DIA 2016 Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-530-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000193; RN 1.25

As the pharmaceutical environment becomes increasingly demanding, it is essential for companies to have a clear understanding of their customer needs in order to both anticipate and adequately address them. Speakers will illustrate the value of capturing and reporting environmental insights (medical information inquiries) to help identify customer needs. We will examine different insights that can be gained, based on real examples encountered. Speakers will also demonstrate one approach to collating and presenting qualitative functional metrics for medical information to internal leadership. Such reporting and analysis of insights and metrics can demonstrate the value of medical information to the medical affairs function and strategic planning process.

Learning Objectives

Discuss how tracking medical information inquiries can identify environmental insights and trends; Illustrate the value of gathering and communicating qualitative functional medical information metrics to stakeholders; Describe the potential contribution of medical information insights and metrics to strategic and operational planning.


Chair

Sara Doshi, PharmD

Speaker

Delivering Value Through Medical Information Metrics
Dipti Tankala, PharmD, RPh

Effective and Efficient Use of Customer Interactions Data to Anticipate Customer Needs Through Text Analytic Metrics
Edward J. Brauer, PharmD

Tools for Data Insights in Medical Information
Zachary Furqueron, MBA

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-603-L04-P; CME 1.00; IACET 1.00; RN 1.00

Medical affairs teams are involved in a wealth of communication methods across the pharmaceutical/device, and biotechnology industries. Communication is at the core of each job unit. However, with the evolving reliance on technology, typical communication methods are being disrupted. One of the greatest issues facing medical affairs teams in recent years has been how to assess and incorporate these new technologies, especially virtual technologies, and expand the impact of their organization. With iPads, notebooks, wearable devices, and other advances in the electronic space, medical affairs team members, both internal facing and external facing, need to become proficient with these new technologies. Additionally, organizations need to establish rules regarding the use of the technologies. This session will address some of the issues and benefits of implementing these new, disruptive technologies within both established and emerging medical affairs teams.

Learning Objectives

Discuss the issues and benefits of implementing new, disruptive technologies for use with medical affairs teams.

Chair

J. Lynn Bass

Speaker

Experience of Leveraging External Virtual Teams to Expand the Capabilities of a Newly Formed Medical Affairs Organization
Rachel Couchenour

Meeting Thought Leader Needs with Technology
Craig J. Klinger, RPh

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Much interest exists in the pharmaceutical industry to develop new technologies to facilitate re-use of content and information across drug development. While structured authoring approaches are being implemented by the industry, it is equally important if not more so to understand the customer’s needs for content and information. Thus, devising strategies to manage content sooner in the drug development process will enable pharmaceutical companies to be better positioned to provide that information in an efficient, timely way while reducing costs. This session will present diverse approaches to content and product information management, while providing useful tips that the audience participants will be able to utilize in their day-to-day workplace.

Learning Objectives

Discuss the importance of content re-use strategies while providing proven tips for medical writers and medical communications professionals to use in their workplace; Recognize pertinent information for how content management and content re-use streamlines document creation and document life cycle for global applications; Identify adaptability to digital media when developing content re-use strategies.

Chair

Frank Hubbard, PhD

Speaker

An Overview of Content Re-use and Product Information Management Strategies: What’s In It for Me?
Frank Hubbard, PhD

Content Management and Re-use: Efficient Streamlining of Product Information Content and Life Cycle
Susan Bairnsfather, MSc

Developing a Strategy for Content Transformation
Cecil Lee, RPh

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-533-L04-P; CME 1.00; IACET 1.00; RN 1.00

Investigators and regulatory agencies find it commonplace to receive protocols with a wide variety of primary and secondary endpoints to demonstrate efficacy for a given disease area. It is also commonplace for a medical writer or clinician to need to reinvent the wheel of endpoints for every new compound. The resulting product is that investigators and regulators receive inconsistent endpoints for similar indications, requiring the interpretive skills of a wizard. We have all gone down the ‘Yellow Brick Road’ of developing protocols and improving our endpoints for a disease area many times. Despite a plethora of research publications with clear descriptions of endpoints, it is common place to begin protocol development with no clear standards of endpoints. Clinical teams involved in protocol development often find that the long circuitous path down the ‘Yellow Brick Road’ is filled with a multitude of choices, missing bricks, potholes and wrong directions. Some of the key inefficiencies in protocol development stem from delays to endpoint finalization and resultant cascade of delays to additional protocol content such as assessments and statistical analyses. Protocol authors, whether medical directors or writers, struggle to achieve clear, consistent endpoints and all wish for ‘Dorothy shoes’ to click together for the right path. Additionally, the common occurrence of endpoint creep translates into significant increases in development costs. This session will provide insights to optimal endpoint and protocol content development required for registration protocols.

Learning Objectives

Describe the approach used to develop primary and secondary endpoints in a therapeutic area.

Chair

Anne B. Cropp, PharmD

Speaker

The ABCs of Writing Effective Clinical Study Protocols
Julia Forjanic Klapproth, PhD

Component Type: Session
Level: Advanced
CE: CME 1.25; IACET 1.25; RN 1.25

The current trend in the industry involves multiple stakeholders working toward a similar goal, whether that be creation of a clinical study report (CSR), an entire marketing application, or any other medical writing deliverable. Such work could include collaborations between pharma companies, CROs, independent contractors, or any combination thereof. The speakers will present successful case studies involving codevelopment of products between two pharmaceutical companies as well as a specialized strategic medical writing partnership between pharma and a CRO, focused on writing and primary publishing of the sponsor’s CSRs. You will leave this session with a strategy for creating high-quality deliverables on time and within budget across a product’s life cycle, regardless of the type of partnership utilized in your organization. Come with questions!

Learning Objectives

Assess challenges associated with different types of partnerships and proactively implement solutions; Evaluate and establish an outsourced strategic medical writing partnership; Identify and incorporate best practices for successful partnerships and submissions in your organization.

Chair

Tammy Franklin, MSc

Speaker

Sponsor Companies as Partners: Tips for Creating a Successful Partnership for Medical Writing
Tammy Franklin, MSc

A Specialized Strategic Medical Writing Partnership: A Case Study
Timothy D. Garver, PhD

Partnerships in Action: Learning from Real-Life Submissions Involving Multiple Stakeholders
Angela Campbell, PhD