Philadelphia, PA, 10 - 11 October 2017

Schedule

Create your personal agenda –check the favourite icon

Oct 1009:00
Conference pass

Keynote Address: Evidence Generation in the Electronic Era - Leveraging Real World Data

Keynotes
  • Learn how the FDA utilizes real world data in regulatory decision-making
  • Current barriers to full implementation of a learning healthcare system
  • Regulatory hurdles to development of real world evidence 
Oct 1009:20
Conference pass

PANEL: Defining value from whose perspective?

Keynotes
  • Value is a term regularly used across the Pricing and Reimbursement Field 
  • From whose perspective? - Payer, Physician or the Pharmaceutical Company?
  • How can we best define value as a universal measurement?
Moderator: Sachin Kamal-Bahl, Vice President & Head, Global Health & Value Innovation Center , Pfizer
Tao Fan, Director of Evidence Based Medicine and North America Medical Affairs, Sanofi Inc
Jason Booth, Global Health Economics and Outcomes Research Lead, Oncology, Shire Pharmaceuticals
Sean McElligott, Director, Market Access, Janssen
Brett Kopelan, Executive Director, DebRa of America
Oct 1010:00
Conference pass

Value Frameworks and their influence on Payers

Keynotes
  • What are the top value frameworks accepted by payers and how you can benefit from them
  • Discussing the growing desire of payers to accept new value frameworks and how you should adapt to these
  • Capturing the patient experience in the value framework
Sachin Palod, Vice President, Access & Value Solutions, Life Sciences, Optum Life Sciences
Aimee Coughlin, mktg, Optum Life Sciences
James Wu, Health Economist, Amgen Inc
Oct 1010:30
Conference pass

Speed Networking

Keynotes
"The musical chairs like phenomenon to get you introduced to the maximum number of people in the shortest time possible"
Oct 1011:30
Conference pass

FIRESIDE CHAT: Future tools and technologies for evidence generation

EVIDENCE
  • A widely cited study for the National Institute of Standards & Technology (NIST) reports that inadequate testing methods and tools annually cost the U.S. economy between $22.2 and $59.5 billion, with roughly half of these costs borne by software developers in the form of extra testing software users in the form of failure avoidance and mitigation efforts
  • How to implement new tools: Demonstrating ethics, value and enabling it to connect databases
  • Ensuring the required standard of evidence is met
  • Exploring data mining, signal detection, patient portals, N of 1 studies, insilico methodologies
James Wu, Health Economist, Amgen Inc
Tehseen Salimi, Head of Medical Affairs-Primary Care and Women's Health, Merck
Oct 1011:30
Conference pass

PANEL: Transparency across the drug supply chain- how can we get costs out in the open?

PRICING & MARKET ACCESS
  • Pharmaceuticals originate in manufacturing sites; are transferred to wholesale distributors; stocked at retail, mail-order, and other types of pharmacies; subject to price negotiations and processed through quality and utilization management screens by pharmacy benefit management companies (PBMs); dispensed by pharmacies; and ultimately delivered to and taken by patients
  • How to deliver the best value to patients and those that are exposed to vulnerability from high prices
  • What each player does and the role that it plays in the flow of pharmaceuticals from manufacturer to patient
  • How cash flow works between the manufacturer and the patient
  • What would be the impact of greater transparency?
Oct 1011:50
Conference pass

Pragmatic EHR trials? So close, yet so far…

EVIDENCE
  • Deciding whether and how to use EHRs as a source of data in clinical investigations
  • Is there enough EHR data to formulate real results?
  • Overcoming data fragmentation within companies; is there a better way of standardizing across platforms
Oct 1012:10
Conference pass

Communicating Medical Product Value at the Time of Market Authorization and along the Product Lifecycle

EVIDENCE
  • Develop a Target Product Profile (TPP) as a strategic development tool to identify desired  target concepts and facilitate communication regarding a particular clinical development program
  • Manage benefit-risk profile up to and beyond product approval by designing studies comprise not only of confirmatory clinical trials of efficacy or safety
  • Learn how to communicate the benefit-risk profile to external stakeholders that is consistent with the FDA-required labeling in a truthful and non-misleading way
Oct 1012:30
Conference pass

