a lack of awareness of both the company and its lead compound, despite the ongoing clinical trials, so this needs to be broadened within the industry. We re engaging our investigators and other KOLs that aren t collaborators with the company; experts who are in the scientific and therapeutic space but haven t 20

26 worked with us; as a means to try to garner feedback about the company, about the MOA [mode of action] of its scientific assets. Sharing information about what we re doing and seeking to get insights from them in terms of whether our development strategy is viable. The medical affairs team is expected to grow rapidly in the coming months, from what was effectively a team of one with one inherited employee. It s a work-in-progress, but the initial thrust of my growth will be field-based medical science liaisons and also to develop and orchestrate a comprehensive publication plan for our compound. I will then develop one of the team members into leading our scientific partnerships initiative. This role is more a strategic role around institutional engagements. One of the key differences in a small company versus a large company is that people are typically more involved in a cross-functional way, simply because they wear a lot of hats. The VP of Medical and Scientific Affairs explains that some of the work undertaken by his department would probably not be classified as a traditional medical affairs function. Our attention is essentially 100 percent on the lead compound and its four registration-directed studies that s going to make or break the company. There are other compounds that are percolating through the pipeline that are coming up through preclinical, [but] our role with those will be limited. As such, he explains, the medical liaisons hired under the new team will be expected to be flexible and cover all aspects of the compound. They could be interfacing with preclinical investigators, scientists at academic centres that want to collaborate with us, and facilitating those relationships. That s where I see our involvement in other compounds coming through the pipeline. But, the main thrust is on the lead compound and the four trials. This is the main focus of probably 90 percent of company employees at this time; working vigorously to move those projects forward. 21

27 The MSL team is expected to be a small team to begin with. In the US, MSLs will be directly employed by the company. In the EU, the team will initially begin with a contract organisation, partly because the employment laws in Europe are more challenging for the company than those in the US. We re working with a group that will essentially represent us in the EU with contracted MSLs. The idea is that over time we will grow that group and then probably internalise the majority of them, bring them on as full-time employees after a period of time. Also among the members of the new team will be an experienced publications strategist to devise a publications strategy that includes cross-functional agreements, and then to implement it through multiple channels, including internal medical writers and external consultants. There is also likely to be someone to provide a medical communications function, which the VP of Medical and Scientific Affairs sees as being different to publications, and someone to lead a medical information function. Medical information, in this case would be the call centre environment; a team of highly trained professionals, either employed or contracted, who would respond to questions from HCPs [healthcare providers] and other sources. As the company approaches commercialisation, there may also be a dedicated medical education person within the team whose role is likely to include the support of representation at conferences and congresses. It is also envisaged that HEOR and market access will also be brought into the team when it is appropriate to do so, probably on a temporary basis. It s not atypical that when a company is on the cusp of being a commercial entity with an approved product in the marketplace, market access tends to be a standalone function that would typically come under a commercial umbrella. I could see this likely happening here. It s a little premature for us right at the moment, but I would say the market access function will initially spend time as part of my team, and then it ll become its own entity at some point. 22

28 Figure 7: A Vision for Medical Affairs Structure at Company E VP of Medical and Scientific Affairs Assistant to VP/Coordinator HEOR & Market Access Scientific Partnerships Director Scientific Affairs Director MSL US Director MSL EU Director Scientific Partnerships (US) Medical Information US MSLs MSLs based in major European markets Scientific Partnerships (US) Medical Communications and Education Established Planned Source: FirstWord research Training for a future sales team is likely to be via an in-house cross-functional team, at least initially, in which the MSLs would be involved. As a commercial organisation grows up, they tend to have a training function within their organisation. A dedicated sales training person [who] would leverage resources within the company to fulfil the necessary training requirements. I see the MSLs being included in that as medical specialists who will have been in the company probably 18 months to two years in advance of the sales team, so they will be very well versed on the data and be able to deliver this training at very high quality. I see it happening for other functions in the company as well. Thus, medical will help train the rest of the company. Vice President of Medical and Scientific Affairs 23

29 The diversity of medical affairs functions Medical affairs functions are diverse and vary according to the size and geographic footprint of the company. Global medical affairs functions can also be quite different to country-level functions. Even at a global level within a single company, day-to-day functions can vary significantly between teams, depending on the lifecycle stage of the product on which they are working. Medical affairs has such a diverse package of tasks to do that you will see different medical affairs directors doing different things. We have a couple of medical affairs directors who are 80 percent occupied with clinical trials. You have other medical affairs directors who spend 80 percent of their time on preparing educational materials and setting up standalone meetings, working with symposia and all those things. It depends on where their interest is, their experience, and then also on the timeline of product launches. Global Medical Affairs Director Figure 8: The Diversity of Medical Affairs Functions Medical/clinical research Medical communications Engaging and managing medical experts/kols Medical information Medical Affairs Functions Competitor intelligence Medical governance Outcomes research Source: FirstWord research Medical education 24

30 Phases IIIB and IV studies are the major cost drivers for medical affairs. As a consequence, most of our time will be spent on ensuring that those trials are running on time, have the right recruitment ratios, and that the budget is well-predicted and forecast. That is the operational excellence that medical affairs needs to demonstrate to the organisation. The other areas where we spend most of our time will be the standalone meetings and all the educational materials. We also spend a significant amount of time on looking at other trials, so what type is the external environment doing, what does the data show, what does it not show, and be an advisor to the internal development organisation as well as the commercial organisation. Global Medical Affairs Director A large part of the role is training the medical field force. I have a medical director who spends 30 percent of his job working with the countries and making sure their MSLs and their medical advisors [are trained]. He does all of their training, he provides them with all of their materials, he reviews all of our new publications with them [and] he provides them slide decks on our competitors. Communication and education Executive Medical Director, Medical Affairs Medical communication includes medical publications; congress activities; medical media activities like symposia; and both internal and external medical education, including online. A lot of these activities were historically managed by the marketing organisation, but in recent years, for compliance reasons, ownership has been transferred to the medical affairs team. 4 In terms of communications, we have both internal and external. So internally we educate our company s medical and commercial colleagues across the globe. With public relations or investor relations, we would be involved. For example, when they write a press release, the medical affairs team would be very much involved with the generation, the content, developing what is in the release, in the creation or simply just verifying the medical accuracy of what is in there. 4 FirstWord (August 2014). Reshaping Medical Affairs: delivering value to KOLs and payers. Retrieved from 25

