Emer Leahy, PhD, reviews how the SmartCube platform represents a novel approach to discovering the next generation of breakthrough treatments for schizophrenia and other neuropsychiatric disorders.
ARTIFICIAL INTELLIGENCE – Practical Applications of Artificial Intelligence (AI) for Drug Data Quality & Research
Robert Stanley believes by treating AI as one more tool within a broad data quality toolkit, and by focusing narrowly on specific research and business bottlenecks, it is possible to efficiently bring real practical benefits to research and business.
CHARACTERIZATION CORNER – From Dilute Sample to Clinically Representative Formulation: Analyzing the Higher Order Structure of mAbs Over a Wide Dynamic Range
Jeff Zonderman explains how the characterization of mAbs at high concentration in clinically representative formulations, without the need for dilution or concern for interference from a formulation buffer’s excipient, is vital.
Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.
TRANSLATIONAL PHARMACEUTICS – Accelerating Early-Stage Drug Development With Integrated CDMO & CRO Services
Peter Scholes, PhD, describes the current challenges and questions faced by drug developers in accelerating molecules to POC and developing optimized and scalable drug products for patient trials.
CLINICAL ANALYTICS SOLUTIONS – Reducing Clinical Cost Budget Variations With State-of-the-Art Data Lifecycle Management Solutions
Srini Anandakumar explores an approach for how sponsor’s operational data, coupled with syndicated data and Real World Evidence data, can enable predictive analytics on clinical cost drivers using a clinical big data and Machine Learning-enabled platform.
Cheryl Johnson says the study of E&L has been evolving for many years, and as pharmaceutical manufacturers, packaging vendors, and regulatory agencies gain more knowledge of extractable compounds, the scope of E&L guidelines grows with it.
CLINICAL TRIALS – Spotlight on Quality in Study Startup: Automated Workflows Encourage Upfront Planning & Downstream Improvements in the eTMF
Elvin Thalund, MS, and Craig Morgan say the emphasis on quality is everywhere, but in particular, the study startup portion of clinical trials is a particular hotspot, as it is pivotal to improving study conduct overall.
EXECUTIVE INTERVIEW – Vetter: Insights on Insourcing Versus Outsourcing in the World of Injectable Manufacturing
Oskar Gold, Vetter’s Senior VP, Key Account Management and Marketing/Corporate Communications, offers his insights on aseptic manufacturing and why careful thought and consideration of different criteria must be applied.
Sameer Navalgund, Global Director at JRF Global, shares his perspective about the on-going trends, current status, and some of the upcoming biggest challenges in the contract services industry.
EXCLUSIVE ONLINE CONTENT
Aptar Pharma recently announce that its Bidose nasal spray device was recently approved by the US FDA for a breakthrough therapy in the field of depression.
For pharma and biotech companies both large and small, the challenges involved in the fill and finish process of drugs for clinical development and scale-up continue to present new challenges.
Ajinomoto Bio-Pharma Services recently provided an update on several of its capital projects currently underway in both the United States and Belgium.
SGS, a leading bio/pharmaceutical analytical and bioanalytical contract solutions provider, today announced the appointment of Dr. Haris Jamil as Biologics Manager of its recently expanded biopharmaceutical testing facility in Lincolnshire, Illinois, USA.
Pharmaceutical Product Development, LLC and Happy Life Tech of China have signed an exclusive agreement to develop a distinctive service offering for the China drug development market delivering data science-driven clinical trials and real-world evidence of drug products’ effectiveness, safety, and value.