Challenges in delivering consistent, efficient and high quality evidence solutions are multi-faceted:

EVIDENCE
  • Companies often lack a consistent way to evaluate, prioritize, develop and evaluate evidence generation programs
  • Stakeholders are moving the goal line of sufficiency in evidence requirements
  • Keeping up with new sufficiency requirements demands an investment in knowledge management-like infrastructure which is often deprioritized within biopharma
Bryan Katz, Managing Director, inVentiv Health
Oct 1012:30
Conference pass

Does Canada do it better - Payer partnerships and HTA in Canada – biosimilar market access

PRICING & MARKET ACCESS
  • Assess how payer partnerships narrow the network and patient assignments
  • Improve patient outcomes and engagement through payer partnerships
  • Decrease healthcare costs while remaining innovative by aligning payers with community partners
  • Biosimilar examples
Oct 1012:50
Conference pass

ROUND TABLES

Keynotes

1) US payer introduction to the structures and processes

  • Jennifer L. Bragg, Partner, FDA regulatory and litigation attorney
  • Asif Velani, Head of Market Access, Puma Biotechnology
2) Statistical methodologies- learning new meta analysis techniques
  • Andy Gunn, Global Head Evidence Generation, UCB BioPharmaceuticals Inc
  • Simon Semus, Observational Data Analyst, GSK
3) Policy framework- Patient data and evidence management
  • Amy Niles, Vice President, External Affairs, Patient Access Network Foundation
  • Leena Patel, President and CEO, PAN Foundation
4) Economic Evaluation of Vaccines- Providing value through the prevention of disease
  • David Davidovic, Former Vice President & Global Head, Commercial Services, Roche & Genentech
5) Value Frameworks - What is the future?
  • Christine Verini, Chief Business Development Officer, CancerCare
  • John Stoeckle, Physician, Thomas Jefferson University Hospitals, Inc
  • Susan Gabriel, Director, Global Health Economics and Outcomes Research, Teva Pharmaceuticals
6) Biosimilars - Market Access
  • Jennifer Voelker, HEOR fellow, Janssen
  • Sonia Lee, HEOR fellow, Ethicon
  • Ravi Iyer, Director Global Health Economics and Reimbursement, Teva
  • Ying Wu, Director HEOR, Teva
  • Ravi Iyer, Director Global Health Economics and Reimbursement, Teva
7) BioBetter Pricing Models- Discovering how biobetters are becoming mainstream
  • Boxiong Tang, Sr. Director, GHEOR, Teva
  • Riad Dirani, Vice President Global Health Economics & Outcomes Research & EBM Global Medical Affairs, Teva Pharmaceuticals
8) Dynamic Drug Pricing Frameworks- Converging supply and demand Uber style
  • Ben Locwin, Ex-Executive Director, Roche
9) EHR records- How to bennefit 
  • Yong Chen, Director of Real World Data & Analytics, GSK
10) Post Release Commercialization - When and how
  • Shailesh Chavan, Vice President, Clinical Research, Drug Safety & Medical Affairs, Biotest Pharmaceuticals

 

Diane Cain, Director of National Accounts, Swedish Orphan Biovitrum
Andrea Souchen, Senior Marketing and Patient Access Manager, Sobi (Swedish Orphan Biovitrum)
Asif Velani, Head of Market Access, Puma
Ravi Iyer, Director GHEOR, Teva
Susan Gabriel, Director of Global Health Economics and Outcomes Research and Oncology, Teva Pharmaceutical Industries
Ying Wu, Director HEOR, Teva
Erika Szabo, Associate Director of Global Oncology, Teva Pharmaceuticals
Michelle Guo, Manager Real World Data Scientist, GSK
Yong Chen, Director of Real World Data & Analytics, GSK
Simon Semus, Observational Data Analyst, GSK
Sonia Lee, HEOR Fellow, Ethicon Inc
Jennifer Voelker, Post-doctoral HEOR fellow, Jansen
Bhakti Arondekar, Senior Director, Global & US Immuno/Oncology Team Leader, Outcomes & Evidence, Pfizer
Andy Gunn, Global Head Evidence Generation, UCB Pharma
Christine Verini, Chief Business Development Officer, CancerCare
Ben locwin, Ex-Executive Director Roche President, Healthcare Science Advisors, Roche & Genentech
Shailesh Chavan, Vice President of Clinical Research, Biotest Inc
Bat-ami Katzman Gordon, Project manager of Precision Medicine at the Sylvester Comprehensive Cancer Center, University of Miami
Oct 1014:50
Conference pass