31 Then we communicate externally: we do publications in medical journals; anytime there are medical congresses and meetings we have presentations there; we do symposia; we do medical education programmes; we do online med-ed [medical education], things like Medscape, for example. Franchise Head, Medical Communications In terms of the communications sent out to a congress, medical affairs involvement may be viewed as strategic or coordinating rather than operational. For some companies, internal education typically involves medical affairs ensuring that everybody in the wider cross-functional teams, such as health economics, market access, and sales and marketing, understands the scientific messages concerning a new product. Most of the time we are asked to give a talk or educate or come and do two days training for the sales reps, marketing people, regulatory or legal. The majority of that training will be for health economics and sales and marketing and market access. At the beginning [prior to launch], it s really intense [but] then it becomes ad-hoc. Imagine marketing wants to launch a product that has gained approval and is going to be ready on the shelf in six months [or less]. There is a lot of effort that goes in at the beginning, making sure that everybody s trained, everybody understands the scientific messages, everybody understands the marketing messages and everybody understands all the different types of support material that they have put together. There s a lot of training on that. After that, maybe about six months or so after the launch of an approved product, then it will be less, it will be more ad-hoc. Head of Strategic Global Medical Affairs Operations 26

32 Medical information Medical information can be seen as a reactive function of medical affairs, mainly providing evidence-based, scientific responses to medical queries, from physicians, for example. The medical information group whenever there are medical queries coming in from wherever they may be across the globe, if it can t be handled at the local level it would come to the global medical information group to answer those queries; questions about products. They also provide basic global guidance documents, such as information Q&As. Franchise Head, Medical Communications Physicians typically want answers very quickly; they are rarely going to wait to schedule an appointment with an MSL that will take place in a week or two following the question. If they want to know something they pick up the phone, they call our Medical Communications department and we have scientists within the office who can answer those questions in real time and who then can then document those answers via a medical letter. So we find that a significant percentage of these requests now are getting answered through medical information rather than the MSL. Head of Regional Medical Affairs However, the type of information that medical affairs professionals are allowed to disclose varies between markets, as an expert from Canada discloses. In Canada, medical affairs can discuss things off label within context. It can t be a promotion, it can t be unsolicited, but if a question comes to you from a physician in terms of an off label use for a drug, you can address it, [whereas] any sort of off label type talk is strictly forbidden in the United States. Engaging external medical experts Associate Director, Field Medical Affairs Medical affairs personnel have an important role in establishing and maintaining relationships with external medical experts, or key opinion leaders (KOLs). For global medical affairs teams, this role is likely to be at a strategic level, as opposed to the more frequent interactions that take place at the local level with MSLs. 27

33 Every medical affairs person in global has a role to play in external expert engagement. Not just the typical medical expert but also nurses, pharmacists and sometimes patients [or] payers. Global Medical Affairs Director I get on the ground and I meet them [external medical experts], but I only want to talk to the key influencers of a specific region who have strategic importance to me, and to initiate projects. If I want to run initiatives, I meet the individuals I need to run initiatives with. Associate Director, Field Medical Affairs For MSLs in the field, establishing and maintaining relationships with KOLs is seen to be their primary function and the one on which they spend the most time. A global MSL survey conducted by the MSL Society found that KOL management, KOL education and investigator-initiated study management (mostly requested by KOLs) accounted for more than half of MSL working time. 5 At a strategic level, MSLs provide an important link between the pharmaceutical company and healthcare providers, and play a key role in gathering insights and bringing these back to the team. For example, these can include suggestions for clinical studies based on unmet medical need. One of the key things that an MSL does, in general, is to gather insights and bring them back to the team. [For example] an MSL in Italy goes and sees his or her physicians. That MSL will gather insights and share it with a medical team in the Italian office and that all feeds back into global [medical affairs] if it has general implications as well. MSLs have a key role in taking insights from their interactions and these insights may very well lead to actions on our part. [If] medical experts are suggesting ideas for a study - here is a clinical question that needs to be answered regarding your product, such as how product X should be used appropriately in particular patients - then maybe those questions and insights will provide ideas of how to design a local study, for example. Franchise Head, Medical Communications 5 Tolmachev, Dr A. (August ) 8 Success Factors of Smart KOL Engagement. Retrieved from 28

