Philadelphia, PA, 10 - 11 October 2017
Schedule
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Oct 10
09:00
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
Jonathan Jarrow,
Senior Medical Advisor to the Center Director of CDER,
F.D.A
Oct 10
09:20
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 Medical Affairs,
Sanofi Inc
Sean McElligott,
Director, Market Access,
Janssen
Brett Kopelan,
Executive Director,
DebRa of America
Oct 10
10:00
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,
Consultant,
Optum Life Sciences
Oct 10
10:20
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 10
11:20
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,
Senior Manager, Global Health Economics,
Amgen Inc
Oct 10
11:20
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?
Moderator:
Bruce Broad,
Clinical Professor of Dermatology at Perelman School of Medicine,
University of Pennsylvania
Adam Kautzner,
Vice President, Formulary & Drug Trends Solutions,
Express Scripts
Oct 10
11:40
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
Vanja Sikirica,
Senior Director of Value Evidence and Outcomes,
GlaxoSmithKline
Oct 10
12:00
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
Nneka Onwudiwe,
PRO/PE Regulatory Reviewer Food and Drug Administration Office of Prescription Drug Promotion,
US Government
Oct 10
12:00
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
Douglas Nanton,
Market Access and Government Affairs - Western Canada and Ottawa,
Valeant Pharmaceuticals International
Oct 10
12:40
Conference pass
ROUND TABLES
Keynotes
1) US payer introduction to the structures and processes
- Jennifer L. Bragg, Partner , FDA regulatory and litigation attorney
2) Statistical methodologies- learning new meta analysis techniques
- Andy Gunn, Global Head Evidence Generation , UCB BioPharmaceuticals Inc
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
- Jennifer Voelker, HEOR fellow , Janssen
- Sonia Lee, HEOR fellow , Ethicon
- Boxiong Tang, Sr. Director, GHEOR , Teva
- Riad Dirani, Vice President Global Health Economics & Outcomes Research & EBM Global Medical Affairs , Teva Pharmaceuticals
- Ben Locwin, Ex-Executive Director , Roche
-
Shailesh Chavan, Vice President, Clinical Research, Drug Safety & Medical Affairs, Biotest Pharmaceuticals
Oct 10
14:40
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 10
14:40
Conference pass
Value in cancer care- how to cope with rising R&D costs and requirements for value demonstration
PRICING & MARKET ACCESS
- Value of new cancer therapies based on clinical benefit
- Achieving high-quality, high-value care for all patients with cancer
- Improvements in patient symptoms or quality of life in the context of cost
Keely Dahl,
Associate Medical Director Biologics,
Novo Nordisk
Oct 10
15:00
Conference pass
Taking a step beyond clinical trial information- why is this essential?
EVIDENCE
- How to improve the quality of risk-sharing agreements between manufacturers and payers that are based on outcomes
Julie Locklear,
Vice President and Head of Health Economics and Outcomes Research,
EMD Serono
Oct 10
15:00
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
Moderator:
Steinar Madsen,
Medical Director,
Norwegian Medicines Agency, Norway
Bill Martin,
Vice President, Pharma Strategy and Account Management,
Express Scripts and Accredo
Jonathan Jarrow,
Senior Medical Advisor to the Center Director of CDER,
F.D.A
Oct 10
15:20
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 10
15:40
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 10
16:00
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?
Moderator:
Bill Martin,
Vice President, Pharma Strategy and Account Management,
Express Scripts and Accredo
Oct 10
16:00
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 10
16:20
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 10
17:40
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 11
09:00
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 11
09:20
Conference pass
Gene therapy and market access, welcoming in a new generation of regenerative medicine
Keynotes
- Considerations for one-off payment and reimbursement strategies in gene therapies
- What is the right pricing framework for this and future cures?
- First fresh data from the recent Abeona gene therapy trials
Timothy Miller,
President, Chief Executive Officer and Director,
Abeona Therapeutics Inc.
