Outsourcing in Clinical Trials East Coast 2023

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Session Details: KEYNOTE Democratizing Decentralised Trials: How Innovative Solutions Can be Accessible for All 24-05-2022, 8:30 am View In Agenda

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: PANEL DISCUSSION Managing Global Trials in a Post-Pandemic World: Top Tips and Key Considerations 24-05-2022, 10:30 am View In Agenda

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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: Dr. Ram Raju has a distinguished career over 40 years as a healthcare provider, teacher, researcher and community organizer. In his role at Northwell Health, Dr. Raju set the strategic vision to improve population health by finding ways to meet the needs of its most vulnerable communities, by examining the existing programs aimed at improving the health system's response to the community's needs and working with local organizations to address them. Northwell Health is the largest healthcare provider in the state of New York, is a system with 23 hospitals and 830 outpatient facilities that sees 2 million people every year in the New York metro area and beyond.

Session Details: Studying the Importance of Getting A Diverse Patient Group Onto Your Study 24-05-2022, 11:30 am View In Agenda

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.

Session Details: Speaker Hosted Roundtables 25-05-2022, 3:30 pm View In Agenda

Biography: Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.

Session Details: Chairman’s Opening Remarks 24-05-2022, 8:20 am Chairman’s Opening Remarks 25-05-2022, 8:50 am OVERVIEW: The state of the biopharmaceutical industry in 2022 25-05-2022, 9:00 am View In Agenda

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Session Details: Reducing Noise: Strategies for Ensuring Quality Data in Clinician and Patient-Centric Outcomes 24-05-2022, 11:00 am View In Agenda

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Session Details: FIRESIDE CHAT Clinical Innovation and Technology: Defining Buying Strategy Based on Overcoming Challenges and Pain Points 24-05-2022, 11:30 am View In Agenda

Biography: Dawn has over 20 years of experience in the pharmaceutical industry. She have worked within every level of clinical data management, from Data Coordinator to Senior Director where she participated in or had oversight for more than 250 clinical trials. During her time in the industry, she has provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter as well as former Co-Chair of the annual conference (2018-2021) and serves on the SCDM Board of Trustees. Dawn is involved as a member of the CDISC-CDASH core team, Diabetes sub-team, CDASH CFAST Expanded Leadership Team and former Co-Chair of the CRF Library project. Dawn currently holds the position of Senior Director, Data Strategies, where she supports business development as a Clinical Subject Matter Expert for both software and data services.

Session Details: Data-Driven Operations and Oversight with elluminate 24-05-2022, 12:00 pm View In Agenda

Biography: Amanda Murphy is the Director of Product Management at GlobalData, a company that focuses on research, data analytics and consulting that provide actionable insight into the pharmaceutical and medical device sectors.  She has 10+ years of experience working in pharmaceutical data science and web platform development (including BioPharm Insight, Lead Sheet, and the Pharma Intelligence Center).  She has developed models and solutions to support Clinical Operations & Feasibility teams plan and optimize trials, including an e-feasibility questionnaire tool resulting in 4x faster response rates from sites.  Amanda also has many years of experience supporting business development at CROs through data-driven lead delivery and CRM integration solutions.

Session Details: Chairman’s Opening Remarks 25-05-2022, 8:50 am WORKSHOP SESSION Solving the Feasibility Questionnaire Dilemma During Site Selection to Ensure a Timely Trial Start and Reduced Recruitment/Logistical Obstacles 25-05-2022, 11:00 am View In Agenda

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• Former Associate Vice President, Global Clinical Trial Management at Allergan
• Former Executive Director, Global Clinical Trial Management at Actavis plc
• Former Executive Director, Clinical Operations at Warner Chilcott
• Former Senior Director, Technical Services at Consumer Product Testing Company
• Former Section Head, Toxicology at Leberco Testing
• A., Biology, Rutgers University

Session Details: LEADERS PANEL DISCUSSION: “The New Constant is Uncertainty”: A Debate of the Future of the Clinical Trial Industry 25-05-2022, 12:00 pm View In Agenda

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Session Details: Combatting Public Mistrust: How Better Community Engagement Can Lead to Better Trial Outcomes 25-05-2022, 1:30 pm View In Agenda

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Session Details: Strategies and Tips for Building a Robust Mobile Data Suite 25-05-2022, 11:00 am View In Agenda

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Session Details: PANEL DISCUSSION Diversity, Equality, & Inclusion: Strategies for Engaging and Recruiting Under-Represented Patients 24-05-2022, 1:30 pm View In Agenda

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Session Details: Steps to Streamline Information Flow and Futureproof Data for a Modern Trial 25-05-2022, 2:30 pm View In Agenda

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Session Details: FIRESIDE CHAT Clinical Innovation and Technology: Defining Buying Strategy Based on Overcoming Challenges and Pain Points 24-05-2022, 11:30 am View In Agenda

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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.

