Manufacturing

Jennifer Markarian is a contributing editor for 

Articles

Contract packaging organizations packaging biologic drugs for clinical trials use technologies that meet the unique requirements of each study. 

Packaging Biologic  Drugs for Clinical Trials

Sterling Pharma Solutions and OncoTEX have entered into a clinical development agreement for the manufacturing of OncoTex’s novel platinum-resistant oncology drug candidate, OxaliTEX, for use in clinical trials.

Sterling Pharma Solutions and OncoTEX to Develop Novel Treatment Against Ovarian Cancer

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

Sandoz Begins Late-Stage Clinical Development for Biosimilar Aflibercept

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

Agnes Shanley is senior editor of BioPharm International.

The COVID-19 pandemic is pushing more companies to adopt just-in-time practices, but success demands careful upfront risk assessment and planning.

Necessity Drives Just-in-Time Approaches to Clinical  Trials Supply 

Natalie Balanvosky is just-in-time manufacturing solutions manager, Almac Clinical Services.

Bryan Thompson is production manager, Almac Clinical Services.

Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.

Demystifying Complex Clinical Trial Kit Preparation

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Biopharma looks to deliver on COVID-19 vaccines and other promising therapies.

Bringing Bio/Pharma’s “New Normal” Into Focus

CDMOs strive for flexible, adaptable processes and fast tech transfer for manufacturing investigational drug products, including COVID-19 treatments and vaccines. 

Manufacturing Materials for Clinical Trials 

A new facility near Frankfurt, Germany expands Avantor's geographic reach and supports the growing demand for scientific research and clinical trial sample storage.

Avantor Opens Biorepository Facility in Germany 

The Phase III clinical trial of NVX-CoV2373 is expected to be fully enrolled in the UK and will begin in the US and Mexico by the end of November 2020.

Clinical Trial Materials