KEY TAKEAWAYS

• Patient journeys should be part of a wider strategy and involve a range of stakeholders.
• Regular updates are key in ensuring patient journeys stay relevant and continue to reflect real world experiences of patients and caregivers.

Patient journeys can provide the pharmaceutical industry with rich data to inform strategy across product life cycles. In a PMLiVE article, Stephanie Hall and Louise Collins discuss 3 actions the industry can take to optimise patient journeys and unlock their full potential.

Patient journeys should be part of the wider strategy

Hall and Collins recommend integrating patient journeys into wider strategy and life cycle management. Combining quantitative and qualitative aspects provides both measurable data and insights into the real-world issues experienced by patients, carers, and healthcare professionals. This information, they say, can help clarify which areas are the most important.

Gather a diverse team

The authors suggest greater collaboration adds greater depth to patient journeys: bringing together medical, marketing, medical affairs, digital, and analytical stakeholders creates an environment that fosters a broader range of information and ideas. Additionally, including patient advocates and healthcare professionals creates richer information, forges stronger relationships, and uncovers nuances that may otherwise remain hidden.

“Including patient advocates and healthcare professionals creates richer information, forges stronger relationships, and uncovers nuances that may otherwise remain hidden.”

Create and iterate

Patient journeys are dynamic; regular reassessments enable new data and insights to be integrated, ensuring the journey continues to represent real experiences of patients and caregivers. When used creatively, patient journeys can help disrupt standard strategies.

The authors describe the importance of choosing the right format for patient journeys:

• Data-rich flowcharts may help identify gaps in care.
• Graphical approaches may allow cross-functional teams to better understand complex interactions.
• Combining these formats can provide measurable outcomes weaved with emotional context.

The authors conclude that developing and regularly updating thorough patient journeys can stimulate innovation, result in more effective processes, and improve patient outcomes.

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KEY TAKEAWAYS

• Digital health technology has the capacity to greatly improve outcomes for patients, but several barriers must be overcome before its full potential is unlocked.
• Early and consistent patient engagement is critical for developing digital health solutions that meet patient’s needs and preferences.

Digital health is recognised by the WHO as an essential strategy for improving health outcomes, yet significant challenges exist that limit its adoption. In a recent commentary in Therapeutic Innovation & Regulatory Science, Popa et al highlight the clear unmet need for digital health solutions designed with patients for patients.

There is a clear unmet need for digital health solutions designed with patients for patients.

Barriers to delivering digital health solutions that truly meet patients’ needs

The group identified several barriers that stand in the way of digital health solutions fulfilling their potential to improve health outcomes:

• Low patient engagement. Many developers do not appreciate the value of adopting a patient-centric approach early and throughout development, with patient involvement often limited to beta-testing during later stages, and digital health solutions not reflecting patients’ needs.
• Fragmentation. Siloed initiatives developed by large numbers of stakeholders (not necessarily including patients) have created a complex, disconnected digital landscape.
• Inefficient regulation. Traditional regulatory systems lack the agility to effectively process fast-paced digital development.
• Poor data transparency. Poor transparency around data sharing contributes to mistrust and reduced adoption of digital health solutions by patients.
• No best practice. Lack of process for best practice sharing or formal validation has led to digital health solutions that are not properly vetted to match patients’ needs.
• Poor education. Insufficient patient education has led to reduced understanding among patients of how to access and engage with digital healthcare solutions.

Engaging patients to break down barriers in digital health development

The authors propose a strategy that places patient engagement at the heart of digital health development, as decision-making partners throughout the life cycle of digital health initiatives. They predict that this has the power to:

1. facilitate a more cohesive digital landscape following improved co-operation between developers and patients;
2. speed up regulation, with patient co-designers serving as integrators between digital and traditional regulatory processes;
3. improve data transparency by involving patient co-designers in data management plans that include FAIR and encourage data sharing;
4. deliver products that truly match patients’ needs;
5. enhance patient education through identification of relevant modes of communication.

Popa et al call for “early, meaningful, and sustained engagement” between digital developers and patients to ensure digital health solutions are aligned with patients’ needs and improve health outcomes.

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The key fundamentals of publication planning are to deliver the right data to the right audience at the right time. For pharmaceutical companies, publication planning is primarily based on the clinical study programme to ensure data are reported in a timely manner, as per guidance from the United States Government and European Commission. Key considerations are often based on authorship (“who”), timing (“when”), and journal/conference selection (“where”). However, publication planning is evolving to address different data demands as the landscape of healthcare decision makers is shifting to involve a range of stakeholders (including physicians, payers, patients and policy makers). In an article for Medical Writing from the European Medical Writers Association, Richard White (Chief Operating Officer, Oxford PharmaGenesis) provides his thoughts on publication planning in a multi-stakeholder era and the importance of patient reported outcomes (PROs).

White emphasises that publication planning must look beyond clinical benefits to utilise all available evidence (including economic, social, behavioural and policy) to demonstrate the full value of a health intervention. In this regard, PROs are essential; however, White notes that the drive for “real world evidence” and “big data” has led to a focus on routinely collected data from healthcare databases which often do not include PRO assessments or the patient voice.

As well as providing insights into clinical assessments, White comments that PROs are important to understand how a disease and potential treatments can impact patients and caregivers from a social and behavioural perspective. It is becoming increasingly common for both patients and caregivers to access specialist literature directly, which brings a wealth of opportunities but also poses several challenges.

To help capitalise on the opportunities and limit the challenges, White provides some guidance/best practice tips for PRO publication planning:

• Identify which PRO data can be published and the associated publication opportunities, such as: systematic literature review; patient/physician focus groups and cognitive interviews; validation study; clinical trials incorporating PRO endpoints.
• Engage with the right authors; for example, clinicians and patients/caregivers to help communicate the clinical relevance of the PRO data.
• Target appropriate mainstream conferences and open access journals to reach physicians, patients, payers, and other decision makers.
• Publications for PRO studies should be written in a clear and engaging way and follow applicable reporting standards (such as CONSORT-PRO).
• Supplementary information or enhanced publication options (such as plain language summaries or explanatory videos) should be used to increase reach, comprehension and impact.

To end his article, White quite rightly reminds us that any studies involving patients should always acknowledge and thank them for their contributions to the study: “A short statement in the Acknowledgements section of a conference presentation or journal article is simple to do, but will be hugely valued”.

Note: There is a poll embedded within this post, please visit the site to participate in this post's poll.

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Summary by Emma Evans PhD, CMPP from Aspire Scientific

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With thanks to our sponsors, Aspire Scientific Ltd and NetworkPharma Ltd

The meeting began with a series of pre-conference workshops before being formally opened by a welcome address from outgoing Chair of ISMPP Board of Trustees, Juliana Clark (Amgen). Clark introduced the theme of this year’s meeting, ‘From Publication to Practice: Advancing Science Through Effective Communication’, which focused on the evolving role of the publication professional, the importance of effective communication, and emerging trends within the medical publications industry. These topics were explored through keynote addresses, lively panel discussions, and interactive roundtables. As in previous years, members were also given the opportunity to share their own research via oral and poster sessions. The meeting was attended by both highly experienced professionals and relative newcomers to the industry.

A summary of the first half of the meeting (Monday and Tuesday morning) is provided below for those who could not attend, and as a timely reminder of the highlights for those who did. Many of the presented slides and posters are available to ISMPP members here. A summary of the second half of the meeting is available here.

Keynote address: beyond disclosure – working toward better outcomes for patients

In the first of three keynote presentations at the meeting, Olivia Shopshear (Pharmaceutical Research and Manufacturers of America [PhRMA]) spoke about data sharing and transparency, a topic that was also discussed at the 2017 Annual Meeting. Expanding on last year’s discussions, Shopshear focused on how meaningful changes could be implemented in clinical practice to lead to an improvement in patient care. Key events resulting from an increased drive for greater data transparency were presented, from the requirement to register all clinical trials outlined by the International Committee of Medical Journal Editors (ICMJE) in 2005, to the Principles for Responsible Clinical Trial Data Sharing published by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) in early 2018. It was noted that there is a current emphasis on making more data available rather than on how to responsibly utilise data.

Shopshear continued by noting that biopharmaceutical companies have been criticised for a lack of clinical data transparency. However, according to a report published by the IFPMA & PhRMA in November 2017, 98% of their 44 member companies were sharing clinical trial data above and beyond legal and regulatory requirements. Findings from the survey also showed that 64% of member companies had received requests for access to data, and that 64% of requests were for patient-level data. The majority (80%) of requests had been approved. Reasons for requests being denied included: data sharing not being covered by the informed consent for the trial; researchers failing to include a research proposal with their request/submitting incomplete applications; and data that could not be sufficiently anonymised.

Despite a large number of requests for data, the overall use of data-sharing platforms has been limited to date and the number of publications resulting from such requests is low. Several non-profit funder initiatives are being implemented with a view to increase data sharing among the medical research community. In addition, regulators such as the FDA, the European Medicines Agency and Health Canada have implemented policies regarding clinical data transparency. However, as highlighted by Shopshear, maintaining shared data while ensuring patient privacy is a challenge.

Shopshear went on to discuss how benefits associated with data sharing can lead to better outcomes for the patient. Increased engagement from both healthcare professionals and academic researchers was considered crucial. Other developments that may potentially lead to improved patient care include: a requirement for lay summaries in the US (similar to that adopted in the EU); improved interoperability of existing data sharing platforms; and a ‘watchdog’ system to measure the impact of data sharing in a clinical setting. Shopshear concluded that the sharing of clinical data will benefit clinicians, researchers, biopharmaceutical companies and patients. However, data must be shared responsibly and, crucially, patient privacy must be maintained.

A new wave of patient privacy measures: the General Data Protection Regulation (GDPR)

With the General Data Protection Regulation (GDPR) due to come into effect later this month, Jordan Louise Fischer (XPAN Law Group and Drexel University) gave a very timely presentation on the relevance of GDPR to patient privacy. Fischer began the discussion by asking the audience whether they had heard of the GDPR. Of the 471 audience members who responded, 73 (15%) believed that they had a good understanding of GDPR, 184 (39%) stated that they were ‘only familiar with the general concept’ and 214 (45%) had not heard of GDPR.

GDPR, which was first announced 2 years ago, will take effect on 25 May 2018 and will apply to the processing of personal data related to a EU natural person. It was noted that the definition of personal data is deliberately broad, as is the term ‘processing’ which encompasses the storage, collection and analysis of information. The new regulations will not only cover data collected from 25 May onwards, but also existing data already on file.

Non-compliance with the new regulations will incur penalties of 4% of global revenue or €20 million (whichever is higher). Fischer highlighted that liability will be dependent on an entity’s role in the processing of data, with ‘controllers’ being those ultimately responsible and ‘processors’ having secondary responsibility.

Although GDPR does not apply in the US, US-based companies collecting data from individuals within the EU will need to comply with the new regulations, regardless of where the data are stored. Further, although an individual has the right to request that their data are deleted, the technicalities of doing so can be a challenge.

