DIA 2019 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-533-L04-P; CME 1.00; IACET 1.00; RN 1.00

The FDA Payer Guidance released in 2018 has provided some clarity to industry and payers. The FDA explicitly noted the important difference between information required for medical product approval and what is needed by payers to make decisions about population-based coverage and reimbursement. The FDA Payer Guidance is largely pragmatic regarding HCEI communications and advances industry’s proactive dialogue with payers. However, there remains areas of uncertainty within the guidance. A panel composed of the relevant stakeholders will have an open dialogue on the intention of the guidance, the challenges with developing a guidance for industry and payers, the practical challenges of operationalizing aspects of the guidance, the remaining informational needs of payers from industry to inform access decisions.

Learning Objectives

Discuss how to decrease the anxiety in proactively communicating relevant coverage and reimbursement information from industry to payers for population-based coverage decisions.

Chair

Sissi Pham, PharmD

Speaker

FDA Perspective
Sheila Ryan, MPH, RAC

Panelist
Chris Leo Pashos, PhD

Panelist
Mitchell Higashi, PhD

Panelist
Denise Sanchez, JD, MPH, MS

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-557-L04-P; CME 1.00; IACET 1.00; RN 1.00

Technology and social media are redefining the ways that healthcare professionals research, receive, and even share medical information. In this new environment, pharmaceutical companies are evaluating different channels for communicating information to their customers. This session will explore delivery different channels pharmaceutical companies are using and present case studies on new methods that companies are using to share information with healthcare professionals..

Learning Objectives

Identify and evaluate the different channels of medical information delivery currently used in the pharmaceutical industry, including cost effectiveness, usage, healthcare professional preference, and future delivery channels; Discuss specific case studies of pharmaceutical companies successfully implementing new communication channels with healthcare professionals.

Chair

David Bowers, PharmD

Speaker

Evolution of Medical Information Response Delivery Channels in the Pharmaceutical Industry
Walter Frank Eng, PharmD, MBA, RPh

Industry Perspective
Jenny Ko, PharmD

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-575-L04-P; CME 1.25; IACET 1.25; RN 1.25

From Watson to self-driving cars to Netflix, the phrase “artificial intelligence” feels like a buzzword. What is reality versus hype and how can this emerging technology impact medical, regulatory, and commercial writing? This session will define the language of artificial intelligence(AI), discuss the potential impact for AI in creation and re-use of medical content, detail the emerging technologies of artificial intelligence in the writing space, and describe the challenges of developing a medical writing tool that uses AI. Participants will leave with an understanding of the practical applications of AI and how those uses could translate into disruption of medical writing, regulatory submissions, and more.

Learning Objectives

Define artificial intelligence (AI) and natural language processing (NLP) in the context of medical writing; Describe the potential for re-use of content across functional areas using AI; Discuss the challenges of developing and socializing an AI tool.

Chair

Robin Whitsell

Speaker

AI in Medical Writing Intelligent Creation and Reuse of Medical Content
Anand Kiran, MBA, MPharm

AI in the Medical Writing Landscape
Julia Forjanic-Klapproth, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-594-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss how meeting both quality and compliance high standards can ensure effective success in supporting any pharmaceutical brand which is primarily defined by its image.

Learning Objectives

Discuss the factors that effectively influence and measure quality and compliance; Describe the risk and impact of the performance in quality and compliance; Identify reliable approaches to monitor and measure the performance at local versus global level.

Chair

Philippe Sorel Takam, PharmD, MSc, RPh

Speaker

Industry Perspective
Joseph Mack, JD

Techniques for Successful System Validation
Joseph Pierce

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-612-L04-P; CME 1.25; IACET 1.25; RN 1.25

Clinical study data is increasingly becoming available in the public domain. This session presents how the data is being utilized by patients and how sponsors are modifying their internal procedures to prepare disclosure-ready documents. Join the Clinical Trial Disclosure Community for a follow up Round Table discussion on Wednesday, June 26, 1:00-2:00PM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Discuss how publicly available clinical data is being utilized by patient organizations; Describe approaches industry is taking to write clinical documents and provide clinical data for disclosure; Discuss Health Canada’s new regulation on publication of clinical trial information.

Chair

Robert Paarlberg, MS

Speaker

Overview of Health Canada’s Public Release of Clinical Information Initiative
Andre Molgat, PhD

Clinical Trial Disclosure and Transparency: An Industry Perspective
Liz Roberts, MSc

How Clinical Data is Being Used by Patients and Patient Organizations
Deborah E. Collyar

Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-630-L04-P; CME 1.25; IACET 1.25; RN 1.25

Join us to hear about our experiences structuring clinical content and conducting a proof-of-concept study with a structured concept management (SCM) solution.

Learning Objectives

Describe what Structured Content Management (SCM) is, and why it should matter to you; Discuss how one company took steps to structure their clinical content and then evaluated SCM in a proof-of-concept study; Identify critical SCM functionalities needed for pharma companies and how they were assessed.

Chair

TK Booker Porter, PhD

Speaker

Structuring Clinical Content and Content Management
Angela M. Horowitz, MPH

Structuring Clinical Content and Content Management
Martha Cruz Naranjo, DVM, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-644-L04-P; CME 1.25; IACET 1.25; RN 1.25

Approximately twelve years ago, pharmaceutical industry leaders convened to create a 10-year future view for medical affairs with the aim of creating a plan for identifying success in the field. In follow-up, a leading consultant company released a white paper five years later reviewing the progress of the plan. This white paper predicted the following areas would be relevant and the primary focus for Medical Affair’s departments in 2020: innovative therapies, patient-centricity, talent acquisition/training, and integrating disparate streams of medical data and knowledge. However, without a crystal ball, future predictions may be unreliable (even from the leading experts) or subject to the changing regulatory and compliance environment for our industry.

With 2020 just one year away, this session will evaluate progress of the industry in establishing success and expertise in these and other areas and and evaluate new and continuing challenges for Medical Affairs professionals as we move into future decades

Learning Objectives

Evaluate the current status of the predictions from the original ‘2020 white paper’ for Medical Affairs departments; Discuss how technology, systems, and organizational models are assisting Medical Affairs departments with their global demands; Evaluate how the evolving regulatory and compliance environment is helping to shape/ morph our Medical Affairs departments and Identify new and emerging areas of focus of the future.

Chair

J. Lynn Bass, PharmD, RPh

Speaker

Industry Update
Rebecca A. Vermeulen, RPh

Industry Update
Ann Westra, MD

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-648-L04-P; CME 1.25; IACET 1.25; RN 1.25

Use of multiple sub-teams, each focused on a topic (eg, safety, efficacy) and responsible for delivering content across multiple documents, can accelerate the delivery of marketing applications. Pros and cons of such approaches will be discussed. Join the Medical Writing Community for a follow up Round Table discussion on Wednesday, June 26, 2:00-3:00PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Describe the basic concepts of a topic-based approach to delivering marketing applications; Identify potential pros and cons of topic-based approaches in order to identify where such approaches may or may not be appropriate to marketing applications in the attendee’s own organization.

Chair

Frank Hubbard, PhD, MS

Speaker

What is Topic-Based Authoring and What is the Problem we are Solving For?
Frank Hubbard, PhD, MS

Accelerated Delivery of Efficacy and Safety CTD Components Using Topic-Based Authoring Strategies
Mary Jean Matus

Topic-Based Authoring: Clinical Pharmacology Components of BLA/NDA Submissions
Lisa Iacono Sheehan, PharmD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-666-L04-P; CME 1.00; IACET 1.00; RN 1.00

Clinical requirements children are different from adults and the strategy to implement a pediatric study has many challenges, in terms of ethical, operational, and scientific issues. Working with a uniquely vulnerable patient population provides additional complexity, with numerous regulatory requirements. The authoring of key documents to optimize pediatric drug development for regulatory approval is being integrated earlier in the drug development process. This forum features three speakers who will describe the current regulatory framework and changes in drug development in pediatric oncology, the challenges in safety reporting in pediatric clinical trials. and key documents that outline the strategy for developing a drug in pediatric patients.

Learning Objectives

Describe the key regulations governing development of trials in pediatric patients; Describe the structure and required content of a PIP and a PSP; Identify changes in oncology development for pediatric patients and opportunities for scientific collaboration; Identify challenges for accurate safety reporting in pediatric clinical trials.

Chair

Darryl Zachary L'Heureux, PhD, MPharm, MSc

Speaker

Regulatory Changes in Oncology Pediatric Trials
Mark W. Kieran, DrMed, MD, PhD

Solid Planning to Optimize Patient Safety and Clinical Outcomes
Judith A. Blacklidge, BSN, MSN, RN

Key Documents For Pediatric Drug Development
Nancy Katz, PhD

Component Type: Session
Level: Basic

Round table discussion tied to session #260: Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients (Tuesday, June 25, 2:00-3:15PM). Seating is limited. To include special guests from the session: Bob Paarlberg, Liz Roberts.

Chair

Nate Root, MSc

Component Type: Session
Level: Basic

Join DIA Medical Writing Community for a round table discussion tied to session #307: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines? (Wednesday, June 26, 8:00-9:15AM). Seating is limited. To include special guests from the session: Mary Jean Matus, Lisa Iacono

Chair

Frank Hubbard, PhD, MS

Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-685-L04-P; CME 1.25; IACET 1.25; RN 1.25

Many sponsors are developing programs to provide the results of clinical trials to participants as “plain language summaries”. As sponsors develop plain language summary programs, they should consider best practices for the content and preparation

Learning Objectives

Describe current best practices for the content and preparation of plain language summaries; Discuss current guidance for how sponsors should work with Institutional Review Boards (IRBs) having oversight of the clinical trials for which the summaries are provided; Apply learnings from an industry sponsor’s firsthand experience with IRBs during the plain language summary creation/delivery process.

Chair

Kenneth A. Getz, MBA

Speaker

Best Practices for Returning Aggregate and Individual Trial Results to Patients
Jill McNair, MBA

The Role of the IRB in the Review of Lay Language Summaries
Lindsay McNair, MD, MPH, MSc

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-702-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will focus on automated approaches (content and process automation) for generating safety narratives.

Learning Objectives

Discuss automated approaches for generating safety narratives; Describe current challenges and future vision of automated approaches will be discussed in light of current technologies and requirements; Discuss strategies for soliciting feedback from health authorities on automated narratives.

Chair

Ulrike Kochendoerfer, PhD

Speaker

Behavior, Process, and AI Driven Technologies: How They Work Together to Create a Streamlined Narrative Workflow
Justin Savesky

Narrative Writing: Organization and Automation
Mary McKenna, MS, MSc

FDA Perspective
Robert Ball, MD, MPH, MSc