lifecycle management of drug · pdf filelifecycle management of drug products: fda’s...

14

Lifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director for Science and Communication Office of Lifecycle Drug Products, OPQ, CDER September 30, 2015

Upload: trankhanh

Post on 06-Mar-2018

218 views

Category:

Documents

2 download

Report

Download

Embed Size (px):

TRANSCRIPT

Page 1: Lifecycle Management of Drug · PDF fileLifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director

Lifecycle Management of Drug Products: FDA’s Perspective

Geoffrey Wu, Ph.D.Lieutenant, U.S. Public Health ServiceActing Associate Director for Science and CommunicationOffice of Lifecycle Drug Products, OPQ, CDERSeptember 30, 2015

Page 2: Lifecycle Management of Drug · PDF fileLifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director

Disclaimer

This speech reflects the views of the author and should not be construed to represent the U.S. Food and Drug Administration’s views or policies.

Page 3: Lifecycle Management of Drug · PDF fileLifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director

Lifecycle Management –Our Quality Journey

• Vision

• Strategies

• Infrastructure

• Support System

Page 4: Lifecycle Management of Drug · PDF fileLifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director

Started with the Birth of OPQ – January 11, 2015

Advances CDER’s Quality Initiative to the next level

Vision:

“A maximally efficient, agile, flexible pharmaceutical manufacturing

sector that reliably produces high quality drugs without extensive

regulatory oversight.”

Page 5: Lifecycle Management of Drug · PDF fileLifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director

Strategy – OPQ

• A single unit in CDER dedicated to product quality– All drug products (new drugs, generic drugs, OTC drugs)

– All sites (domestic and foreign)

• Creates ‘one quality voice’ streamlining quality oversight throughout the lifecycle of a drug product– Aligns review, inspection, and research functional areas

– Spans pre- and post-approval for brand and generic drugs

– Strengthens surveillance and inspections of facilities globally

Page 6: Lifecycle Management of Drug · PDF fileLifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director

Strategy – OPQ

• Encourages use of modern, more efficient manufacturing technologies

• Establishes consistent quality standards and clear expectations for industry

• Balances potential quality risks with the risk of a patient not getting a drug

• Anticipates quality problems before they develop to help prevent drug shortages

Page 7: Lifecycle Management of Drug · PDF fileLifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director

OPQ Structure

Office of Process and FacilitiesActing Director:Christine Moore

Office of SurveillanceActing Director:Russell Wesdyk

Office of Testing and ResearchActing Director:Lucinda Buhse

Office of Program and Regulatory OperationsActing Director: Giuseppe Randazzo

Office of Lifecycle Drug ProductsActing Director:Susan Rosencrance

Immediate OfficeActing Director: Janet WoodcockDeputy Director: Lawrence Yu

Office of Policy for Pharmaceutical QualityActing Director:Ashley Boam

Office of New Drug ProductsActing Director:Sarah Pope Miksinski

Office of Biotech ProductsDirector:Steven Kozlowski

Page 8: Lifecycle Management of Drug · PDF fileLifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director

NDADMF

Biopharm…

ONDP & OLDP: Lifecycle Partners

ONDP OLDP

GDUFAPDUFA

KnowledgeExpertise

…

sNDAANDA

sANDALifecycle

…

Page 9: Lifecycle Management of Drug · PDF fileLifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director

Resource and Functions

Division of Lifecycle API

Division of New Drug API

Division of Biopharmaceutics

Division of New Drug Products 1

Division of New Drug Products 2

Post-Marketing Activities I (sNDAs)

Post-Marketing Activities II (ANDAs)

Immediate Release Products I

Modified Release Products

Immediate Release Products II

Liquid-based Drug Products

ANDA Pre-Marketing Divisions

Page 10: Lifecycle Management of Drug · PDF fileLifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director

Integrated Knowledge Base

Hand-off: NCE - 3 yrs; 505(b)(2) - 1 yr

Page 11: Lifecycle Management of Drug · PDF fileLifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director

Lifecycle Management of Drug Product Quality

Work in a continuum rather than in silos

Knowledge Management System

Page 12: Lifecycle Management of Drug · PDF fileLifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director

Acknowledgments

• Susan Rosencrance

• Sarah Pope Miksinski

• Glen Smith

• Andre Raw

• Maria Manzoni

• Arwa ElHagrasy

Page 13: Lifecycle Management of Drug · PDF fileLifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director

Questions?

13

Please complete the session survey:

surveymonkey.com/r/DRG-D2S5

https://www.surveymonkey.com/r/DRG-D2S5

Page 14: Lifecycle Management of Drug · PDF fileLifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. Lieutenant, U.S. Public Health Service Acting Associate Director

Thank You!

14

FDA’s Proposed Generic Labeling€¦ · FDA’s Proposed Generic Drug Labeling Rule – The Details (cont’d.) •Under the Proposed Rule, when an ANDA holder has safety-related

Orphan Drug Topics - ISCTM...Orphan Drug Topics: 1. Discovery of FDA’s Flexibility 2. Evolving Voice of the Patient in Drug Review ISCTM 14th Annual Scientific Meeting February 21,

Demystifying FDA’s 505(b)(2) Drug Registration Processdjaglobalpharma.com/Demystifying_FDA.pdf · 1 October 2009 Demystifying FDA’s 505(b)(2) Drug Registration Process By Harriette

USA FDA’s DRUG PROCESS VALIDATION & DRUG APPLICATIONS

Science Board FDA’s New Bioresearch Monitoring Initiative Dr. Janet Woodcock Deputy Commissioner for Operations Food and Drug Administration November 4,

1978 GMP Pre - Temple UniversityFDA’s CURRENT DRUG GMP — 1978 FINAL RULE FDA’s important regulation setting forth Current Drug Good Manufacturing Practice (GMP) requirements—published

FDA’s Bad Ad Programnahnnet.org/docs/2016_March_Bad_Ad_MedWatch_Presentation.pdf1 FDA’s Bad Ad Program Empowering HCPs to Recognize and Report False or Misleading Drug Promotion

Clinical Trials of Radiation-Drug Combinations: The FDA’s ...€¦ · Clinical Trials of Radiation-Drug Combinations: The FDA’s Perspective Amanda Walker, M.D. Acting Associate

Drug/Device Combination Products: Bioequivalence - PQRIpqri.org/wp-content/uploads/2017/02/4-BingLi-final-version.pdf · Drug/Device Combination Products: Bioequivalence ... FDA’s

FDA’s Clinical Investigator Course by. FDA’s CDER, Office of Medical Policy. and. The Duke University School of Medicine. FDA’s Clinical Investigator Course

Drug Discovery & Development FDA’s Ability to Protect Questioned A · · 2007-08-14FDA’s Ability to Protect Questioned A ... drug approval process needs to be ... the United

GAO-06-402, DRUG SAFETY: Improvement Needed in FDA’s

Progress in FDA’s Drug Product Quality Initiative Janet Woodcock, M.D. November 13, 2003

U.S. Food and Drug Administration · U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes

[PPT]Slide 1 - Drug Information Association · Web viewWhat are Generic Drugs Drug Information Association US FDA’s Definition: A generic drug is identical, or bioequivalent to

GLOBAL APPROACHES TO DRUG DEVELOPMENT: WHEN EX-US … · 4 | Global Approaches to Drug Development: When Ex-US Clinical Data Can Support US Drug Approvals FDA’S TRACK RECORD OF

Updates on FDA’s Drug-Drug Interaction (DDI) Final Guidances · 2020. 4. 24. · Updates on FDA’s Drug-Drug Interaction (DDI) Final Guidances Kellie S. Reynolds, Pharm.D. Director,

Data Mining AERS FDA’s (Spontaneous) Adverse Event Reporting System Division of Drug Risk Evaluation Office of Drug Safety Carolyn McCloskey, M.D., M.P.H

FDA’s Current Thinking on Quality - Food and Drug … · 2017-12-05 · FDA’s Current Thinking on Quality Agreements and Contract Manufacturing Paula Katz Manufacturing Quality

A Practical Guide to FDA’s Food and Drug Law and …A Practical Guide to FDA’s Food and Drug Law and Regulation Sixth Edition Edited by Kenneth R. Piña and Wayne L. Pines FOOD

Re: Draft Guidance; Pharmacy Compounding of Human Drug ... · PDF fileFood and Drug Administration 5630 ... FDA’s rapid response to the passage of the Drug Quality and Security Act

FDA’s PV Guidance

CARES Act: OTC Pathway for Novel Drug Dosage …...as old OTC monograph system • Pre-clinical Lab Tests • File Investigational New Drug (IND) with FDA’s CDER • Significant

Improving FDA’s approach to new drug approval and post-marketing surveillance

State Departments of Corrections Are Violating FDA’s ......FDA’s Investigational New Drug Regulations By Experimenting With Lethal Injection Drugs May 5, 2014 This paper is the

The FDA’s 505(b)(2) Drug Approval Process And Implications ... · The FDA’s 505(b)(2) Drug Approval Process And Implications For Managed Care Pharmacy AMCP 2004 Educational Conference

FDA’s Experience on IVIVC-New Drug Products - PQRIpqri.org/wp-content/uploads/2015/08/pdf/Suarez.pdf · FDA’s Experience on IVIVC-New Drug Products Sandra Suarez Sharp, Ph. D

The Voice of the Patient - Food and Drug Administration · The Voice of the Patient . A series of reports from the U.S. Food and Drug Administration’s (FDA’s) Patient-Focused

GAO-20-251, DRUG DEVELOPMENT: FDA’s Priority Review

The Future of Drug Safety — Promoting and … Future of Drug Safety — Promoting and Protecting the Health of the Public FDA’s Response to the Institute of Medicine’s 2006 Report

GAO-20-251, DRUG DEVELOPMENT: FDA’s Priority Review ... · A drug sponsor is the person or entity that assumes responsibility for the development of a new drug, including responsibility

A Purposeful Engagement: FDA’s International Food Safety Capacity-Building Plan Association of Food & Drug Officials 118 th AFDO Annual Educational Conference

Fda’s warning on_ortiga

The U.S. Food and Drug Administration: Big ...€¦ · FDA Has Been Protecting Public Health for Over a Century 1 The Food and Drug Administration’s (the FDA’s) roots can be traced

The future The FDA’s PAT of drug - Sigma Plus Novartis...The FDA’s PAT Initiative, past and present Terry McMahon, PAI Partners The future of drug discovery We talk with leaders