Outsourcing in Clinical Trials East Coast 2021

Biography:

• Susan has 20+ years of experience working in the early development space with Bristol-Myers Squibb
• She is a RN with a Masters Degree in Health Care Administration
• Has held a variety of roles such as Administrator of BMS Phase 1 Clinic,  Outsourcing Manager and recently is the Director of Clinical Pharmacology and Oncology Operations

Session Details: Is the Full Service Approach the Best Outsourcing Model When Working with Tight Timelines and Budgets? Exploring the Options to Help us Come to the Best Decision 25-05-2021, 11:45 am View In Agenda

Biography: 100 Most Influential Leaders in Healthcare 2014, 2015 & 2016 50 Most Influential Physicians Leaders and Executives 2013,2014,2015 & 2016 Top 25 Minority Healthcare Executives in Nation 2012,2014 &2016 Chicago United’s Business Leaders of Color for 2013. Who is Who in Chicago Chicago’s Most Influential People- Crain’s Business 2012 & 2013 Becker’s Top Physician Executives 2013 &2014 Becker’s 20 Hospital and Health System Leaders to Follow on Twitter Hispanic Health Leadership Award National Hispanic Health Foundation Community Service Award Touro College 2015 Healthcare Visionary award Comunilife 26th anniversary Breakfast 2015 Distinguished Leader of Indian Origin AAPIQLI Gala 2015 Excellence in Health services Award; Concerned Women of Brooklyn Crown Heights Jewish Community Council Humanitarian Award 2016 National Minority Quality Forum: Booker T Washington Award (for promoting Diversity at all levels and reduce healthcare disparities at a national level) 2016 Wheel Chair Charities: Health Care Visionary Award 2016 Primary Care Development Corporation Leadership award 2016 CRAIN 100- 100 Innovators, Disruptors and Change-Makers in Business 2016 South Asian Council for Social Services SACSS; Award in recognition of service to immigrant communities Community Award- Russian American Foundation 2010 Humanitarian award- Metropolitan Auxiliary 2011 Standing on our Fathers Shoulders- Congressional Citation 2012 Healing Hands Award – Chicago Family Health Center 2013 Doctorate of Humane Letters- NY College of Podiatric Medicine 2014 NYC Public Advocate’s Award for Public Service 2014 Tamil Ratna US Tamil Sangam 2014 Leadership and Service Award TANA 2015 Justice and Opportunity Award NY Immigration Coalition `2015 Leadership Award Indian Association of Long Island 2015 Tamil Pioneer Award Federation of Tamil Sangams USA 2015 Professional Achievement Award- Medical Society of the County of Kings

Session Details: PANEL DISCUSSION Studying the Importance of Getting A Diverse Patient Group Onto Your Study 25-05-2021, 11:45 am View In Agenda

Biography: Jigna Parekh is a registered Pharmacist with a degree in PharmD and MS in Pharmacology & Toxicology. Dr. Parekh has over 12 years of experience working in clinical research with extensive knowledge of phase I, II, III, extension clinical trials (in-patient and out-patient studies). She has managed diversified global clinical trials that are in-house based, consortium, fully outsourced and partially outsourced in various therapeutic areas such as Rare disease indications, Oncology (adult and pediatric), CVS, CNS, Respiratory (adult and adolescent) and Diabetes. She has experience working for both CRO & Sponsor in clinical trial conduct and presents strong leadership, decision-making and problem-solving skills. Dr. Parekh joined Incyte not very long ago as a Senior Clinical Trial Manager and is very excited to join the team. She is currently managing rare disease clinical trials at the Incyte’s Inflammation & AutoImmunity (IAI) group. In addition, Dr. Parekh interacts with media with regards to clinical trial processes, presenter at the Clinical trial conferences. She also has paper publications and a peer-reviewer of scientific journals.

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Biography: Behtash Bahador is an Associate Director at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

Session Details: This is Not a Trend: Exploring Why Patient-Centered Clinical Research Will Continue to Change the Research Paradigms of the Past and the Impact it Can Have 25-05-2021, 12:45 pm View In Agenda

Biography: Sameer is a senior executive with over 24 years of both pharma/CRO experience in operations, feasibility, site selection, business development, procurement, strategic planning, and project management. Recent roles have focused on innovative approaches to support digital solutions integrated in our clinical trials to reduce patient burden and maximize efficiency in site selection and patient recruitment.

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Biography: Ratan Ratnesh is a Director and Head of Clinical Outsourcing at Otsuka Pharmaceutical. He received his Bachelors in Mechanical Engineering from National Institute of Technology, India and an MBA from University of Louisiana. Ratan has broad experience in strategic sourcing, clinical outsourcing, operations and supply chain improvements in Fortune 500 and growth companies. He started his career in management consulting specializing in supply-chain across different industries and moved to clinical outsourcing in early 2000. In Pharmaceutical industry he worked at Wyeth and Novartis prior to joining Otsuka and he has managed different categories related to clinical outsourcing.

Session Details: Debate Session: What the Clinical Trials Industry Really Want From Their Solution Providers 25-05-2021, 9:45 am View In Agenda

Biography: Pharmaceutical professional with over 20 years of experience in clinical research, operations, outsourcing and vendor relationship management. Diverse experience in multiple therapeutic areas and various clinical trial phases. Experience leading large cross functional teams and developing supplier governance models. Associate Director at Merck & Co., Inc. in the Portfolio Sourcing and Relationship Management group within Global Clinical Trial Operations. Currently manages Strategic Functional Service Providers within eight Clinical Development Business Units (areas have included Statistics, Regulatory, Data Management, Global Clinical Monitoring, Clinical Sciences, Medical Writing and Clinical Trial Operations). Began my career as a Study Coordinator for the Cardiovascular Disease Prevention Center at Thomas Jefferson University Hospital, Philadelphia, PA. Earned a Masters of Public Health from DREXEL UNIVERSITY COLLEGE OF MEDICINE (formerly MCP HAHNEMANN UNIVERSITY), Philadelphia, PA and a duel Bachelor’s degree from Villanova University.

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Biography: Kristi Koontz is currently the Head of US Clinical Operations for GSK.   Prior to this, she has held a variety of roles across clinical development and global medical affairs.  Kristi has established numerous oncology corporate and academic and alliance partnerships, life cycle strategies, external engagement initiatives, and advocacy partnerships. She holds a BS in Biology from The Pennsylvania State University, an MBA from LaSalle University, and is finishing her PhD in Business Psychology from The Chicago School.

Session Details: KEYNOTE - Exploring How Best to Manage a Shifting Portfolio 25-05-2021, 8:45 am View In Agenda

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Biography: Kathy Leach is Senior Director, Clinical Study Team Lead at Pfizer. She has been in the pharma industry for 25 years, spanning numerous therapeutic areas, phases and roles supporting clinical trial conduct at several large pharmaceutical companies. Her recent roles have focused on cross functional operational oversight of global programs. Kathy is a certified Project Management Professional, received her bachelor degree from Villanova University and Masters in Organization Leadership from Immaculata.

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Biography:

Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman, speaker, moderator, and facilitator for many life-sciences and drug development events.

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Biography: Tormey has more than 44 years of Sales and Marketing, and Executive experience in the global pharmaceutical market. 2017-2020, Mr. Tormey held the position of Chief Executive Officer at Kibow Biotech, where the company developed product a novel treatment for Chronic Kidney Disease. Prior to Kibow, he was a Member of the Board, and Vice-Chairman of Prevention Pharmaceuticals Inc, where he previously held the position of President/CEO beginning July 2010. From 1985 to 1990, Tormey lead Medical/Hospital/Industrial Sales with Wyeth. From 1990 to 2003, Tormey was with Nelson Communications Worldwide. First, as VP at PDN, and then as President of The Medical Phone Company®, and later as President/COO of Nelson Communication’s flagship company, Nelson Professional Sales (later known as Publicis Selling Solutions), Publicis, S.A., Paris. From 1976 to 1985, Mr. Tormey held Sales & Sales Management positions at Ortho Pharmaceuticals, and then as Director of Sales Staff Management with McNeil CPC (Johnson & Johnson).

Session Details: Debate Session: What the Clinical Trials Industry Really Want From Their Solution Providers 25-05-2021, 9:45 am PANEL DISCUSSION Studying the Importance of Getting A Diverse Patient Group Onto Your Study 25-05-2021, 11:45 am View In Agenda

Biography:

Tim Koch has spent the last 18 years working in Big Pharma including time at Johnson & Johnson, GlaxoSmithKline, and currently Novartis, along with prior experience in the Financial Services Industry and the Hospital Setting. He is a Lean Six Sigma Black Belt who’s deepest passion is Metrics and Analytics but has a broad range of experience from Finance to IT to Quality Assurance to Resource & Risk Management. He is known as a domain expert in Clinical Trial Optimization via Data and Technology, supporting the operational delivery of thousands of Trials from feasibility/site selection to recruitment planning/tracking to instream monitoring, resource maximization and risk detection to leading health authority inspections. Tim has been an innovative pioneer, infusing an evidence-based analytical culture in countless areas of the business, building multiple Analytics units from the ground up and launching >50 industry-first analytics platforms to >20,000 users in Drug Development. In his current role as  Global Head of Key Account Mgmt, he partners closely with the Trial Mgmt Leadership team providing consultation, solutions and know-how anchored around  the use of data, analytics, processes and technology during Trial Delivery.

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Biography: Mike Child currently holds the position of Vice President, Clinical Operations at Arbutus Biopharma located In Warminster PA, near Philadelphia. Arbutus Biopharma Corporation (NASDAQ:ABUS) is a publicly traded biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic hepatitis B infection, a disease of the liver caused by hepatitis B virus (HBV). Prior to that, Mike spent approximately 31 years at Bristol-Myers Squibb (BMS) near Princeton, NJ where he attained the role of Director, Clinical Operations, Infectious Disease contributing to the global approval of novel therapies designed to treat HIV and Hepatitis C. In addition, while at BMS, Mike spent significant time learning the ways of Drug Development while working in Discovery Labs, in the Data Management Department, and finally in roles of increasing responsibility within Early Development/Clinical Pharmacology. Mike’s additional experience includes that related to due diligence and risk mitigation, outsourcing, model document management, and the maintenance of Standards and Processes. Mike graduated with a BS in Animal Production from The Pennsylvania State University (PSU) and completed graduate coursework in Physiology before leaving PSU for Squibb. Mike was born in Lancaster, PA and currently lives in Newtown, PA where he has raised 2 sons.

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Biography: Jeremy Cress, Director of Operations of Fibrocell Science, has 15 years of experience in the biotech/pharmaceutical industry developing and leading solutions-based strategies across all phases of drug development through commercialization, including global manufacturing and distribution. His management experience at Fibrocell is highlighted with the manufacture and commercial scale-up of the first approved cell therapy for aesthetics, LAVIV® azficel-T. Today, Mr. Cress and his team are working in collaboration with Precigen, Inc., a wholly owned subsidiary of Intrexon Corporation, to advance development of Fibrocell’s gene therapy candidates for the treatment of rare diseases affecting the skin and connective tissue. Currently, the team is focused on FCX-007, the Company’s lead candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB)—a devastating, congenital, blistering skin disease with high mortality. Prior to joining Fibrocell in 2011, Mr. Cress was Director of Operations for Fisher Clinical Services where he had responsibility for manufacturing, domestic and international logistics, and distribution and supply chain activities for >30 pharmaceutical companies and >100 clinical trials.

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Biography:

Though new to ERT, Madeline Geday has more than two decades of senior leadership experience and subject matter expertise within the pharmaceutical industry. After beginning her career as a clinical research associate, Madeline spent 17 years at Merck optimizing both global trials and patient and stakeholder engagement to become director of global patient engagement and innovation, implementing patient-centric methodologies while increasing the diversity of patient representation.

By continuing to incorporate the voice of the patient and other key stakeholders, Madeline provides strategic analysis, enhancement, innovation, and direction at ERT in the areas of patient and site experience, diversity of patient recruitment, health literacy, employee engagement, sales and marketing, and more.

Session Details: PANEL DISCUSSION Studying the Importance of Getting A Diverse Patient Group Onto Your Study 25-05-2021, 11:45 am Mitigating the New Patient Burden in Decentralized Trials 26-05-2021, 12:30 pm View In Agenda

Biography:

Colleen is a pharmaceutical industry leader experienced in building, changing, and growing teams into highly successful organizations

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Biography: I have worked in the industry for 15+ years, and joined Boehringer Ingelheim in 2011. During my tenure at BI, I managed multiple pivotal Phase 3 trials within the Metabolic, CNS, Cardiovascular, and Respiratory therapeutic areas. In 2018, I took on the role of Global Clinical Operations Integration Lead for Decentralized Clinical Trials. This position coordinates with all other supporting trial enabling functions, as well as, facilitation of educational and change management activities for BI’s clinical research ecosystem.

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Biography: Alice Drumheller has over twenty years’ experience in the clinical operations area with the focus on executing clinical trials. Prior to joining the Sensei Bio, Alice was Senior Director of Clinical Operations at MacroGenics where she executed the company’s clinical strategy. Previous to MacroGenics, Alice was part of the team at Amgen/Micomet where she contributed to the approval of BLINCYTO®. Alice has held positions of increasing responsibility at large pharmaceutical companies, start-up companies and clinical research organizations, including Nabi Biopharmaceuticals, Bristol-Myers Squibb, Kendle (now Syneos), British Biotech and Henri Beaufour Institute (a subsidiary of Ipsen). Alice holds a BS in Public and Community Health from Southern Connecticut State University in New Haven, CT.

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Biography: Kristina has excellent interpersonal, verbal and written communication skills; A flexible attitude with respect to work assignments and new learning; Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail; Ability to identify and address issues proactively in a timely manner and willingness to work in a matrix environment and to value the importance of teamwork. She also possesses team leadership skills and excellent organizational ability.

