DIA 2017 Annual Meeting

Component Type: Session
Level: Basic

This session will explore three areas of interest to advanced students in pharmacy, pharmaceutics, life sciences, and related programs:
1) The uses and abuses of business cards.
2) Opportunities in the pharmaceutical industry for recent graduates.
3) What recruiters want and how to help them advance your career.

Learning Objectives

Define due diligence (DD) in an M&A and describe what due diligence includes; Construct key questions to ask in the DD process to inform go/no-go decisions.

Chair

Danny Benau, PhD

Speaker

Facilitator
Sameer Thapar, PharmD, RPh

Facilitator
Emily Cox

Component Type: Session
Level: Intermediate

The life science industry is dominated by teams. High-performing teams create a dynamic where innovation and productivity flourish. They respect and amplify the talents of the individual. Put simply: they get more done. However, even the most motivated teams can have challenging team members and, possibly, be derailed by those individuals. With candor (and humor), this session will outline specific extreme team member personalities (archetypes) that can disrupt a project or process. Small groups will focus on strategies for keeping cool, obtaining information, and maintaining team rapport with their challenging team member. Attendees will be encouraged to share their examples and solutions within their small group and then the larger audience. This will be an interactive session for attendees at all levels.

Learning Objectives

Discuss the challenges of working in a group dynamic; Detail strategies for handling challenging team members; Strategize how to create a better rapport.

Chair

Robin Whitsell

Component Type: Session
Level: Intermediate

Global drug development has long been an accepted practice and expectation for clinical research success. Despite the proliferation of technology and other industry innovations, success or failure still depends on a high performing team. Teams are increasingly spread out across the globe and in many cases working remotely which further challenges communication and direct collaboration. Still other challenges emerge when project teams are potentially comprised of representatives from the sponsor, contract research organizations (CROs) and independent contractors. This session will examine the role of the study start-up process, how to spot the early warning signs of dysfunction and practical strategies for how to best align and engage the global team.

Learning Objectives

Discuss how to design a successful project kick-off meeting; Discuss getting the most out of study start-up; Recognizing the signs of a team in trouble; Strategies to align objectives across multiple cultures and diverse backgrounds.

Chair

Peter A. DiBiaso, MHA

Component Type: Session
Level: Intermediate

This interactive session will analyze a CRO/sponsor relationship that has been in effect for many years. In groups, participants will discuss the strengths and weaknesses of this case study and what might be their “Secret Sauce” and/or if people or process have allowed them to continue as partners for many years. As participants reflect on their analysis of the case study they will compare with their own experiences and determine what is the recipe for a healthy long lasting CRO/Sponsor relationship. The groups will then reveal their findings to all participants for feedback, discussion, and/or actions they may take to their organizations.

Learning Objectives

Describe the common pitfalls of CRO/Sponsor relations; Identify various strategies and best practices for maintaining healthy and long lasting CRO/Sponsor relationships.

Chair

David Burnham

Speaker

Facilitator
Sondra Smyrnios, MSc

Component Type: Session
Level: Intermediate

Do you ever wonder how your peers manage their interactions with FDA?  Do you wonder why your peers get a response when you do not?  What challenges, and what successes, have you had?  Join us for an interactive session to discuss best practices and strategies for communicating with FDA.  You will work in groups to evaluate a communication scenario, develop a set of options for your approach to communicating, and develop strategies, best practices, tips, etc. based on your experience and general knowledge.  This is not an overview of meeting types or timelines; this is an opportunity to brainstorm ideas and share strategic best practices around communication.

Learning Objectives

Explore various strategies for communication with FDA; Discover best practices for communication from your peers.

Chair

Leah Christl, PhD

Speaker

Session Co-Chair
Kim M. Quaintance-Lunn

Component Type: Session
Level: Intermediate

Mergers and acquisitions (M&A) are increasingly common in our industry. The due diligence (DD) necessary to drive the best course of action requires careful planning and forethought by key stakeholders. In this session, we will walk through an M&A scenario to brainstorm on pivotal questions to ask in pursuit of the go/no-go decision. Participants will actively engage in group brainstorming to synthesize key DD questions in finance, operations, commercial, legal, HR, IT, facilities, and other corporate functions, and will be provided with key considerations to take back to their workplace.

Learning Objectives

Define due diligence (DD) in an M&A and describe what due diligence includes; Construct key questions to ask in the DD process to inform go/no-go decisions.

Chair

Donny Chen, MBA

Component Type: Session
Level: Intermediate

A workshop to explore the world of combination product safety. Discuss the real-world, least burdensome approach to Postmarket Safety Reporting (PMSR) for US Combination Products, in light of the final rule. Help the audience appreciate the complexity of implementing PMSR in a global organization. Participants will work in teams to work through mock case(s) of combination products approved as drug application type with a device constituent part. We will have interactive discussion about key challenges including global impact and highlight industry best practices.

Learning Objectives

Describe the basic requirements as highlighted in the final rule; Identify simple solutions to comply with the regulation.

Chair

Khaudeja Bano, MD, MS

Component Type: Session
Level: Intermediate

Mergers and acquisitions (M&A) are increasingly common in our industry. Managers gaining new employees and employees entering new structures and systems - and often entirely new workplace cultures - may struggle to adapt, sometimes with disastrous consequences. Even with careful planning and thoughtful communication, stress and anxiety levels can remain high in the period of time before and after the event. In this session, we will discuss the factors that impact emotional well-being in an M&A, from both the manager’s and the employee’s perspectives. We will walk through two M&A scenarios in which the manager or the employee has become disenchanted or disengaged, and we will discuss ways in which to ‘hit the reset button’ in order to mitigate the harm. Participants will engage in role play, and will be given a guide to healthy M&A communication to take back to their workplace.

Learning Objectives

Describe how a mergerand acquisition can impact both a manager’s and an employee’s emotional well-being; Develop a communication plan to reduce levels of stress and anxiety; Recognize when the level of anxiety is high, and employ corrective action to mitigate that anxiety.

Chair

Margaret S. Richards, PhD, MPH

Component Type: Session
Level: Intermediate

This session will explore a variety of factors that enter into patients’ decisions to join and remain in clinical trials as well as strategies for increasing the odds that a given patient will agree to join a trial.

Learning Objectives

Discuss the relative weight of key emotional, motivational, and scientifically objective factors that impact patients’ willingness to join (and then remain in) clinical trials; Outline possible strategies for increasing the likelihood that a given patient will agree to join a trial; Develop a detailed plan for implementing one of these strategies for recruiting a patient into a clinical trial with which they (participants) are currently involved.

Chair

James A. Seaton

Component Type: Session
Level: Intermediate

This session will include a facilitated discussion about real life experiences in implementing RBM. We will use case studies to illustrate operational approaches to RBM and to provide examples of lessons learned from companies already employing the methodology. We will also provide an overview of the TransCelerate Interactive Guide for RBM as an example of the resources available to support the RBM process.

Learning Objectives

Review the concepts of the Risk-Based Monitoring methodology; Share case studies and experiences of RBM in action; Provide resources available for support.

Chair

Esther M. Huffman, MA

Component Type: Session
Level: Intermediate

In the global and complex pharmaceutical ecosystem that exists today, the information and expertize that you need may be spread out all over the world. This means you need to work effectively and efficiently with various external partners (for instance, big and small companies, academics, etc.). These partners may have different standards, priorities, and/or values. If well managed, this diversity creates further opportunities, including new ways of doing things, but it also brings some challenges. In this session, focusing mainly on the US and Japan (with additional comments related to Europe and Asia), we will identify common pitfalls and issues related with the above, and also discuss potential solutions, with an eye to seizing the highly diverse opportunities in drug development.

Learning Objectives

Identify their own characteristics and preferences in communication and values; Discuss common pitfalls and issues in highly diverse situations; Acquire practical tools to manage cultural diversity .

Chair

Atsushi Tsukamoto, PhD, MSc

Speaker

Facilitator
Gareth Julian Monteath

Component Type: Session
Level: Intermediate

Come learn about how Medical Affairs must liaise with other functions from drug development to commercial as we connect with customers and share real world insights. We will also discuss how Medical Affairs plays a key role in the evolving healthcare landscape. Finally we will discuss the competencies necessary for professionals in this emerging field of practice.

Learning Objectives

Describe how medical affairs must liaise with other functions from drug development to commercial as we connect with customers and share real world insights; Discuss how medical affairs plays a key role in the evolving healthcare landscape; Discuss the competencies necessary for professionals in this emerging field of practice.

Chair

Rebecca A. Vermeulen, RPh