Oct 11
09:50
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,
Vice President of Business Development and Consulting,
Optum Life Sciences
Oct 11
10:50
Conference pass
From Astrology to Astronomy - The science demonstrating value of personalized medicines
EVIDENCE
- Big Data Health Epidemiology: its progress and impacts on value
- Population Centric Phenotypes and how we must consider them
- Making inferences from Personal Genomes
Athula Herath,
Global Head of Real world Evidence Disease Epidemiology,
Novartis
Oct 11
10:50
Conference pass
Develop a successful market 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 11
11:10
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?
Moderator:
Christine Lu,
Co-Director of the PRecisiOn Medicine Translational Research (PROMoTeR) Center,
Harvard Pilgrim Health Care
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 11
11:10
Conference pass
The Biologics Price Competition and Innovation Act
PRICING & MARKET ACCESS
- On March 23, 2020, hundreds of approved and pending applications for biological products will face a regulatory transition as the FDA implements the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA)
- Are your products ready for the regulatory transition?
- How the provision and FDA’s implementation of it may affect approved applications for biological products, their biological product pipelines, and the timing and procedures of related patent litigations
Michael Reilly,
Executive Director,
Alliance for Safe Biologic Medicines
Oct 11
11:30
Conference pass
Winning with biosimilars!
PRICING & MARKET ACCESS
- Ex-US biosimilars uptake and pricing, and what are the key take-aways?
- Hurdles for biosimilar utilization
- Extrapolation and interchangeability –what are the issues?
Jim McKay,
Director, Clinical Development and Medical Affairs,
Sandoz
Oct 11
12:10
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
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
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
4) Asian Access and Reimbursement- Discussing new developments in HTA in Asia
- Jack Shea, Director Corporate Development , Merck
- Sean McElligott, Director, Market Access , Janssen
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
- Christina Matteucci, Market Access Head, Brazil , Bristol Myers Squibb
- Roberta Monteiro, Market Access and Commercial Director , Eisai Brasil
- Shanthy Krishnaraja, Global Head of Health Economics and Reimbursement Strategy , CSL Behring
- Ashley John, Senior Specialist, Advocacy and Policy , American Academy of Dermatology
Oct 11
14:10
Conference pass
Pricing and reimbursement experiences and insights: Lessons learned to approach adaptive payer pathways
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
David Nash, MD MBA,
Dean/Board of Directors,
Jefferson College of Population Health
Oct 11
14:10
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 11
14:30
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
Douglas Nanton,
Market Access and Government Affairs - Western Canada and Ottawa,
Valeant Pharmaceuticals International
Oct 11
14:30
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
- How to develop a truly international orphan drug pricing strategy
- New evidence requirements throughout Europe – what do you need to do to be prepared?
Anna Bucsics,
Project Advisor,
University of Vienna
Oct 11
14:50
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
Edmund Pezalla,
Former VP Pharmaceutical Policy and Strategy,
Aetna
Durhane Wong-Rieger,
President and Chief Executive Officer,
Canadian Organization For Rare Disorders
Peter Dehnel,
Medical Director,
Blue Cross and Blue Shield of Minnesota
Anna Bucsics,
Project Advisor,
University of Vienna
Oct 11
15:10
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
Moderator:
Brett Kopelan,
Executive Director,
DebRa of America
Peter Hull,
Post-Doc at Microsoft Research,
M.I.T
Shailesh Chavan,
Vice President of Clinical Research,
Biotest Inc
Melissa Paige,
UVA Cancer Center, Oncology Patient Access Principal Coordinator, Patient Advocate,
U.V.A. Health System
Oct 11
15:10
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 11
15:30
Conference pass
Vaccine pricing model for pediatric immunization
PRICING & MARKET ACCESS
- Practical results of the pediatric vaccine market analysis
- Developing appropriate costs for combination vaccines
- Entering new markets with pediatric vaccines
Shanthy Krishnaraja,
Head of Global Health Economics and Reimbursement Strategy,
C.S.L. Behring
Oct 11
15:50
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 11
15:50
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
Meredith Wadman,
Policy Reporter,
American Association for the Advancement of Science (AAAS)
Oct 11
16:10
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: 24/Aug/17 14:25 GMT
Organiser
