Cambridge Healthtech Institute’s 4th Annual

Clinical Biomarkers Strategy and Innovation

Enabling Precision Medicine Trials

February 19-20, 2019


The concept of personalized or precision medicine has brought to life several types of clinical trials that involve biomarkers and require biospecimen collection and management. Effective management of these trials can be complicated and requires specific operational approaches. Cambridge Healthtech Institute’s Fourth Annual Clinical Biomarkers Strategy and Innovation conference is designed to exchange solutions to overcome operational and scientific challenges with various types of studies including trials with biomarker-based stratified trials, biomarkers as end points, etc. Informed consent, innovative solutions for biospecimen management and other important topics will be discussed by leading experts from top pharmaceutical companies.


Stay on and attend Part 2 (Wed-Thurs): Clinical Biospecimens and Central Lab Solutions


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)

BIOMARKER DRIVEN TRIAL: STRATEGY AND INNOVATION

BioAssets Strategy to Advance Precision Medicine Trials

Mohan Bangalore, Global Head, BioAsset Management, GSK

The Challenges of Implementing 10 Years of Industry Advancement, in 1 Year!

Caoimhe Vallely-Gilroy, Director, Global Head, Clinical Trials Biosample Management, Global Clinical Operations, Merck KGaA

Challenges of Clinical Specimen Management in the Era of Precision Medicine

Debra Reinhard, Head, Translational Medicine Enabling Solutions, Bristol-Myers Squibb Company

INFORMED CONSENT AND DATA PERMISSIONS

Consent for Biospecimens: The Basics

Karina Bienfait, PhD, Principal Scientist & Head, Global Genomics Policy, Process & Compliance, Merck

Returning Data and Results to Clinical Trial Participants

David Leventhanl, Director, Clinical Innovation, Global Product Development, Pfizer

TECHNOLOGY TO ADDRESS SAMPLE & BIOMARKER LOGISTICS & BEST PRACTICES

Clinical Sample Tracking: Switching from Project to BAU and Providing Enhancements Including a Dashboard

Ron Bourque, Hons. BA, Associate Director, MedImmune Clinical Business Analyst, Science & Enabling Units, IT, AstraZeneca

Innovations along the Specimen Management Value Chain

Brenda Yanak, Former Global Head, Specimen Strategy and Innovation, Q2 Solutions a Quintiles Quest Joint Venture

Patient Friendly Biomarkers: Utility of Minimally Invasive Blood Sample Collection Technologies In Clinical Trials

Dmitri Mikhailov, PhD, Biomarker Development, Novartis Institutes for BioMedical Research, Inc.

INTEGRATING SAMPLE MANAGEMENT INTO CLINICAL TRIAL CYCLE: RBM CONSIDERATIONS

Specimen-Centric Considerations for Possible Extensions of Risk-Based Monitoring (RBM) Principles

Michael Tanen, MBA, Director, Clinical Biomarker Specimen Management, Merck Research Laboratories

The Risk Assessment as a Foundation for RBM – Engaging Functional Area Stakeholders

Suzanne Lukac, Director, Risk-Based Monitoring Implementation, Merck

Eurofins_Central_LabBRIDGING LUNCHEON PRESENTATION: Where in the World are my Specimens? (And how do I Fetch Them?)

Kevin Smith, Vice President, Technology & Data Solutions, Eurofins Central Laboratory

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): Clinical Biospecimens and Central Lab Solutions


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

Executive Director, Conferences

Cambridge Healthtech Institute

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