GDPR applies to the processing of personal data for scientific research purposes and publications, so has a direct relevance to the medical communications industry. With GDPR coming into effect in a matter of days, Fischer advised the audience to know their data, systems and partners/vendors in preparation for these impending new measures.

Patient engagement and involvement in medical publications: how much and how far?

In this panel discussion Steven Rizk (Genentech), Bill Silberg (Patient-Centered Outcomes Research Institute [PCORI]), Beverley Yamamoto (Hereditary Angioedema, International) and Moderator, Karen Woolley (Envision Pharma Group), shared their views on how and why patients should be involved in the entire medical research process, including publications.

Woolley began with an overview of guidelines that reflect the importance of patients (eg from IFPMA, ICMJE) and advocate patient engagement in medical research (eg from PCORI). She also highlighted that as ‘persons with expertise in the therapeutic area’, the Good Publication Practice guidelines (GPP3) allow for patients to be involved in publication steering committees and that ICMJE does not prevent patients from being authors on publications.

The panel went on to discuss the benefits of engaging patients, noting that their participation can lead to more focused questions being addressed by clinical trials and more patient-centric publications. The panel then suggested ways in which publication professionals could involve patients, advising attendees to ask their clients whether patients have been included in publication steering committees, and to be aware of the EU regulation regarding lay summaries. Yamamoto felt that the inclusion of patients should be a requirement for funding requests, to demonstrate the pharmaceutical industry’s commitment to the involvement of patients from the outset.

The view that patients should have a more active role in publications was overwhelmingly shared with audience members, with most agreeing that a section on patient engagement should be included in GPP4. Woolley rounded off the presentation, by urging medical professionals to more actively reach out to patients, stating that the “time to change is now”.

Following this presentation and a coffee break, delegates had the opportunity to attend two of five parallel sessions, four of which are summarised below. The fifth parallel session was a guided poster tour that featured three delegate posters on the topic of ‘patient engagement’.

Scientific platforms 101: introduction to scientific communication platform development – a cross-functional approach

In one of four parallel sessions, Jamie Kistler (CHC Group) described how to successfully develop and implement a scientific communication platform (SCP). Kistler explained that the SCP “provides a strategic foundation for a product’s medical communication plan” and should be a continually evolving document, which is developed by a cross-functional team. Kistler outlined and shared examples of the key elements of a SCP:

• scientific pillars: key communication themes that help to prioritise the overall story flow
• communication objectives: highest-priority objectives for communication of disease state information and product attributes
• core scientific statements: high-level, standardised statements used to describe the disease state and product
• supporting statements: detailed statements linked to specific supporting references or data sources
• lexicon: clear, accurate and uniform vocabulary supporting the disease state and product.

The SCP should be based on scientific and clinically relevant evidence, taking into account internal factors relating to the product itself and the external environment, such as competitor products and stakeholder perceptions. Kistler noted that there may be global or regional differences with regards to factors such as reimbursement, regulatory bodies, patient groups and treatment guidelines. The SCP is likely to be rolled out to a large group of users and impact a wide range of activities spanning publications, public relations, medical affairs and regulatory information. Finally, the audience were presented with a series of case studies demonstrating how SCPs can be effectively used in practice.

Scientific platforms 201: successful implementation of a scientific communication platform

Building on the Scientific Platform 101 session in which Jamie Kistler (CHC Group) discussed the development and implementation of a SCP, in this session Todd Parker (MedThink SciCom), Noella Vang (Amgen) and Kistler focused on broader considerations related to a SCP.

Parker began by highlighting that training the wider team is critical to the successful implementation of a SCP. The process should involve the identification of key stakeholders and selecting the optimal training format (such as online training modules). The uptake and use of a SCP can be monitored through usage metrics across document types, gap analyses and, for training administered online, web metrics such as page visits and resources downloaded.

Vang continued by describing how the supporting statements and lexicon in the SCP should be used in other project types and activities. These include publications, congress presentations and booth activity, symposia, websites, mode of action videos, training materials, regulatory documents, medical information/FAQs and press releases. Case studies were shown on how the consistency of implementation of the SCP could be tested.

Kistler concluded the session by presenting a case study of the successful development and implementation of a franchise-level SCP. Elements of best practice included holding a cross-functional workshop that included senior leaders, producing a short and interactive PDF that accompanied the full SCP to increase accessibility, and conducting SCP training before key meetings. The measure of success was immediate internal and external uptake of the SCP.

Best practices in video abstracts

Michele Avissar-Whiting (Research Square) provided an overview of video abstracts, best practice tips, and their benefits. Citing examples of how the results of scientific publications can be misrepresented in the lay press, Avissar-Whiting suggested this disconnect may start with the publication itself, which is often full of jargon and scientific terminology. Video abstracts are a way of communicating complex scientific ideas and concepts in a more accessible fashion.

Video abstracts are often in ‘talking head’ format (‘blog’-style, filmed using free software such as Wistia, Camtasia or Spark, or professionally filmed); animated and infographic-style videos are also popular. ‘Talking head’ videos have a more personal feel, and selecting a dynamic speaker is recommended. Animation videos are engaging and are better suited to illustrate certain concepts, but the human touch is lost. Avissar-Whiting recommended that a video abstract should have a link to the primary manuscript and be:

• accessible: plain language, 2–4 minutes in length
• clear: clearly state purpose, methods and implications
• easy on the eyes: uncluttered data, engaging imagery
• easy on the ears: intelligible narration, music (when appropriate).

