No longer is the patient expected to be a silent bystander in the healthcare process. Increasingly, the patient stands at center stage, surrounded by healthcare providers, payers, educators, and other players.  This new patient-centricity—so crucial to quality healthcare—elevates the role of COMMUNICATION in the pharmaceutical industry. COMMUNICATION—between physician and patient, between pharmaceutical company and physician, between pharma and external regulators, and more —  and, as the hub of all that COMMUNICATION, Medical Affairs holds the reins to success, providing added-value to both internal and external stakeholders . This session will examine the factors that foster effective COMMUNICATION, both externally and internally,  and will provide data-driven case-based insights and examples.

• Overview of main payment mechanisms
• Basics of hospital financing
• Activity-based payments: DRG
• Value-based payments
• Shift to value: is it happening now?

• Quantification of the unmet need for SUS.
• Development of cost-effectiveness and budget impact analyses.
• Potential scenarios for SUS with inclusion of technology.
• Project results and next steps.

• Evolution of cost-containment tools in Latin America: reference pricing, health technology assessment and harnessing competition through procurement

• Rise of health technology assessment as a decision-making tool in Latin America and implications for manufacturers looking to demonstrate the value of their innovation

• Designing successful market access strategies that meet growing payer expectations 

• Payer expectations.
• The regulatory landscape.
• Access to data.
• The Increasing voice of the patient.
• What is in store for sponsor-CRO partnerships?

• Understand how these programs have been used extensively by pharma companies to address unmet medical need, but have broader market access benefits including another source of real world data.  This session will help people understand the basics about EAPs, the current landscape and industry trends around EAPs, and the types of data that various companies are capturing.  A case study will be provided.

• A new paradigm: Introduction to blockchain technology and its applications in healthcare
• Digipharm: overcoming barriers to innovative pricing solutions and value based reimbursement
• Innovative evidence generation and the impact on pricing & reimbursement

• Aggregated budget impact of these therapies
• Funding and contracting approaches
• Value-based thinking

There is a well-recognized long-standing decline in R&D productivity in the pharmaceutical industry which has driven exploration of new approaches to the clinical development of pharmaceuticals.  These include innovative randomized controlled trial designs, including adaptive, umbrella, and basket studies. Adaptive trials, perhaps the best established of these, have already been the subject of guidance documents by both the European Medicines Agency and Food and Drug Administration. However, in many markets it is the reimbursement hurdle (rather than the regulatory hurdle) that is proving the major barrier to overcome in order to enable patient access. Therefore, payer perceptions on such innovative trial designs will be key to informing pharmaceutical company utilization of such approaches. This presentation will provide an overview of these innovative new designs and present payer perspectives on the benefits and challenges posed by conducting reimbursement assessments on data coming from these trial designs, based on discussions with a German and UK payer.

- Real world data solutions in the post-marketing world: the multiple sclerosis experience

- Introduction to the MSBase international registry

- Methods for separating drug signals from bias in observational data

- Pharma / disease registry collaborations in comparative effectiveness analyses

- Big data: Big MS and beyond

• Internal training
• Engagement tool
• Keeping the conversation going

• Keeping consistency in communications with both HCPs and patients to maximise high quality patient-HCP conversations

• Appreciate the importance of understanding human behaviour in designing effective and affective medical communications
• Recognise the synergistic benefits of bringing behavioural insights and multichannel strategy together for smarter, more targeted communications
• Challenge your communications strategy: not doing things ‘because we’ve always done it this way’, looking critically at the end goals, the behavioural context and barriers, and designing a smart multichannel strategy

•  The hidden link between product strategy and scientific approach
• Challenges and opportunities in dealing with many stakeholders
• Prioritizing multiple interests in one “finer” research question
• A project design workflow for clinical research with RWD

• Regulator and payer perspectives on patient-centric data in decision making.
• Highly successful strategies for leveraging the patient voice in RWE research.

• Case Study: How outsourcing can unburden your team to focus on value-adding relationships

• Moving beyond NPS
• Engaging a global team to get local customer insight
• Maintaining the focus on the customer
• Driving the global process forward.
• It’s not just the numbers: Tell the story of the customer

• What does the new world of medtech and digital health look like?
• How can digital technologies and services enhance the value of devices in a meaningful way to payers?
• How will these innovative solutions be regulated and reimbursed?

Explore how new digital technologies enhance your customer interactions and deliver real commercial benefit 

• Understand how your customers’ needs have changed
• Learn how digital technology enables you to respond to these new challenges
• Explore how virtual engagement technologies create new opportunities
• See real-life examples of how digital solutions have transformed customer relationships
• Bringing it all together: learn how to use the data to extend commercial opportunities

• Empowered buyer teams force Marketing & Sales to step up their game
• Marketing can support sales teams to become more solution-centric
• Sales teams can go beyond the expected and impact the modern day buyer
• Ceterix, bioMérieux and ARGEN use sales enablement technology to step change Marketing and Sales alignment and grow sales productivity.

• Situation before the project start
• Evaluation process and piloting
• Implementation approach
• Outlook for the future

• Becoming an integral partner in strategic business decision making
• Organizing the competency in today’s value-based healthcare (VBHC) environment
• Case studies

• What is Value and how to quantify it?
• “Doctors love my product, but I still cannot sell it” - an evolving balance of power
• Do I need Reimbursement? What are the risks?
• “Your product is too expensive”: fact or misperception?
• Case example: from “easy-to-use” to “cost-saving”
• Practical recommendations for Value-Based Sales

• Current and future regulatory environment
• How is the industry geared to address these changes?
• What are the constructs of an ideal marketing claims strategy?
• What are the gold standard practices for marketing claims?
• How to deal with unsuccessful claims?

• Understanding the shifting buyer universe.
• Defining the organisation of the future.
• Key challenges & opportunities when transforming your business around the customer.
• Outlining different transformation pathways depending on your organisational imperative & operational maturity.

• What is the role of market access in economic selling?
• The challenge of quantifying value.
• Building effective tools and training methods.
• Partnering with commercial teams.
• Case studies: Selling value in the UK and Germany.

• It is all about the quality of the data.
• RWE to understand target indication and plausibility of clinical trial success.
• Single arm / registry to comparative effectiveness data.

Planning for a global product launch means a coherent evidence plan and value dossier must address the needs of multiple geographies. This session will review the evolving perspectives of US payers on evidence for medical devices, and contrast these trends with major EU markets and Japan. Specific topics to be addressed will include:

• US Medicare and private payer bundled payment models.
• New bundling of In Vitro Diagnostics under Medicare outpatient rules.
• British requirements for Specialised Services.
• French programs to generate real world evidence.
• Germany’s trial regulation.
• Japan’s new HTA requirements.

• More professional purchasers and decision makers need a different approach
• Why price is not the priority for providers (even though it seems so)
• Developing the value message: Quantifying benefits
• Roadmap to preparing commercial teams to use value to justify price
• Best practices from real case studies

• Market access supporting key value processes
• The mergers & acquisitions process
• Key issues examined during due diligence
• Anonymised case studies

• The revolution in our kitchen: The changing landscape of medical Affairs.
• Introducing new ingredients: A new blend of responsibility for medical affairs leaders.
• Prepare, mix, bake: Using the right approach to create an effective and affective medical affairs plan.
• Serving suggestions: How powerful communications can change patients’ lives.

• Necessary conditions for better, more useful real-world data.
• Importance of a comprehensive and robust RWE strategy, including identification of optimal data sources, methods, and data gaps.
• The use of technology in data analytics for increased cost savings and decreased time for results

• Regulatory classification of real-world studies.
• Why are the regulations for non-interventional studies so difficult/frustrating/confusing?
• Pragmatic clinical trials: The missing RWE link?

• Post-marketing commitments: PASS, PAES.
• Article 20s and DUS: Prospective or retrospective data.
• ENCePP: How to make the most of it.
• Leveraging innovation to meet commitments.
• Real World Evidence 3.0.

• Why medical affairs must adapt and consider this educational format to engage physicians.
• What is the value of IME?: Benefits and considerations in funding IME/CME.
• Interactive case study of IME, identifying best practices to providing IME/CME.

• Regulator and payer perspectives on patient-centric data in decision making.
• Highly successful strategies for leveraging the patient voice in RWE research.

• Identify key questions that should be asked when determining if medical communications are meaningful for patients.
• Working with stakeholders to provide insights for patient-centric communications.
• Describe two case studies that demonstrate how medical communications to patients were vastly improved by applying patient insights.

• Transformation of medical affairs to deliver greater value.
• Executing long term engagement strategies in today’s complex disease space.
• Developing and delivering scientific insights to achieve strategic differentiation.

• New organisational capability needs to address major market changes.
• Optimising global strategy and local agility: Updated planning and governance structures.
• Cross-functional leadership and aligned KPIs.
• Digital tools to drive efficiency, effectiveness and feedback.

• How a product’s characteristics or attributes contribute to both individual willingness to pay and “value” from different perspectives (e.g., stakeholder, society).
• The various methodologies through which attribute value can be assessed.
• A real-world case study of how decision-analytic modelling helped a leading medical device company establish the value of a unique product attribute, and by so doing justify higher tender pricing in a key EU market.

• Organisational excellence provides the bridge from strategy to results.
• What are the building blocks of the bridge and what gets missed.
• How should we apply organisational excellence to market access strategy.
• What can we learn from other industries?