Cambridge Healthtech Institute’s 9th Annual

Clinical and Translational Biomarkers
( 臨床研究およびトランスレーショナル研究でのバイオマーカー )

精密医療の分野における進歩の実現

2019年6月18日~19日


The promise of precision medicine has been driven by the need to accurately predict patient response to therapy while ensuring drug efficacy and safety. Reducing costs and the time required for drug development is also a driving force in the use of biomarkers. Cambridge Healthtech Institute’s 9th Annual Clinical and Translational Biomarkers conference will cover novel biomarker discovery, clinical and analytical biomarker validation, and the role of biomarkers in clinical decision making.

Final Agenda

Stay on to attend Wednesday, June 19 - Thursday, June 20

Immuno-Oncology Biomarkers 2: Immune Profiling and Immune Monitoring

6月18日(火)

7:00 am Registration Open and Morning Coffee

バイオマーカー発見と開発の進展

8:00 Chairperson’s Remarks

Abdel B. Halim, PharmD, PhD, DABCC-CC, DABCC-MD, DABCC-Tox, Vice President, Translational Medicine, Biomarkers & Diagnostics, Celldex Therapeutics

8:10 Have We Progressed in Biomarkers and Diagnostics over the Decade 2008 to 2018?

Abdel B. Halim, PharmD, PhD, DABCC-CC, DABCC-MD, DABCC-Tox, Vice President, Translational Medicine, Biomarkers & Diagnostics, Celldex Therapeutics

Incredibly high failure rate in the pharmaceutical industry has been positioning biomarkers and precision medicine in the frontline as optimistic rescuers. Successful development and implementation of biomarkers and CDx strategies can likely mark the difference between winners and losers in this crowded space. Biomarkers and diagnostics have been suffering some critical pre-analytical and analytical challenges which, likely, adversely impacted the whole initiative.

8:40 Overcoming Challenges in Clinical Biomarker Development

Xuemei Zhao, PhD, Senior Principal Scientist, Translational Molecular Biomarkers, Merck Research Labs

The utility of various types of clinical biomarkers is to aid decision-making in drug development. After a pre-clinical candidate is approved for development in clinical studies, biomarker activities are transitioned from discovery to clinical biomarker development and implementation. Clinical biomarker development includes clinical biomarker assay development, fit-for-purpose assay validation, and clinical biomarker qualification in clinical studies. Overcoming challenges of clinical biomarker development will be discussed.

9:10 Serum IRAP: A Novel Direct Biomarker for Screening for Prediabetes

Serge Bottari, MD, PhD, Professor, Cell Biology, Grenoble-Alps University Hospital and Medical School

Prediabetes is considered to affect 40 to 50% of the population in industrialized and emerging countries, resulting in a growing incidence of type 2 diabetes with a huge socioeconomic cost. There is, however, no reliable and affordable test allowing for its diagnosis and screening yet. We developed a simple and robust ELISA for serum IRAP, a protein associated with GLUT4 and secreted in the bloodstream in response to insulin. It is therefore the first direct serum biomarker of insulin sensitivity.

9:40 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing

バイオマーカーのトランスレーショナル研究

10:25 Novel LC-MS/MS Approaches from FFPE Tissue Sections for Translational Biomarker Investigations

Mireia Fernandez Ocana, PhD, Global Biomarker Lead, Drug Safety, Pfizer

Formalin-Fixed Paraffin-Embedded (FFPE) samples are a valuable source for translational protein biomarker studies to understand disease progression or response to therapy. Proteins from FFPE samples are considered to have good long-term stability and thus enable the retrospective analysis of archived tissues. Recently, protein LC-MS/MS emerged as a complementary technique to immunohistochemistry. This presentation describes successfully established workflows in our lab and applications to protein biomarker analysis from FFPE tissues.

10:55 Developing and Implementing Successful Biomarker Strategies to Demonstrate Target Engagement and Identify Patient Selection Biomarkers

Tammie Yeh, PhD, Associate Director, Oncology Translational Sciences, AstraZeneca

Analysis of patient samples from clinical trials can inform on clinical development by providing evidence of target engagement, additional understanding of downstream biology, and potential biomarkers to help select patients who will best respond. A successful translational strategy requires a strong scientific-based rationale but also an understanding of clinical feasibility and practicality. Dr. Yeh will present several case studies to illustrate the journey from preclinical research into Phase 1 clinical trials and some of the considerations and challenges that come along the way.

11:25 Presentation to be Announced

11:55 Transition to Lunch

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:30 Session Break

臨床試験段階にあるバイオマーカー

1:05 Chairperson’s Remarks

Iman Jilani, PhD, Director, Oncology Clinical Assay Group, Early Development, Pfizer


1:10 KEYNOTE PRESENTATION: Biomarker-Driven Patient Selection and Outcome Measures in Neurology Trials

Johan Luthman, DDS, PhD, Senior Vice President, Head of Clinical Development, Neurology, Eisai

In recent years, biomarkers have become critical for identification of subjects eligible for trials in neurology disease, such as determination of presence of amyloid brain pathology by amyloid PET or CSF measures when evaluating intervention therapies for Alzheimer’s disease. Increasingly also Tau PET is used for establishment of tangle pathology in clinical trials. Similar possibilities may also emerge for alpha synuclein/Lew body pathology determination in various Lewy body dementia studies. These measures are also commonly used to verify target engagement and activity of drug candidates, and together with more general markers of neurodegenerative processes, such as neurogranin and neurofilament light, as well as neuroinflammation markers increasingly used as exploratory or secondary outcome measures. Recent clinical data even suggest that amyloid PET has good relationship to the clinical effects of certain drugs, paving the way for possible future surrogate uses of such measures.

1:40 Business of Fit-for-Purpose: From Sample Management to Validation to Final Sample Analysis Data

Iman Jilani, PhD, Director, Oncology Clinical Assay Group, Early Development, Pfizer

The analytical process and oversight of biomarkers for clinical trials are complicated and vary from vendor to vendor/pharma to pharma. In this presentation, I will be discussing the challenges and requirements for biomarker analysis support from the pharma perspective.

2:10 Transforming Tissue-Based Translational and Clinical Research with Advanced Multiplexing Solutions

Sean Downing, PhD, MBA, Director of Customer Engagement, Ultivue

The benefits of multiplex immunohistochemistry assays for tissue analysis are numerous. High-level multiplexing, whole slide imaging, workflow compatibility, and spatial analysis are all must-have requirements for effective multiplex IHC solutions. Ultivue’s InSituPlex® technology addresses each of these needs and enables researchers to unmask the true biology of tissue samples.

2:25 Refreshment Break in the Exhibit Hall with Poster Viewing

3:10 ‘Patient-Centric’ Biomarkers: Utility of Minimally Invasive Sampling in Clinical Trials

Dmitri Mikhailov, PhD, Director & Head, Biomarker Study Coordination, Novartis Institutes for BioMedical Research

The emergence of smart sampling procedures can facilitate subject recruitment, improve retention, and promote simplification of trial conduct. Such technologies allow clinical trials to reach broader patient population and enable collections at patients’ homes. In addition, 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.

3:40 Advances in Clinical Biomarkers

Soma Ray, PhD, Senior Director, Clinical Pharmacology & Biomarkers, Vertex Pharmaceuticals

4:10 Transition to Keynote


4:20 PLENARY KEYNOTE SESSION

5:20 Welcome Reception in the Exhibit Hall with Poster Viewing

6:35 Find Your Table, Meet Your Moderator

6:40 Breakout Discussion Groups

7:30 Close of Day

6月19日(水)

7:00 am Registration Open and Morning Coffee

コンパニオン診断と予測バイオマーカーアッセイ

8:00 Chairperson’s Remarks

Philip Hemken, PhD, Principal Research Scientist, Biologics Discovery and Design, Abbott

8:05 Development of Automated Companion Diagnostic Immunoassays in Collaboration with Therapeutic Partners

Philip Hemken, PhD, Principal Research Scientist, Biologics Discovery and Design, Abbott

Abbott partnered to develop two automated diagnostic immunoassays as potential future companion diagnostic tests to identify patients with severe asthma who would most likely benefit from an investigational anti-IL-13 immunotherapy. Abbott developed tests to measure the serum levels of the proteins periostin and DPP4 (dipeptidyl peptidase-4), which have potential to be predictive biomarkers for up-regulated IL-13 in patients with severe asthma.

8:35 Development and Validation of a Phasing Assay to Haplotype SNPs on Huntingtin Gene

Ramakrishna Boyanapalli, PhD, Associate Director, Bioanalytical and Biomarker Development, Wave Life Sciences

Wave Life Sciences has antisense oligonucleotides (ASOs) in clinical trials to evaluate safety and efficacy in Huntington’s Disease. These ASOs target mutant and leave wild type Huntingtin transcripts using allele specific approach. To achieve allele specificity patients must undergo predictive biomarker testing using a complex whole blood NGS assay known as “Haplotype Phasing Assay.” This assay will identify SNPs status on both the alleles. We have developed and validated the assay on PacBio Sequencing Platform.

9:05 Presentation to be Announced

9:35 Coffee Break in the Exhibit Hall with Poster Viewing

精密医療の分野におけるリキッドバイオプシー

10:20 KEYNOTE PRESENTATION: ctDNA Utility and Challenges

Carl Barrett, PhD, Vice President, Translational Sciences, Onc iMed, AstraZeneca

Circulating tumor DNA (ctDNA) is becoming increasingly used in clinical practice and clinical/translational research. Examples of this utility will be given for patient selection, monitoring disease response and elucidating mechanisms of resistance to targeted therapies. Despite the common use in many commercial and academic labs, issues remain with sensitivity and specificity of some assays.

10:50 Preanalytical Variables in Cell-Free DNA Analysis

Angela Silvestro, MS, Principal Scientist, Novartis Oncology Precision Medicine

Controlling pre-analytical variability in the clinical laboratory is key to informative diagnostic results from cfDNA-based assays. Pre-analytical variables generally include factors around specimen collection and handling, storage, and transportation. For cfDNA analysis, these factors are critical due to the low abundance of circulating mutant copies in patient samples. The results from testing the effect of pre-analytical errors and how they create challenges to cfDNA test interpretation will be presented.

11:20 Liquid Biopsy in Precision Medicine

Hector A. Alvarez, MD, PhD, Scientific Manager, System Biology & Personalized Medicine, Sheikh Ahmed Bin Zayed Al Nahyan Center for Pancreatic Cancer Research, The University of Texas MD Anderson Cancer Center

11:50 Transition to Lunch

12:00 pm Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:30 Transition to Plenary


12:50 PLENARY KEYNOTE SESSION

2:20 Dessert and Coffee Break in the Exhibit Hall with Poster Viewing

3:05 Close of Conference

Stay on to attend Wednesday, June 19 - Thursday, June 20

Immuno-Oncology Biomarkers 2: Immune Profiling and Immune Monitoring

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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2019/05/23
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