Innovation in an already crowded oncology space has created a challenge for medical affairs.  The proliferation of compounds in development has reinforced the need to accurately identify strategic opportunities, address the  scientific need of experts, while continuously demonstrating value.  To achieve these goals, medical leaders must develop clear, comprehensive insights. With an immense amount of data at their disposal, medical affairs must develop novel approaches to  leverage this information to inform targeted decisions and investments. 

• UK Data Sources and Access:
  • Hospital Episode Statistics
  • Primary care datasets – GPES, CPRD, OPCRD
• Overview of key processes
• Expanding the global reach
• What the future could hold?

Recent advances in AI such as clinical natural language processing (NLP) and Machine Learning are enabling the mining of data from the EMR across multiple sites and in multi-languages enabling new insights and accelerating innovation.

• From RWD to deep RWE
• Ensuring patient data privacy and security
• Developing the research eco-system
• Deep Real World Evidence in practice - the big COVID data study

Learn about the power of patient insights and discover real-world patients' insights generation. Understand the value of patients' insights at each step of a product's lifecycle from Target product profiling to Preference study, through Clinical trial optimization and patient's experience (disease and treatment management, unmet needs..).

• Integrating market access, medical affairs and deep clinical understanding
• Building a strategy with KOL engagement and collaboration with scientific societies - a case study explaining the process and decision-making algorithms
• Clinical guidelines, the reimbursement system and medical standards and protocols as a key focus of the strategy

COVID-19 significantly impacted how providers reach out to patients. Besides, there has been a series of changes in the reimbursement and funding of medical technologies and procedures. These aspects created opportunities to address new market needs and leverage data and learning to deliver more value to a growing network of payers, providers, and patients. Welcome to the new era of Network Value.

• Key decisions of today that brings you into the world of opportunities tomorrow
• Setting out Product Claims with recognizable aspirational value.
• Understanding pricing & reimbursement landscape and payers needs
• Designing adequate evidence to demonstrate this value for regulatory and reimbursement purposes.
• Informed choices for stronger claims and data generation with the full circle of multi-disciplinary insights  
• Defining key success factors to capture new market access opportunities

In today's demanding world of national requirements, how can companies develop the right evidence portfolio to succeed? How can they integrate evidence for payers with their regulatory studies?  This in depth review will discuss core principles in evidence development for diagnostics and therapeutic medical devices, and how these concepts can align with the requirements of the major global markets -- the UK, France, Germany, Japan and the USA. Learn about the evolving landscape of evidence demands in:

• The UK, with NICE's development of new pathways for innovative devices
• France's Forfeit Innovation and evidence demands
• Germany's NUB evidence review requirements for high risk devices
• Japan's emerging new pathways for breakthrough innovations
• The US Medicare programs special coverage of FDA designated Breakthrough Devices

• So what does omnichannel actually mean for Medical Affairs?
• Examples of evidence and data-based healthcare communications
• Right message, right place, right audience

Innovation in an already crowded oncology space has created a challenge for medical affairs.  The proliferation of compounds in development has reinforced the need to accurately identify strategic opportunities, address the  scientific need of experts, while continuously demonstrating value.  To achieve these goals, medical leaders must develop clear, comprehensive insights. With an immense amount of data at their disposal, medical affairs must develop novel approaches to  leverage this information to inform targeted decisions and investments. 

• Insights and feedback from HCPs on 2020 virtual activities
• Recommendations for impactful virtual engagements in 2021
• How to effectively have peer-to-peer conversations virtually

• How KOL-expertise can be accessed to curate and publish high quality content for a variety of target audiences
• Possibilities of engaging different types of KOLs to fill knowledge gaps via medical communications.
• Values and benefits of co-operating with medical publishing professionals when involving and/or addressing KOLs.

Within3 offers a virtual engagement platform that gives stakeholders the freedom to communicate anytime, anywhere, on any device

• Leading insights on the role of RWE in regulatory decision-making
• Lessons from inside the FDA's RCT-DUPLICATE demonstration
• Implications for Medical Affairs planning and key decision makers

• Identify the logistical and resource barriers to domestic and global stakeholder engagement & insight retention
• Learn about innovative communication solutions that leading organizations utilize to overcome these challenges and drive value-added insight development.
• Discuss how to use these solutions to deliver improved engagement outcomes while maintaining regulatory compliance

• Addressees & Purposes
• Challenges in compiling the right data
• Current solutions and suitable data sources
• Outlook to the future: a new claims data treasure through the digital care act?

