October 17 – 19 2017 | Boston, MA

Hilton Boston/Woburn

Speakers

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Drug Developers

Sunita Badola
Director, Functional Genomics
Takeda

Sunita holds the role of Director of Functional Genomics at Takeda. She has previously held positions at Amgen, Milennium and Scriptgen Pharmaceuticals. She gained her BSc in Chemistry from HNBG University in 1991 before completing her MSc in Biotechnology from the Indian Institute of Technology in 1993.

Carl Barrett
Vice President, Translational Sciences, Oncology
Astrazeneca

Dr. J. Carl Barrett is vice-president of translational science in the Oncology Innovative Medicines Division at AstraZeneca Pharmaceuticals. His responsibility is to develop and execute biomarker strategy and translational sciences efforts to support compound development from research through early and full development in oncology. Dr. Barrett’s longstanding research interests focus on the discovery of the critical genetic and epigenetic changes in the cancer cell, in particular the discovery of genes involved in breast cancer (BRCA1) and in the processes of cellular senescence and cancer metastasis. He has made significant contributions to the identification of molecular defects in cancers and the role of the biosystem in the carcinogenesis process.

Christina Bender
Director, Global Oncology, Diagnostic Pipeline Strategy
Novartis

Christina Bender is responsible for early commercial CDx strategy as part of Novartis Oncology’s global new products team. Following her postdoctoral studies in Molecular Biology (Cancer Mutagenesis) at London’s Imperial Cancer Research Fund in 1999, Christina began her professional career in the Biotechnology industry as a Genomics Sales Specialist for Molecular Devices Ltd, responsible for Region Europe. She returned to the US in 2001 to join Gyros US Inc. as a Key Account Manager, focusing on micro-fluidic technologies serving the Life Sciences and Diagnostics sectors. In 2005 she changed careers, joining the Pharma industry in a commercial marketing capacity at Novartis Pharmaceuticals. Christina has enjoyed a variety of marketing and business analysis roles at Novartis, including support of the Neuroscience franchise in the US General Medicines organization, and numerous product franchises across Global Oncology. She also lead Novartis’ BCR-ABL diagnostics commercialization efforts in support of the Tasigna-Glivec CML (chronic myelogenous leukemia) franchise. Christina received a B.S. in Biological Science from UCLA (university of California, Los Angeles), a Ph.D. in Biochemistry at USC (University of Southern California), and an MBA in Pharmaceutical Marketing from the Rutgers Business School.

Jason Christiansen
Vice President, Diagnostics
Ignyta

Rodolphe Clerval
Chief Business Officer & Vice President, US Operations
Enterome Bioscience

Before joining Enterome, Rodolphe Clerval was VP Corporate and Business Development of TcLand Expression, a molecular diagnostic company. During his tenure with TcLand Expression, he led strategic planning activities and closed several collaborations and licensing deals. Previously he was Business Development Manager at Genzyme. Prior to this he was financial analyst for the brokerage firm Natixis Bleichroeder. Earlier in his career, Rodolphe served as Research Scientist at Aventis Animal Nutrition

Benoit Destenaves
Director, Diagnostics Lead
AstraZeneca

Emmanuelle di Tomaso
Vice President & Head of Translational Medicine
Syros Pharmaceuticals

Dr. di Tomaso obtained her Ph.D. in Clinical Chemistry at the Institute of Child Health, University College, London, UK. She first focused her career in academia spending 11 years at the Massachusetts General Hospital studying angiogenesis and vascular biology in the context of several cancers. This included the first successful implementation of anti-angiogenic therapy to restore hearing in patients with NF2 acoustic neuroma. She then spent 7 years at Novartis where she led the precision medicine strategy for multiple clinical programs in late development with a focus on the breast cancer portfolio (including PI3K and CDK4/6 inhibitors). She is currently Head of Translation Medicine at Syros Pharmaceuticals where she established and developed the Translational Medicine function to leverage precision medicine for two drug target candidates discovered by the Syros gene control discovery platform.

Dan Dransfield
Senior Vice President Research & Development
Siamab Therapeutics

Dr. Daniel Dransfield joined Siamab Therapeutics in October 2016. Dan has more than 20 years of drug development and research experience. Prior to Siamab, he served as the Vice President and Head of Translational Medicine at Tokai Pharmaceuticals, Inc., the Vice President of Discovery Research and Translational Medicine at ArQule, Inc., and the Vice President of Cell Biology and Translational Research at Dyax Corporation. Dan received his PhD from Tufts University

Jakob Dupont
Vice President & Global Head, Breast & Gynecologic Cancer Development
Genentech

