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12: Value-Access [clear filter]
Monday, June 24
 

11:00am

#119: Making Value-Based Contracting Stick
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-532-L04-P; CME 1.00; IACET 1.00; RN 1.00

Value-based contracting between payers, providers and manufacturers is an evolving space. Finding approaches that will can both scale and succeed long term have been challenging. The first speaker will describe a set of examples that focus on the payer-pharma relationships. The second two speakers will describe a new approach to using provider clinical outcomes in specialty conditions as the level of measurement.

Learning Objectives

Describe the current state of value-based contracting; Discuss examples of success and failure in value-based contracting; Identify a new approach to using provider clinical outcomes.

Chair

Richard Gliklich, MD

Speaker

Trends and Practices of Applying Real World Evidence to Market Access and Value-Based Care
Robert A. DiCicco, PharmD

Medical Scores to Enable Value-Based Care
Richard Gliklich, MD

Industry Update
Thomas Michael Renshaw, MBA, RPh



Speakers
avatar for Richard Gliklich

Richard Gliklich

Chief Executive Officer, OM1
Dr. Richard Gliklich is the CEO of OM1, Inc., an outcomes and technology company focused on real world evidence and measuring and predicting outcomes. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale... Read More →
avatar for Thomas Renshaw

Thomas Renshaw

Senior Director, Business Solutions, Acentrus Specialty (Vizient)
Tom currently functions as the Senior Director of Business Solutions for Apexus with responsibility for innovative business strategies and development. Tom has served as a subject matter expert in the areas of transitional care, population health management, bioinformatics, 340B... Read More →
avatar for Robert DiCicco

Robert DiCicco

Deputy Chief Health Officer, IBM Watson Health
Rob DiCicco is a Deputy Chief Health Officer for IBM Watson Health where he focuses on Life Sciences. Rob joined IBM in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years. His area of expertise includes clinical pharmacology and experimental medicine, clinical... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11:00am

#120: FDA Payer Communication Guidance, Twenty Years in the Making: Now What?
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-533-L04-P; CME 1.00; IACET 1.00; RN 1.00

The FDA Payer Guidance released in 2018 has provided some clarity to industry and payers. The FDA explicitly noted the important difference between information required for medical product approval and what is needed by payers to make decisions about population-based coverage and reimbursement. The FDA Payer Guidance is largely pragmatic regarding HCEI communications and advances industry’s proactive dialogue with payers. However, there remains areas of uncertainty within the guidance. A panel composed of the relevant stakeholders will have an open dialogue on the intention of the guidance, the challenges with developing a guidance for industry and payers, the practical challenges of operationalizing aspects of the guidance, the remaining informational needs of payers from industry to inform access decisions.

Learning Objectives

Discuss how to decrease the anxiety in proactively communicating relevant coverage and reimbursement information from industry to payers for population-based coverage decisions.

Chair

Sissi Pham, PharmD

Speaker

FDA Perspective
Sheila Ryan, MPH, RAC

Panelist
Chris Leo Pashos, PhD

Panelist
Mitchell Higashi, PhD

Panelist
Denise Sanchez, JD, MPH, MS



Speakers
avatar for Mitchell Higashi

Mitchell Higashi

Vice President, Health Economics and Outcomes Research, Bristol-Myers Squibb
Mitch is the Vice President of HEOR at Bristol-Myers Squibb. Prior to joining BMS, he was the Chief Economist for GE Healthcare, where he led global efforts in health economics, pricing, reimbursement, and health policy. Mitch is a published author, including JAMA, and his work in... Read More →
avatar for Chris Pashos

Chris Pashos

Vice President, Global Evidence Strategy, AbbVie Inc.
Dr. Pashos oversees AbbVie’s Real-World Evidence Generation and Patient Centric Research Center of Excellence, demonstrating the value of medicines in addressing needs perceived by regulators, health technology assessment agencies & payers, the medical community and patients. He... Read More →
avatar for Sissi Pham

Sissi Pham

Chief Executive Officer, AESARA
Sissi Pham is a founder and CEO of AESARA, Inc. and AESARA Foundation, both established in 2016. AESARA, Inc. was established with the commitment to absorb the administrative cost of the AESARA Foundation to enable the charity to give 100% of the donations to directly to humanitarian... Read More →
SR

