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Abhishek |
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Gupta |
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Senior Director, Research & Development | Quality Capabilities |
BlueRock Therapeutics |
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Abhishek is a senior data, business, and technology leader with more than 2 decades of experience in building and driving digital and transformation capabilities within the pharma and biotech environments. He is primarily recognized for enterprise perspective, technical acumen, and collaborative style. Abhishek currently heads up the strategic as well as operational aspects of digital capabilities and solutions for clinical development and quality assurance at BlueRock Therapeutics.
Previously, Abhishek led diverse leadership roles across Sage Therapeutics and Vertex Pharmaceuticals. Abhishek holds a master’s in strategic management and a bachelor’s in CS & IT. He is also an MIT fellow for systems design and management. |
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Allison |
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Kemner |
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Vice President, Clinical Sciences and Operations |
Tyra Biosciences |
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As a clinical nurse scientist, Allison Kemner’s focus is grounded in patient-centered cancer care. and access to clinical trials. During her 20+ year career, she has held senior and executive positions in drug development at large and small companies pursuing operational excellence while delivering value to the business. She has been part of numerous submission teams. supporting multiple FIH INDs for novel NCE through to NDAs and sNDAs.
For the last several years, her attention has been on instituting early collaboration with patients and advocates, ensuring their voices are present throughout clinical development.
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Amy |
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McCagg |
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Executive Director and Head, Patient Innovation |
Sarepta Therapeutics |
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Amy McCagg, MBA, is a biopharmaceutical leader with over 20 years of drug development management, contributing to 7 approvals and label expansions. Ms. McCagg began her career leading the clinical operations for large cardiovascular outcomes trials with the TIMI Study Group. Following her transition into industry, she focused on rare diseases and highlighted the patient voice within clinical development and commercial. She spent the last 10 years leading teams within Sanofi-Genzyme, Rhythm Pharmaceuticals, and Sarepta Therapeutics to improve patient identification, include the patient perspective within protocols, and offer services to reduce barriers to clinical trial participation. |
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AnneMarie |
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Winkler |
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Associate Director, Clinical Trial Optimization and Innovation |
Genmab |
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Business Lead for DEI in Clinical Trials. Lead for patient experience and patient-focused drug development across R&D. Prior to joining Genmab, I was Development Unit Lead for Patient Engagement, Equity & Transparency at Biogen, Manager Clinical Operations, Syneos Health/Merck, Indication Lead for Global Trial Optimization at Syneos Health/Merck, for End-to-End Feasibility and Recruitment in Tumor Agnostic Basket Studies, Novel Biomarkers, and Rare Diseases. During my time as Clinical Research Manager and IRB Administrator, Portsmouth Regional Hospital also served on New Hampshire’s Comprehensive Cancer Collaboration: Emerging Issues Work Group, Public Policy Education Committee Head of Human Rights Protections, and Patient Advocate at North Suffolk Mental Health. |
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Bill |
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Jackson, Ph.D |
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Founder & CEO |
Base Pair Biotechnologies, Inc. |
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As CEO of BasePair Biotechnologies, Bill has been leading the development and commercialization of aptamer-based diagnostics and therapeutics since 2012. In addition to private capital, Dr. Jackson has also secured significant non-dilutive funding through government grants and contracts as well as revenue from earlystage products and services. He has served as principal investigator on more than 20 federally funded research projects and established collaborations with clinicians and researchers at world-class research institutions and universities. Bill also serves frequently as a panel reviewer regarding molecular diagnostics and related tools, environmental monitoring, and biodefense. His stated mission is to leverage the potential of aptamers to create innovative solutions for global health and environmental challenges, and to advance the field of aptamer science and technology. |
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Caroline |
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Potts |
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General Manager – MRN Site and Patient Services |
MRN |
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Before joining MRN, Caroline worked in the public sector for 15 years supporting research in hospitals and the primary care setting as well as providing support to research academics by writing funding applications, making submissions to regulatory authorities and running a large portfolio of studies to ICH- GCP requirements in clinical specialties such as stroke medicine, Parkinson’s disease, orthopaedics, gastrointestinal medicine and respiratory medicine. During this time, Caroline was one of the founding members of the UKRD group as well as an Executive member of the RD Forum providing R&D Directors and research staff working in the public sector with strategic guidance in supporting high quality research in the NHS. In her current role, Caroline leads the development and expansion of MRN’s global site network, site training programs, and on-site support services. |
