Cambridge Healthtech Institute’s 5th Annual

Clinical Biospecimens Technology and Outsourcing

Managing Specimens and Partnering with Labs & Biorepositories

February 20-21, 2020


The availability of high-quality biological specimens, laboratory access, and diagnostics services are of the utmost importance for biomarker-driven clinical trials and future research. The complexity and number of samples collected and analyzed during studies has increased steadily over the years and we need to come up with best practices, operational models, and IT solutions to deal with this volume and complexity. CHI’s 5th Annual Clinical Biospecimens and Central Lab Solutions conference brings together leading experts, clinical trial sponsors, and CROs to discuss challenges and identify actions to improve infrastructure for biomarker-driven clinical trials.

Arrive early and attend Part 1 (Wed - Thurs): Clinical Biomarkers Operations and Innovation

Final Agenda

Thursday, February 20

11:30 am Registration Open  (Regency Rotunda)

12:30 pm Enjoy Lunch on Your Own 

1:00 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)BioTelResearch

 

2:00 Afternoon Plenary Keynotes (Regency Ballroom S)

3:10 Booth Crawl & Refreshment Break in the Exhibit Hall. Last Chance for Exhibit Viewing (Windermere Ballroom)

CLINICAL SPECIMEN MANAGEMENT IN THE ERA OF PRECISION MEDICINE & TECHNOLOGICAL ADVANCEMENTS
Celebration 3-4

4:10 Chairperson’s Remarks

Brenda Yanak, Principal, Clinical Transformation Partners

4:15 Outsourcing Your Biospecimens: Quality Considerations for Biospecimen and Consent Management

L. Scott ClarkL. Scott Clark, PhD, ASQ-CQA, Senior Director, GCLP Quality Assurance, CRISPR Therapeutics

Outsourcing your biospecimens is a major decision but maybe the easiest decision in the whole process. Choosing a company to handle, track, and potentially process invaluable specimens as well as aggregate usable data can be a complicated process. This discussion will outline some of the items a company should consider when using an outside entity to manage biospecimens and their associated consents.

4:45 A Modern Approach to Risk-Based Monitoring: Linking Specimen & Consent Operations to Risk-Based Monitoring Efforts

Kate DuganKate Dugan, Client Engagement Director, Global Specimen Solutions, Inc., a Covance Company

With purpose, strategy, and rules, innovation can occur. As companies are looking for the most efficient ways to streamline specimen management, let’s discuss and define (refine) what traditional specimen management & risk-based monitoring means. I present a modernized way to maximize the strategic possibilities of how a unified platform with supported services can inform on decisions beyond specimen use and show how in-life sample reconciliation is in a new era of risk-based monitoring opportunities.

5:15 Patient Focused Clinical Trial Sample Collection, Management and Tracking

Stephanie Weber, Director, Advanced Therapy Services, LabConnect

Labconnect has led the industry in providing innovative strategies and solutions to simplify the ever growing complexities of clinical trial virtual sample management. To address the parallel growth in advanced therapies and in clinical trial patient centric services, LabConnect will discuss the challenges and strategies for a patient focused sample management plan. Topics will include the integration of home health care visits, solutions for virtual sample and product tracking, patient scheduling, and logistical solutions.

5:45 Performing Research during a Clinical Trial: Managing the Biospecimens

Nguyen_MatthewMatthew Nguyen, Manager, Clinical Biospecimen Operations, BioMarin Pharmaceutical Inc.

BioMarin Pharmaceutical Inc. has developed an on-line approval process that leverages our inventory tracking and process management IT system to ethically manage, efficiently triage and prioritize competing business needs for using residual consented biospecimens to support our research efforts. This approach allows our researchers to actively pursue cutting-edge science while BioMarin concurrently runs a clinical trial. Our presentation will describe the review, approval and fulfillment process that is documented in our IT system.

6:15 Networking Reception (Sponsorship Opportunity Available)

7:15 Close of Day

Friday, February 21

7:15 am Registration Open (Regency Rotunda)

7:45 BREAKFAST PRESENTATION: Breaking Down the Roadblocks to Site Activation (Regency Ballroom T)

Johnston_JillJill Johnston President, Study Planning & Site Optimization, WCG


8:15 Session Break

OUTSOURCING AND PARTNERING STRATEGIES
CELEBRATION 3-4

8:20 Chairperson’s Remarks

Mary Zuniga, Consultant, Translational Science, Immunology, Eli Lilly and Co.

8:25 Collaboration of Major Stakeholders (CRO, Laboratory and Sponsor) to Support Biomarker-Driven Clinical Trials-Operation

Zuniga_MaryMary Zuniga, Consultant, Translational Science, Immunology, Eli Lilly and Co.

Developing biomarkers is key to delivering medicines that improve patient’s lives. Good biomarkers have the potential to confirm that the compound/study drug affects the intended biological pathway and confirm the mechanism of action and help with dose setting. Novel biomarker assays are developed by the sponsor and transferred to a performing qualified lab to have a fully qualified assay for a global clinical trial. Partnering between the sponsor, the CRO managing the trial, and the central lab to successfully meet timeline deliverables is a well-orchestrated production requiring open communication and flexibility.

8:55 Innovations along the Specimen Management Value Chain

John Smutko, Manager, Biospecimen Operations, Clinical Biomarker Innovation and Development, Takeda

When the term “specimen management” is used, people generally think of biobanking, although recently more and more companies are starting to take a cross-functional viewpoint. This talk describes a vision in which the term “specimen management” is further expanded to encompass an end-to-end approach. Innovation along the end-to-end drug development value chain and how it will impact operations and technology of specimen management within future clinical trials will be discussed.

9:25 Biobanking Strategy Using Advanced Informatics to Enable Scientific Discovery and Innovation

Wetherwax_LynnLynn Wetherwax, Senior Manager, BSM & Biobank, Research Operations, Amgen

Sophisticated specimen management tools are crucial to answer key questions that will enable advancement of translational medicine. Systems that can be easily queried will help manage the size of the collection, track consent and identify any storage or use restrictions. Specimen management tools must also adapt to innovative trial designs. This talk will focus on specimen management systems and recent upgrades to adapt to the changing clinical trial landscape.

9:55 Enabling Organizations to Leverage Samples as AssetsQ2_Solutions_NoTagline

Jason Attanucci, Global Head Customer Solutions, Global Sales, BioFortis, a Q2 Solutions Company

10:25 Networking Coffee Break (Session Room Foyer)

PREDICTING QUALITY ISSUES
Manatee Spring

10:55 Chairperson’s Remarks

Francis Kendall, Senior Director, Biostatistics & Programming, Cytel

11:00 CASE STUDY: Can Artificial Intelligence Identify Recurring Quality Issues

O'Brien_FayeFaye O’Brien, Director, Performance & Metrics, AstraZeneca

Mining, Categorizing and Analyzing quality data through machine learning has the potential to improve clinical trial delivery processes.


11:30 In-Silico Patients

Wael Salloum, PhD, CSO & Co-Founder, Mendel.ai

AI technologies can generate digital patients as a substitute for human subjects. Although this may sound like science fiction today, it definitely won’t in a few years. We have already achieved the first few milestones: synthesizing a digital copy of a patient journey from EHR records and building technologies to interrogate these digital replicas to generate clinical evidence. The future is patientless.

12:00 pm Transition to Shared Sessions

FACILITATING THE TRIALS OF THE FUTURE NOW VIA THE CONNECTED PATIENT & DECENTRALIZED TRIALS (SPECIAL SHARED SESSION)
Manatee Spring

Chairperson’s Remarks

Neil Weisman, President, Continuum Clinical

12:05 The Connected Patient: A “One Stop Shop” for Trial Information and Data

McBride_MeganMegan McBride, MPH, Associate Director, Janssen Clinical Innovation, GCDO, R&D, Janssen, The Pharmaceutical Companies of Johnson & Johnson

Learn how we are creating a connected experience for trial participants before, during and after the trial where patients can access meaningful information, their individual data to share with their EHR, aggregate study results and provide ongoing feedback and insights to ensure a better experience for patients, caregivers and the site teams. Explore the possibilities to remain connected via communities to raise awareness around trials. The audience can gain insights as to the ins and outs of how we managed to create a platform to share data directly with patients – from legal, privacy, regulatory and other key stakeholder hurdles to our vision for broadening the scope of data sharing across industry.

12:35 INTERACTIVE PANEL: Translating Virtual to Reality: Decentralized Trial Transformation

Myles_JaneModerator: Jane Myles, Head, Operational Intelligence and Innovation, Roche


Forman_DarcyPanelists: Darcy Forman, Vice President, Clinical Operations, Science37


Kadhim_HassanHassan Kadhim, Director, Clinical Trial Business Capabilities, GCO, Bristol-Myers Squibb


Melvin_CarrieCarrie Melvin, Vice President, Global Clinical Sciences and Delivery TA Head of Oncology, GSK/TESARO


McBride_MeganMegan McBride, MPH, Associate Director, Janssen Clinical Innovation, GCDO, R&D, Janssen, The Pharmaceutical Companies of Johnson & Johnson

Our expert panel will include a variety of perspectives and the aim is to provide pragmatic solutions and actionable advice to make virtual trials a realistic option for your study needs. We’ll discuss strategic and tactical needs to help you determine how to navigate and implement virtual and decentralized options to drive your pipeline goals. Topics to be discussed include:

  • Discuss the settings for virtual trials and help define best fit options for study needs.
  • How and when does the regulatory strategy get set to enable a successful filing?
  • What are the challenges to drive both site and patient participation in virtual trials?
  • What are the timeline and cost differences in planning for and executing virtual trial components?
  • What are the key lessons learned from those who have been early adopters and champions?

1:05 Transition to Lunch

Teckro 1:10 SCOPE Send Off Luncheon Presentation: Is Your Paper Protocol Really Fit for Purpose?

Brendan Buckley, MD, DPhil, Chief Medical Officer, Teckro

When did you last use a telephone directory for a restaurant booking? It might seem absurd to flip through a dated paper directory when the latest information is always searchable online. Why, then, are we still using paper protocols to manage clinical trials? It’s time we bring clinical trials into the digital era. Join this session to find out how to transform your protocol into actionable data for research staff, study teams and CROs.

1:40 Closing Remarks

1:45 SCOPE Summit 2020 Adjourns

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning and Thursday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

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

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

 

Arrive early and attend Part 1 (Wed - Thurs): Clinical Biomarkers Operations and Innovation




For more details on the conference, please contact:
Marina Fishtinsky, MD

Executive Director, Conferences
Cambridge Healthtech Institute
Phone: (+1) 781.972.5496
Email: mfilshtinsky@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K
Ilana Quigley
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.5457
Email: iquigley@healthtech.com

Companies L-Z
Patty Rose
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.1349
Email: prose@healthtech.com