A year like no other: a reflection on 2022 from our CEO

I am excited to share some of our key highlights in 2022, my thoughts on the future of clinical research sites and where we go from here.

Our key strengths of agility and pragmatism are always at the heart of how we work with our clients. This was acknowledged with the company winning the Gold award for SME Business of the Year 2022. We have adapted and transformed the way we work, invested in long term technology solutions to better support our clients, whilst still managing to offer a cost effective, quality-driven service.

1. A randomised,  phase II UK multi-centre study to  determine reactogenicity and immunogenicity of booster vaccination against ancestral and novel variants of SARS-CoV-2 evaluating COVID-19 vaccine boosters – COVBOOST

PHARMExcel was the selected CRO to run the world’s first  COV-Boost study in 2021. Since then we have been involved in four further sub studies:

1. Fourth Dose Booster -started in Jan 22 and recruited 166 participants
2. Omicron Specific Fourth Dose Booster -started in Feb 22 and recruited 414 participants
3. Bivalent Omicron Fourth Dose Booster -started in Jul 22 and recruited 195 participants
4. Young Adult Fractional Dose-started in Sept 22 recruited 580 participants.

Testament to our team’s tenacity and adaptability during this challenging study, the team celebrated meeting 100% of the study milestones and targets.

2. Phase I/IIa Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL Amyloidosis- Targeted Radiotherapy for AL-Amyloidosis  – ‘TRALA’

Having been involved end to end in this study from 2016 we were delighted to officially close it this year. The study is an important step in treatment options for patients with AL-Amyloidosis, a debilitating and often life shortening illness.

PHARMExcel remained committed to the  study throughout despite limited funding, working with the teams to ensure quality output remained the focus. The trial results obtained were positive with overall survival at 100% at study close. Data obtained in this study can be used for a much larger clinical trial in the future.

3. IBD Reference and Biosimilar adalimumab CroSS over Study – iBaSS

This was a single-centre, prospective, randomised, single-blind, cross-over study in patients with Crohn’s Disease (CD) comparing Imraldi (biosimilar adalimumab) with Humira, as assessed by maintenance of baseline clinical status at both 24 and 48 weeks after initiation of study therapy. It was an important trial looking at the effects of using a biosimilar (a product similar in nature to the reference product) in patients with CD, providing an alternative, more cost-effective option, whilst maintaining clinical efficacy.

We provided full service CRO support for this study, starting in 2019 and closing out in February 2022. We await the results of the study and if positive this will open up future treatment avenues in not only this patient population but also other inflammatory diseases.

4. Phase IV interventional study: Switching InflixiMab to Subcut from Intravenous Therapy – SWIMSUIT

This was a single centre, phase IV interventional study evaluating the outcome of transitioning a cohort of Inflammatory Bowel Disease (IBD) {Ulcerative Colitis (UC) and Crohn’s Disease (CD)} and Inflammatory Arthritis (IA) {Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosis Spondylitis (AS)} patients established on IV infliximab to subcutaneous (SC) CT-P13 (Remsima).

We  provided protocol development, regulatory and EC submissions along with monitoring, study project and safety management, starting in Dec 2020 and completing in April 2022.  If the results of the study are positive, this will open up a valuable alternative treatment options for this cohort of patients.

5. A phase II, multicentre, randomised, double blind, placebo controlled parallel group study, followed by a 36 week active treatment phase to evaluate the efficacy and safety of secukinumab in patients with non-ocular Behçet’s Syndrome

This is a study in a cohort of patients with active non-ocular Behçet’s Syndrome, a rare chronic, auto-inflammatory, multisystem disorder. The primary outcome of the study is to evaluate the change in oral ulcer severity score following 16 weeks of treatment with multiple secondary end points including patient Quality of Life and Patient Reported outcomes.

 PHARMExcel has worked intensively on this Investigator Initiated Study (IIS) to design the trial and provide full service CRO support. The study started in September 2022, opening three centres and recruiting the first 10 participants.  We hope this study will provide pivotal data to support a larger phase III trial in the future and widen treatment options for patients.

6. First in human study of Sirona: A study to determine safety, feasibility and tolerability of an expanding hydrogel tablet, designed to promote weight loss in adults with a body mass index of 30-40

This is an open label, first-in-man study evaluating a hydrogel for weight loss with a primary focus on evaluating safety, feasibility and tolerability. As this is the Sponsor’s first human clinical trial, PHARMExcel has been working directly alongside the Sponsor and the wider multidisciplinary groups, bringing its experience and expertise to shape the study design, gaining ethics approval and latterly progressing to site activation in October 2022. The study will provide a unique non-surgical, minimally invasive and affordable weight loss treatment option.

