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
8:00 Chairperson’s Remarks
Abdel B. Halim, PharmD, PhD, DABCC-CC, DABCC-MD, DABCC-Tox, Vice President, Biomarkers and Companion Diagnostics, Taiho Oncology, Inc.
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, Biomarkers and Companion Diagnostics, Taiho Oncology, Inc.
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 Panel Discussion: Biomarkers from Discovery to Development
Moderator: Darshana Jani, MSc, Associate Director, Global Lead, Biologics, Clinical Assay Group, Global Product Development, Pfizer
Panelists:
Dan Sikkema, PhD, Vice President, Quanterix Corp.
Ramakrishna Boyanapalli, PhD, Associate Director, Bioanalytical and Biomarker Development, Wave Life Sciences
Topics include:
-Difficulties and challenges in current day multiplexing techniques that are used for biomarker discovery
-Issues in critical reagents required for biomarker development and qualification (both molecular and immunoassays) when ultrasensitive techniques such as next-generation sequencing, SIMOA, SMC, etc. are used
-Adapting non-invasive biomarkers such as digital and imaging biomarkers (wearables, sensitive PET imaging, MRE, etc.) in clinical development
9:40 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing
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 Considerations for Integrating Clinical and Biomarker Data for Research and Cohort Selection
Suresh Madhavan, CEO, PointCross Life Sciences
Data collected during discovery, nonclinical studies, clinical trials, and assays conducted on bio-samples carry disparate types of semi-organized and unstructured data. Presented are various schemas which show how systematic standards, terminology,
data curation governance and management environment can allow biomarker researchers to correlate genomic data from these bio-samples with patient or subject’s history and clinical end-points to test various hypotheses for disease, diagnostics
and therapeutics.
11:55 Transition to Lunch
12:00 pm Luncheon Presentation: Radiomics: Transforming Standard Imaging into Mineable Data for Diagnostic and Theragnostic Applications
Sean 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
1:05 Chairperson’s Remarks
Deborah Shepard, PhD, Senior Manager, Biomarker Assay Specialist, Early Development, Translational and Immuno-Oncology Global Product Development, Pfizer
Vaios Karanikas, PhD, Biomarker Experimental Medicine Leader, 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
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
2:30-2:45 Speed Networking: Young Professionals
3:10 ‘Patient-Centric’ Biomarkers: Utility of Minimally Invasive Sampling in Clinical Trials
Michael 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 PANEL DISCUSSION: Challenges in Clinical Biomarker Development
Moderator: Vaios Karanikas, PhD, Biomarker Experimental Medicine Leader, Oncology, Roche
Panelists:
Abdel B. Halim, PharmD, PhD, DABCC-CC, DABCC-MD, DABCC-Tox, Vice President, Biomarkers and Companion Diagnostics, Taiho Oncology, Inc.
Michael Patel, PharmD, Fellow, Biomarker Development, Novartis Institutes for BioMedical Research
Deborah Shepard, PhD, Senior Manager, Biomarker Assay Specialist, Early Development, Translational and Immuno-Oncology Global Product Development, Pfizer
Xuemei Zhao, PhD, Senior Principal Scientist, Translational Molecular Biomarkers, Merck Research Labs
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
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 Longitudinal, Event-Based, Same-Day Sample Collection: The Implications for Biomarker Development
Brian 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.
9:20
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
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
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 EV-Based Biomarkers for the Diagnosis and Monitoring of Malignant Gliomas
Leonora Balaj, PhD, Instructor, Neurosurgery, Massachusetts General Hospital
11:50 Transition to Lunch
12:00 pm Bridging Luncheon Presentation: Advancing High-Throughput Screening Using FirePlex-HT Immunoassays
Elnaz Atabakhsh, PhD, Senior Product Manager, Multiplex Assays, 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