At MarketsandMarkets, Shekhar Gupta is leading US Central region and managing global client relationship for key strategic accounts with a focus on building and growing client services group. Shekhar has 20 years of consulting experience at various executive levels spanning from Technology Delivery, Business Development and Account Management, and has worked with client’s leadership across key business verticals in Finance, Insurance, Resources, Retail and Healthcare. Before joining MarketsandMarkets, Shekhar was Client Executive at Avanade (Accenture & Microsoft JV) leading Midwest region accounts. Shekhar is passionate about Customer Service Excellence through building strong client relationships and driving business value for both client and company.
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 joined Kite in February 2015 and is currently a Senior Director in the Department of Translational Medicine. John leads the Cell Therapy Clinical Pharmacology group and also supports or leads biomarker activities related to clinical development of Kite’s CAR T-cell pipeline. At Kite, John has led the development of a biomarker strategy and has also built an effective translational team to support the clinical development of axicabtagene ciloleucel/KTE-C19 and KTE-X19. During this time, John’s team has contributed directly to the US and European approval of axicabtagene ciloleucel through pharmacokinetic and pharmacodynamic evaluation of this product. Among many achievements at Kite, John has represented Kite through external scientific presentations and collaborative manuscripts with leading academic researchers such as Dr. Steven Rosenberg and Dr. James Kochenderfer at the National Cancer Institute. Scientific accomplishments include the discovery of novel metrics to characterize CAR T cells based on their functionality, novel biomarker knowledge of how CAR T cells work in the clinic, mechanistic information on CAR-related toxicities, novel insights into the biology of the tumor immune microenvironment, including immune checkpoints, and the pivotal role of IL-15 in the context of CAR T-cell function.
Amber Donahue, Ph.D. is a Senior Manager, Biomarker Clinical Assay Lead in the Oncology Clinical Assay Group in Global Product Development at Pfizer. She is responsible for scientific technical oversight and operational management of external and internal partners performing clinical trial biomarker sample analyses aligned with translational oncology strategies. Prior to joining Pfizer in early 2015, she developed and validated esoteric testing assays for the Hematology/Oncology R&D group at Quest Diagnostics-San Juan Capistrano. Amber holds a Ph.D. in Molecular Biology & Biochemistry, with a focus in Immunology, from the University of California, Irvine.
Dr. Katz is a board-certified internal medicine physician and director of clinical applications for Calviri, Inc. In this role, Dr. Katz has been instrumental in setting up early-phase clinical trials for FAST Vaccines (Frameshift Antigens for Specific Therapy), for multiple indications including pediatric brainstem tumors as well as adult head/neck and non-small cell lung cancers. Dr. Katz’s medical training was completed at Georgetown University Hospital; he continues to practice inpatient hospital medicine at the University of California – San Diego. He is also the founder of Clinical Strategy, LLC, and is a nationally-recognized clinical educator, having taught at over twenty US medical schools. Dr. Katz’s background in translational research includes previous work in biochemistry and neuroimaging, ongoing drug discovery work for neurodegenerative disease at the University of Pennsylvania, and oncology diagnostics and therapeutics at Calviri and the Biodesign Institute in Arizona.
Naveen Babbar, Ph.D., is currently a Precision Medicine Leader at Novartis Oncology. Before joining Novartis in 2014, Naveen led product development teams at multiple diagnostic companies, including Genmark Diagnostics. Naveen holds a Doctorate from the University of Arizona and a Postdoctoral fellowships from Sidney Kimmel Cancer Center at Johns Hopkins.
Dr. Qian Wu (go by Vicky) is the Assistant Member at Fred Hutch. Vicky received her Ph.D. in Biostatistics at UPENN and her advisor is Dr. Hongzhe Li. She got her M.S. in Biostatistics at UCLA and B.S. in Statistics at Beijing Normal University. Vicky has worked as part-time researcher at Radiation Therapy Oncology Group (RTOG) from 2010 to 2013, and then worked as a statistical consultant at BioStat Solutions Inc until she joined Hutch in June 2016. Vicky’s major research focus is using complex genetic/biomarker information to optimize trial design and developing efficient statistical algorithms to identify patient subgroups with better/worse responses/survival profile to a particular treatment.
Elisabeth (Els) Coart, PhD, is Director, Consulting Services IDDI. She is IDDI’s expert in analytical and clinical validation of IVDs. She has a strong background in assay development combined with 10 years’ experience as statistician for biotech and diagnostic industries. She has a longstanding interest in Alzheimer’s disease (AD) biomarkers and presents IDDI’s work in this field at AD symposia (AAIC, AD/PD). Areas of Expertise:
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.