Expanding our quality and regulatory capabilities

7. Working towards ISO 9001 certification

Our outstanding quality of service is what differentiates PHARMExcel from other CROs. We are an award-winning organisation that prides itself on its customer-centric approach and ability to get close to all aspects of the clinical trial to influence a successful outcome.
We are in the final stages of audit for the internationally acclaimed ISO 9001 certification which we are confident of attaining. So, watch this space in 2023!

8. Launch of Dot Compliance eQMS, to enhance clinical management operations

As part of the company’s digital transformation strategy we have invested heavily this year in technology integrations to enhance our business quality and clinical management operations. The value add for our clients will be underpinned by  streamlining critical quality functions like document management, training management, change control, deviation/corrective and preventative action (CAPA), risk management, supplier quality and audit management.

9. Triple gold honours for business performance

We were absolutely thrilled to win multiple achievement awards this year in recognition of  the company’s exceptional  innovation and outstanding service in the drug development sector. All our clients get access to a highly collaborative and responsive team of experts that act as an extension to their own teams – a true partnership; something larger organisations fail to achieve as voices and progress get stifled in an over bureaucratic system.

A look ahead for clinical research and PHARMExcel in 2023

The importance of robust trial development to ensure inclusion and diversity

Inclusion and diversity will remain hot on the agenda in 2023, building upon the recent draft FDA guidance published in April 2022 “Diversity Plans to Improve Enrolment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials’.

COVID-19 clearly shone a spotlight on the importance of diversity and inclusion. We’ve witnessed first-hand many communities continuing to be underrepresented across the spectrum of vaccine  trials we have worked in.

The EU Clinical Trial Regulation No 536/2014 requirements for including subjects that represent the population groups that will ultimately use these products under investigation intensifies the necessity to appropriately recruit  into trials.

That’s why PHARMExcel stand committed to ensuring diversity and inclusion are at the forefront of sponsors’ minds during the trial development stages.

The importance of feasibility and site selection in promoting inclusion and diversity

For many sponsors and research organisations, there can be an inclination to rely on sites already known to them, therefore adequate feasibility is often missed leading to under representation across patient groups.

Having recently supported  a number of clients through full feasibility, we have been able to identify access to patient populations required for the trials, engaged committed and driven investigators and sites and will now build upon this in 2023 to set up a collaboration of experts and patient representatives in key therapeutic areas to design the trials.

PHARMExcel remains committed to working with its sponsors to ensure selection of trial sites are a top focus.

End to end partnerships – Choosing the right CRO

The selection of a sponsor’s Contract Research Organisation (CRO) continues to be debated and we will see more emphasis on CROs’ adaptability and deliverables in 2023. Certainly for biotech and medtech organisations, many of whom are starting out on their journey into conducting clinical trials, choosing the right partner CRO is imperative. At PHARMExcel, we will be making key steps to ensure we continue to partner with companies that have shared values and a commitment to openness and inclusiveness. With over 13 years’ experience in academic clinical trials, we understand the requirements of smaller organisations – the need for expert support, guidance and strategic direction along with a larger degree of  “hand holding”. Our established relationships, agility and unprecedented trials knowledge provides a complimentary service to any biotech or medtech’s scientific and development teams. Becoming a trusted partner will remain PHARMExcel’s 2023 mission.

Patient-centric clinical trial design

Clinical trial design is one of the most important places to involve the patient. Creating a patient-centric solution involves getting feedback at a very early stage, and making decisions on trial delivery based on patient needs and perspectives.

PHARMExcel is committed to patient-public initiatives and will be engaging during 2023 in a nationwide, multi-stakeholder network to address shortfalls in, and improve delivery and impact of, clinical research. Part of this initiative is to look at the challenges and opportunities for effective partnerships between patients, relatives, clinicians (including trainees), research staff and academics.

It’s important for us to support researchers in ensuring trial design provides improved patients experiences, sees an increase in recruitment activity and ultimately improves data quality.  We have observed the benefits of patient reported outcomes (PROs) and collection of “real time’ data across a number of our phase II and phase IV studies and we will continue to promote this aspect during our study start-up phase.

I would like to take this opportunity to thank all our staff and partners for embracing the PHARMExcel vision, putting our clients first and committing themselves to the substantial role that PHARMExcel plays in the CRO industry.