John (JD) Alvarez

Vice President and Head, Oncology Diagnostics

Janssen

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John (JD) Alvarez

Vice President and Head, Oncology Diagnostics

TBA

Steve Anderson

Chief Scientific Officer and Senior Vice President

Covance

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Steve Anderson

Chief Scientific Officer and Senior Vice President

Steven Anderson, PhD, is a Senior Vice President at Laboratory Corporation of America (LabCorp), and the Chief Scientific Officer for the Covance Drug Development business of LabCorp. He has been with the LabCorp organization for 28 years and has held a variety of positions including Director of Operations for ViroMed Laboratories, Director of Operations for Monogram Biosciences, Director of Operations for the Center for Molecular Biology and Pathology, Director of Operations for Integrated Oncology and Genetics, National Director of Research and Development, and Global Head of LabCorp Clinical Trials. Dr. Anderson is a member of a variety of professional societies including the American Association for Cancer Research, the American Society of Clinical Oncology and the Association for Molecular Pathology.

Dr. Anderson’s research interests are in the development and applications for molecular diagnostics, including several examples of companion diagnostics and pharmacogenomic assays. He has authored more than 175 articles and abstracts published in such journals as Genetics, Proceedings of the National Academy of Sciences, Clinical Chemistry, the Journal of Infectious Disease, Human Pathology, American Journal of Obstetrics and Gynecology, Oncogene, the Journal of the National Cancer Institute, Clinical Cancer Research, Breast Cancer Research, BMC Cancer, the Journal of Molecular Diagnostics, Archives of Pathology and Laboratory Investigation and Expert Reviews in Molecular Diagnostics.

He has a PhD in Genetics from Iowa State University, and was an American Cancer Society postdoctoral fellow at the Waksman Institute of Rutgers University.

Jerry Catanese

Discovery Business Manager

Roche

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Jerry Catanese

Discovery Business Manager

TBA

Mark Curran

Vice President of Immunology

Janssen Research & Development

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Mark Curran

Vice President of Immunology

Dr. Curran is currently Vice President of Immunology at Janssen Research & Development, LLC.

Mark is a member of the Immunology Senior Leadership Team (SLT), is the Clinical Development Team Leader (CDTL) for JNJ-64304500 (anti-NKG2D / Crohn’s Disease) and JNJ-64873133 (anti-CD28 / RA and Psoriasis). In addition he leads the Companion Diagnostics and Digital Healthcare strategy and is a member of the Early Clinical Development Leadership. Prior to taking on these responsibilities, Mark lead the Janssen Immunology Biomarkers effort for 8 years.

Mark’s experience in drug development in big pharma includes nine years with Janssen and five years at Bristol Myers-Squibb. In addition to leadership in biomarkers and diagnostics he has lead clinical development, experimental medicine, Phase 1 and 2 trials for multiple compounds in immunology. Prior to joining big pharma, Mark gained valuable experience in biotech and venture oriented companies with focus on genomics, target discovery and validation, genetic diagnostics and early drug discovery.

Mark earned his doctorate in Human Genetics at the University of Utah, has co-authored over 50 scientific publications and holds multiple patents. He has contributed seminal discoveries in the field of heritable cardiac arrhythmias and developed the Familion™ diagnostic test for long QT syndrome. His primary interests are discovery of novel therapeutics, implementation of molecular diagnostics for personalized medicine and evolution of Digital Health Care and Integrated Patient Care Solutions to improve the lives of all patients living with auto-immune disease.

Nic Dracopoli

Nic Dracopoli

Senior Vice President, Translational Science

Personal Genome Diagnostics

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Nic Dracopoli

Senior Vice President, Translational Science

Nicholas Dracopoli, Ph.D. recently joined Personal Genome Diagnostics (PGDx) as Senior Vice President of Translation Science after eighteen years working in oncology drug development at Bristol Myers-Squibb (BMS) and Janssen Research & Development. In these roles, he was responsible for building two new translational science teams whose work contributed to the approval of six new oncology drugs for BMS and Janssen. Prior to joining the pharmaceutical industry, he spent five years in the biotechnology industry at Sequana Therapeutics. Nicholas obtained his bachelor’s degree and doctorate from the University of London and completed post-doctoral fellowships at the Memorial Sloan-Kettering Cancer Center in New York City and the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts. Subsequently, he served as an Assistant Director at the Whitehead/MIT Genome Center and as a Section Chief at the National Center for Human Genome Research at the National Institutes of Health, Bethesda, Maryland. Nicholas has authored more than 70 scientific publications and has extensive experience in the fields of genomics, molecular biology and cancer research.

Rob Dumanois

Manager of Reimbursement Strategy

Thermo Fisher Scientific

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Rob Dumanois

Manager of Reimbursement Strategy

Rob has over 20 years’ experience working with payers, providers, employers, and CLIA labs. His current role includes design and execution of reimbursement strategies for Oncomine™ Dx Target Test: the first FDA-approved next-generation sequencing (NGS) in vitro diagnostic test for non-small cell lung carcinoma (NSCLC), offering clinically actionable and analytical cancer-driver biomarker information to inform treatment decisions. This was a multi-marker companion diagnostic, now covered by Medicare’s NCD and several commercial payers, and developed in partnership with Pfizer and Novartis.