Avissar-Whiting explained that Cell Press were the first to widely adopt video abstracts and many other publishers have now followed suit. Video abstracts help authors and journals stand out from the crowd, promote communication among a broad readership or across disciplines and can represent added value for journals with high article processing charges. With the ever-increasing use of videos on social media and the internet, enhanced digital content is expected to continue to grow in popularity.

The role of RWE in a value-based world: who’s listening?

Melissa Hagan (Peloton Advantage) began the session by providing an overview of real world data (RWD) and real world evidence (RWE), their definitions, benefits and limitations, their use in health economics and outcomes research, and how they can enhance the value proposition of a drug. After reviewing the differences between randomised controlled trials (RCTs) and real world studies, she continued by outlining the potential sources of RWD, including administrative data (generally collected for reimbursement purposes), health surveys, electronic medical records, pragmatic clinical trials (prospective trials in a diverse population), and registries.

Discussing the advantages and disadvantage of RWD, Hagan noted that RWD may be used to confirm the findings or generalisability of RCTs and provide additional information which could not be obtained from RCTs, which in turn may lead to an expanded indication for a product and improved clinical care guidelines. While real world trials enable a diverse population to be assessed for a broad range of outcomes, they do have certain limitations (eg potential for bias due to the lack of randomisation and the potential for unknown/unmeasured confounding variables). However, by providing additional insights into the patient treatment journey, data on real world clinical effectiveness, and a greater understanding of economic value, RWD enhance the value proposition of a drug.

In the second half of the session, Judith Lenhart (Celgene) showed how RWD could be applied in a practical setting, using an example of patient care in elderly patients with acute myeloid leukaemia. The case study showed how RWD complemented clinical trial results by providing insights into the epidemiology, disease burden, treatment journey and resource utilisation in this setting, ultimately leading to a fuller understanding, to better inform treatment guidelines and improve clinical practice.

Following the parallel sessions, delegates could attend one of 10 roundtable discussions, which afforded delegates with the opportunity to have an in-depth conversation on their chosen topic in a smaller group setting. Day 1 concluded with the member poster presentations and reception.

Keynote address: preprints and bioRxiv

Day 2 began with the second keynote presentation of the meeting, delivered by Richard Sever (Cold Spring Harbor Laboratory Press; Editor, CSH Perspectives, bioRxiv Co-Founder) on the topic of preprints.

Preprints, unpublished manuscripts yet to undergo peer review, are not a new concept and have been established in the physics and math fields for over 25 years (eg arXiv). Preprint services are a great way of accelerating communication around data or advances in the scientific community. To illustrate this point, Sever provided an example of a preprint posted on bioRxiv (the preprint server for biology, established in 2013), which resulted in a successful research collaboration before the manuscript was published in a traditional peer-reviewed journal. Other benefits of preprint services include speed of communication, pre-publication feedback/discussion, visibility (which is especially important for junior researchers who are at an early stage in their career), and immediate availability of data to grant/hiring committees.

The uptake of the bioRxiv preprint service since its inception has been remarkable:

• ~24,000 papers posted (~1,400 posts/month)
• 30% revised
• 100,000 authors
• ~2 million views per month
• >60% papers are subsequently published
• ~1,000 journals have published biology preprints.

In addition, an increasing number of papers posted on preprint services are being tracked on the commenting platform DISQUS, with many other preprint discussion forums now available (eg preLights, PREreview, Peer Community In, Academic Karma and PubPeer).

The increased use of preprint services has led to changes in behaviour (more biologists posting, reading and citing preprints), policy (most basic research journals allow preprints), rules (funding bodies allow preprints to be cited in grants), and culture (the latest data are presented at meetings).

All scientific disciplines are covered by preprint services, with the field of neuroscience soaring ahead in the uptake of preprints and the field of biology likely to follow suit. Since the creation of bioRxiv, a number of other preprint services have launched, including ChemRxiv, PsyArXiv and SocArXiv, with MedRxiv (a proposed partnership between Cold Spring Harbor Laboratory, the Yale University Open Data Access [YODA] Project, and the British Medical Journal) set to launch later this year.

Sever ended his presentation by highlighting some of the screening issues faced by preprint services, including ethics (pseudoscience, plagiarism, patient identity) and ‘do no harm’ considerations (dual use research, vaccine safety, infectious disease transmission, drug regimens, toxicity/carcinogenicity).

Debate: do preprints have a role to accelerate the communication of industry-sponsored medical research?

Following his keynote presentation, Richard Sever was joined by Jon Druhan (AstraZeneca) and Joseph Soloman Ross (Yale University) in a thought-provoking panel debate, moderated by Brian Falcone (Oxford PharmaGenesis), on the value of preprints. Specifically, whether preprints have a role in, and will accelerate the communication of, industry-sponsored medical research.

When questioned on who stands to benefit or lose out from the use of preprints, Druhan suggested HCPs, patients (ultimately) and the pharmaceutical industry could all benefit. There is a drive to disclose data, including negative study results, as soon as possible and preprints would help with this. Moreover, preprints can help disseminate data to a wider audience.

When discussing possible misuse or irresponsible use of preprints, it was suggested that misuse was more likely to be associated with the lay media rather than with the authors themselves. The lack of peer review for preprints was also raised and it was questioned whether quality is being sacrificed for the benefit of speed. The panel noted that preprints do not remove the need for peer review but should be viewed as an avenue for rapid data dissemination, and should be clearly marked as such to avoid confusion. The panel considered how preprints will affect follow-on publications, with Sever noting there is some debate around whether preprints are citable. The panel agreed there was minimal risk of preprints spreading misinformation.

