Co-Founder, Senior Vice President & Chief Analytics Officer
Slava Akmaev, Ph.D., is the Senior VP and Chief Analytics Officer at BERG. Dr. Akmaev is the industry leader in AI and machine learning applications in life sciences and healthcare. He heads the BERG Analytics business division and is the chief architect of Bayesian Artificial Intelligence software, bAIcis®. Dr. Akmaev is an avid advocate for data driven research and promotes wider utility of advanced mathematical modeling techniques in pharmaceutical and clinical research. Prior to his role at BERG, Dr. Akmaev spent a decade at Genzyme R&D and the CLIA diagnostic laboratory, Genzyme Genetics. He led the development and commercialization of novel multi-omic panel diagnostics in oncology and prenatal medicine. Dr. Akmaev has published numerous peer-reviewed manuscripts in genomics, systems biology, biochemistry and human genetics. He is a frequent speaker at AI, analytics and precision medicine conferences. Dr. Akmaev holds a Ph.D. in Applied Mathematics from the University of Colorado at Boulder.
Director & Diagnostics Lead
President & CEO
Josh Bilenker, M.D., founder of Loxo Oncology, serves as President and Chief Executive Officer, and sits on the board of directors. Previously, Dr. Bilenker was a Partner at Aisling Capital, a multi-strategy healthcare investment firm based in NY, where he remains an Operating Partner. From 2004-2006, Dr. Bilenker worked as a Medical Officer at the U.S. FDA in the Office of Oncology. Dr. Bilenker trained at the University of Pennsylvania in internal medicine and medical oncology, earning board certification in these specialties. He received his M.D. from The Johns Hopkins School of Medicine and his A.B. from Princeton University.
Senior Director & Head, Translational Medicine
Dr. Michael E. (Ted) Burczynski is a Senior Director and Head of Translational Medicine at Teva Pharmaceuticals. He received a PhD in pharmacology from the University of Pennsylvania School of Medicine and conducted his postdoctoral work in Toxicogenomics at Johnson and Johnson’s R.W. Johnson Pharmaceutical Research Institute. He has previously led translational research groups and biomarker laboratories at Wyeth, Roche and BMS. He is currently an adjunct professor in the Department of Systems Pharmacology and Translational Therapeutics at the University of Pennsylvania. He has edited two textbooks and published over a hundred abstracts, articles, reviews and book chapters in the fields of genomics and biomedical research. In his spare time he is the novelist Michael Ransom whose debut novel THE RIPPER GENE won the prestigious Silver Falchion literary award for “Best Horror Novel” in 2016 (www.michaelransombooks.com).
Global Head, Drug Regulatory Affairs, Companion Diagnostics
Head, Translational Pathology
Dr. Robin Edwards, M.D., is Head, Translational Pathology, at Bristol-Myers Squibb. Following an academic career in Molecular Genetic Pathology and Laboratory Hematology, Robin has held industry positions over the last decade spanning the drug development paradigm and has deep expertise in the design and application of biomarker strategies. In her current role, she leads a team of pathologists and scientists who develop tissue-based biomarkers that are embedded within immuno-oncology development, incorporating multiplex platforms, image analysis and deep learning algorithms
Biomarker & Companion Diagnostic Lead
Jeff holds the role of Biomarker and Companion Diagnostic Lead at Merck, where he owns the development and delivery of the US Companion Diagnostics Marketing Plan, integrating with the pebrolizumab (KEYTRUDA) Global strategic marketing plan and local therapeutic marketing plans. He has previously held positions at GSK, Roche Dx and Ventana. He gained his BSc in Microbiology from the University of Guelph in 1995 and his MBA in Pharmaceutical and Healthcare from Saint Joseph’s University in 2017.