Digital technologies for value based healthcare

EVIDENCE
  • The future of healthcare will be almost entirely digital, driven by new and existing generations of consumers who are more mobile, technologically sophisticated and want more control over their own healthcare decisions
  • How to demonstrate value and develop awareness & empowerment across the whole drug development process
  • The regulatory, economic and other challenges the new digital landscape presents
James Harnett, Sr. Director, Analytical Sciences Lead, Real World Data and Analytics, Global Health and Value, Pfizer
Oct 1014:50
Conference pass

Improvements in patient symptoms or quality of life in the context of cost

PRICING & MARKET ACCESS
  • Bridging perspectives of industry, government and advocacy groups on the patient
  • Recent Teva GHEOR publications on QOL in the cancer patient
  • Building in the changing patient focus in treatment regimens and decisions
Erika Szabo, Associate Director of Global Oncology, Teva Pharmaceuticals
Oct 1015:10
Conference pass

Gene therapy and market access, welcoming in a new generation of regenerative medicine

EVIDENCE
  • How to improve the quality of risk-sharing agreements between manufacturers and payers that are based on outcomes
Timothy Miller, President, Chief Executive Officer and Director, Abeona Therapeutics Inc.
Oct 1015:10
Conference pass

PANEL: Accelerated Approval and Expensive Drugs — A Challenging Combination

PRICING & MARKET ACCESS
  • Despite the uncertain evidence of clinical benefit, drugs receiving accelerated approval enter the market as FDA-approved products. Insurers must decide whether and how to pay for them
  • How do insurers decide whether to pay for these drugs in light of little evidence?
  • Ensuring that confirmatory trials conducted after receiving accelerated approval are performed in a timely fashion and are designed optimally to limit the period of uncertainty about true clinical effect
Oct 1015:30
Conference pass

Brazil focus: Market access and value generation

EVIDENCE
  • Analyze what stakeholders in Brazilian healthcare can bring to the table to create business opportunities and provide value at the same time
  • Challenges can only be met together: Discover how helping partners keeps you one step ahead of future health trends
  • Find out how creating long-lasting relationships helps pinpoint business opportunities where there are common goals
Christina Matteucci, Market Access Head, Brazil, Bristol Myers Squibb
Oct 1015:50
Conference pass

Safer, Smaller, and More Cost-Efficient Clinical Trials: The Value of Biomarkers for Clinical Trial Enrichment

EVIDENCE
  • Understanding the Rationale and Importance of Clinical Trial Enrichment
  • Case Study: Use of Existing Study Data to Qualify a Biomarker for Clinical Trial Enrichment in Chronic Obstructive Pulmonary Disease (COPD)
  • Lessons Learned and Implications for Use in Other Therapeutic Areas
Oct 1015:50
Conference pass

A Time and Opportunity for “Non-traditional” Approaches and Models in Market Access?

PRICING & MARKET ACCESS
  • What are some of the more innovative approaches we have been involved with or observed?
  • Are there learnings or aspects at the specific country level that may apply to the evolving situation in other markets?
  • What are the implications for biopharma planning? Our observation on some different practices?
Keith Ruark, VP of Strategy Consulting, INC Research
Oct 1016:10
Conference pass

PANEL: The impact of precision medicine and biomarkers on drug pricing structures

EVIDENCE
  • Understanding how biomarkers will have an increasing role to play in drug pricing 
  • What impact will precision medicine have on the overall cost of healthcare
  • Do we have the necessary evidence to put a price on precision medicine?
Oct 1016:10
Conference pass

Value and Impact of early collaboration between commercial and development

PRICING & MARKET ACCESS
  • The importance and benefits of early and ongoing communications and collaboration
  • How can such collaboration be appropriate in the current regulatory environment?
  • How this collaboration is essential for patient centricity
Oct 1016:40
Conference pass

Is this the start of a revulsion revolution?! Are patient centered outcomes changing the equation of value?

