Roy Baynes is Senior Vice President Global Clinical Development and Chief Medical Officer at Merck Research Laboratories in Rahway, New Jersey. He was previously Senior Vice President of Oncology, Inflammation and Respiratory Therapeutics at Gilead Sciences and prior to that was Vice President Global Clinical Development and Therapeutic Area (TA) Head for Hematology / Oncology, at Amgen Inc. In the early years of his tenure at Amgen before becoming TA head of Hematology / Oncology in Clinical Development he was TA head for Hematology / Oncology in Global Medical Affairs. He graduated as a Medical Doctor and obtained a Master of Medicine and Doctor of Philosophy from the University of the Witwatersrand, Johannesburg, South Africa. He has had a long and distinguished career in the haematology-oncology-and stem cell transplantation fields, including drug development, basic research, clinical practice, clinical research, teaching and administration. He is a member of many international societies, including the American Society of Hematology (ASH) and the American Society of Clinical Oncology (ASCO), and has authored some 150 publications. He has been recurrently named among America’s top physicians. Before joining Amgen in 2002, he was the Charles Martin Professor of Cancer Research at the Barbara Ann Karmanos Cancer Institute, an NCI designated Comprehensive Cancer Center, at Wayne State University, Detroit, Michigan, USA.
John M Rossi is Vice President of Translational Medicine at Syncopation Life Sciences. John is an experienced Cell Therapy and Biotechnology leader with over 22 years of experience building robust clinical pharmacology, predictive biomarker, and correlative science processes to support oncology drug development. Most recently John was Senior Vice President of Research and Head of Translational Medicine at CERo Therapeutics. At CERo, John helped to guide Research, Process Development and Vector Sciences teams to advance preclinical initiatives. Prior to CERo, John was Senior Director and Head of Clinical Pharmacology at Kite, a Gilead Company. At Kite, John played an instrumental role in supporting global approvals of both Yescarta® and Tecartus® as well as IND approvals to advance investigational autologous T cell therapy products (KITE-363 and KITE-222). Among John’s notable achievements at Kite, he has represented the organization through numerous external scientific presentations and collaborative manuscripts with leading academic researchers in the cell therapy field. Significant scientific accomplishments include the discovery of novel metrics to characterize CAR T cells based on functionality and fitness, novel biomarker knowledge helping to elucidate CAR T-cell mechanism of action in humans, mechanistic information on CAR-related toxicities, novel insights into the biology of the tumor immune microenvironment, and the pivotal role of IL-15 in the context of CAR T-cell function. John began his tenure in clinical pharmacology and biomarker development at Amgen in 2002, leading global biomarker development for Phase III registrational trials in oncology (trebananib, AMG386), and preclinical, first-in-human and Phase II clinical trials (AMG780, AMG224 and AMG176). John has co-authored over 35 publications in the field of cell therapy and is co-inventor on 9 issued or submitted patents. John earned his Master of Science degree in Molecular Biology at Portland State University and his B.S. degree in Biology at Pitzer College in Claremont CA.
Mike Baratta currently serves as a Scientific Director for the Clinical Biomarker Innovation and Development group at Takeda Pharmaceuticals in Cambridge, MA. He received his B.A. from Loyola University of Chicago and a Masters Certificate in Applied Healthcare Project Management from Villanova University. Mike began his career as a member of the Global Drug Metabolism group at Pharmacia/G.D. Searle and transitioned to a Principal Scientist role with Pfizer after the closure of the merger. Prior to joining Takeda in 2013, he served as a Director on Nonclinical Development, Pharmacokinetics and Biometrics with Duck Flats Pharma. Mike is a member of several FNIH biomarker consortia, industry committees and serves as a standing member of the NIH/NSD-B grant application reviewer. Mike’s research focus is mass spectrometry focused analytical assay development and clinical validation of post translation biomarkers supporting patient characterization/stratification strategies.