Session Details: Think Sync/aSync 24-05-2022, 2:15 pm View In Agenda

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Session Details: Q&A SESSION Moving Vendors: Exploring What We Need to Know When Choosing the Right Partner for your Trial 25-05-2022, 2:00 pm View In Agenda

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Session Details: Top Tips in Effective Budget Management, Forecasting and Contracting: Ensuring Your Resources Are Allocated Correctly 25-05-2022, 10:00 am View In Agenda

Biography: Jef Benbanaste has led the launch and commercialization of multiple analytical SaaS solutions at Medidata and currently leads Intelligent Trials. Jef has over 16 years of experience improving business processes and decision-making through the use of technology and analytics. Prior to joining Medidata, Jef led projects at the global insurance company AIG which applied predictive modeling and machine learning techniques to improve risk segmentation and shape business unit strategies. Before that, he was in technology consulting at Deloitte. Jef has a MBA from MIT and a BS from the University of Virginia.

Session Details: AI Powered Enrollment Forecasting, Site Selection, and Real Time Study Tracking Against Industry 24-05-2022, 9:00 am PANEL DISCUSSION Managing Global Trials in a Post-Pandemic World: Top Tips and Key Considerations 24-05-2022, 10:30 am View In Agenda

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Session Details: PANEL DISCUSSION Diversity, Equality, & Inclusion: Strategies for Engaging and Recruiting Under-Represented Patients 24-05-2022, 1:30 pm View In Agenda

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Session Details: Taking a patient centric approach in developing a virtual trial for your study 24-05-2022, 3:45 pm View In Agenda

Biography: Dr. Solomon is a Clinician / Scientist with over 15 years of experience in clinical research and development in neuropsychiatry and neurodegenerative diseases. Previously to his role at Mind Med, Todd was a Director of Global Clinical Development at Avanir Pharmaceuticals leading development programs in neurologic and psychiatric disorders such as Schizophrenia and Traumatic Brain Injury. Prior to that, Todd served as the Associate Director of Clinical Programs and Data Science for CNS programs at Signant Health. He holds degrees in psychology and neuroscience (BA) from St. Lawrence University and Clinical Neuropsychology (PhD) from New York University. Todd completed his fellowship in neurodegenerative disease at Boston University School of Medicine where he served as an associate faculty member, clinician, and investigator for several years.

Session Details: LEADERS PANEL DISCUSSION Framing Pandemic-Based Disruption as an Opportunity for Technological Advancement: What Have we Learnt? 24-05-2022, 1:30 pm Developing a Platform for Conducting Decentralized Studies in Precision Psychiatry: The Mind Med ADDAPT Program 25-05-2022, 10:00 am View In Agenda

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Session Details: CASE STUDY: Moving Forward for Clinical Trials on Alzheimer’s Disease: How Technology is Enabling Progress in Drug Development 24-05-2022, 2:45 pm View In Agenda

Biography: Tom Julian started his career in various dot coms and moved into digital health, working in managed care and then pharma. He was most recently at Bristol Myers Squibb where he led clinical trial innovation initiatives and built out the R&D group’s digital recruitment strategy. Tom is passionate about helping patients and puts them at the center of his work.

Session Details: Innovation: Good or Evil? 25-05-2022, 9:30 am View In Agenda

Biography: Malia Lewin is global head of strategy, ensuring both clinical and market fit for Teckro products. An attorney by training, Malia Lewin has over 20 years of experience in the life sciences industry. Passionate about getting life-changing healthcare innovations to patients, Malia has worked on behalf of non-profit organizations, pharmaceutical and biotechnology companies, hospital systems, and technology companies to expedite the path of scientific discoveries from bench to clinic. Most recently, Malia served as chief business officer of CherryCircle Software, where she led the global go-to-market strategy for QbDVision, a SaaS platform to optimize the development and manufacturing of drug products. Prior to that, she served as director of global oncology strategy at Veeva Systems, where she worked closely with clients in the oncology space to harness the power of technology to develop and commercialize oncology innovations. During her seven-year tenure as VP of client services and head of strategic operations at Rivermark, LLC (an IQVIA company), Malia led strategic consulting teams advising on the development, launch, and adoption of diagnostics and treatments, across therapeutic areas. This included the development of novel digital products for stakeholder mapping and engagement, network visualization and activation, and reporting and analytics. Earlier in her career, Malia had the opportunity to serve non-profit organizations as the founding CEO and executive director of the International Psoriasis Council and as lead partner of Networking and Affiliations at Ascension Health. Malia holds Bachelor of Arts Degrees in English and in Women’s Studies from the University of Richmond and a Juris Doctor from The George Washington University Law School.

Session Details: Innovation: Good or Evil? 25-05-2022, 9:30 am View In Agenda

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Session Details: Supporting technology deployment in a global decentralised clinical trial 24-05-2022, 12:00 pm View In Agenda

Biography: Greg is an expert at designing innovative data collection plans, managing quality control of collected data, and creating custom tools and databases for end users, leveraging expertise in clinical software applications including SAS, DataFax, OpenClinica, Excel, and Access.

