All articles by Vemula Pravalika
Vemula Pravalika
What is comparator sourcing in clinical trials?
When it comes to clinical trials, sourcing comparators can be a challenge that could expose companies to various roadblocks. There are so many factors to consider, from regulatory and operational risks to cost and waste targets. Tom Rose, SVP of clinical trial sourcing at Clinigen, explains how these risks can be managed and why it’s so important to have a contingency plan in place.
Everything you need to know about adaptive design in clinical trials
Using an adaptive design for clinical trials can often result in a more efficient, informative and ethical trial over traditional designs. This is often due to the better use of resources and sometimes fewer participants, but what is an adaptive design and what are the advantages of using it in oncology trials? Monica Karpinski speaks to Lillian Siu, senior medical oncologist at the Princess Margaret Cancer Centre and Patrick Wen, MD, director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, to find how adaptive design differs from the traditional fixed design and what CRO and sponsors can expect from this approach.
How much do clinical trials cost?
In the ever changing landscape of clinical trials, markets have increasingly seen associated costs rise over the years with an estimated 140% increase in the past decade. With roughly $2.6bn – and 15 years to bring a new drug to market – what can be done to cut costs and raise efficiency? Andrea Valentino talks to Dawn Anderson, managing director, Deloitte Life Sciences R&D and Salman Shah, R&D consulting field of play leader and principal at EY, to find out how optimised clinical supply sourcing, and the clever use of technology and data, can help keep prices down.
Everything you need to know about Expanded Access Programmes for clinical trials (EAPs)
The benefits of access programmes for clinical trials extend beyond patient recovery and treatment. Providing patients with treatments or drugs that have not yet been approved in their country is advantageous not just for patients, but for all stakeholders involved. Phoebe Galbraith speaks to Sheela Upadhyaya to explore how the benefits of access programmes can be maximised and how best to design a programme to meet everyone’s needs while managing outcomes and uncertainties.
LogiPharma 2024 The Premier Event for Pharma, Biotech, and Medtech Supply Chain Executives**
LogiPharma, the leading event for pharma, biotech, and medtech supply chain executives in North America, returns for its 19th edition, promising an unparalleled opportunity for industry leaders to learn, benchmark, and share best practices in a highly interactive format.
How is generative AI used in clinical trials?
In the era of precision medicine, generative AI is poised to revolutionise clinical trials as a formidable tool. As healthcare becomes more data-driven, integrating advanced technologies such as artificial intelligence (AI) into clinical trials promises to deliver faster, more efficient medical research and expedite the development of new treatments. Clinical Trials Insight discusses the transformative potential and ethical implications of this technology with Jonathan Crowther, PhD, head, predictive analytics Pfizer Research & Development, OARS.
What is CTIS?
With just one year left before all ongoing clinical trials in the EU must transition to the Clinical Trials Information Systems (CTIS), marking the end of the three-year transition period since Clinical Trials Regulation came into effect in the EU, Jim Banks speaks to Lene Grejs Petersen, senior advisor, Danish Medicines Agency and Inge Christoffer Olsen of the Department of Research Support for Clinical Trials, Oslo University Hospital about the most recent updates, challenges and benefits the new regime has brought about.
Atomic shift
When creating new pharmaceutical drugs, replacing a carbon atom with a nitrogen atom could make an immense difference and drastically change how the drug interacts with the body, from reaching the brain easier or preventing it from attracting the wrong proteins. While current methods are tricky and costly, recent studies have come up with potential methods to solve this. Phoebe Galbraith speaks to Tyler Pearson about his findings and their potential for drug development.
Keep it eco
Recent technological advances have brought improvements to cold chain logistics – but with aviation remaining a major part of pharma supply chains, the industry is under pressure to reduce its carbon footprint. Andrea Valentino speaks to Frank Van Gelder of Pharma. Aero and Dorethe Nielse of Novo Nordisk to learn how pharma aviation can deliver more sustainable practices – and how sustainable fuel is only one part of the puzzle.
Tracking safety
As one of the most regulated industries on earth, safety and effectiveness of medication is of the utmost importance across global pharma. One way of ensuring safety is traceability in the pharma supply chain: the process of tracking and tracing the movement of pharmaceuticals. Andrea Valentino speaks to experts across the sector to understand how it is leveraging technology to implement robust traceability systems – and why digitalisation and data can’t succeed independently of broader stakeholder management.