PRICING & MARKET ACCESS
  • Healthcare is no longer a disease-centric process. Modern healthcare is patient-centric, where patients (and their families) are active participants in care
  • Defining end points through patient involvement and the advantages that this
  • How accelerating patient-centered CER improves value
Rafael Alfonso, Director, Analytics and Innovation, Value Evidence and Outcomes, GSK
Oct 1017:30
Conference pass

Show me real evidence - Evaluating strength of evidence in systematic reviews

Keynotes
  • Reports of study design issues that lead to low strength of evidence and how to mitigate your chances of pitfalls.
  • Working with patient registries and generating strong data to empower the value equation
  • Making information valid and reliable for patient and policy decision making 

Create your personal agenda –check the favourite icon

Oct 1109:00
Conference pass

Assessing value frameworks for cellular and gene therapy products

Keynotes
  • Understanding fundamental differences in gene and cellular therapies
  • What preliminary requirements are needed to be met to satisfy CBER FDA
  • ​Current work of Fibrocell and the ever growing field of cellular and gene therapies
Oct 1109:20
Conference pass

Global Physician Perspectives on Biosimilar Naming and Substitution

Keynotes
  • Building physician confidence in biosimilars is critical to increasing uptake of biosimilars and reaping their health benefits and cost savings. 
  • Surveys of biologic prescribers provide valuable insight to national regulators about what level of data and transparency prescribers need to feel comfortable prescribing biosimilars, or permit substitution of a biosimilar by a third-party payer such as a government or private insurer.
  • Surveys from 12 countries examine prescriber perspectives on biosimilar approval, naming, automatic or pharmacy-level substitution, indication extrapolation, and other policy issues currently being addressed by regulators worldwide.
Oct 1109:50
Conference pass

Putting real world evidence data to the test in real world systems

Keynotes
  • Real-world evidence (RWE) research is an increasingly important component of biopharmaceutical product development and commercialization
  • Since implementation of real world evidence systems, how have health care systems been impacted economically?
  • Should you be investing more in real world evidence generation!?
Steve Clark, Senior Vice President, Optum Life Sciences
Oct 1110:40
Conference pass

From Astrology to Astronomy - The science demonstrating value of personalized medicines

Keynotes
  • Big Data Health Epidemiology: its progress and impacts on value
  • Population Centric Phenotypes and how we must consider them
  • Making inferences from Personal Genomes
Oct 1111:00
Conference pass

PANEL: Value based frameworks for precision medicine

EVIDENCE
  • Are current value frameworks suited to precision medicine?
  • What factors should be considered?
  • What are the ethical perspectives? 
john mattison, CHIO, Asst Med Dir, Kaiser Permanente
Catherine Brownstein, Scientific Director, Manton Center for Orphan Disease Research
James Barbeau, Director of Clinical Pathology, Lifespan/Brown University
Oct 1111:40
Conference pass

Understanding Barriers to HCV Treatment

EVIDENCE
  • What are the Clinical, Financial and Policy Issues that Impact Patient Access?
  • How do Physicians, Pharmacies and Payers Impact Real-World Patients?
  • Is Hepatitis C a precursor for future access to specialty drugs?
Brent Clough, CEO, Trio Health
Oct 1112:00
Conference pass

Developing a successful market access strategy in biologic and biosimilar development.

PRICING & MARKET ACCESS
  • Review the development and trends of biologic and biosimilar from the payer’s perspective
  • Different opportunities and challenges of biologic vs biosimilar and chemical brands vs generics
  • Review the evidence needs and role of HEOR in the development of biologics and biosimilar
Oct 1112:20
Conference pass

