Outsourcing

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

Articles

The agency has published multiple guidance documents and policy initiatives for updating and advancing the clinical research process. 

FDA Promotes Master Protocols to Modernize Clinical Trials

Jennifer Markarian is a contributing editor for 

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

FDA is threatening enforcement action against a clinical trial sponsor that has ignored requirements to post study results on the ClinicalTrials.gov website.

 FDA Gets Tough on Sponsors Not Reporting Clinical Trial Results 

SGS is supporting Selecta Biosciences and Asklepios BioPharmaceutical with the Phase I dose-escalation trial of SEL-3999, an AAV8 vector capsid containing no transgene with ImmTOR.

SGS Facilitates Phase I Study of ImmTOR in Gene Therapy

Heidi J. Einolf is director, modeling and simulation, pharmacokinetic sciences, Novartis.

Stephen D. Hall is senior research fellow, drug disposition, Eli Lilly and Co.

Tracy Williams is senior director ADME/Toxicology/PKPD, Eli Lilly and Co.

Aarti Patel is director, DMPK modeling, GlaxoSmithKline.

Christopher Gibson is distinguished scientist, Merck.

Nancy G.B. Agrawal is vice-president, pharmacokinetics, pharmacodynamics, and drug metabolism, Merck.

Jens Sydor is vice-president, DMPK, GlaxoSmithKline.

Basic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed. 

Enabling the Virtual Human Through Physiologically-based Pharmacokinetic Modeling

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 

Agnes Shanley is senior editor of Pharmaceutical Technology.

New approaches to clinical trials, spurred by the COVID-19 pandemic, have dramatically shortened development timeframes. Can these gains be sustained once conditions return to normal?










Drug Developers Put Pedal to the Metal

Shannon Parisotto, MBA, is the corporate senior vice president of Charles River Laboratories.

Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.  

Toxicology: Ensuring Drugs are Safe for People

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.

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