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Jim |
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DiCesare |
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Vice President, Financial Management Solutions |
IQVIA Technologies |
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Jim DiCesare is passionate about delivering innovative Cost Benchmarking, CTA Negotiation and Site Payment services that support clinical research conducted by sponsors and CROs. With over 25 years of industry experience leading clinical operations teams at Merck, DrugDev, and now IQVIA Technologies, Jim has expertise across the contracting, budgeting, and investigator grant payment management continuum. He is a frequent speaker at industry conferences and has written for a variety of publications. He has a B.S. in Accounting from Kutztown University. |
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Kevin Landells |
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Vice President, Business Head for IRT |
IQVIA Technologies |
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Kevin has over 25 years of experience in the IRT/ RTSM industry, having worked across many technical and project management leadership roles. Experienced with developing and leading global teams delivering managed services spanning operations, project management, client partnerships and Business transformation. Kevin is passionate about improving healthcare and utilizing technology that makes a real difference to patients’ lives. Kevin holds a Bachelors’ Degree in Computer Science from Hertfordshire University in the UK.
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KK |
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Rumrill |
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Senior Director, Site Suite |
IQVIA Technologies |
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KK Rumrill has more than 25 years’ experience in product development, customer support, and implementation services teams in clinical trials. She was a key leader in client operations at BBK Worldwide, driving growth in global patient recruitment, site engagement, and trial optimization. In 2013, KK moved to TrialNetworks, which was acquired by DrugDev and subsequently by IQVIA in 2017. She now leads several key product teams in IQVIA Technologies’ Orchestrated Clinical Trials platform. |
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Murray |
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Aitken |
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Executive Director, Senior Vice President |
IQVIA Institute for Human Data Science, IQVIA |
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As head of the IQVIA Institute for Human Data Science, Murray Aitken provides policy setters and decision-makers in the global health sector with evidence, analysis, and insights that contribute to the advancement of Human Data Science to improve human health outcomes. Aitken is tasked with creating and managing a research agenda that leaders in global governments, payers, providers, academia, and the life sciences industry use to accelerate the understanding of global trends in disease patterns, data science, and technology. This research is used to foster innovation critical to evidence-based decision-making and the advancement of human health. |
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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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Amit |
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Gulwadi |
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Vice President, Head of Transformation |
Alexion Pharmaceuticals, Inc. |
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Amit is responsible for leading Data Science, Digital and Operating Model Transformation of Alexion’s Development, Regulatory and Safety (DRS) functions which involves use of several cutting edge technology, analytics, partnership programs with a variety of partners and process redesign with a goal to accelerate the execution of the portfolio, drive patient centricity into clinical development, regulatory and safety operations to unlock value of data & strengthen risk posture. Post-acquisition of Alexion by AstraZeneca (AZ), he led a very large and complex integration program to harmonize and secure access to advanced AZ capabilities across technology, analytics, geographic footprint expansion and frameworks such as RBQM to accelerate Alexion’s clinical development pipeline. Amit continues to lead numerous technology and other transformation programs across Alexion and AZ. In addition, he is the Digital lead for rare disease, where he is responsible for the development and execution of innovative digital efforts for heterogeneous use cases in the rare disease. Amit holds a Masters Degree in Neuropharmacology from Massachusetts College of Pharmacy in Boston, Masters in Pharmacognosy from University of Mumbai (India) and Bachelors in Pharmacy from University of Pune (India). |
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Barry |
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Moore |
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Head, Randomization and Trial Supply Management |
GSK |
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Barry Moore has been a clinical trial chain professional working in the field for more than 25 years. While working at both the sponsor and vendor, He has gleaned a wealth of experience in systems development and clinical supply chain management. As a recognized thought leader, Barry has been pushing for the adoption of advanced technologies across the clinical trial supplies landscape. His strategic insight and adept leadership have significantly contributed to the optimization of clinical study operations, making him a respected figure in the life sciences sector. |
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Brian |
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Dole |
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Vice President, Global Clinical Supply Chain |
Bristol Myers Squibb |
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Brian has over 20 years of experience in exploring and advancing game-changing supply chain and product development resource capabilities for bio-technology industry leaders. He has in-depth experience in supply chain, design thinking, next-generation technologies, technical and lean process excellence, and digital transformation. Brian leads the global clinical supply chain organization delivering on the promise to patients across the BMS global footprint. Brian brings a passion for technology and supply chain and is excited to discover, learn and grow. |
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Eve |
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Dryer |
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Vice President, Patient Advocacy Emerita |
Travere Therapeutics |
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Eve Dryer recently retired as Vice President, Patient Advocacy at Travere, and has served as a patient advocacy leader for more than 25 years. She is a founder of the Rare Disease Diversity Coalition, which is actively addressing delays in diagnosis and treatment of rare disease patients of color. Prior to Travere, Eve worked on rare oncology with Lexicon Pharmaceuticals, where she built the Patient Advocacy strategy and team. Working with Sisters Network, the national African American breast cancer association, she launched Teens for Pink, to engage African American teenagers in breast cancer education and family health navigation. She spent 15 years as a partner in a healthcare PR agency, Vox Medica, working with clients including AstraZeneca, GlaxoSmithKline, Eisai and Janssen. She was the Healthcare Businesswomen’s Association’s 2013 international STAR honoree for her efforts in mentoring up-and-coming women healthcare leaders, and was recognized in the PharmaVOICE 100 in 2008, 2016 and 2021 for her innovative work in patient advocacy and her health diversity and equity efforts. |
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Kathy |
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Machuzak |
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Former Director, Patient Advocacy |
Travere Therapeutics |
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Kathy Machuzak is a Patient Advocacy Executive with experience in rare kidney and rare metabolic diseases, oncology, rheumatology and ophthalmology. She brings the patient voice to early development through commercialized products. Her work in DEI has helped biopharma to understand various patient communities and diversify clinical trials |
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Jackie |
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Foster |
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Senior Director, Clinical Supplies |
PTC Therapeutics, Inc. |
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Jackie Foster has been with PTC Therapeutics, Inc. since Dec. 2021 and is Senior Director, Clinical Supplies. She has over 22 years of experience in the pharmaceutical industry from both pharmaceutical companies and contract manufacturing companies. Her experience includes a wide range of roles within the clinical trial supply chain, giving her unique insight into the end-to-end clinical trial management process. In her current role, she manages a team of Clinical Supplies professionals and works with cross-functional colleagues to ensure efficiency and quality in the planning and execution of clinical trials. Jackie has her BA in Business Management from Moravian University
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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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Karrie |
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Hilsinger |
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Senior Director, Head of Clinical Operations |
UroGen Pharma |
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Karrie Hilsinger has over 20 years of global clinical operations leadership experience, having held leadership positions at companies such as Covance, Eisai, Hoffmann-La Roche as well as pharmaceutical startup companies such as Immunomedics and medical device organizations. Karrie, in many of her previous roles has been responsible for FDA inspection readiness and Preparedness. She has experience in all phases of Clinical Research and has a range of therapeutic experiences as well. |
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Rose |
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Satz |
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Founder & CEO |
AIP |
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Paresh |
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Patel |
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Former Global Head, Clinical Intelligence |
Otsuka Pharmaceutical Companies (U.S.) |
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Paresh Patel is a visionary in Clinical Data, Systems, and Operations, pioneering advanced technologies for operational excellence. He led global initiatives like enrollment forecasting models and Covid-19 impact assessments. As a Data Science Technologist, he drove efficiency through automation and innovative review processes. His tenure saw the transformation of teams and strategic partnerships for technological advancements. Paresh has championed excellence, revenue growth, and collaborative relationships throughout his career, ensuring the highest standards in clinical research operations |
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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. |