Weighing up the pros and cons, the panel believed that preprints provide pharmaceutical companies with a great opportunity to fulfil their obligation to disseminate data. However, with preprints starting to be used by the pharmaceutical industry for early research (modelling, basic science, toxicology), and the uncertainty surrounding whether regulators will view preprints as pre-approval promotion, they noted that it is important to ensure appropriate policies are put in place.

To conclude the session, the audience voted on two questions related to data dissemination via preprints: while most believed that all data (from preclinical to phase III) should be shared using preprints, most also felt that only preclinical/basic science could be shared.

Ensuring transparency: the future of authorship credit

In this talk, Monica Bradford (Science, American Association for the Advancement of Science [AAAS]) focused on the standards for authorship and contribution. Based on an increased demand for more transparency around authorship within the scientific community, Bradford described a workshop organised by the National Academy of Sciences in February 2017 and associated manuscript that provided recommendations for authorship and responsibilities. Authorship implies both credit and accountability, but the trend of having multiple authors on a paper means it is sometimes difficult to establish individual contributions. Furthermore, authorship conventions can vary between scientific disciplines, which causes confusion.

Bradford outlined the recommended criteria for authorship. These are based on ICMJE recommendations, but they have been generalised to encourage wider adoption. There are additional expectations for corresponding authors, who must:

• ensure all authors received/approved the manuscript prior to submission and received all substantive correspondence with editors as well as the full set of reviewer comments
• verify all data, materials, and code comply with the transparency and reproducibility standard of both the scientific field and the target journal
• ensure original data, materials and code are preserved and retrievable for re-analysis
• confirm that the paper accurately reflects the original data, materials and code
• foresee and minimise obstacles to the sharing of the data
• ensure the author group is compliant with best practices.

Two systems are now commonly used to help track authorship and Bradford encouraged their use. These are unique digital identifiers for authors (ORCID) and the Contributor Roles Taxonomy (CRediT) to track author contributions to the work. Many major journals have adopted ORCID as standard for first, corresponding, or all authors, and some (eg Science journals) are now implementing the use of ORCID and CRediT during manuscript submissions. When ORCID and CRediT are used together, author records can be reliably linked to publications and author contributions can be captured in the journal’s metadata, thereby enabling an individual’s author contributions to be tracked across publications and time. The Transparency in Author Contributors in Science (TACS) website is a resource showing authorship and contributor criteria, ORCID requirements, and CRediT policies of various journals.

Bradford concluded by emphasising the need to promote integrity and transparency in medical publishing and how clarifying the rules/norms will help all stakeholders to achieve this.

Following this presentation and a coffee break, delegates had the opportunity to attend two of five parallel sessions, one of which is summarised below. Two of the parallel sessions were guided poster tours that each featured three delegate posters; one tour was on the topic of ‘communicating more effectively’ and the other on ‘practical matters and professional practices’. The latter included a poster from The Publication Plan entitled ‘How do medical publication professionals engage with online news resources?’ which ISMPP members can view here.

Journal rejections: strategies for resubmission

Journal rejections are costly, both in terms of time and budget. In this session, Caroline Halford (Springer Healthcare) and moderator Gary Burd (who presented slides on behalf of Bradford Challis [Janssen]) provided their perspectives on how to minimise journal rejections. Presenting data from an analysis of journal rejections (n=34) at Janssen, Burd showed that the two most common reasons were (i) the paper did not meet the journal’s priority criteria and (ii) that the topic was not appropriate or in scope.

Recommended approaches that could limit these reasons for rejection include:

• research the journal’s scope and rejection rate
• obtain consensus on target journal early and encourage authors to be realistic
• presubmission enquiries can help gauge an editor’s interest
• draft a comprehensive cover letter along with the submission
• provide previous journal comments, indicating which have been addressed and why other comments cannot be; for issues that cannot be fixed, be transparent and consider whether they can be addressed within the discussion/limitations sections of the paper.

Focusing on the presubmission enquiry in more detail, Halford provided information on the editor’s perspective on the level of detail to include. Information such as author names, drug name, drug class, therapy area, region of development (eg US, EU, Rest of World), whether the data have been published in abstract form, how the data extend current knowledge, limitations of the research, and anticipated submission timelines were all considered to be important.

The parallel sessions concluded the morning portion of the program.

A summary of the second half of the meeting is available here.

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By Aspire Scientific, an independent medical writing agency led by experienced editorial team members, and supported by MSc and/or PhD-educated writers

The 2018 Annual Meeting of the Medical Affairs Professional Society (MAPS) was held in Miami, FL on 25–27 February. The theme of the meeting—reflected throughout a busy programme of keynote presentations, expert panel sessions, hot topics chat groups and workshops—was ‘Strengthening Medical Affairs Impact for Improved Patient Outcomes: Building our Future Together’.

The meeting was opened by current MAPS president, Kirk Shepard (Eisai), who provided a recap of the history of MAPS so far, beginning with the society’s formation in August 2016. MAPS was created in response to the need for an organisation that could act as an advocate for medical affairs within the pharmaceutical, biotechnology and medical device industries, as captured in the society’s vision statement: ‘Elevate the role of Medical Affairs to be a partner with its Commercial and R&D colleagues, and lead the industry in the education of customers on the safe and appropriate use of products for the benefit of patients’. MAPS has experienced rapid growth since its foundation, with its current global membership representing over 100 small, medium and large companies.

A key aspect of the meeting was the ‘Challenges and Solutions Workshops’, which are summarised below.

Building a medical affairs acumen tool to articulate functional value to business partners

New challenges in this time of change in the Life Sciences require bold thinking. Medical affairs (MA) are integral to industry’s long-term impact in terms of strategic acumen, innovative thinking and technical expertise, yet the importance of communicating this value is often overlooked. This interactive workshop demonstrated how MA professionals, in collaboration with their colleagues, can develop new tools to build recognition of their value by business partners and stakeholders.

