Andrew Aijan, Principal, DeciBio Consulting
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 Sciences
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).
Steve Anderson, Chief Scientific Officer and Senior Vice President, Covance
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.
Andrew Barry, Product Marketing Manager for Target Enrichment, New England Biolabs
Andrew Barry is the Product Marketing Manager for Target Enrichment at New England Biolabs. Prior to joining NEB, Andrew spent the first 10 years of his career at the Broad Institute of MIT and Harvard where he developed high-throughput processes for genomic applications. Following his time at the Broad, he joined Caliper Life Sciences (later acquired by PerkinElmer), where he held various positions in product management, strategic marketing, and R&D. Andrew joined New England Biolabs in 2016.
Andy Beck, Co-founder and CEO, PathAI
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
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.
Carrie Brodmerkel, Head, Immunology Biomarkers, Janssen Pharmaceutical Companies,
Carrie currently leads Immunology Biomarkers with responsibility for strategic and operational implementation of biomarker efforts for the Immunology Therapeutic Area of Janssen R&D. The team is responsible end to end for biomarkers in support of assets in development for disease interception, early disease intervention and treatment of established disease in the areas of autoimmunity and inflammation including lupus and inflammatory bowel disease. This includes efforts in early development for pharmacodynamics assays and developing alternative endpoints for improved decision making in early phase trials. In addition, the team is responsible for patient stratification and response prediction efforts. Carrie has been with Janssen R&D since 2005 with a focus on biomarkers and in her early career worked in pre-clinical drug discovery utilizing in vivo pharmacological modeling of immune diseases in her roles at Dupont Pharmaceuticals and Incyte Corporation.
Jerry Catanese, Discovery Business Manager, Roche Diagnostics Corporation, Custom Biotech
Jerry Catanese is a Discovery Business Manager with Roche Custom Biotech, based out of Indianapolis and is regionally located in Central Eastern Pennsylvania. In his current role he supports Pharma and Biotech research scientists with optimized antibodies, reagents and automated tissue staining platforms for IHC and ISH/FISH for Target Discovery and Drug Safety projects. While at Roche, Jerry was deployed as a Senior Project Manager with extensive experience in Lean Six Sigma Methodology, including Procurement/Supply Chain/Contract Management, Business Process Improvement and Cross-functional Team Leadership to ensure developmental, organizational goals and objectives. Experience includes manufacturing for customer driven design goals (CDDG), workflow process mapping, Lean design, capital placement and healthcare /research projects including ROI analysis. Prior to joining Roche, Jerry was a Worldwide Development and Sr. Product Manager for medical devices with J&J and Abbott. Jerry received his Bachelor’s degree from Long Island University.
Jennifer Dacpano-Komansky, Director, Regulatory Affairs & Precision Medicine, Novartis
Jennifer Dacpano–Komansky 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, Senior Vice President, Translational Science, Personal Genome Diagnostics
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
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
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.
Mark Girardi, Vice President, Boston Healthcare Associates
Mark Girardi has over 30 years of experience in life sciences, in vitro diagnostics, and medical devices commercialization and reimbursement. He has had roles in product management, sales and marketing, and most recently in strategy consulting. Mr. Girardi joins Boston Healthcare from GfK Health, a global consultancy and market research firm, where he was Senior Vice President responsible for the MedTech consulting practice. Prior to joining GfK, Mr. Girardi spent five years at Predictive Biosciences as VP of Sales and Marketing. He also served as Senior Director of Marketing at Z-Tech Medical where he was responsible for commercialization of the company’s breast cancer screening devices. As a Director of Marketing at Cytyc Corporation (now Hologic), he managed the worldwide launch of the Thin Prep Imaging System. Mark has also held senior marketing positions at Genzyme Genetics and Millipore. Mr. Girardi received his BS in Chemistry from Merrimack College and an MS in Analytical Chemistry from the University of New Hampshire.
Alberto Gutierrez, Former Director, FDA Office of In Vitro Diagnostic Device Evaluation and Safety, Consultant
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.
Sarah Hersey, Head of Precision Medicine and Companion Diagnostics, Celgene
Sarah is currently the Head of Precision Medicine and Companion Diagnostics for Celgene Corporation. She has more than 20 years’ of industry experience in leading R&D organizations, CLIA laboratories, device manufacturing, assessment and implementation of technology strategies and development of in vitro diagnostics. Prior to joining Celgene, Sarah was at Novartis, initially as an Executive Director, Global Program Diagnostics and subsequently moved into the role of Global Head of Future Precision Medicine, leading a team which submitted multiple pre-market applications including one for NGS. Prior to Novartis, Sarah held multiple roles with increasing responsibility within Johnson and Johnson including Global Head of Operations, Assay Program Leader for Companion Diagnostics Center of Excellence, Director of Materials Process Development and Enabling Technologies. In addition, her prior experience includes start-up and establishment of a pre-clinical GLP laboratory, technical support and quality assurance. Sarah has BS and MS degrees in Chemistry and Biology from Northern Illinois University, Regulatory Affairs Certification (RAC) and MBA from California State University.
Laurie Howard, Vice President, Policy and Payer Relations, LabCorp
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.
Kamala Maddali, Vice President, Biopharma Collaborations, Market Development and Companion Diagnostics, Cancer Genetics
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
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.
Charles Mathews, Principal, ClearView Healthcare Partners
Charles leads ClearView’s diagnostics industry initiatives. This includes work with in vitro diagnostic platform and kit developers, laboratories, and pharma players launching products with companion diagnostics. His expertise is in advising both venture backed and more established clients on commercialization and market access strategies. Over the past 13+ years he has been involved in the launch of over 100+ different test products in the cancer, diabetes, cardiovascular disease, and infectious disease spaces. These tests range from simple point of care technologies to esoteric molecular and next generation sequencing approaches. He has unique knowledge about reimbursement pathways for diagnostic testing including pursuit of novel coding as well as seeking value-based pricing and securing market access for drug diagnostic combinations. For example, he lead a project for AMP that was focused on assessing the cost and value of various next generation sequencing applications. Charles’ prior experience includes several years of working on health policy issues as a legislative aide on Capitol Hill. He also worked for the government affairs office of Genentech and has worked on a National Institutes of Health sponsored clinical trial focused on genetic testing for Alzheimer’s disease. He completed his undergraduate work at Colgate University and received a Masters Degree in Public Policy at Duke University.
Mike Montalto, Executive Director and Head of Translational Pathology, Clinical Biomarker Laboratories, Translational Medicine, Bristol-Myers Squibb
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.
Oscar Puig, Chief Scientific Officer, Phosphorus
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
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,
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
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
Agnes Seyda is currently a Director of Precision Medicine and Companion Diagnostics at Celgene Corporation. She has more than 15 years of industry experience in medical devices and diagnostics development. Prior to joining Celgene, Agnes was at Bristol-Myers Squibb. She held multiple roles with increasing responsibility within Johnson and Johnson including Director of Operations which included the oversight of Janssen Diagnostics CLIA laboratory. Her prior experience also includes various R&D roles at Ethicon and DePuy (both Johnson & Johnson Companies). Agnes has B.Sc. degree in Biochemistry from McMaster University, Hamilton, Ontario, Canada and a Ph.D. degree in Biochemistry from University of Toronto, Canada.
Gary Spitzer, Consultant, Strategic Medical Testing Services
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
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
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
James Wang received his Bachelor Degree in Science from Eckerd College and his Masters’ degree in Molecular Biology from University of Massachusetts. James spent many years doing Gene Therapy research using AAV at University of Florida in Dr. Terence Flott’s lab. After receiving his MBA from the University of Florida in 2002, James worked for many life sciences companies, such as Guava Technology, Affymetrix, Millipore, etc. to promote new technology to life sciences researchers. In 2013, he joined ACD as it launched the next generation RNA ISH technology (RNAscope). James has worked with many major pharma and biotechnology companies on east coast to promote RNAscope as RNA based biomarker discovery and diagnostics.
Xiaolei Xu, Director of Global Regulatory Affairs, Agilent
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
Adriane Zernhelt, Translational Biomarkers Operation, Merck & Co.
After graduating Bloomsburg University and Sacred Heart School of Medical Technology, Adriane spent many years as a staff medical technologist at Lehigh Valley Hospital. She then became the Clinical Research Coordinator for the Department of Pediatrics where she worked on several haematological and solid tumor protocols for COG (Children’s Oncology Group). Adriane joined Merck in 2007 as an Associate Clinical Research Specialist in clinical oncology where she worked on several Phase I to III studies. She joined the Translational Molecular Biomarkers group in 2015 and currently works with clinical oncology, various CRO vendors, and companion diagnostic partners to operationalize biomarkers in Phase II to III clinical studies.
Andrew Aijan, Principal, DeciBio Consulting