Cambridge Healthtech Institute’s 4th Annual

Clinical Biospecimens and Central Lab Solutions

Managing Biospecimens and Partnering with Biorepositories & Labs

February 20-21, 2019

The availability of high quality biological specimens, laboratory access and diagnostics services are of utmost importance for biomarker-driven clinical trials and future research. The complexity and number of samples collected during studies has increased steadily over the years and we need to come up with best practices, operational models and IT systems to deal with this volume and complexity. The next step, the testing of the samples and various laboratory services also requires significant managerial efforts whether they are outsourced or provided by an in-house laboratory. The Cambridge Healthtech Institute’s 4th Annual Clinical Biospecimens and Central Lab Solutions conference brings together leading experts, representing clinical sponsors as well as biorepositories, to discuss challenges and identify actions to improve infrastructure for biomarker driven clinical trials.

Final Agenda

Arrive early and attend Part 1 (Tues-Wed): Clinical Biomarkers Strategy and Innovation

Wednesday, February 20

11:30 am Registration Open

12:30 pm BRIDGING 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

With the ever increasing complexity of each clinical trial being conducted globally, a universal challenge faced by the industry is specimen visibility as it proceeds through the processing pathway from point of collection, to shipment to central laboratory, to potential aliquoting and disbursement to long term storage, 3rd party laboratories or specialty laboratories within your vendor organization. When you add the potential for discrepancies in shipping manifests, demographics contained in multiple databases/systems and queries generated from paper based requisitions, you add the additional real world risk of database lock delays. Please come share in a case study of technology utilization to mitigate all of these operational risks and engage with your colleagues in an exploration of best practices.

1:10 Coffee and Dessert Break in the Exhibit Hall

2:10 Plenary Keynotes

3:20 Booth Crawl & Refreshment Break in the Exhibit Hall, Last Chance for Exhibit Viewing


4:05 Chairperson’s Remarks

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

4:10 Overcoming Challenges in Sample Collection for Biomarker-Driven Trials

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

As clinical trial design becomes more biomarker-driven, and biomarker sampling becomes more complex, the challenge of converting these protocols into an operational success looks like a science in its own right. This presentation will look at examples of challenges experienced, what actions were taken to mitigate the risks, and processes developed to prevent the issues in the future.

4:40 Considerations for Secondary Use of Biospecimen Data to Enable Scientific Discovery and Data-Driven Decision Making

Wetherwax_LynnLynn Wetherwax, BS, Senior Manager, Translational Sciences Operations, Biobank, Amgen

Clinical trial data is a treasure trove of information that has value to the scientific community well beyond the clinical study report. With improved access to aggregated data and user-friendly tools, scientists can answer questions related to safety, disease mechanisms, underlying conditions, and adverse event triggers. We will review a case study involving a data platform where this was accomplished successfully while maintaining required privacy and data protection.

5:10 Sponsored Presentation (Opportunity Available)

5:40 Pharma and Central Laboratory Collaboration to Customize and Enhance the Execution of the Laboratory Manual

RawleyPayne_MelissaMelissa Rawley-Payne, Executive Director, Biospecimen Operations, Celgene

To enhance the execution and customization of the Laboratory Manual, Celgene and Covance have partnered cross-functionally across and within their respective organizations to develop standardized collection guidelines that include graphical representations of the collection and processing procedures. These enhancements are meant to facilitate the development process of the document and to ensure that sites receive all required information in one comprehensive document.

6:107:10 Networking Reception (Sponsorship Opportunity Available) or Close of Day

Thursday, February 21

7:15 am Registration Open

7:45 BREAKFAST PRESENTATION (Sponsorship Opportunity Available) or Morning Coffee

8:15 Session Break


8:20 Chairperson’s Remarks

Chairperson to be Announced

8:25 Biomarkers in Late Stage Oncology Drug Development: Operational Considerations

Estay_IvetteIvette Estay, PhD, Biomarker Operations Program Leader, Product Development Global Clinical Operations, Oncology, Genentech

With advances in biomarker and CDx platforms, biomarker discovery and operations has become exceedingly complex and is occurring throughout the life cycle of clinical development. Here, I will discuss operational challenges specifically associated with late stage oncology biomarker assay development and implementing new study endpoints with novel biomarkers using prospective-retrospective analysis.

