Patient recruitment and retention is an oft-cited challenge in discussions about clinical trial concerns. Panthera Biopartners, a site management organization (SMO) has seen notable growth since it launched just three years ago. To learn more about its history, a recent infusion of investment funds, and plans for the future, Outsourcing-Pharma connected with Chris Dodd, chief commercial officer of the company.
OSP: Please share the ‘elevator presentation’ description of Panthera Biopartners—who you are, what you do, key capabilities, and what sets you apart from other companies in the same sphere.
CD: Panthera is an SMO that recruits patients and runs clinical trials at dedicated sites in the UK and Europe on behalf of its clients - CROs and pharma. Because of its scale, more than 12 sites – and growing - across the UK and Western Europe, it has access to millions of patients and can recruit thousands to studies very quickly - can be less than three months.
While it was only founded in 2019 its rapid growth is due to the very experienced management team who have been able to leverage both their expertise in building a world-class organization and enrolling clients – the team already had close relationships and the confidence of the major CROs and pharma.
Panthera has access to very experienced PIs across its areas of expertise – general medicine, respiratory, oncology, neurology, vaccines, and NASH. Many of their clinical trial sites are sited in major hospitals, Oncology specialist centers, large primary care practices which not only provide access to their considerable patient bases but also on-site access to biopsies, all types of screening, and other support services.
Panthera prides itself in being able to provide very rapid start-up, access to millions of patients, experienced PIs, and perhaps most importantly its very experienced management team which can ensure top-quality research and a partnership model to its clients.
OSP: Could you please tell us what an SMO is, and how it differs from your typical CRO/CDMO or other such company?
CD: An SMO is totally focused on recruiting patients, retaining the patients, and running the clinical trial on behalf of its clients in CROs and pharma. The SMO model was begun in Europe by Ian Smith – one of the founders of Panthera – when he founded Synexus back in 1991 which became the largest SMO in the world.
While some CROs have SMO organizations the CROs themselves do not recruit, retain patients, and run the clinical trial. The alternative is to run a trial through a primary care practice or at a hospital. Neither of these organizations is totally focused on carrying out trials and their other activities often take precedence.
- strategically sources patients through local patient records of GP or hospital, advertising, social media, database, etc
- is recruiting tens if not hundreds of patients at a single site
- has minimal setup costs – could be millions of dollars at sites delivering the equivalent patient numbers
- handles monitoring covering tens if not hundreds of patients
- offers extensive expertise, as it is the sole focus of the SMO and they are doing many patients for each protocol
- ensures that waiting times are minimal; otherwise, they lose patients
- have waiting rooms that are generally comfortable with refreshments and TVs, etc.
- are set up to reimburse patients for travel, etc.
- have one contract covering a multitude of sites
- set up and organise tests, biopsies scans
- have patient retention strategies built in to avoid losing patients, particularly in long studies
With a hospital or GP:
- recruitment happens on an opportunistic basis
- 48% of primary care sites fail to recruit a single patient
- 60 % of these sites recruit one or fewer patients – even more expensive as have to monitor one patient site
- compared to an SMO, it takes 4-6 months longer to recruit the first patient/last patient
- the cost for finding training and opening a site is >$55,000
- one company spent $20m on opening sites that did not recruit a single patient
- low recruitment for each site means monitoring costs are very high
- there is little expertise – 75% of sites are new to the sponsor company
- few patients, unfamiliar with protocol, and therefore errors occur
- patients often have to wait beyond their appointment time at GP surgeries and hospitals due to other priorities; this becomes a deterrent to continuing
- waiting rooms are usually more basic and involve many other people often sick – another deterrent for long term compliance
- they are not generally set up to provide easy reimbursement
- they each demand a separate contract often with considerable differences
- they put the patient into the system which causes delays
- retention strategies rarely put in place
SMOs have a double-check system to avoid mistakes. While the cost per patient in GP/hospital appears to be cheaper as SMOs charge for recruitment activities, in overall terms, they are more cost-effective as there are more patients per site, less monitoring costs, and much of the recruitment budget is performance-based and only paid on randomization of patients to share risk with the sponsor.
Most important, because SMOs are focused, they are first to recruit and first to finish the last patient in of their quota.
Cancer is a special case. The average planned time for a cancer study is 3.2 years – on average recruitment takes 170% longer than scheduled – 21months to 41 months. The average budget for a Phase III is $158m. For each month saved $5.2mn, each year of the planned recruitment study adds 8.4 months of additional fees.
Because oncology studies are usually complex there is great pressure to use top PIs from leading sites. However, the KOLs rarely recruit outside their own lists.