Jakob Dupont is the Vice President and Global Head of Breast and Gynecologic Cancer Development in Product Development Oncology (PDO).  Jakob is also Adjunct Clinical Faculty in Medical Oncology at Stanford University.  Jakob is the Development Review Committee (DRC) Chair for Herceptin, Perjeta, Kadcyla, Taselisib and Tecentriq for Breast and GYN indications and he co-chairs the Breast Cancer Disease Area Strategy Team (BDAT).  Jakob is also a member of the Oncology Leadership Team (OLT).  Jakob has almost 20 years of Academic, Biotech and Pharma Oncology Drug development experience.  Jakob returned to Genentech / Roche in January 2017 to this role..   Prior to returning to Genentech, Jakob spent five and a half years as Chief Medical Officer and Senior Vice President of OncoMed Pharmaceuticals Inc. in Redwood City, Ca.  OncoMed is a biotechnology company discovering and developing first-in-class anti-Cancer Stem Cell and Immune-Oncology therapeutics.  Currently, OncoMed has eight novel drug candidates in the clinic targeting the Notch, WNT R-spondin pathways and cancer immunotherapy like anti-TIGIT.  Over the course of 5+ years at OncoMed Jakob oversaw the successful submissions of eight INDs, 26 oncology clinical trial initiations and conduct. OncoMed has major partnerships to develop novel cancer therapeutics with Celegene, GSK and Bayer.   From September 2006 to October 2011, Jakob served in various capacities at Genentech and Roche, including Global Medical Director, Avastin® based in Basel, Switzerland; Group and Associate Group Director and Global Clinical Leader for Avastin Breast and GYN Cancers in South San Francisco; Associate Group Director and Medical Director overseeing the angiogenesis pipeline in the gRED organization. During his time at Genentech / Roche Jakob was instrumental in the development and approval of Avastin® in ovarian, cervical and breast cancers as well as three IND filings of novel anti-angiogenic agents.   Prior to joining Genentech in 2006, Dr. Dupont was a faculty member and laboratory researcher at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City. At MSKCC he oversaw a Phase 1 solid tumor and GYN oncology clinic and a tumor immunology laboratory. Dr. Dupont has received numerous grants and awards, including a Damon Runyon Clinical Investigator Award, ASCO Merit, Young Investigator, and Career Development Awards and been an author on more than forty peer-review publications and over 10 patents.   Dr. Dupont received an A.B. in Philosophy from Vassar College, an M.A. in Philosophy from New York University, studied pre-medical science at Columbia University and received an M.D. degree from the Joan & Sanford I. Weill Medical College of Cornell University.  He also served as Assistant Chief Resident at Memorial Sloan Kettering.  Dr. Dupont completed his Medical Oncology Fellowship at Memorial Sloan Kettering Cancer Center; his Internal Medicine Residency at the New-York Presbyterian Hospital—Cornell Campus; and his Internal Medicine Internship at The University of Michigan Medical Center in Ann Arbor, Michigan.  

Day One

Wednesday, October 18, 2017

08.30 | The Pharmaceutical Perspective on the Advancement of Precision Medicine

Kenneth Emancipator
Executive Medical Director & Head of Companion Diagnostics
Merck

Dr. Emancipator led the Merck team which partnered with Agilent Technologies to develop the 22C3 PD-L1 immunohistochemistry test which identifies those non-small cell lung cancer patients most likely to benefit from Keytruda® (pembrolizumab), which is the first FDA-approved companion diagnostic in cancer immunotherapy, and which enabled Keytruda to become the first immunotherapy to be approved for first-line treatment of lung cancer. He was one of six members of the Keytruda Team to receive the 2015 PhRMA Research and Hope Award for Biopharmaceutical Industry Research on behalf of Merck. His has held positions at National Institutes of Health, Cornell University Medical College, Beth Israel Medical Center (NY), and Bayer Healthcare. He is a former officer of the American Society for Clinical Pathology, and is a regular reviewer for the American Journal of Clinical Pathology. His credits include more than 100 papers and abstracts, and more than 100 extramural presentations.

Day One

Wednesday, October 18, 2017

08.00 | The First Biomarker-Defined Tumor Indication: FDA Approval of Pembrolizumab For MSI-High Cancer

Jeffrey Emch
Biomarker & Companion Diagnostic Lead
Merck

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.

Sarah Hersey
Companion Diagnostics & Precision Medicine Head
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.

Day Two

Thursday, October 19, 2017

08.15 | Collaborations and Technologies to Deliver Precision Medicine

Peter Hoehn
Co Diagnostics Commercial Strategy Leader
Janssen Pharmaceuticals

Peter Hoehn, J.D. is responsible for setting overall business objectives and strategic priorities for diagnostic solutions for Neuroscience, Immunology and Cardiovascular & Metabolism, and for leading development and implementation of identified companion and complementary diagnostics opportunities that support the short- and long-term growth objectives of these three therapeutic areas. In this role, Peter also has responsibility for developing health economic, reimbursement and pricing strategies across the Janssen Diagnostics portfolio. Peter obtained a B.A. in Government and Economics from the College of William and Mary in Williamsburg, Virginia, and a J.D. from New York University in New York City. Peter started his career as a corporate lawyer and entered the pharmaceutical industry as an attorney for Bristol-Myers Squibb. He then moved in to various strategy, marketing and sales management roles, primarily in the oncology and cardiovascular areas. Peter joined Johnson & Johnson in 2003 in the Pharmaceuticals Group Strategic Marketing organization as a Global Commercial Leader, and in 2005 was promoted to Global Marketing Leader – Neurology, where he had global commercial responsibility for in-line neurology products as well as products in late-stage development. In 2008 Peter joined the Ortho Clinical Diagnostics (OCD) organization as Global Marketing Leader and was promoted to Vice President for Worldwide Marketing and Strategic Marketing in 2010. In this role, Peter and his team set overall marketing strategies and plans for the worldwide clinical laboratory diagnostics business, defined and managed the pipeline of new products, and identified and assessed new growth opportunities. Peter was also an original team member of the Janssen Companion Diagnostics Center of Excellence while at OCD.

Michael Kiebish
Chief Precision Medicine Officer
BERG

Michael Kiebish, PhD is the Chief Precision Medicine Officer at BERG.  Michael joined BERG in 2012 and has overseen numerous technical and translational roles during his tenure. Dr. Kiebish and his team have pioneered novel systems medicine strategies for biomarker, pharmaceutical and theranostic development to ensure target populations’ are stratified based on biological and physiological status. Through the implementation of artificial intelligence platforms, BIG Data integration, population health strategies, and integrative phenomic technologies, the precision medicine division overseen by Dr. Kiebish synergizes BERG’s efforts in improving patient care, stratifying populations, and guiding molecular adaptive clinical trials.

David Kaufman
Executive Director, Translational Immuno-Oncology
Merck

David Kaufman is an Executive Director of Clinical Oncology at Merck Research Laboratories, where he serves as the translational research lead for Merck’s immuno-oncology programs.  He has had multiple roles in the pembrolizumab program, including oversight of early-stage through registrational clinical studies.   He joined Merck through the Merck Drug Development and Leadership Program, and has worked across multiple divisions including Vaccines, Biologics, Clinical Pharmacology and Clinical Oncology.  He received his M.D. from Cornell University and his Ph.D. in immunology/molecular virology from The Rockefeller University.  He trained in Internal Medicine at the University of California, San Francisco, and in Infectious Diseases at Massachusetts General Hospital and Brigham and Women’s Hospital.   Prior to joining Merck, he was a staff physician at Beth Israel Deaconess Medical Center and an Instructor in Medicine at Harvard Medical School, where his research focused on preclinical HIV vaccine development and mechanisms of vaccine-elicited mucosal immunity.

Catherine Lofton-Day
Medical Sciences Director
Amgen

Jennifer Mataraza
Senior Investigator & Group Leader, Translational
& Exploratory Immuno-Oncology, NIBR

Jennifer Mataraza, PhD, is currently a Group Leader in Oncology Translational Research at the Novartis Institutes for Biomedical Research (NIBR), supporting the biomarker strategy across the Immuno-Oncology portfolio.   Dr. Mataraza began her tenure at NIBR in the Exploratory Immuno- Oncology Group, where she is led several biologics programs from lead selection to Proof-of-Concept.  Prior to Novartis, she held positions of increasing responsibility at CoStim Pharmaceuticals, Merck Research Laboratories, Schering Plough Research Institute and Organon Biosciences. Dr. Mataraza has drug discovery experience with targeted therapies and biologics ranging from early target discovery to IND filing in both autoimmune/inflammatory disease and oncology. Her areas of research interest and expertise include immunology, oncology, cell biology, cell cycle and signal transduction.

Eric Meadows
Research Advisor, Global Patient Outcomes & Real World Evidence,
Alzheimer's Diagnostics, Eli Lilly

Dr. Meadows is studying improved methods of diagnosing disease and monitoring treatment response within Alzheimer’s, diabetes, and other conditions. His responsibilities include leveraging technological advances to collect patient-generated physiological, behavioral, functional, and other health measures. Eric has experience with a variety of real world data sources in multiple disease states.  He is passionate about helping patients obtain accurate diagnoses and affordable, effective treatments for their condition. Eric previously served as Senior Director of Scientific Development at MedMining, a Geisinger Health System business. He led the development of real world data projects in collaboration with external sponsors. Eric received a BS in chemistry from West Virginia Wesleyan College. He went on to receive a PhD in Biomedical Sciences from Washington University School of Medicine in St. Louis, followed by a postdoctoral fellowship at Stanford University. His education and research experience span a broad range of topics from the molecular to the health system level. Outside of work, Eric and his wife stay very busy raising five boys.

Dmitri Mikhailov
Head, Biomarker Coordination
Novartis

Dmitri Mikhailov is the Global Head of Biomarker Study Coordination, Translational Medicine at Novartis. Dmitri’s team is responsible for clinical biomarker study setup across multiple therapeutic areas, and for developing new processes and technologies to improve clinical study conduct. As part of his role, Dmitri represents Novartis at the industry Pharmacogenomics Working Group, pharma industry consortium developing best practices for pharmacogenomics research. Dmitri is also the global lead for Novartis Human Tissue Network, the company wide effort to develop risk-based strategy and efficient processes to enable translational research using human samples. Dmitri joined Novartis in 2003 and had several positions of increasing responsibility in early biology, lead discovery, safety pharmacology and drug repositioning. Dmitri Mikhailov holds Ph.D. in Biology and M.S. in Physics & Applied Math.

Matthew Onsum
Director & Head of Bioinformatics
Seattle Genetics

Matt holds the role of Director and Head of Bioinformatics at Seattle Genetics. He has previously held positions at Silver Creek Pharmaceuticals, Merrimack Pharmaceuticals and Astrazeneca. He gained his PhD in Mechanical Engineering from the University of California, Berkeley in 2005.