Head & Director, Nonclinical & Biomarker Statistics
Head of Pharmacodiagnostics
George A. Green, IV Ph.D. is Head, Pharmacodiagnostics in the Bristol-Myers Squibb Translational Medicine organization. He joined BMS in March 2010 and played a key role in establishing Pharmacodiagnostics as a core capability within BMS. In his role, George has been responsible for leading pharmacodiagnostic development programs in oncology, neuroscience, cardiovascular, and virology, as well as early diagnostic development programs in a number of therapeutic areas and across multiple technology platforms. In his current role, George heads the Pharmacodiagnostics team, providing strategic direction and support for all diagnostic platforms across the portfolio BMS Oncology and Innovative Medicine assets. Prior to joining BMS, George was the Director of Assay Development at Veridex, LLC (a Johnson & Johnson Company), where he focused on oncology molecular diagnostic products. Prior to Veridex, George worked at Ortho Clinical Diagnostics, Inc., in the development of immunoassay products for transfusion medicine and clinical diagnostics. Dr. Green received his Ph.D. degree in Microbiology from The Ohio State University, Columbus, OH. He also holds a B.A. degree from University of Pennsylvania, Philadelphia, PA and is a certified Six Sigma Black Belt.
Translational Pathology & Biomarker Technologies
Dr. Cyrus Hedvat is a pathologist in the Translational Pathology and Biomarker Technologies group in Translational Sciences at Bristol-Myers Squibb. His research interests focus on cancer immunotherapy, predictive biomarkers, and digital image analysis. He received his M.D. and Ph.D from Georgetown University and has 15 years of experience as a faculty member in academic institutions as a molecular pathologist and hematopathologist. He is a member of the Society for Immunotherapy of Cancer, the American Society of Hematology and the College of American Pathologists and has authored over 60 peer-reviewed publications including a number of studies demonstrating the utility of molecular and protein biomarkers in hematological malignancies and solid tumors.
Director, Biomarkers & Companion Diagnostics
Vice President & Head, Global Value-Based Partnerships
Head, Biomarkers & Companion Diagnostics
Chief Scientific Officer
Executive Director & Head, Clinical Biomarkers & Diagnostics
Head, Market Enabling Technologies & Companion Diagnostics
Vice President, Translational Medicine
Stephen G. Miller, Ph.D. is Vice President, Translational Medicine at Blueprint Medicines in Cambridge. He joined Blueprint in 2014 and is responsible for strategy and implementation of clinical biomarker, pharmacodynamic and diagnostic approaches for Blueprint’s personalized medicine portfolio. He joined Blueprint from Array Biopharma, where he led biomarker, pharmacodynamic and patient selection efforts for Array’s non-oncology portfolio and select oncology programs. Prior to Array he led research and translational efforts at Kémia, a company focusing on allosteric kinase inhibitors, and Ligand Pharmaceuticals where he worked on programs targeting both nuclear hormone receptors and the JAK/STAT signaling pathway. He began his career in biotech at Amgen, where he utilized genomic approaches for new target discovery and validation. He received his PhD in Biology at Caltech and undertook post-doctoral studies at UC Berkeley.
National Account Director, Diagnostics
With over 23 years of experience in the lab industry, working for many large commercial labs in Management of Sales related roles, Julie joined Pfizer Oncology five years ago to provide subject matter expertise to their growing portfolio of therapies with companion diagnostic activities. With expansive background in pathology, technologies, platforms, reimbursement and regulatory matters, Julie has also become one of Pfizer Oncology’s primary experts in data aggregation, purchase, and evaluation within the business unit in regards to biomarkers. Julie also serves on the Board of Directors for the California Clinical Lab Association as their previous president and now as the Secretary of the board. She is involved in many organizations such as Precision Medicine Coalition, and patient advocacy groups.
Head, Clinical Biomarkers
Director, Diagnostic Development
Susanne has worked at Eli Lilly and Company for 14 years, initially implementing clinical trials in early phase oncology. This experience provided her with a broad knowledge of drug development as well as direct involvement in the activities required for clinical trial operations and execution. As the field of companion diagnostics in the pharmaceutical industry emerged, she was intrigued and excited about the opportunity to combine her drug development background with her knowledge of basic lab techniques obtained during her graduate school and post-doctoral fellowship training. Over the past 7 years, Susanne has led 10 companion diagnostic development programs using molecular techniques, immunohistochemistry, and immunoassays in oncology and other therapeutic areas. In her current role, Susanne is responsible for the diagnostic development work performed by diagnostic manufacturers and the integration of these investigational companion diagnostics into Lilly clinical trials.
Director, Translational Sciences
Vice President & Head of Diagnostics
Vice President, Oncology Precision Medicine
SVP & CMO, North America
In his role, Dr. Su is responsible for working with the local and global medical, development and regulatory teams to lead EMD Serono’s medical strategy, clinical presence, scientific leadership in the US. Dr. Su's expertise complements the global organization's R&D strategy, which focuses on delivering a transformative pipeline in the core therapeutic areas of oncology, immuno-oncology and immunology with several high-priority programs in late development, as well as a number of promising early-stage assets. A physician executive with more than 20 years of experience, Dr. Su held roles at a number of academic institutions – including at Duke University and University of Florida, where he led early clinical development in Immuno-Oncology as a faculty member – before joining the biopharmaceutical industry. Within EMD Serono, he most recently held the position of Global Head of Medical Affairs, Oncology, prior to which, he held leadership roles in general management, clinical development and medical affairs at Sanofi and GlaxoSmithKline. Dr. Su earned his MD degree from the Technical University of Dresden, Germany and completed his MBA training at the University of Toronto, Canada.
GSK Fellow & Group Leader Exploratory Biomarker Assay Group
Head, Biomarkers & Diagnostics
Vice President, Bioanalysis, Immunogenicity & Biomarkers
Executive Vice President & Chief Technology Officer
Dr. Roman Yelensky serves as chief technology officer and is responsible for overseeing the Company’s genomics, proteomics and informatics programs. He joined Gritstone at its inception in October 2015 as executive vice president of sequencing and bioinformatics. Prior to that, he was vice president of biomarker and companion diagnostic development at Foundation Medicine, which he also joined at its inception. While at Foundation Medicine, he co-led sequence data analysis for FoundationOne™ and led validation studies supporting clinical laboratory accreditation and testing of more than 100,000 patients. Dr. Yelensky established Foundation Medicine’s FDA-regulated products program, leading to the FDA approval of FoundationFocus CDxBRCA, the first NGS-based companion diagnostic. He also contributed to key national initiatives on the clinical implementation of next-generation sequencing (NGS), leading the diagnostic implementation of Lung-MAP, a first-of-its-kind NCI-sponsored trial matching lung cancer patients to investigational treatments using comprehensive genomic testing. Prior to Foundation Medicine, Dr. Yelensky was a senior scientist in biomarker development at Novartis. He has co-authored more than 75 manuscripts on bioinformatics, statistical genetics, NGS biomarker and assay development and cancer genomics. He earned an M.S. in computer science from Stanford University and a Ph.D. in bioinformatics and integrative genomics from the Harvard-MIT Division of Health Sciences and Technology.
Academics, Advocates & Associations
Lakeside Life Science
Chief Medical Officer
Dr. Roy Beveridge is Humana's Chief Medical Officer, where he is responsible for developing and implementing the company's clinical strategy and advancing its integrated care delivery model. He is known for creating collaborative environments among physician communities and providing thought leadership, publishing extensively in the fields of medical oncology, quality design, ethics, and population health. Previously, Dr. Beveridge served as Chief Medical Officer for McKesson Specialty Health and as Executive VP and Chief Medical Officer for US Oncology. He practiced for more than 20 years in medical oncology and stem cell transplant in northern Virginia.
