Loading…
This event has ended. Visit the official site or create your own event on Sched.

Sign up or log in to bookmark your favorites and sync them to your phone or calendar.

Trk 02: Proj-Port Mgt-Strat Planning [clear filter]
Monday, June 27
 

8:30am

#104: Impact of Biologics, Vaccines, Oncology, and Breakthrough Therapy Designation on Traditional Global Drug Development Strategy
Limited Capacity seats available

Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-523-L01-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000186; RN 1.25

This forum will provide an overview of traditional small molecule drug development, and highlight special considerations, opportunities, requirements, and risks for specialized programs, such as oncology, vaccines, biologics, or breakthrough therapies.

Learning Objectives

Explain how oncology, vaccine, and biologic drug development are similar to, or different from, a traditional small molecule program; Compare and contrast oncology, vaccine, and biologic drug development with respect to project leadership and project management strategies, approaches, and resource investment decisions; Discuss the impact of breakthrough therapy designation on each of these.

Chair

Eva M. Finney, PhD, PMP

Speaker

Panelist
Susan Uptain, PhD

Panelist
David Robinson, PhD



Chair
avatar for Eva Finney

Eva Finney

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... Read More →

Speakers
DR

David Robinson

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... Read More →
avatar for Susan Uptain

Susan Uptain

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... Read More →
avatar for Susan Uptain

Susan Uptain

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... Read More →


Monday June 27, 2016 8:30am - 9:45am
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#105: Maximize the Value of Your Product by Beginning with the End in Mind
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000189; RN 1.25

Less than 1% of compounds make it to market. It is critical for biopharmaceutical developers to evaluate their probability of success. In this interactive forum, experts will share their insights to help you maximize the value of your asset.

Learning Objectives

Describe the elements of a regulatory strategy and why it is needed; Discuss the value of your product as part of your development strategy; Explain why and how to develop a target product profile; Discuss how the TPP guides the drug development process and sets expectations; Describe how to avoid typical reasons for delays and denials of a product marketing application.

Chair

Jayanthi Reddy, MBA, MS, PMP

Speaker

Panelist
Bill Hanlon, PhD

Panelist
Carrie Furin



Chair
JR

Jayanthi Reddy

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
avatar for Carrie Furin

Carrie Furin

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... Read More →
avatar for Bill Hanlon

Bill Hanlon

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... Read More →


Monday June 27, 2016 8:30am - 9:45am
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#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
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

10:30am

#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
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#210: Effective Strategies to Leverage PMO Best Practices for Program and Portfolio Management
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000190; RN 1.25

This session will familiarize the audience with the Project Management Office (PMO), with a focus on the value added opportunities that a PMO can provide to your organization. Utilizing best practices and real-world examples, we will identify those PMO processes and tools that assist companies with achieving their project goals along with their overall portfolio strategies. This session will dovetail information regarding value added portfolio management, the effective utilization of processes and tools within a PMO, and the challenges of building a culture of innovation in project portfolio life cycle.

Learning Objectives

Define the role of a Project Management Office (PMO) and how it can bring value to an organization; Describe what a structured PMO can do in partnership with their functions; Discuss how to introduce incremental and radical innovation to drive the project portfolio and gain a competitive edge and accelerate growth.


Chair

Karen M. Marks

Speaker

What Value Can a Project Management Office Bring to Your Organization?
Kristin Fitzgerald, MBA, PMP

Best Practices for a PMO: Developing a PMO with Effective Processes
Karen M. Marks

Driving Innovation by Expanding the Role of Integrated Project Portfolio: Challenges and Best Practices
Dinesh Singh, MBA



Chair
avatar for Karen Marks

Karen Marks

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... Read More →

Speakers
avatar for Kristin Fitzgerald

Kristin Fitzgerald

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... Read More →
avatar for Dinesh Singh

Dinesh Singh

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... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#236: Expanded Access: Ethical, Regulatory, and Policy Challenges and Considerations
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-522-L04-P; CME 1.25; IACET 1.25; RN 1.25

The legislative and regulatory landscapes for expanded access to investigational therapies are evolving due in part to public attention. This session will examine strategies proposed by stakeholders to address ethical, regulatory, and policy considerations.

Learning Objectives

Recognize FDA requirements for expanded access and the current regulatory, political, and social environment; Identify challenges faced by stakeholders from ethical, regulatory, and policy perspectives; Describe industry best practices for managing expanded access programs.

Chair

Kim M. Quaintance-Lunn

Speaker

Is There a Better Way? An Industry Perspective
Sandra A. Morris, PhD, PMP

The Ethics of Compassionate Use
Alison Bateman-House



Chair
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Vice President and Head, Regulatory Policy, North American Regulatory Affairs, Bayer
Kim Quaintance-Lunn serves as Vice President and Head, Regulatory Policy, North American Regulatory Affairs, 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... Read More →

Speakers
avatar for Alison Bateman-House

Alison Bateman-House

Assistant Professor, Division of Medical Ethics, NYU Langone Health
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 of the Working Group on Compassionate Use and Preapproval Access (CUPA), an academic group that studies ethical issues concerning... Read More →
avatar for Sandra Morris

Sandra Morris

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
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

10:30am

#310: Bridging CMC and Project Management to Achieve High Quality Product Submissions and Launch
Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000191; RN 1.25

This session will review case studies of differing delivery modality, to demonstrate diversified perspectives on product development, highlighting the project management-CMC interface.

Learning Objectives

Describe how to integrate the key/critical elements for successful pharmaceutical product project management into a receptive organization; Recognize the key/critical elements (critical path and common decision points) for successful CMC development, submission, and launch of pharmaceutical products.

Chair

Russell Maus, PhD

Speaker

CMC Case Study 2: Combination Device/Biologic Product
Maria Paola Schick, PMP

Case Study 3: Bioequivalency of Inhaled Products
Bela Elkin, PhD



Chair
avatar for Russell Maus

Russell Maus

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... Read More →

Speakers
avatar for Bela Elkin

Bela Elkin

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... Read More →
MS

Maria Schick

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... Read More →


Wednesday June 29, 2016 10:30am - 11:45am
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#336: Effect of International Reference Pricing on Planning for Global New Product Launches
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-597-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000184; RN 1.25

As more countries adopt cost containment strategies, it becomes increasing difficult to plan and execute successful, global launches of new drugs. This session will provide an overview of how to plan a successful launch given these challenges.

Learning Objectives

Identify the variables which influence the price of new drugs; Explain how international reference pricing affects optimal launch sequence; Recognize the other considerations (e.g., country scope, intellectual property, clinical plan) when planning a successful launch.

Chair

Matthew Steven Curin, PharmD

Speaker

What Every Project Manager Should Know about HTA and Pricing
Claire Corry, MS

Mapping the Global Launch Sequence in a Partnership
Nathan J. Murray

Practical Application of Global Launch Best Practices
Matthew Steven Curin, PharmD



Chair
avatar for Matthew Curin

Matthew Curin

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... Read More →

Speakers
avatar for Claire Corry

Claire Corry

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... Read More →
avatar for Nathan Murray

Nathan Murray

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... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#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

Senior Director, Strategic Projects, Office of the Chief Medical Officer, Johnson & Johnson
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
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA