Outsourcing in Clinical Trials East Coast 2020

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 10-11-2020, 12:15 pm 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 10-11-2020, 4:00 pm 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.

Session Details: Speaker Hosted Roundtables 11-11-2020, 3:30 pm View In Agenda

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 10-11-2020, 1:45 pm View In Agenda

Biography:

• 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: CASE STUDY - Exploring the Use of Technology When Moving Towards a More Patient-Centric Trial 10-11-2020, 4:00 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.

Session Details: Decentralized Trials: Managing the Moving Parts to Result in a Successful Trial 10-11-2020, 1:45 pm 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: DEBATE SESSION - Exploring What We Need to Know When Choosing the Right CRO for your Trial 10-11-2020, 10:00 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.

Session Details: Speaker Hosted Roundtables 11-11-2020, 3:30 pm View In Agenda

Biography: Kristine Koontz, Phd(c), MBA Kristi Koontz is currently the Head of US Global In Country 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. She lives in Malvern, PA with her husband and two daughters.

Session Details: GSK KEYNOTE - Exploring How Best to Manage a Shifting Portfolio 10-11-2020, 9:00 am View In Agenda

Biography:

Session Details: Pfizer KEYNOTE: A Fresh Look at Patient Recruitment Focusing on the Top of the Funnel – Is Our Image the Problem? 10-11-2020, 3:00 pm View In Agenda

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.

Session Details: PANEL DEBATE - “This House Believes that Larger Pharma Companies have the Better Approach When it Comes to Organizing a Clinical Trial” 11-11-2020, 10:00 am View In Agenda

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.

Session Details: View In Agenda

Biography: Terrence “Terry” Tormey is a Pharmaceutical / Life Sciences C-suite executive with a proven, 40⁺-year track record of dynamic leadership and sustained success! He has developed rigorous strategies and driving significant growth at biopharmaceutical companies and Pharma Industry service providers as Vice-Chairman, CEO, and President. He is recognized as Senior Executive with exceptional business development experience. Created new markets for the Contract Sales Industry (CSOs) and Contract Research Organizations (CROs) in emerging technology and medical device industries. Tormey has developed innovative patient retention services for the pharmaceutical market. A recognized industry expert in the area of contracted sales, promotional outsourcing, O-T-C, and Dietary Supplement Marketing. He has launched dozens of R_x products in numerous categories in the US (CV, CNS, Antibiotics, Oncology); He also extensive experience in promoting O-T-C medications & nutraceuticals/medical-foods.

Session Details: DEBATE SESSION - Exploring What We Need to Know When Choosing the Right CRO for your Trial 10-11-2020, 10:00 am PANEL DISCUSSION - Studying the Importance of Getting A Diverse Patient Group Onto Your Study 10-11-2020, 4:00 pm 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.

Session Details: Chairperson’s Opening Remarks 11-11-2020, 8:50 am Speaker Hosted Roundtables 11-11-2020, 3:30 pm View In Agenda

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.

Session Details: Ensuring Top Quality Project Teams from Vendors from a Small Biotech’s Point of View 11-11-2020, 2:30 pm View In Agenda

Biography:

Session Details: PANEL DEBATE - “This House Believes that Larger Pharma Companies have the Better Approach When it Comes to Organizing a Clinical Trial” 11-11-2020, 10:00 am View In Agenda

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.

Session Details: Bringing a Small Supplier into your Trial: Exploring How to Work With a Niche Supplier 11-11-2020, 11:15 am View In Agenda

Biography: Madeline is Director of Global Patient Engagement and Innovation within the Global Clinical Trial Operations group at Merck and Co., Inc. She spearheads the Patient Engagement and advocacy efforts for her organization. In this role, she is responsible for optimizing clinical trial feasibility and execution through integrated data-driven expert analysis and recommendations, while promoting its engagement, development, and opportunities for innovation in recruitment and retention. With a keen focus on the perspective of the patient, she is intent on capturing and integrating the voice of the patient into operational aspects of clinical trial design, feasibility and recruitment and retention. She also works on several collaborative projects surrounding Diversity in Clinical Trials. Her efforts are targeted at creating awareness and education for the need for diversity and inclusion and in late stage drug development. Trained in Health Literacy principles, she has used her knowledge and expertise to champion changes to patient facing materials to ensure health literacy for clinical trial participants, caregivers, and their families around the world.   Madeline joined Merck in 2004. She began her work as a Medical Program Clinical Specialist working on several insomnia programs in clinical neuroscience with a focus on patient recruitment and retention. Madeline joined Global Trial Optimization in 2006 where she has spearheaded hundreds of patient recruitment initiatives, served as Therapeutic Area lead for Neuroscience, Ophthalmology, Hematology and Multiple Myeloma as well as Process Owner and Subject Matter Expert for the department. While at Merck, she has helped launch the Clinical Trials Microsite of merck.com; has led multiple voice of the patient projects; and has served as an industry expert in the field of patient engagement, recruitment and retention and heath literacy.   Prior to Merck, Madeline held positions in Business Development, Education, and in Clinical Research as a CRA.   Madeline received a dual B.S. degree in Psychology and Exercise Physiology from Ursinus College in Collegeville, Pennsylvania and is pursuing graduate coursework in Marketing from Temple University.

