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Sunday, June 26
 

9:00am EDT

#40: Analysis of Safety Data from Clinical Trials
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-16-503-L04-P; CME 6.50; IACET 6.50; RN 6.50

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

This tutorial is a combination of theory, guidelines, practical considerations, and real-life solutions for those working in the clinical development environment (pharmaceutical, biotech industry, or CRO). The instructors, with the use of a case study presentation, will provide a basic understanding of the underlying methodology and the current guidelines on safety data. Aspects of the planning of clinical trials as well as the problems and pitfalls during the analysis of safety data will be presented.

Who should attend?

This tutorial is designed for regulatory affairs professionals, drug safety specialists, biostatisticians, medical writers, clinical researchers, project managers, and investigators.

Learning Objectives

• Discuss how to utilize guidelines and regulatory requirements for clinical trials;
• Describe ways to contribute to safety analysis plans;
• Discuss the statistical safety analysis process and pitfalls that could occur;
• Identify impact of benefit-risk assessment in safety data.


Speakers
avatar for Jürgen Kübler

Jürgen Kübler

Global Head, Quantitative Safety Sciences, CSL Behring GmbH
Dr. Kübler has over 15 years of experience in the pharmaceutical industry. He has published in statistical and scientific journals, regularly gives scientific - presentations and organized various sessions at scientific conferences. He has a Masters and PhD in Statistics from the... Read More →
avatar for Jürgen Kübler

Jürgen Kübler

Global Head, Quantitative Safety Sciences, CSL Behring GmbH
Dr. Kübler has over 15 years of experience in the pharmaceutical industry. He has published in statistical and scientific journals, regularly gives scientific - presentations and organized various sessions at scientific conferences. He has a Masters and PhD in Statistics from the... Read More →
avatar for Joachim Vollmar

Joachim Vollmar

Executive Consultant, International Clinical Development Consultants LLC (ICDC)
Mr. Vollmar has been an independent consultant since 2004 and founded International Clinical Development Consultants, LLC in 2005 and Preclinical Research and Scientific Consulting Services, LLC in 2008. From 1970-1992, he was with Boehringer Mannheim as a senior statistician in clinical... Read More →


Sunday June 26, 2016 9:00am - 5:00pm EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Preconference Tutorial, Tutorial |   Trk 15: Statistics, Tutorial
 
Monday, June 27
 

10:45am EDT

#129: Delivering Value Through Medical Information Metrics
Limited Capacity seats available

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



Chair
avatar for Sara Doshi

Sara Doshi

Director, Medical Information Strategy and Capabilities, GMI, Eli Lilly and Company
Sara graduated with her PharmD from Butler University and then completed the Purdue University/Eli Lilly and Company Drug Information Residency. She then accepted a role with Global Medical Information (GMI) at Lilly. Sara spent several years supporting numerous products/therapeutic... Read More →

Speakers
avatar for Edward Brauer

Edward Brauer

US ML/RML Strategy and Capabilities Fellow, Lilly USA, LLC
Edward Brauer received his PharmD degree from the University of Southern California in 2015 and received his undergraduate degree in Chemistry from Fresno State in 2010. Currently Edward is a US MSL/RML Strategy and Capabilities Fellow within the US Medical Affairs department at Eli... Read More →
ZF

Zachary Furqueron

Director/Team Leader, Analytics and Reporting Group, External Medical Comm, Pfizer Inc
Zachary has over 20 years of experience at Pfizer, and currently serves as the Director, Team Leader of the Analytics and Reporting group within the company’s Medical Division. In this role he oversees the analytics and reporting activities on behalf of several external-facing functions... Read More →
avatar for Dipti Tankala

Dipti Tankala

Associate Medical Information Manager, Astellas Pharma Canada Inc.
Dipti received her Bachelors of Science in Pharmacy and Doctor of Pharmacy Degree from the University of Toronto in 2013. She went on to complete a specialty Industrial Pharmacy Residency in Medical Information at Eli Lilly Canada for and won the 2014 Residency Award. Currently, Dipti... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

10:30am EDT

#215: Exploring the Use of Virtual Technologies and Virtual Teams Within Medical Affairs Organizations
Limited Capacity seats available

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



Chair
avatar for J. Lynn Bass

J. Lynn Bass

Senior Director, MSLs & Lead, Global Field Medical Affairs, Rakuten Medical
With 20+ years of experience in Medical Science Liaison and Medical Affairs roles across the pharmaceutical industry, Lynn is currently the Sr. Director, MSLs and Field Medical Affairs at Rakuten Medical, Inc. Her industry career has spanned many therapeutic areas and she has authored... Read More →

Speakers
avatar for Rachel Couchenour

Rachel Couchenour

Senior Director, Medical Affairs, Mateon Therapeutics
Rachel Couchenour, PharmD, MBA is a recognized leader with 15 years experience in the pharmaceutical industry. She currently serves as Sr. Director, Medical Affairs at Mateon Therapeutics, accountable for building and executing the medical affairs strategy for this clinical stage... Read More →
avatar for Craig Klinger

Craig Klinger

Global MSL Trainer, The Office of Medical Professional Development, Eli Lilly and Company, United States
In Craig’s 30 years working at Lilly, he has successfully worked in various positions in multiple therapeutic areas including neuroscience, diabetes and osteoporosis. Craig is a founding member of the Medical Science Liaison (MSL) program at Lilly where he worked in the New York... Read More →


Tuesday June 28, 2016 10:30am - 11:30am EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 06: Med Comm-Wrtg-MSL, Session

10:30am EDT

#214: Product Management Strategies: Maximizing Content Re-Use to Meet Diverse Customer Information Needs
Limited Capacity seats available

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



Chair
avatar for Frank Hubbard

Frank Hubbard

President, Global Regulatory Writing Solutions Inc., United States
Following a 14-year career in the Medical Communications Science group at AstraZeneca, Frank founded Global Regulatory Writing Solutions Inc. in late 2013. GRW Solutions provides regulatory submission advice and Communications best practice to the pharmaceutical industry. From 2015... Read More →

Speakers
avatar for Susan Bairnsfather

Susan Bairnsfather

CEO, Regulatory Writer, Regulatory Affairs Professional and Statistical Analyst, EPharmaTech LLC
Susan Bairnsfather is CEO of EPharmaTech, LLC which offers clinical development and regulatory submission consulting to the pharmaceutical and biotech industry. With >20 years’ experience, she is a cross-trained individual in the functional roles of regulatory writer, regulatory... Read More →
avatar for Cecil Lee

Cecil Lee

Knowledge Management Advisor, Global Customer Information, Eli Lilly and Company
The Knowledge Management advisor role has a mission to develop and execute content strategies which continuously drive innovation in knowledge management. Such work enhances efficiencies on content optimization and its reuse for our global function. I have been in Global Medical Information... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm EDT

#255B: Lost in Translation: The Importance of Data Presentation
Limited Capacity seats available

Component Type: Workshop
Level: Basic

Participants will “learn by doing” how poorly conceived and executed tables and graphs can actually prevent understanding of the science. In contrast, when data presentations are well-designed, they can communicate the key messages of even very large and complex data sets. After a short presentation on the fundamentals of good data presentation, participants will be divided into smaller working groups where they will be challenged with complex and difficult to understand examples of figures and datasets and asked to consider what are the key messages and the best method for communicating them. These real-life data examples are guaranteed to open eyes and enlighten. After each exercise, the groups will come back together to discuss, share, and analyze the messages and their presentations, and conclude with a summary of lessons learned.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Demonstrate how to change uninformative tables and graphs into data presentations that communicate clearly.

Chair

Barry Drees, PhD


Chair
avatar for Barry Drees

Barry Drees

Senior Partner, Trilogy Writing & Consulting, Germany
Barry holds a Ph.D. in molecular genetics. Following his postdoctoral work as a fellow of the NIH, he worked as a medical writer in the pharmaceutical industry for 12 years, and leading several regulatory submission teams. Barry is a frequent speaker on medical writing, statistics... Read More →

Tuesday June 28, 2016 2:00pm - 3:00pm EDT
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm EDT

#262: Solving Challenges and Employing Best Practices in Medical Information Contact Centers
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-531-L04-P; CME 1.00; IACET 1.00; RN 1.00

The medical information sector is growing and changing significantly due to rising health care costs, population growth in emerging markets, advances in technology, changing product landscapes, and regulatory pressures. As the demand for medical information increases globally, medical information organizations need to be trusted partners in guiding health care professionals and consumers in obtaining high quality, authoritative, science-based information. This session will discuss how these centers, which serve as crucial lifelines between patient, health care provider, and life sciences companies, are facing increased challenges as well as demands to adjust to changing consumer communication trends and needs.

Learning Objectives

Discuss some of the biggest challenges facing medical information contact centers; Identify which specialized languages and skills are growing in demand; Describe how future trends will impact the flow of information and how companies will need to adjust.

Chair

Chris O'Shaughnessy

Speaker

Industry Point of View
Dominick L. Albano

Industry Point of View
Elke M. Blaetz



Chair
avatar for Chris O'Shaughnessy

Chris O'Shaughnessy

Vice President, Sales, C3i Healthcare Connections
Chris O'Shaugnessy R. PH has nearly 20 years of experience in the pharmaceutical industry in varying roles. Today, Chris serves as the Vice President of Sales at C3i Healthcare Connections where he leads a team in developing strategic multi-channel contact solutions to meet the needs... Read More →

Speakers
avatar for Dominick Albano

Dominick Albano

Vice President, Global Medical Information, Pfizer Inc
Dominick Albano is Vice President, Global Medical Information at Pfizer. He also serves as President on the Board of Directors for phactMI, (Pharma Collaboration for Transparent Medical Information). He has more than 20 years of experience in the pharmaceutical industry. Dr. Albano... Read More →
EB

Elke Blaetz

Regional Medical Information Lead, North America, Shire PLC
Has spent most of her career pursuing excellence in the practice of medical information, fulfilling every department role from front-line telephone agent, medical writer of standard response documents, dossier development, systems validation, employee training, line management, compliance... Read More →


Tuesday June 28, 2016 4:00pm - 5:00pm EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 06: Med Comm/Wrtg/MSL, Session