Cambridge Healthtech Institute's 3rd

Biospecimen, Central Lab and Technology for Precision Medicine Trials:
( 個別化医療の治験に対応する生体試料、中央検査室、技術 )
 

Infrastructure to Support Biomarker-Driven Clinical Research
バイオマーカーに重点を置いた臨床研究を支援するためのインフラストラクチャ

2018年2月13-14日 | Hyatt Regency Orlando | フロリダ州オーランド

 

個別化医療の治験に対応する生体試料、中央検査室、技術をテーマにしたこのカンファレンスプログラムでは、この分野の主要な専門家が一堂に会し、バイオマーカーに重点を置いた臨床試験のためインフラストラクチャを改善していくうえでの課題について議論し、必要な対応策を明らかにします。

 

Monday, February 12

9:00 am - 7:30 pm Registration Open

5:00 - 6:15 pm Pre-Conference Plenary Keynote Panel

6:30 - 8:30 pm SCOPE's Kick-Off Networking Happy Hour on the Garden Terrace Hosted by CHI, DrugDev, & Praxis

8:30 Close of Day

Tuesday, February 13

7:15 am Registration Open and Morning Coffee

8:20 Opening Plenary Keynotes

9:45 Grand Opening Coffee Break in the Exhibit Hall

ENABLING PRECISION MEDICINE TRIALS

10:45 Chairperson's Remarks

Michael Tanen, Director, Clinical Biomarker Specimen Management, Merck

10:50 Precision Medicine Trials, and How the Bio-Repository Can Support Biomarker and Diagnostic Development

Michael_TanenMichael Tanen, Director, Clinical Biomarker Specimen Management, Merck

Personalized medicine initiatives have led to a marked increase in biomarker-driven research objectives within clinical trials. This has re-defined traditional biospecimen management into a more comprehensive information management role requiring innovative technology and best practices. The ability to integrate disparate data sources into centralized systems and present the information in a way that can guide decision-making and biomarker development, will define the utility and success of the biorepository.

11:15 Clinical Biomarker Sample Management: Taking Time to Do It Right, Rather than Do It Over

Dmitri_MikhailovDmitri Mikhailov, Ph.D., Director, Head, Biomarker Study Coordination, Novartis

The emergence of global clinical trials with complex biomarker analyses performed at CROs pushes the industry to reconsider clinical sample management. How to mitigate risks of losing samples or compromising quality? How to maximize sample usage beyond clinical study objectives? This presentation discusses how Novartis approaches these challenges, starting with trial documentation setup, to systems used in biorepository for sample inventory and enabling additional research use of clinical samples.

11:40 Operationalizing Precision Medicine Trials in Oncology

Karina_BienfaitKarina Bienfait, Ph.D., Head, Global Genomics Policy, Process and Compliance, Principal Scientist, Clinical Pharmacogenomics and Operations, Genetics and Pharmacogenomics (GpGx), Translational Medicine, Merck Research Laboratories

The immuno-oncology revolution has required many sponsors to rethink the infrastructure needed to support complex biomarker driven trials. This presentation will discuss challenges and solutions in operationalizing such trials, including governance committees, roles and responsibilities of functional areas, biomarker plan structures, and vendor alignment.

12:05 pm Sponsored Presentation (Opportunity Available)

12:30 Session Break

12:40 Luncheon Presentation: Best Practices in Clinical Trial Samples & Consent Tracking

Jian_WangJian Wang, Ph.D., CEO, BioFortis, Inc.

In biomarker-driven precision medicine clinical trials, patient samples (biospecimens) are as important as patients themselves. Sample assay results often determine patient segmentation, and support primary and key secondary objectives. The lack of proper sample tracking & management escalate risks of milestone delays and regulatory scrutiny. We illustrate best practices and technology solutions that address the rise in complexity and importance of biospecimen operations, with unique perspectives from risk-based monitoring approaches.

1:20 Coffee and Dessert Break in the Exhibit Hall

SOURCING AND PROCUREMENT

2:00 Chairperson's Remarks

Jonathan Reuter, Associate Director Global Procurement R&D, Clinical Labs, Bristol-Myers Squibb

2:05 Use of Make vs. Buy Analyses and "Should-Cost" Modeling in Clinical Laboratory Procurement

Jonathan Reuter, Associate Director, Global Procurement R&D, Clinical Labs, Bristol Meyers-Squibb

Elevating the role of procurement in company decision-making. Using comprehensive analysis to enable informed sourcing decisions. Partnering with external supply base to implement cost-controlled and sustainable models in support of the clinical development cycle.

2:30 Comprehensive Bio-Inventory System to Support Clinical Biomarker Strategy

Sandra_HudgensSandra Hudgens, MT(ASCP), BS, MBA, Associate Principal Scientist, Clinical Specimen Management Operations, Merck

Precision medicine is a key component to drug development strategy. The management of clinical specimens to support genetic and biomarker testing is critical to realizing precision medicine. This includes having a biospecimen inventory management system which can seamlessly link specimens to informed consent and clinical data to appropriately select specimens for analysis. Based on established business criteria, the biospecimen inventory management system should be able to track the specimen life cycle to provide a cost-effective inventory for the organization.

2:55 PANEL DISCUSSION: Biospecimen and Core Lab Considerations for Risk-Based Monitoring

Moderator: Michael Tanen, Director, Clinical Biomarker Specimen Management, Merck

Panelists: Jonathan Reuter, Associate Director Global Procurement R&D, Clinical Labs, Bristol-Myers Squibb

Jian Wang, Ph.D., CEO, BioFortis, Inc.

Dmitri Mikhailov, Ph.D., Director, Head, Biomarker Study Coordination, Novartis

Karina Bienfait, Ph.D., Head, Global Genomics Policy, Process and Compliance, Principal Scientist, Clinical Pharmacogenomics and Operations, Genetics and Pharmacogenomics (GpGx), Translational Medicine, Merck Research Laboratories

  • Importance of Biospecimens in Precision Medicine trials
  • When patient samples are as important as the patient themselves
  • Specimen-centric RBM approaches
  • Inclusion of specimen KRIs (key risk indicators)
  • Working with RMB colleagues to improve quality

3:20 Sponsored Presentation (Opportunity Available)

BREAKOUT DISCUSSION GROUPS

3:50 Find Your Table and Meet Your Moderator

4:00 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. 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

6:30 Close of Day

Wednesday, February 14

7:15 am Registration Open

7:45 Breakfast Presentation: A New Way to Pay: SaaS Technology and Outsourcing How You Need It

Stuart Thiede, President, Payments, DrugDev


8:15 Session Break

TECHNOLOGY SOLUTIONS

8:25 Chairperson's Remarks

Lynn Wetherwax, Senior Manager, Biobank, Translational Sciences Operations, Amgen

8:30 CO-PRESENTATION: Clinical Sample Tracking Project Implementation: A Case Study

Ron_BourqueRon Bourque, Associate Director, RDI, Clinical Biologics, MedImmune/AstraZeneca

Venkatraman Raman, Senior Project Manager, R&D Information, Clinical Biologics, AstraZeneca

We have developed a new and innovative sample management model combining MedImmune Clinical Operations with close alliance/partnership to a Central Lab. Together the technology we are employing is Labmatrix. This initiative is focused on accepting standardized data from all lab vendors. Discrepant data will be corrected at the source lab and reflected back into the tool. Labmatrix is also receiving consent data from our EDC.

8:55 Enabling Scientific Discovery and Innovation Using Biomarker Specimens by Means of Advanced Informatics

Lynn_WetherwaxLynn Wetherwax, Senior Manager, Biobank, Translational Sciences Operations, Amgen

Biomarker specimens may be collected with a specific purpose in mind or they may be stored until that "a-ha" moment when scientific discovery hinges on biomarker investigation. This presentation will provide an overview of biomarker specimen management strategy using informatics to track, confirm consent and search clinical data attributes related to available specimens.

9:20 Leveraging Systems and Automation to Address the Challenges in GSK's Sample Management Strategy Implementation

Kim_BojczukKimberly Bojczuk, Investigator, Discovery Supply - Global Biological Assets, RD Platform Technology & Science, GSK

GSK is developing a cross-functional strategy working with IT and global teams, to increase the visibility and use of human biomaterials in Discovery and Clinical. This integrated approach will increase standardization, allow GSK to maximize investment in biological materials and ensure increased compliance. An IT platform to provide a single interface to both on-site and off-site storage, as well as rapid delivery of samples from an automated sample store will facilitate addressing challenges faced.

9:45 Sponsored Presentation (Opportunity Available)

10:10 Coffee Break in the Exhibit Hall

BIOSPECIMEN MANAGEMENT AS AN INTEGRAL PART OF OVERALL OPERATIONAL STRATEGY

11:10 Chairperson's Remarks

Brenda Yanak, Global Head, Specimen Strategy & Innovation, End-to-End Specimen Management, Q² Solutions

11:15 Biospecimen Tracking as an Integral Part of Risk Based Monitoring

Morten Pedersen,, M.Sc. (Pharm), GDBA, Senior Manager, Novo Nordisk

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.

11:40 PANEL DISCUSSION: Biospecimen and Core Lab Considerations for Risk-Based Monitoring

Moderator:
Brenda_YanakBrenda Yanak, Global Head, Specimen Strategy & Innovation, End-to-End Specimen Management, Q² Solutions


Panelists: Morten Pedersen,, M.Sc. (Pharm), GDBA, Senior Manager, Novo Nordisk


Kim_BojczukKimberly Bojczuk, Investigator, Discovery Supply - Global Biological Assets, RD Platform Technology & Science, GSK


Sandra_HudgensSandra Hudgens, MT(ASCP), BS, MBA, Associate Principal Scientist, Clinical Specimen Management Operations, Merck


  • Key Areas of Interest from Sponsors
  • What Vendors Wish Sponsors Knew
  • Innovation Opportunities

12:05 pm Session Break

12:10 Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:50 Coffee and Dessert Break in the Exhibit Hall

1:30 Close of Conference

Melissa DolenGroup Discounts Are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts, contact us.


 

2018 SCOPE Conference at a Glance


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In Memory of Gerald "Jerry" Matczak
Matczak Jerry

Gerald "Jerry" Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world, someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.

- Cambridge Healthtech Institute (CHI)



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