Trk 02: Proj-Port Mgt-Strat Planning [
clear filter]
8:30am EDT
#104: Impact of Biologics, Vaccines, Oncology, and Breakthrough Therapy Designation on Traditional Global Drug Development Strategy
Chair
Director, Global Project & Alliance Management, Merck & Co., Inc.
Eva M. Finney, Ph.D., PMP, is Director, Global Project and Alliance Management at Merck, where she has been a Project Manager for 15 years. She has managed multiple development programs from early to late stage, including several NDA submissions leading to successful product approvals...
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Speakers DR
Principal Consultant, Robinson Vaccines and Biologics LLC
Independent consultant with 25 years experience in global vaccine and biologics product commercialization, process development and CMC regulatory strategy/execution (IND, BLA, PAS). Over 20 years at Merck, chaired the CMC development team that achieved approval of RotaTeq, an oral...
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Head of Regulatory Affairs Operations, Baxalta
Dr. Susan Uptain is currently Head of Global Regulatory Operations at Baxalta, where she is responsible for operational excellence in execution of global regulatory strategy and tactics. Previously, she was Director of Project Management and Alliance Management at Merck & Co., Inc...
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Head of Regulatory Affairs Operations, Shire
Dr. Susan Uptain is currently Head of Global Regulatory Operations at Baxalta, where she is responsible for operational excellence in execution of global regulatory strategy and tactics. Previously, she was Director of Project Management and Alliance Management at Merck & Co., Inc...
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Monday June 27, 2016 8:30am - 9:45am EDT
105AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 02: Proj-Port Mgt-Strat Planning,
Forum
- Credit Type ACPE, CME, IACET, PMI, RN
- Audience Advanced
- Featured Topics Approval Pathways, Design Thinking, Precision-Personalized Medicine-Targeted Therapy, Biologics-Biosimilars, Vaccines, Increasing Research and Development Innovation
- Interest Area Regulatory Affairs, R&D - Strategic Issues, Strategic Planning, Biotechnology, Rare - Orphan Diseases
- format json
- Interest Area Regulatory Affairs,R&D / Strategic Issues,Strategic Planning,Biotechnology,Rare / Orphan Diseases
- Featured Topics Approval Pathways,Design Thinking,Precision/Personalized Medicine/Targeted Therapy,Biologics/Biosimilars,Vaccines,Increasing Research and Development Innovation
- Credit Type ACPE, CME, IACET, PMI, RN
- Tags Forum
8:30am EDT
#105: Maximize the Value of Your Product by Beginning with the End in Mind
Chair JR
Director, Global Project Management, Merck & Co., Inc.
Jay has over 20 years of pharmaceutical industry experience and over 14 years of project Management experience. She is currently the cardiovascular franchise leader within the Project Management group at Merck.
Speakers
Manager, Clinical Trial Management, Eli Lilly and Company
Carrie is a Manager with Eli Lilly and Company overseeing Clinical Trial Managers on Oncology trials. She has over 10 years of drug development experience in clinical operations and project management. Carrie has led teams across multiple therapeutic areas and phases, which has provided...
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Chief Development Officer and Head of Global Regulatory Affairs, Covance Inc.
Dr. William Hanlon, PhD, is the chief development officer and head of global regulatory affairs for Covance. He has been with Covance for four and a half years, after spending 25 years in pharma in the discovery and the development side of developing drugs for global commercialization...
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Monday June 27, 2016 8:30am - 9:45am EDT
107AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:45am EDT
#126: Hope Is Not a Strategy: Quantifying Knowledge for Better Decision Making in Clinical Development
Chair
Associate Director, Biostatistics, PAREXEL
Colleen is an experienced pharmaceutical R&D statistician who has oversight of drug development and execution, insuring that work processes and client expectations are satisfied. She is focused on applying published statistical methods for comparing like devices to understand the...
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Speakers DB
Director, Biostatistics, Trevena Inc
David received his PhD in Statistics from Virginia Tech in 2000 and has since been working in the pharmaceutical industry for a number of different companies. Currently he is serving as the Director of Biostatistics at Trevena Inc a biotech company based out of King of Prussia, P...
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Associate Director, Biostatistics, PAREXEL
Sharon Murray is Associate Director, Statistics at PAREXEL Ltd. She provides statistical support for the design, analysis and operational aspects of Oncology clinical trials as well as for drug development strategy. Sharon holds an MS and PhD in Biostatistics from the University of...
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Monday June 27, 2016 10:45am - 12:00pm EDT
102AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 02: Proj-Port Mgt-Strat Planning,
Workshop
- Credit Type ACPE, CME, IACET, RN
- Audience Basic
- Featured Topics Clinical Trial Designs
- Interest Area Statistics, Clinical Research, R&D - Strategic Issues
- format json
- Interest Area Statistics,Clinical Research,R&D / Strategic Issues
- Featured Topics Clinical Trial Designs
- Credit Type ACPE, CME, IACET, RN
- Tags Workshop
10:30am EDT
10:30am EDT
#210: Effective Strategies to Leverage PMO Best Practices for Program and Portfolio Management
Chair
Vice President, Global Program Management Office, Baxter International, Inc.
Karen Marks is the Vice President of the Global PMO for Baxter. Prior to joining Baxter, she has held positions in ConvaTec and Merck & Co and AT&T. Karen’s educational background includes a BS from Muhlenberg College in Human Resources Management, Master's Certification in Project...
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Speakers
Director, Global Project Management, Project Management Office, Merck & Co., Inc.
Kristin Fitzgerald has been in the pharmaceutical industry for over 16 years and has worked in many different areas including, IT, Data Management, and Operations. In her current role, she manages support and leadership to Project Managers, Finance, and IT with respect to project...