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Biography: Sudip is a performance driven executive with 25+ years of global experience in delivering business value through R&D Digital Technology management. His roles have had progressive scope, complexity and authority for planning and execution of strategic business and technical delivery. He is a proven leader with multi-sector international experience in building organizations, establishing business relationships, developing high performance teams, and innovative clinical digital solutions & services to enable science in accelerating delivery of the drug pipeline. Sudip's specialties include: Significant experience in the global Pharmaceutical and Information Technology industry in a variety of strategic senior management roles. He has a proven ability to lead major change initiatives and transform R&D technology and Clinical Digital Solutions organizations. He has also effectively developed relationships with key business partners and managed diverse stakeholder interests.

Session Details: Moving to An Electronic TMF and The Benefits it can Bring 25-05-2021, 11:45 am View In Agenda

Biography: Karrie Hilsinger is  Director, Clinical Operations at Immunomedics. She has been in the pharma industry for 20+ years, spanning numerous therapeutic areas, phases and roles supporting clinical trial conduct at several large pharmaceutical companies, CROs and Medical Device organizations. Her recent roles have focused on cross functional operational oversight of global programs. Karrie has been crucial to leading organization through SOP development, Inspection readiness and successful agency inspections.

Session Details: Debate Session: What the Clinical Trials Industry Really Want From Their Solution Providers 25-05-2021, 9:45 am View In Agenda

Biography: Adam Barrows is a Clinical Trial Lead/Study Director for Bristol-Myers Squibb working in Oncology Clinical Development working on Immuno-Oncology agents in the Emerging Tumors team.  Adam started his career in clinical research working for ICON Clinical Research in data management and study start-up. Following his time at ICON, he worked in clinical pharmacology at Wyeth then trial operations at Merck.  Having spent the majority of his clinical research profession in clinical operations Adam has shifted his focus to strategic trial design and execution as part of the clinical development team at BMS.  As a passionate researcher, Adam has worked across multiple therapeutic areas in every phase of clinical research, from start-up to study closeout and brings his operational skills to the scientific execution of clinical trials.

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Biography: Narayan has and ten (10)+ years of award-winning and progressive experience delivering the highest standards of clinical data management at Bayer and Bristol Myers Squibb (BMS). Bayer Gold Award 2017, Bronze Award 2016, and Pinnacle Award 2015; BMS Performance Award. In-depth knowledge of all aspects of clinical data management, reporting, reconciliation, study reviews, and standards development that drive pharmaceutical businesses forward. 

Session Details: Exploring how data managers should be analysing data in order to achieve high-quality, statistically accurate findings 26-05-2021, 12:00 pm View In Agenda

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Session Details: Simplifying the Route to ICH E6 (R2) Compliance: harnessing the benefits of the various RBQM tools at your disposal 26-05-2021, 9:00 am PANEL DEBATE : The Time, Money and Quality Triangle - is it possible to achieve all three with the coupling of eData management and manual data systems? 26-05-2021, 10:00 am View In Agenda

Biography: With over 15 years of extensive clinical-trial experience, Mirriam has extensive working knowledge of data management and GCP and ICH guidelines. As such, I oversee the activities of direct reports and serve as a mentor. I am also responsible for creating the CRF design and ensuring that all protocol required assessments are being collected and the database is built according to specifications. Specialities include; mentoring, leadership and coaching skills, matrix organization, project management skills, GCP/ICH guidelines, CRF Design, DB development, tables and listings, validations, derivations, database testing, SAE reconciliation, discrepancy management

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Biography: Phi is currently working as currently working as a Central Monitor (Manager) at Pfizer in the Risk-Based Monitoring (RBM) team to monitor and identify risks associated with conducting clinical trials and the quality/integrity of clinical data.  Responsible for timely and high quality risk-based monitoring (RBM) analytics to clinical trial monitoring which utilizes data and site level information to determine needs for performing on-site, remote, and centralized activities and focuses resources on risks that have the most potential to impact patients’ safety and data quality.

Session Details: ROUNDTABLE DISCUSSION: Discussing proven methods for training CMs to successfully identify specific KRIs and modernise Clinical Outcomes Assessments 26-05-2021, 1:30 pm View In Agenda

Biography: Lisa has been in data management in the pharmaceutical industry for almost 30 years. Prior to working for Boehringer-Ingelheim, Lisa has worked at Bristol-Myers Squibb and Purdue Pharma. She has been involved in several projects under multiple therapeutic areas including immunology, neuroscience, sexual medicine, diabetes and cardiovascular health, and pain management. Lisa holds a Ph.D. in Health Psychology, a Master’s of Public Health and a Master’s of Business Administration in the area of International Business. Lisa is also a volunteer certified Emergency Medical Technician in her local town of Monroe, CT and has been involved in emergency services for nearly 15 years.

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Biography: Kelly Ragins joined Bristol-Myers Squibb as Vice President of Clinical Trial Strategy and Operations in February of 2018. In this role, she led program and trial management across the portfolio. With the integration, Kelly will focus on the late development activities including non-registrational, investigator sponsored, and medical affairs trials as a member of the Global Development Operations leadership team. With over 25 years R&D experience with concentration on strategic roles, Kelly has developed expertise in the implementation of departments, effective alliance management, and cross-functional collaboration. Prior to joining BMS, Kelly served as Vice President of Internal Medicine Clinical Strategy at Syneos Health. For many years, she was a leader in the Pfizer Global R&D organization within Oncology operations, and as head of Study Management for Vaccines at Pfizer she co-led the Wyeth portfolio integration. Over her career, Kelly held leadership positions at Amgen in the Global Development organization establishing Clinical Operations Management group. She worked for many years within the Clinical Development & Medical Affairs organization at Merck, and conducted pre-clinical research at the Mayo Clinic. Kelly has a pre-med Bachelor's degree in Anthropology and Spanish, and a Master’s degree in Healthcare Leadership.

Session Details: Debate Session: What the Clinical Trials Industry Really Want From Their Solution Providers 25-05-2021, 9:45 am View In Agenda

Biography: Justin Albani is the Director of Imaging Services at Invicro, an imaging solutions provider specializing in the application of imaging biomarkers in drug development and clinical research. Justin has over ten years of experience in clinical research and medical imaging, where he focused on imaging operations and data collection, review, and standardization. At Invicro, Justin is responsible for the oversight of global training and imaging equipment qualification across center’s participating in Phase I -III clinical trials, as well as imaging data receipt and processing.

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Biography: As Chief Product Officer at AiCure, Michelle Marlborough is responsible for the product direction, definition and delivery of the company’s award-winning artificial intelligence platform. With over 24 years of experience in life sciences and software development, Michelle has been at the forefront of transforming clinical trials through innovative technology and analytics and previously held the positions of Vice President of Product Management at Veeva and Vice President of Product Strategy at Medidata Solutions. Before making the shift to the technology sector, Michelle worked in data management roles at GlaxoSmithKline and AstraZeneca. There she experienced firsthand the industry’s struggle with outdated processes and systems. Michelle earned her bachelors of science degree in biology and mathematics from Coventry University.

Session Details: Predictive Dosing: Understanding Patient Behavior to Enhance Trial Efficiency 25-05-2021, 2:15 pm Predictive Dosing: Understanding Patient Behavior to Enhance Trial Efficiency 25-05-2021, 2:15 pm View In Agenda

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Worked in the Pharmaceutical/Biotech/CRO industry since last 23 years with more than 20 years of experience in the Clinical Data Management area on both Sponsor & CRO Side. Successfully led multi-faceted data management project teams to globalize clinical data management processes, systems & organizations and currently working at Regeneron Pharmaceuticals as the Data Management Site Head (Basking Ridge, NJ)/ Associate Director, CDM. Handled and supported several Clinical Studies (Phase 1 to Phase 4) across various therapeutic areas like Immunology, Oncology, CV, CNS, & Rare diseases. Completely familiar with technology and its role in the Clinical Data Management space and performed/supported several technology related initiatives.

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Bill Cooney founded MedPoint Digital in 1990. As President and CEO, he continues to lead the strategic growth of a world-class digital services company to the medical industry. Prior to launching MedPoint, Bill was on the Executive Committee and helped start-up Discovery International, the medical education arm of Publicis Healthcare.

In the 1980s, Bill worked in sales and marketing positions at Wyeth and Abbott. He was Business Unit Manager for the Depakote brand at Abbott, and helped form the first telemarketing sales department at Abbott.

Throughout his career, Bill has spoken at numerous healthcare industry events and bylined articles in pharmaceutical trade journals on topics ranging from medical education to research training and digital technology. Bill is Chairman of the Board of Directors for Healthcare Consultants International, Inc., a company providing training and consulting services to healthcare providers and facilities. Bill holds an M.B.A. from the Fisher College of Business of The Ohio State University and a B.A. from The University of Virginia.

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Biography: Dennis is a life sciences executive bringing over 18 years of experience in Clinical Research, Technology, and Operations. Offering broad achievements in the Pharmaceutical industry in clinical operations, portfolio management, vendor qualification, relationship management and eClinical solutions. He possesses focused leadership skills to drive results in highly competitive markets.

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Biography: Since 2002 Jorge has been involved in pharmaceutical, biotech, and biologics research in a variety of roles including clinical, operations, finance, market Intelligence and business development at the site level, SMO, CRO, and now for clinical supply solutions and access at TrialCard.  Past employment includes Sarkis Clinical Trials, Radiant Research, Covance, Interventional Concepts,  MedPrimo Research as an independent consultant, FutureLife LLC advisory board member, and the University of Florida/VAMC Department of Neurology.  Cumulatively he has been involved in over 350 clinical trials including Phase I-IV, PK/PD, vaccine, 510k submission, vaccine research, and has conducted both pediatric and adult trials. Mr. Franceschi completed his undergraduate work at the University of Florida in Food Science & Human Nutrition and completed his Masters of Science in Health with emphasis in nutrition at the University of North Florida in Jacksonville.  A majority of his clinical trial work has been within the CNS realm supporting major depressive disorder, anxiety, bipolar, ADHD, and PTSD research but most recently he is learning about and supporting clinical teams needing oncolytic co-therapy medications.

Session Details: Case studies in Decentralization: Transforming Patient Accessibility 26-05-2021, 9:30 am View In Agenda

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Marie has over 20 years’ experience working in the area of medical devices and in-vitro diagnostics.  Her focus for that last 11 years has been the use of wearables and sensors to generate digital endpoints in clinical trials

She has been with ICON for five years working as a Subject Matter Expert in the deployment and use of wearables and sensors in clinical trials. As part of the ICON innovation team she provides insight into outcomes addressed by wearable technology and has designed and led a number of pilot projects focusing on the use of mHealth technologies in redesigning the clinical trial.

Marie has presented at a number of Industry and Scientific Conferences, is a member of a number of industry panels including DIA wearables workstream and DIME and is a co-leads one of the MobliseD work packages and has authored over 50 publications on the use and implementation of wearables in clinical trials.  Marie has an MSc and an MBA.

Session Details: Digital Health Technologies –Maximising the value in clinical trials 25-05-2021, 2:15 pm View In Agenda

Biography: Executive intrapreneur turned digital health entrepreneur, my career includes 18+ years leading global drug development, clinical research and decentralized trials for life science organizations. As CEO of THREAD, I lead our efforts to change the way clinical research is conducted focused on decentralized approaches, enabling the use of our one platform for conducting modern research studies and leading partnerships with our customers. After launching and growing THREAD, we were acquired in 2019 by JLL Partners and Water Street with strategic investment for continued growth and focus on accelerating drug development for our customers. Named one of the Top 100 Influencers in Digital Health, I also provide expertise and execution experience in digital health, clinical trials and decentralized, remote, virtual, community-based clinical research. I enjoy being a keynote speaker at global industry events, guest lecturer at Duke University on digital health/innovation/entrepreneurship and a published author featured in various conferences, journals, articles and media outlets.

Session Details: PANEL DEBATE : The Time, Money and Quality Triangle - is it possible to achieve all three with the coupling of eData management and manual data systems? 26-05-2021, 10:00 am Best Practices to Scale Your Global Hybrid Decentralized Studies 26-05-2021, 11:30 am View In Agenda

Biography: Elizabeth has been an expert in the cold chain life sciences healthcare industry for over 10 years. Her experience spans operations, account management, and business development. She established herself as a subject matter expert on active and passive packaging, and collaborated on education and a solutions portfolio for cold chain pharmaceutical logistics. As part of the DHL Life Sciences & Healthcare sector, Elizabeth drives the cross-divisional development of clinical trials logistics offering. She sits at the head of the marketing work stream, and is a primary stakeholder for marketing collateral and content. She is also a primary contributor to the commercial aspect of the company’s COVID-19 vaccine distribution strategy and public sector initiatives.

Session Details: Shifting gears: Accelerating clinical trial logistics in 2021 & beyond 26-05-2021, 11:30 am View In Agenda

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Session Details: Closing the Gap in Clinical Trial Communication 25-05-2021, 12:15 pm View In Agenda

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Session Details: Closing the Gap in Clinical Trial Communication 25-05-2021, 12:15 pm View In Agenda

Biography: Andrea is a senior-level strategic leader with 19 years of experience spanning clinical research, global quality assurance, strategic alliance management and business process optimization. She is responsible for driving strategic-level decisions that enable Teckro to challenge today’s status quo in the conduct of clinical trial research. She is also responsible for ensuring that Teckro products meet all regulatory requirements, including GCP and data privacy. Andrea holds a Bachelor of Science degree from the University of Tennessee.