34 Health economics and outcomes research The rise in health economics and outcomes research (HEOR, or HE&OR) is at least partly due to the wider changes in the pharmaceutical market environment and an increasing emphasis on value-based healthcare and the shift in decision making from physicians to payers. Historically, if a product gained regulatory approval, it could be launched on the market. Now, regulatory approval is just the first hurdle towards market access and additional studies beyond the pivotal Phase III trials are often required to demonstrate value to payers and obtain reimbursement status. Payers and healthcare providers increasingly demand comprehensive scientific evidence that the results obtained in the controlled environment of the clinical study can be repeated in the real world. The role of HEOR on a potential new therapy includes input into clinical study design to help ensure that the health outcomes data generated will be appropriate to support future health technology assessment (HTA) or comparative effectiveness research (CER), including the impact on the quality of life of patients, as well as the economic value of the product. The data need to clearly demonstrate the value of the drug, not only through pivotal safety and efficacy trials, but also through comparative efficacy trials and health economics endpoints. In the past, we ve done clinical trials and if we packaged everything into a registration file, we got approval for a product and then we could bring it to the market. For this, you needed to have some medical support, development and regulatory. In the new world, the pressure is not so much on getting the regulatory approval because those processes have all been streamlined [and] the whole regulatory world and health authorities are well-evolved. What is happening now, and you see differences across different countries, is change in the payer environment. It s not as much about the clinical efficacy or safety, but it s about what is it worth to society to pay for it, or do we get money in return because of health benefits? The emphasis is not as much on the Phase III clinical trials, it s on the additional studies and the additional data we need to convince payers to accept our medicines and get them reimbursed. That is [now] turning into a larger obstacle than the regulatory approval. Global Medical Affairs Director 29

35 Within medical, there is a managed markets team; they also do HEOR. This is a group in medical that interacts directly with the managed markets side of the business. They look at the evolution of costs and other things of a particular disease state. They run research studies, health economics studies, and also work closely with the managed market MSLs who are doing the presentations with third party payers. So they have two roles [but] it s the same as medical in general: generating data and communicating data. We make a case that it is important from a clinical perspective; HEOR makes a case from a cost perspective, and how useful it is to our patients from a quality of life perspective. Vice President, US Medical Affairs Health outcomes and health economics scientists are totally embedded within medical affairs. These are scientists who conduct research of the same quality as the controlled clinical trial, but they are answering questions that are more of a health economics or real world evidence nature, which is a key part of the evidence medical affairs needs to generate in a high quality ethical fashion. Physicians, scientists and payers are becoming increasingly interested in real world evidence data to assure that the data that s generated out of a controlled clinical trial is relevant to a real world scenario and their patient population. Head of Regional Medical Affairs The reporting line of HEOR teams varies between companies. In some, HEOR is within medical affairs, while in others it may come under development or market access, or it may be a standalone team. This is partly because HEOR typically becomes involved in product development at an earlier stage than has traditionally been the case for medical affairs. However, as the HEOR role gains prominence and medical affairs teams evolve and become more rounded, there is a growing trend for HEOR to be seen as a key competency within medical affairs. The organisers of a medical affairs leadership summit noted that 68 percent of respondents to a survey cited HEOR among the unique skills expected from medical affairs. 6 Another study found that HEOR teams were thriving within medical affairs, with budget increases reflecting the rapidly growing importance of the HEOR function. 7 6 Menta, M and Sutter, T (July 2013). Medical Affairs changing role in market access and reimbursement. Retrieved from 7 Health Economics Teams in Medical Affairs: A growing Trend (2013). Retrieved from 30

36 We are one and the same. Part of medical affairs is we are preparing a product for launch in a market, [it is] about market access. A lot of things that we do are closely aligned and linked in partnering with our health economics outcomes group. Franchise Head, Medical Communications In the last two years, HE&OR has had a more prominent role. They are at the table with the conception of a clinical trial. They work together with countries to understand the local environment and where that environment may be in two to three years time when we are actually filing the product [for regulatory approval]. What data do we need to generate to successfully launch a product in France or in Germany? Can we do one large global clinical trial to bring all the data so that many of the countries can benefit, or do we need to fund a separate local study to ensure local approval? Understanding that and bringing the expertise to the table is more important than ever for HE&OR and market access. I think at some point, payers will not pay for a product that is based on a clinical trial; they will pay based on value and outcomes. HE&OR will be a core capability of medical affairs in the future. Global Medical Affairs Director Global medical affairs has core medical teams for each product and on the core medical team sits a representative from each region, and generally that s the head of that molecule for that region. It also includes the global medical affairs director for that molecule and the global health outcomes person as well. So when we re discussing the entire portfolio of work that we re doing for any given molecule at that core medical team, the whole portfolio of research or data generation [including] health outcomes and real world evidence. Then for particular topics if we need more in-depth discussion, let s say from a couple of countries, then the health economics people from that country will join that meeting. So it s a matrix level organisation, but global health outcomes people are very well connected to the regional and local countries health outcomes people. They don t have direct line reporting, but they all work within the same discipline; they have regular interactions so that we re sharing best practices across the globe. Head of Regional Medical Affairs 31

37 Data generation and dissemination post-approval Following regulatory approval, medical affairs teams continue to be involved with data generation and dissemination through additional clinical and real world studies, particularly looking at things that did not form part of the main R&D programme. When you re getting to the post-approval and you re post-launch, there are still different studies that the company wants to do. We don t try to do everything with the pivotal study; we try to do a lot of studies also after it s approved. When we look at the whole list, some of those may be health economics, some would be medical, some may be R&D. Head of Strategic Global Medical Affairs Operations In medical affairs we are involved in Phase IIIb, Phase IV, local studies, investigator initiated trials and patient registries; that is the type of data generation that we would do on the medical affairs side, and then we are responsible for disseminating our data, being able to turn the data into a story that is relevant to healthcare providers and patients with regard to how medicines are being used to treat patients. Franchise Head, Medical Communications Supporting post-marketing studies, including company-sponsored and investigator initiated trials (IITs) falls into the remit of the medical affairs team in a number of pharmaceutical companies. Medical affairs teams have a scientific and governance role to play in IITs, ensuring regulatory compliance. For example, companies are not able to solicit particular studies or influence the nature of the study. However, it is common for a pharma company to provide support to a doctor to enable him or her to conduct an IIT and the whole process is often managed within the medical affairs team. 8 At Allergan, for example, the global medical affairs team supports both Phase IV investigator-initiated trials and Allergan-sponsored post-approval studies. The latter are designed, conducted and/or supervised after a product has been approved for marketing. These studies are distinct from any Phase IV R&D studies that are required by a regulatory body to satisfy post-marketing commitments. 9 8 FirstWord (August 2014). Reshaping Medical Affairs: delivering value to KOLs and payers. Retrieved from 9 Allergan Global Medical Affairs, Investigator-Initiated Trial Support. Retrieved from 32

