PHASTAR's San Diego office, our third in the US, just passed its six-month 'anniversary'. This office was set up to serve as a strategic operations hub for PHASTAR, further supporting our west coast sponsors and is a key component of our five-year plan. It has been an exciting, busy, and challenging year thus far – COVID-19 has modified our working world, and we continue to focus on thriving during these uncertain times.
I joined the PHASTAR team to open the San Diego office, focusing on all aspects of PHASTAR’s strategies including business development, developing proposal and processes for delivery of clinical trial projects, staff development and recruitment. I also manage senior technical staff and am involved in oversight of multiple projects to ensure clinical trial reporting is delivered to agreed timelines with optimal quality.
PHASTAR statistician Ian Wadsworth has had a new research article published in Statistical Methods in Medical Research examining modelling approaches for quantifying how exposure-response parameters vary over different ages in paediatric populations. Here he summarises the methodologies considered:
Within paediatric populations, different age groups of children treated with a new medicine may experience differences in dose–exposure and exposure–response (E–R) relationships due to age-related differences in growth, development and physiological differences . One possible suggested age grouping by the International Council for Harmonisation (ICH) E11 document is preterm newborn infants; term newborn infants (0–27 days); infants and toddlers (28 days to 23 months); children (2–11 years); and adolescents (12 to 16–18 years, depending on region) . However, such groupings are general suggestions, with specific treatments and therapeutic areas having the potential for differences. Our paper  developed approaches to estimate the E–R relationship in children and to identify age groupings which define practical and effective dosing rules.
PHASTAR’s inaugural Life Science Summit took place on 30th June and 1st July and welcomed over 350 attendees from 40 countries to two days of engaging, insightful statistical and data science discussions. We were delighted to have such well respected speakers such as Frank Harrell, Janet Wittes, Stephen Senn and Thomas Jaki join us and share such in-depth knowledge with all those who attended.
The impact of the COVID-19 pandemic has been far reaching in every facet of peoples’ lives, both personally and professionally. PHASTAR decided that there was a demand for a forum to discuss statistical issues relating to both COVID-19 and non-COVID-19 studies, where participants from across the globe could join, with ease, and participate in discussions from industry leaders, as well as offering those in pharma the opportunity to deliver their own content of interest.
Functional Service Provision (FSP) and Full- Service outsourcing models have been hotly debated topics over the past decade. Of course, both have their places in the market however market share shifts between the two have certainly been observed. As service providers continue to match their offerings with customers' wishes, hybrid models of FSP and Full-Service have emerged on the market.
The pros and cons of each model are well worn. Those who advocate the Full-Service approach often note the ‘one-stop-shop’ benefit - the simplified contractual arrangement, the integrated team, alongside the potential for cost savings both in efficiency and increased bargaining power, particularly if a sponsor awards several programs of studies to a single provider. Supporters of FSP often point to access to specialist providers, similar cost savings from efficiencies, flexibility on team size and the ‘plug-and-play’ nature of functional contracts.