Jonathan Pan
Vice President & Head of Biomarker Strategy & Development
Aevi Genomic Medicine

Jonathan is currently VP, Head of Biomarker Strategy and Development at Aevi Genomic Medicine, a biotechnology firm focused in translating genetic discoveries into novel therapies to improve the lives of children and adults with pediatric onset life altering diseases. At Aevi, he is focused on bringing precision medicine and companion diagnostic testing to diseases outside of oncology, such as ADHD and IBD. Prior to Aevi, Jonathan led competitive strategy for the I-O franchise at BMS and was the Head of Oncology Companion Diagnostics and Disease Strategy at GSK, launching companion diagnostic testing globally. He was a former management consultant at Deloitte, IMS Consulting and Scientia Advisors. He has a PhD and MBA from the University of Michigan.

Charles Paulding
Director, Pharmacogenomics
Regeneron Pharmaceuticals

Charles Paulding received his BA in biology from Tufts University and his Ph.D. in genetics from Harvard University while working in the laboratory of Dr. Daniel Haber at the Massachusetts General Hospital. Charles joined Regeneron in 2013 and is currently leading the pharmacogenomic studies at Regeneron. His responsibilities include developing and implementing pharmacogenomic strategies for a wide range of clinical development programs at Regeneron. Prior to joining Regeneron, Charles worked at Millennium Pharmaceuticals in the translational medicine group, and also at Novartis as head of the pharmacogenetic analysis group. While at Novartis Charles led a range of pharmacogenetic projects across a number of therapeutic areas.

Debra Rasmussen
Diagnostics Leader & Senior Director, Global Regulatory Affairs
Janssen Pharmaceuticals

Day One

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

Victoria Rimkunas
Senior Scientific Investigator
H3 Biomedicine

Dr. Vicki Rimkunas joined H3 Biomedicine in 2016 as a Sr. Investigator in the Biomarker and Companion Diagnostics Group.  She is responsible for developing and executing the biomarker and CDx strategies for two clinical stage programs currently in phase I/II clinical development in solid tumors.  Prior to joining H3 Biomedicine, Vicki served as the Head of the Integrated Diagnostics Lab at Merrimack Pharmaceuticals and was responsible for preclinical and clinical assay development across the Merrimack therapeutic portfolio focusing on developing novel, fit for purpose tissue diagnostics, multiplex assay development and digital pathology.  Prior to joining Merrimack, Vicki was a Senior Scientist at Cell Signaling Technology where she developed clinical assays utilizing rabbit monoclonal antibodies focused in oncology with most notably, the ALK D5F3 rabbit monoclonal antibody currently being used to identify ALK positive NSCLC patients as a class III IVD.  She earned a Ph.D. from Tufts University, Sackler School of Biomedical Research and a B.S. in Biological Sciences from Cornell University.

Hakan Sakul
Vice President & Head of Diagnostics,
Pfizer

Hakan Sakul is an Executive Director at Pfizer and leads Pfizer’s Companion Diagnostics efforts across the Worldwide R&D organization. Hakan worked Pfizer’s Executive Leadership Team to define and implement Pfizer’s current companion diagnostics strategy. Hakan served on the clinical development and drug/diagnostics submission teams and led the companion diagnostics program to a successful delivery. Hakan received his Ph.D. in Quantitative Genetics from University of Minnesota-Twin Cities.

Jason Simon
Scientific Director, Oncology Diagnostics
Janssen R&D

Dr. Jason S Simon is Scientific Director, Oncology Diagnostics at Janssen R&D, LLC, Pharmaceutical companies of Johnson & Johnson. In this role, he is responsible for leading cross functional teams to develop companion and complementary diagnostics in support of the oncology development portfolio. Prior to joining Janssen, he led teams performing genetic, pharmacogenomic and translational research at Genome Therapeutics, Schering-Plough (where he led a team that identified IL-28b as a critical factor in HCV patient response to interferon therapy), as well as Eisai and Bristol-Myers Squibb (including work on nivolumab). Dr. Simon obtained his BA at Emory University in Atlanta GA, and his Ph.D. in Pharmacology at the University of Iowa and completed a post-doctoral fellowships at the Massachusetts General Hospital/Harvard Medical School

Day Two

Thursday, October 19, 2017

08.45 | Key Trends in CDx Development for Precision Medicine Success

Daniel Stetson
Associate Principal Scientist
AstraZeneca

Daniel Stetson is an Associate Principal Scientist in Translational Science in the Oncology Innovative Medicines Division at AstraZeneca Pharmaceuticals. He manages the internal next generation sequencing lab, which works to support preclinical research through to full development in oncology. He has been working on novel methods for sequencing nucleic acids from liquid biopsies

Zhen Su
Vice President & Head of Global Medical Affairs Oncology
EMD Serono

Dr. Zhen Su, Vice President and Head of Global Medical Affairs - Oncology at EMD Serono leads medical strategy and the team for the franchise. A physician executive with more than 15 years of experience, Dr. Su has strong clinical expertise in oncology, immuno-oncology and urology. He has held positions in academic and pharmaceutical medicine, including general management, clinical development, medical affairs and business development. Prior to EMD Serono, Dr. Su served as Associate Vice President and Global Head of Jevtana® (cabazitaxel) at Sanofi. Prior to joining industry, Dr. Su held several academic positions, including Assistant Professor of Surgery at Duke University, where he also received his fellowship in oncology. He has deep ties to the oncology community, having worked with leading oncologists at organizations across the country. Dr. Su earned his MD degree from the Technical University of Dresden, Germany and completed his MBA training at the University of Toronto, Canada.