38 As part of its commitment to delivering innovative therapies to patients around the world, Novartis has supported the funding of IITs conducted by third-party investigators for many years, with defined processes and governance measures in place. The company sees this as being complementary to Novartis-sponsored research in helping to ensure better understanding of the benefit/risk profile of its therapies. 10 Similarly, Pfizer has an Investigator-Initiated Research (IIR) Program that provides support for IIR that advances medical and scientific knowledge about Pfizer products and generates promising medical interventions Novartis Investigator Initiated Trials (IITs) Guidelines (July 2014). Retrieved from 11 Pfizer Investigator-Initiated Research (IIR) Program Details. Retrieved from 33

39 Building strong cross-functional teams By adopting a more holistic approach to lifecycle management that involves cross functional collaboration, companies can improve the processes of product development and launch, while lowering operational costs. 12 A recent benchmarking report highlights that companies can achieve better operating results if they continuously encourage collaborative behaviour to optimise productivity and efficiency. 13 Medicine is clearly the focus of every pharmaceutical company and the medical affairs team is involved with all aspects of the product lifecycle. As a central function, the medical affairs team interacts with other teams throughout the company. It is, therefore, important to form cross-functional partnerships with other teams in order to work effectively together towards a common goal. Figure 9: Medical Affairs Internal Partnerships R&D Sales & Marketing Legal/ compliance Medical Affairs Market Access Regulatory HEOR Source: FirstWord research 12 Hein T. (October 2012). Product Lifecycle Management for the Pharmaceutical Industry. Retrieved from 13 Best Practices LLC. Managing Cross-Functional Teams for Pharmaceutical Product Commercialization Excellence. Retrieved from 34

40 Medical typically is in the whole approval process, so any material that is going out from global to a country will be reviewed and approved by a cross-functional team. That is regulatory, legal, medical and commercial. Global Medical Affairs Director We interact with the development teams, as well as with the commercial teams and regulatory. Depending on where in its lifecycle a product is, or the specifics of a particular project, we could very well be interacting with very broad groups all across [the company], even as diverse as investor relations and things like that. Depending on the circumstance, there is a possibility that we may have an interaction with just about any group [in the company]. Franchise Head, Medical Communications Medical affairs is involved in every single cross-functional team, because core within pharmaceutical is the medicine. Without the evidence and the medicine, essentially nothing gets done. That is in the realm of clinical development, then you have the commercial side of things and then you have the market access side of things. Medical affairs is involved in all of those. Associate Director, Field Medical Affairs 35

41 Case study: Cross-functional development of an integrated strategy for each molecule Medical affairs has a key role in cross-functional strategy teams The development of an integrated strategy for a molecule is undertaken by a cross-functional team in which medical affairs has a key role, alongside R&D and other functions as required. Cross-functional strategy teams at Company C operate at both global and local levels. At the global level, the aim is to create an integrated brand medical affairs plan for each molecule. At the country level, the team focuses on the local medical affairs strategy. The main functions involved in brand strategy teams include R&D, medical affairs, HEOR and market access, and sales & marketing. It s important to have an integrated strategy for each molecule. This occurs at several levels. At the global level, the net result of planning is to create for each molecule an integrated brand medical affairs plan. Very senior commercial/ marketing leaders and global med affairs leaders agree on a common set of strategic imperatives, then commercial and medical write their own separate tactics towards those, and they are formed into an integrated plan. There are formal global marketing and global med affairs committees that build that plan and have the appropriate discussions to agree upon the integrated strategy. Then at the local level, to use the US as the largest example, we have what we call medical affairs strategy teams. It s the same principle; they meet on a regular basis to be aligned on the strategic imperatives for a given molecule across medical and commercial. They align on intelligence, share information on a new science or a new drug or a new need in the community and there is joint discussion. Again these are senior level marketing and corporate-based med affairs people; it doesn t occur at a lower level. The four core members of that team from any given molecule are the most senior medical affairs medical director, the health outcomes health economics senior scientist, the head of marketing for that molecule and the head of 36

42 managed markets. Legal and compliance are members of these teams and their role is to ensure that the discussions are focused on strategy and do not delve into tactics. Marketing and managed markets are not permitted to opine on or direct medical affairs activities. Then other team members can be invited on an ad hoc basis. Sometimes regulatory is invited to give a regulatory update; sometimes pharmacovigilance is there if there s been a new safety signal that we want to make sure that marketing understands how medical is handling, et cetera. But these are information sharing and strategic meetings. Medical affairs involvement on R&D project teams Head of Regional Medical Affairs The global medical affairs team has an active role on the R&D project teams. Part of this role is to gather information from the regional and country teams in order to provide a central point of contact for the R&D team. Our global med affairs teams sit on the R&D project teams. [The project team includes] all of the components of research and development that are required to run a development programme; it includes regulatory, biostatistics and the clinical scientists from R&D. Then med affairs has a seat at that project team committee, as does global commercial, which is a strategic committee responsible for helping understand how the drug will get used once it s approved, just like med affairs is. [This involves] working through the matrix of med affairs, getting information from countries, regions, providing strategic and tactical work to the R&D team. So that R&D doesn t have to talk to 500 people to get an answer, they work through the global med affairs team; they re the direct contact between R&D and med affairs and it s the country and region s role to make sure that the global team has the correct information that s needed to provide the proper insights or advice. Head of Regional Medical Affairs Involvement on the R&D project team also allows medical affairs to plan for potential gaps in the data that would be required to attain reimbursement status in a particular market. 37

43 Being very cognisant that R&D s primary role is to get the drug approved with the label that we believe is most appropriate for the data, by med affairs sitting on the R&D team, they can also begin to plan for what data gaps may be present to assure that the Healthcare Technology Assessments and payers in the United States have the data they need to make reimbursement and access decisions about the drug in question. The two teams are very clear with what each is doing and med affairs can work in parallel and alignment with R&D, so that at the time of launch, we have generated the data that we need for the product to be successful, not just the pivotal trial that gets a label. The controlled clinical trial that assures registration is rarely enough data for a payer today. [For example], there are supportive and supplementary health outcomes, health economics data; there may be additional controlled clinical trial data. The pivotal trial may have one endpoint; the payers may be interested in another endpoint. There may be patient reported outcomes that are important to a payer but that couldn t be incorporated into the trial design because the regulators do not need this information to approve a drug application. It s usually patient reported outcomes, health economics and other kinds of outcomes data which payers want to see but that the regulators do not need as part of their review process. We set the goal that all of the prospective type research that s needed for launch, we try to have done by launch. Then in the first launch setting, we re much more interested in collecting and evaluating real world evidence. So then medical affairs post-launch shifts more towards real world data than the controlled data that is pre-launch. Head of Regional Medical Affairs 38

44 Case study: Strategic involvement of medical affairs from proof of concept Early involvement as part of a therapeutic area cross-functional team At a strategic level, early involvement of the medical affairs team can provide valuable input into identifying unmet medical need to ensure that the right products are developed. At Company A, medical affairs teams get involved at the proof of concept stage, which is viewed as an evolving role for medical affairs. We get involved at the proof of concept. This is another evolving area for medical affairs, which means companies allowing R&D teams to get used to the idea of medical affairs being involved from the beginning. Why? Because the medical affairs team understands the market very well much better than somebody in the R&D department. We ve got a long way to go, but we have been able to involve medical affairs from proof of concept. Head of Strategic Global Medical Affairs Operations This involvement is effectively as part of a therapeutic area cross-functional team, which also includes input from commercial, market access and HEOR, as well as R&D. The real value of medical affairs involvement at this early stage is the value they bring to the team in terms of customer knowledge and the ability to talk about unmet medical need. Basically what happens at that point is that commercial asks what would be the ideal product? [For example] I want a product that the patients can take one tablet every month. Then the market access or the health economic people say, okay we want to be able to show that these are the economical values of our product. Everybody has an ideal of what this should look like. A lot of the focus of medical affairs is on unmet medical need because they are so close to the customers. The value they bring back is that [knowledge allows them to suggest things like] patients would really like to have a product that is infused every week rather than every other day, and they provide a reason. They re very scientific. Head of Strategic Global Medical Affairs Operations 39

45 The next stage for this team is to look at what is already available on the market and to establish whether the potential product is likely to have advantages over the competition. You look at what the competition already has and what additional value you re bringing in with your product. Is your product just going to be a me-too product or is your product going to have clear advantages over the competitor product, because that also decides what your product portfolio should look like. At the beginning, the team meets a lot to get to a point that they all agree on what the product is going to look like. Then R&D will say, if you want this product, this is the protocol for that study. Then it gets approved, it gets the funding and it is started. Head of Strategic Global Medical Affairs Operations The consequences of not assessing the medical need early enough and not developing a strategic plan could prove to be expensive in a competitive marketplace. There was a time that R&D will have an idea for a product or for a molecule; the business says this is great. Then R&D takes over and they go through the Phases and they get approval and then they give the approved product to marketing, and marketing goes and sells it. That s no longer enough because there are so many competitors in the market and there are so many different variables. If you don t think about it ahead of time you may have a product in the market that is going to be useless after you spent $700 million developing it, because you didn t research your market early enough to know what their needs are. You design your study in a way that, once your product is approved, it really is meeting an unmet need. Head of Strategic Global Medical Affairs Operations Medical affairs involvement increases once clinical studies begin Beyond the initial strategic planning discussions, the medical affairs function becomes less involved until clinical studies begin and data are generated. At the beginning, there s not a whole lot of work [for medical affairs] because no data has been generated. Within six months to a year into the study, when 40

46 patients are enrolling, then there is a data cut and that s when they come back all together again. When we have these studies, medical communication or publication planning gets involved. Head of Strategic Global Medical Affairs Operations During a three-year clinical study, for example, the team may organise symposia or medical conferences with posters, abstracts and oral presentations at certain milestones. It s very clear what the milestones are and how these are connected back to the data we can get to start communication. The key point here is that you don t wait until your study is finished and you have approval and then you go launch it. The launch of the product starts about two years prior to the approval date. Head of Strategic Global Medical Affairs Operations Cross-functional team dynamics change but key members remain At the early stage of the lifecycle, the cross-functional product team has involvement from medical affairs, R&D and commercial, but would be led by project management from within R&D. As the project moves close to the launch, the dynamics of the cross-functional team change, with commercial, medical affairs, HEOR and market access taking a more prominent role as R&D begins to fade away, although they are still involved. However, it is essentially the same team that goes through to post-launch. R&D s involvement in the study may vary from company to company, but they will still be involved in the papers, the review of the communication materials, and some of the medical directors on the R&D side, maybe even an author on some of these papers. [But] it s not going to be at the same level that it is right at the beginning or in the middle of the study. Head of Strategic Global Medical Affairs Operations Effective communication is vital within a cross-functional team In a cross-functional team, effective communication is vital to ensure cohesion and consistency. To this end, a scientific communication platform is developed for each project by the medical communications team. 41

