Cambridge Healthtech Institute’s 2nd Annual

Managing Precision Medicine Trials:  

Biomarker and Genomics Considerations
January 24-25, 2017 | Hyatt Regency Miami | Miami, FL


The concept of personalized or precision medicine, with medical decisions, practices, and/or products being tailored to the individual patient, has brought to life several types of clinical trials that involve biomarkers. Effective management of these trials can be complicated and requires specific operational approaches. CHI’s Second Annual Managing Precision Medicine Trials symposium is designed as an educational event to discuss solutions to overcome operational and scientific challenges with various types of studies including trials with biomarker-based stratified trials, trials for biomarker discovery and trials with biomarkers as end points. Study design specifics and operational challenges in biomarker-involved clinical trials will be discussed by experts from top pharmaceutical companies.

Preliminary Agenda

Stay on and attend Part 2: Sample, Lab and Diagnostics Services in Clinical Trials
Keynotes | Monday Short Courses | Speaker Biographies

Monday, January 23

Recommended Pre-Conference Short Course
2:00 - 6:00 pm
SC4: Managing Trials in Oncology and Immuno-Oncology*
*Separate registration required

Welcome and Networking Happy Hour on the Patio hosted by CHI, DrugDev and Praxis
6:30 - 8:30 pm

Tuesday, January 24 – Wednesday, January 25


OPENING PLENARY KEYNOTES
RE-THINKING THE DESIGN AND PLANNING OF OUR STUDIES


Two Keynote Sessions – Tuesday Morning and Wednesday Afternoon

  • Tuesday Morning: RE-THINKING THE DESIGN AND PLANNING OF OUR STUDIES
  • Wednesday Afternoon: MOVING TOWARD TRIALS OF THE FUTURE

Featuring:
Murray Abramson, M.D., Vice President, Global Clinical Operations, Biogen
Bardia Akbari, Pharm.D., Vice President, Product Global Development, Oncology, Genentech, Inc.
Robert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
Craig Lipset, MBA, Head of Clinical Innovation, R&D, Pfizer, Inc.
Paulo Moreira, Vice President, Global Clinical Operations - External Innovation, EMD Serono, Inc.
Christine Pierre, President, Society for Clinical Research Sites (SCRS)
John Reites, Head, Digital Health Acceleration, Quintiles
Jeremy Sohn, Vice President, Head of Digital Business Development & Licensing, Novartis
Katherine Vandebelt, Senior Director, Clinical Innovation, Eli Lilly and Company

For more details on the Tuesday Opening Plenary Keynote and Wednesday Afternoon Plenary Keynote click here.


Grand Opening Coffee Break in the Exhibit Hall


STRATEGIZING DESIGN AND OPERATIONS IN BIOMARKER-DRIVEN TRIALS

Operational Challenges and Opportunities in Design and Implementation of Biomarker Selective Clinical Trials
Bardia Akbari, Pharm.D., Vice President, Product Global Development, Oncology Genentech, Inc.

Conducting Genomic Research in Global Clinical Trials
Karina L. Bienfait, Ph.D., Head, Global Genomics Policy, Process and Compliance, Principal Scientist, Clinical Pharmacogenomics and Operations, Genetics and Pharmacogenomics (GpGx) ,Translational Medicine, Merck Research

Operationalizing Precision Medicine
Brenda Yanak, Ph.D., Director, Precision Medicine Leader, Clinical Innovation, Pfizer

Critical Decisions in Designing and Implementing Precision Medicine Trials
Jim Stolzenbach, President, Jim Stolzenbach Consulting, LLC (former Vice President for Abbvie Renal and Immunology Therapeutic Development)


BASKET AND N-of-1 TRIALS

Innovative Trial Designs for Precision Medicine: Intertwining Science and Clinical Operations
Amir Handzel, Ph.D., Statistical Science Director Astrazeneca

The VA Research Precision Oncology Program
Louis Fiore, M.D., Executive Director, Department of Veterans Affaris, MAVERIC


OUTSOUCING IN PRECISION MEDICINE TRIALS

Leverage Strategic CRO Partnership and Technology Innovation to Modernize Clinical Sample Management and Compliance in Managing Precision Medicine Trials
Rebecca Simamora, Senior Director, Clinical Operations Head, MedImmune
Daniel Joelsson, Director, Global Business Planning & Operations, MedImmune


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 more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal, yet informative, format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive 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.

View Detailed Interactive Breakout Discussion Groups

Welcome Reception in the Exhibit Hall


Stay on and attend Part 2: Sample, Lab and Diagnostics Services in Clinical Trials
Keynotes | Monday Short Courses | Speaker Biographies

2017 SCOPE Conference at a Glance

SCOPE 2016 Wrap-Up

The 7th Annual SCOPE Summit, held February 23-25, 2016 in Miami, Florida, had record attendance with more than 1,150 industry leaders joining 3 days of in-depth discussions covering important issues in clinical trial planning and management. As SCOPE grew in attendance by 30% over last year, the 2016 program offered 12 distinct conference tracks, 2 symposia, 3 short courses, and 4 plenary keynote sessions, focused on advances and innovative solutions in all aspects of clinical trial management and operations, including Data Integration, Feasibility, Site Selection and Management, Patient Engagement, Recruitment and Retention, Mobile Tech, Project Management, Outsourcing, Forecasting, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, Observational Research, Statistics and Biomarker-Driven Trials.

For Further Information

For questions or suggestions about the meeting, please contact:

Marina Filshtinsky, M.D.
Senior Director, Conferences
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5496
E: mfilshtinsky@healthtech.com

For partnering and sponsorship information, please contact:

Ilana Quigley
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457
E: iquigley@healthtech.com

For media and association partnerships, please contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456
E: rhandy@healthtech.com




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