Quality/GMPs

 Washington Editor, jillwechsler7@gmail.com.

Articles

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

FDA Inspectors Cited Critical Problems at Emergent Facility

Scrutiny of the vulnerability in the biopharmaceutical supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities. 

Pressure Mounts for FDA to Ramp Up Drug Inspections

The agency’s human medicines committee has approved new manufacturing sites for COVID-19 vaccines.

EMA Adopts Recommendations to Increase COVID-19 Vaccine Capacity

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

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

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 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.

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

Agnes Shanley is senior editor of Pharmaceutical Technology.

A plant inspection backlog caused by COVID-19 restrictions threatens innovation and public health. Now pressured to step up on-site inspections, will FDA embrace new methods?

Can FDA Reinvent Inspections?

Feliza Mirasol is the science editor for 

FDA’s newly proposed draft guidance will support IND filings of antisense oligonucleotides, a new class of drugs.

Regulatory/GMP Compliance