I have extensive experience in translational research and clinical trial design, especially in melanoma. My post-doctoral fellowships were at Cleveland Clinic and Indiana University respectively working in basic science labs on fundamental biologic processes. At Memorial Sloan Kettering Cancer Center, I trained with Drs David Spriggs, Carol Aghajanian and Paul Chapman gaining a broad understanding of experimental therapeutics. Over the next 7 years, at the Moffitt Cancer Center, A collaboration with Dr Heller has resulted in intratumoral IL12 as a treatment for melanoma. At UCSF, I lead the melanoma program and several early phase and melanoma specific clinical trials as well as collaborating with my colleagues Michael Rosenblum, Max Krummel and Jeff Bluestone at UCSF and with Meromot Singer and Arlene Sharpe at Harvard to analyse scRNA from melanoma patients. Im excited to collaborate with Susana Ortiz on her projects targeting nanoparticles for drug delivery in melanoma and novel kinase dependencies to Treat Metastatic NRAS Tumors
I am the Director of the Program for Neurotrauma, Neuroproteomics and Biomarkers Research and tenured Professor of Emergency Medicine, Neuroscience, Physiological Sciences and Chemistry at the University of Florida in USA. I am also Research Health Neuroscientist, and Executive Committee Member of the Brain Rehabilitation Research Center, Malcom Randall VA Medical Center (Gainesville, FL). I have been involved as an a neurotrauma researcher since the late 1990’s. I have served as President and Council Member of the National Neurotrauma society, Board Member, Board of Governors of the International Brain Injury Association and Presidium Member of the Academy for Multidisciplinary Neurotraumatology. I am a co-founder of a biotechnology company Gryphon Bio, Inc. My research focus is translational research for biomarkers and therapies for traumatic brain injury (TBI), spinal cord injury, post-traumatic epilepsy, and chronic traumatic encephalopathy. Two acute TBI blood-based protein biomarkers (UCH-L1/GFAP) that I co-discovered have received FDA clearance as the first in vitro diagnostic tests for detecting pathoanatomical lesions in TBI patients. I also hold leadership positions on various TBI initiatives such as International TBI Research Initiative (InTBIR), and multicenter TBI consortium studies (e.g. TRACK-TBI, CENTER-TBI, ICON-TBI). I am principle Investigator of multiple research grants funded by National Institute of Health, Department of Defense, Veterans Affairs and other research foundations. I have also authored over 300 peer-reviewed publications and edited /co-edited 5 scientific books.
Ian Pike is the Chief Scientific Officer at Proteome Sciences and has over 30 years’ experience working in the diagnostics and biotechnology sectors. Since joining Proteome Sciences in 2002 he has held a number of roles covering intellectual property management, business development, operational management and is now focused on leading the Company’s scientific strategy to offer clients a flexible, high-quality service.
George Pell is the Principal and Chief Strategy Officer of Thirty-Six, an innovation studio bringing a series of ventures to life for advancing neuroscience, medical intelligence, and human potential. George brings over 20 years from this space, where emerging technologies are first crafted and brought to life, including several which have helped shape the landscape of AI for the life sciences, such as discovery, augmented intelligence, and other cognitive technologies. He has made a multi-billion dollar impact in a range of innovation, strategy, and transformation roles for some of the world’s largest companies in the most high stakes of circumstances. George has invested his most recent 14 years in the life sciences space, where he brings a multidiscipline of advanced biology together with discovery and intelligence technologies, for next-gen applications in neuroscience and precision medicine.
Eric earned his MD and trained in pathology at the University of Michigan. He was a research fellow at the National Cancer Institute and is certified by the American Board of Pathology. Before RareCyte he was the Medical Director of Companion Diagnostics at Ventana Medical Systems/Roche Tissue Diagnostics. Eric’s pharmaceutical experience has included discovery research, toxicology, and exploratory and late phase clinical development at Hoffmann-La Roche and Parke-Davis / Pfizer. He was a director of clinical genomics at Gene Logic and Chief Scientific Officer at Transgenomic. He has degree in chemistry from Harvard and studied music at Trinity College, Cambridge, England.
Dr. Xianyin Lai received his Ph.D. from Peking University. He joined Indiana University School of Medicine as a postdoctoral fellow and progressed to become an Assistant Research Professor before transitioning to Eli Lilly. During his work in academia, Xianyin focused on research of mechanisms, biomarkers, and drug targets using mass spectrometry-based proteomics from numerous types of materials for multiple diseases. He has 62 peer-reviewed publications and over 50 publications are biomarker focused or related. For biomarker research, he developed unique protein extraction methods from formalin-fixed paraffin-embedded tissues and cell membranes, collaborated with bioinformatic scientists to create software named IdentiQuantXL for protein quantification in proteomics, and developed platforms for biomarker selection. In Eli Lilly, Xianyin applies his about 15 years of mass spectrometry knowledge and skills to fulfill various project needs, especially in peptide drug discovery and development. Due to his excellent contributions, Xianyin won Lilly Innovator Top100 Award in 2019.