Session Details: Decentralized Clinical Trials/Hybrid Trials: What You Need to Understand to Run Them Successfully 24-05-2022, 2:15 pm View In Agenda

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Session Details: Pfizer & Decentralized Clinical Trials 24-05-2022, 4:45 pm View In Agenda

Biography: As an Associate Director on the Listening Team, Christopher Farina collaborates with clients to develop and implement research programs that provide rich insight into stakeholder perspectives. Along with a team of linguists, he employs qualitative methods to illuminate meaningful patterns in complex language data which he distills into practical solutions for specific business needs. Christopher holds a doctorate in linguistics from the University of South Carolina. He has over 10 years of experience across a wide range of functions in qualitative and quantitative research in applied linguistics and in the social sciences more broadly.

Session Details: Optimize Your Study Through Technology-driven Patient Co-Creation 25-05-2022, 9:30 am View In Agenda

Biography: Gene Filipp currently leads the ArisGlobal Clinical and Regulatory Solutions Consulting team.  Gene brings over two decades of experience that begin in the classroom teaching 7^th grade science in Texas. Very quickly he completed his masters focusing on instructional technology and transitioned into a technology administrator role. After 10 years working in the Texas education system, Gene left education for clinical research by joining the CRO Chiltern International. Starting as a Trainer in the eClinical Solutions team, Gene ended his time managing the Americas for the team. Gene often speaks of his time at Chiltern as basis of his deep knowledge and understanding of the clinical research process. With his education and experience, Gene has been a solutions consultant for 11+years with several life science technology companies which include Medidata, ERT and presently ArisGlobal.

Session Details: Discover the Power of the TMF Reference Model Exchange Mechanism Standard Between Clinical Systems 24-05-2022, 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.

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Session Details: OPENING KEYNOTE Decentralised Trials: Practical Today, Predicting Tomorrow 25-05-2022, 9:00 am View In Agenda

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Session Details: Ensuring Top Quality Project Teams from Vendors from a Small Biotech’s Point of View 24-05-2022, 2:45 pm View In Agenda

Biography: Patrick has over 27 years’ experience in new drug development.   He joined Regeneron in March 2020.  His current role is the Head of the Global Clinical Trial Services group, responsible for global site management, central monitoring, study feasibility and site selection, study/site start up and eCOA and patient technology initiatives. Prior to this, Patrick spent 25 years at Pfizer, with most of his time spent in clinical program operations but also includes GCP Quality (level 1) and Analytics.  Patrick has extensive international experience in drug development.   He helped establish the Pfizer country office development teams in Latin America, India and other parts of Asia.   Subsequently, Patrick spent 10 years in Pfizer’s Development Japan organization as Head of Japan Development Operations and Development Japan Portfolio & Project Management Groups.  He was the recipient of the PGRD Achievement Award in 2007. Patrick is a former officer in the U.S. Army and is a veteran of the first Gulf War.  He holds a bachelor’s degree in Biology from the University of Rhode Island and a Master of Business Administration from Temple University.

Session Details: LEADERS PANEL DISCUSSION: “The New Constant is Uncertainty”: A Debate of the Future of the Clinical Trial Industry 25-05-2022, 12:00 pm View In Agenda

Biography: Aubrey Verna guides eCOA product development using evolving industry needs and stakeholder-informed insights across sponsors, sites, and patients. Her experience includes building and executing product strategies starting with the creation of roadmaps all the way to product releases. Additionally, Aubrey has experience in the management of global eCOA programs and has oversight of the teams responsible for implementation.

Session Details: Keeping Patients Engaged: Digital Innovation & Patient Retention 24-05-2022, 4:15 pm View In Agenda

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Session Details: Agility and Accessibility in the Development of a Vaccine in a Pandemic 24-05-2022, 4:15 pm View In Agenda

Biography: Ms. Olorunnisola is currently VP – Innovation, Marketing & Digital in the Avantor Services business unit. She leads Innovation, Marketing and Digital Solutions for the Supply Chain (Lab) Services and Clinical Services. She has over 15 years of experience in the Medical Device and Life Science industry developing and executing digital and go-to-market strategies. Additionally, she has led the development and deployment of large-scale enterprise solutions. Ms. Olorunnisola received her BA in Electrical Engineering from the University of Illinois at Chicago.

Session Details: How will the Supply Chain Need to Adapt to Support the Growth of Decentralized Clinical Trials? 25-05-2022, 11:30 am View In Agenda

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Session Details: Acceleration of Clinical Development in the World’s Fastest Growing Region: China 24-05-2022, 9:30 am PANEL DISCUSSION Diversity, Equality, & Inclusion: Strategies for Engaging and Recruiting Under-Represented Patients 24-05-2022, 1:30 pm View In Agenda