Trk 22: Engage and Exchange [
clear filter]
10:45am EDT
#144: Root Cause Analysis: Getting to ‘Why’ When Something Goes Wrong in Your Trial
Chair
Executive Director, INC Research
Keith Barber has worked in Quality, Process, Training and Clinical management positions for over 20 years. He currently manages INC's Process Quality Management department, which includes CAPA management, controlled document management and internal GXP consultancy. Keith has also...
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Speakers
Director, Process Quality Management, INC Research
Monday June 27, 2016 10:45am - 11:45am EDT
Exhibit Hall A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
12:15pm EDT
#147: Interpreting Meaningful Change on PRO Instruments: Methods in Action
Chair
Principal, Outcometrix
Cheryl D. Coon, PhD is a psychometrician with over a decade of experience in the pharmaceutical field. She applies qualitative and quantitative methods to the development and evaluation of PRO instruments. During her years in the field, she has been involved in all stages of instrument...
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Speakers SK
Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining...
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Monday June 27, 2016 12:15pm - 1:15pm EDT
Exhibit Hall A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
1:30pm EDT
#149: EMA's Publication Policy 0070: Best Practices for Implementation
Chair
Principal, Paarlberg & Associates LLC
Robert Paarlberg is Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob worked at Pharmacia (Upjohn) and UCB...
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Speakers
Senior Director, Medical Writing and Alliance Management, Janssen Research & Development, LLC
Head Med Affairs Writing/ MW Alliances, previously director of Early Development and multiple therapeutic area writing at J&J for 17yrs. 2-term MW SIAC Chair, and CDISC Protocol Rep/Glossary Group from 2001. Held positions of increasing responsibility in MW and management for 40...
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Monday June 27, 2016 1:30pm - 2:15pm EDT
Exhibit Hall A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
9:40am EDT
#205: It’s Not You; It’s Me: Dealing with Team Challenges, Critique, and Criticism
Chair
President, Whitsell Innovations, Inc.
Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 20 years’ experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior...
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Tuesday June 28, 2016 9:40am - 10:25am EDT
Exhibit Hall A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:45am EDT
#228: Increase Value of Clinical Trials Through Impactful Branding
Chair BC
Director, Marketing, Continuum Clinical
Speakers
Global Feasibility and Recruitment Partner, AstraZeneca
Marie Eckerd is currently a Feasibility and Recruitment Partner at Astra Zeneca. She has lead large global programs through submission across various therapy areas. Previous to AstraZeneca, Marie held leadership positions in Project Management and Data Management with the former Wyeth-Ayerst...
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Chief Strategy Officer, Continuum Clinical
Bob Klein, Chief Strategy Officer of Blue Chip Marketing Worldwide and Continuum Clinical, is dedicated to helping pharmaceutical and biotech companies unearth insights that accelerate clinical trail enrollment and retention. With more than 30 years of experience, Bob is responsible...
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Tuesday June 28, 2016 10:45am - 11:45am EDT
Exhibit Hall A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
12:00pm EDT
#231: Introduction to Structured Content
Chair
Chief Executive Officer, The Rockley Group Inc.
Ann Rockley has helped pharmaceutical, medical devices, and healthcare providers create intelligent content strategies and adopt structured content management for more than 15 years. She has helped clinical, labeling, and marketing content teams meet the increasing demands of regulatory...
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Tuesday June 28, 2016 12:00pm - 1:00pm EDT
Exhibit Hall A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
2:00pm EDT
#255B: Lost in Translation: The Importance of Data Presentation
Chair
Senior Partner, Trilogy Writing & Consulting
Barry Drees received his PhD in molecular genetics at the University of California, San Francisco. Following his postdoctoral work as a fellow of the National Institute of Health, he worked as a medical writer at Hoechst/Aventis for 12 years. Barry is a frequent speaker on medical...
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Tuesday June 28, 2016 2:00pm - 3:00pm EDT
Exhibit Hall A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
4:00pm EDT
#278: Real Life Application of Risk-Based Monitoring
Chair
Head, Monitoring Excellence, Bristol-Myers Squibb Company
Brett Wilson, BSP, is Head of Monitoring Excellence at Bristol-Myers Squibb and leads both Risk Based Monitoring and eSource initiatives with TransCelerate BioPharma. Within BMS, Brett is responsible for ensuring an accountable and sustainable adaptive monitoring model focused on...
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Speakers
Consultant, RBM Operations, Clinical Risk Management, Eli Lilly and Company
Lisa is an RBM Operations Consultant in Eli Lilly’s Clinical Risk Management organization. She develops and implements RBM processes, procedures and training as she guides study teams through the RBM implementation process. She has been a key leader in the implementation of RBM...
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Vice President, Clinical Trial Management, Novo Nordisk Inc.
Kate is the Vice President of Clinical Trial Management at Novo Nordisk (Princeton, NJ) with 22 years’ experience within the biotech, pharmaceutical and CRO space. Her leadership has led to improved productivity, cost-effectiveness, quality and staff morale. She sponsors the Novo...
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Tuesday June 28, 2016 4:00pm - 5:00pm EDT
Exhibit Hall A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
9:40am EDT
#305: MedDRA: Use in the Review of New Drug Applications at the FDA
Speakers
Medical Officer, Office of New Drugs, CDER, FDA
Dr Breder is Medical Officer at the FDA with a focus on neurological disorders. He serves as the FDA Topic leader on the ICH team that maintains the MedDRA Points to Consider document. Prior to his employment at the FDA, Dr Breder served in several leadership roles in industry. He...
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Owner, Richardson M.D. Consulting, LLC
David W. Richardson, M.D. is a drug safety/pharmacovigilance consultant, based in Atlanta, Georgia. Dr. Richardson is an adult neurologist; he attended Harvard College and University of Pennsylvania School of Medicine. He is a part-time consultant for the MedDRA Maintenance and Support...
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Wednesday June 29, 2016 9:40am - 10:25am EDT
Exhibit Hall A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:45am EDT
#328: The Ethics of “Big Data” Biomedical Science
Chair
Senior Research Fellow, Centre for Values, Ethics and the Law in Medicine, University of Sydney
Dr Wendy Lipworth is a medically trained bioethicist and qualitative social researcher from the Centre for Values, Ethics and the Law in Medicine, University of Sydney, Australia. Her program of research focuses on the ethics and politics of biomedical innovation, with a particular...
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Wednesday June 29, 2016 10:45am - 11:45am EDT
Exhibit Hall A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
12:00pm EDT
#331: Applying Design Thinking to Clinical Development: Human-Centered Approaches to Improve Quality and Efficiency
Chair
Chief Operating Officer, The Avoca Group
With 20 years in the pharmaceutical industry as a sponsor, provider, and consultant, Dennis Salotti's experience spans preclinical research, clinical operations, data management, quality assurance, eClinical, business operations, and strategic management. Prior to Avoca, he was Director...
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Speakers
Global Head Franchise Quality Assurance, Novartis Pharmaceuticals Corporation
JoAnn Muir is Global Head Quality Assurance/Vendor Oversight at Novartis. JoAnn has 20 years’ experience in clinical research and has spent her career in clinical trial management, drug development, and quality assurance. She supports clinical teams by providing regulatory compliance...
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Executive Director, Quality Consortium, The Avoca Group
Steven Whittaker, Executive Director, Avoca Quality Consortium (retired from Eli Lilly and Co.) , consults for the pharmaceutical, biotech, and CRO industries, providing expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution...
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Wednesday June 29, 2016 12:00pm - 1:00pm EDT
Exhibit Hall A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
2:00pm EDT
#354: Protocol Optimization: Making It Real
Chair
Consultant-Process & Technology, Eli Lilly and Company
Speakers
Head, Industry Collaborations, Genentech, A Member of the Roche Group
Virginia Nido is the Global Head of Industry Collaborations Management for Roche Product Development. In this role, Ms. Nido is accountable for strategic oversight of external collaboration initiatives. Ms. Nido serves on the Oversight Committee of TransCelerate Biopharma and the...
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Sr. Manager, Regulatory Technology Consulting, Accenture
Stacy Tegan brings 20+ years of experience in the Pharmaceutical industry with expertise in Regulatory Operations, Clinical Development Processes, and Project Management. Starting in Regulatory Operations, she managed sponsor and outsourced publishing teams and led multiple transitions...
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Strategic Planning and Operations Senior Manager, Amgen Inc.
Over the past 10 years Bryan has led global cross-functional teams in the design and implementation of large-scale transformation initiatives at Amgen. He is currently a member of a team focused on creating a best-in-class clinical development capability to bring more medicines to...
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Wednesday June 29, 2016 2:00pm - 3:00pm EDT
Exhibit Hall A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
3:15pm EDT
#356: Let's Enjoy Global Stakeholder Management
Chair
Vice President, New Drug Regulatory Affairs, Daiichi Sankyo Co., Ltd.
Atsushi is VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He is also Head of Specialty Medicine RA in R&D division, to lead gobal specialty medicine regulatory strategies. As Head of Japan New Drug RA, he is responsible for leading new drug RA activities for all projects...
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Wednesday June 29, 2016 3:15pm - 4:00pm EDT
Exhibit Hall A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA