Quality Systems

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

Is FDA approving too many new drugs and added indications too quickly based on surrogate endpoints that fail to pan out? 

FDA Reviews Gains and Risks of Accelerated Approval Process

The agency says that data do not support the use of ivermectin to prevent or treat COVID-19 outside of clinical trials.

EMA Advises Against Use of Ivermectin for COVID-19 Outside of Clinical Trials 

FDA has issued warning letters to two US-based manufacturers, Honest Globe and Biolyte Laboratories, for selling products labeled as containing cannabidiol in ways that violate the Federal Food, Drug, and Cosmetic Act.

FDA Issues Warning Letters to Companies Illegally Selling CBD Products

MHRA and EMA have confirmed that the benefits of the AstraZeneca COVID-19 vaccine continue to outweigh the risk of side effects.

Regulators Confirm Benefits of AstraZeneca Vaccine Outweigh Risks

BIA has released comments urging the UK government to take a science-based approach to the regulatory framework for gene editing and GMOs.

BIA Urges Adoption of Science-Based Approach to Gene Editing and GMO Regulations

Timothy Curran is executive director in process chemistry, Vertex Pharmaceuticals.

J.P. Bercu is senior director in nonclinical safety and pathobiology, Gilead Sciences.

Managing the Risk of Nitrosamine Impurities

Saroj Ramdas is GSK fellow and director, CMC regulatory strategy and advocacy with GlaxoSmithKline.

Renata Varga is principal scientist, Teva Branded Pharmaceutical Products R&D, Inc.

Martin Gastens is senior director program management, AbbVie Deutschland GmbH & Co. KG.

Twinkle R. Christian is process development scientist, Bharat Jagannathan is process development senior scientist at Amgen.

Bharat Jagannathan is process development senior scientist at Amgen.

Barbara Rellahan, rellahan@amgen.com, is director, product quality at Amgen.

Jillian Brady is manager, science, regulation & policy, Faegre Drinker Biddle & Reath LLP.

Many biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.

Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based Strategies

Sebastian Haertter, sebastian.haertter@boehringer-ingelheim.com, is clinical pharmacology expert (director) translational medicine and clinical pharmacology, Boehringer Ingelheim.

S. Y. Amy Cheung is senior director, Certara.

Angela James is director, Astellas Pharma Global Development.

Ashley Strougo is head of M&S Germany,pharmacokinetics, dynamics and metabolism, translational medicine, Sanofi.

Christina Bucci-Rechtweg is global head, pediatric and maternal health policy, Novartis Pharmaceuticals Corporation.

Jing Liu is senior director, clinical pharmacology, Pfizer.

Meina Tao Tang is principal scientist, clinical pharmacology, Genentech, Inc.

Paulien Ravenstijn is senior consultant, qPharmetra LLC.

Raafat Bishai is global clinical program lead, AstraZeneca.

Satyendra Suryawanshi is director, clinical pharmacology and pharmacometrics, Bristol Myers Squibb.

Solange Corriol-Rohou is senior regulatory affairs and policy director for Europe, CMO office and chair of AZ Paediatric Work Group Regulatory Excellence, AstraZeneca.

Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.

Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development

Ganapathy Mohan, Ganapathy_mohan@merck.com, is executive director, global quality compliance, Merck & Co., Inc., Kenilworth, NJ, USA

Christopher Turner is associate director, quality laboratory practices, Bristol Myers Squibb.

Dennis O’Connor is senior associate director, GMP QA, Boehringer Ingelheim.

Lisa Fink is senior quality technical consultant (retired), Baxter Healthcare Corporation.

Thomas Purdue is quality analyst V, Boehringer Ingelheim.

Jeffrey Beebie is director and GLP QA team lead, Pfizer, Inc.

Kerri Robles is director, quality laboratory practices, Bristol Myers Squibb.

Karen Waetjen is director, GCP/GLP Compliance, Amgen.

Maintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.


Collaborative Efforts Address Key Data Integrity Challenges

The agency’s focus appears to be on generic drugs for the upcoming year. 

Regulatory Oversight and Compliance