The premise of this tool is to allow MA professionals to articulate the value of their expertise, ask the right questions and contextualise their roles for the business. Delegates were encouraged to consider who they interact with, which peers they should aim to influence and how well they communicate their value.

It was concluded that MA are at the centre of care and have an opportunity to reposition themselves as drivers of change in today’s environment. MA professionals should master talking points and triggers to drive conversations about patient outcomes that resonate with internal and external executives. This workshop laid the foundation for a valuable, practical tool to support the growth and success of MA, a tool which MA professionals can develop with colleagues by considering key value drivers. This tool can also be used to improve leadership agility and performance and crucially, can accelerate the success of MA in improving patient outcomes.

Capabilities and competencies in the new MA: A roadmap to success

In recent years, MA has evolved dramatically from a local support function, often embedded within the commercial organisation, to a fully-fledged strategic partner acting as the bridge between Research and development and Commercial. MA professionals have adapted well to meet the changes in the scope and expectations of MA function in pharma, yet they are faced with a challenge in terms of the new capabilities and skills necessary to maintain this momentum. This workshop explored the critical competencies now required by MA professionals on their road to success:

• learning agility
• business leadership
• strategic vision
• emotional intelligence and communication skills
• deep understanding of compliance
• scientific and technological thought leadership.

So, how can MA professionals develop these skills? Using the metaphor of a ladder, this workshop highlighted the importance of seeking transfer between divisions and functions prior to pursuing a senior leadership career. In other words, a career ladder is stronger with a broader base.

The importance of continued learning was also discussed. MA learning and development initiatives should be designed and implemented carefully, identifying and prioritising critical gaps to develop a medical capabilities framework curriculum. Important factors to consider are the suitability of venues for delivery of such initiatives, the use of virtual learning and audience-directed personalisation of learning. Engagement is key to all of these factors.

Overall, there are high future expectations for MA. Improved understanding of what the newly required capabilities and skills are, and their continued development through effective learning initiatives, will be essential for success.

Let’s get digital. A step-by step guide to building your next tech program: Best practices and unmet needs in MA

The challenges associated with the rapidly evolving landscape of MA was a key theme in these workshops, and this one tackled the somewhat-daunting availability of innovative technology solutions. Digital platforms can provide a novel approach to solving important problems in MA. However, they can seem complex and overwhelming to an unfamiliar user.

This workshop introduced learners to current and future trends in digital media consumption by healthcare professionals (HCPs) and the pharmaceutical industry. Equipped with this understanding, MA professionals can exploit emerging technology to engage key stakeholders and generate innovative ideas for valuable new programs. Delegates were encouraged to discuss unmet information consumption needs, both within MA teams and for key stakeholders, and to identify design programs to address these needs. These ideas were discussed in the context of best practices in digital delivery in MA.

To summarise, digital platforms in MA can unlock the potential to solve important problems and address unmet needs. MA professionals should be able to define their current practices and future state vision, and facilitate the rapid development of MA technology solutions.

Maximising medical science liaison (MSL) value with internal customers: Executing field activities aligned with corporate strategies

A corporate strategy is the ultimate goal, objective or target set by a company to achieve critical success factors. Aligning MSL activity with corporate strategy is important; this ensures the effective use of MSL resources and demonstrates the value of MSL activity to stakeholders. However, field-based medical teams are often disconnected — both physically and strategically — from ‘corporate’. In this workshop, delegates explored how to maximise MSL value though insight gathering with corporate strategy at front of mind.

MSLs hold critical strategic value as integrators between internal and external stakeholders, and are in a prime position to gain crucial actionable intelligence. Through their numerous activities, such as publication planning, market research and competitive intelligence, MSLs gain scientific, clinical, therapeutic and competitive insights, as well as insights into potential barriers to success. Using these insights, MSLs should provide input during the development of scientific message platforms (SMPs), which lay the foundation for communication strategies and are the heart of any product-related communications supporting a company’s product usage and value. SMPs define clear, coordinated and resonating communication points that can be applied to all tactics and are therefore a key component of corporate strategy.

Communication was a key theme in this workshop. MSLs should ensure that communication is not a one-way dialogue from the company to its external stakeholders; strategy alignment and stakeholder consensus can be achieved through early cross-functional communication. Furthermore, actionable intelligence obtained by MSL insight gathering must be documented and communicated to the right audience, and the internal audience must play in role in deciding how this information is disseminated. To conclude, if MSL activities are aligned with corporate strategy, are well documented and effectively communicated, the value of MSLs can be self-evident.

Global alignment in an era of complex therapeutic portfolios: Is it possible to achieve a borderless, unified, scientific voice?

This workshop was centred around the creation and communication of complex, multi-product, multi-indication SMPs that span across varied geographic regions and regulatory landscapes. The challenges and opportunities associated with developing a unified scientific narrative were discussed. Clearly, the complexity of scientific communications coupled with unique regulatory and cultural differences between regions can confound alignment across a global MA organisation. Delegates were introduced to best practices and encouraged to consider the value of early involvement of global stakeholders in development of scientific narratives in a global MA setting.

Facilitating the data journey in MA: Applying analytics and getting answers

Data, analytics and insight generation are transforming decision-making in the MA environment. This workshop opened with a discussion of the ‘analytics value chain’, whereby better decisions and improved outcomes can be driven by first asking intelligent business questions and then seeking answers in the data. In other words, while a project moves from left to right, our thinking must sometimes move from right to left.

Delegates explored applications of the ‘data to insight’ model, which encapsulates the fact that data have little utility in isolation, without interrogation or interpretation. Data must be optimised, processed and contextualised to generate information, organised and structured into knowledge and finally, applied to gain insight. It is important that MA professions are familiar with frameworks for identifying data, distilling it into useful information and generating insight. Furthermore, systems should be in place to ensure MA teams remain up-to-date with emerging data and competitor information in their therapeutic areas, such as using keywords or scoring mechanisms.

Learning is another aspect of MA that could be enhanced through the use of analytics. For example, the Kirkpatrick Model is a worldwide standard in evaluating the effectiveness of training and educational programs. Analytics are also valuable in the evaluation of scholarly versus online impact of a publication, the latter of which demonstrates important ‘social’ impact on clinicians, patients and advocates. Finally, analytics offer a crucial means of identifying key opinion leaders (KOLs) through the use of bibliometric and sociometric approaches.

The workshop concluded with a summary of the ‘Blade’ training tool: Begin with the end in mind; Look high and low for data; Analyse for meaning; Determine who benefits; Evaluate the outcome. MA professionals should utilise such tools to apply data-centric thinking in their work environment.

Thinking smarter: Multichannel communications and behavioural science – the perfect partners for smarter communications

Behavioural science gives an insight into how people interact, react, process data and make decisions. This workshop discussed how behavioural science can be applied alongside multichannel communications to promote positive behaviour change among stakeholders and to help establish or reinforce critical relationships. The take-home message was simple: smarter communications are the key.

Understanding the behaviour of HCPs, in particular with regards to decision-making, can have a real impact. The majority of our decisions are made subconsciously using ‘autopilot’, which helps us to act quickly and efficiently. However, clinical decisions made on autopilot can lead to errors and be based on natural tendencies of cognitive bias, such as following peers and existing beliefs, focusing on losses more than gains or thinking in the short term. Behavioural insights into these tendencies among stakeholders can be used to steer communications strategies. In order to personalise communications on the basis of such behavioural insights, it is essential to develop multiple personas for all relevant stakeholder groups. Numerous factors should be considered, including areas of interest, potential biases and communications channels utilised.

To summarise, MA professionals should rethink their approach to medical communications and harness behavioural science as a springboard to develop multichannel communications and engage all stakeholders. Communications developed with behavioural insights in mind should be smart, personalised and adhere to the ‘EAST’ principles: easy, attractive, social and timely. This strategy allows drivers of and barriers to decision-making to be identified and addressed, thus providing optimised conditions for positive behaviour change.

Payer perspective in use of real world evidence

Real world evidence (RWE) plays an important role in supporting access decisions by payers. For example, RWE informs assessment of relative value and facilitates evaluation of predicted versus actual use and outcomes. This workshop explored the evolving role of MA in market access-related payer discussions; MA are now involved throughout all three phases of RWE activities: evidence strategy, evidence generation and scientific exchange. Delegates were encouraged to consider, from the payer’s perspective, the roles that MA should play in leading or supporting the use of RWE. Three case scenarios were presented to facilitate discussion:

In case #1 (disease burden), MA could use or gather RWE to help payers understand how this treatment could impact on patients, such as from a quality-of-life perspective. For case #2 (change in access), in order to support forecasting, formulary and utilisation management and contracting, MA would need to pre-empt the types of evidence payers might request prior to FDA approval in the broader indication. Finally, studies to address case #3 (comparative effectiveness) would require a very high level of scientific rigor within a real world population. To help address this evidence gap, MA could support by providing key design- and data-related considerations.

These scenarios highlight the need for MA teams to strengthen their understanding of payer perspectives and their consideration of RWE in reimbursement decisions. Furthermore, MA should be able to apply an evidence development framework to evaluate the potential value of RWE programs to payers.

OK, so what’s next?: How MSLs can take charge of their career development

The availability of MSL career path choices, and the resources required to follow these, are key factors in job satisfaction and retention. However, MSL career paths are often indiscernible. This workshop outlined how MSLs can take charge of their career development using a career development plan checklist:

1. Conduct a critical self-appraisal to identify strengths and weaknesses
2. Categorise short term career goals (1–2 years) in terms of promotions, training and advanced opportunities beyond the immediate MSL environment
3. Identify gaps by evaluating competencies and seeking feedback
4. Address gaps in competencies by using the necessary resources and securing support from management.

Each of the above requires a thorough understanding of MSL competencies. The core MSL competencies are scientific or technical expertise, an ability to communicate effectively, strong problem-solving skills, self-motivation and flexibility. Advanced competencies, which have become desirable as the MA landscape has evolved, include the ability to interact with emerging customer groups, emotional intelligence and multidisciplinary expertise. For example, emotional intelligence — coined ‘EQ’ — encapsulates advanced self-awareness, self-management, social awareness and relationship management.

The career plan checklist above highlights a number of ways in which MSLs can strategically pursue career development. MSLs should conduct a frank self-assessment from the perspective of those responsible for promotion decisions. Obtaining 360° feedback from trusted peers is also important, particularly from those who have already travelled down a desired career path. Competency gaps identified using these approaches should be addressed by harnessing the power of networking and by using online information sources, such as job aggregator sites and MSL blogs. Finally, MSLs should ensure their management is in agreement with their aspirations; after all, direct managers are the single most important promotion advocate.

