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
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)
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)
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 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 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
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
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 President, Study Planning & Site Optimization, WCG
8:15 Session Break
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
Mary 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
9:25 Biobanking Strategy Using Advanced Informatics to Enable Scientific Discovery and Innovation
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 Assets
Jason Attanucci, Global Head Customer Solutions, Global Sales,
BioFortis, a Q2 Solutions Company
10:25 Networking Coffee Break (Session Room Foyer)
10:55 Chairperson’s Remarks
Francis Kendall, Senior Director, Biostatistics & Programming, Cytel
11:00 CASE STUDY: Can Artificial Intelligence Identify Recurring Quality Issues
Faye 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
Neil Weisman, President, Continuum Clinical
12:05 The Connected Patient: A “One Stop Shop” for Trial Information and Data
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
Moderator: Jane Myles,
Head, Operational Intelligence and Innovation, Roche
Panelists: Darcy Forman, Vice President, Clinical Operations, Science37
Hassan Kadhim, Director, Clinical Trial Business Capabilities, GCO, Bristol-Myers Squibb
Carrie Melvin, Vice President, Global Clinical Sciences and Delivery TA Head of Oncology, GSK/TESARO
Megan 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
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