October 17 – 19 2017 | Boston, MA

Hilton Boston/Woburn

Speakers

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Drug Developers

Naveen Babbar
Executive Director, Global Program Diagnostics
Novartis

Naveen holds the role of Executive Director, Global Program Diagnostics at Novartis Oncology. He has previously held positions at Applied Proteomics and GenMark Diagnostics . He gained his MSc in from the Jawaharlal Nehru Technology University in 1999 before completing his PhD in Biochemistry, Molecular and Cellular Biology from the University of Arizona in 2003.

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

Jean-Marie Cuillerot
Chief Medical Officer
Agenus

Jean-Marie Cuillerot joins the company with 16 years of experience in oncology clinical research and drug development. Most recently, he served as the Global Head of Clinical Development, Immuno-Oncology, and Vice President of Clinical Immunotherapy/Immuno-Oncology at EMD Serono Research and Development Institute, an affiliate of Merck Serono. At Merck Serono he oversaw the development of the company’s immuno-oncology portfolio, which included two checkpoint inhibitors and two immuno-cytokines. He also advanced the PD-L1 antibody avelumab from pre-IND to filing and was responsible for delivering the dataset leading to the $880 million co-development deal with Pfizer. Dr. Cuillerot led the Global Clinical Research team in all interactions with health authorities, including the FDA and EMA.

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.

Nicholas Dracopoli
Vice President, Oncology Diagnostics
Janssen

Dr. Nicholas Dracopoli is Vice President, Oncology Diagnostics at Janssen R&D, LLC, Pharmaceutical companies of Johnson & Johnson. In this role, he is responsible for building and leading the Oncology Diagnostics group, which is focused on developing all companion and complementary diagnostics in the oncology development portfolio. Previously, he was Vice President, Oncology Translational Research where he was responsible for biomarker discovery, development and application for oncology products. Prior to that, he was Vice President of Clinical Discovery Technologies at Bristol-Myers Squibb, and before that he spent five years in the biotechnology industry at Sequana Therapeutics. Dr Dracopoli obtained his B.Sc. and Ph.D. degrees from the University of London, and completed post-doctoral fellowships at the Memorial Sloan-Kettering Cancer Center and the Massachusetts Institute of Technology (MIT). 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 NIH before moving to the biotechnology industry. Dr Dracopoli has authored >70 scientific publications, and has extensive experience in the fields of genomics, molecular biology and cancer research.

Day Two

Thursday, October 19, 2017

08.45 | Key Trends in CDx Development for Precision Medicine Success

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
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.

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

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

Ron Kamienchick
Senior Director, Diagnostics & Personalized Medicine
Teva Pharmaceuticals

Ron holds the role of Senior Director of Diagnostics and Personalized Medicine at Teva Pharmaceuticals, where he integrates strategy technologies and solutions that help tailor treatment to the individual needs, characteristics, and preferences of Teva’s customers. He has previously held positions at Kadimastem and Rosetta Genomics. He gained his BA in Psychology & Cross Disciplinary Studies from the University of Haifa in 2005 before completing his MBA from the Interdisciplinary Center in 2014.

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.

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.

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.

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.

Cecilia Schott
Vice President, Precision Medicine, Global Product & Portfolio Strategy
Astrazeneca

Cecilia Schott is the Head of Personalized Healthcare, Corporate Business Development for AstraZeneca. Cecilia and her team are responsible for identifying, evaluating, facilitating and establishing external collaborations supporting personalized healthcare strategies alongside AstraZeneca’s small and large molecules portfolio. Prior to her current role in Business Development Cecilia held positions in AstraZeneca’s Global Marketing and US Medical Affairs. He background includes direct patient care as a clinical pharmacist; and she also has various roles in the biotech and device industries including clinical research, drug safety and medical publications. Cecilia holds a Doctor of Pharmacy degree from Massachusetts College of Pharmacy, Boston; a BS in Pharmacy from University of Sao Paulo, Brazil and a MBA from Babson College, Boston