Rob joined Thermo Fisher (formerly Life Technologies) in 2012, through an acquisition of Navigenics – where he led development and growth of health plans, large employers, and voluntary benefit providers. Rob was also a Territory Vice President at RelayHealth, with duties that included payer-facing sales of solutions that included e-prescribing and webVisits. And prior to RelayHealth, Rob held senior sales and sales management positions with UnitedHealthcare.

Alberto Gutierrez

Former Director, FDA Office of In Vitro Diagnostic Device Evaluation and Safety

Consultant

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Alberto Gutierrez

Former Director, FDA Office of In Vitro Diagnostic Device Evaluation and Safety

TBA

George Lee

Digital Pathology Informatics Lead

Bristol-Myers Squibb

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George Lee

Digital Pathology Informatics Lead

TBA

Mike Montalto

Executive Director and Head of Translational Pathology, Clinical Biomarker Laboratories, Translational Medicine

Bristol-Myers Squibb

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Mike Montalto

Executive Director and Head of Translational Pathology, Clinical Biomarker Laboratories, Translational Medicine

Dr. Montalto is a research and development leader with a broad range of experience at the executive level including R&D, clinical, regulatory, medical and scientific affairs. He is currently the Executive Director and Head of Translational Pathology and Clinical Biomarker Laboratories in Translational Medicine at Bristol-Myer Squibb. In this role he leads genomics, genetics, flow cytometry, histo-chemistry, pathology and emerging clinical laboratories in support of clinical trials, exploratory biomarker research and companion diagnostics development. Prior to this role, Dr. Montalto was a co-founder and executive of Omnyx, LLC, a joint venture of GE Healthcare and the University of Pittsburgh Medical Center that commercialized diagnostic pathology imaging and software products. He has patented and published on novel pathology-based multiplexing technology (MultiOmyx™, Clarient/Neogenomics) for oncology biomarker discovery. He has designed and led global clinical development for in vitro diagnostic digital pathology devices and served as chair of the regulatory taskforce of the Digital Pathology Association (DPA). He currently sits on the board of directors as President of the DPA. He has served as a member of NIH study sections for in vivo molecular imaging centers. Dr. Montalto earned his PhD in tumor biology from Albany Medical College and received his post-doctoral training in anti-inflammatory drug discovery and whole animal physiology at Brigham and Women’s Hospital, Harvard Medical School.

Susanne Munksted

Commercial Director, Companion Diagnostics

Agilent

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Susanne Munksted

Commercial Director, Companion Diagnostics

Susanne Munksted holds a Master of Science in Pharmaceutical Sciences from The Royal Danish University of Pharmacy, followed by an Executive CBA (Certificate in Business Administration) and a number of Diplomas in People Management and Sales and Marketing. She worked +10 years in various International Commercial roles in the pharmaceutical industry before joining Agilent (before Dako) in 2009 and is now Global Commercial Director for Companion Diagnostics.

Susanne have been the commercial lead in launching many CDx products globally. Recently two high profiled and first FDA approved PD-L1 IHC assays.

Julie Ramage

National Accounts Director, Diagnostics, Oncology

Pfizer

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Julie Ramage

National Accounts Director, Diagnostics, Oncology

TBA

Gary Spitzer

Consultant

Strategic Medical Testing Services

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Gary Spitzer

Consultant

Dr Spitzer Graduated from the University of Melbourne Australia. He has many years in the Practice of Medical Oncology, practicing as a Professor at the MD Anderson Hospital Houston TX for many years. He subsequently has been the director of several Medical Oncology Programs in Academic centers. Of recent years he has been involved in the evaluation of Precision Medicine Tests submitted to MolDx for coverage. His expertise is, determining the Clinical Validity and potential Clinical Utility of a test. He now is an independent consultant focused on the initial design of a test, intended use, and clinical validation, without resorting to impractical, costly trials.

John Wagner

Senior Vice President, Head of Translational Research and Early Clinical

Takeda Pharmaceuticals

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John Wagner

Senior Vice President, Head of Translational Research and Early Clinical

TBA

Steven Walker

Head of Product Management

Almac Diagnostics

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Steven Walker

Head of Product Management

Dr Steven Walker heads the internal product management activities at Almac Diagnostics. Specifically this includes the development of internal discovery of biomarker assays towards commercialisation as a diagnostic test delivered directly from Almac CLIA and CAP accredited laboratories, or as a companion diagnostic test for in partnership with Pharma / Biopharma. Steven studied at the University of Dundee, leading to a PhD before postgraduate work at the Beatson Cancer Research UK Institute in Glasgow. He joined Almac Diagnostics in 2005, initially as a Senior Scientist, then as Team Leader and then Research Manager before taking the role in Product Development. As part of his time with the research team, he was involved in the discovery and development of several of the internally discovered biomarker assays.

Xiaolei Xu

Director of Global Regulatory Affairs

Agilent

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Xiaolei Xu

Director of Global Regulatory Affairs

  • Working in the IVD regulatory affairs field for 10 + years on a variety of IVD products.
  • Joined Dako/Agilent in 2010 and focusing on Companion Diagnostic (CDx) co-development and pre-market registration
  • Extensive experiences in regulatory submissions and communications with regulatory authorities
  • Successfully led multiple drug-diagnostic co-development projects with major pharma companies, developing and implementing regulatory strategies to enable timely registrations and approvals
  • Obtained approvals for Companion/Complementary diagnostic products in major markets including US, EU, Canada, Japan, Korea, Taiwan, Australia and ROW countries