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.

Final Agenda

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

Scientific Advisory Board

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

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

Monday, February 18

9:00 am 7:15 pm Registration Open (Convention Level)

2:005:00 pm User Group Meetings

Shared Investigator Platform User Forum

Trifecta Annual User Group Forum

5:006:15 pm Pre-Conference Plenary Keynote Panel & Participant Engagement Award (Regency PQ)

6:157:15 pm SCOPE’s Kick-off Networking Happy Hour Hosted by CHI (Sponsorship Opportunities Available) (Pool Decks)

7:15 pm Close of Day

Tuesday, February 19

7:15 am Registration Open and Morning Coffee (Convention Level)

8:15 Opening Plenary Keynotes (Regency PQ)

9:35 Grand Opening Coffee Break in the Exhibit Hall (Plaza International Ballroom)

Florida B

10:35 Chairperson’s Remarks

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

10:40 Implementation of GSK’s Biological Sample Management Strategy

Bangalore_mohanMohan Bangalore, Global Head, BioAsset Management, GSK

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 sample stores.

11:10 The Challenges of Implementing 10 Years of Industry Advancement in 1 Year!

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

It is rare in the industry to get the “luxury” of implementing a function within an established pharmaceutical company, so when the opportunity presents itself, it is not one to easily turn down! This presentation will give an overview of the highs (and lows!) of establishing the function of Clinical Trial Biosample Management in a reputable clinical operations organization.

11:40 Challenges of Clinical Specimen Management in the Era of Precision Medicine

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

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.

12:10 pm Biomarker Management in Immuno-Oncology Clinical Trials: Operationalizing Biomarker Assessments

Tverskoy MariaMaria Tverskoy, PhD, Biomarker Operations Program Leader, Product Development Global Operations, Genentech

Clinical trials are becoming more complex by shifting to personalized medicine, looking at mechanisms of actions of immuno-oncology (I-O) agents and evaluating responses to new immunotherapy combinations. Inclusion of biomarkers has been critical to understanding the underlying biological response in clinical trials. This talk will focus on specific challenges in biomarker management and strategies that can be used for successfully operationalizing biomarker assessments in I-O clinical trials.

12:40 Transition to Lunch

12:45 LUNCHEON PRESENTATION: Clinical Trial Biospecimen Lifecycle Management

Jian Wang, PhD, CEO, BioFortis

Biomarker-driven clinical trials are the foundation for precision medicine. In these trials, sample collection, consent, transportation, and testing, involving multiple CROs, vendors, and labs, must be carefully designed and executed. Deviation from design must be quickly accounted for to allow continuous improvement; otherwise, trials risk milestone delays and regulatory non-compliance. Here we showcase our “complete biospecimen lifecycle management” approach that has proven to increase trial execution efficiency and reduce regulatory risk at numerous R&D organizations.

1:25 SCOPE Turns 10! Champagne and Dessert in the Exhibit Hall (Plaza International Ballroom)

Florida B

2:05 Chairperson’s Remarks

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

2:10 Consent for Biospecimens: The Basics

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

Obtaining consent for research with biospecimens in global clinical trials is complex. This presentation will provide an understanding of the basics of consent for biospecimens, a background and several influential cases which have shaped the way we consent today, and an overview of today’s global challenges in obtaining consent for research use of biospecimens.

2:40 Returning Data and Results to Clinical Trial Participants

Leventhanl_DavidDavid Leventhal, Senior Director, Clinical Innovation, Global Product Development, Pfizer

Clinical trials rely on the participation of patients who are willing to have data collected about them, as these complete results are posted online and published in scientific journals. Little, however, is routinely given back to the patient to acknowledge their contribution. Pfizer has pioneered the returning of data to patients by making plain-language summaries of study results available to participants as well as returning individual patient data to clinical trial volunteers.

3:10 Real World Sample-Based Approach for Qualification of GLDH as a Liver Specific Biomarker of Liver Injury

Aubrecht_JiriJiri Aubrecht, PhD, Scientific Director, Translational Biomarker Research, Takeda 

Diagnosis of the onset of liver injury in subjects with underlying muscle impairments is an unmet medical need.  We have evaluated glutamate dehydrogenase as a liver specific biomarker of hepatocellular damage.  The presentation will introduce a translational biomarker development paradigm based on real world samples.  We will discuss biomarker qualification study design and feedback from regulatory agencies.

3:40 PANEL DISCUSSION: Returning Clinical Trial Data to Patients

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

Panelists: Speakers of the Session

Regency R

4:10 Find Your Table and Meet Your Moderator

4:15 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions. 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.

5:00 Welcome Reception in the Exhibit Hall (Plaza International Ballroom)

6:30 Close of Day

Wednesday, February 20

7:15 am Registration Open (Convention Level)

7:45 BREAKFAST PRESENTATION: ICF Authoring - The Next Evolution of Informed Consent (Regency P)

Delente_EricEric Delente, Head, Patient Consent, DrugDev, An IQVIA Company

This session will explore how the recent introduction of informed consent form (ICF) authoring systems, including IQVIA ICF Author, have evolved the informed consent process by allowing sponsors and CROs to create, distribute, and track ICFs from a centralized portal, whether using paper forms or eConsent. It will also explore the features and benefits of these portals, showing why sponsors and CROs should consider adoption.

8:15 Session Break

Florida B

8:20 Chairperson’s Remarks

Morten Thorup Pedersen, Risk Based Monitoring Specialist, Centralised Monitoring Unit, Clinical Systems, Data & Trial Management, Novo Nordisk A/S

8:25 Clinical Sample Tracking: Switching from Project to BAU and Providing Enhancements Including a Dashboard

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

Once clinical sample tracking was implemented, our goal was to allow the business to take it on. This would be about the processes and the guidance we as an implementation team provided to the business for them to take on the daily functionality. And as an enhancement, provide simple inventory feedback to a larger audience through an existing clinical dashboard.

8:55 Innovations along the Specimen Management Value Chain

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

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

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

Most clinical blood samples are obtained via venipuncture which can be unpleasant to the subject and requires a trip to a clinical site. The emergence of minimally invasive and patient friendly procedures can facilitate subject recruitment, improve retention, and promote simplification of trial design and conduct. Such technologies allow clinical trials to reach a broader patient population and enable collections of follow-up samples from patients for an extended period of time including post-study conduct. More importantly, the minimally invasive and virtually painless procedures have a great potential to be deployed in pediatric trials by reducing blood volume. This talk will review utility of some of these technologies for exploratory clinical biomarkers.

9:55 Q&A with Speakers

10:25 Coffee Break in the Exhibit Hall (Plaza International Ballroom)

Orlando M

11:20 Chairperson’s Remarks

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

11:25 Specimen-Centric Considerations for Possible Extensions of Risk-Based Monitoring (RBM) Principles

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

Clinical trials play a central role in the development and delivery of breakthrough diagnostics for patient care, and specimens collected in these trials are becoming increasingly significant and subject to regulatory compliance. As biomarker data continues to drive an increasing number of trial decisions and clinical endpoints, a specimen-centric focus needs to become part of any comprehensive clinical trial monitoring process. As Risk-Based Monitoring (RBM) matures and adoption becomes more widespread, the extension of the established principles to include specimen-centric elements seems like a reasonable path forward.

11:45 CO-PRESENTATION: What Can We Learn from RBM to Enhance the Utility of Biospecimens in Clinical Trials?

Harlin_MattMatt Harlin, Associate Director, Clinical Pharmacology, Otsuka Pharmaceutical Companies

Sharin_RothSharin Roth, Director, Clinical Pharmacology, Bioanalysis, Otsuka

Establishing business processes to govern the life cycle of biospecimens collected in clinical trials is essential to any drug developer. Leveraging existing risk-based monitoring (RBM) systems can enhance the utility of biospecimens, ensuring they are of high quality, consented properly, accounted for, and easily selected for analysis. RBM system attributes that are specific to biospecimens will be evaluated.

12:05 pm Biospecimen Tracking as an Integral Part of Risk Based Monitoring

Pedersen_Morten_ThorupMorten Thorup Pedersen, Risk Based Monitoring Specialist, Centralised Monitoring Unit, Clinical Systems, Data & Trial Management, Novo Nordisk A/S

Novo Nordisk has implemented Risk Based Monitoring with biospecimen tracking being an integral part of the approach. With biospecimens being the primary endpoints in many trials, we took the approach of centrally monitoring the collection and analysis of these to be able to do a targeted follow up with the sites where results of biospecimen samples were missing. Combining data from several sources, we have set up a system to predict where the risk may emerge and do a proactive targeted follow-up.

12:25 Transition to Lunch

12:30 BRIDGING LUNCHEON PRESENTATION: Where in the World Are My Specimens? (And How Do I Fetch Them?) (Florida B) 

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, third 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 (Plaza International Ballroom)

2:10 Close of Conference

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

video recap

SCOPE 2019 is dedicated to the life and memory

Christine K. Pierre
September 8, 1958 - October 23, 2018

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“SCOPE Featured Author”
Emmanuel Fombu, MD, MBA
Global Commercial Strategy and
Digital Innovation, Johnson & Johnson

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