Session Details: Closing the Gap in Clinical Trial Communication 25-05-2021, 12:15 pm View In Agenda

Biography: Since 2002 Jorge has been involved in pharmaceutical, biotech, and biologics research in a variety of roles including clinical, operations, finance, market Intelligence and business development at the site level, SMO, CRO, and now for clinical supply solutions and access at TrialCard.  Past employment includes Sarkis Clinical Trials, Radiant Research, Covance, Interventional Concepts,  MedPrimo Research as an independent consultant, FutureLife LLC advisory board member, and the University of Florida/VAMC Department of Neurology.  Cumulatively he has been involved in over 350 clinical trials including Phase I-IV, PK/PD, vaccine, 510k submission, vaccine research, and has conducted both pediatric and adult trials. Mr. Franceschi completed his undergraduate work at the University of Florida in Food Science & Human Nutrition and completed his Masters of Science in Health with emphasis in nutrition at the University of North Florida in Jacksonville.  A majority of his clinical trial work has been within the CNS realm supporting major depressive disorder, anxiety, bipolar, ADHD, and PTSD research but most recently he is learning about and supporting clinical teams needing oncolytic co-therapy medications.

Session Details: Case studies in Decentralization: Transforming Patient Accessibility 26-05-2021, 9:30 am View In Agenda

Biography: Matt is responsible for defining and leading the product strategy for ERT’s digital patient product line, with a focus on direct to patient enablement in both post approval research and patient support. Matt has spent the last 12 years leading teams and innovating products in both the clinical research and commercial healthcare settings to reduce patient burden of participation and to support patients in their healthcare journey.  Most recently, Matt was Global Head of Patient Engagement for ICON’s Commercialization & Outcomes division and, prior to that, Head of Direct to Patient Research (Virtual Trials) at IQVIA.

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Session Details: How to ensure speedy recruitment for your virtual/decentralized trial 25-05-2021, 11:15 am View In Agenda

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Session Details: 5 Key Considerations for Successfully Deploying your Sensor Strategy 25-05-2021, 12:15 pm View In Agenda

Biography: Carol Tester, Vice President, eCOA Partnerships, focuses on development of global customer relationships to identify ways that YPrime can serve its biopharmaceutical clients. A recognized subject matter expert in eCOA technology, she brings 20 years of industry experience with more than 15 years of operational and strategic business experience. Carol began her career as a member of the Royal Navy before moving into the Life Science industry after 5 years of service. Her industry tenure started in Data Management at Novo Nordisk, Pfizer and Novartis before accepting a Consultant role for Actelion in Switzerland. Her eCOA experience stems from positions as Relationship Manager, Director of Client Relations as well as Program Director with various eCOA vendors.  Carol has overseen global study programs, supervised project management teams and managed key account relationships.

Session Details: Is BYOD right for your eCOA Clinical Trial? 26-05-2021, 10:30 am View In Agenda

Biography: Celeste A. Elash, MS, is the Vice President of eCOA Science for YPrime. Throughout her 25-year industry career, Celeste has served as a clinical research scientist, with a variety of contributions to the advancement of patient-focused drug development and eCOA adoption. Celeste has conducted research for Purdue University, Western Psychiatric Institute and Clinic. She also contributed to some of the earliest electronic patient-reported outcomes studies at the University of Pittsburgh. Prior to joining YPrime, Celeste served as an independent consultant to biopharmaceutical companies and both in operations and as clinical science advisor for two eCOA providers. She currently represents YPrime on the Critical Path Institute’s ePRO Consortium.  

Session Details: Is BYOD right for your eCOA Clinical Trial? 26-05-2021, 10:30 am View In Agenda

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Session Details: Digital Strategies to Power #NoGoingBack 26-05-2021, 12:30 pm View In Agenda

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Session Details: Accelerating Clinical Trials in China and the Asia-Pacific 25-05-2021, 9:15 am View In Agenda

Biography: Radha is a cross-functional biopharmaceutical executive with expertise in leading business transformation projects driving process excellence, cost synergies and technological innovation in the management of Clinical trials/Biobanking. Her in-depth understanding of Central lab operations coupled with experience in financial planning and strategic pricing enabled the successful implementation of various technologies supporting the central lab process delivery and optimization.

Session Details: The critical role of biorepositories and archiving in successful clinical research 25-05-2021, 11:15 am View In Agenda

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Session Details: Clinical Trials from Home: The Role of Research Nurses 26-05-2021, 10:30 am View In Agenda

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Session Details: Clinical Trials from Home: The Role of Research Nurses 26-05-2021, 10:30 am View In Agenda

Biography: Robyn C. Griffith has been in the Pharmaceutical R&D industry for over 16 years.  She began her career as an Emergency Department R.N., became a Certified Nurse Midwife and worked in that field for over 6 years and then joined Quintiles in 2004 as a CRA.  It was at Quintiles that she developed into a Senior Project Manager and has continued her career in this exciting field at other CROs.  Her most recent experience was as the Regional Head of Biotech at a competing CRO.  She recently joined PRA to help the Biotech division continue to grow in alignment with the upcoming merger.  Robyn earned her Bachelor’s Degree of Nursing from Austin Peay State University and her Master’s of Science in Nursing from the University of Colorado.  She resides in Colorado Springs, Colorado with her husband and family and enjoys figure skating, snowboarding and enjoying the beautiful outdoors!

Session Details: Biotech Compass: Navigating Competing Priorities 25-05-2021, 1:15 pm Biotech Compass: Navigating Competing Priorities 25-05-2021, 1:15 pm View In Agenda

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Session Details: Clinical Trials from Home: The Role of Research Nurses 26-05-2021, 10:30 am View In Agenda

Biography: Mike Hutton graduated from University of East Anglia with a PhD in Biochemistry and spent 10 years in Scientific and Medical Research in Birmingham, Cambridge and Norwich. In 1999, Mike joined a leading central laboratory provider in London in a Project Management capacity before moving to Almac Clinical Technologies in 2002 as a Project Manager. Mike has now been with Almac over 17 years, working in various roles of increasing responsibility, from Project Management to Operational Management, and now, in a tactical commercial role. Mike is currently Head of Strategic Relationship Management, EU and oversees several key clients along with developing new and exciting business in EU and beyond with Almac’s leading Interactive Response Technology.

Session Details: Catching up during COVID: Proven Technology for meeting the accelerated timelines 2021 hybrid clinical trials demand 26-05-2021, 9:30 am View In Agenda

Biography:

Aernout has 25 years of drug development experience at biotechnology companies as well as CROs. This experience includes designing drug development strategies through Proof-of-Concept as well as hands-on experience in the design and conduct of early clinical studies in a breadth of therapeutic areas.

As Director, Scientific Affairs, Aernout is a member of Celerion’s respiratory and vaccine research teams and works closely with external experts in the fields of pulmonology and vaccine development to support drug development programs of Celerion’s clients.

Session Details: Optimizing early clinical trials in special populations 25-05-2021, 11:15 am View In Agenda

Biography: Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific. Novotech has been instrumental in the success of over a thousand Phase I - IV clinical trials for biotechnology companies and has a unique capability in offering expert global product development and regulatory affairs consulting to support global programs.

Session Details: Debate Session: What the Clinical Trials Industry Really Want From Their Solution Providers 25-05-2021, 9:45 am View In Agenda

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Session Details: Clinical Trials from Home: The Role of Research Nurses 26-05-2021, 10:30 am View In Agenda

Biography: Following his studies at Ecole Polytechnique and UC Berkeley, Alexis has identified unmet clinical needs within rehabilitation. Alexis has built a team of engineers, physicians, designers with broad expertise, ranging from physics to signal processing and biomechanics. He has set up a strong tech culture, including a focus on testing.

Session Details: Delivering value with wearables: the example of a problem-solving approach 25-05-2021, 12:15 pm View In Agenda

Biography: Heather DiFruscia is the Associate Director RTSM / IWRS and is responsible for managing and overseeing the RTSM department operations, strategy, processes, and software product development

Session Details: Benefits and Advantages of a Unified Platform Approach to Global Studies 25-05-2021, 1:15 pm View In Agenda

Biography: Brian Dempster has over 25 years of clinical development experience, gained across a variety of therapeutic areas and geographical regions. He began his career as a CRA before being accepted to Amgen’s Leadership and Management Program. During a decade at Amgen, Brian held program leadership positions in Oncology, Endocrinology and Bone Health in Europe, Canada and the US.   In 2014 Brian joined Vital Therapies (VTL) where he was instrumental in the creation and execution of clinical development strategy, overseeing the entire Phase II and Phase III programs of VTLs combined device and biotherapeutic system for the treatment of liver failure.   Utilizing Fusion eClinical Suite in partnership with Axiom: Before joining Axiom, Brian led the clinical development group at Endologix, which oversaw the global team involved in the pre-approval and post-market clinical development of Endologix’s products, serving patients with a need for abdominal aortic aneurysm sealing and repair.   Brian has a thorough understanding of the clinical development process and has used this to successfully bring products to market. This includes leading teams through several regulatory inspections in relation to submissions, to FDA, MHRA and PMDA. Brian has a particular interest and passion for trial documentation standards, having forged the path for introduction and transition of several eTMF programs.

Session Details: Benefits and Advantages of a Unified Platform Approach to Global Studies 25-05-2021, 1:15 pm View In Agenda