Jason Christiansen, Chief Technology Officer for Boundless Bio has served in multiple leadership positions overseeing the development of new technologies and strategies for, research, diagnostic use, and targeted therapy development. He has served as Head of Assay Development at Roche Sequencing Solutions, providing leadership in initiatives around oncology testing, Dx development, NIPT testing and platform development. Prior to Roche, Jason was VP of Diagnostics at Ignyta, where he led CDx development efforts including an in-house CLIA laboratory and molecular testing R&D group working both internally and externally to drive molecular testing in support of a global clinical trial for Rozlytrek (entrectinib). Prior to Ignyta, Jason served in multiple senior positions developing new platforms and technologies in NGS, digital pathology and molecular testing so that they could be brought into the clinical laboratory for patient testing and to support drug development.
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.
Nicole has responsibilities to drive the integration of key functions of JSR Life Sciences portfolio companies in support of the services and products development. Nicole formerly served as Head of Field Marketing for WuXi AppTec Laboratory Testing Division, a healthcare consultant at Quintiles and regional sales leader at GenScript. Nicole received her PhD in Biochemistry from Indiana University, Bloomington and MBA from Columbia University.
Ian Pike is the Chief Scientific Officer at Proteome Sciences and has 30 years’ experience working in the diagnostics and biotechnology sectors. Having gained a PhD in Medical Microbiology, he joined Welcome Diagnostics as a research group leader and spent 8 years working on new diagnostic assays, particularly for hepatitis. In December 1999, he joined the Technology Transfer Office of the UK Medical Research Council with responsibility for patents and commercialization of a wide portfolio of technologies related to the biomedical sector. Ian also worked for Cancer Research Ventures managing intellectual property and performing business development activities in Europe and the USA. 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.
BJ Kerns has more than thirty years of marketing and business development experience along with a successful track record in diagnostics. BJ has helped HTG penetrate the clinical research market and develop its diagnostic applications utilizing our unique qNPA system for clinically relevant gene expression signatures. Prior to joining HTG Kerns was the director of integrated solutions and molecular diagnostics at Promega Corp. Inc. A seasoned diagnostics executive, Kerns held several positions at Ventana Medical Systems Inc., including director of women’s health, director of strategic marketing and senior director of product technical support in operations. While at Ventana she launched the company’s first FDA-cleared companion diagnostic PATHWAYÂ® HER-2. Kerns has also managed a variety of functions at BioGenex and Becton Dickinson, including business development, sales and marketing, and research and development.
Kristin is leading a novel Molecular Disease Characterization program that provides new opportunities to benefit cancer research and patient empowerment. Prior to this role, as Biomarker Lead, Kristin developed Biomarker strategies for gene-engineered T cell therapy clinical trials ranging from first-in-human Phase I through Pivotal Phase II. Kristin joined the Clinical Biomarker Team after conducting preclinical translational research in the Oncology Cell Therapy Research Unit. Prior to joining GSK, she worked at the University of Pennsylvania within the Center for Cellular Immunotherapies working on generation of CAR T cells and CAR macrophages, across solid and liquid tumor indications, under the mentorship of Drs. Carl June, Laura Johnson, and Saar Gill. Prior to UPENN, Kristin worked analyzing patient samples at Fox Chase Cancer Center (Philadelphia, PA). Kristin got her start in cancer immunology research with Dr. Charles Drake at Johns Hopkins University in characterizing checkpoint blockade molecules LAG3 & PD-1 on T cells. Her formal education was in Biology/Biotechnology at Shippensburg University.
Michael Yasiejko serves as Chief Commercial Officer at Tempus, where he leads customer collaborations for providers and industry partners. Prior to Tempus, Michael was a Principal at Bain and Company, where he supported clients in multiple industries in growth strategy, commercial excellence and performance improvement. He has also advised early-stage emerging technology ventures to accelerate growth and scale operations. He began his career at W.L. Gore as an engineer before moving into healthcare at Eli Lilly and Intuitive Surgical in several commercial capacities. Michael received a bachelor’s degree with honors in Engineering from Virginia Tech and earned an MBA from the University of Chicago Booth School of Business.
