Andrew Aijian

Principal

DeciBio Consulting

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Andrew Aijian

Principal

Dr. Andrew Aijian is a Principal at DeciBio Consulting, where he leads market landscape, product development, and strategy engagements for a wide variety of stakeholders in the biotechnology and life sciences industries.  Andrew’s areas of interest and expertise include oncology biomarkers and diagnostics, -omics technologies, pharmaceutical services, and business intelligence data aggregation and visualization.  At DeciBio, Andrew has led CDx-related market evaluation and strategy engagements for stakeholders across the CDx landscape, include diagnostic manufacturers, pharmaceutical services providers, translational research tools companies, and pharmaceutical manufactures.  Andrew has also served as author and editor for DeciBio’s companion diagnostics and oncology diagnostics market research reports, and developed DeciBio’s Immuno-Oncology Biomarker Analysis Platform and associated database of I/O clinical trial biomarkers.  Andrew earned his Ph.D. in Biomedical Engineering from UCLA, focusing on the development of microfluidic research tools for biomedical applications.  He obtained his B.S. in Chemical and Biomolecular Engineering from the University of Notre Dam

Jeff Allard

President

Lakeside Life Science

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Jeff Allard

President

Dr. Allard served most recently as Director of Development for Caris Life Sciences where he designed and implemented a Product Development System, designed multiple clinical and regulatory strategies for novel multiplex oncology tests, wrote clinical protocols for prospective research and PMA-submission trials, and designed a Patient Registry. As Vice President and Chief Scientific Officer of Fujirebio Diagnostics, Inc. (FDI), Dr. Allard directed the Applied Research, Product Development, Clinical Affairs, Regulatory Affairs and Process Engineering Departments. He directed the US introduction of the Mesomark Assay as a Humanitarian Use Device for monitoring patients with mesothelioma. He also managed clinical trials leading to FDA clearance of HE4 for monitoring and for CA 125/HE4 and a logistic regression algorithm for differential diagnosis in women with pelvic mass. In addition, he managed FDI’s expanding global network of in-licensing institutions, and administered an international program in Clinical Research.! He also managed all intellectual property for FDI. Prior to joining FDI in 2004, Dr. Allard previously held positions as Vice President of Clinical Research and Development for Immunicon Corporation (Currently Veridex, LLC, a division of Johnson & Johnson) where he designed and managed clinical trials that led to worldwide introduction of the CellSearch Assay for measurement of circulating tumor cells (CTC). Dr. Allard designed three clinical trials that led to FDA clearance of CTC for prediction of overall survival and progression free survival in patients with breast, colorectal and prostate cancers. He was also Research Fellow and headed the effort in Clinical and Regulatory Oncology for Bayer Corporation (currently Siemens Medical Solutions Diagnostics) where he introduced novel immunoassays for complexed PSA and serum HER-2/neu along with a number of known cancer biomarkers.! Prior to joining Bayer, Dr. Allard was a Diagnostics Researcher for E.I. du Pont de Nemours (also currently a division of Siemens Medical Solutions Diagnostics).

John (JD) Alvarez

Vice President and Head, Oncology Diagnostics

Janssen

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John (JD) Alvarez

Vice President and Head, Oncology Diagnostics

J.D. Alvarez, M.D., Ph.D. is Vice President, Oncology Diagnostics, for the Janssen Pharmaceutical Companies of Johnson & Johnson.  In this position, he is responsible for developing and delivering diagnostic solutions that enable registration of compounds in the Oncology pipeline.

J.D. joined Janssen in 2009 as an Associate Director of Oncology Biomarkers and was responsible for establishing a molecular pathology laboratory to support the oncology biomarker investigations and strategies.  He has held positions of increasing responsibility within Biomarkers, Translational Research and Clinical Research.  He also represents Janssen on working groups within the Society for Immunotherapy of Cancer, the Association of Molecular Pathology and the Medical Device Innovation Consortium.