47 The scientific communication platform basically looks at everything that has been published currently. We come up with the platforms for the new product that we are developing [by asking questions such as] What are the key scientific concepts that we want to communicate? How do we paint a picture and tell a story about this new product? Everybody gets aligned behind that it s what glues all of us together R&D, market access, health economics, commercial, medical affairs. The scientific platform clarifies what we want to tell about this product. The way we get to that is based on what s already published, what our competitors are doing and what s the advantage that we re going to bring to the market with our product. It helps you to tell a story about your product. Head of Strategic Global Medical Affairs Operations To explain the importance of developing the scientific communication platform at an early stage of product development, an analogy can be drawn to a book or a film. Unless you read the book or watch the film from the beginning, you may not completely understand what is going on. We want to have the scientific communication platform that everybody can stand behind from the beginning because the communication starts from the beginning. The story telling starts from the time you have that proof of concept and everything else approved. Head of Strategic Global Medical Affairs Operations 42

48 Case study: Increased participation in cross-functional teams from Phase II to Phase III Strategic planning from Phase II At Phase II, the global medical affairs team in Company B plays an active role in product development teams and provides strategic input into the clinical development plan. The team will begin to work on the market access strategy, as well as planning a communications strategy. It is also at this stage that the team assesses the competition in the marketplace and the likely data requirements for reimbursement and market access. The development teams are organised into global product teams. Medical affairs sits on those teams and really gets involved at Phase II. There s a strategy document called a clinical development plan, and medical affairs teams start to provide input into that plan at this point. We input things like the scientific strategy and the scientific platform. We work with market access and country, local, regional teams more than with the R&D teams directly, because the development teams tend to be more focused on US and Europe and regulatory requirements for filing, and less about reimbursement. So we tend to, with development, work more closely with those teams to talk about what sort of data are going to need to be generated for reimbursement and market access. What sort of data are we going to need to show? How crowded, how genericised is the market going to be when we get there? They need to at least input and say, it s going to cost you $500 million to develop this drug but the market s highly genericised so you re not going to get reimbursed so why are we doing this? We need to know that early on. Executive Medical Director, Medical Affairs Typically a medical affairs team would start working on a product in Phase II. The team will start putting out our market access strategy, putting together a communication strategy based on when data is going to be available, [looking at] when are the studies going to be completed? What are the studies looking 43

49 at? Who are the physicians that we want to communicate these data to? Where, when and how do we prepare and educate physicians about the therapy area or the product prior to its anticipated approval? Franchise Head, Medical Communications From a medical perspective, the team may already be considering what studies they will want to undertake in addition to the pivotal Phase III programme that is required for regulatory approval, at Phase IIIb, as well as HEOR. While development is doing studies to gain regulatory approval, which studies does medical have to do to find new endpoints, to have different comparators, to have more real-world evidence? What is it that medical needs to do on top of development to have an enriched data package by the time of launch? Typically at Phase IIb, HE&OR and market access would have a role to play as well. What we try to establish is a targeted product profile at Phase IIb, so what else does the product need to demonstrate for it to have a reasonably high chance of success for getting approval and subsequent market access? That is a cross-functional teamwork. Medical affairs involvement increases from Phase III Global Medical Affairs Director When the drug moves into Phase III, the medical affairs team takes on responsibility for developing a more comprehensive medical affairs plan from the outlined plan that is already in place. Early planning aims to provide a seamless transition from Phase III to Phase IIIb. As the drug goes into Phase III, a medical affairs team is launched and HEOR spends less time with the global product team and more time on the medical affairs team side. That s when you will start to develop a global medical affairs plan. There will already be an outlined medical affairs plan that s part of the overall development plan, but now you ll start to have a much more enriched medical affairs plan which includes your medical communication strategy, your medical expert engagement strategy, your HEOR, your real-world evidence development strategy. Your Phase IIIb strategy will probably be relatively mature at that point because that ll be part of the overall development plan. 44

50 You re not going to do everything in Phase III because you want to balance cost and speed to market. So even if it s not completely fleshed out, you ve probably started to have discussions relatively early on. That discussion becomes more mature as a decision is made to take the compound from Phase II to Phase III. Then in the best of all worlds, if your planning is correct, you ve got your Phase IIIb plan pretty much in place and ready to go when the Phase III reads out. So if the Phase III is positive, you can seamlessly start your Phase IIIb. Similarly, you re probably doing something on the HEOR side early, just trying to understand the market and the unmet need. The interaction early on with HEOR is at the global product team level. There is a sub-team [of the global product team] called a value and access team, which is market access and HEOR, but medical affairs sits on that team more so than research and development, so we interact with them there. Executive Medical Director, Medical Affairs The level of involvement of teams changes through the lifecycle As a product progresses through clinical development and launch to maturity, the level of involvement of different teams changes, particularly R&D and sales & marketing. However, the medical affairs team stays with the product throughout its lifecycle. Throughout the different stages of development, we work very tightly together with development. It loosens up after Phase III, but even then we might still be doing development programmes for Japan, China or the US, so we will still have quite a close relationship with development, as well as commercial. The emphasis changes from working very closely together with the different groups at the early stage, especially development, through to commercial. That s the challenge for medical affairs. The emphasis changes throughout the product lifecycle from Phase IIa all the way to a mature product. They [medical affairs] exist throughout the whole product lifecycle. Regular interaction with sales & marketing is important Global Medical Affairs Director The medical affairs team has a responsibility to ensure that all promotional material is medically correct. The medical team may also be able to assist the commercial team with a better understanding of the medical needs in the marketplace, as well 45