Dr. Shamim Mollah is an Assistant Professor of Genetics and Institute for Informatics at Washington University School of Medicine in St. Louis. She received her Ph.D. in Bioinformatics and Systems Biology from University of California San Diego. Her research was focused on applying network analysis-based models on multi-omics data using dynamic modeling, graph-theory, and machine-learning techniques to characterize drug responses in cancer cells. She received her Master’s degree in Biomedical Informatics from Columbia University studying natural language processing. She received her undergraduate degrees in Computer Science and Mathematics from Indiana University where her research was focused on reinforcement learning. Previously, she served as the bioinformatics scientist at the Rockefeller University, where she managed bioinformatics data analysis core for the Center of Clinical and Translational Science. During her tenure at the Rockefeller University, her proposed bioinformatics research proposals led to the 2008 Obama challenge grant award and its renewal in 2011.
I am Yuk Yee Leung, a Research Assistant Professor at the Department of Pathology and the Penn Neurodegeneration Genomics Center at the University of Pennsylvania. I am the Data production leader of the Genome Center for Alzheimer's Disease. I am also with the Alzheimer's Disease Sequencing Project, and the National Institute on Aging Genetics of Alzheimer's Disease Data Storage Site (NIAGADS). I have extensive experience in building computational pipelines, databases and analyzing different kinds of genetics and omics data on clouds like Amazon for Alzheimer’s dementia.
Dr. Parag Mallick is an Associate Professor at Stanford University. Originally trained as an engineer and biochemist, his research spans computational and experimental systems biology, cancer biology and nanotechnology. Dr. Mallick received his undergraduate degree in Computer Science from Washington University in St. Louis. He then obtained his Ph.D. from UCLA in Chemistry & Biochemistry, where he worked with Dr. David Eisenberg. He completed Post- Doctoral studies at The Institute for Systems Biology, in Seattle, WA with Dr. Ruedi Aebersold. Beyond studying fundamental disease mechanisms, his group has been pioneering novel approaches for enabling personalized and predictive medicine. This work has led to the creation of several successful companies. In addition, he is actively advising dozens of companies at various stages and working with venture funds on both scientific and fiscal evaluation of potential investments. Most recently, his group has been developing model-based and physics-based approaches to machine learning that enable learning over domains that span a wide range of time and length scales.
Tanja is a board-certified veterinary pathologist and Diplomate of Safety Pharmacology, working in the development sciences, safety assessment group at Genentech since 2012. She completed her BA in ecology and evolutionary biology from Princeton University, veterinary degree from University of Georgia and residency from UC Davis. At Genentech she supports safety assessment pathology, was selected to establish and co-lead the Safety Biomarker Expert Resource and lead the comparative oncology initiative, is the therapeutic area pathology lead for neurologic indications, and supports cardiovascular and neurologic expert working groups. She is an executive committee member of the IMI, TransBioLine consortium and co-chair for the vascular work package; an advisory committee member of the C-Path, Predictive Safety Testing Consortium, co-chair of the vascular working group, and member of the skeletal muscle working group; the chair for the IQ DruSafe safety biomarkers working group; and member of ILSI HESI cardiac integrative strategies working group.
Nancy G. Casanova graduated as a physician (Medicine Doctor) at the Universidad Autonoma de Aguacalientes, in Mexico. Later on, she continued her residency training in medical genetics. In the United stated she got her MD degree certified by the Educational Commission for Foreign Medical Graduates, completed a degree in Public Health and then completed her PhD degree in clinical translational Sciences at the University of Arizona.
She has over eight years of experience conducting clinical lung research at two academic institutions; University of Illinois in Chicago and currently at The University of Arizona. Her research is focused on developing potential novel biomarkers and therapeutics in Idiopathic pulmonary fibrosis (IPF), Acute Respiratory Distress syndrome (ARDS) and sarcoidosis. Her clinical experience expands to the implementation and design of clinical research studies, in projects that involve molecular techniques such as mononuclear cell isolations, cell cultures, RNA isolations and NGS analysis.
Her publications include transcriptional regulation of gene expression and epigenetics for molecular biomarkers for predictive features in sarcoidosis. Gene expression secondary to the administration of CO in IPF and ARDS biomarker for mortality risk prediction.
Since 2008, Shashi has been employed by Pfizer, overseeing translational biomarker strategies for developing innovative medicines. Currently, Shashi is the Executive Director-Global Head of Biomarkers within Drug Safety R&D, Pfizer Inc. In his current role, responsible for Safety Biomarker activities across all DSRD sites and for establishing and maintaining scientific strategy and operations group across global biomarker groups. Shashi is leading several precompetitive consortia (IMI, PSTC) involving biomarkers and safety biomarker initiatives. During his 20 years of combined academic and pharmaceutical industry experience, Shashi has delivered over 50 invited seminars and written more than 45 peer-reviewed publications and over 15 book chapters including serving on editorial board of peer reviewed journals and leadership within scientific societies. Shashi Ramaiah completed his PhD from University of Louisiana at Monroe in Pharmacology and Toxicology. After completing his PhD, Shashi enrolled in the Clinical Pathology residency program at University of Florida and completed his certification in Veterinary Clinical Pathology. Following his residency training, Shashi accepted a tenure track faculty position in the department of Veterinary Pathobiology, College of Veterinary Medicine at Texas A&M University. During his ~6 yr stint as a faculty at Texas A&M, Shashi pursued his independent research on an NIH-NIAAA funded research grant on alcoholic hepatitis and non alcoholic fatty liver syndrome. In addition to his research, Shashi participated in diagnostic clinical pathology service, residency training and graduate student teaching at Texas A&M University.
Martin Schlumpberger is Director, Product Development at QIAGEN focusing on exosomes and circulating, cell-free nucleic acid isolation. Before his current role, he successfully led the development of various RNA isolation products at QIAGEN, including RNeasy FFPE, RNeasy Plus, AllPrep DNA/RNA, miRNeasy and QIAsymphony RNA kits. Prior to joining QIAGEN, Martin worked as a postdoctoral fellow at the Institute for Neurodegenerative Diseases at UCSF, USA. He holds a Ph.D. in chemistry, with a strong focus on molecular biology and yeast genetics, from the University of Stuttgart, Germany
Scott Reid heads up companion diagnostic services and strategic alliances at NeoGenomics. He has been with NeoGenomics since 2016 and previously covered Business Development for the New England territory. He has been working in oncology since graduate school with a focus on diagnostics and IVD commercialization that has included previous positions at LabCorp and Covance. Scott completed his PhD in Biochemistry and MBA at Duke University.
Zev’s nearly two-decade industry experience spans big pharma, life sciences tools and diagnostic companies where he led R&D teams, drug-discovery and product development projects. He is a biochemist by training with research background in protein phosphorylation, proteolysis and growth-factor signaling. Zev’s discoveries contributed to better understanding of the mechanism of ectodomain shedding and provided new insights into the regulatory role of extracellular phosphorylation. Zev led a broad range of research and development projects and has a successful track record of leveraging rigorous science to drive the development of new products aimed at facilitating research and speeding-up discovery. He earned his Ph.D. from the Weizmann Institute of Science, Israel under the guidance of Prof. Shmuel Shaltiel and conducted his post-doctoral studies at the Children’s Hospital, Boston in the laboratory of Prof. Michael Klagsbrun – a growth-factors pioneer. Zev has authored over a dozen of peer-reviewed publications and presented at numerous scientific conferences.
Dhiman Ghosh, Ph.D. is working as a Scientist at Takeda Pharmaceuticals, Boston with core expertise in proteomics and systems biology, biomarker discovery and bioanalysis. Dhiman received his PhD in Biochemistry from the University of Manitoba, Canada for his research work on the elucidation of membrane proteomes of lymphoid and myeloid precursors by mass spectrometry. During his postdoctoral work at the Institute for Systems Biology with Dr. Leroy Hood, he developed integrated multidimensional omics-based analytical platform to query disease-perturbed networks that revealed the identity of several blood circulating proteins with potentials in disease diagnosis. Dhiman held positions both in academia and industry and is passionate about the implementation of novel tools and technologies to advance the understanding of biology and drug discovery.
Tom Li is the Head of US Biopharma Business Development from Burning Rock Dx. He has over 10 years of research, business development, and CDx experience from City of Hope, Thermofisher, MDx Health, Genscript and Burning Rock Dx.
Nadia Hassounah, Ph.D. is a Principal Scientist in the Translational Immuno-oncology group at Novartis Institutes of Biomedical Research (NIBR). She is responsible for biomarker assay development, scientific technical oversight and biomarker data analysis for phase I/II clinical trials. Prior to joining NIBR in 2017, she completed a postdoctoral fellowship at Dana-Farber Cancer Institute where she focused on PD-L1 biology as well as CRISPR technology for model generation. Nadia holds a Ph.D. in Cancer Biology from the University of Arizona.