Measuring the impact of medical information: New metrics for the ‘Medical Affairs 2.0’ paradigm

The shifting of the MA industry to a new, data-driven paradigm has been termed ‘Medical Affairs 2.0’. Medical information is now readily available for key stakeholders to search for directly, 24/7 and across a plethora of digital resources, such as Wikipedia and Medscape. This has reshaped the way in which corporate R&D evaluate their pre-launch efforts. So, how is it possible to keep track of a digital pulse that is constantly moving, available in all major languages and spread across the internet? This workshop explored the new MA strategies and alternative metrics being employed to effectively assess the impact and reach of pre-launch scientific communications.

The metrics landscape has evolved dramatically. Metrics now go far beyond traditional journal citation metrics, and ‘interactive’ impact can be measured through web analytics and engagement with digital platforms, such as news and social media. These indicators of engagement with online research sources, termed ‘alternative metrics’, have assumed a critical position in facilitating impact assessment in digital spaces. For example, new approaches to gauging medical publication impact on social media domains include the use of Altmetrics and Plum Analytics.

The emergence of alternative metrics coincides with a core theme of MAPS 2018, which is to address opportunities and challenges in optimising communication and engagement. Alternative metrics go beyond traditional citation impact; not only do these metrics offer far quicker — sometimes immediate — timelines, they can also assess the impact on a wider audience, including patients and media. The potential MA utilisation of such metrics also extends to other areas, such KOL identification, share-of-voice analyses and information dissemination strategies.

Managing up/down boomers, genXers and millennials in MA

The landscape of our workplace is ever-changing, and the days of generational hierarchies are gone. ‘Boomers’ (1946–1964) have begun to retire, ‘GenXers’ (1965–1980) are progressing to senior leadership and ‘Millennials’ (1981–2000) are entering the workplace. In this workshop, generational differences and similarities in the workplace were explored, and the importance of identifying generation-specific motivations and attributes was highlighted for the optimal management of a multigenerational team.

Members of different generations grew up in eras associated with contrasting moods and messages. Boomers — the generation of post-war optimism, exploration and achievement — have earned a ‘live to work’ reputation but have been rewarded with delayed retirement. On the other hand, GenXers grew up in an era where autonomy and self-reliance were respected traits, and this generation holds family values and work–life balance in high regard. Millennials are considered to be high performance and high maintenance; technology is an integral part of their every-day lives, yet their upbringing has grown them accustomed to constant positive feedback.

To ensure a thriving, successful team, there is a need to appreciate the distinguishing values, expectations and motivations of each generation. Managers should aspire not only to manage but to lead by alignment in a more agile and collaborative manner. Tools should be offered to maximise efficiency and productivity across all generations within a team, while also retaining and attracting high-performing workers. Overall, rather than generation gaps being a source of stress or conflict in the workplace, the diversity of a multigenerational workforce should be harnessed as a source of creativity and productivity.

Data visualisation and multichannel delivery – let the numbers speak for themselves

The average attention span of an adult has been estimated to be approximately 8 seconds. In our digital age, data must be used to “tell a story” that resonates with the target audience in a concise, clear and engaging manner. Visual perception plays a key role in the interpretation of data, and different data sets and communication channels require strategic selection of visual formats to achieve the greatest impact. This workshop educated delegates on how best to visualise data in scientific communications:

• find a story
• only visualise data if it helps to tell the story
• use one story per table/figure
• always show a legend
• if a story has many chapters, guide the reader through them
• sections within a chapter should be broken into manageable chunks.

When translating data into a visual format, it is critical to factor in the desired impact of the take-home message. When is a scientific message best conveyed using a table? When is a graph preferable, and which type?

A picture doesn’t always paint a thousand words; if values need to be looked up or an intricate level of detail is required, a table is the best way forward. However, graphs depict messages not visible in a table and better showcase the ‘big picture’, trends and differences. Alternative graph types have specific pros and cons. For example, column charts are easy to read and clearly display patterns, but they can be visually dull and uninteresting. On the other hand, bubble charts are elegant and lend themselves well to colour but, like pie charts, can make value comparison difficult. Delegates were encouraged to think beyond the basics. For example, a 3D waterfall plot is an interesting alternative to portray tumour response data. Overall, the value of strategic data visualisation should not be underestimated in producing impactful scientific communications.

Your science communication platform has been built. So, now what?

Science communication platform (SCPs) are integral to scientific communications and serve as a repository of evidence supporting pre-clinical, clinical and value statements. An effective SCP has well-supported content that is grounded in the literature, is internally aligned with the core communication approach, assists in prioritisation and improves efficiency upon implementation. Once a strong SCP has been built, it is essential that all stakeholders are aligned with the content and committed to its use. This workshop outlined the steps that can be implemented to achieve such a goal.

Step 1: Encourage adoption. An SCP must warrant leadership buy-in, and it is important to consider the ‘who, when, what and where’. Leadership involvement should be invoked at the right time and obtain commitment from the right stakeholders through customisation for individual functional teams or geographic regions. Companion materials should be generated that define the strategy, strengthen the scientific statements and support downstream activities.

Step 2: Ensure relevance and usability. SCPs are ‘living documents’ and can be influenced by new data, changes in programs or shifts in the landscape. Updates should be performed at regular intervals to maintain relevance. Furthermore, SCPs should always be presented in a user-friendly manner that enhances learning.

Step 3: Train. Training should be rolled out to the right people, at the right time and in an effective format, ideally complemented by the distribution of quick reference guides. For ongoing training, a process should be defined and the responsible parties identified for delivering such training.

To summarise, these steps can reinforce the importance of an SCP throughout an organisation and crucially, can facilitate widespread and sustained SCP adoption

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By Aspire Scientific, an independent medical writing agency led by experienced editorial team members, and supported by MSc and/or PhD-educated writers