Loading…
This event has ended. Visit the official site or create your own event on Sched.
Trk 02: Proj-Port Mgt-Strat Planning [clear filter]
Monday, June 27
 

10:45am EDT

#126: Hope Is Not a Strategy: Quantifying Knowledge for Better Decision Making in Clinical Development
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-596-L04-P; CME 1.25; IACET 1.25; RN 1.25

If studies have 90% power, why don’t 90% of studies have a successful outcome? This workshop will demonstrate how eliciting knowledge from experts and calculating the probability of success of a study or development program can leverage strategic decision-making.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Explain the statistical concept of Assurance (a.k.a. Probability of Success or PoS) with respect to drug development strategy; Describe the benefits of quantifying current knowledge (prior elicitation) among product and disease experts; Quantify the probability of success of a future clinical trial by participating in a mock exercise to elicit a prior.

Chair

Colleen Russell, MS

Speaker

Facilitator
Sharon Cornell Murray, PhD

Facilitator
David A. Burt



Chair
avatar for Colleen Russell

Colleen Russell

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... Read More →

Speakers
DB

David Burt

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... Read More →
avatar for Sharon Murray

Sharon Murray

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... Read More →


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
 
Tuesday, June 28
 

10:30am EDT

#209: The Promotable Project Manager: Leadership Behaviors Critical to Success in the Life Sciences
Component Type: Workshop
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000187; RN 1.25

This workshop will facilitate the participants' examination of their own leadership behaviors and provide unique insight on how participants might develop new skills to expand their influence and impact.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Describe the results of new research on the leadership skills that lead to professional advancement of project and program managers; Explain how project and program managers can expand their influence and deepen their leadership impact when leading or managing life science projects.

Chair

Richard J Heaslip, PhD


Chair
avatar for Richard Heaslip

Richard Heaslip

Founder, Programmatic Sciences LLC
Rick Heaslip is the Founder of Programmatic Sciences LLC, a consultancy specializing in the development of highly effective project and program leaders. Rick often advises life science companies seeking to improve their abilities to lead and manage projects. Rick is also a faculty... Read More →

Tuesday June 28, 2016 10:30am - 11:45am EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj-Port Mgt-Strat Planning, Workshop
 
Wednesday, June 29
 

4:00pm EDT

#358: Don’t Shoot the Messenger: Techniques for Delivering the Hard Messages
Component Type: Workshop
Level: Basic
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000183; RN 1.25

Strong communication skills are vital for effective collaboration and working in complex, matrixed environments. Yet dealing with conflict and delivering hard messages can be challenging and often uncomfortable for people at all levels in an organization. This workshop will explore scenarios routinely faced, such as: providing constructive feedback to a peer, delivering bad news to management, and dealing with poor behavior from a direct report. In this interactive forum, participants will be able to learn tips and become familiar with tools to help frame and deliver difficult communications, role play to pre-determined scenarios, receive real-time feedback and then apply the tools/tips to their own specific scenarios.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Describe strategies to assist in the communication of difficult messages to peers, direct reports, and senior leaders; Through role playing, demonstrate strategies and receive feedback on delivery of difficult messages.

Chair

Diane Neiman, MBA

Speaker

Facilitator
Karla Childers, MS



Chair
DN

Diane Neiman

Director, Global Project Management, Merck & Co., Inc.
Global Project and Alliance Management at Merck

Speakers
avatar for Karla Childers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj-Port Mgt-Strat Planning, Workshop
 

Filter sessions
Apply filters to sessions.
  • Preconference Tutorial
  • Trk 01: Clinical Operations
  • Trk 02: Proj-Port Mgt-Strat Planning
  • Trk 02: Proj/Port Mgt/Strat Planning
  • Trk 03: Innov Part Model-Outsourcing
  • Trk 03: Innov Part Model/Outsourcing
  • Trk 04: Preclin Transl-Early Clin Dev
  • Trk 05: Reg of Prod Adv-Mkting
  • Trk 05: Reg of Prod Adv/Mkting
  • Trk 06: Med Comm-Wrtg-MSL
  • Trk 06: Med Comm/Wrtg/MSL
  • Trk 07: Tech-Data- Records-Subs
  • Trk 07: Tech/Data/ Records/Subs
  • Trk 08: Reg Affairs
  • Trk 09: Med Devices-InVitro-CombProd
  • Trk 09: Med Devices/InVitro/CombProd
  • Trk 10: Pub Pol-HealthCare Compl-Law
  • Trk 10: Pub Pol/HealthCare Compl/Law
  • Trk 11: Quality in CT-GCP
  • Trk 11: Quality in CT/GCP
  • Trk 12: Pharm Quality
  • Trk 13: CER-Glob Health Econ
  • Trk 13: CER/Glob Health Econ
  • Trk 14: Clin Safety-PV
  • Trk 14: Clin Safety/PV
  • Trk 15: Statistics
  • Trk 16: Prof Development
  • Trk 17: Rare-Orphan Diseases
  • Trk 17: Rare/Orphan Diseases
  • Trk 18: Global Regulatory
  • Trk 19: DIAmond
  • Trk 20: Innov Theater
  • Trk 21: Poster Presentations
  • Trk 22: Engage and Exchange
  • Trk 23: Opening Plenary
  • Credit Type
  • ACPE
  • CME
  • IACET
  • PMI
  • RN
  • Audience
  • Advanced
  • Basic
  • Intermediate
  • Featured Topics
  • 21st Century Cures
  • Agency Participation
  • Approval Pathways
  • Audits and Inspections
  • Benefit-Risk
  • Big Data
  • Biologics-Biosimilars
  • Clinical Trial Designs
  • Clinical Trial Transparency-Clinical Trial Disclos
  • Cloud Computing
  • Community-led-Scientific Working Group Offerings
  • Current Issues in Policy and Law
  • Design Thinking
  • Disease Specific
  • Disruptive Technologies
  • Electronic Health Records (EHR)
  • Emerging Markets
  • GDUFA-Generics
  • Hot Topics in Policy and Law
  • IDMP
  • Increasing Research and Development Innovation
  • Interactive Workshop
  • Labeling
  • Mobile-Wearable Technology
  • Observational Studies
  • Partnership Strategies
  • Patient Engagement
  • Patient Recruitment and Retention
  • Patient Registries
  • Pediatrics
  • Precision-Personalized Medicine-Targeted Therapy
  • Pricing- Reimbursement and Access
  • Program Offerings for Student Attendees
  • R&D Innovation
  • Regulatory Harmonization-Convergence
  • Risk Evaluation and Mitigation Strategies (REMS)
  • Risk-Based Monitoring
  • Social Media Strategies
  • Topics Related to Asia-Pacific Region
  • Topics Related to Canada
  • Topics Related to China
  • Topics Related to Europe-EMEA
  • Topics Related to India
  • Topics Related to Japan
  • Vaccines
  • Value-Based Evidence
  • Women's Health
  • Interest Area
  • Academic Health Centers-Investigative Sites
  • Advertising & Promotion
  • Biotechnology
  • Clinical Data Management
  • Clinical Data Management - eClinical
  • Clinical Research
  • Clinical Safety & Pharmacovigilance
  • Clinical Supplies
  • CMC
  • CMC-GMP
  • Combination Products
  • Comparative Effectiveness
  • Document & Records Management
  • eClinical
  • Finance
  • Good Clinical Practices & QA
  • Information Technology
  • Manufacturing
  • Marketing & Sales
  • Medical Communications
  • Medical Devices & Diagnostics
  • Medical Science Liaison
  • Medical Writing
  • Non-clinical Safety
  • Outsourcing
  • Patient Engagement
  • Pharmaceutics
  • Pricing - Reimbursement
  • Professional Education - Training & Development
  • Project Management
  • Public Policy - Health Care Compliance - Law
  • Public Policy - Law
  • QA-QC
  • Quality Assurance - Quality Control
  • R&D - Strategic Issues
  • Rare - Orphan Diseases
  • Regulatory Affairs
  • Statistics
  • Strategic Planning
  • Study Endpoints
  • Submissions
  • Val - Electronic Info Integrity