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Sunday, June 26
 

9:00am EDT

#41: A Rare Disease Program Case Study: Strategies for Successful Outcomes
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-16-507-L01-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.

Working through a multifaceted case study, this one-day, intensive tutorial will address heads-on the unique challenges associated with the development of rare disease therapies. Successful outcomes are a direct result of early planning, design and engagement with patients, patient advocacy groups, treating physicians, specialists, and regulators.

This interactive case study will emphasize how “spending” time in early planning assures appropriate study outcome measures, timely enrollment of clinical trials, and successful regulatory interactions which affect the bottom line and improve the potential for developing therapies for rare disease patients faster.

Who should attend?

This tutorial is designed for professionals working with rare disease therapies including by not exclusive to researchers from academia and industry, senior managers, regulatory affairs specialists, clinical trialists, government officials and investors focused on the future of rare disease and orphan product development.

Learning Objectives

• Examine rare disease clinical and regulatory program issues and challenges;
• Discuss special considerations for study endpoint identification and development;
• Distinguish differences between working with FDA on the development of rare disease therapies as compared to more common diseases;
• Develop ideas for educating, building visibility and understanding of a rare disease programs with key stakeholders.


Speakers
avatar for Ronald Bartek

Ronald Bartek

Co-Founder/Founding President, Friedreich's Ataxia Research Alliance (FARA)
Co-founder/President, FARA, Board of Directors, NORD; NIH/NINDS National Advisory Council; partner/president, government affairs firm; 20 yrs federal service in defense, foreign policy & intelligence; U.S. Delegation to Intermediate-Range Nuclear Forces (INF) Treaty talks, Geneva... Read More →
avatar for Linda Deal

Linda Deal

Head of Patient-Centered Outcomes Measurement, Pfizer Inc.
Linda currently serves as PCOA Lead working across Pfizer’s therapeutic categories addressing efforts to develop, validate and use COAs as endpoints for providing evidence of medical treatment benefit differentiation, labeling and value. Linda has served patients and the pharmaceutical... Read More →
avatar for Jessica Foley

Jessica Foley

Head of Regulatory Services, NovusLife, LLC
Jessica is a senior regulatory professional and consultant with 10 years of experience in the global biopharmaceutical industry. She provides strategic product development and approval strategies to pharmaceutical and biotechnology companies with a focus on investigational therapies... Read More →
avatar for Jonathan Goldsmith

Jonathan Goldsmith

Associate Director for Rare Diseases, Office of New Drugs, CDER, FDA
Dr. Goldsmith is Associate Director for Rare Diseases in the Office of New Drugs/CDER/FDA. Prior to federal service, he was a tenured professor in academia and focused on clinical drug development in regulated industry, at NHLBI/NIH and at orphan disease foundations. He earned his... Read More →
avatar for David Schubert

David Schubert

Vice President of Regulatory and Quality, Stealth BioTherapeutics
David Schubert is the Vice President of Regulatory and Quality at Stealth BioTherapeutics Inc. Previously, Mr. Schubert held positions at MediVector Inc., Logical Therapeutics Inc., Coley Pharmaceutical Group, Genzyme and Cubist Pharmaceuticals. Mr. Schubert has over 30 years of experience... Read More →


Sunday June 26, 2016 9:00am - 5:00pm EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Monday, June 27
 

8:30am EDT

#118: The Interpretation of PRO Scores and Responder Analyses in the Presence of Missing Data
Limited Capacity seats available

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

This forum will review best practices for quantifying a meaningful change in a patient-reported outcome (PRO) endpoint and establishing a responder definition in the presence of missing score data. Missing data strategies that do not assume absence of a PRO score means “non-responder.”

Learning Objectives

Recognize problems in responder analyses if subjects discontinue study treatment or withdraw from a trial; Compare approaches published by EMA, NAS, and in the ICH E9(R1): Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials; Recognize how to combine multiple missing data approaches to tell the data story.

Chair

Scott Komo, DrPH

Speaker

Panelist
Yeh-Fong Chen, PhD

Panelist
Lisa A Kammerman, PhD, MS



Chair
SK

Scott Komo

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining... Read More →

Speakers
avatar for Yeh-Fong Chen

Yeh-Fong Chen

Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER, FDA
Dr. Chen is the Team Leader of the Division of Biometrics IX within CDER of FDA, supervising reviewers for the Division of Non-Malignant Hematology Products. She joined FDA in 2000 after receiving her Ph.D. from the University of Iowa. She has had years' experience in reviewing drug... Read More →
LK

Lisa Kammerman

Senior Statistical Science Director, AstraZeneca
Lisa Kammerman, PhD is a Senior Statistical Director in Oncology at AstraZeneca. She consults on PRO projects and regulatory submissions. She developed AZ's PRO guidance document and led AZ's missing data project. After 24 years of public service, she retired from the FDA, where she... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Forum

10:45am EDT

#132: Electronic Implementation of New PRO Measures to Assess Treatment Benefit in Irritable Bowel Syndrome Trials: Lessons Learned
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-540-L01-P; CME 1.25; IACET 1.25; RN 1.25

This forum describes the electronic implementation of patient-reported outcomes (PRO)-based endpoint measures developed by the PRO Consortium for irritable bowel syndrome treatment trials. The panel will share lessons learned when pairing technology with clinical measurement.

Learning Objectives

Describe advantages of collecting clinical trial endpoint data electronically, particularly with patterns of data as observed in irritable bowel syndrome treatment trials; Discuss how regulatory agencies view the electronic capture of endpoints in clinical trials; Distinguish between operational and measurement aspects of the electronic implementation of PRO instruments used to assess endpoints in clinical trials.

Chair

Stephen Joel Coons, PhD

Speaker

Pharmaceutical Industry Perspective
David S. Reasner, PhD

ePRO Technology Provider Perspective
Cindy Howry, MS

ePRO Technology Provider Perspective
Adam Butler

FDA Perspective
Sarrit Kovacs



Chair
avatar for Stephen Joel Coons

Stephen Joel Coons

Executive Director, PRO Consortium, Critical Path Institute
Stephen Joel Coons is Executive Director of the Patient-Reported Outcome (PRO) Consortium at Critical Path Institute (C-Path). C-Path, an independent nonprofit organization, established the PRO Consortium in cooperation with the U.S. Food and Drug Administration and the pharmaceutical... Read More →

Speakers
avatar for Adam Butler

Adam Butler

Senior Vice President, Strategic Development and Corporate Marketing, Bracket
Mr. Butler is the Senior Vice President of Strategic Development at Bracket. Bracket offers a unique suite of solutions, with a unique perspective on clinical research development. Mr. Butler is responsible for Strategic Development for Bracket’s service offerings in Randomization... Read More →
avatar for Cindy Howry

Cindy Howry

Vice President, Product Strategy and Innovation, YPrime Inc
Cindy Howry is nationally recognized thought-leader in the area of eCOA which empowers the patient and engages them to maintain and improve their health, simultaneously enabling clinical teams to have real-time access to better quality clinical data. Ms. Howry has more than 30 years... Read More →
avatar for Sarrit Kovacs

Sarrit Kovacs

Clinical Outcome Assessments (COA) Staff, OND, CDER, FDA
Sarrit Kovacs, PhD is a reviewer with the Clinical Outcome Assessments (COA) Staff in the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) at FDA. Sarrit has nearly 20 years of social science research experience and is a consultant to CDER and other... Read More →
avatar for David Reasner

David Reasner

President and Founder, Albemarle Scientific Consulting LLC
David is VP, Data Science and Head, Study Endpoints at Ironwood Pharmaceuticals located in Cambridge, Massachusetts. The Data Science group is responsible for development of analytical strategies bridging early phase research through development into the biopharmaceutical product... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Forum
 
Tuesday, June 28
 

10:30am EDT

#224: Identifying Patient-Centered Outcomes for Use in Observational Research: Why and How
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-569-L01-P; CME 1.00; IACET 1.00; RN 1.00

The inclusion of valid, reliable patient-centered outcomes is increasingly important for observational studies. Yet, identifying such outcomes is challenging. This session will discuss resources for identifying and developing outcome measures.

Learning Objectives

Describe the need for standardized or harmonized outcome measures for use in observational clinical research studies; Identify challenges to identifying valid, reliable, standardized outcome measures for use in new studies; Discuss examples of disparate outcome measure definitions; Summarize resources that can assist researchers in selecting appropriate outcome measures.

Chair

Richard Gliklich, MD

Speaker

Panelist
Elise Berliner, PhD



Speakers
EB

Elise Berliner

Director, Technology Assessment Program, Agency For Healthcare Research and Quality (AHRQ)
Dr. Berliner is the Director of the Technology Assessment Program at the Agency for Healthcare Research and Quality (AHRQ). The Technology Assessment Program provides technology assessments to the Centers for Medicare & Medicaid Services (CMS) to inform Medicare coverage decisions... Read More →
avatar for Richard Gliklich

Richard Gliklich

Chief Executive Officer, Better Outcomes
Dr. Richard Gliklich is the CEO of Better Outcomes Corporation. He was founder and CEO of Outcome Sciences, a health information and services company. He led the company from inception through its acquisition by Quintiles. A graduate of Yale University and Harvard Medical School and... Read More →


Tuesday June 28, 2016 10:30am - 11:30am EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 13: CER-Glob Health Econ, Session

2:00pm EDT

#239: Cloud Compliance: Clinical Software Challenges and Vendor Auditor Views
Limited Capacity seats available

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

We will share practical experience and tips for addressing the compliance challenges for clinical solutions using cloud technology and auditing vendors of IaaS, PaaS, and SaaS services. Benefits, challenges, and possible remediation are discussed.

Learning Objectives

Identify infrastructure issues related to data integrity and system security for SaaS, IaaS, and PaaS services; Discuss audit compliance issues related to cloud based software solutions; Identify how to check for critical quality evidence based on 50+ audits of IT suppliers.

Chair

Teri Stokes, PhD, MS, MT

Speaker

Software as a Service (SaaS) and Cloud Provider Qualification: An Auditor's Perspective
Calvin H Kim, MS

Maintaining the Validation Status of Software as a Service (SaaS) in a Regulated Environment
Anu Virkar

Are You Cloud Compliant? Practical Considerations for Managing Clinical Data in the Cloud
Srinivas Karri, MSc



Chair
avatar for Teri Stokes

Teri Stokes

Director, Quality Assurance Compliance, Cytel Inc.
Dr. Stokes worked 11 years as a Medical Technologist in hospital, research, and central medical laboratories. Then 16 years at Digital Equipment Corporatin (DEC) first in the Large Computer Group, second in the Laboratory Data Products Group, and finally at DEC in Basel, Switzerland... Read More →

Speakers
avatar for Srinivas Karri

Srinivas Karri

Senior Director, Clinical Warehousing Cloud Strategy, Oracle Corporation
As an industry strategy lead for clinical data cloud based applications, I help identify, define and create new services to support management of clinical data using cloud based technologies and capabilities. I have over 20 years experience with developing, implementing, selling and... Read More →
avatar for Calvin Kim

Calvin Kim

Senior GxP IT Auditor, Bayer
Calvin is a seasoned IT auditor with over 20 years of experience in various sectors of GxP regulated industries. As a core member of a global QA organization responsible for quality oversight and regulatory compliance assessment of computerized systems (CS) and technologies used in... Read More →
avatar for Anu Virkar

Anu Virkar

Vice President, Quality and Compliance, eClinical, IBM Watson Health
Anu Virkar, MS, MA, PMP is the VP of Q&C. Anu has been in the SQA field for over 23 years, & has focused on clinical trial mgmt and Med device industry for over 15 yrs. She has extensive experience in software QA, SDLC, project mgmt as well as policy development, implementation. She... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Symposium

2:00pm EDT

#247: Fit for Purpose and Modern Validity Theory in PROs
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-575-L01-P; CME 1.25; IACET 1.25; RN 1.25

Fit for purpose is an important consideration in patient-reported outcomes (PROs). This session will provide an overview of current validity theory and the thinking on the idea of fit for purpose, and situate the concept of fit for purpose within the broader topic of validity.

Learning Objectives

Articulate key concepts in modern psychometric validity theory; Describe the notion of fit for purpose as it relates to patient/clinician reported outcomes.

Chair

R.J. Wirth, PhD

Speaker

Current Thinking in Validity Theory
Jonathan D Rubright, PhD, MSc

Validity: US Regulatory Considerations
Ashley F. Slagle

How Does Fit for Purpose Fit in Validity Theory?
Michael Edwards, PhD, MA



Chair
avatar for R.J. Wirth

R.J. Wirth

President, Vector Psychometric Group, LLC
R.J. Wirth is President and managing partner at VPG. He trained in the L. L. Thurstone Psychometric Lab, receiving his PhD in Quantitative Psychology from the University of North Carolina – Chapel Hill. His research focuses on modern psychometrics with an emphasis on measurement... Read More →

Speakers
ME

Michael Edwards

Managing Partner, Vector Psychometric Group, LLC
Michael C. Edwards is a managing partner at VPG. He earned his PhD in Quantitative Psychology from the University of North Carolina – Chapel Hill. His research is generally focused on modern psychometrics with specific emphases on item response theory, factor analysis, and computerized... Read More →
avatar for Jonathan Rubright

Jonathan Rubright

Psychometrician, National Board of Medical Examiners
As psychometrician at the National Board of Medical Examiners, Jonathan shoulders operational responsibility for high-stakes medical exams and leads exam-related research. Prior to NBME, he worked at AICPA and also evaluated tests to support research on human subjects with impaired... Read More →
avatar for Ashley Slagle

Ashley Slagle

Principal, Scientific and Regulatory Consulting, Aspen Consulting, LLC
Dr. Slagle is a scientific and regulatory expert, providing advice on patient centered drug development to drug product developers. Formerly with the US FDA Clinical Outcome Assessment (COA) Staff, her experience includes over 15 years of policy analysis and outcomes research, including... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 13: CER-Glob Health Econ, Session

4:00pm EDT

#265: Enabling Innovative New Endpoint Measurement Using Mobile Technology
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-541-L04-P; CME 1.25; IACET 1.25; RN 1.25

Mobile phones and tablets are becoming ubiquitous and contain components and data some of which can be leveraged to make novel health measurements. This session explores three areas of innovation in the use of smartphones in clinical research.

Learning Objectives

Identify the potential of smartphones to act as a sophisticated measurement device for new and novel health outcomes measurement; Recognize smartphone sensors, components, and passive data in the measurement of health outcomes and the potential of Apple ResearchKit; Explore the potential of artificial intelligence approaches using smartphones including the potential of facial analysis in health screening and outcomes research.

Chair

Bill Byrom, PhD

Speaker

Leveraging Smartphone Sensors and Apple Research Kit to Measure Health Outcomes
Bill Byrom, PhD

Bringing Active Tests and Passive Monitoring for Parkinson’s Disease Into an Interventional Clinical Trial: Towards Measuring Health Outcomes Using Smartphones
Christian Gossens, PhD



Chair
avatar for Bill Byrom

Bill Byrom

Senior Director of Product Innovation, and Vice Director of ePRO Consortium, ICON, plc.
Bill serves as a Senior Director within Product Innovation at ICON, focusing on harnessing new technologies for clinical trials. He has worked in the Pharma industry for over 25 years and is the author of 60+ publications and an industry textbook on electronic Patient Reported Outcomes... Read More →

Speakers
avatar for Christian Gossens

Christian Gossens

Global Head, Early Development Workflows, F. Hoffmann-La Roche Ltd.
Christian is leading the Early Development Workflow team in Roche’s Research and Early Development Informatics (pREDi) organization. He is driving technology innovation into clinical trials - focusing currently on the adoption of mobile sensors for digital biomarker development... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session

4:00pm EDT

#271: The Things Kids Say: Clinical Outcome Assessments in Pediatric Clinical Trials
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-570-L01-P; CME 1.25; IACET 1.25; RN 1.25

Patient perspectives in clinical trials are a regulatory focus. Challenges exist when considering pediatric patients. This forum will further explore FDA guidance, challenges, and solutions regarding clinical outcome assessments/patient-reported outcomes in pediatric clinical trials.

Learning Objectives

Define clinical outcome assessments (COAs), including patient-reported outcomes (PROs), with special attention to the FDA PRO guidance document; Describe possible challenges when implementing pediatric COAs, as exemplified in case studies involving pediatric functional constipation and sickle cell disease; Describe best practice recommendations for the development, selection, and use of COAs in pediatric trials.

Chair

Gina Calarco

Speaker

Overview of Regulatory Perspective of Developing and Utilizing COA/PRO in Pediatric Clinical Trials
Andrew E. Mulberg, MD

Case Studies for the Development of COA/PRO Tools for Use in Pediatric Clinical Trials
Diane Turner-Bowker, PhD



Chair
avatar for Gina Calarco

Gina Calarco

Associate Director, Pediatric Center of Excellence, Quintiles
Gina Calarco is an Associate Director of Project Management and the Deputy Head of the Pediatric Center of Excellence (PCoE) at Quintiles. Ms Calarco completed her BSN at Saint Luke’s College and MPH from the University of Kansas. She is an affiliate member of the American Academy... Read More →

Speakers
avatar for Andrew Mulberg

Andrew Mulberg

Deputy Division Director, Gastroenterology and Inborn Errors Products, OND, CDER, FDA
Andrew E. Mulberg, MD, FAAP, CPI, is Associate Professor of Pediatrics University of Pennsylvania and Professor of Pediatrics at Unviersity of Maryland. He has principally edited a book entitled Pediatric Drug Development: Concepts and Applications published in 2009 and 2013 with... Read More →
avatar for Diane Turner-Bowker

Diane Turner-Bowker

Director, Patient-Centered Outcomes, Adelphi Values
As Director of Patient-Centered Outcomes at Adelphi Values, Diane Turner-Bowker provides senior scientific leadership on the development of COAs for use in medical product development to support regulatory, payer, and communication strategies, as well as for use in clinical practice... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 13: CER/Glob Health Econ, Forum

4:00pm EDT

#276: Using Input from Patient Communities to Develop PRO Instruments
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-592-L04-P; CME 1.25; IACET 1.25; RN 1.25

Capturing quality of life via patient-reported outcomes (PROs) is critical to understanding the patient experience in the course of disease and treatment. This information can improve clinical care and the development of new therapies. Conventional approaches to developing PRO instruments rely heavily on input of leading physicians and cursory or indirect input from patients. Capturing more granular and direct input from patients on outcomes related to social impact, emotional impact, daily functional living, coping, disease and treatment burden, and satisfaction with therapies would be useful to building and validating a PRO instrument. In particular, online platforms for patient communities stand to accelerate and optimize collection of this input.

Learning Objectives

Describe the process for developing patient-reported outcome (PRO) instruments; Identify the challenges of developing PRO instruments; Explain the benefits and risks of using data and input from patient communities (including those online); Discuss alternate methods to develop PRO tools.

Chair

Badri Rengarajan, MD

Speaker

Engaging Online Communities to Understand Patient Experiences
Chad Gwaltney, PhD

Developing a Disease-Specific PRO Tool from a Patient-Centric Research Network
Badri Rengarajan, MD

Regulatory Perspective
Elektra Johanna Papadopoulos



Chair
avatar for Badri Rengarajan

Badri Rengarajan

Medical Affairs Lead, ASPIRE Unit, Actelion
15 years’ experience across medical affairs, product development strategy and new product planning, regulatory affairs, business development, strategy: Former Board President, International Pemphigus and Pemphigoid Foundation (rare disease foundation); Senior Medical Director, Archimedes... Read More →

Speakers
avatar for Chad Gwaltney

Chad Gwaltney

Principal Consultant, Gwaltney Consulting
Dr. Gwaltney’s work focuses on the development of innovative methods to measure patient-centered outcomes in clinical trials. He has published numerous articles and book chapters addressing how the patient’s perspective can be examined to better understand product efficacy and... Read More →
avatar for Elektra Papadopoulos

Elektra Papadopoulos

Deputy Director (acting) Division of Clinical Outcome Assessment, OND, CDER, FDA, United States
Dr. Papadopoulos serves as the Deputy Director (acting) of the Division of Clinical Outcome Assessment in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The Division provides consultation to CDER’s Review Divisions as well as other FDA Centers on... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 17: Rare/Orphan Diseases, Session
 
Wednesday, June 29
 

4:00pm EDT

#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

Senior Partner, Trilogy Writing & Consulting, Germany
PhD in Developmental Neurobiology, Julia started her career as a medical writer in the pharma industry. In 2002, Julia co-founded Trilogy Writing & Consulting, a company specialized in providing medical writing of clinical regulatory documentation. In addition to company management... Read More →


Wednesday June 29, 2016 4:00pm - 5:00pm EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 06: Med Comm-Wrtg-MSL, Session