• Health technology assessment challenges in assessing clinical and cost effectiveness of cell / gene therapies.
• Who pays? Healthcare system determinants of funding/reimbursement paradigm.
• Affordability: Pricing and budget impact challenges

• Regional diversities in approaches to public funding decision making.
• Comparative measures to enable informed allocation of company strategic efforts.
• Analysis of public funding decision making practice as a tool to identify risks and opportunities and to provide unbeatable arguments to CEE decision makers

• Is differentiation possible or even necessary in the biosimilars market? Although the impetus for a biosimilar development originally might have been solely economic, we argue thatmmanufacturers should devise a value proposition for biosimilars that moves beyond price, demonstrating value to payers, physicians, and patients.
• Presenting a unifying value framework as a guiding tool for biosimilar manufacturers supporting internal processes - for example: Building internal business cases for differentiating concepts with the end goal to develop a value-enhancing strategy.

• The US is essentially a “secondary” market for biosimilars; as such, what can be learned from other markets?
• The business model for biosimilars, neither branded or generic products, is likely to be different in the US than in other markets, especially when it comes to pricing. How will business models be structured and operate?
• With only 5 applications and 1 approval to date, there isn’t yet a clear regulatory pathway for biosimilars in the US. What might that pathway look like when more fully developed?
• With originators of branded products making more defensive manoeuvres in the US than in other countries, lifecycle management of biosimilars is likely to be different in the US than elsewhere. What differences will there be?

An interactive session exploring the lifecycle of a drug including:

• Comparison of regulatory and HTA agency clinical trial evaluations
• Impact of the label indications on the HTA review process
• HTA opinion on submitted evidence

• What do we mean by RWE?
• Usefulness and limitations of RWE in supporting medical device reimbursement.
• Case studies of the successful use of RWE in device reimbursement.
• Summary.

• Early stage or commercialisation: When is the right moment to focus on economic evidence?
• Identifying what decision-makers are looking for.
• Less is more: Identifying the relevant data to support value claims.
• Case example: From evidence to compelling value proposition.

• The changing US landscape.
• Evolving care delivery and incentive models.
• Implications for innovators.
• Organising to demonstrate value in the new environment

• How applicable is MTEP outside of England?
• How does MTEP compare to other MedTech HTA?
• What benefit is there to submitting to MTEP?

How do we avoid the greatest threat to carefully crafted medical strategy – the inevitable boiling down of delicately nuanced arguments into bullet points, charts and tables? To the outside observer it appears to be largely generic and is hardly reassuring to senior stakeholders who must bless it, or clear to those who must ultimately implement it. This presentation will discuss how to create and communicate your medical strategy in a way that informs and inspires the reader.

• 2015 research highlights: HCP demand versus industry supply of medical content.
• Types, sources, formats and funding of medical content: HCP behaviour and preferences.
• Closing the gap: Overcoming challenges to meeting audience needs and increasing engagement.
• Independent platforms: Why and how to work with them for targeted audience reach.

• Findings from an analysis of nearly a million data points comprising 1000 KOLs across 12 therapy areas.
• Which quantitative metrics/characteristics correlate most closely with “KOL status”?
• Disparity between qualitative & quantitative metrics: Does Qual add anything beyond the Quant?
• What about identifying specific KOL subgroups? e.g. Digital KOLs,Rising stars & Orphan diseases.
• How to apply this research to create in-house protocols for firstpass identification and validation of KOLs, easily and quickly?

• Address key medical affairs communication challenges: Case study review.
• Disrupt traditional conventions to optimise medical strategy, hit communication objectives and maximise ROI.
• Integrate digital technologies to gain better insight, foster more valued engagement and vitalise healthcare professional education.
• Empower your teams to drive effective, consistent and compelling external communications.

• Dynamic mosaic of stakeholders, strategic drivers and key challenges.
• ‘Late becomes Early’: Changing time frame of late-phase research.
• The concept of best practices as a ‘Net Force’.

• When would you choose a retrospective design over a prospective design when planning for a PASS as part of a postmarketing commitment?
• What have we seen in the PRAC feedback in the past year?

• Using existing information and prospective research in evidence generation.
• Strategic planning and tactical decision making in RWE datageneration and utilisation.

Research questions around real-world evidence development can include a breadth of evidence needs including the prevalence, clinical characteristics, treatment patterns and effect, etc. of a given cohort and/or sub-cohort. Addressing the question(s) can be complicated by the size/characteristics of the cohort and the complexities of the health system. Consequently, we propose a practical and feasible approach to assessing study design options which we believe will meet both the research objectives as well as consider the realities of timelines and budget constraints. We will discuss a number of options for study design and cohort identification, including use of administrative claims and/or electronic healthcare records, sitebased recruitment, and web-survey panelists. We will identify a set of common methodological challenges and discuss the relative strengths of each approach in addressing these issues.

Life sciences organisations need to dramatically reduce analytics time and speed up clinical interventions, but most still rely on shipping physical disks due to inherent problems with existing networks and transfer protocol inefficiencies. Spending days to transport data is not a viable option, this session will explore technology infrastructure for file transfer that will catalyse the transition from 1GbE to 10GbE and beyond.

• Enabling geographically distributed collaborative teams to exchange huge data sets at maximum speed, regardless of distance and network conditions.
• Utilising proven, secure and reliable transfer technology, widely adopted for business-critical data movement.
• Transferring large data sets, including next-generation genomic sequencing sets, amounting to hundreds of gigabytes.

The MedTech industry is at an inflection point. Healthcare providers at every level are professionalising their procurement and creating tectonic shifts in their demands on your pricing, sales, and tendering and contracting operations. While the industry appears to be aware of these shifts and what the impacts will be, many MedTech companies are struggling to identify and prioritise the changes they need to make to stay ahead of these trends without sacrificing revenue or growth.