Burkhard Jansen, MD, is a melanoma expert with background as a tenured professor of both dermatology and clinical pharmacology with FDA experience. Dr. Jansen has served as founder, director, and senior executive of a number of dermatology and oncology focused life sciences companies, including Novelix, Avienne, and Oncogenex in the US, Canada, and Europe. His scientific work is published in leading peer reviewed journals including Lancet, Nature, Nature Medicine, PNAS and top-tier dermatology and oncology journals. Dr. Jansen received his medical doctorate and dermatology training from the Universities of Graz and Vienna in Austria, his postdoctoral science training at the University of Minnesota, and his executive business education at UCLA.
Karina Kulangara holds a Bachelor’s degree in Biological Sciences and a Master’s degree in Immunology and Pathology from Geneva University, Switzerland; she earned her PhD degree at the Federal Institute of Technology in Lausanne, Switzerland. She conducted research in the field of medical devices at Duke University, Durham, NC and joined Agilent over 5 years ago. During her time at Agilent she has been working closely with Pharma partners to develop companion diagnostic assays. She was also involved in the Blueprint I project comparing several PD-L1 assays in the pre-market setting.
Jennifer is a skilled cancer cell biologist specializing in experimental pathology, biomarker discovery, platform development and image analysis techniques. She is currently a Principal Investigator in the digital pathology department at Navigate BioPharma Services and leads the development of new technical applications using the immunofluorescence-based automated quantitative analysis (AQUA) technology. Jennifer manages digital pathology group activities related to early phase clinical trial testing, data analysis and process optimization for complex and specialized projects.
Dr. Traylor is a published scientist and has served as a Medical and Clinical Affairs professional in healthcare industry for more than 20 years. Her career has spanned big pharma companies, mid-sized pharma, cell therapy and medical devices, and cancer diagnostics. She is passionate in the belief that the success of clinical research moving forward is completely dependent on appropriate use of biomarkers, advanced technology and real-world data collection. At Biodesix, as the head of clinical development and medical affairs, Dr. Traylor works cross-functionally to advance diagnostics from early stage development to post-market clinical utility studies, constantly exploring ways to implement new tools to maximize study design for optimal patient outcomes. Dr. Traylor joined Biodesix in 2015 to contribute to their multi-omic approach for identifying clinically relevant biological signatures that robustly characterize disease states and response to therapies, which she considers the new norm for clinical research and precision medicine.
Dan Edelstein, M.S., MBA is VP of Commercial Operations at Sysmex Inostics. He previously studied at Johns Hopkins School of Medicine and worked on the initial clinical studies of circulating tumor DNA with Bert Vogelstein’s group. In 2011, Dan led the development of a CLIA laboratory for BEAMing-based (enhanced digital PCR) ctDNA analyses, delivering the first commercial ctDNA assay for clinical practice and prospective clinical trials. Since then, he has worked on clinical utility evidence development and novel reimbursement pathways for ctDNA assays for the management of patients with cancer from therapy selection to disease monitoring.
Dr. Miller is a scientist, inventor and entrepreneur dedicated to Improving Lives with Precision Diagnostics®. He founded Invivoscribe twenty-five years ago. This privately-held global network of eight wholly-owned companies has proven expertise in designing, validating, and commercializing internationally standardized RUO and IVD molecular tests, controls, and bioinformatic software products. Many of these optimized tests target biomarkers that are used to improve drug efficacy through better selection of patients for drug trials and therapeutic treatment regimens. Invivoscribe’s tests and software are also used to monitor and track subject response throughout the course of treatment. The company’s Streamlined CDx® program has accelerated submissions and approvals worldwide. Dr. Miller received his undergraduate degree in Biochemistry from UCLA and a combined Ph.D. in Biochemistry & Molecular Biology from UCSB.
Currently Business Development Manager for Leica Biosystems’s Companion Diagnostics business in the Pharma Partnerships Unit. Previously in a variety of roles with Beckman Coulter, Inc. including Open Innovation Development, Alliance Management for Molecular Diagnostics, Corporate Business Development (M&A) and Corporate Licensing. Ph. D in Biochemistry and Biophysics from Texas A&M University and a BS in Biochemistry from Pennsylvania State University.
Dr Ghoddusi has over 15 years of experience in some of the most challenging areas of oncology with focus on drug discovery and clinical development. Dr Ghoddusi has broad and overarching insights into unmet therapeutic areas with expertise in translational sciences and clinical biomarker development which allows him to provide unique perspective on how to propel therapeutic projects from discovery to approval. Trained as a translational pathologist he has held numerous positions at large pharmaceutical and small biotech companies including Novartis, Celgene and Juno Therapeutics. His current focus is Gene and Cellular Therapy.