8:55 The Evolution of a Sample Management Infrastructure in a Growing Biopharmaceutical Company

Dianna Blessington, MEd, Research Expert, Translational Sciences, Laboratory & Biospecimen Operations, Incyte Research Institute

Since its inception less than 20 years ago, Incyte Corporation has brought together rigorous drug discovery and development, leading to the identification of novel therapies for patients with significant unmet medical needs. As the development pipeline has expanded, and the number and complexity of clinical trials has grown, so has the number and different types of samples associated with each of these studies. This presentation will focus on the de novo development of a sample management organization to manage the receipt and tracking of samples collected to conduct translational research.

9:25 CO-PRESENTATION: Clinical Sample Vendor Qualification and Process Management

Zuniga_MaryMary Zuniga, Consultant, Translational Science, Immunology, Eli Lilly and Company

Pascarella_Cole_AnitaAnita Pascarella Cole, Consultant, LRL Sourcing, Eli Lilly and Company

This presentation will walk participants through the vendor qualification process and the process management related to the use of clinical samples in research, taking into consideration appropriate risk levels when selecting and qualifying vendors, along with the vendors’ capabilities for assay development, validation, and data delivery.

9:55 Sponsored Presentation (Opportunity Available)

10:25 Networking Coffee Break (Sponsorship Opportunity Available)


11:10 Chairperson’s Remarks

Joachim Silber, Scientific Director of Operations, Precision Pathology Biobanking Center, MSKCC

11:15 Precision Pathology: Taking Clinical Trials and Biomarkers to the Next Level

Joachim Silber, Scientific Director of Operations, Precision Pathology Biobanking Center, MSKCC

The role of pathology in modern precision clinical trials has grown very rapidly. Specimen-centered, biomarker-based therapeutic development and precision measurements of treatment response and resistance are novel key developments. My talk will show examples of these exciting developments and will highlight examples of exciting collaborations between academic pathology and the diagnostic and pharma industries that reshape the path towards precision healthcare.

11:45 Kaiser Permanente Research Bank: Core Resource for Collaborative Research

Lituev_AlexAlexander Lituev, MD, Practice Leader, Biorepository Head, Kaiser Permanente Research Bank

The Kaiser Permanente Research Bank (KPRB) is a research-ready resource that supports the scientific community inside and outside of Kaiser Permanente in a wide variety of health conditions and diseases. With over three-hundred thousand enrolled members, KPRB is one of the largest and most diverse biobanks in the US. Background, technical, and operational structure and access policies will be presented.

12:15 pm Brief Session Break


Chairperson (continued from morning session)

12:20 CASE STUDY: The Site’s First Initiative: Understanding Patients and Site Relationships to Improve Trials

Rackley_MarisaMarisa Rackley, Director, Clinical Development Execution, Vertex Pharmaceuticals

This presentation will share Vertex’s site-focused initiatives and our journey to put sites first. How did the initiative start? What were the obstacles? In addition to describing the other parts of the initiative, the talk will focus on the installation of our new Regional Site Advocate group and share data from the sites on how this role has helped to bring value to the sites.

12:50 INTERACTIVE PANEL: Moving from Technology Indigestion to Workable Solutions

Vulcano_DavidModerator: David Vulcano, MBA, Vice President, Research Compliance & Development, HCA

Abbott_StephanieStephanie Abbott, PharmD, Clinical Research Program Director, Western Washington Medical Group

Perera_JeewaJeewa Perera, CEO, Champ IT Solutions

Yanak_BrendaBrenda Yanak, Former Global Head, Specimen Strategy and Innovation, Q2 Solutions a Quintiles Quest Joint Venture; Former Precision Medicine Lead, Pfizer

Moyer_MattMatt Moyer, MBA, Director, Clinical Supply Technology, Merck

Multiple technologies are advancing healthcare delivery each and every day. This not only pertains to better utilizing both data at rest and data in motion, but also pertains to communication technologies breaking down the traditional boundaries of medicine. As clinical trial site operations are often dwarfed by the larger healthcare delivery ecosystem, how can pharma leverage that already developing ecosystem so that they don’t have to recreate the wheel?

  • What technologies are out there right now that are underutilized by pharma in clinical trials?
  • What regulatory or operational issues need to be either “myth busted” or challenged to make this happen?

1:20 Transition to Lunch

1:25 LUNCHEON PRESENTATION (Sponsorship Opportunity Available)

1:55 Closing Remarks

2:00 SCOPE Summit 2019 Adjourns

Arrive early and attend Part 1 (Tues-Wed): Clinical Biomarkers Strategy and Innovation


“SCOPE Featured Author”
Emmanuel Fombu, MD,
Director, Digital Health Solutions

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