Roundtable Agenda

December 8, 2017

Morning Agenda: 8:15 AM – 12:00 PM

8:15am
Welcome and Introductions (Corrona)
8:30 – 9:15am
Morning Keynote: Changing standards of evidence for assessing benefit/risk – learnings from other diseases and applicability to autoimmune diseases. Roy A. Beveridge, MD, Senior Vice President & Chief Medical Officer, Humana.
9:15 – 10:45am
Session 1: What is the available clinical evidence from RCTs, registries, and other sources to support biologic selection?
What data are available from Head to Head RCTs, registries, and other relevant sources of information for demonstrating safety, efficacy, and cost effectiveness? How do we tell the drugs apart in a sustained era of comparable clinical efficacy across different mechanisms of action?
  • RA (Jeffrey Curtis, MD MS MPH, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham), 20 minutes
  • Psoriasis (Bruce Strober, Professor and Chair of Dermatology, Univ. of Conn. Health Center), 20 minutes
  • IBD (Joshua Korzenik, MD, Director of Crohn's and Colitis Center, Brigham and Women's Hospital of Harvard Medical School), 20 minutes
10:45 – 11:10am
Networking and phone break
11:10 – 12:00pm
Moderated Q&A session with audience questions (Jeff Greenberg, MD, CSO Corrona)
12:00 – 1:00pm
Lunch

 

Afternoon Agenda: 1:00 PM – 5:15 PM

1:00 – 2:30pm
Session 2: Perspective of key stakeholders on evidence requirements
What are the evidence requirements for each stakeholder? How do stakeholders view RCTs, versus registries and other information sources? Where is evidence on safety and effectiveness headed and what are the benefits of the different paths moving forward?
  • How real world patient experience is redefining evidence (Ben Heywood, Co-Founder & President, PatientsLikeMe), 20 minutes
  • Payer perspective on evidence requirements (Steven Peskin, MD, MBA, FACP, Executive Medical Director, Population Health, BCBSNJ, Associate Clinical Professor of Medicine, Rutgers RWJ Medical School), 20 minutes
  • PBM perspective on evidence requirements (Sumit Dutta, MD, MBA, SVP and CMO, Optum Rx), 20 minutes
2:30 – 3:00pm
Moderated Q&A session with audience questions (Ray Hill, CEO Corrona)
3:00 – 3:20pm
Networking and phone break
3:20 – 4:30pm
Session 3: Review of data sources and gaps, and evidence for comparative and cost effectiveness going forward
What are the strengths and weaknesses of each information source? Where is evidence for comparative and cost effectiveness going forward? What is novel and compelling in data collection? What different data sources will emerge to enrich the status quo? Will we have different outcomes measures in 5 years? 10 years?
  • Novel study designs to generate real-world evidence (e.g., pragmatic trials, nested sub studies) (Dan Solomon, MD, MPH, Professor, Harvard Medical School), 20 minutes
  • Expansion of Real World Data from EMR and Claims: Strengths and Weaknesses (Jim Harnett, PharmD, MS, Industry Perspective on Real World Data & Analytics Pfizer), 20 minutes
  • Artificial Intelligence and the Role of Machine Learning to Derive new Insights from Different Clinical Sources (Gary Kurtzman, Managing Director, Healthcare, Safeguard Scientifics), 20 minutes
4:30 – 5:00pm
Moderated Q&A session with audience questions (Joel Kremer, MD, CMO, Corrona)
Panelists: Jim Harnett, Gary Kurtzman, Dan Solomon, Jeff Curtis, Ben Heywood, Sumit Dutta
5:00 – 5:15pm
Key conclusions and close (Corrona)