51 as providing education and training on the science around a therapy. While these teams must work within their own operational boundaries for compliance reasons, regular interaction can be an important part of developing a partnership. Interacting daily with the global commercial team and also regional and local commercial teams is a large part of what my medical affairs team does. We start in Phase II. As we work with them to understand the marketplace, we help them to understand which thought leaders that they may want to start talking to. We develop more of a partnership with them as we get into Phase III and beyond because we are involved in providing medical input and approval to everything they do. We have a big scientific and compliance role; all of their promotional materials come through us for approval. They also have legal and regulatory approval, but we have responsibility for making sure that everything they do is medically accurate, so it s clearly a partnership. We re also responsible for training the commercial teams on the science [and] we help them develop training materials for their field force. We also provide input, for example, on how we deal with competitors. We help them to review competitors materials to see if they re medically accurate. But also, we occasionally get complaints from our competitors saying they think our commercial pieces are inaccurate and we help the commercial teams provide a response to those things as well. Sharing a physical location is helpful Executive Medical Director, Medical Affairs Working in close physical proximity may help teams to work better together as they will have the opportunity to interact with each other on a more regular basis. Internally we work very closely together and we re co-located with the commercial and development teams so that we re actually functioning as one product team. I think this co-location is very helpful; it really helps us to understand each other better, engage more, feed back, everything that helps understand each other s roles. Within commercial, we have global patient access, which is a combination of both market access and HE&OR. Market access is more technical; it s pricing and access in a country. HE&OR is more about the health economics evidence building. It s a relatively separate skill from market access, but in the markets they go together. Global Medical Affairs Director 46

52 Case study: Field medical affairs is less involved from pre-launch to Phase IV The field medical team has limited involvement pre-launch Where clinical development is handled at corporate level, the field medical team has comparatively little involvement until the product has been approved. A field medical affairs associate director at Company F separates compounds into pipeline projects and approved products to explain where the responsibilities for development lie, although he cautions that things are not always straightforward. If you have a pipeline product that s never been approved in any indication, it is solely clinical operations. After it s been approved, it gets taken up by medical affairs. When you re looking at a label extension, for example, that s initiated by medical affairs, not clinical development. The idea is that they [clinical operations] handle pre-market approval. We [medical affairs] handle post market approval. In theory that s nice, but how it actually is applied and works is not, because label extensions on different things are in the grey zone. Associate Director, Field Medical Affairs Cross-functional interaction is limited to three or four meetings per year In this company, cross-functional teams are in place, but meetings tend to be less frequent, making it more difficult for field teams to find out what is happening at the corporate level. We have quarterly or five-monthly meetings between clinical development, medical affairs, and drug regulatory affairs meetings, which update us in terms of which trial they re starting and where it s starting. But this happens on a five-monthly basis and that s how we find out about that development. Otherwise you re looking at clinicaltrials.gov or the physicians are telling us, or something of that sort. There s a reason why that is; it s because clinical developments run through corporate. Even though they have members within our local offices, they actually don t report to anyone in the local offices, so they have no need to inform the rest of us. Associate Director, Field Medical Affairs 47

53 Field medical involvement increases from Phase IV For field medical affairs, involvement in the product lifecycle really begins from Phase IV and includes earlier phase studies for line extensions or new indications for approved products. Phase IV is where we start playing a role. Worldwide, post-marketing is where you really see it. So we re looking at post marketing and investigating issues, that is where we start playing a true role. If you look at the R&D side of things, in Phase III and Phase IV we have involvement [but] more in the Phase IV programme than the Phase III development programme. In terms of Phase III, what we could do ideally is identify sites, identify KOLs, what would be excellent to be considered clinical trial sites. In terms of Phases I and II, what actually happens is that we can start investigating initiated studies, which are often used as proof of concept into new types of indications. You can interpret that as being Phase II studies for already-approved compounds. Associate Director, Field Medical Affairs However, while local studies can be organised by field medical affairs, a multicentre Phase III study for a new indication would revert back to the corporate team since these cannot be run by a local or regional team. 48

54 Information flow and the importance of the internal firewall The flow of information between teams should be optimised while remaining within the boundaries of regulatory compliance. Pharmaceutical companies have strict internal firewalls in place as part of their standard operating procedures (SOPs) to ensure there are no blurred lines between medical affairs and commercial activities. Information can flow both ways, particularly at the strategic level, but both teams must remain aware of the restrictions. Figure 10: Information Flow in the Cross-Functional Workspace Medical Affairs Marketing Sales Compliance Regulatory Market Access Source: IMS Health IMS Health. Lead an Actionable Compliant Medical Strategy. Retrieved from 49

55 We have a very strict and tight firewall. Just to be clear, we interact with our commercial colleagues in terms of product strategy; when we are planning activities, commercial is very much involved in the strategic planning phases in whatever we do. When it comes to actual execution and content development, then there is a firewall. Commercial is not allowed to provide input or comment on any medical materials. When the final material is ready, it is really just like an FYI . There is a firewall it is in our SOP [standard operating procedure] they can t provide content. Franchise Head, Medical Communications We have help from our compliance and legal people if we ever question is this appropriate to share with commercial? That s a very difficult area and we tend to be rather conservative and share only that information that we think is necessary for them [commercial] to know to develop a strategy and conduct their business in a compliant manner. Sometimes data is shared when it s important to make sure that they know it, but they re not the team to act on it. We are very clear with those boundaries. We share it and we document those boundaries because defining and managing appropriate interactions between the commercial side of the business and the medical side continues to be a challenge [particularly in the US]. We want to be able to share information and data between medical and commercial in a compliant way and we believe that we achieve this by taking a very conservative stance. How medical communicates effectively and appropriately with its commercial colleagues is something we continually monitor. Head of Regional Medical Affairs When we function, we have the traditional firewalls that are within the organisation. For example, we could organise an advisory board; the conduct of these events and programmes is definitely set with the appropriate separation [to ensure compliance]. All the content overseeing is led by my team [medical affairs]. But we have a set of SOPs that are in place to maintain that firewall. Vice President, US Medical Affairs Within the cross-functional team environment there are clear lines that individual teams must not cross in order to remain compliant. Activities undertaken to ensure this may include the publication of an agenda prior to a cross-functional meeting, as well as minutes of the meeting to record the content and ensure transparency of the discussion. 50