Sheila Ryan

Acting Director, Division of Supply Chain Integrity, Fda/cder/Office Of Compliance/Office of Drug Security, Integrity and Response
Sheila Ryan, PharmD, MPH, RAC is currently the Acting Director of the Division of Supply Chain Integrity in the Office of Drug Security, Integrity and Response within CDER's Office of Compliance at FDA. She has over 15 years of FDA regulatory experience, including over 10 years in... Read More →
avatar for Denise Sanchez

Denise Sanchez

Executive Director, Regulatory Affairs Advertising and Promotion, Allergan
Denise joined Allergan with 15 years of combined industry, government and law firm experience. Prior industry roles include Regulatory overview of commercial promotion and practices at Ironwood Pharmaceuticals, Celgene Corporation, and Cubist Pharmaceuticals. While at the law firm... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

2:00pm

#272: Aligning Facilitated Regulatory and Access Pathways: Observations from the North American Experience
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-622-L04-P; CME 1.25; IACET 1.25; RN 1.25

The purpose of this session is for agencies, industry, and other organizations to present their observations around the types of facilitated pathways that are available in North America to speed access to medicines that address an unmet medical need.

Learning Objectives

Describe initiatives that the US and Canada has implemented to streamline the process for approval of and access to therapies that address unmet medical need (UMN); Illustrate opportunities and challenges with aligning regulatory and access pathways; Discuss if these pathways may have a broader remit than just for therapies for UMN.

Chair

Lawrence Eugene Liberti, PhD, RPh, RAC

Speaker

Market Access on the Two Sides of the Atlantic: Barriers and Opportunities
Maria Isabel Manley, LLM

Aligning Approval and Access: The US Experience
Sean Tunis, MD, MSc

Patient Perspective
Julie Eller



Speakers
avatar for Lawrence Liberti

Lawrence Liberti

Executive Director, Centre for Innovation in Regulatory Science (CIRS)
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been... Read More →
avatar for Maria Manley

Maria Manley

Partner, Head of the UK Life Sciences, Sidley Austin LLP
Marie advises on a broad spectrum of matters, both contentious and non-contentious, that arise in the conduct of a bio pharmaceutical business. Marie represents pharma companies before UK and EU institutions (EMA, MHRA, NICE, PMCPA DOH and the European Commission). Marie is Chairperson... Read More →
avatar for Julie Eller

Julie Eller

Manager of Grassroots Advocacy, Arthritis Foundation
Julie leads a patient network of more than 100,000 patient Advocates as they share their story to effect change. Julie has had arthritis since she was seven years old and the Arthritis Foundation has helped her foster a passion for translating the patient experience into advocacy... Read More →
ST

Sean Tunis

Senior Strategic Advisor, Center For Medical Technology Policy (CMPT)


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#294: Update From the US FDA on Progress and Topics of Current Interest in US Biosimilar Policy, Regulation, and Outreach/Education
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-636-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will include an update from members of the US FDA on progress and topics of current interest in US biosimilar policy, regulation, and outreach/education.

Learning Objectives

Discuss topics of current interest in US biosimilar policy.

Chair

Sarah Yim, MD

Speaker

FDA Update
Joseph B. Franklin, JD, PhD

FDA Update
Sarah Crowley-Ikenberry, MA

FDA Update
Christopher Downey, PhD



Speakers
avatar for Sarah Yim

Sarah Yim

Director (Acting), Office of Therapeutic Biologics and Biosimilars, FDA
Sarah Yim, M.D. is acting Director of the Office of Therapeutic Biologics and Biosimilars in CDER's Office of New Drugs (OND). Prior to joining the Biosimilars group in March 2019, she was director of the Division of Clinical Review in the Office of Generic Drugs (OGD) for 2 years... Read More →
avatar for Sarah Crowley-Ikenberry

Sarah Crowley-Ikenberry

Senior Communication Advisor, OTBB, OND, CDER, FDA
Sarah Ikenberry is Senior Communication Advisor for the Office of Therapeutic Biologics and Biosimilars (OTBB), in the Food and Drug Administration’s (FDA), Center for Evaluation and Research (CDER) where she provides communication advice and support to senior leaders and the agency... Read More →
avatar for Christopher Downey