Session Details: PANEL DISCUSSION - Studying the Importance of Getting A Diverse Patient Group Onto Your Study 10-11-2020, 4:00 pm View In Agenda

Biography:

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

Session Details: Getting Inspection Ready – Taking Steps now to Ensure you Comply to International Guidelines 11-11-2020, 9:00 am View In Agenda

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.

Session Details: Patient Centricity through Decentralized Clinical Trials and Telemedicine 10-11-2020, 3:00 pm 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: THINK TANK - A Group Exercise Focused on Working with Colleagues to Find Solutions to Stumbling Blocks that can Arise During your Trial 10-11-2020, 4:30 pm Speaker Hosted Roundtables 11-11-2020, 3:30 pm View In Agenda

Biography: Mr. Hooks has been active in clinical research since 2004, having conducted studies in the non-profit, biotechnological, pharmaceutical, academic, medical device and in vitro diagnostic arenas. His research prowess is further derived from years of experience in clinical laboratory, study site and CRO settings. He has managed clinical trials in over 15 countries; specializing in expedited site activation techniques and creative study rescue activities. He enjoys teaching at professional research conferences and volunteering his time as a career development mentor to other research professionals. Mr. Hooks earned a Master of Public Health degree in Epidemiology in 2006, and a Master of Forensic Science degree in 2002. He is a native Oklahoman, and proud alumnus of both the University of Central Oklahoma and the University of Oklahoma Health Sciences Center.

Session Details: What Sponsors Can Do to Support the CRO to Achieve Accurate Site Selection and Rapid Study Start-Up 10-11-2020, 11:15 am View In Agenda

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.

Session Details: CASE STUDY - CRO Relationship Management: Working Through Issues with your CRO to Stay in Control of Your Study 11-11-2020, 12:15 pm View In Agenda

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 10-11-2020, 12:15 pm 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 - Exploring What We Need to Know When Choosing the Right CRO for your Trial 10-11-2020, 10:00 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.

Session Details: Bristol Myers Squibb Insights Sharing Session: Streamlining the Flow of Information to Address the Hypothesis and Futureproof Data 11-11-2020, 12:15 pm View In Agenda

Biography:

Session Details: Novartis Led - Ask the Expert: Building a Data Science Team for Medium – Large Enterprise: Key models to consider 11-11-2020, 11:15 am View In Agenda

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 11-11-2020, 9:30 am View In Agenda

Biography: Terry Katz is Director, Head of Global Data Management and Statistics for the Animal Health Division of US-based Merck & Co (known as MSD outside of the USA & Canada). Previously, he was VP, Biometrics, at ImClone Systems (human oncology) and a statistical manager at PRA International and Schering-Plough. He earned a BS in Microbiology, MS in Statistics, and post-MS certificate in Management Information Systems. Terry is a Certified Quality Engineer, a Certified Six-Sigma Green Belt, an Accredited Professional Statistician, a 2018 MSD Fellow for Global Health (human oncology project in Kenya) and is the current Chair, DIA’s Good Clinical Practices – Quality Assurance Community.

Session Details: Solving the Dilemma with Merck: Simplifying the Route to ICH E6 (R2) Compliance: harnessing the benefits of the various RBM tools at your disposal 11-11-2020, 9:00 am The Big Debate: The Time, Money and Quality Triangle - is it possible to achieve all three with the coupling of eData management and manual data systems? 11-11-2020, 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

Session Details: The Big Debate: The Time, Money and Quality Triangle - is it possible to achieve all three with the coupling of eData management and manual data systems? 11-11-2020, 10:00 am View In Agenda

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: The Big Debate: The Time, Money and Quality Triangle - is it possible to achieve all three with the coupling of eData management and manual data systems? 11-11-2020, 10:00 am Speaker Hosted Roundtables 11-11-2020, 3:30 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.

Session Details: Speaker Hosted Roundtables 11-11-2020, 3:30 pm View In Agenda

Biography:

Session Details: Accelerating Clinical Trials in the Asia Pacific Region 10-11-2020, 9:30 am View In Agenda

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 - Exploring What We Need to Know When Choosing the Right CRO for your Trial 10-11-2020, 10:00 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.

Session Details: Obtaining High Quality Imaging Data from Clinical Trials 11-11-2020, 9:30 am View In Agenda

Biography: Michelle is a highly experienced Product Management professional, with over 20 years of Life Sciences and technology experience. She is passionate about transforming clinical research through the use of innovative technology and analytics.

Session Details: Accessing Meaningful Subject Data and Clinical Insights Throughout the Clinical Trial Process 10-11-2020, 11:45 am View In Agenda

Biography:

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.

Session Details: The Big Debate: The Time, Money and Quality Triangle - is it possible to achieve all three with the coupling of eData management and manual data systems? 11-11-2020, 10:00 am View In Agenda

Biography:

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: Digital Document Ecosystem 11-11-2020, 2:00 pm View In Agenda

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.

Session Details: Current State and Future Vision of Vendor Qualification and Oversight 10-11-2020, 2:30 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: Proven Technology Driven Clinical Trial Supply Alternative 10-11-2020, 2:30 pm View In Agenda