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.
Taras Seniuch, Director of Business Development at SHL’s contract manufacturing organization, SHL Pharma, talks about his company’s unique service offering for its partners.
EXCLUSIVE ONLINE CONTENT
To facilitate the demand for this new world order, we’ve unveiled the Accenture INTIENT Clinical platform. It helps companies run faster clinical trials with better transparency and….
Gerresheimer is driving innovation in pharmaceutical glass, primary packaging glass products, technologies, and digitized processes. In the future, highly qualified engineers at the recently opened Gx Glass Innovation and Technology Center will develop….
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
Accenture recently announced a collaboration with Bayer to implement the Accenture INTIENT Clinical platform to help simplify and speed its……
Ajinomoto Bio-Pharma Services Acquires Remaining Interest in Granules OmniChem Joint Venture in India
Ajinomoto Bio-Pharma Services recently announced its intention to purchase the remaining 50% ownership interest in its Visakhapatnam, India, joint venture, Granules OmniChem Private Limited (GOC) from its….