• Understanding payer attitudes to optimise business performance.
• What is the optimal reach and frequency of a payer tracker to maximise impact of such an approach.
• How can payer trackers can be utilised to leverage business performance.
• Benefit of payer trackers when sharing information with key internal stakeholders.

Most developed countries apply some form of IRP as a factor in negotiating or regulating domestic pricing. With the emergence of risk sharing agreements and in particular confidential price / volume agreements tied to HTA assessments some experts are suggesting the end of IRP systems in imminent. In contrast, some countries like Canada are placing greater reliance on IRP to lower drug prices.

• Beginnings and Evolution of IRP.
• Overview of approaches to IRP.
• Impact of IRP on product launches and HTA.
• Role of risk-sharing agreements to mitigate impact of IRP.
• Canadian IRP as a case study.

• The revolution has already happened in other sectors: Is health next?
• How is digital technology being deployed along the health value chain?
• How will technology change patient, physician and payer engagement?
• Can technology radically change data collection and analysis in clinical trials and the real world and therefore the assessment of value?

• Current perception of PRO evidence among payers and its influence in decision-making 
• Differences between payer and regulators in assessing PRO evidence

• How similar are HTA agencies in methods and procedures?
• Is there a development towards shared standards?
• What are stakeholders doing to encourage harmonisation/standardisation?
• Is there a need for a European institution to get the job done?

• Medical Affairs and MSL synchronicity: Linking efforts to ensure a positive outcome.
• MSLs and KOLs: The data sweet spot: Finding balance within the current regulatory environment.
• The role of MSLs in audience engagement: Strategic & tactical approaches to engagement.
• MSL-directed educational communications: An appropriate path forward.
• Measuring the impact of MSL-driven activities: Applying metrics to establish impact.

With the rise of medical affairs as healthcare’s core scientific partner, industry leaders are reimagining their organizations to achieve a world-class standard–and deliver greater value. Learn how to align engagement strategies to healthcare stakeholders’ scientific goals and interests, based on actionable insights.

• 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.

• What is driving changes such as conditional market authorisation and adaptive pathways?
• What are the challenges for HTA agencies and their evaluation approaches?
• What are the critical success factors for pharma companies?

• What value does your technology bring to address the needs of the country’s health system?
• How can you develop the market to create a receptive and favorable environment for your technology?
• Case study: Established vs. emerging markets.

• Ground breaking technology from Harvard Medical School.
• Used by life science sales teams and healthcare professionals.
• Extend retention of complex processes and facts from weeks to years.
• Mobile and social gaming methods to drive adoption and motivation.
• Maximise return on investment in product training.
   

In today’s digital age, marketers can use marketing automation and analytics technology enabling them to be hyper-relevant to the customer via online channels. But what happens when the customer schedules a call or meeting with your sales team? How do you know whether or not your content performs well during this offline phase of the customer journey? Learn how to grow your business by supporting your sales and indirect channels with sales driven marketing.

• Analysis of the real case of a global medical device companythat launched an innovative device to prevent seriouscomplications of a disease and was facing significant market barriers across Europe.
• In spite of the product’s clinical benefits, commercial teams couldnot quantify the value of the product to purchasers and decisionmakers.
• The solution came with the development of a process positioningthe best product evidence to directly address the clinical andeconomic needs of stakeholders.
• Commercial teams were able to quickly demonstrate and quantifyvalue, helping hospitals and clinics to understand the costs and benefits of adopting the medical innovation.

• Developing and implementing a scientific strategy to effectively disseminate evidence and show value and engaging with diverse stakeholders.
• Understanding how, when, and to whom you communicate evidence.
• Benefits and challenges of consistent communications.

• The term “KOL”: Too toxic for everyday use, or still the best tool for the job?
• Results from a survey of pharma and KOLs on the use of terminology alternatives.
• Should pharma work towards using one universal replacement for the term “KOL”?
• How does this change the way we engage with KOLs and stakeholders in medical affairs?
• And what exactly do KOLs think of all this?

• Defining quality in the context of today’s observational research needs.
• Developing a framework to deliver quality every time you conduct non-interventional studies.

• Evaluating and developing a medical affairs team’s skill sets for more flexibility.
• Developing a life-cycle dependent model for flexible medical affairs resourcing.
• The impact of a flexible resourcing approach on talent acquisition.
• The role of strategic outsourcing for medical affairs.

• Key challenges in early phase oncology recruitment.
• Therapeutic, supportive and other compounds from trial management perspective.
• Pros and cons of early phase trials for the investigator and for the cancer patient.
• Role and potential of professional CPU (Clinical Pharmacology Unit) within indication.
• Satellite Centre Concept for proper recruitment and controlled quality.

• Patient pharmacology services: Concept and operational set up.
• ADME concepts, incl. micro-dose and tracer-dose.
• Underlying dossier requirements incl. preclinical safety package.
• General design considerations incl. radiodose and radioburden calculation.
• Devil is in the details: Operational challenges.
• Selection of geographic region and patient population.
• Ethical aspects.

• What is the role of an MSL today in developing strategic relationships with KOLs.
• Learn what a typical ‘day in the life’ of an MSL is like.
• Is the role of an MSL here to stay for the long term?

• The importance and benefits of an effective pre-market communication plan.
• The when, where and how of the various elements who need to be engaged.
• Development and implementation of the plan: Where the magic happens and results are driven!
• The essential elements to any pre-market communication plan.
• The need for achieving balance between the speed, timing and volume of pre-market communications.

• A review of success rates in recent drug launches.
• Look at where launches haven’t gone well and where RWE could have played a role in mitigating this: The bad.
• Building an Integrated Medical Plan to prepare for success (Begin with the end in mind): The good.
• The resource vs. demand challenge and the consequent benefit of outsourcing: The necessary.

• Regulators and payer considerations of the ‘key value drivers’ in RWE generation.
• Highly successful RWE strategies, study designs and best practices and how they differ across global markets.
• How medical affairs can best utilise RWE to support market access decision making.

• Apply a single framework for patient centricity in medical affairs.
• Uncover what patients value and how it changes on their treatment journey.
• Structure and prioritise innovative medical activities in a patientcentric way.

• Challenges facing medical affairs functions today.
• Medical affairs transformation as pipelines shift to specialty care.
• Getting to ‘world class’ through focus on delivering an exceptional stakeholder experience.

•  Promotion response modelling for ROI on sales calls to derive optimal size.
•  Territory alignment based on Potential Index and Workload Index.
•  Incentive design for salesforce based on fairness, motivation and financial risk.

•  Identifying commercial learning challenges.
•  Shifting middle performers.
•  Implementing solutions to support continuous commercial learning at scale.
•  The path to continued commercial effectiveness.

• Overview of the main reimbursement systems in Europe.
• Price: The main barrier for medical technology.
• When is it (really) necessary to apply for reimbursement?
• Demonstrating value to access healthcare payment pathways.
• Moving ahead: The new EU perspective on medical innovations.

Prioritising and targeting the best business opportunities is crucial for medical device
companies to create an optimal offering strategy while controlling and minimising
discounting. Therefore it is critical for global pricing, commercial and marketing
leaders to standardise their price configuration, quotes and tender processes with
best practices. This approach will lead to new business and optimal deal structures,
resulting in higher revenues and margins.

•  Why is recruitment important?
•  Issues seen in studies (generally not just MENA).
•  What are the possible reasons for this?
•  Are there differences between MENA and ROW in patient recruitment numbers and retention rates?
•  How could we actively prevent these issues?
•  Case studies (both good and bad) & lessons learned.

•  Current state of RWE in Asia markets.
•  Key trends and how it is evolving.
•  What this means for healthcare companies.

• An ever-increasing number of individuals routinely contribute and consume solicited and unsolicited information about a variety of health-related issues using a wide range of internet and social media channels.
• Personal web-based reports on health status, symptoms, treatments and associated interventions may provide a rich source of data to support discovery, clinical development and post marketing analytics.
• A key challenge in the applicability and utility of these data is related to the veracity, accuracy and reliability of information collected from web-based media sources.

• Convergence of data, technology and advances in the field ofneural networks.
• Increased opportunities for the use of real-world evidence data sets from the genome revolution, clinical trials, medical imaging and electronic health records.
• Accelerate the use of Artificial Intelligence (AI) within Pharma R&D to develop actionable insights.

• Identify new patient target groups for innovative drug development by applying predictive analytics to real world and trial data.
• Enhance R&D productivity by mapping the real world using predictive analytics.
• Facilitate the implementation of Adaptive Pathways through predictive analytics.

• 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.