Morten Sogaard
Vice President & Head, Genomic Sciences & Technologies
Pfizer

PFIZER. Responsibility for Genome Sciences & Technologies reporting to the president of worldwide R&D, and a member of the worldwide R&D leadership team (WRDLT). As part of his responsibilities Morten oversees Pfizer’s human genetics, computational biomedicine &  target validation, companion diagnostic and biospecimen management organizations. He also has responsibility for guiding Pfizer’s investments in platform technologies and is the R&D member on Pfizer’s big data operating committee. He was previously responsible for strategic technology and oncology collaborations as part of External R&D Innovation, and co-led several Pfizer-wide strategy initiatives on Precision Medicine and scientific technologies. INDUSTRY CAREER. Morten started his industry career at Pharmacia in Lund, Sweden, where he quickly advanced to section head, protein engineering and responsible for all aspects of next generation immuno-oncology antibody therapeutics overseeing a cross functional team across 3 sites in Italy and Sweden. In 1998, Morten moved to AstraZeneca where he headed up the Molecular Sciences Department in Mölndal, Sweden  leading about 100 scientists conducting genomics, proteomics, genetics and protein family research. He also headed up AZ’s global nuclear receptor program and was a member of the CVGI management team In 2004 Morten moved to Boehringer Ingelheim in Ridgefield, CT as VP and global head of enabling technology and a member of  BI’s global research leadership team. In this role he helped build a world-wide enabling technology function comprising global technology skill centers (Mab Lead discovery, high throughput protein expression, functional genomics, compound pool optimization, and fragment based screening), research informatics and an infrastructure for biologics research, and briefly served as Head of R&D Informatics. EDUCATION. Morten received his Ph.D. degree in Biochemistry from the University of Copenhagen, Denmark. Thesis work done at the Carlsberg Laboratory, Dept. of Chemistry focused on heterologous protein expression and enzymology, and he subsequently did postdoctoral studies at Sloan Kettering Institute in New York with Nobel Laureate Jim Rothman  focusing on protein transport funded by NIH Fogarty and EMBO fellowships.  30+ publications including first author publications in PNAS, JBC, Cell, Gene, and BIO/technology.

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

Miro Venturi
Global Head, Diagnostics Biomarkers
Roche

After receiving his PhD from the Max-Planck Institute of Biophysics in Frankfurt, Miro specialized in molecular medicine, virology and immunology at the National Institutes of Health, Bethesda, USA. In 2002, Miro joined the pharmaceutical industry as a Biomarker Laboratory Head and project team representative at Pharmacia Corp (later Pfizer Inc.) at the Oncology R&D site located in Nerviano, Italy. In this role, he initially established the biomarker laboratories and actively contributed to the development of numerous oncology programs focusing on small molecular weight kinase inhibitors, including the early development of sunitinib (Sutent) as well as research and exploratory biomarker strategies for several preclinical programs, from lead optimization until PoC clinical studies. In 2005, Miro was invited to join the faculty of the University “Vita Salute San Raffaele” in Milan as Adjunct Professor of preclinical and early clinical development of biopharmaceuticals. In 2007 Miro moved to Novartis as Divisional Head in Biomarker Development, supervising a team of scientists developing assays and supporting project teams in the realization of personalized medicine strategies across the portfolio, with a focus on biologics and oncology programs. His team has contributed to the development of nilotinib (Tasigna) and early programs in both solid tumors and hematological malignancies. Since 2009, Miro joined Roche Oncology where he has contributed the biomarker and personalized medicine strategies and directed the execution for global drug development programs with companion diagnostics, including the development and approval of Perjeta in breast cancer. In 2011, he was appointed Site Head for Oncology Biomarkers within the DTA Oncology Dept, under the leadership of William Pao, and based in Penzberg, Germany. Miro has then been appointed Global Head of Diagnostics Biomarkers at Hoffmann-la Roche and is based at the Company´s headquarters in Basel. Miro has contributed to several drug research and scientific development projects and published in a number of relevant scientific journals, including Nature, Cell, PNAS and others.

Day One

Wednesday, October 18, 2017

07.50 | Chairs' Opening Remarks

Day Two

Thursday, October 19, 2017

08.05 | Chairs' Opening Remarks

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

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

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.

