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07: ProjMgt-StrategicPlanning [clear filter]
Monday, June 24


#155: Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-570-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss how to complement existing activities and regulations, we propose an additional approach blending evidence derived from pharmacological and organizational science which addresses human factors and transparency to enhance organizational learning and continuous improvement. This systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future.

Learning Objectives

Identify evidence-based techniques for better defining causal factors in system failure; Recognize that those techniques which can be used now; Appraise how we should best develop these concepts, identify best practice and engage all stakeholders; Discuss how to volunteer to join the team aiming to improve the safety of the system for clinical research.


Brian Edwards, DrMed


Applying CAUSAL Analysis System Theory to the TGN1412 First-In-Human Clinical Trial
Brian Edwards, DrMed

Innovation in First-in-Human Safety
Howard Greenberg, DrMed, MD, MBA, MS

Investigators from the Warfarin-Stimulated Frail Hospitalized Patients Project
Nichola Crust, MSc


Nichola Crust

National Investigator, Healthcare Safety Investigation Branch
Nichola has worked at a strategic level in a variety of healthcare settings spanning primary and secondary care. Her roles have included professional nurse leadership and mentoring of nursing teams, mobilisation of new services including service and workforce redesign, and training... Read More →
avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →
avatar for Howard Greenberg

Howard Greenberg

Medical Safety Officer, Janssen Research and Development, LLC
Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next,Patient Focused
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session
Wednesday, June 26


#337: Application of Project Management Methodologies and Tools in NonProfit Institutions
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-668-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166QWTSEW; RN 1.00

Effective project management is crucial to every organization to execute effectively on strategic goals. Yet it may be a relatively new concept to healthcare and research organizations. Assessment of the need and development of the "right size" solution to encourage collaborative decision making, good stakeholder communication and robust planning will be discussed.

Learning Objectives

Discuss the need for project and portfolio management and assessment in academic and nonprofit institutions and learn how to implement project management in a non-traditional setting; Illustrate the use of and construction tools in resourced constrained environments.


Elizabeth Somers, MS


Benefits of Adapting Project Management Methodologies to Meet the Specific Needs of an Organization
Elizabeth Somers, MS

How to Adapt Traditional Project Management Methodology for Research Institutions
Neha Pannuri, PMP

Developing and Deploying a Resource Management System in a Non-Profit Vaccine Development and Implementation Organization
Rami Scharf, DrSc, MBA, MSc

avatar for Neha Pannuri

Neha Pannuri

Project Manager, Icahn Institute At Mount Sinai
Neha is a Project Manager at the Icahn Institute of Data Science and Genomic Technology at the Mount Sinai Hospital in New York City. She is primarily involved in the management of a multitude of projects including NIH-funded grants, industry collaborations, and internal strategic... Read More →

Rami Scharf

Director Project and Portfolio Management, CVIA, PATH
Rami Scharf began his professional career training as a biologist at the Technion – Israel Institute of Technology, earning a doctorate in applied microbiology. He started working in industry, honing his project management skills while applying science to complex environmental issues... Read More →
avatar for Elizabeth Somers

Elizabeth Somers

Executive Director of Infectious Disease, Global Project and Alliance Management, Merck & Co., Inc.
Liz is an Executive Director of Infectious Diseases in Global Project and Alliance Management at Merck. In addition to accountability for the ID TA, she manages a team focused on Discovery collaborations which leverages her experience managing complex cross functional drug development... Read More →

Wednesday June 26, 2019 10:30am - 11:30am
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA


#364: Effective Portfolio Management of Assets Across an Organization
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-688-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166TTL5PH; RN 1.25

This session will share information on portfolio management from different perspectives: integration of an asset into an established portfolio and ensuring alignment with an established strategy; brand development to articulate differentiation and how to approach this component from a portfolio lens; and leadership techniques and skills needed to manage portfolios.

Learning Objectives

Discuss portfolio management from different perspectives: Identify how to integrate an asset into an established portfolio and ensure alignment with an established strategy; Describe brand development to articulate differentiation and how to approach this component from a portfolio lens; Describe leadership techniques and skills needed to manage portfolios.


Mark Kryah, PMP


Integration of an Acquired Asset into the Drug Development Portfolio
Nathan R. Kreischer, MS, PMP

Building for Commercial Success in Clinical Development: Defining your Asset’s Brand Story to Build Equity and Understanding
Kirstin Dawson

Leadership Capabilities That Enable Effective Project and Portfolio Management
Daniel Patrick, MBA

avatar for Kirstin Dawson

Kirstin Dawson

Vice President, Account Director, Addison Whitney, A Syneos Health Company
As the Vice President, Account Director in San Francisco for Addison Whitney, Kirstin leads day-to-day communication & direction for both client projects and the account services team. Her background in healthcare marketing and experience across multiple disease states give Kirstin... Read More →
avatar for Nathan Kreischer

Nathan Kreischer

Director, Global Project & Alliance Management, Merck & Co., Inc
Nathan is a Director within Global Project & Alliance Management at Merck. He has over 13 years of experience in the Pharmaceutical industry spanning Basic Research, Sales, Clinical Research and Project/Program Management. He has successfully lead teams through strategy development... Read More →
avatar for Mark Kryah

Mark Kryah

Senior Advisor/COO, Bio-Medicines Business Unit, Eli Lilly and Company
Mark Kryah is COO/Senior Advisor in Eli Lilly’s Bio-Medicines Business Unit, leading Phase 3 development in Immunology. He has been leading global development projects for 20+ years, with extensive international and partnership experience. Mark has been involved with DIA for over... Read More →

Daniel Patrick

Global Group Leader - R&D Program Management Office, Daiichi Sankyo
Dan Patrick has more than 25 years of experience in the Life Sciences and Financial Services industries. He is presently Global Group Leader, R&D Program Management Office, at Daiichi Sankyo Co. (a global pharmaceutical company) where he is responsible for developing and implementing... Read More →

Wednesday June 26, 2019 2:00pm - 3:15pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA