3rd Real - World Evidence
10th Market Access, Pricing & Reimbursement
- World Congress & EXPO 2023 Americas
- 22nd - 23rd June 2023 | Philadelphia, PA, USA
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Available Shortly!
KEY INDUSTRY EXPERT SPEAKERS
Meet Our Professionals
Introduction
Real world evidence is the clinical evidence regarding the usage and potential benefit/risk of medical products derived from analysis of RWD. These are empirical data acquired outside the framework of randomized controlled trials and originated from routine clinical practice. RWD are data associated to patient health status and/or the delivery of health care routinely collected from a variety of sources such as, patient disease registries, electronic health records (EHRs), patient generated data, other sources such as wearables and mobile devices, etc. It is gathered and converted to RWE through robust analytics and validated approach. The focus on RWE affects every stage of drug/device development lifecycle.
With exponential growth in the use of technologies such as computers, medical devices, wearables and biosensors to collect and amass considerable amounts of health-related data along with the development of advanced, new analytical capabilities, these data can now be analysed. The information collected is increasingly accessible and useful for outcomes research and regulatory purposes and can be applied to medical product development and approval. RWE are now being used by medical product developers to aid clinical trial designs and observational studies to generate innovative, new treatment approaches. The healthcare community and regulatory agencies utilized RWE to develop guidelines and decision support tools for use in clinical practice and to make informed healthcare and regulatory decisions.
While RWE is playing an increasingly critical role in supporting every aspect of successful evidence-generation programs and presents immense possibilities, it also brings substantial challenges that continue to cast shadows on its validity. Concerns such as data viases, data quality and the possible false results due to data mining, progress has diminished primarily.
The 2 days congress aims to provide a cutting edge, and comprehensive discussions in collaborative format to improve standards and practice for the collection and analysis of data for better decision making for health globally. We are putting together an agenda that focuses on “The significance of RWE in changing the future of drug development and healthcare”. We are gathering high calibre expert speakers to participate and share their knowledge and expertise through Keynote, Presentations and Panel discussions.
We look forward to welcoming you to the RWE World Congress 2023!
GAIN LATEST INSIGHTS ON:
Available Shortly!
WHO SHOULD ATTEND?
Network with members of the boards, VP’s, Directors, Heads/Chiefs, and Senior Managers of leading Biopharmaceuticals and Biotech Companies, Government, CRO’s and Solution Providers Involved in:
- Real-World Evidence
- Real-World Data
- Clinical Research
- Data Analytics
- Regulatory Science
- Policy
- Regulatory Affairs
- Technology Science
- Epidemiology
- Clinical Development
- Clinical Trials
- Clinical Studies
- Emerging Markets
- Data Science
- Product Lifecycle
- Oncology
- Disease Registries
- Wearables
- Electronic & Medical Records
- Lab & Biomarkers
- Hospital Data
- Pharma Data
- Pharmacy
- Social Media
- Patient Data
- Mortality
- Oncology Trials
- Omics
- Research & Development
INTRODUCTION
Market Access, Pricing & Reimbursement 2023 Americas
In the competitive world of pharmaceutical and medical technology, market access represents the process of understanding the implications
and the impact of a product in the healthcare market where a positive environment and communicating the ‘value’ of your product to the range
of customers who influence uptake will make a big difference.
Only a fully integrated organization can implement the processes, techniques and strategies required to get the right messages to the right
stakeholders at the right time.
The U.S. pharma market is the largest pharmaceutical market worldwide and continues to grow even though there are expected some structural
changes in the healthcare system due to evolving political landscape.
The two-day Market Access, Pricing, and Reimbursement Global Congress 2023 Americas will provide a unique platform and a dynamic
approach to key trends, methodologies, and insights on market access, real-world data, pricing, reimbursement, patient access, and data
collection than the current industry standard is anticipated.
The upcoming 2023 Market Access, Pricing and Reimbursement Global Americas will present a dynamic approach to key trends and insights on market access, health
technology assessment, real-world data, patient access, pricing and reimbursement on the current European landscape.
This year, we are putting together an agenda that addresses “A New Model of Access Strategy for the Next Normal.”. We are gathering together high calibre expert speakers to participate and share their knowledge and expertise through Keynote Presentations and Panel discussions, addressing all aspects of the industry.
We look forward to welcoming you to the MAPR 2023 congress!
Sincerely yours,
Paradigm Global Events Team
Gain insights on:
- Strategies for one of the pharma industry’s greatest
challenge: market access - Health Technology Assessment in Health-Care
- Real world evidence and randomized control trials, close
the gap - Growth of biosimilars and importance of RWE for orphan
drugs and rare diseases - Emerging markets: the impact on global pricing and
commercialization - Challenges and opportunities in pricing, reimbursement
and patient access - Risk-sharing agreements, benefits, and challenges
- Looking to the future: what is there to expect?
Who Should Attend
Network with members of the boards, VP’s, Directors, Heads/Chiefs and Senior Managers of leading biopharmaceutical and biotech companies, government, CRO and solution providers involved in:
- Market Access
- Pricing and Reimbursement
- Patient Outcomes
- Health Economics and Outcomes Research
- Payer Relations/ Evidence
- Data Management/ Analysis
- Regulatory Affairs
- Public/ Government Affairs
- Payers, HTA Officials, and Physicians
- Business Development
- Marketing
- Commercial Executives
- Product Launch
- Real-world Evidence
- Commercialization
- Value Strategy
- Product Strategy
- Forecaster
- Finance Officer
The programs
3rd REAL-WORLD EVIDENCE WORLD CONGRESS 2023 AMERICAS
The significance of Real-World Evidence in changing the future of trial design, drug development and healthcare to improve patient outcomes
Day 1 - Thursday 22nd June 2023
LATEST REGULATORY LANDSCAPE
- Regulatory updates in brief
- Understanding current changes in regulatory guidelines, considerations
- Establishing data sources and standards
- Creating a robust RWE strategies in a new regulatory landscape
- Maintaining data security and privacy
- Best practices and lessons learned
- Understanding the NICE Real-world Evidence Framework
- Possible influence it will have on the UK and global health technology assessment (HTA) landscape
- Comparison with other framework
- What are we hoping to see on future update of the framework?
- Establishing how it will support regulatory decision making
- Role of DARWIN in delivering real-world evidence from across Europe on diseases, populations and the uses and performance of medicines.
- How will this connect the European medicines regulatory network to the European Commission’s
European Health Data Space - What are the range of approved healthcare databases enabling distributed data access via DARWIN EU will evolve and expand over time.
- Benefits of understanding differences across stakeholders
- Multiple stakeholder approach to planning and delivering evidence is required
- A dedicated strategy to meet their specific evidence needs
- Determine whether a multiple stakeholder approach is justified.
- How to identify regulatory situations that can benefit from leveraging RWE
- Choosing an appropriate type of study design
- Key success factors ensuring fit-for-purpose data and rigorous methods
- Tips to encourage further use of RWE in regulatory decision-making
- New sources of data besides those generally collected
- Benefits of acquiring new data types
- Type of data to acquire
- How and when to get started
CURRENT TRENDS AND STRATEGIES
- RWD as input into HTA dossier
- Examples of RWD use as part of reimbursement submissions
- Challenges and limitations related to RWD use
- Drivers of investment in RWE
- Recent advances in digital and advanced analytics for RWE generation
- What role can it play across the pharma value chain?
- Building the ideal data architecture to unlock business outcomes
- Review use of RWD to guide pipeline and portfolio strategy
- Considerations when using RWD to inform internal decisions
- The growing use of data tokenization and advanced analytical techniques based on artificial intelligence in RWE
- The importance of data quality and methodological transparency in RWE.
- How is RWD and RWE bringing innovation to patients and gaining approval
- Importance of RWD in transforming clinical research and clinical trial design
- Experiences to date and identify practical and technological considerations to further implement realworld clinical research
- The use of RWD early in the process to boost trial diversity and inclusion
- Challenge in setting diversity goals early in clinical trial planning
- Development of a diversity plan to ensure adequate representation of racial and ethnic subgroups in clinical trials
- Utilizing RWE in the post-marketing setting to complement clinical trial findings and support postmarketing requirements or commitments for safety and efficacy data in a diverse patient population
- Why is RWE increasingly being recognised and acknowledged as an evolution in product research and development.
- How does RWE help regulators, pharmaceutical companies and clinicians better identify trends and patterns in patient outcomes
- How can you make sure that only quality, reliable and relevant information are collected?
- How is it use to reduce risk and increase safety?
- Its use in supporting a robust post market surveillance and accelerating products to market
3rd REAL-WORLD EVIDENCE WORLD CONGRESS 2023 AMERICAS
The significance of Real-World Evidence in changing the future of trial design, drug development and healthcare to improve patient outcomes
Day 2 - Friday 23rd June 2023
CHALLENGES AND POTENTIALS
- Challenges that could inhibit the administration and efficiency of RWE
- Best practices and lessons learned from other industries
- Collaboration between regulators and RWD/RWE organisations to develop collective experience so that RWE use can be better regulated
- Analyzing RWD to determine brand marketing effectiveness
- Major factors contributing to the pharmaceutical industry’s excitement about RWE
- Addressing the challenges of collecting and consolidating RWD data that can be put to good use.
- Important role of RWE clinical trials
- Real-world data and evidence as a more integral part of the drug development process.
- How are patient registries used to generate real-world data for rare diseases and orphan drugs?
- Does different stakeholder types have different RWE information needs for decision making?
- Well-targeted evidence which encourages orphan medicine adoption by supporting the approval, reimbursement, and prescribing
- Benefits of understanding differences across stakeholders
- Multiple stakeholder approach to planning and delivering evidence is required
- A dedicated strategy to meet their specific evidence needs
- Determine whether a multiple stakeholder approach is justified.
- The shift from RCT to RWE; closing the gap
- Best practices and lessons learned in developing robust RWE studies
- Example of technologies currently being used to harness data
- Are there pitfalls in using these technologies?
- How are these new technologies providing valuable understanding of the use of RWE in real-world settings
- Upcoming development
Collection of high-quality patient-centered data relevant to the design, conduct, and translation of realworld
research.
Applying qualitative patient experience data to make informed study design decisions
Recommendations that may improve the patient centricity of RWE
- Why personalised medicines require RWE and disruptive technologies intervention?
- Data that have potential to be implemented in personalized medicines discovery
- How will RWE curve the future path of personalized, precision medicines
- Glimpse into a future of next-generation medicine
- Recent advances in scientific research and technologies
- Main areas that need improvement
- Innovative strategies needed to engage patients and generate the necessary evidence to propel new advances into the clinic
- Latest changes in RWE landscape and its advantages
- What exciting new breakthroughs exist for RWE?
- The next big innovations and advances in RWE
- Perspective on future directions and harmonisation
10th Market Access, Pricing & Reimbursement 2023 Americas
"A New Model of Access Strategy for the Next Normal"
Day 1 - Thursday 22nd June 2023
Market Access And Strategies
- Global synergies between clinical, HEOR and RWE data
- Evidence required to achieve adequate device price and market access in US
- Successful evidence strategies for medical devices vs. pharma
- Public and private agencies using HTA reports
- Factors shaping private and public sector HTA programs
- Effectiveness of DERP (drug effectiveness review project)
- Affordability and infrastructure changes
- Healthcare reform increasing broader patient access
- Defining biopharmaceuitical brand value in emerging versus
developed economies
- Review the development and trends of biologic and biosimilar in EU and US from payer’s perspective
- Different opportunities and challenges of biologics vs biosimilar and chemical brands vs generics
- Review the evidence needs and role of HEOR in the development of biologics and biosimilar
- Essential market access strategies to ensure appropriate use
Challenges & Opportunities
- Defining the terminology, agreeing with the approach, and crossfunctional working within a pharmaceutical company
- Actively learning about changes in stakeholder’s needs
- HEOR in rare and orphan disease
- Incerasing HTA and payer outcomes and economic evidence requirements
- Potential paths forward
- Capture basic metrics needed to optimize value
- Place the patient at the heart of decision-making
- Track emerging evidence to ensure developemtn evolves with the
landscape
- How to improve long term profi tability
- Developing different pricing models
- What drives the value of the product in the real-world evidence in terms of outcome and impact
- Value-based contracting and outcomes-based arrangements
- Discounted pharmaceutical pricing
- Increasing shortage of competencies
- Improved patient access & RWE
- Increasing price transparency
- Rise of high-value combination therapies
- Coverage with Evidence Development
- HTA and Clinical Practice Guidelines
- Cost-Effectiveness Thresholds, Comparative Effectiveness Programs
- What lies ahead?
10th Market Access, Pricing & Reimbursement 2023 Americas
"A New Model of Access Strategy for the Next Normal"
Day 2 - Friday 23rd June 2023
Pricing, Reimbursement And Patient Access
- Understand key price drivers within and across the U.S.
- Shift from a pay-for-pill to a pay-for-performance model
- Recognize trends in the industry, capitalize on the opportunities, and overcome the challenges
- Identifying value from the point of view of different stakeholders
- Providing clinical and RWE to support claims of value from payer perspective
- Translating clinical evidence into economic value to payers
- Rising Control & Cost Share for Access
- Impact of biosimilars in specialty drugs
- Need for risk-sharing
- What does the future bring?
- Policy advocacy has been pivotal to the quality and safety of advanced diagnostic imaging.
- In recent years major gaps have emerged in how providers maintain imaging equipment: (a) providers had few rules on the
frequency of preventative maintenance, and (b) servicers faced unequal FDA regulation of maintenance. - A coalition of stakeholders has engaged with policymakers to close these gaps, resulting in changes to guidance for frequency of preventative maintenance from the Centers for Medicare and Medicaid Services and The Joint Commission, opening of a docket and a public workshop on the regulation of service at the Food and Drug Administration and a requirement in the 2017 FDA Reauthorization Act for the FDA to produce a report on the regulation of equipment service.
Data Collection And Management
U.S. diverse multi-payer system
• Reimportation
• Value Proposition & Value Dossier to the R&D
- How will patients respond to a product when it enters the market
- Observational studies and pragmatic clinical trials (PCT) in HER
- Real-world Intelligence
Collaboration & Looking To The Future
- Industry should transition from being a transactional supplier of medicines to an integrated collaborative partner within the healthcare system
- Value-based partnerships are mutually benefi cial endeavors to deliver the highest value to the healthcare system and society by focusing on improving patient outcomes in the context of system and societal total costs
- Value-based partnerships can range from research-oriented collaborations to commercially-oriented arrangements
- Unlocking data from early access
- Effective communications with your internal and external
stakeholders - Embracing the digital vision
- Intellectual property rights (IPR)
- Ever-greening strategy
- What’s the rationale for a product’s price point?
- The implications of Trans-Pacifi c Partnership (TPP) Agreement
- Affordable Care Act
- Digital pharma
- Patient centricity
- Collaborations, mergers and acquisitions
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Available Tickets & Discounts
Market Access, Pricing & Reimbursement 2023 Americas
- Academic, Non Profit & Patient Group Rates
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Testimonials
Thank you for a good experience with the PARADIGM Global Events… very high level, very good Organization, we overpassed our expectatives, we will be pending for another congress related to pharmaceutical and biotech… we learned a lot, and i think that the content of agenda was state of the art, thank you again.
SALVADOR BERRIOS
ERP/ CRM / Product Configurator Manager
The consistently high quality of international faculty was most impressive. It was also obvious that they were carefully chosen not only for their particular expertise but also for their ability to communicate the subject matter to clinical and non-clinical participants alike. As market access consultant for pharma clients of various sizes, I now feel much better prepared to explain the nuances & dynamics involved in bringing their products to market. In addition, I am in a much better position to intelligently advice my clients & help them set realistic expectations
THOMAS MARTIN
Associate Vice President, VCGA - Quintiles
I was impressed with the organization of this event. I attend many conferences per year and find the organizers on site to be detached and not focus on good service to the delegates. This team was even providing weather forecast warning to ensure everyone was aware and made appropriate plans. Well Done.
ADRIANA E. MANZI
PhD, Managing Director, Atheln, Inc
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