Christopher Downey

Review Chief, OBP, OPQ, CDER, FDA
Christopher (Chris) Downey is a Review Chief in FDA/CDER’s Office of Biotechnology Products (OBP). He was been with FDA since 2012, and currently oversees CMC reviews of therapeutic proteins, including new molecular entities and biosimilars. He received his PhD in Biochemistry from... Read More →
JF

Joseph Franklin

Policy Director for the Principal Deputy Commissioner, FDA
Joe Franklin is the Policy Director for the FDA Principal Deputy Commissioner. Until April 2019, Dr. Franklin was the Director of the Policy Staff in the Office of Therapeutic Biologics and Biosimilars at FDA. Previously, Dr. Franklin was an Associate Chief Counsel in FDA’s Office... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

2:00pm

#372: Advancing Value and Access With Technology
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-695-L04-P; CME 1.25; IACET 1.25; RN 1.25

The purpose of this session is to describe advanced technologies being used to advance value and access through specific, real case examples, in terms of their use for contracting and value assessment. Speakers will describe the technology and use cases associated with blockchain, distributed networks and use of artificial intelligence in outcomes-based contracting among other technological advances.

Learning Objectives

Describe the use of technology to advance value and access; Discuss the use of specific technologies, including blockchain, artificial intelligence, and distributed networks.

Chair

Richard Gliklich, MD

Speaker

The Power of the New Healthcare Data Intelligence
Ian Rentsch, JD

Advancing Outcomes-Based Contracts with AI
Robert A. DiCicco, PharmD



Speakers
avatar for Richard Gliklich

Richard Gliklich

Chief Executive Officer, OM1
Dr. Richard Gliklich is the CEO of OM1, Inc., an outcomes and technology company focused on real world evidence and measuring and predicting outcomes. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale... Read More →
avatar for Ian Rentsch

Ian Rentsch

Chief Executive Officer, Clinerion
Ian Rentsch has over 23 years’ experience in Multinational Corporate Affairs, Outsourcing Management & Clinical Research Development working in large multinational companies including large biopharma and Contract Research Organizations Globally and in Emerging Markets. Most recent... Read More →
avatar for Robert DiCicco

Robert DiCicco

Deputy Chief Health Officer, IBM Watson Health
Rob DiCicco is a Deputy Chief Health Officer for IBM Watson Health where he focuses on Life Sciences. Rob joined IBM in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years. His area of expertise includes clinical pharmacology and experimental medicine, clinical... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#396: Challenges to Access: Bringing Payers to the Table
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-711-L04-P; CME 1.25; IACET 1.25; RN 1.25

While the FDA and EMA avail themselves for early engagement with pharmaceutical manufacturers, non-binding joint consultations with regulators and payers have been to-date available to manufacturers primarily in Europe. With the moving target of paradigm shift from volume-based to value-based healthcare delivery in the US, the question remains if viable avenues for engagement with payers exist in the fragmented market place. Traditional engagement opportunities through payer advisory boards and standing panels have proven moderately effective and with the growing focus on health technology assessment in the US that spans comparative effectiveness, short-term affordability and long-term value for money assessments, a dialogue may be warranted to explore more formal ways to engage manufacturers, regulators and payers. A panel composed of the relevant stakeholders will have an open dialogue on the topic offering a forum for generating potential concepts for testing to enable formal early payer engagement in the medicine development process in the US.

Learning Objectives

Identify potential innovative ways of early engagement with payers in the US to enhance medicine development programs and produce a “reimbursable file” at the time of regulatory approval.

Chair

Ruslan Horblyuk, PhD, MA

Speaker

Panelist
Sean Tunis, MD, MSc

EMA Perspective
Tânia Teixeira, PharmD

Industry Perspective
Cristina Masseria



Speakers
RH

Ruslan Horblyuk

Chief Strategic Consulting Officer, AESARA, Inc.
Ruslan Horblyuk started his career in international health policy consulting over 20 years ago working in the countries of former Soviet Union as part of the US Agency for International Development funded Health Policy Reform Initiative. He transferred to the industry in 2003 and... Read More →
avatar for Tânia Teixeira

Tânia Teixeira

EMA Liaison Official at FDA, European Medicines Agency (EMA)
Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product... Read More →
CM

Cristina Masseria

Methods and Capabilities Lead, Pfizer Inc
ST

Sean Tunis

Senior Strategic Advisor, Center For Medical Technology Policy (CMPT)


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA