The Future of Drug Development in Pulmonary Fibrosis—A Regulatory Perspective
EXPIRED
At the PFF Summit 2015, keynote speaker Janet Woodcock, the Director of the Center for Drug Evaluation and Research of the US Food and Drug Administration (FDA), suggested two key areas in which patient advocacy groups can accelerate drug development: developing biomarkers (specifically, patient-reported outcomes) and facilitating clinical trials.
Developing Biomarkers
Biomarkers are defined as characteristics that are objectively measured and that inform outcomes such as response to a therapeutic intervention. 1 Biomarkers may be direct measures of symptoms or physical performance, or they may be indirect (ie, surrogate) measures that are known to be linked to clinically meaningful measures. For example, forced vital capacity is a biomarker that was successfully used in developing nintedanib and pirfenidone for idiopathic pulmonary fibrosis, and the field is in desperate need of others—in particular, biomarkers that reflect patient-centric measures such as quality of life and symptoms. Patients with pulmonary fibrosis (PF) are generally most concerned about cough, shortness of breath, progressive loss of the activities of daily living, and the decline in quality of life. Patients and advocacy groups can partner with academia and industry to develop biomarkers of these important issues (often called patient-reported outcomes [PROs]). PROs that are accepted by the FDA represent a substantial advance to drug developers because they establish a pathway that involves a patient- and disease-specific outcome that is already approved for use.
PFF Summit 2015: Key Takeaways in IPF Disease Management and Effective Clinician-Patient Partnering
This journal supplement is intended for pulmonologists, family practitioners, internists, nurse practitioners, physician assistants, and other clinicians who treat patients with idiopathic pulmonary fibrosis (IPF).
Supported by an educational grant from:
Genentech
Activity Information
EXPIRED
Release Date: May 2016
Most Recent Review Date: May 2016
Expiration Date: April 30, 2017
Estimated time to complete this activity 1.25 hours
EXPIRED
 | Harold R. Collard, MD, FCCP — chair |
 | Gregory P. Cosgrove, MD, FCCP |
 | Sonye K. Danoff, MD, PhD |
 | Kevin R. Flaherty, MD, MS |
 | David J. Lederer, MD, MS |
 | Steven D. Nathan, MD, FCCP |
 | Jesse Roman, MD, FCCP, FACCP |
 | Ivan O. Rosas, MD |
 | Andrew M. Tager, MD |
Acknowledgement
The faculty acknowledge the editorial assistance of Global Academy for Medical Education, LLC, and Deborah Hall, PhD and Harold Silverman, PhD medical writers, in the development of this supplement.
This continuing medical education (CME/CE) supplement was developed from faculty presentations at the PFF Summit 2015: From Bench to Bedside, November 12-14, 2015, in Washington, DC. www.pffsummit.org/professionals.html The opinions expressed are those of the faculty and do not necessarily reflect the views of the accredited provider, supporter, or of the publisher.
This activity is not an official program of the American College of Chest Physicians (CHEST), and accordingly is not accredited by CHEST.
Accreditation Statements
Physician Continuing Medical Education
Accreditation Statement
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Postgraduate Institute for Medicine and Global Academy for Medical Education. The Postgraduate Institute for Medicine is accredited by the ACCME to provide continuing medical education for physicians.
Credit Designation
Physicians: Postgraduate Institute of Medicine designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Nursing Continuing Education
Accreditation Statement
Postgraduate Institute for Medicine is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
Credit Designation
This educational activity for 1.2 contact hours is provided by Postgraduate Institute for Medicine.
Learning Objectives
After reading and studying this journal supplement, participants should be better able to:
Employ a multidisciplinary care team approach for IPF to enhance patient outcomes.
Review clinical trial data supporting the efficacy and safety of pirfenidone and nintedanib.
Select appropriate pharmacologic therapy for patients with IPF.
Communicate with patients with IPF and provide effective disease-state education.
Method of Participation
There are no fees for participating and receiving CME credit for this activity. During the period May 27, 2016 through April 30, 2017, participants must read the learning objectives and faculty disclosures and study the educational activity and complete the online post-test and evaluation. Upon completing this activity as designed and achieving a passing score on the post-test, you will be directed to a webpage that will allow you to receive your certificate of credit via email or you may print it out at that time.
The online post-test and evaluation can be accessed at http://tinyurl.com/PFFsupp15.
Inquiries may be directed to Global Academy for Medical Education [email protected] or (973) 290-8225.
Disclosure Declarations
Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.
The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:
Harold R. Collard, MD, FCCP: Grant Research: Boehringer Ingelheim and NHLBI; Consultant: AstraZeneca/MedImmune, Bayer, Biogen, FibroGen, Five Prime, Genentech/Roche, Genoa, Gilead, GlaxoSmithKline, Mesoblast, Moerae Matrix, Parexel, Pfizer, Promedior, Prometic, and Pulmatrix
Gregory P. Cosgrove, MD, FCCP: Grant Research: Bristol-Myers Squibb; Advisory Board: Boehringer Ingelheim and Genentech
Sonye K. Danoff, MD, PhD, FCCP: Consultant: Boehringer Ingelheim and Genentech/InterMune
Kevin R. Flaherty, MD, MS, FCCP: Grant Research: Boehringer Ingelheim, Bristol-Myers Squibb, and InterMune/Genentech; Consultant: Boehringer Ingelheim, Biogen, Fibrogen, InterMune/Genentech, Moerae Matrix, Roche, and Veracyte; Advisor: UpToDate
David J. Lederer, MD, MS, FCCP: Grant Research: Bayer, Boehringer Ingelheim, and Gilead; Consultant: Boehringer Ingelheim, Genentech/InterMune, Gilead, ImmuneWorks, the Pulmonary Fibrosis Foundation, and XVIVO Therapeutics
Steven D. Nathan, MD, FCCP: Grant Research: Boehringer Ingelheim and Genentech; Consultant: Boehringer Ingelheim and Genentech
Jesse Roman, MD, FCCP, FACCP: Grant Research: Boehringer Ingelheim, Department of Veterans Affairs, Gilead, ImmuneWorks, InterMune, and NIH; Consultant: Boehringer Ingelheim; Advisory Board: American Lung Association/MS, the Association of Professors in Medicine, and the Alliance for Academic Internal Medicine
Ivan O. Rosas, MD: Grant Research: NHLBI; Consultant: PatientsLikeME; Advisor: Genentech
Andrew M. Tager, MD: Grant Research: Biogen and Boehringer Ingelheim; Consultant: PharmAkea Therapeutics
The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity: The following PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CCMEP, and Jan Schultz, MSN, RN, CCMEP, hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.
Global Academy for Medical Education Staff: Sylvia H. Reitman, MBA, DipEd; Shirley V. Jones, MBA; Mike LoPresti, Deborah Hall PhD, and Harold Silverman PhD have no relevant financial relationships to disclose.
Contact Information for Technical Questions
Please technical questions or concerns to Global Academy for Medical Education at 973-290-8225 or email [email protected].
Copyright Statement
Copyright © 2016 by Global Academy for Medical Education, LLC, Frontline Medical Communications Inc., and its Licensors. All rights reserved. No part of this publication may be reproduced or transmitted in any form, by any means, without prior written permission of the Publisher. Global Academy for Medical Education, LLC, will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein.
References
1. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001;69:89-95.
Disclosures
This continuing medical education (CME/CE) supplement was developed from faculty presentations at the PFF Summit 2015: From Bench to Bedside, November 12-14, 2015, in Washington, DC. www.pffsummit.org/professionals.html
The faculty acknowledge the editorial assistance of Global Academy for Medical Education, LLC, and Deborah Hall, PhD and Harold Silverman, PhD, medical writers, in the development of this supplement.
The opinions expressed are those of the faculty and do not necessarily reflect the views of the accredited provider, supporter, or the Publisher.
Copyright © 2016 by Global Academy for Medical Education, LLC, Frontline Medical Communications Inc., and its Licensors. All rights reserved. No part of this publication may be reproduced or transmitted in any form, by any means, without prior written permission of the Publisher. Global Academy for Medical Education, LLC, will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein.