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

12:30 pm Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:00 Coffee and Dessert Break in the Exhibit HallBioTelResearch

 

2:00 Afternoon Plenary Keynotes

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

CLINICAL SPECIMEN MANAGEMENT IN THE ERA OF PRECISION MEDICINE & TECHNOLOGICAL ADVANCEMENTS

4:10 Chairperson’s Remarks

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

4:15 Challenges of Clinical Specimen Management in the Era of Precision Medicine

Reinhard_DebraDebra Reinhard, Head, TM Enabling Solutions, Translational Medicine, Bristol-Myers Squibb

In the era of precision medicine in the pharma industry, historical paradigms for clinical operations are giving way to new structures designed for maximum flexibility and speed. Biospecimen management is fundamental to the biomarker research informing our translational strategy. Traditional operations are no longer sufficient to respond to this need for speed and agility to pivot as scientific insights are revealed. Learn about how BMS is addressing this challenge.

4:45 Implementation of GSK’s Biological Sample Management Strategy

Bangalore_MohanMohan Bangalore, Global Head, BioAsset Management, GlaxoSmithKline

GSK is implementing a biological sample management strategy to increase the visibility and use of human biological samples in discovery and clinical R&D. This cross-functional strategy is leveraging systems and automation to increase efficiency, reduce manual effort and ensure increased compliance in biospecimen management. An integrated IT platform is being developed to create a master sample repository with links to automated samples.

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

7:45 Breakfast Presentation to be Announced

8:15 Session Break

OUTSOURCING AND PARTNERING STRATEGIES

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 Pharmaceuticals

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 Sponsored Presentation (Opportunity Available)

10:25 Networking Coffee Break

TECHNOLOGY TO ADVANCE BIOMARKER AND BIOSPECIMEN MANAGEMENT

10:55 Chairperson’s Remarks

Brenda Yanak, Principal, Clinical Transformation Partners

11:00 PANEL DISCUSSION: Innovations along the Specimen Management Value Chain

Yanak_BrendaModerator: Brenda Yanak, Principal, Clinical Transformation Partners


Reinhard_DebraPanelists: Debra Reinhard, Head, TM Enabling Solutions, Translational Medicine, Bristol-Myers Squibb


Bangalore_MohanMohan Bangalore, Global Head, BioAsset Management, GlaxoSmithKline


Fang_JaneJane Fang, MD, Head, Clinical Business Management & Analytics, MEDI Biologics Unit, AstraZeneca


Multiple technologies are advancing healthcare delivery and clinical trials. How does this process involve biospecimen and biomarker management?

11:30 Sponsored Presentation (Opportunity Available)

12:00 pm Transition to Shared Sessions

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

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


Akbari_BardiaPanelists: Bardia Akbari, PharmD, Senior Vice President, Clinical Operations, Science37


Hersch_GregGreg Hersch, PhD, Head, Innovation, Global Development Operations, Novartis


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

FDA Panelist to be Announced

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 (Sponsorship Opportunity Available)

1:40 Closing Remarks

1:45 SCOPE Summit 2020 Adjourns

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning, Wednesday 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