Prior to joining Janssen, J.D. served as a research associate at the University of Pennsylvania conducting independent National Institutes of Health grant-funded research on the function of circadian rhythms in disease physiology.  He also held positions in both discovery research and oncology translational medicine at Nippon Roche K.K. and at Wyeth Research.

J.D. received his medical degree and his doctorate in Molecular Cell Biology from the Washington University School of Medicine in St. Louis, Missouri.  He completed his residency and fellowship training through the University of Pennsylvania School of Medicine Department of Pathology and Laboratory Medicine.  He is board certified in Anatomic Pathology and Molecular Genetic Pathology.

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.

Andy Beck

Co-founder and CEO

PathAI

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Andy Beck

Co-founder and CEO

Andrew Beck earned a Bachelors of Arts in History from Brown University in 2002 and completed a Masters of Medical Science in Biostatistics and a Medical Degree from Brown Medical School in 2006. He completed his residency in Anatomic Pathology and clinical fellowship in Molecular Genetic Pathology from Stanford in 2010. He then joined the Advanced Residency Training at Stanford program and completed a PhD in Biomedical Informatics from Stanford University in 2013, working with Professor Daphne Koller. In 2011, he was appointed as an Assistant Professor in the Departmet of Pathology at Harvard Medical School and the Beth Israel Deaconess Medical Center. In 2016, he was promoted to Associate Professor.

In 2016, Dr Beck co-founded PathAI, a company that develops artificial intelligence technology for pathology, where he serves as President and CEO.

Flora Berisha

Director Companion Diagnostics

Daiichi Sankyo

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Flora Berisha

Director Companion Diagnostics

Flora Berisha is a Director of companion Diagnostics, at Daiichi Sankyo Pharma. Flora received her BS in Biochemistry and Master Degree in Biology from City University of New York. She currently lead CDx development for multiple projects in the oncology portfolio. Prior to Daiichi Sankyo, Flora was at Kyowa Hakko Kirin Pharma as a Senior Manager. At KHK she focused on strategic biomarker selection, development and translation into CDx assays. She was the CDx lead on representing the strategies to external partners and regulatory agencies. Prior to KHK, Flora was at Bristol‐Myers Squibb where she progressed through the ranks gaining valuable experience in GLP and clinical Bioanalysis, biomarker and CDx assay development from design control through commercialization. In addition to Flora’s industry experience, she is currently an Adjunct Professor in the Department of Biology at CUNY (City university of New York) where she teaches anatomy‐physiology and biology over a decade.

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.

Jennifer Dacpano-Komansky

Director, Regulatory Affairs & Precision Medicine

Novartis

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Jennifer Dacpano-Komansky

Director, Regulatory Affairs & Precision Medicine

Jennifer DacpanoKomansky is currently a Director for Novartis Global Regulatory Affairs where she supports the Precision Medicine within the Oncology division. In this role, she is responsible for providing regulatory guidance specializing in complementary/companion diagnostic development strategies associated with oncology and immuno-oncology (IO) therapeutic  trials.  Prior to joining Novartis, Jennifer came from Leica Biosystems where she established her career in companion diagnostics serving as an IVD Product Development Scientist and later as a Regulatory Affairs Specialist. In addition, her exposure to FDA and regulated GxP-environments include her decade-long employment working in the Preclinical Drug Safety Investigative Pathology division at Sanofi-Aventis. Jennifer’s broad range of experience includes: quality systems, design control development, database validation, CDx partnership/technology regulatory assessments, clinical trial design, liquid biopsy initiatives, premarket applications and post market IVD surveillance reporting. 

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.

Daniel Edelstein

Director of Commercial Operations

Sysmex Inostics

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Daniel Edelstein

Director of Commercial Operations

Dan is the Director of Commercial Operations at Sysmex Inostics.  He previously studied at Johns Hopkins and worked on early clinical studies of circulating tumor DNA. At Hopkins, he also described novel genotype-phenotype relationships and diagnostic approaches for hereditary cancer syndromes.  In 2011, Dan led the development of a CLIA laboratory for BEAMing ctDNA analyses, delivering the first commercial ctDNA assay for clinical practice and prospective clinical trials. Since then, he has worked on clinical utility evidence development, market access and novel reimbursement pathways for ctDNA assays for the management of patients with cancer

Joseph Ferrara

CEO

Boston Healthcare Associates

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Joseph Ferrara

CEO

Mr. Ferrara has over 20 years of experience in life sciences consulting, working with biopharmaceutical, medical device, diagnostics, and health care IT clients in market and business development strategy. He leads the global consulting team with practice areas in reimbursement and pricing, health economics, market analysis, and business development strategy. Mr. Ferrara has extensive experience in the development of novel business approaches designed to capture evidence-based value for innovation health care technologies. Mr. Ferrara writes and speaks extensively on the subject of the value of medical technology innovation, with particular focus on pharmacogenomics, specialty pharmaceuticals, and novel therapeutic devices.

Prior to his consulting role, Mr. Ferrara led a joint venture between Boston Healthcare and a non-profit research organization focused on a global electronic medical record network for the purposes of clinical trials and health outcomes research.

Mr. Ferrara completed undergraduate studies at the University of Cincinnati and received a master’s degree from Harvard University.

Federico Goodsaid

President

Regulatory Pathfinders

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Federico Goodsaid

President

Federico Goodsaid, Ph.D., is President at Regulatory Pathfinders LLC, a regulatory consulting practice focused on the strategy and pathways required for regulatory submissions of precision medicine therapeutic and diagnostic products. He worked as Senior Vice President of Clinical and Regulatory Affairs at TOMA Biosciences, where he has worked on the preclinical and clinical development and regulatory submission for a 130-gene targeted NGS onco panel. His previous work at Vertex was focused on therapeutic product submissions in cystic fibrosis and diagnostic and biomarker development and regulatory submissions in rare diseases. He was previously Associate Director for Operations in Genomics and Biomarker Qualification Coordinator at the Office of Clinical Pharmacology/Office of Translational Sciences/ Center for Drug Evaluation and Research/ U.S. FDA, working on the regulatory application and development of genomics and biomarkers at the FDA. His B.A. was in Biochemistry and Biophysics from the University of California at Berkeley and his Ph.D from Yale University in Molecular Biophysics and Biochemistry. He was a Postdoctoral Fellow at Cornell University and at Washington University in St. Louis. Before he joined the FDA, he was Senior Staff Scientist at Applied Biosystems and Lead for the Molecular Toxicology Group at the Schering-Plough Research Institute.

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

Alberto Gutierrez, Ph.D., is an expert regulatory consultant with the firm NDA Partners. Dr. Gutierrez recently retired from the FDA after 25 years of working in research and regulation. Dr. Gutierrez was the director of FDA’s Office of In Vitro Diagnostics and Radiological Health for 8 years, responsible for the pre-market review and post-market regulation of in vitro diagnostics and radiology devices, as well as responsible for FDA’s regulation of radiation emitting products and regulation of mammography facilities in the US. Dr. Gutierrez received a bachelor’s degree from Haverford College, and master and doctorate degrees in Chemistry from Princeton University. Dr. Gutierrez research experience is in structural organic and organometallic chemistry. Dr. Gutierrez joined the FDA in 1992 as researcher and reviewer in FDA’s Center for Biologics Evaluation and Research working on vaccine adjuvants and method development for determination of purity and structure of vaccine components. In 2000, he joined the Office of In Vitro Diagnostic Device Evaluation and Safety as a scientific reviewer, joining management in 2003. Dr. Gutierrez moved up the management chain finally reaching Executive Service level as Director of the Office of In Vitro Diagnostics in 2009. Between 2009 and 2017 the Office grew and acquired the responsibility for regulating Radiological Health devices and products and the oversight of the mammography program. By 2017, the Office had more than 300 employees. Dr. Gutierrez retired from the FDA in September 2017 joined NDA Partners LLC as an expert consultant, becoming a Partner in May 2018.

Laurie Howard

Vice President, Policy and Payer Relations

LabCorp

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Laurie Howard

Vice President, Policy and Payer Relations

Laurie Howard is Vice President of Policy and Payer Relations for Laboratory Corporation of America in Burlington, North Carolina. Laurie has over 35 years of experience resolving coverage and reimbursement issues on a national level with Government and Commercial Payers. She is an active reimbursement committee consultant for the American Clinical Laboratory Association, and a current board member for the California Clinical Laboratory Association. Most recently, Laurie has been instrumental in representing the lab industry perspective with CMS relative to PAMA and other reimbursement challenges.

Seamus Kearney

CEO

ARC Regulatory

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Seamus Kearney

CEO

TBA

Grace Kim

Manager, Business Development & Alliance Management - Companion Diagnostics

Agilent Technologies

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Grace Kim

Manager, Business Development & Alliance Management - Companion Diagnostics

Dr. Grace Kim is a Business Development and Alliance Manager within the Companion Diagnostics Division of Agilent Technologies, Inc.  She specializes in working with pharmaceutical partners in the contracting, development, registration, and commercialization of biomarker assays.  Her recent experience includes two Dako products – PD-L1 IHC 28-8 pharmDx and PD-L1 IHC 22C3 pharmDx. Grace received her B.S. from the University of California, Berkeley and Ph.D. from the Massachusetts Institute of Technology and Harvard Medical School.

Gabriela Lavezzari

Principal

Vertex Advisors

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Gabriela Lavezzari

Principal

Dr. Lavezzari is the founder and Principal of Vertex Advisors, a business development and strategy consulting firm that specializes in creating sustainable growth for startup businesses and small-, to medium-sized companies through successful expansion.

She served most recently as SVP Business Development at Biocerna, a clinical laboratory diagnostics company with the unique mission of making personalized medicine available and affordable to patient and providers.  While there she led business development and corporate strategy and was able to develop and negotiate novel reimbursement models to bring Biocerna at the forefront of the healthcare debate with public and private payers and partners.

Prior to joining Biocerna, Dr. Lavezzari was a Research Director at the Duke-Robert J. Margolis Center for Health Policy where she led the development of new evidence-based policies to support the shift the current payment models for innovative medical products from fee-for-service (FFS) to value-based. Dr. Lavezzari has invested the past 10 years of her career in advancing the field of personalized medicine by addressing the scientific, regulatory and reimbursement challenges that hinder patients’ access to innovative medical products. By combining her experience working at PhRMA, the leading pharmaceutical trade association and Express Scripts (previously Medco Health Solutions), the largest pharmaceutical benefit manager, Dr. Lavezzari is uniquely positioned to understand the current gaps in the healthcare space and develop novel approaches to improve patient outcome while lowering the overall healthcare costs.

Dr. Lavezzari received her PhD in Biological Sciences from University of Milano (Italy), and has received her MBA from the New York Institute of Technology (NYIT, NY).

George Lee

Digital Pathology Informatics Lead

Bristol-Myers Squibb

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George Lee

Digital Pathology Informatics Lead

TBA

Kamala Maddali

Vice President, Biopharma Collaborations, Market Development and Companion Diagnostics

Cancer Genetics

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Kamala Maddali

Vice President, Biopharma Collaborations, Market Development and Companion Diagnostics

Dr. Kamala K Maddali is currently Vice President, Biopharma Collaborations, Market Development and Companion Diagnostics at Cancer Genetics Inc, Rutherford, NJ. Cancer Genetics, Inc. (CGI) is a leader in the field of personalized medicine, offering diagnostic products and services that enable precision medicine in the field of oncology.

Dr. Maddali holds a DVM Ph.D., in Pharmacology from University of Missouri-Columbia and a DVM Veterinary Medicine from Acharya N.G. Ranga Agricultural University in India.