Robert Goldberg
Vice President & Co- Founder
Center for Medicine in the Public Interest

Robert Goldberg is co-founder and vice president of the Center for Medicine in the Public Interest. (CMPI) Along with Peter Pitts, Dr. Goldberg hosts the popular and controversial blog on the pharmaceutical industry and healthcare, www.drugwonks.com. Prior to founding CMPI, Goldberg was Director of the Manhattan Institute’s Center for Medical Progress and Chairman of its 21st Century FDA Task Force that examined the impact of the FDA’s Critical Path Initiative on drug development and personalized medicine. He has written for The Wall Street Journal, The Washington Post, the Los Angeles Times, National Review Online, The Chicago Tribune, The Philadelphia Inquirer, The New York Sun and writes regularly for The American Spectator (where he broke the story about Obama Medicare director Donald Berwick’s admiration for Britain’s National Health Service); the New York Post and The Weekly Standard. He is an expert on Medicare reform, comparative effectiveness and FDA’s Critical Path Initiative and the author of many papers including, "Insta-Americans: The Empowered (and Imperiled) Health Care Consumer in the Age of Internet Medicine," and with John Vernon, "Alzheimer's Disease and Cost-effectiveness Analyses: Ensuring Good Value for Money?" and “Economic Evaluation and Comparative-Effectiveness Thresholds: Signals to Firms and Implications for R&D Investment and Innovation.” He is also author of the forthcoming book, “Tabloid Medicine: How the Internet is Being Used To Hijack Medical Science For Fear and Profit.” (Kaplan, December 2010).

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

Reena Philip
Director, Division of Molecular Genetics and Pathology, OIR/CDRH
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

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

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.

Nicholas Schork
Professor
The Translational Genomics Research Institute

Dr. Schork is a Distinguished Professor at the Translational Genomics Research Institute (TGen) in Phoenix Professor; Director, Human Biology, at the J. Craig Venter Institute (JCVI); and an Adjunct Professor at the University of California, San Diego. Prior to his position at the TGen, Dr. Schork was a Professor, Molecular and Experimental Medicine, at The Scripps Research Institute (TSRI) and Director of Bioinformatics and Biostatistics for the Scripps Translational Science Institute (STSI). Dr. Schork has also held faculty appointments at Case Western Reserve University (CWRU) and Harvard University. Between 1999 and 2000 Dr. Schork spent a sabbatical at Genset, where he helped guide efforts to construct the first high-density map of the human genome. He has published over 500 articles in the area of the genetic dissection of complex phenotypes. He also has a long history of collaborative and consortium-related research in which he has contributed analysis methodology and applied data analysis expertise. Dr. Schork has a number of patents associated with genetic analysis methodology, been involved with more than 10 start-up companies, and has mentored over 75 students and post-doctoral fellows.

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

Dan Edelstein
Senior Manager, Medical Scientific Affairs
Sysmex Inostics

Eric Faulkner
Vice President, Precision & Transformative Technology Solutions
Evidera

Jay Foust
Vice President , Companion Diagnostics & Business Development
Ventana Companion Diagnostics

  Mr. Foust has a unique combination of relevant experience gained from both the pharmaceutical and diagnostic sectors. Prior to his tenure at Roche and Ventana Medical, where he has helped grow and shape their Companion Diagnostics lifecycle, he spent 10 years as a venture capitalist, licensing manager, and product developer focused on the pharmaceutical sector.

Jay earned both his Bachelor of Science in Molecular and Cellular Biology as well as his Master of Business Administration, at the University of Arizona.

Day Two

Thursday, October 19, 2017

10.15 | Taking a Well Measured Biomarker and Executing a Robust IVD Development Strategy for Your Targeted Therapy

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

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.

Claire Huguet
Head, Biomarker Services
Randox

Joseph Krueger
Chief Scientific Officer
Flagship Biosciences

Matthew McManus
CEO
Asuragen

Michael Natan
CEO
Ultivue

Jessica Riley
Senior Director, Business Development, Pharma Partnerships
Leica Biosystems

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

Elodie Sollier
Chief Scientific Officer
Vortex Biosciences

Vishal Sikri
US General Manager
Biocartis

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.

Gina Wallar
Division Vice President, Pharma Services, National Sales
NeoGenomics Laboratories

Rosanne Welcher
Senior Director, Regulatory, Quality & Clinical Affairs
Agilent Technologies

Katarina Wikstrom
Director of US Operations
Almac Diagnostics