Martin Tolar
Founder, President & Chief Executive Officer
Alzheon

Prior to founding Alzheon, Dr. Tolar has held executive positions in life sciences companies, where he has successfully established and grown new companies, business areas and product opportunities. Dr. Tolar served as President & CEO of Knome, Inc., where he pioneered human genome interpretation systems and services for academic, pharmaceutical and clinical clients, as President & CEO at NormOxys, Inc., where he built and financed the business for novel cancer therapeutics, and as Chief Scientific Officer and Chief Business Officer at CoMentis, Inc., where he built the first clinical beta secretase inhibitor platform, and negotiated a landmark deal for the program for $1.1 billion with Astellas Pharma in 2008. Dr. Tolar held a variety of clinical development and business leadership positions at Pfizer, was instrumental in a wide range of business transactions, including acquisition of Rinat Neuroscience for $500 million in 2006, and directed programs through all stages of clinical development and FDA approvals including NDA filings.

During his academic career, Dr. Tolar served as an Assistant Professor in the Department of Neurology at Yale University School of Medicine from 1992 to 1997, where he focused on movement disorders. Dr. Tolar trained in Neurology at the Boston Medical Center, received a Ph.D. in Neuroscience for his work on the role of apolipoprotein E in Alzheimer’s disease, and published many scientific publications in the area of neuroscience and neurodegenerative disorders. Dr. Tolar received his M.D. from Charles University in Prague, where as a medical student he helped organize and lead the Velvet Revolution that toppled the communist regime in the former Czechoslovakia in November 1989.

Dr. Tolar serves on business and scientific boards including the Alzheimer’s Drug Discovery Foundation, the Alzheimer Foundation and Advance Healthcare Management Institute.

Dr. Tolar was recognized by The Medicine Maker Magazine’s Power List 2016 and 2017 as one of the Top 100 Most Influential People in the world of drug development and manufacture.

Sudha Visvanathan
Immunology & Respiratory Team Lead, Translational Medicine
& Biomarker Experts Group, Boehringer Ingelheim

Sudha is currently the Team lead for Immunology and Respiratory in the Translational Medicine and Biomarker Expert group at Boehringer-Ingelheim.  She joined BI in 2012 as a Principal Translational Medicine expert and has supported the risankizumab, BI655064 (CD40) and multiple other programs in the early Immunology portfolio in addition to Respiratory programs.  Sudha has a PhD in Immunology and has spent the last 10 plus years working in the autoimmune disease area with a focus on developing translational and biomarker approaches in early and late phase clinical studies. Prior to coming to Boehringer-Ingelheim, Sudha lead a Biomarker Expert team in a Translational Medicine group at Hoffman La Roche and prior to this she was in a similar position at Centocor/Janssen.  Sudha has developed biomarker strategies, implemented assays and interpreted data on multiple clinical trials with remicade, simponi , stelara  and sirukinumab in rheumatology  and CNS indications and several of these studies have been published. She has also worked on the risankizumab Ph II studies in psoriasis and crohn’s disease with select clinical and biomarker results recently published. Sudha has also been responsible for developing and implementing several translational/ disease characterization studies in RA, PsA, IBD, SLE, asthma and COPD in collaboration with key opinion leaders.

Roman Yelensky
Executive Vice President & Chief Technology Officer
Gritstone Oncology

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

Jeff Allen
President & CEO
Friends of Cancer Research

Jeff Allen is President and CEO of Friends of Cancer Research (Friends). Friends is an advocacy organization based in Washington, DC that drives collaboration among partners from every healthcare sector to power advances in science, policy, and regulation that speed life-saving treatments to patients. During the past 20 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. For over 10 years, Jeff has been a driving force in the growth and success of the organization. Under his leadership, Friends has evolved into a nimble, forward-thinking policy, public affairs, and research organization. As President and CEO, he leads the strategic development and implementation of Friends’ scientific, policy, research, and legislative initiatives, as well as overseeing Board governance and organizational operations. As a thought leader on many issues related to the Food and Drug Administration, regulatory strategy, and healthcare policy, he is regularly published in prestigious medical journals and policy publications. In addition to participating in major scientific and policy symposiums around the country each year, Jeff has had the honor to be called to testify before Congress on multiple occasions and regularly contributes his expertise to the legislative process. Recent Friends initiatives include the establishment of the Breakthrough Therapies designation and the development of the Lung Cancer Master Protocol (Lung-MAP), a unique partnership that will accelerate and optimize clinical trial conduct for new drugs. Jeff has the privilege to also serve on a variety of influential committees, boards, and advisory councils including the Alliance for a Stronger FDA (Board Member, Past President), the Medical Evidence Development Consortium (MED-C; Board Chair), Lung-MAP Senior Leadership Team Member, and a participant on working groups convened by the National Academies of Medicine and President’s Council of Advisors on Science and Technology (PCAST). Prior to joining Friends, Jeff was an endocrinology researcher at the National Institutes of Health. His background in cancer research focused upon molecular changes associated with cancer formation as well as treatments to prevent cancer progression. Jeff received his Ph.D. in cell and molecular biology from Georgetown University, and holds a Bachelor’s of Science in Biology from Bowling Green State University.