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Charlie |
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Pattrell |
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Associate Director, Solution Engineering |
IQVIA |
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Ed |
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Carneglia |
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Business Development Manager |
Peli BioThermal USA |
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Frank |
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Leu |
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Founder & Managing Member/ Managing Member |
BioPharMatrix LLC/ Novapeutics LLC |
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Frank Leu is a Founder & Managing Member/ Managing Member of BioPharMatrix LLC/ Novapeutics LLC located in Philadelphia, developing a first-in-class insulin-producing beta-cell restoration curative for diabetes. Prior, Frank was at a specialty pharma, Verto Institute, developing curatives for a neuroendocrine cancer. Frank received his Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences, postdoc-ed at a HHMI lab at the Rockefeller University, and served as an instructor at the Rutgers Cancer Institute of NJ. Currently, he is an adjunct professor at Thomas Jefferson University, advisor to 1776 for Pennovation Center Labs, founder of BioPharMatrix (life-science ecosystem), and serving on numerous life-sciences advisory boards. |
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George |
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Naumov |
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Chief Operations Officer & Chief Business Officer |
RS Oncology |
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Graham |
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Wylie |
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Executive Chairman |
Medical Research Network |
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James |
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Kirwin |
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COO and Head, Clinical Development Operations |
SFA Therapeutics |
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James Kirwin is a seasoned pharmaceutical executive with over 20 years industry experience and has been involved in more than 20 NDAs. He has experience at major pharmaceutical companies such as AstraZeneca where he was Clinical Operations Team Lead for the Nexium program. He was VP of Global Clinical Development Operations at Wyeth Pharmaceuticals for the 10 years prior to its acquisition by Pfizer. Since then, he has led Clinical Development Operations at several startups, Intrexon, Intercept Pharmaceuticals, Iterum Therapeutics and Arvinas. He has been responsible for many “firsts” in clinical trial operations. While leading Global Clinical Operations at Wyeth, he was the first to implement Electronic Data Capture across all studies in the company globally. He developed the concept of the Functional Service Provider Model with RPS, implementing a US based monitoring group and also developed back-office data management and Trial Master File support in Bangalore India in partnership with Accenture. |
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Jamie |
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Morisco |
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Vice President, Sales, Marketing & Operations |
Glemser Technologies |
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Jamie serves as a Director of Sales for Glemser. In this role, Jamie draws from his extensive background in technology and business transformation to assist clients along their modernization journey.
Jamie has a proven track record leading clients and team through complex technology enabled transformations delivering benefits across time, quality, cost and compliance.
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Justin |
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Buie |
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Clinical Program Manager |
Candel Therapeutics |
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Maria |
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Margarita Corvez |
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Global Program Director Hematology |
AstraZenca |
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Meredith |
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Frank-Molnia |
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Vice President, Clinical Affairs |
Vericel Corporation |
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Meredith joined Vericel in 2024 with more than 25 years of experience in the clinical research industry. She most recently served as Senior Director of Clinical Operations at Third Pole Therapeutics. Prior to Third Pole, Meredith also held roles of increasing responsibility at Axiom Real-Time Metrics, Advanced Clinical, Smith & Nephew, and Stryker Biotech.
Throughout her career, Meredith has been involved in various aspects of clinical operations, including project management, vendor selection, implementation of new technologies, and regulatory approvals. She holds a B.S. in Biology and German Literature |
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Michael |
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Kleinrock |
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Senior Research Director, IQVIA Institute for Human Data Science |
IQVIA |
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Michael Kleinrock serves as Research Director for the IQVIA Institute for Human Data Science, setting the research agenda for the Institute, leading the development of reports and projects focused on the current and future role of human data science in healthcare in the United States and globally. Kleinrock leads the research development included in Institute reports published throughout the year. The research is focused on advancing the understanding of healthcare and the complex systems and markets around the world that deliver it.
Throughout his tenure at IMS Health, which began in 1999, he has held roles in customer service, marketing, product management, and in 2006 joined the Market Insights team, which is now the IQVIA Institute for Human Data Science.