48% of specialist cancer sites underperform and it is difficult to find capacity at leading sites.
Panthera’s oncology SMO model is different. Panthera works through a number of leading oncology sites using the top PIs. It recruits not only the PI’s patients but also pro-actively seeks appropriate patients through an outreach program. It actively manages the whole process to ensure that deadlines are met, and recruitment meets or exceeds the quota of patients agreed upon.
OSP: You’ve only been around for about three years but have seen some notable growth. Could you please tell us about that, and what you might attribute to your success?
CD: Panthera was founded by Ian Smith, founder of Synexus, and John Lyon, who was previously a global VP at Covance. This expertise and close relationship with the clinical trial teams at the CROs and major pharma enabled them to:
- raise a series A which gave them the firepower to start
- immediately engage with the decision-makers at their clients
- were offered space for clinical trial sites at major hospitals, major primary care groups
- have the confidence of the CROs and pharma they could deliver and therefore were given the opportunity to recruit and run trials
- attract the top talent in the SMO area which includes:
- CEO Stuart Young previously managed Synexus UK
- Chief Compliance Officer Jane Restorick previously COO of Synexus globally
- As chief commercial officer, I was previously head of commercial at AES where I led the world’s largest team on-site and patient recruitment
- General Manager Oncology Matt Cooper was previously Executive Director of the NIHR Clinical Research Network
OSP: Panthera launched not too long before COVID-19 hit. The pandemic threw a lot of clinical research organizations for a loop—how did it impact yours, and how have you weathered the COVID storm?
CD: Panthera had just launched in late 2019 three months later COVID closed all sites. However, one of the sites – Rochdale - was a standalone site on its own grounds. Panthera was, therefore, able to open this site as the patients waited in their cars and then were invited in one at a time. The patient and the staff were provided with full PPE and a stringent SOP was developed for those patients who were willing to come to the clinic.
Soon after that Panthera opened its other clinics with longer gaps between appointments to reduce contact. Because Panthera sites have their own waiting areas, even where the site is part of a hospital/clinic or a primary care hub, Panthera was able to start running trials without trialists mixing with other patients. Panthera also commissioned a mobile unit that was used outside the existing sites to increase patient flow.
Panthera was approached to run several COVID vaccine studies and continues to run not only Covid vaccine studies but other vaccine studies. A special protocol was agreed upon for COVID studies with remote monitoring wherever possible. Panthera had the top-performing sites in every case.
While COVID did reduce the initial rate of growth it has since accelerated it as many medical facilities were not open to run trials at all. In fact, many sites particularly NHS specialist sites are still not open due to the backlog of patients and staff shortages.
OSP: Panthera just announced a significant infusion of investment funds—please tell us about that, and what that funding might be used for.
CD: Panthera Biopartners secured £10m of investment from BGF and Gresham House Investments in May this year. This investment will allow Panthera to further:
- Grow its network of dedicated clinical trial sites across both the UK and Europe with its own dedicated research sites either by acquisition, in partnership with hospitals and clinics, or a new build.
- Build on its existing experienced management team.
Panthera chairman John Lyon commented, ”We are very pleased to have the backing of such reputable and respected investment houses as BGF and Gresham which will supercharge our expansion. In the last two and half years, our management team has built a new exemplar SMO model which has been welcomed by our clients in the major pharma companies and CROs. In the next twelve months, we will become not only a leader in the UK but also in Europe.”
OSP: What’s next for your company—any interesting accomplishments, partnerships, or other upcoming projects you might like to share?
CD: Panthera intends to continue to expand its network of sites in Western Europe as it believes that this region is particularly attractive to its clients and the value proposition to Eastern Europe is now negligible.
This includes further expanding its nine sites in the UK with clinics in areas of high population, particularly in partnership with large primary care networks and major hospitals. It is presently concluding deals to own three clinical sites in Southeast Sweden. It is in negotiation in another country in Western Europe to complete a deal with a major hospital group to open a further three clinics with the opportunity to expand that further.
Panthera is also examining further expansion in Western Europe and is in discussion with several other parties. Panthera is in discussion with partners in the US and other countries outside Europe.
Panthera is working with its clients to develop a partnership model whereby trials can be planned well in advance which accelerates recruitment and shortens the length of the trial. This has a huge cost benefit for clients.
CEO Stuart Young said, “We are planning to continue our expansion over the next few years in a planned strategic way so that we continue to offer our clients the best service. We will therefore also be investing in expanding our management team with experienced professionals who share our commitment to providing an exemplar SMO model.”