56 Both at the global and local levels, cross-functional meetings between commercial and medical are co-chaired by both the head of medical and the head of commercial. They co-chair and they build the agenda. We publish an agenda and we publish minutes to enable us to monitor what s discussed and have a clear written record of these discussions. It s really largely around information sharing. In terms of insights generated from one of 100 different sources, each team, medical and commercial, makes a decision of what is important to share with their commercial and medical colleagues and this meeting is a forum through which that s done. For formal clinical trial data [for example], each study has its own communications plan and in general we analyse data, do peer review and make sure that we clearly know how to interpret the study totally with medical first. Then we disclose data to our commercial colleagues as needed and appropriate before it s publicly disclosed. Commercial s use of the data in conducting its business undergoes a separate and rigorous legal and regulatory review. Head of Regional Medical Affairs There s definitely a firewall in terms of the specifics, but as a [cross-functional] team we don t need to discuss specifics. We just need to discuss things like, let s look at our compound. What is excellent about it? Where is it lacking? Let s discuss what you re going to present and then I ll step back in terms of the pricing negotiations because I m not supposed to know that. Associate Director, Field Medical Affairs 51

57 Challenges for medical affairs and the main drivers for change Among the main drivers for change in medical affairs are regulatory compliance, transparency and a desire for the company to excel in disease understanding at a scientific level. It [medical affairs] is driven by compliance, transparency and a need to be a peer on a scientific and disease understanding level. Global Medical Affairs Director Internal challenges in a cross-functional team environment Figure 11: Internal Challenges for Medical Affairs Early strategic input at the proof of concept stage Becoming more rounded professionals Being on the right cross-functional teams at the right time Understanding where medical affairs has a critical role to play Global teams need to understand and support local teams Understanding what the other person does and how you can work together Getting the right funding and support Source: FirstWord research 52

58 As the demands from medical affairs teams increase, challenges within the organisation include: Being able to provide early input into projects, such as strategic involvement at the proof of concept stage; Being on the right cross-functional teams at the right time depending in the lifecycle stage of the product; Getting the right funding and support; and Becoming more rounded professionals with both medical and disease expertise, an understanding of HEOR, and knowledge of the commercial requirements of the pharmaceutical business, while maintaining high standards of integrity. For me the challenge is all about building new skills and capabilities and understanding where medical affairs has a critical role to play. We re asked to do more, we re asked to be disease experts, yet we are asked to understand commercial services. We have to be a very all-round person and work with the highest integrity and ethically to ensure that we do the right things for society. I think that that s what medical is here for. It s a very demanding role that will become more demanding. Global Medical Affairs Director As the demands on medical affairs teams increase, the people who work within medical affairs should ideally be open to new ways of working. I think the biggest thing you need is people that are flexible and open to change. For budget reasons, for compliance reasons, you need people who are flexible and are willing to look at new ways of doing things, [such as being] open to considering digital [technology]. Executive Medical Director, Medical Affairs Operationally there are strict lines that cannot be crossed between medical affairs and commercial sales and marketing teams. As the demands from medical affairs increase, however, there is a greater need for the development of a better understanding of the individual roles within other teams and of the business in general. 53

59 We will need to develop more business understanding as a medical function. Global Medical Affairs Director You have to understand there s a clear division of duties, but also understand what the other person does and how that synergises with your duties. That s actually a very key component; although there needs to be a division, there has to be a great deal of understanding, otherwise you re dealing with a very dysfunctional team in terms of what can actually be done. Associate Director, Field Medical Affairs In addition, the global medical affairs team has an important role in supporting teams that operate at the local level. My vision for a good medical affairs organisation is fully supporting the local organisations with the right data and the right communication and tools, supporting them with different projects, anything that is cross-border. That is, I think, what the medical affairs organisation should be doing for local organisations. Global Medical Affairs Director In order to achieve this goal, building a team that includes people with both global and regional experience is essential. You need to have a group that s made up of people both with global but also regional experience and knowledge. Because I think if your perspective is all global, it s hard to understand the diversity of needs at the regional and the local level, which can be very different in Latin America than Europe, than Asia Pacific. Global Medical Affairs Director The all-round experience and expertise of individual team members and their ability to work together is also seen as vital to the effectiveness of a cross-functional team. While individuals have their own roles and responsibilities and there is a clear division of operational duties, there is also a need for someone on the team to understand and align the functions of all team members if the team is going to perform effectively. 54

60 A cross functional team will not work if everyone is partitioned into their own little bucket and there s no one who understands multiple roles at once. You need someone who understands how the regulatory process works, and you need someone that understands how the medical process works that can integrate the two together. If you have someone who is solely science and someone who is solely economics that don t have a similar language, then you re dealing with a team that won t work. You need someone to bring them together. That s the core asset of the cross functional team; why some work, some don t, is that if you have highly specialised people with no one to bring them together then you re not going to have a very cross-functional team. Increasingly complex external demands Figure 12: External Challenges for Medical Affairs Associate Director, Field Medical Affairs The changing healthcare landscape Compliance with complex rules that vary from region to region The rising importance of payers Meeting the expectations of patients Smarter use of digital technology Transparency demands us to think differently Getting the right funding and support Source: FirstWord research 55