Cambridge Healthtech Institute’s 8th Annual

Late Stage Research Strategy and Operations

RWE for Regulatory Decisions, Market Access and Pharmacovigilance

February 19-20, 2019


Real world evidence solutions have changed the design and execution of peri-approval and post-marketing research. Real time real world data generation, pragmatic trials, and next generation databases open new opportunities for post-marketing research as well as regulatory and market access needs. Data generated in peri-approval real world data-based studies is essential for multiple stakeholders within and outside pharmaceutical companies, such as regulatory agencies, payers, health care management organizations, formulary inclusion decision makers, healthcare professionals, and patients. Cambridge Healthtech Institute’s 8th Annual Late Stage Research Strategy and Operations conference is designed to facilitate knowledge exchange around all aspects of peri-approval studies and major application of their outcomes/generated data.


Stay on and attend Part 2 (Wed-Thurs): Leveraging RWD for Clinical and Observational Research


Monday, February 18

MONDAY USER GROUPS, KICK-OFF KEYNOTE, PARTICIPANT ENGAGEMENT AWARDS

User Group Meetings & Hosted Workshops (opportunities available): www.scopesummit.com/pre_conference_user_group_meetings

Plenary Keynotes: www.scopesummit.com/keynotes

Participant Engagement Award: www.scopesummit.com/participant-engagement-award

SCOPE’S Kick-Off Networking Happy Hour


Tuesday, February 19– Wednesday, February 20 (Part 1 of SCOPE)

RWD TO SUPPORT REGULATORY DECISIONS

RWD: Studies for Formulary Decision Making and Health Technology Assessment – a US Perspective

Martin Marciniak, PhD, Vice President, US Medical Affairs, Customer Engagement, Value, Evidence & Outcomes, GSK

Evolving Role for Real-World Evidence in Facilitating Regulatory, Payer and Provider Decision-Making

Cathy Critchlow, PhD, Vice President, Center for Observational Research, Amgen

Use of Real World Data (RWD) to Assess Cardiovascular Safety of Prucalopride to Support a New Drug Application in the U.S.

William Spalding, MS, Director, Outcomes Research-Epidemiology, Shire

Methodologies of Incorporating Patient Focused Drug Development into Regulatory Submissions

Emily C Freeman, MSc, PhD, Director, HEOR- Patient Centered Outcomes, Abbvie

RWD: SOURCES & APPROACHES

RWD Strategies for Improving Development and Access to Innovative Therapeutics

Gregory Daniel, PhD, Deputy Center Director, Duke-Margolis Center for Health Policy, Duke University

Systematic Approach to Use RWD to Inform Study Design: Going beyond Simple Feasibility

Hui Cao, PhD, Executive Director, Real World Evidence, Global Medical Affairs, Novartis Pharmaceuticals

Using Data and Analytics to Synthesize Real-World Evidence

Victoria Gamerman, Associate Director, Biostatistics, Head, Health Informatics & Analytics, Boehringer-Ingelheim Pharmaceuticals, Inc.

Identifying Breast Cancer Stage and Biomarker Status in Administrative Claims Data Using Predictive Modeling

Cynthia de Luise, PhD, MPH, Senior Director, Epidemiology, Worldwide Safety and Regulatory, Pfizer, Inc

INTERNAL CONSIDERATIONS AND OPERATIONAL CHALLENGES

Considerations and Challenges Associated with The Implementation Of An Integrated Value Based Pharmaceutical Data And Evidence Strategy

 

Tony Hebden, Vice President, Health Economics & Outcomes Research, Abbvie

Cross-Company Coordination of Postmarketing Research Efforts

Sean Zhao, PhD, Head, US Patient Safety Surveillance, US Medical Affairs, AstraZeneca Pharmaceuticals, Inc

Bridging Luncheon Presentation (Sponsorship Opportunity Available)

PLENARY KEYNOTES

 
Monday Evening, Tuesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:
 
SCOPE’s 2019 Participant Engagement Award, in Memory of Jerry Matczak
Empowering Humans to Own Their Own Data
Digital Trends That Are Changing the Healthcare Experience
Why Do We Need Caregivers in Clinical Trials; Exploring Real-life Applications in Engagement and Retention
Welcome, Pharma, to AI. Here’s What You Have Been Missing.
 
For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

INTERACTIVE BREAKOUT DISCUSSION GROUPS

Interactive Breakout Discussion Groups
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing: www.scopesummit.com/breakouts
 
Tuesday PM Welcome Reception in the Exhibit Hall

Stay on and attend Part 2 (Wed-Thurs): Leveraging RWD for Clinical and Observational Research


For more details on the conference, please contact:
Marina Filshtinsky

Executive Director, Conferences

Cambridge Healthtech Institute (CHI)

Phone: 781.972.5496
Email: mfilshtinsky@healthtech.com

For partnering and sponsorship information, please contact:

Companies A-O

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: 781.972.5457

Email: iquigley@healthtech.com

Companies P-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: 781.972.1349
Email: prose@healthtech.com

Signature Sponsor

IQVIA


Premier Sponsors

Appian

Bioclinica_new

ClinicalInk

Covance

DrugDev

ERT

PRA Health Sciences

Praxis

Syneos Health

UBC

Veeva