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Trk 06: Med Comm-Wrtg-MSL [clear filter]
Monday, June 27
 

10:45am

#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
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

10:30am

#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

Consultant, Field Medical Liaison Strategy and Capabilities - Trainer, Lilly USA, LLC
Craig has been an employee of Eli Lilly and Company for the past 25 years. Craig was a Senior Medical Liaison Consultant in the New York City Metropolitan area for over 13 years. He currently is the USMD Operations Consultant - Trainer for all on boarding MLs at Lilly.


Tuesday June 28, 2016 10:30am - 11:30am
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am

#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.
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
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

2:00pm

#339: Evolution of Patient Safety Reporting: PSURs to RMPs, Challenges, and How to Face Them
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-532-L05-P; CME 1.25; IACET 1.25; RN 1.25

The EU pharmacovigilance (PV) legislation has introduced significant changes to the presentation of clinical trial and postmarketing information. Data relevant to the benefit-risk balance of a product must be assessed against the existing standard of care, all of which evolve over time. Documents such as the risk management plan have become increasingly complex and writing them requires strong project management and regulatory skills. This session will describe the experience of managing PV documents and regulatory feedback in this new era, explain why writing for a lay audience is challenging and why it is an important challenge for the pharmaceutical industry to embrace, and will illustrate the challenges of producing, managing, and dealing with evolving benefit-risk assessments with some concrete examples.

Learning Objectives

Describe how to manage the writing of EU-Risk Management Plans including possible challenges and hands-on solutions; Identify the importance of writing for the lay audience along with suggested approaches; Discuss synergies within the preparation of periodic safety documents including how to effectively use them with respect to continuous benefit-risk evaluation.

Chair

Sven Schirp

Speaker

Periodic Reporting in Drug Safety: From Safety Updates to Continuous Benefit-Risk Evaluations
Leonardo Ebeling

The EU-Risk Management Plan from a Medical Writer’s Perspective
Sven Schirp

Writing the Lay Summary (Section VI) of Risk Management Plans: Why and How?
Lisa Chamberlain James, PhD



Chair
SS

Sven Schirp

Head of Global Pharmacovigilance Writing, Boehringer Ingelheim Pharma GmbH & Co. KG
Sven Schirp started his medical writing career in 1997. To date, he has covered a wide range of medical writing services, from biomedical publications and pharmacovigilance documents to global marketing applications. He is currently Head of Global Pharmacovilgilance Writing at Boehringer... Read More →

Speakers
LE

Leonardo Ebeling

General Manager, Dr. Ebeling & Assoc. GmbH
Dr. Leonardo Ebeling, general manager and co-founder of Dr. Ebeling & Assoc., located in Hamburg, Germany. He studied medicine at the universities of Marburg and Hamburg. After completing his studies in 1984, he worked for big and medium-sized pharmaceutical companies in leading positions... Read More →
avatar for Lisa Chamberlain James

Lisa Chamberlain James

Senior Partner, Trilogy Writing & Consulting Ltd.
After her PhD, Lisa started her writing career in the pharmaceutical industry in 2000. At Trilogy, in addition to company management, she writes a wide array of clinical documents and has a special interest in drug safety and patient information. Lisa is an experienced trainer, running... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#361: Protocol Endpoints: A Clear Map to Navigate the Yellow Brick Road and the End of Endpoint-Creep
Limited Capacity seats available

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



Chair
avatar for Anne Cropp

Anne Cropp

Vice President, Pfizer Inc
Anne Cropp has led the strategic planning and clinical development of several compounds in Cardiovascular and Metabolic diseases, Phases 2-4. Anne has led many business process improvements and has led several initiatives across the spectrum of clinical trial planning, design and... Read More →

Speakers
avatar for Julia Forjanic-Klapproth

Julia Forjanic-Klapproth

President/Senior Partner, Trilogy Writing & Consulting
After receiving her PhD in developmental neurobiology, Julia started her career as a medical writer in the regulatory group at Hoechst Marion Roussel (later Sanofi) in 1997. Since then she has been president of the European Medical Writers Association (EMWA) twice and is an active... Read More →


Wednesday June 29, 2016 4:00pm - 5:00pm
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Thursday, June 30
 

10:45am

#406: Navigating Partnerships and Submissions: Best Practices for Successful Medical Writing Deliverables Involving Multiple Stakeholders
Limited Capacity seats available

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



Chair
avatar for Tammy Franklin

Tammy Franklin

Head of Global Medical Writing, UCB
Tammy Franklin is the Senior Director of Global Medical Writing at UCB and is responsible for the leadership and management of a medical writing organization. She has over 15 years of experience in regulatory writing, including extensive knowledge of submission planning and content... Read More →

Speakers
avatar for Angela Campbell

Angela Campbell

Principal Medical Writer/AD, Shire Pharmaceuticals
I have been a medical writer for over 14 years, with experience at all phases of drug development, from pre-clinical to post-marketing. I have prepared a variety of regulatory documents in support across many therapeutic areas. I have also worked on suport documents such as manuscripts... Read More →
TG

Timothy Garver

Chief Operating Officer and Executive Vice President, Impact Pharmaceutical Services
Tim Garver, PhD, is the Executive VP and COO of Impact Pharmaceutical Services, Inc., a consulting and contract research organization. Tim has over 20 years of medical writing experience for both drugs and biologics, during which time he has played a key role in over 25 marketing... Read More →


Thursday June 30, 2016 10:45am - 12:00pm
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA