PHASTAR was delighted to attend BIO Conference in Boston in June. The theme was "Making History" - celebrating 25 years since the BIO organisation came into being and the subsequent innovations that have been introduced, as well as looking to our future. There were over 18,000 attendees, and the conference won a Guinness World Record for 46,916 partnering meetings that took place - the most in any business conference ever. We felt that PHASTAR contributed to this record as we met more companies than last year and were 100% fully booked on the partnering system.
Many of the attendees are early stage biotech entrepreneurs who are seeking to find financial support from investors or more established companies. Our key message this year was to seek statistical support before financial budgets are finalised. Although there are times when a statistician will say that more patients are needed, at PHASTAR we have a checklist of around 20 items that enable us to reduce the number of subjects required in a study, covering both optimisation of clinical trial design and analysis. As scientists, it is our duty to ensure that properly designed trials are conducted with the minimum amount of subjects exposed to potential risks of clinical trials.
Webinar: Tuesday, July 24, 2018 | 10am EDT (NA) / 3pm BST (UK) / 4pm CEST (EU-Central) 60 min
How do you instil quality and efficiencies into your clinical database from beginning to end? Join the webinar Efficiencies When Delivering a Quality Database, hosted by PHASTAR and Medrio, for insight into steps you can take early in your trial that will optimize your operations throughout: implementing efficient processes and establishing the parameters that best equip you to assess the quality of your database. You’ll learn how to roll out a Quality Plan template at study setup and tailor it to meet the specific needs of your study. You’ll use this plan to identify the risks and processes around the review and cleaning of all data as well as the primary efficacy endpoints based on the protocol, analysis plan and, of course, the safety data. Moreover, you’ll learn how to define and set out the acceptance criteria for each of these items, including how and when the criteria will be assessed.
The 41st annual PSI 2018 conference was held in Amsterdam from 3rd to 6th June with the theme “Breaking Boundaries in Drug Development”. The conference witnessed a new record of 391 attendees in total, with a 20% increase on abstract submissions compared to 2017.
The first keynote speaker at the conference focused on the future of healthcare, discussing growing pressures on the healthcare industry due to the changing demographics of the world, improvements in technological development and a comparison between the Dutch and other European healthcare systems. The second keynote speaker compared statistics with the newly evolving discipline of data science and whether statisticians should reinvent themselves to stay relevant and play a bigger role that goes beyond clinical development and R&D.
Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose.
The number and range of medications already referencing pharmacogenomics can be found at Drugs@FDA, providing an extensive list of therapeutic products with pharmacogenomic information found in the drug labelling, with a few of these medications shown in the table below. The labelling for some, but not all, of the products includes specific actions to be taken based on the biomarker information.