• Early stage or product launch: When is the right moment to focus on value?
• Identifying the key value propositions to drive the market.
• Building the relevant economic data to support value claims.
• Case example: From feature-centric to value-based model

• How pharma can utilise digital programmes to support publication strategy.
• Using materials and real world evidence to reach new KOL audiences.

• Compliance and transparency regulations are causing many pharmaceutical companies to re-evaluate how they pay and partner with external experts.
• How do we define a KOL and what are models for effective KOL engagement in the changing environment?

• In the context of spending constraints, and aggressive go-tomarket timelines, the generation of compelling real world evidence of the effectiveness, safety and value of a novel therapy or medical device has never been more challenging.
• Peri- and post-approval evidence requirements, which vary markedly across countries, are increasingly demanding both in terms of data needs, and total research and development cost.
• To navigate this reality, a comprehensive evidence development plan that systematically identifies gaps, and organises and prioritises a synergistic program of scientifically robust real world studies in support of market access is of paramount importance.
• An evidence development plan that is based on a thoughtful and stepwise multi-national data and feasibility assessment strategy, will result in the right evidence to support a product’s value proposition while optimising cost savings and timeline efficiencies.
• Data strategy and feasibility assessment case studies alongside a roadmap for cost and timeline savings in the context of technology enabled programs of research will be presented.

• Why linking medical affairs strategy and capability together is important.
• How to build capabilities in medical affairs functions at different stages of their growth.
• Future challenges in building medical affairs capability.
• Sharing case study examples.

• Assessing the market through a medical affairs lens.
• How market specific characteristics influence medical affairs capabilities.
• How the market dictates medical affairs size and structure.
• How specific roles within medical affairs vary due to market characteristics.

• Payer perception/considerations of innovative pricing in the context of health budget pressures.
• Analytics overview of geographies and therapeutic areas where key changes are occurring.
• Key strategic lessons over how these agreements are being designed.

• How do payers evaluate products in an increasingly crowded marketplace.
• How successful are companies in getting new products approved?
• Comparing major payers: Where are similarities and where are the difference in their evaluations?
• Do companion diagnostics make a difference in the approval success rate?

• Review of post-marketing requirements in the USA, Europe, and South Korea.
• How to interpret the demand of the authorities,
• Proactive planning to drive design.
• Real-world case studies from the USA, Europe and South Korea.

• Differences between real-world evidence studies and randomized controlled trials.
• Asia Pacific country specific examples of real-world evidence studies.
• Local regulations on study approval and execution.
• KOL value and working with investigators in APAC.

• How the complex characteristics of biologics (and biosimilars) contribute to perceived value to different stakeholders.
• The salient issues facing upstarts (marketers of biosimilars) and defenders (marketers of “original” biologics) in communicating comparative worth to stakeholders.
• How MCDA modelling methods can assist both groups in better defining and communicating value.

• Overview of cell & gene therapies.
• Health technology assessment & cost effectiveness challenges.
• Who pays? Healthcare system determinants of funding / reimbursement.
• Affordability: Pricing and budget impact challenges.
• Lessons learned: Early case studies.

Market access is value contextual, thus using RWE to secure appropriate market access allows evidence to reflect effectiveness in the real world where protocols may not be followed, patients don’t take their medications, and where every population is viewed as unique requiring data to reflect that specific population . This presentation walks through the reality of developing RWE for an EUmarketed, post-anaesthesia medication using a retrospective observational study format and demonstrates the importance of thinking carefully about your strategy (the benefits, risks, costs and mitigations) before embarking.

• The problem: High investment with limited reach and high output that is short-lived.
• The objective: Capitalising on events to extend the value through sustained targeted engagement.
• The strategy: An end-to-end programme designed to be multicontent, multi-event & multi-channel.
• The evidence: Research and metrics that supports this approach and better outcomes.

A plethora of studies suggest that an astonishing 50 – 75% of all CRM implementations fail in some form. So we started our KOL CRM development programme with the assumption “why should ours be any different?” Our two-year case study highlights the many challenges we (vendor & our clients) encountered in the medical affairs context, our many failings, and the innovations we built to overcome them. We’ll also present a simple framework for Medical Affairs to help maximise the success of CRM implementations to boost external expert management.

• Assessment of viable online solutions to KOL stakeholder engagement in the pharmaceutical industry.
• Review major pharmaceutical company cases using web-based engagement solutions.
• Understand a variety of KOL engagement scenarios, shared learnings and best organisation practices for success.

• How companies can successfully navigate the EHR and secondarydata landscape.
• Designing and implement studies that reap the benefits of combining EDC and EHR data to answer key questions.
• Transforming the theory of real-world hybrid studies into reality.

• Real-world data sources: What information needs can they address?
• Considerations, potential challenges and solutions.
• Types of hybrid studies with case studies.
• Chart reviews with additional data collection from patients.
• Recruitment of patients from registries for burden of disease outcomes.
• Linkage of different types of registries with the addition of patient interviews.

• Why and when to run them?
• Benefits and pitfalls.
• Strategic considerations.
• Case study: The French ATU programme.

• Review of benefits of NGS and challenges associated with securing payment for multiplex testing technologies.
• Overview of EU5 payment systems for diagnostics.
• Case studies: Payment for NGS oncology applications in Germany and France.
• Case studies: Reimbursement initiatives for non-invasive, prenatal testing.
• Best practices/insights for innovators.

• Identifying decision-makers’ needs.
• Assessing the relevant data to support claims.
• Building a concrete value story.
• Next steps: Teams, not tools, demonstrate value.