Kristina McGuire, Ph.D. has spent her career in the field of precision medicine and companion diagnostics and is currently a Sr. Director of Precision Medicine at Regeneron in Tarrytown, NY. Kristina has been at Regeneron since 2017 and is building and leading a team that is responsible for delivery of companion diagnostics as well as leading biomarker operations. Throughout the course of her career, Kristina has gained valuable experience in various aspects of precision medicine and companion diagnostics from positions held at pharmaceutical/biotechnology companies as well as at institutions that provide outsourced laboratory work for the pharmaceutical industry. Her early career at Amgen focused on assay validation; first in a GMP environment and then applying sound validation principles across various technologies to build processes for fit-for-purpose biomarker assay validation and clinical sample analysis for clinical trial support. From there she has continued to support precision medicine but focused her career to become an expert in companion diagnostics and supporting successful patient selection strategies for eventual registration of both the drug and the diagnostic.
Dave Stanforth has over 20 years of experience in IVD / CDx development working in both diagnostic companies and pharma. He worked at Dako / Agilent where he held positions in leadership positions in product development, program management and business development. He led the development of the first companion and complementary diagnostics for PD-1 / PD-L1 checkpoint inhibitors in partnership with Merck and BMS. He joined Daiichi Sankyo in 2017 where he led the development of CDx assays for Daiichi’s ADC portfolio. Dave is currently heading up IVD Strategy and Development for Amgen and is the global team lead for the development of CDx assays for Amgen’s G12C targeted therapy AMG 510.
Christelle Fasano is a strategic leader who understands the needs and priorities of the world’s top pharma and biotech companies. As the Senior Director of Business Development for Pharma and Biotech at Imagia, Christelle leverages her healthcare knowledge & strong relationships with top global companies to co-create products using Imagia AI expertise. Leading projects for the pharmaceutical and diagnostic industries during the rise of precision medicine, Christelle spent more than 20 years in Pharma and strategic healthcare consulting firms across the EU and Canada. She most recently spearheaded Montreal International’s Life Sciences & Health Tech division while leading the International AI for healthcare initiative. Within this investment promotion agency, Christelle attracted foreign direct investments for developing the Greater Montreal life sciences ecosystem. Christelle is a Doctor of Pharmacy (PharmD) and holds a Masters Degree in Industrial Pharmacy from the University of Lyon.
Liying started EpigenDx to provide genomic and epigenomic solutions to research and pharmaceutical communities with the focus at product development and lab services in DNA methylation analysis. Before starting EpigenDx, she worked as a process development scientist involving DNA Pap testing kit validation and production scale up at Digene Corporation. Later, she worked at Apogene Discoveries as a scientist involved in an entire process of developing a diagnostic kit for bacterial screening in platelets. In 2001, she joined Pyrosequencing, where she developed the expertise in Pyrosequencing technology and was directly involved in the development, validation, and final market launch of PyroMark RUO kits. She earned a Bachelor of Medicine in Shanghai University of Chinese Medicine and Pharmacy, a Master of Sciences in Organic Chemistry at University of Alabama in Huntsville, and a Master of Sciences in Molecular Biology at University of Oklahoma Health Science Center.
Dr. Lokesh Agrawal at NCI, directs and leads projects on biospecimen integrity and understanding the role of biospecimens in biomarker development by studying pre-analytical variables using molecular approaches. Currently at NCI he also leads and directs a Cancer Moonshot Biobanking program. Dr. Agrawal has expertise in biomarker development including clinical laboratory science and regulatory experience to strengthen programs in biospecimen acquisition and biospecimen research. Before joining NCI in 2012, Dr. Agrawal worked at MedImmune Inc./ Astrazeneca, and Rapid pharmaceuticals where he was a team leader on various projects involving pre-clinical/clinical biomarker assay development/validation and managed several cross functional teams across to qualify and validate clinical biomarker assays in oncology, vaccine and infectious diseases space. Dr. Agrawal also led and directed several gene therapy NIH-sponsored projects at Thomas Jefferson University and did his postdoctoral fellowship at Indiana University-Purdue University at Indianapolis (IUPUI, where he discovered the role of CCR5 Delta32 protein in HIV pathogenesis. He earned his Ph.D. from All India Institute of Medical Sciences, India and has authored and co-authored several manuscripts in high impact journals. Dr. Agrawal current main interests include development and validation of predictive and prognostic biomarkers using biospecimen science for cancer treatment and diagnosis.