Day One

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

Adam Berger
Senior Staff Fellow, Personalized Medicine
FDA

Day One

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

Chandra Branham
Vice President, Payment and Health Care Delivery Policy
AdvaMed

Chandra Branham, J.D., joined the Advanced Medical Technology Association (AdvaMed) as Vice President, Payment and Health Care Delivery Policy, in 2011. Ms. Branham leads AdvaMed’s policy work in a number of areas, including diagnostics payment, coverage issues, and comparative effectiveness. Prior to joining AdvaMed, Ms. Branham was an associate at large D.C. law firm where she focused on healthcare regulatory and legislative issues involving Medicare coverage, coding, reimbursement and quality for providers and suppliers of Medicare items and services. Ms. Branham previously was a senior legislative analyst at the Centers for Medicare & Medicaid Services (CMS) Office of Legislation; and early in her career, served as associate director of regulatory affairs at the National Association for Home Care. Ms. Branham has a Bachelor of Science from Drexel University and a J.D. from the George Mason University School of Law.

Khatereh Calleja
Senior Vice President, Technology & Regulatory Affairs
AdvaMedDx

Khatereh Calleja is Senior Vice President of Technology and Regulatory Affairs for AdvaMed, the Advanced Medical Technology Association (AdvaMed). AdvaMed is the world’s largest association representing manufacturers of medical devices, diagnostic products, and medical information systems. Ms. Calleja works closely with AdvaMedDx, a Division of AdvaMed, which is the only multi-faceted, policy organization that deals exclusively with issues facing diagnostic innovators in the United States and abroad. In her role, she works on a variety of device regulatory issues and also leads the Association’s diagnostics working groups, including the Diagnostics Task Force, Personalized Medicine and Molecular Diagnostics Working Group, and Diagnostics Standards Subteam. Calleja joined AdvaMed’s Technology and Regulatory Affairs Department in December 2007, as the FDA was embarked on implementing the provisions of the Medical Device User Fee Act II (MDUFMA II) legislation to support innovation and improve the device regulatory review process. Since that time, she has also played an instrumental role in assuring appropriate implementation of key device provisions in the Food and Drug Administration Safety and Innovation Act (MDUFA III) and developing initiatives to promote the public health and support timely and high quality technology. Ms. Calleja has extensive policy, legal, technical and scientific background in healthcare, device, and diagnostic issues. Calleja previously served as federal affairs manager and established a Washington office for the American Society of Plastic Surgeons. Prior to that, she directed legislative and regulatory affairs outreach activities at the American Academy of Otolaryngology—Head and Neck Surgery, in Alexandria, VA. She has also provided strategic consulting for the pharmaceutical industry, health care professional groups, and Fortune 500 companies. Calleja is a graduate of Emory University and Villanova University School of Law.

Day One

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

Daniel Catenacci
Associate Director, Gastrointestinal Oncology Program
The University of Chicago Medical Center

As an adult medical oncologist, Daniel Catenacci, MD, specializes in the treatment of gastrointestinal malignancies. He provides skilled care for a range of conditions, including esophageal, gastric, pancreatobiliary, liver (hepatocellular carcinoma), colorectal, appendiceal, neuroendocrine (carcinoid), and anal cancers. Dr. Catenacci works with a multi-disciplinary team of surgical oncologists, radiation oncologists, and medical oncologists to provide the most optimal care possible for cancer patients. An active basic and clinical researcher, Dr. Catenacci is involved in bench-to-bedside translational research. He conducts basic investigations on normal and cancer cell signaling with the ultimate goal of developing new inhibitory drugs for the treatment of gastroesophageal cancer and other digestive malignancies. Additionally, Dr. Catenacci designs and executes clinical trials based on laboratory findings and discoveries. Early in his training, he completed a William J. von Liebig Summer Research Fellowship at the Harvard Institutes of Medicine.

Philip Lerner
Vice President & National Medical Director
Aetna

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.

Day One

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

John Longshore
Director, Molecular Pathology, Carolinas Pathology Group
Carolinas HealthCare System

Doctoral Training

University of Alabama at Birmingham, Birmingham, AL Fellowship: Clinical Molecular Genetics, Greenwood Genetic Center, Greenwood, SC

Certification

American Board of Medical Genetics

Practice

  • Human Molecular Genetics
  • Molecular Infectious Disease
  • Molecular Oncology
  • Molecular Cytogentics
  • Molecular Analysis of Hematologic Malignancies
  • Molecular Analysis of Solid Tumors
  • Personalized Medicine and Companion Diagnostics

Stuart Martin
Professor
University of Maryland, speaking on behalf of ANGLE plc

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.