He holds a B.A. degree in History and Political Science from the University of Essex, Colchester, UK, and an M.A. in Journalism and Radio Production from Goldsmiths College, University of London, UK. |
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Michael |
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Tolentino |
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Co-Founder, Chief Innovation Officer |
Aviceda Therapeutics |
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ML |
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Ujwal |
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Associate Director, Data Science |
Johnson & Johnson |
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ML Ujwal PhD leads the PSTS/Data Science at Janssen R&D (J&J). He is a proven scientific leader with a strong pedigree in Drug Discovery and Applied Machine Learning. He has 15+ years of experience in academia, biotech, and large pharma. Before joining Janssen R&D, he co-founded and was the head of Data Sciences at Inciton, an early-stage startup that used MD simulations and ML approaches. Earlier he led predictive toxicology efforts at Eli Lilly & Co. He was on staff at the Institute for Genomic Research (TIGR). His academic credentials include MIT Engineering Management with an emphasis on systems thinking and ML frameworks. As an IIJMB Wood-Whelan fellow, he is a joint PhD in Computational Biochemistry/Biophysics from the Indian Institute of Science (IISc) and the University of Texas, Austin, followed by post-doctoral work both at Yale and Harvard. He has extensively published in peer-reviewed journals and serves on scientific advisory committees. |
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Nancy |
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Dubois |
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Head, Global Patient Safety, US Region |
EMD Serono, Inc. |
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Dr. Nancy Dubois oversees Global Patient Safety for the US Region at EMD Serono. With over 20 years of expertise in healthcare and clinical trial research, she has held significant roles in both academic and sponsor environments. Over the past decade, Dr. Dubois has excelled in managing pharmacovigilance programs, implementing REMS ETASUs in healthcare settings, establishing compliant safety operations for US startups, and offering strategic insights to improve global collaboration and operational efficiency by dismantling silos. Her clinical training and extensive experience underscore her commitment to patient safety and innovation in the healthcare industry. |
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Naouel |
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Baili |
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Director, AI Scientist |
IQVIA Technologies |
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Naouel is an expert in emerging technology solutions, leveraging over ten years of experience in the life sciences industry to transform clinical trial management. Her proficiency in embedding sophisticated AI tools into SaaS platforms has significantly improved both user experience and operational efficiency. A holder of a Ph.D. in Computer Science, she excels in the development and design of innovative AI capabilities that streamline and optimize clinical research. |
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Pawan |
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Gandhi |
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Director, R&D |
Glemser |
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Pawan serves clients as the Director of Global Research and Development. He brings along extensive experience in designing and implementing enterprise compliance solutions for life sciences clients. Pawan directs and coordinates development activities for organizational products to deliver quality solutions catering to complex regulated use cases. |
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Rakibou |
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Ouro-Djobo |
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Global Clinical Supply Chain & Logistics Leader |
Bill & Melinda Gates Medical Research Institute |
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Rakib Ouro-Djobo is a visionary supply chain leader with over 15 years of experience driving global impact in life sciences and biotechnology. As the Clinical Supply Chain Lead at the Bill & Melinda Gates Medical Research Institute, he leverages and implements innovative supply chain strategies that streamline clinical trial materials (CTM), packaging, and labeling for global distribution. His leadership has been instrumental in advancing cutting-edge storage technologies and fostering global networks that ensure the seamless delivery of life-saving treatments, particularly in low-income countries. Rakib is committed to leveraging his expertise to transform clinical supply chains and accelerate worldwide access to critical health interventions.
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Seshu |
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Tyagarajan |
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Chief Technical and Development Officer |
Candel Therapeutics |
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Dr. Seshu Tyagarajan is the Chief Technical and Development Officer at Candel Therapeutics. She has two decades of technical, manufacturing and development experience in Biologics and Cell & Gene therapies. Prior to Candel, she was Global Head, CMC Strategy for CGT at Novartis where she developed the clinical and commercial manufacturing strategy for T-Charge™(CAR-T). She successfully led several BLAs and INDs and was a key contributor to the groundbreaking BLA submission for Kymriah®.
Seshu held roles of increasing responsibility at Merck, Roche, Phyton, Biogen and Lilly. She holds a Ph.D. in Chemical and Biochemical Engineering (Rutgers), and MS in Bioengineering (Purdue).
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Yuyi |
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Shen |
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Vice President, Technical Operations |
Abcuro,Inc. |
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Yuyi Shen is an inspirational CMC thought leader with management experience in biopharmaceutical development, manufacturing, and clinical supply chain. She is an accomplished program leader in the early to late phase development and commercialization of a wide range of recombinant proteins for immuno-oncology, infectious and rare disease drug platforms. She brings extensive expertise in CDMO selection and oversight, facility/team build- out, technology transfer, budget planning, partner collaboration, and CMC strategic direction of global regulatory filings. She is also an industry-recognized innovation-driven CMC expert on disruptive technology implementation, including process modeling, to deliver with high efficiency and better quality under an accelerated timeline.
She served various leadership roles in CMC at large pharma to emerging biotech companies, including Bolt, XOMA, Bayer, BioMarin, and Grifols. She holds a Ph.D. degree in Chemical Engineering from the University of California, Davis. |
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Uday |
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Harle |
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Assistant Vice President and Head, Global Clinical Research |
Kashiv Biosciences |
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Uday Harle is a global clinical development leader with two decades of experience as Ex-Global Head at Abbott, Ferring Pharma, and is presently serving Kashiv Bioscience and an associated group of companies. PhD in medicine with many research publications, awards, and scientific text book authors. |