The principles of market access differ greatly from traditional 4 P  product price place promotion Marketing. The winning combination of clear demonstration of Patient, Provider Payer and Product benefits (Optimizing price but maximising the availability to patients who need the technology most) to HTA’s leads to faster adoption meaning patients receive great technologies sooner.

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

While evidence requirements have changed under the new European framework for CE arking, the movement towards pan-European Health Technology Assessment also has gained traction, prompting greater conformity of HTA evidence requirements and "transplantation" of evidence reviews across geographies within the European Union.  Companies can expect CE Mark requirements to be more aligned with the demands of HTA bodies for reimbursement, but the challenges for medical device firms are greater, as local HTA bodies may be commissioned to implement assessments that have a pan-European impact. 

Value Based Healthcare requires a new way of thinking.  It requires fluently navigating clinical outcomes and economic costing.  This presentation will cover WHY VBHC is necessary, HOW Value based procurement enables VBHC, WHO needs to be involved in the collaborative dialogue, and WHAT the role of VBAPs are in overcoming clinical and economic uncertainty to drive medtech adoption.

• Understand how to turn the C-Suite into digital advocates 
• Experience how the first movers in medtech have proven digital technology ROI
• See how you can use your digital investments to enable better customer experiences for payers and HCPs
• Explore how digital technology supports a key account strategy
• Learn how to get it right: start small and scale fast 

1. ‘The milkman model’ evolution(?) in the MedTech industry
2. Fundamental barriers to commercial model innovation in the MedTech industry
3. The role of customer insights in breaking the evolution barriers  
4. Key learnings for the MedTech industry 

• Meeting the needs of health system stakeholders demanding both clinical and real-world evidence to inform decisions regarding product use and reimbursement
• Case study: The benefits of a Biopharmaceutical Acceleration Model approach to product development and commercialization, involving comprehensive evidence development to meet clinical, regulatory, and commercial needs

• Identify the logistical and resource barriers to domestic and global KOL engagement 
• Which solutions can enable Pharma & MedTech to better engage & generate valuable insights from KOLs & External Experts 
• Improving KOL engagement outcomes while maintaining regulatory compliance

• Evolution in the strategic role of Medical Affairs
• Insight management as a core capability
• Optimising the sourcing and use of insights

• How can Medical Affairs lead the charge to develop an organizationally-aligned narrative and drive scientific positioning within the medical landscape?
• How do we ensure cross-functional alignment on holistic evidence generation from (early) clinical development to post-approval lifecycle management?
• How do we ensure all Medical Affairs activities are clearly driving value?

• Identify the logistical and resource barriers to domestic and global stakeholder engagement & insight retention
• Learn about innovative communication solutions that leading organizations utilize to overcome these challenges and drive value-added insight development.
• Discuss how to use these solutions to deliver improved engagement outcomes while maintaining regulatory compliance

As the life sciences industry shifts its understanding of customers to help meet organizational goals, account management can help power strategic partnerships in an increasingly complex healthcare landscape. The session audience will learn: 

• Key developmental stages of a multi-dimensional account management model, the specific value drivers in each stage, and how to effectively leverage current and emerging data
• How to build a strategic key account management (KAM) program that enables effective planning, visualization, and execution across accounts and teams
• How to leverage data to drive collaboration among stakeholders. 

• Historically, product development has largely been disengaged from commercialization
• However, in the current environment, health system stakeholders demand both clinical and real-world evidence to inform decisions regarding product use and reimbursement
• This presentation will describe and illustrate with a case study the benefits of a Biopharmaceutical Acceleration Model approach to product development and commercialization, involving comprehensive evidence development to meet clinical, regulatory, and commercial needs

• Target Audience
• Why this course?
• Why is sales a life skill?
• Course Outcomes
• What will you achieve?