Scientific Director, Immuno-Oncology Lab & Director,
Translational Research/Biomarker Lab, Massachusetts General Hospital Cancer Center
Executive Vice President, Business Development
President & Managing Partner
MAWD Pathology Group
Associate Professor, Department of Neurology
Duke University Medical Center
Chief, The Institute for Precision Cardiovascular Medicine
American Heart Association
Vice President & National Medical Director
Dr. Phil Lerner is a Vice President and National Medical Director at Aetna. He is the Head of Condition Analysis and leads multiple clinical teams that analyze claims data and develop strategies to help Aetna members receive evidence based cost effective health care. He also leads Aetna’s strategy to prepare for emerging medical technologies. In addition, Dr. Lerner serves as Aetna’s National Medical Director for Pharmacy Policy and Strategy and the National Medical Director for Aetna’s Institutes of Quality. Dr. Lerner has 20 years of Corporate Occupational Medicine experience. He was previously Medical Director for United Technologies’ Pratt & Whitney division and Consulting Medical Director for their Hamilton Sundstrand, Carrier and Otis divisions. Prior to United Technologies, he held Corporate Occupational Medicine leadership positions at 3M and the Dow Chemical Company. Dr. Lerner earned his B.A. Magna Cum Laude in Economics from Brandeis University and his M.D. from the University Of Cincinnati College Of Medicine. He completed his Occupational Medicine Fellowship and Masters of Public Health at the University of Michigan. He is Board Certified in Occupational Medicine, a Fellow of the American College of Occupational and Environmental Medicine, Past President of the New England College of Occupational and Environmental Medicine, and an Assistant Clinical Professor at the University Of Connecticut School Of Medicine.
Wednesday, October 18, 2017
10.00 | Keynote Panel: “Precision Medicine” Under the Microscope: A Frank Look at the Impact of Precision Medicine on Patient Welfare
University of Maryland
Dr. Martin received his Ph.D. from the University of California, San Diego, after training as a Howard Hughes undergraduate research fellow at the University of Virginia. Dr. Martin completed a Damon Runyon postdoctoral fellowship at Harvard Medical School that combined functional genomic studies with mouse models of breast tumor metastasis, under the mentorship of Dr. Phil Leder. In 2004, Dr. Martin joined the Marlene and Stewart Greenebaum Cancer Center (UMGCC) and the Department of Physiology at the University of Maryland School of Medicine. Dr. Martin is working to apply physical science and engineering approaches to study the mechanical properties of circulating tumor cells. In 2010, Dr. Martin was one of only 3 investigators in the United States recognized with an Era of Hope Scholar Award from the Congressionally-directed Medical Research Program for his innovative research on breast cancer metastasis.
Wednesday, October 18, 2017
09.00 | Microfluidic Cell Tethering Enables Rapid Analysis of Drug Responses in Live Patient CTCs
Medical Director, HEOR/Health Informatics
McKesson Specialty Health/US Oncology Network
Senior Principal Application Scientist
MD, Real-World Value & Strategy
Vice President, Global MHS IVD
Independent Cancer Drug Discovery & Development Advisor
R&D Coordinator, Center for Personalized Diagnostics
University of Pennsylvania
Former President & CEO
PAML & PAML Ventures
Professor, Department of Pharmacology
Johns Hopkins Medical School
Diagnostic & Technology Developers
Chief Scientific Officer
Senior Vice President, Operations & Regulatory Affairs
Chief Medical Officer
EVP, Partnerships BU
Corinne leads the Partnerships Business Unit at HalioDx a French diagnostic company. HalioDx is an immuno-oncology diagnostic company, founded in 2015 by Corinne and 4 others co-founders. Her focus is to develop partnerships with Pharma, by including HalioDx proprietary assays in Pharma clinical trials to demonstrate potential predictive value. HalioDx has the capabilities & experience to partner with Pharma from early stage to Companion Diagnostic commercialization. Corinne worked during 15 years in Pharma (Lilly), and during 10 years in the Diagnostic Industry. Corinne has a MBA from Insead.
Director, Clinical Diagnostics New Technology
MD & CEO
Vice President, R&D, Clinical Sequencing Division
Thermo Fisher Scientific
Head, Biomarker Services
Claire Huguet is a PhD Pharmacist with 15 years’ experience in the CRO industry as a Central Lab and Biomarker expert. Claire joined Randox Laboratories to develop the Biomarker services already provided by Randox Biosciences to the Pharma Industry, CROs and other key players in the field of biomarker discovery, research and clinical diagnostic use.
Global Head, Molecular Services
Chief Scientific Officer
Director, Profiling & Diagnostics
Vice President, Business Development, Personalized Diagnostics
Dawn has a background in Sales, Marketing, Pharma Advertising and Business Development and has spent most of her career in Personalized Medicine. She recently joined Corgenix from QIAGEN, where she spent 5.5 years as a member of the Companion Diagnostics Business Development Team, responsible for establishing collaborations with Pharma, for the development, registration and commercialization of Molecular Companion Diagnostics. Prior to joining QIAGEN, Dawn managed the pharma advertising team that developed the global campaign for the launch of Pfizer’s XALKORI (crizotinib), a first-in-class ALK-inhibitor for treatment of ALK-positive non-small cell lung carcinoma (NSCLC). Dawn’s other experience spans the oncology therapeutic and diagnostic markets with roles at AstraZeneca (Oncology Sales-Iressa), Becton Dickinson (Oncology Diagnostic Marketing), and Oncor, Inc (Diagnostic Sales, Product Management and Marketing-HER2 FISH IVD). At Corgenix, Dawn will focus on growing their Personalized Diagnostics program by establishing relationships and collaborations with Pharma and other Personalized Medicine stakeholders for the development of serum protein-based companion diagnostics.
Dr. McManus joined in August 2014 bringing more than 20 years of clinical diagnostic leadership experience. Matt was most recently CEO and President of PrimeraDx, Inc., a molecular diagnostics company acquired by Qiagen. He has held leadership positions in a number of other companies, including as Head of Cleveland Clinic Laboratories, COO of the Pathology and Laboratory Medicine Institute at the Cleveland Clinic, and a variety of positions at Novartis, McKinsey & Co., and Procter & Gamble. Dr. McManus received his M.D. and Ph.D. from the University of Pennsylvania, M.B.A from Boston College and B.A. from the College of the Holy Cross.
Wednesday, October 18, 2017
10.00 | Keynote Panel: “Precision Medicine” Under the Microscope: A Frank Look at the Impact of Precision Medicine on Patient Welfare
Chief Operating Officer
Senior Vice President
Associate Director, Diagnostic Strategy
Director, Business Development
Senior Director, CDx Pharma Services & Pharma Alliance
Roche Tissue Diagnostics
Head, Biomarker Solution Center, Global Leader Precision Medicine
Chief Technical Officer
Senior Director, Pharma Business Development
Senior Director, Diagnostics Development
Vice President, Business Development & Strategy
Steve Rosen is the Vice President of Business Development and Strategy at Elucida Oncology, Inc. He has an excellent track record of maximizing the impact and success of both diagnostic and therapeutic assets. Dr. Rosen has more than 30 years of operational and leadership experience in the life sciences industry. Prior to Elucida, he was Executive Director, Pipeline and Commercial Strategy for the Oncology Business Unit of Novartis Pharmaceuticals. In this role, he led a team responsible for strategic direction for global personalized medicine commercial strategy for Phase I through III compounds in the Novartis Oncology pipeline as well as supported execution of personalized medicine commercial programs for in-line brands. He was also a Novartis representative on the Oncology Strategic Governance Group of the European Innovative Medicines Initiative, the Novartis representative to the US Personalized Medicine Coalition and member of the Novartis translational Clinical Oncology/ Companion Diagnostics Committee Prior to Novartis, Dr. Rosen enjoyed a 14 year career at Johnson & Johnson as a co-founder of the Veridex circulating tumor cell-focused division and as a World-Wide Senior Director of Business Development and Healthcare Investment for the Ortho Clinical Diagnostics franchise. In this role, he oversaw 5 strategic business alliances that created over $300MM per year in revenue and delivered 10 significant business transactions, driving overall business growth. He also managed the company’s complex IP portfolio of hundreds of patents.
Business Development Manager
Martin Shaw has had long experience in the development and application of many novel biomarkers. He has published several peer-reviewed articles on the application of novel biomarkers. He has participated in industry-wide consortia on the qualification of biomarkers for their application in pre-clinical and clinical trials. He has spoken at many congresses including being a guest speaker at the FDA.
US General Manager
Vishal Sikri is the General Manager for Biocartis US. He has been in the diagnostics industry for over 20 years with extensive experience identifying new and emerging technologies focused on cancer theranostics and bringing them to market. Prior to Biocartis, Vishal worked in various management positions in both the life sciences and diagnostics industries.
Vice President, Development & Scientific Affairs
Dr. Spittle joined MolecularMD in 2010 as Scientific Affairs Liaison. In her current role as Vice President, Development and Scientific Affairs she provides strategic scientific leadership related to oncology drug development and biomarker trends as well as new technology platforms and products. Her responsibilities include identifying and initiating opportunities to collaborate in clinical biomarker studies with both industry and academic partners. She also oversees the assay development teams, and facilitates scientific communications between external and internal stakeholders. With over 20 years of experience in oncology biomarker translational research and diagnostic assay development, Dr. Spittle has held leadership positions at Pfizer, Fox Chase Cancer Center, and SmithKline Beecham Clinical Laboratories. She has authored numerous peer-reviewed publications and abstracts, and has been awarded research grants as Principal Investigator. Dr. Spittle holds a BS in Microbiology from The Pennsylvania State University, an ASCP Medical Technology Certification from Pennsylvania Hospital and a Ph.D. in Molecular Biology from Lehigh University.
Founder & CEO
Bob Terbrueggen is the CEO and Founder of DxTerity, a molecular diagnostic and information company that is transforming the management of chronic autoimmune disease with from home RNA monitoring. Bob has 20 years of experience in the development of genomic tests and technologies. He started out his career at Clinical Micro Sensors (CMS), where as Director of R&D he oversaw the development of the world’s first bio-electronic DNA detection platform, the e-Sensor. Bob then became Director of Research at Motorola Life Sciences following Motorola’s acquisition of CMS on 2000 for $300 million. He then left Motorola to start DxTerity.
Vice President, Companion Diagnostics
Thomas Turi, Ph.D. is Vice President Companion Diagnostics for Covance Central Laboratory Services. He joined Covance in 2008 to establish the Biomarker Center of Excellence and was integral to the acquisition of the Covance Genomics Laboratory and the formation of Discovery and Translational Services. He is currently responsible for Covance’s Companion Diagnostics efforts. Prior to Covance, Dr. Turi spent fifteen years in the pharmaceutical industry, where he held a broad array of scientific leadership positions of increasing responsibility. Most recently he served as the Senior Director of Translational Biomarkers and Mechanistic Biology at Pfizer. In addition to his current responsibilities, Dr. Turi has served on the Board of Trustees for The Life Sciences Foundation and is a member of the Global Health Research Roundtable of the Indiana Clinical and Translational Sciences Institute. He has previously served on the Board of Directors for Caprion Proteomics and led several external partnerships including those with Rules Based Medicine, Celera, Incyte, and Affymetrix. He has also served on grant and program project review boards for NASA’s Section for Biotechnology and Tissue Engineering. Dr. Turi received dual bachelors degrees in Biochemistry and Chemistry from the University of Illinois at Urbana-Champaign and his doctorate in Molecular Genetics from the University of Cincinnati College of Medicine. He completed postdoctoral training at the Yale University School of Medicine applying molecular genetic techniques to investigate the mechanisms of protein transport.
President & CEO
Vice President, Business Development, Oncology & Precision Diagnostics
Chief Science Officer, Companion Diagnostics
Senior Medical Director
Keith Wharton MD PhD FCAP is Senior Medical Director at Leica Biosystems since 2017 supporting companion diagnostic assay and reagent development, the BOND automated IHC tissue stainer, and Danaher Diagnostics platform initiatives. He has >30 years of experience in diverse roles in academic and biopharma settings, including Novartis Institutes for BioMedical Research and Biogen. Following certification by the American Board of Pathology in anatomic pathology and fellowships in autopsy pathology and developmental biology at Stanford University, he ran an NIH-funded research laboratory at UT Southwestern Medical Center in Dallas, holding several leadership positions including Director of the Laboratory of Molecular Pathology and Associate Dean of the medical school
Head, US Operations
Senior Vice President & Chief Medical Officer, R&D, Medical & Employee Health
Director, Global Regulatory Affairs, Companion Diagnostics