Marc van der Schee has close to 10 years of experience in the field of volatile biomarker research. During his PhD Marc pioneered the use of exhaled breath analysis in Lung Cancer, Asthma and Colorectal Cancer amongst others. For this work he received various awards including a Marie Curie Fellowship. His background spans both medical, epidemiological, chemical analytical and data-analysis aspects of biomedical research. By building on this expertise he designs and oversees all clinical trials within Owlstone Medical helping to collect data that drives product development and implementation into clinical practice. As a trained medical doctor Marc helps prioritise medical applications and is the primary interface between clinical partners and Owlstone. Marc holds a medical degree and a doctorate in Biomedical Sciences and obtained a PhD degree by studying the use of volatile biomarkers for disease diagnosis, monitoring and prognosis prediction.
As Director of Biomarkers at Larvol, Dr. Gramling leverages his years of experience in research, technology development, and healthcare industry. As a researcher, he has examined novel pathways ranging from the impact of coagulation factors on breast cancer to modulators of Ras and Myc signaling in lymphoma. Outside of research, Dr. Gramling has focused on building the teams and tools to serve markets ranging from clinical trial study start up and health economics outcomes research to benefits management and pharmaceutical competitive intelligence. With Larvol’s platform Veri, Dr. Gramling is developing solutions and analytic tools around predictive biomarkers in oncology.
Reinhard Ortmann is Director Oncology & Precision Diagnostics at QIAGEN and focuses on companion diagnostic commercialization. He is responsible for early companion diagnostic and drug launch preparation and alignment with QIAGEN’s pharmaceutical partners. Reinhard worked for many years in pharmaceutical companies, such as Johnson & Johnson and Chiron Biopharmaceutical, and held various sales and marketing positions covering multiple therapeutic areas. After joining the QIAGEN headquarters in Hilden/Düsseldorf in 2010, he established a number of collaborations between QIAGEN’s sales, marketing, medical and reimbursement teams with the equivalent teams in pharmaceutical companies.
Reinhard holds a Doctor of Veterinary Medicine degree and is a Graduate Economist.
Michael Cardone leads Eutropics’ efforts to achieve scientific and corporate milestones. His experience includes 17 years of scientific and business management at early to mid-stage biotech companies. Prior to Eutropics, he was a scientific co-founder of publicly traded Merrimack Pharmaceuticals, a Cambridge, MA-based company. Michael Cardone received a Ph.D. in protein trafficking from the University of California San Francisco and completed post-doctoral studies at the Burnham Institute in La Jolla, CA.
Morten heads up Global Marketing in Agilent’s Pathology Division that develops market-leading solutions for tissue-based diagnostics and commercialization of novel companion diagnostics solutions. Morten has been with Agilent for 6 years and prior to his current responsibility he was part of the Executive Management team in Agilent’s Diagnostic sales organization. Morten has also worked with Strategy and M&A in Agilent’s Corporate Development function specifically focusing on the Diagnostics and Genomics Group and Agilent’s investments in the clinical and diagnostics market segment. Prior to joining Agilent Morten worked as a management consultant for IMS Consulting Group (Now IQVIA) where he advised leading pharmaceutical companies on top-line growth and commercial strategy. Morten holds a MSc in Economics and Business Administration from Copenhagen Business School in Denmark with complementary executive MBA courses from Stanford University, California.
Michael Valentino is currently Scientific Director of Companion Diagnostics within the Business Development team at Exosome Diagnostics, a Bio-Techne Brand. Michael joined Exosome Diagnostics in 2014 as one of the first five Senior Scientists and was leading up next generation sequencing efforts in the R&D Team prior to joining the business development team in 2017. In his current role, he is responsible for providing the scientific support and expertise for the commercial biopharma services and partnerships and facilitates conversations between partners and internal R&D scientists. Michael has nearly 20 years of experience in a molecular laboratory setting and received a Ph.D. in Immunology and Microbiology from The University of Rochester School of Medicine before moving to Boston for a postdoc at Harvard Medical School.
Prior to his current position, Michael has held various scientific roles including an environmental biologist, cancer research scientist in the US Government, as well as teaching positions in high school and at a nationally accredited zoo. He has authored or co-authored on more than 10 peer-reviewed publications. Michael has had a love of science from a very young age and passionately believes that a key element for positively impacting human health is successfully communicating scientific understanding.