All articles by Schattopadhaya
Schattopadhaya
Lean, mean cold-chain machine
Global ATMP supply chains have unique challenges. Building a lean and efficient global supply network for these products is not an easy task. Omri Machnay, supply chain director at Pluristem Therapeutics, speaks to Abi Millar about how his company delivers its products globally within a limited time.
Connect the dots
Drug Supply Chain Security Act (DSCSA) compliance demands significant time and investment. Huge amounts of data have been gathered and organisations are now looking to leverage this data for additional ROI. Emma Green speaks to Andrew Stevens, senior director analyst at Gartner, about best practices.
Change with the times
The cannabis industry is rapidly growing, but developing these products is no easy feat. Regulation varies widely depending on the region and is constantly changing. There are many uncertainties, particularly around issues such as branding and packaging. Emma Green speaks to industry experts about the key considerations when entering this market.
Let’s be clear: transparency and disclosure of clinical trials
Ambitious new EU guidance on transparency and disclosure aims to boost public trust, but it faces an industry-wide lack of awareness. Eleanor Wilson explores the landscape with Merete Jørgensen at Novo Nordisk and Behtash Bahador of the Centre for Information and Study on Clinical Research Participation.
Remember the reader: importance of clinical trial transparency
Trilogy Writing & Consulting’s Barry Drees and Lisa Chamberlain James explain how to communicate the results of clinical trials clearly to a lay audience, and stress the importance of bearing patients in mind when complying with new EMA regulations.
Face up to failure: improving the strike rate of clinical trials
The overwhelming majority of pharmaceuticals fail when tested in humans, particularly in oncology, where 95% of drugs tested in phase-I trials never make it to market. Kim Thomas speaks with Italo Poggesi, scientific director of global clinical pharmacology/quantitative sciences at Janssen, about how that figure might be brought down.
Forward together: combining the forces of academia and pharma
Tight budgets mean that combining the forces of academia’s innovation with pharma’s resources is happening with increasing frequency. Dr Christopher Milne, associate professor of medicine and director of research at the Tufts Center for the Study of Drug Development, tells Bradford Keen about the popularity of these outsourcing relationships, and why the traditional view of academia and pharma standing in opposition no longer rings true.
Platform for success: Integrated data management platform for clinical trials
The digital age is upon us, yet many clinical trials are still rooted in cumbersome paper-based procedures. An integrated data management platform can reduce trial costs and times, as Margaretta Nyilas, senior vice-president, clinical and business operations, at Otsuka Pharmaceutical Development & Commercialization, tells Ross Davies.
Organisation is key: factors involved in the clinical trial life cycle
Dr Sanjay Sethi is a leading clinical trials manager in CPOD from the University of Buffalo, with a wealth of experience running trials with corporate and government agencies. He speaks to Andrew Putwain about setting clinical team expectations with early protocol involvement, and the logistical and operational factors one must evaluate when going through a trial’s life-cycle.
Blind ambition: unblinded study medication for better clinical trials
Providing subjects with unblinded medication in studies and supplies is fraught with difficulty. Clinical Trials Insight examines how traditional processes cope with the challenge, and asks how studies might be made more flexible and affordable while increasing safety and adherence.