ROUND TABLES

Keynotes

1) Global Market Access For Orphan Drugs - How to include developing countries

  • Durhane Wong-Rieger, President, Canadian Organization for Rare Disorders
  • Ron Marchessault, Vice President, Value and Access, Specialty Care Sanofi Genzyme
  • Ramaiah Muthyala, President, Indian Organization for Rare Diseases
  • George Wyatt, Executive Senior Consultant, Innomar Strategies, Amerisource Bergen
  • Lisa Phelps, VP Policy, NORD National Organization for Rare Diseases
  • Meryem Nimour, VP- Medical Affairs Lead – Rare Disease- Emerging Markets, Pfizer
  • Pam Gavin, Chief Operating Officer, National Organization for Rare Diseases
2) Patient led Evidence - Discussing new levels of patient centricity in pricing models
  • Bert Vrijhoef, CIO & Senior Principal, Investigator, Panaxea & Maastricht University Medical Center
  • Lauren Bartolome, HEOR fellow, Novartis
  • Nneka Onwudiwe, PRO/PE Regulatory Review Officer, US Government​
3) I/O Pricing Models- New models to stumulate a fluctuating market
  • Bhakti Arondekar, Sr Director, Outcomes & Evidence, Oncology, Pfizer
  • Alberto Batista, HEOR fellow, Jefferson College of Population Health
  • Francisco Burgin, PGY-1 Managed Care Pharmacy Resident, Humana
4) Asian Access and Reimbursement- Discussing new developments in HTA in Asia
  • Jack Shea, Director Corporate Development, Merck
  • Sean McElligott, Director, Market Access, Janssen
  • Elizabeth Richardson, Managing Associate, Duke Margolis Center for Health Policy
5) Paying for gene therapy- Single fix medication and pricing models
  • John Maslowski, President and CEO, Fibrocell
  • Timothy Miller, President, CEO and Director, Abeona Therapeutics Inc
  • Christine Lu, Associate Professor, Harvard Medical School & Harvard Pilgrim Health Care Institute
  • Marianne Hamilton Lopez, Research Director, Duke-Robert J. Margoli Centre for Health Policy
6) Brazil Focus: Market Acess and Value Generation
  • Christina Matteucci, Market Access Head, Brazil, Bristol Myers Squibb
  • Roberta Monteiro, Market Access and Commercial Director, Eisai Brasil
7) Pluralistic approaches to value - Does the one size fits all approach still work?
  • Shanthy Krishnaraja, Global Head of Health Economics and Reimbursement Strategy, CSL Behring
  • Ashley John, Senior Specialist, Advocacy and Policy, American Academy of Dermatology

8) One payer systems - Consequences of implementation

  • Stephen Smith, Reimbursement Associate, Merck
Dawn Ireland, President, CDH International
Stephen Smith, Reimbursement Associate, Merck
Stephen Smith, Reimbursement Associate, Merck
Pamela Gavin, Chief Operating Officer, National Organization for Rare Disorders
Meryem Nimour, VP- Medical Affairs Lead – Rare Disease- Emerging Markets,, Pfizer
Lisa Phelps, Director Community Relations and Marketing, National Organization for Rare Disorders
George Wyatt, Managing Director and Founder, Wyatt Health
Ramaiah Muthyala, Professor/Director at University of Minnesota, Indian Organisation of Rare Diseases
Ron Marchessault, VP, Market & Patient Access, Genzyme, a Sanofi Company
Ashley John, Senior Specialist, Advocacy and Policy, American Academy of Dermatology
Elizabeth Richardson, Managing Associate, Duke Margolis Center for Health Policy
Francisco Burgin, PGY-1 Managed Care Pharmacy Resident, Humana
Marianne Lopez, Research Director, The Duke-Margolis Center for Health Policy
Alberto Batista, HEOR fellow, Teva Pharmaceuticals
Lauren Bartolome, HEOR Fellow, Novartis
Bhakti Arondekar, Senior Director, Global & US Immuno/Oncology Team Leader, Outcomes & Evidence, Pfizer
John Shea, Director Corporate Development, Merck & Co Inc
Sean McElligott, Director, Market Access, Janssen
Christina Matteucci, Market Access Head, Brazil, Bristol Myers Squibb
Bert Vrijhoef, CIO & Senior Principal Investigator, Panaxea & Maastricht Unniversity Medical Center
Timothy Miller, President, Chief Executive Officer and Director, Abeona Therapeutics Inc.
Oct 1114:10
Conference pass

Value based pricing in pharma

EVIDENCE
  • Understanding how to develop a culture in which Evidence will prevail
  • How to encompass frameworks earlier cross-stakeholder engagement, regulatory tools, and iterative evidence generation through the life cycle of the medicinal product
  • Access through flexible and adaptive payer approaches to pricing and reimbursement that reflect the emerging generated evidence
Oct 1114:10
Conference pass

Shining a light on the black box of Orphan Drug Reimbursement

PRICING & MARKET ACCESS
  • Discussing abuses of the Orphan Drug reimbursement system
  • Comprehensive review of the current US Orphan reimbursement system
  • Examining the explosion of orphan drug research and development
Peter Dehnel, Medical Director, Blue Cross and Blue Shield of Minnesota
Oct 1114:30
Conference pass

PANEL: Market access evolution in Canada – past, present, and the future

EVIDENCE
  • Ensure that prices at which pharmaceutical companies sell their patented medicines in Canada are not excessive
  • Ensuring a sustainable pharmaceutical system where payers have the information they need to make smart reimbursement choices
  • Ensuring effective access of your biosimilar into the marketplace
Oct 1114:30
Conference pass

Expanding your horizons - Orphan drug considerations in Health Technology Assessment in European countries

PRICING & MARKET ACCESS
  • The importance of understanding international HTA systems
  • Fair prices for orphan drugs - from the payers' perspective
  • New evidence requirements throughout Europe – what do you need to do to be prepared?
Anna Bucsics, Project Advisor, University of Vienna
Oct 1114:50
Conference pass

PANEL: Market access of orphan drugs and the role of multi-criteria decision making

PRICING & MARKET ACCESS
  • Ways for orphan drug manufacturers to improve their ability to compete in competitive markets
  • Advantages of abandoning a (one-size-fits-all) approach
  • The influence of orphan drug biosimilars
Peter Dehnel, Medical Director, Blue Cross and Blue Shield of Minnesota
Anna Bucsics, Project Advisor, University of Vienna
Oct 1115:10
Conference pass

PANEL: Patient Affordability: Bridge the gap between access and the patient's pocket

EVIDENCE
  • Examine how you can address Patient Affordability and alleviate coverage inequality for oral therapies
  • Develop meaningful and progressive assistance programs which address a patients’ ability to afford medication
  • Drive solutions that will relieve patient paying points as they move between different sites of care
Oct 1115:10
Conference pass

Variation in provider vaccine purchase prices and payer reimbursement

PRICING & MARKET ACCESS
  • Highlighting the need for individual practices to understand their own costs and reimbursements
  • Opportunities to reduce costs and increase reimbursements
  • Evolution of new pricing strategies
S D Ravetkar, Executive Director, Serum Institute of India Ltd
Oct 1115:30
Conference pass

The vaccine race: science, politics and the human costs of defeating disease

PRICING & MARKET ACCESS
  • Gaining insights into the history of vaccines and developments that have been made over the course
  • Understanding the importance of vaccines in a healthcare systems inventory
  • What are the future requirements to make vaccination programs successful
Oct 1115:50
Conference pass

Are patient preferences being reflected in value assessment frameworks?

EVIDENCE
  • Where is the patient voice in major Value Assessment Frameworks?
  • Do the models meet the rubric created by the National Health Council?
  • Is Faster Cures/Avalere's Patient Perspective Value Framework a solution?
Kevin Mayo, Ex Senior Director, Global Patient (Market) Access - Commerical Strategy and Consumer Operations, Shire Pharmaceuticals
Oct 1116:10
Conference pass

Keynote address: The future of evidence, pricing and reimbursement in the US healthcare system and what it means to you

Keynotes
  • Impact of the Trump administration on the payer/buyer relationship 
  • The impact of leveraging buying power for Medicare
  • Will drug prices be significantly reduced as a result?
  • What will the effects on global R&D be?
Oct 1116:10
Conference pass

Closing Keynote: Assessing value frameworks for cellular and gene therapy and one off cure products

Keynotes
  • Understanding the impact of one off cures
  • What preliminary requirements are needed to be met to satisfy CBER FDA
  • Current work of Fibrocell and the ever growing field of cellular and gene therapies
last published: 06/Oct/17 22:05 GMT