All articles by Venugopal Immadi
Venugopal Immadi
A new age of industry
A lot of discussion has taken place about how industry 4.0 is transforming a number of sectors; however, less has been said about the applications for pharmaceutical manufacturing. Louise Thomas explores its potential to boost quality and productivity, while decreasing risk and waste.
The scale of things to come
Washington State University researchers have developed a novel way to deliver drugs into cells at the nanoscale level without causing toxic effects that have stymied other such efforts. Gary King talks to Chunlong Chen, senior scientist at the Department of Energy’s Pacific Northwest National Laboratory, about the implications of this breakthrough for cancer treatments and drug delivery systems.
A popular combination
Drug-device combination products are rapidly gaining popularity as a result of the huge variety of benefits offered to patients. However, there are many opportunities to improve efficiencies in manufacturing these devices and optimising quality. Emma Green speaks to Paul Greenhalgh, director of design at Team, about best practices when developing drug-device combination products.
Technology for the future
Emerging technologies offer huge value for data integrity and accountability. However, implementing them strategically is key to optimising their effectiveness. Kim Thomas speaks to Julia Spain, partner, and Cameron Brown, director, in Deloitte’s cyber team about best practices to ensure success.
Trial by comparator
Comparator sourcing is often an essential element of successful clinical development programmes. However, securing a reliable supply requires navigating operational, regulatory and financial challenges. Emma Green explores best practices to ensure a smooth-running trial.
No clear path
Driven by ethical considerations and the aim to gain an edge within drug approval, comparator use is growing steadily in clinical trials. However, implementation is by no means straightforward. Will Moffitt speaks to Niklas Mattsson, head of comparator planning at Merck, about the potential pitfalls and how the Falsified Medicines Directive (FMD) adds an extra layer of complexity.
Lay summaries and writing for patients
Lisa Chamberlain James of Trilogy Writing & Consulting and Trishna Bharadia, patient
engagement consultant, examine the trend for increasing and more transparent patient
information, and ask how close we have come in the past few years to producing useful and
meaningful information for patients.
All on file
Given the new EMA guidelines put in place to assist sponsors and investigators with clinical trial master file (TMF) requirements, it’s more important than ever to work closely with vendors and CROs to ensure compliance. Isabel Ellis talks to Francis Crawley, executive director of the GCP Alliance, about the role of oversight in maintaining data integrity.
Choose wisely
Choosing the right vendor is a hugely important aspect of planning for a clinical trial. There are a number of different factors to consider when working with these contract research organisations. Emma Green speaks to Ken Getz, director of sponsored programmes, research professor at Tufts Center for the Study of Drug Development, about the key strategies to ensure smooth study delivery.
Chain of command
There are a number of technologies available to accelerate the trial process, paving the way for a new paradigm. Leeza Osipenko, senior lecturer in practice at the London School of Economics and Political Science (LSE) and visiting fellow of the Centre for Global Development, speaks to Louise Thomas about the potential for blockchain to optimise workflow and improve transparency.