Cambridge Healthtech Institute’s 9th Annual

Clinical and Translational Biomarkers

Enabling Advances in Precision Medicine

June 18-19, 2019


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

 

Tuesday, June 18

7:00 am Registration Open and Morning Coffee

ADVANCES IN BIOMARKER DISCOVERY AND DEVELOPMENT

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?

Halim_AbdelAbdel 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

TRANSLATIONAL BIOMARKERS

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

Ocana_Mireia_FernandezMireia 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

Yeh_TammieTammie 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

Speaker to be Announced, PointCross

11:55 Transition to Lunch

Oncoradiomics 12:00 pm Luncheon Presentation: Radiomics: Transforming Standard Imaging into Mineable Data for Diagnostic and Theragnostic Applications

Walsh_SeanSean Walsh, PhD, CSO, Oncoradiomics

Radiomics, the high-throughput extraction of quantitative image features from standard-of care medical imaging enabling clinically actionable insight to improve diagnosis, prognosis, and therapy response monitoring, is gaining increasing importance in precision medicine. Radiomic analysis exploits sophisticated medical imaging artificial intelligence to provide a powerful tool for drug development. This talk describes in detail the field of radiomics, with an emphasis on oncology: challenges, opportunities,limitations, and the potential to radically improve decision making in drug development  

12:30 Session Break

BIOMARKERS IN CLINICAL TRIALS

1:05 Chairperson’s Remarks

Deborah Shepard, PhD, Senior Manager, Biomarker Assay Specialist, Early Development, Translational and Immuno-Oncology Global Product Development, Pfizer

1:10 KEYNOTE PRESENTATION: Challenges and Opportunities for Biomarkers in Early Clinical Development

Bruno Gomes, DVM, PhD, Global Head of Biomarkers Oncology, Roche

The presentation will present the opportunities and challenges in developing impactful biomarker strategies for early clinical development of new immuno-oncology drugs. We will focus on the design of fit-for-purpose entry into human clinical trials, proof or dis-proof of mechanism of action and optimal biological dose finding.

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

Deborah Shepard, PhD, Senior Manager, Biomarker Assay Specialist, Early Development, Translational and Immuno-Oncology Global Product 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

Downing_SeanSean 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

2:30-2:45 Speed Networking: Young Professionals

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

Patel_MichaelMichael Patel, PharmD, Fellow, Biomarker Development, 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 Presentation to be Announced

4:10 Transition to Keynote


4:20 PLENARY KEYNOTE SESSION 

5:20 Taste of New England Welcome Reception in the Exhibit Hall with Poster Viewing

5:25 Meet the Plenary Keynotes

6:25 Find Your Table, Meet Your Moderator

6:30 Breakout Discussion Groups

7:30 Close of Day

 

Wednesday, June 19

7:00 am Registration Open and Morning Coffee

COMPANION DIAGNOSTICS AND PREDICTIVE BIOMARKER ASSAYS

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

Hemken_PhilipPhilip 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

Boyanapalli_RamakrishnaRamakrishna 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.

Sanguine_Biosciences 9:05 Longitudinal, Event-Based, Same-Day Sample Collection: The Implications for Biomarker Development

Neman_BrianBrian Neman, CEO, Sanguine Biosciences

Sanguine partners with patients and leverages their health data to accelerate your research for their condition. By working together with patients, directly, Sanguine is able to perform home visits, and to easily retrieve medical records, on their behalf. 500+ completed studies. 20/40 top pharma. 30,000+ patients.

Mission-Bio9:20 Unleashing the Power of Single-Cell DNA Analysis to Accelerate Drug Development Pipelines

Nicholas Dracopoli, PhD, Strategic Advisor, Mission Bio

 

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

10:05 Poster Winner Announced

LIQUID BIOPSY IN PRECISION MEDICINE

10:20 Liquid Biopsy Using the Nanotube-CTC-Chip for Precision Medicine

Balaji Panchapakesan, PhD, Professor, Founding Director, Small Systems Laboratory, Department of Mechanical Engineering, Worcester Polytechnic Institute

10:50 Preanalytical Variables in Cell-Free DNA Analysis

Silvestro_AngelaAngela 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

Alvarez_HectorHector 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

Abcam 12:00 pm Bridging Luncheon Presentation: Advancing High-Throughput Screening Using FirePlex-HT Immunoassays

Elnaz AtabakhshElnaz Atabakhsh, Product manager, Regional Sales & Marketing, Abcam

To address the need for high-throughput and sensitive quantification of protein biomarkers from biological samples, we at Abcam have developed FirePlex®-HT immunoassays: a high-throughput multiplex platform that can quantify 10 protein analytes per well in a 384-well format. FirePlex-HT is ideally suited to drug discovery projects screening large compound libraries, safety assessment and toxicity screening in large sample sets, and clinical focused studies for disease identification, patient stratification or therapy responses in large patient cohorts.


12:30 Transition to Plenary


12:50 PLENARY KEYNOTE SESSION 

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

2:25 Meet the Plenary Keynotes

3:05 Close of Conference

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

Immuno-Oncology Biomarkers 2: Immune Profiling and Immune Monitoring