DIA 2016 Annual Meeting

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

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

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

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

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

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

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

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

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