Dr. Maddali brings over 10 years of extensive experience of global P&L scientific and commercial management of clinical biomarker and companion diagnostics (CDx) services covering personalized medicine strategy. She has promoted the proper utilization of biomarkers, personalized medicine and diagnostics in drug development and patient management to bridge the gap between drug and diagnostic industries. She was Global Director Scientific Development -Biomarkers & Companion Diagnostics for Q2 Solutions (A Quintiles & Quest Diagnostics joint venture). She brings a lot of strategic values from her previous roles at Quest Diagnostics, Quintiles and Merck Schering Plough in the arena of biomarkers and companion diagnostics.

Chris Major

Director of Oncology Diagnostics

Janssen Pharmaceuticals

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Chris Major

Director of Oncology Diagnostics

Christopher Major, Director of Oncology Diagnostics at Janssen Pharmaceuticals R&D, received his PhD in Cell and Molecular Biology from the University of Pennsylvania. He completed post-doctoral fellowships at the National Cancer Institute and Johnson and Johnson Pharmaceutical Research & Development. He joined Janssen Pharmaceutical R&D in 2011 and has directed companion and complementary diagnostic development in support of Janssen therapeutic compounds. In 2017 he joined the Janssen Oncology Diagnostic group as Scientific Director, developing the companion diagnostic strategy for multiple oncology programs, providing oversight of all diagnostic development activities in support of the oncology portfolio at Janssen Pharmaceuticals.

Chris has over 15 years’ experience in the pharmaceutical and medical diagnostic industries, bringing expertise in development of in vitro diagnostic assays and companion diagnostics in accordance with global regulations. He has collaborated on NSRs, IDEs, Pre-Subs, & PMAs with IVD partners as well as participated in regulatory interactions with FDA, CFDA, and PMDA. His mission is to ensure the first Janssen drug-companion diagnostic submission to FDA in 2018.

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.

Edmund Pezalla

Founder and CEO

Enlightenment Bioconsult

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Edmund Pezalla

Founder and CEO

Dr. Pezalla is Founder and CEO of Enlightenment Bioconsult, LLC, a strategic payer consultancy advising biopharmaceutical firms on access, technology assessment, and drug evaluation in the US market. His clients include established pharmaceutical firms and emerging companies with innovative therapies.

Dr. Pezalla served for nine years as VP for Pharmaceutical Policy and Strategy for Aetna, and four years as VP of Clinical Services for RxSolutions. In these roles he developed programs for drug evaluation, creation of clinical policy and formulary inclusion. Dr. Pezalla also served as the leading executive for Aetna on public policy issues related to drug approval, drug pricing and regulation. He is a member of the MIT Center for Biomedical Innovation NEWDIGS project and was a member of the inaugural class of Scholars-in-Residence at the Duke-Margolis Center for Health Policy.

Dr. Pezalla received his BS and MD degrees with honors from Georgetown University and holds an MPH from the University of California at Berkeley. He was a Health Services Research Fellow and doctoral student at the University of Michigan Schools of Medicine and Public Health.

Oscar Puig

Chief Scientific Officer

Phosphorus

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Oscar Puig

Chief Scientific Officer

Oscar Puig is the Chief Scientific Officer at Phosphorus, a genetic diagnostic company founded in 2016 that develops diagnostics for complex genetic diseases and software for clinical data management and analysis. We currently commercialize three genetic panels (Reproductive Health, Cardiology, and Oncology). Prior to that, he was a Biomarker Leader in Oncology at the Roche Innovation Center in New York. He earned his Ph.D. at the University of Valencia, Spain, and carried out postdoctoral research at the European Molecular Biology Laboratory, in Heidelberg, Germany, and in the lab of Bob Tjian, at UC Berkeley, CA. Before joining Roche in 2012, he worked at Merck and at the University of Helsinki, where he is a docent. Dr Puig has over 40 publications in peer-reviewed journals.