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Client Partner, Life Sciences, Cognizant
He is a seasoned advisor with 13 years of experience in business strategy, complex program management and large transformation/integration initiatives in life sciences industry. He has worked with leading pharmaceuticals clients to help them address key business problems and align...
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Tuesday June 28, 2016 10:30am - 11:45am EDT
105AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
2:00pm EDT
#236: Expanded Access: Ethical, Regulatory, and Policy Challenges and Considerations
Chair
Vice President and Head, Regulatory Policy, Regulatory Affairs Americas, Bayer U.S. LLC, United States
Kim Quaintance-Lunn serves as Vice President and Head, Regulatory Policy, Regulatory Affairs Americas, at Bayer. Kim joined Bayer in February 2014 to establish and lead the US regulatory policy function for the organization. She works with colleagues to analyze regulatory policy and...
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Speakers
Assistant Professor, Division of Medical Ethics, Dept of Population Health, NYU Langone Health, United States
Alison Bateman-House, PhD, MPH, MA, is an assistant professor in the Division of Medical Ethics at NYU Langone Health's School of Medicine. She is co-chair, with Arthur Caplan PhD, of the Working Group on Compassionate Use and Preapproval Access (CUPA), an academic group that studies...
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Vice President, Strategy Realization, Johnson & Johnson
Dr. Morris is currently VP, Strategy Realization for the J&J CMO. Prior to joining J&J, Dr. Morris spent 18 years at Merck where she was VP, Global Project Management. Dr. Morris received her PhD in Organic Chemistry and completed postdoctoral research in biochemistry.
Tuesday June 28, 2016 2:00pm - 3:15pm EDT
108B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 02: Proj-Port Mgt-Strat Planning,
Session
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Current Issues in Policy and Law, 21st Century Cures, Patient Engagement
- Interest Area Public Policy - Health Care Compliance - Law, Regulatory Affairs, Advertising & Promotion, Rare - Orphan Diseases, Patient Engagement
- format json
- Interest Area Public Policy / Health Care Compliance / Law,Regulatory Affairs,Advertising & Promotion,Rare / Orphan Diseases,Patient Engagement
- Featured Topics Current Issues in Policy and Law,21st Century Cures,Patient Engagement
- Credit Type ACPE, CME, IACET, RN
- Tags Session
10:30am EDT
#310: Bridging CMC and Project Management to Achieve High Quality Product Submissions and Launch
Chair
Director, Merck & Co., Inc.
Russell joined Merck in 2002 in Merck Manufacturing in a role supporting analytical methods for in-line products. In 2006 he moved to Merck Research Labs to provide analytical support for PhI and PhII pharmaceutical development. In 2012 he took on a 2.5 yr stint as Scientific Project...
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Speakers
Laboratory Manager, PPD
Dr. Bela Elkin has +30 years of experience in numerous chemistry-related fields, including research, drug development, the pharmaceutical industry, teaching, management and administration. She has +15 years of analytical chemistry laboratory experience in the FDA regulated pharmaceutical...
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CMC Integration Sr. Project Manager, Amgen Inc.
Biotechnology professional with 13+ years of industry experience with a focus on project management to enable commercialization of biologics and combination products by partnering with scientific leads and Global Operations Leads to co-lead and manage cross-functional project teams...
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Wednesday June 29, 2016 10:30am - 11:45am EDT
108B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
2:00pm EDT
#336: Effect of International Reference Pricing on Planning for Global New Product Launches
Chair
Executive Director, Program Management, Epizyme
Matt has been working in the pharmaceutical industry for almost 20 years, spending the first 8 years in clinical manufacturing before moving into project management in 2007. Since then, Matt has provided project, program, and portfolio management leadership in clinical development...
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Speakers
Director, Global Project and Alliance Management, Merck & Co., Inc.
Claire Corry currently is a Director in Global Project and Alliance Management at Merck and has been working in project and portfolio management roles for 15 years. Claire has a wealth of knowledge across all phases of drug development, working with both small molecules and biologics...
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Global PRA Advisor, Autoimmune, Eli Lilly and Company
Currently lead a cross-functional (and multinational) team in the development of global price, reimbursement and access (PRA) strategy for both pre-launch and commercialized products. Primarily responsible for achieving acceptable access and reimbursement levels for patients and for...
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Wednesday June 29, 2016 2:00pm - 3:15pm EDT
105AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 02: Proj-Port Mgt-Strat Planning,
Session
- Credit Type ACPE, CME, IACET, PMI, RN
- Audience Intermediate
- Featured Topics Pricing- Reimbursement and Access, Value-Based Evidence
- Interest Area Pricing - Reimbursement, Strategic Planning, Comparative Effectiveness, Finance
- format json
- Interest Area Pricing / Reimbursement,Strategic Planning,Comparative Effectiveness,Finance
- Featured Topics Pricing/ Reimbursement and Access,Value-Based Evidence
- Credit Type ACPE, CME, IACET, PMI, RN
- Tags Session
4:00pm EDT
#358: Don’t Shoot the Messenger: Techniques for Delivering the Hard Messages
Chair DN
Director, Global Project Management, Merck & Co., Inc.
Global Project and Alliance Management at Merck
Speakers
Senior Director, Strategic Projects, Office of the Chief Medical Officer, Johnson & Johnson, United States
Karla Childers is a Senior Director of Strategic Projects in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibilities are the Clinical Trial Data Transparency Initiative and the Johnson & Johnson Bioethics Committee.
Wednesday June 29, 2016 4:00pm - 5:15pm EDT
102AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA