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.
Rosamund Round says most companies know they need to make trials more patient-friendly, but few have access to the tools and methodologies to transform their protocol design process. Fortunately, thoughtfully applied common sense practices can create better patient experiences and more robust trials.
Contributor Cindy H. Dubin reviews some of the innovative and novel technologies developers are deploying to make self-injection easier and improve patient adherence.
William Boomershine, PhD, explains how high-resolution mass spectrometry is a key component to the characterization of novel biologics and biosimilars.
EXCLUSIVE ONLINE CONTENT
TrakCel & Quick Partner to Provide Industry-Leading Digital Supply Chain IT Solution for Cell & Gene Therapies
TrakCel and The Quick Life Science Group recently announced a partnership to offer an integrated IT logistics orchestration platform.
MedPharm Ltd recently announced the expansion of its US Center of Excellence in Durham, NC, in response to increasing service demand for its topical and transdermal formulation development and performance testing services.
PCI Pharma Services Announces $20-Million Expansion of Biotech Technologies, Including Advanced Injectable Delivery Forms
Leading global biopharmaceutical services provider PCI Pharma Services (PCI) has announced a momentous investment in support of biologic medicines and advanced injectable delivery forms, totaling more than $20 million.
Experic Launch Marked by Announcement of Plans for State-of-the-Art cGMP Pharmaceutical Supply Services Facility
Experic, a high-quality pharmaceutical supply services provider, marked its official launch by announcing it has leased a 45,500 square foot, state-of-the-art Class A research, manufacturing and packaging facility located at 2 Clarke Drive in Cranbury, NJ, the heart of the state’s pharmaceutical belt.
Quotient Sciences and Druggability Technologies recently announced a collaboration to utilize Quotient’s integrated Translational Pharmaceutics platform to advance the development of DRGT-46, a novel, fast-acting formulation of celecoxib using proprietary super-API compositions developed by DRGT.