Julie Ramage

National Accounts Director, Diagnostics, Oncology

Pfizer

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Julie Ramage

National Accounts Director, Diagnostics, Oncology

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.

Debra Rasmussen

Senior Director, Global Regulatory Affairs, Diagnostic Leader

Janssen Diagnostics

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Debra Rasmussen

Senior Director, Global Regulatory Affairs, Diagnostic Leader

Deb’s regulatory and quality career has spanned both large and small companies and both US and global programs. She has been in medical diagnostics for over 25 years and gained her experience working at Bio-Rad Laboratories, Roche Molecular Systems, Chiron Corporation, Applied Imaging Corporation, and Visible Genetics. She joined Johnson and Johnson in 2003. Deb is the Global Regulatory Affairs Diagnostics (GRA Dx) leader at Janssen Pharmaceuticals. GRA Dx is integral in the companion and complementary diagnostic product development programs. For Janssen, GRA Dx is responsible for development of regulatory strategy, policy, and registration of the in vitro diagnostic devices associated with Johnson and Johnson drug development and commercialization.

Aaron Schetter

Scientific Reviewer, Division of Molecular Genetics and Pathology

U.S. Food and Drug Administration

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Aaron Schetter

Scientific Reviewer, Division of Molecular Genetics and Pathology

Aaron Schetter, PhD MPH, is scientific reviewer in the Division of Molecular Genetics and Pathology/Office of in vitro Diagnostics/CDRH/FDA where he performs premarket review of molecular- and immunohistochemistry-based in vitro diagnostics for a variety of oncology indications. He earned his PhD in molecular biology and Genetics from Cornell University and MPH focusing on epidemiology and biostatistics from University of California at Berkeley. Prior joining the FDA in 2014, Aaron spent 10 years at the National Cancer Institute where he focused on molecular profiling of various tumor types to identify potential biomarkers and therapeutic targets. His research has led to (co)authorship for over 50 manuscripts in peer-reviewed journals and 9 US patents.

Agnes Seyda

Director, Precision Medicine and Companion Diagnostics

Celgene

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Agnes Seyda

Director, Precision Medicine and Companion Diagnostics

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

John A. Wagner, MD, PhD, FCP, FAAPS is currently Senior Vice President and Head of Clinical and Translational Sciences at Takeda Pharmaceuticals International Co.  He is also currently Immediate Past-President, the American Society for Clinical Pharmacology and Therapeutics (ASCPT).  Dr. Wagner has over 20 years of experience in pharmaceuticals, drug research and development, translational medicine, experimental medicine, clinical pharmacology, biomarkers and surrogate endpoints, modeling and simulation, precompetitive collaboration, project leadership and management, portfolio management and prioritization, and scientific strategy.  Dr. Wagner received his M.D. from Stanford University School of Medicine and Ph.D. from the Johns Hopkins University School of Medicine. Postgraduate training included Internal Medicine Internship and Residency, as well as Molecular and Clinical Pharmacology Postdoctoral Fellowships at Stanford. He began his professional career in academic research on Cystic Fibrosis and has continued in the pharmaceutical industry, largely in the context of drug development as well as biomarkers. Previously, Dr. Wagner’s professional positions included Senior Consultant to the Institute of Medicine, Vice President and Head, Early Development Pipeline and Projects and Head, Global Project Management at Merck & Co., Inc., Vice President and Head, Clinical Pharmacology, at Merck & Co., Inc and Acting Modeling and Simulation Integrator, Strategically Integrated Modeling and Simulation at Merck & Co., Inc.  He is the past chair of the PhRMA Clinical Pharmacology Technical Group, past chair of the adiponectin work group for the Biomarkers Consortium, past committee member of the National Academies Institute of Medicine Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, and past member of the National Academies Institute of Medicine National Cancer Policy Forum.  Over 200 peer-reviewed publications detail work across a variety of therapeutic areas and disciplines.

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.

James Wang

Business Development Executive

ACD Bio

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James Wang

Business Development Executive

TBA

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