Day One

Wednesday, October 18, 2017

09.00 | Microfluidic Cell Tethering Enables Rapid Analysis of Drug Responses in Live Patient CTCs

Bill Pignato
Principal
W.J. Pignato & Associates

Ferran Prat
Vice President, Strategic Industry Ventures
MD Anderson Cancer Center

Dr. Prat is Vice President of Strategic Industry Ventures.  He helps the faculty and researchers at MD Anderson develop collaborative opportunities with pharmaceutical, biotech, diagnostics, imaging, laboratory medicine and other industry partners.  Prior to joining MD Anderson, Ferran held a number of industry and academic positions, including vice president, oncology and women’s health at Alere Inc. vice president for licensing at Biosite Inc., management consultant at McKinsey & Co., engineer at Chromogenia-Units and researcher at the University of California – Los Angeles.  Prat has a Ph.D. in organic chemistry from the University of California – Los Angeles and a J.D. from the University of San Diego School of Law.

Joshua Xu
Principal Investigator, National Center for Toxicological Research (NCTR)
FDA

Dr. Joshua Xu is a Principle Investigator at the FDA’s National Center for Toxicological Research (NCTR). He specializes in data mining and integration, next-generation sequencing data analysis, image analysis, and high performance computing. Currently, he is leading the deep sequencing QC study, a component of the FDA-led SEQC project phase 2 (SEQC2). SEQC2 is a large international collaborative consortium led by the FDA to evaluate the technical reliabilities and scientific applications of DNA sequencing technologies. Deep sequencing focuses its sequencing reads on few small regions of the genome and thus achieves very sensitive detection of sub-clonal mutations. Liquid biopsy of circulating tumor DNA is a special application of deep sequencing.

Diagnostic & Technology Developers

Steve Anderson
CSO
Covance

Jason DeLoach
International Product Manager, CDx
Ventana Companion Diagnostics

Day Two

Thursday, October 19, 2017

10.15 | Accelerating The Adoption of Companion Diagnostics

Dan Edelstein
Director, Clinical Marketing & New Technology
Sysmex Inostics

Eric Faulkner
Vice President, Precision & Transformative Technology Solutions
Evidera

Jim Godsey
Vice President, R&D, Clinical Sequencing Division
Thermo Fisher Scientific

Day Two

Thursday, October 19, 2017

09.15 | Successful Development of an NGS-Based Companion Diagnostic Test to Support Multiple NSCLC Drug Therapies

Karen Gutekunst
Vice President, Diagnostic Development
Illumina

Karen Gutekunst is currently Vice President of Product Development for Clinical Genomics at Illumina.  Karen holds a Ph. D. from the Georgia Institute of Technology and has over 20 years in the Diagnostic industry.  Karen leads a team of scientists who are responsible for taking Illumina’s cutting edge sequencing technology and instrumentation through regulatory approval processes world-wide.  She started her career at Roche Molecular Systems, a business unit of Roche Diagnostics.  Karen has led product development efforts, Project Management teams and Regulatory Affairs during her tenure at Roche.  She led the successful development of the first FDA approved nucleic acid test for the detection of Hepatitis C, and participated in the development of many PCR-based tests for infectious disease as well as genetics and oncology.  Karen was a key member of the team that conducted the Athena Trial; a major clinical study involving over 45,000 subjects that was the basis for the approval of Roche’s HPV DNA test.  After leaving Roche, Karen joined Clarient, a GE Healthcare company where she led the R & D team responsible for developing laboratory developed tests to enable better characterization of tumor samples from cancer patients.  Her team also supported several clinical studies in collaboration with pharmaceutical companies developing better personalized therapeutics.  Karen has a passion for enabling technology to be used to improve healthcare.  As part of the Illumina team, she is excited to see next generation sequencing transform the way we think about complex genetic diseases, particularly cancer.  Karen also believes in developing our next generation of leaders who will continue to bring innovation into the healthcare space.

Kalyan Handique
Chief Executive Officer & President
Celsee Diagnostics

Kalyan Handique has deep domain knowledge in microfluidics and medical devices. Before joining Celsee Diagnostics, he was a co-founder of HandyLab; a molecular diagnostic company sold to Becton Dickinson. Dr. Handique serves as an advisor and board member to several companies. He earned his Ph.D. from the University of Michigan.

Keith Hanigan
Vice President, Integrated Oncology
LabCorp

Debra Hanks
Chief Pathologist, CDx Histopathology
Agilent Technologies

Debra Hanks, MD holds the role of Chief Pathologist of Agilent’s Companion Diagnostics Histopathology Department where she leads a team of pathologists, histologists, and scientists in developing prognostic assays for cancer treatment. She is triple US Board certified in Anatomic, Clinical and Hematopathology. She gained her medical degree and pathology training at the University of California, San Francisco and undergraduate BS degree from Stanford University. Over her career, she led the development and commercialization of in vitro diagnostic assays for SYVA Co., served as Medical Director for CLIA and CAP accredited clinical laboratories and managed her own privately held Anatomic Pathology laboratory. She joined Agilent in 2014 and has served as a key contributor to the development of Agilent’s 22c3 and 28-8 CDx kits.

Claire Huguet
Head, Biomarker Services
Randox

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.

