Research stories: Pharmacy in research

Michelle Taylor-Siddons

This interview with Michelle Taylor-Siddons, Associate Director of Pharmacy at Oxford University Hospitals, appeared on the Oxford Academic Health Partners website.

Michelle Taylor-Siddons' first experience of research was by chance. As a newly qualified pharmacist at Addenbrooke's Hospital in Cambridge, she was allocated to the liver transplant and intensive care units, and she soon began to be involved with the research taking place there.

"At the time, the more senior pharmacists didn't provide clinical pharmacy services, so as a junior pharmacist I supported research and got up in the middle of the night to dispense the investigational medicinal products (IMPs)" she recalls. "I was a resident pharmacist, lived on site and as part of the clinical team you joined your nursing and medical colleagues to deliver the trial, rather than being officially part of a research team. It meant I had quite a lot of involvement in the clinical trials early in my career. It was my first opportunity to see research in action and it was a really good experience."

Michelle put this experience into practice in her next role, as a pharmacist at the Horton General Hospital, now part of Oxford University Hospitals NHS Foundation Trust (OUH). She'd seen at Addenbrooke's how sickness post-chemotherapy treatment had a negative impact on survival and outcomes for cancer patients. At the Horton, she saw a similar effect but to a much lesser extent for women who had undergone a hysterectomy, and how being sick had a physical impact on their surgical wound as well as affecting their overall recovery.

Michelle teamed up with two anaesthetists to trial ondansetron, at the time a relatively new medicine which was used in cancer and was starting to be used in theatre. The trial was successful, and ondansetron became standard of care at the Horton for post-sickness. It's now widely used to treat sickness associated with chemotherapy, radiotherapy and surgery.

"The trial was only a very small piece of the research that led to that medicine becoming part of standard practice" says Michelle. "But it did mean that the Horton could put that change in place based on research conducted on site, using ondansetron as the antiemetic instead of the less effective ones being used at the time."

After working at Reading's Royal Berkshire Hospital, Michelle moved to Stoke Mandeville Hospital in Buckinghamshire, famous for its spinal unit. There she worked collaboratively with the lead nurse for spinal research, looking at the effectiveness of laxatives for spinal patients.

"It might sound inconsequential but managing your bowels when you're initially incapacitated by a spinal injury is a really important element of care" says Michelle. "So, we did a piece of research looking at the best combination of laxatives for different types of spinal injuries. And that was quite unusual, as it was a nurse-led trial rather than being led by a consultant, which remains most often the case."

In 2018, Michelle took up the post of Associate Director of Pharmacy at OUH, with responsibility for clinical trials, research and manufacturing. Her team of 55 staff support a portfolio of around 500 clinical trial IMP studies at any one time. The team work with any clinical specialty, although around half of the studies they support are in cancer.

As part of trial set-up, the team take the trial protocol, sponsor documents, pharmacy manual and customise it for OUH, to ensure it matches OUH processes and workflow. Where that's not possible, they go back to the trial sponsor to discuss options or adjust the local procedures to match the trial requirements.

Issues the team might have to resolve include how to store, handle and prepare the IMP, depending on the conditions it requires and the dosage, and whether the correct consumables are available to administer it. The pharmacy team also have to think through the workflow to make sure patients are safe, have a good experience, and that staff are also protected.

A significant proportion of the trials undertaken at OUH are early stage, as there are several Clinical Research Facilities (CRFs) on site in a number of specialties. This makes the trial set-up and delivery of the doses more complex from a pharmacy perspective.

"It actually makes the work more interesting, as we have to use a range of skills including problem solving to help get these studies open" says Michelle. "With phase III trials involving medicines that are already licensed, it's fairly straightforward, but with very novel IMPs, there are usually more questions than answers at the start of the set-up process."

The cutting-edge nature of research at OUH is also one of the benefits of the role, from Michelle's perspective.

"It's exciting to be part of something that's very new or where we might be one of only a small number of trusts working in this area" she says. "It's also really satisfying to feel you're helping to bring these cutting-edge treatments closer to patients."

Areas where OUH is conducting research at the forefront of the field include advanced therapy medicinal products (ATMPs), radiopharmaceuticals, and hyperpolarised molecules. Michelle's team has set up a small, standalone clean room to aseptically dispense doses of ATMPs, as they can't be handled in the same environment as other medicines.

"We have dispensed about 80 doses of ATMPs now for patients, with some living locally and some travelling quite a long way to access these treatments" explains Michelle. "We're at the cusp of a new era in terms of what we can offer as health benefits for patients. It's only small numbers so far, in quite niche diseases, but it's only set to grow."

Michelle has seen a lot of change in the role of pharmacy in research over her career.

"When I started, the senior people in research were men and clinical pharmacy was in its infancy, which created an interesting dynamic" she recalls.

"However, that's changed a lot. Now we have a massive amount of diversity in pharmacy, which is really positive. Within the team, we have a lot of people from different backgrounds, different countries, and everyone brings different skills and knowledge to the table, which is really positive. And pharmacy is now an accepted partner in the research team."

Pictured: Michelle Taylor-Siddons