3rd Real - World Evidence

10th Market Access, Pricing & Reimbursement

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Available Shortly!

KEY INDUSTRY EXPERT SPEAKERS

Meet Our Professionals

Eric Boldy

Senior Representative

Available Shortly

Eric Boldy

Senior Representative

Available Shortly

Eric Boldy

Senior Representative

Available Shortly

Eric Boldy

Senior Representative

Available Shortly

Eric Boldy

Senior Representative

Available Shortly

Eric Boldy

Senior Representative

Available Shortly

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

  • Real - World Evidence - Day 1
  • Real - World Evidence - Day 2
  • Market Access, PRicing & Reimbursement - Day 1
  • Market Access, PRicing & Reimbursement - Day 2

10th Market Access, Pricing & Reimbursement 2023 Americas

"A New Model of Access Strategy for the Next Normal"

Day 1 - Wednesday 11th October 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 - Thursday 12th October 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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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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