Patrick Hurban
Senior Director & Global Head, Translational Sciences
Q2 Solutions

David Kern
Senior Director, Regulatory Affairs
Illumina

Joseph Krueger
Chief Scientific Officer
Flagship Biosciences

Hannah Mamuszka
CEO
ALVA 10

Ms Mamuszka is a senior executive in the Cambridge, MA biotech community, with extensive experience in both drug and diagnostic development, validation, and commercialization. With more than 20 years experience in healthcare from the bench to the business side, Ms Mamuszka believes that diagnostics are the key to Precision Medicine. Her thorough command of cutting-edge science compliments her business acumen when evaluating the complex diagnostics deals that shape this industry. She is a well-respected voice for diagnostics in the industry, and a natural choice to bring change to this field. Prior to founding Alva10, Ms Mamuszka was VP of Business Development at Exosome Diagnostics, where she led some of the earliest deals in the liquid biopsy diagnostic space.  Earlier in her career, she was Global Director for Pharma Services at Exiqon A/S (now QIAGEN), and worked on the NDA for Bortezmib (Velcade) at Millennium Pharmaceuticals (now Takeda). Ms Mamuszka writes a column for the Journal of Precision Medicine on the increasing value of diagnostics in our healthcare system. She is a competitive marathon runner.

Dawn McHugh
Vice President, Business Development, Personalized Diagnostics
Corgenix

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.

Matthew McManus
CEO
Asuragen

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.

Day One

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

Susanne Munksted
Director, Global Commercial Alliances, Companion Diagnostics
Agilent Technologies

Michael Natan
CEO
Ultivue

Bill Powell
Senior Director, CDx Development
Leica Biosystems

Scott Reid
Director, Strategic Accounts & Companion Diagnostics
NeoGenomics Laboratories

Mark Roberts
Senior Director, Diagnostics Development
Covance

Dr Roberts received his PhD in Pharmaceutical Sciences from the University of Nottingham (UK) and has worked in the clinical diagnostics arena for over 20 years holding senior positions in both the in vitro diagnostic and reference laboratory industries. He joined Covance at the end of 2012 to spearhead the company's companion diagnostics program which is designed to assist pharmaceutical and diagnostic companies in drug / companion diagnostic co-development.

Day One

Wednesday, October 18, 2017

09.30 | Leveraging Companion Diagnostics in Support of Clinical Trial Design and Execution

Christophe Roos
Chief Scientific Officer
Euformatics, speaking on behalf of Horizon Discovery

Craig Shimasaki
President & CEO
Moleculera Labs

Shimasaki is co-founder and CEO of Moleculera labs, a precision medicine CLIA laboratory focused on neuropsychiatric disorders triggered by autoimmune dysfunction. He is serial entrepreneur with over 33 years of biotechnology industry experience, starting his career at Genentech. He co-founded three companies and led five clinical diagnostic tests through FDA 510(k) approval. He has been involved in raising over $60 million for these companies and participated in taking one company public. His passion is to see acutely needed medical products become readily available for patients who need them. He has assisted professors, physicians and scientists in translating their ideas into commercial products. He an Adjunct Professor at the University of Oklahoma, Price School of Business and teaches biotechnology entrepreneurship.

Bob Silverman
Head of Externalized Drug Discovery Partnering
Roche

Day One

Wednesday, October 18, 2017

07.50 | Chairs' Opening Remarks

Elodie Sollier
Chief Scientific Officer
Vortex Biosciences

Vishal Sikri
US General Manager
Biocartis

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.

John Simmons
Director, Translational Sciences & Diagnostics
Personal Genome Diagnostics

Daniel Simon
Vice President, Pharma Business Development
Guardant Health

Dan Snyder
President & Chief Executive Officer
Molecular MD

Day Two

Thursday, October 19, 2017

09.45 | Mitigating Risk when Navigating the Journey from Clinical Trial Assay Validation to the Commercial Deployment of a Companion Diagnostic

Steen Thaarup
Business Development Manager, Pharma
Unilabs

Steen Thaarup is the Business Development Manager for Pharma at Unilabs, a European Bioanalytical and Diagnostics partner to the Pharma industry. Prior to this, he worked as Managing Director of Mobile Chamber Experts GmbH, a German start-up delivering mobile exposure chamber for clinical trials in allergy. Prior to this position, he worked as an independent consultant for European based life science companies. Until 2012, Steen Thaarup was the Vice President Emerging Markets at ALK, Denmark. ALK is an innovative research-based bio-pharmaceutical company and is the worldwide market leader in allergy-specific immunotherapy for humans. He was associated with ALK Abelló since February 2009 as Vice President, Southern Europe and General Manager, Italy. Prior to ALK, Mr. Thaarup was the Chief Executive Officer at Aresa, Denmark – a start-up company within plant biotechnology working with GMO plants for landmine clearance listed at Nasdaq. Before Aresa, he spent 5 years as Executive Vice President S&M for MediCult (now Origio) working with IVF, assisted reproduction. He was globally responsible for all sales and marketing activities among subsidiaries and distributors on all continents.

Tom Turi
Vice President, Companion Diagnostics
Covance

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.

Katarina Wikstrom
Director, US Operations
Almac Diagnostics

Jay Wohlgemuth
Senior Vice President & Chief Medical Officer, R&D, Medical & Employee Health
Quest Diagnostics