Specialist
Former Director at Science 37 Inc
Agenda
- Trends and developments in the virtual and hybrid clinical trial industry, focusing on Science
- Patient recruitment and retention dynamics and potential cost and time savings of virtual and hybrid vs bricks-and-mortar clinical trials
- Science 37’s software vs services offerings portfolio, including needed improvements for the latter
- Potential M&A expectations for Science 37 and possible synergies with a CRO (contract research organisation) acquirer
Questions
1.
Could you walk us through Science 37’s offering and overall business model, particularly how it’s shifted as of late, given the broader interest towards decentralisation and hybrid models?
2.
We’ve heard a significant driver for the broader case for decentralisation is decreasing cost and the overall time it takes to complete a trial. How has that delta been trending, particularly as this model matures and where does Science 37 fall in that regard vs competitors?
3.
Do you think the ease with recruiting patients virtually and subsequent difficulty retaining them is a problem all decentralised trial players are having to contend with? How much variance do you think is in the sector or that Science 37 is experiencing in that regard, given your comment about its website claiming it recruited patients 15 times faster in a study? How might that potentially hinder your earlier comments regarding the company’s significant interest towards decentralisation or a hybrid model, that might make up for some of that shortfall in the actual data for recruitment, retention or cost?
4.
When considering recruitment, you mentioned trials are easier for patients to do at home. Could you quantify that or give us an average range for that potential improvement? How significant of a change is there for retention vs a traditional bricks-and-mortal trial? Obviously, from your context, it’s more towards the negative, or more patient turnover.
5.
What have software and services margins been historically? How might they trend when considering scale, expertise of crossing those services and figuring out how to effectively recruit? What are your expectations for those, particularly given that you’re saying it might not even be profitable, depending on how the recruitment actually goes?
6.
You mentioned some of execution risk associated with being an all-in-one offering where, for example, failure to recruit would lead to not being able to charge for subsequent milestones in the study. What impact is that operational risk having towards Science 37’s reputation in the decentralised trial industry, given it is one of the most mature players? Do you think the company is in the right place to execute in a better form? What might be missing, particularly if you’re thinking about reputation risk? What hinders it in the longer term?
7.
How are you expecting Science 37’s relationship with CROs [contract research organisations] to develop relative to players such as Medable or Thread considering its software and services offerings? Do you expect the relationship or competitive dynamic to shift any particular way, particularly as the company expands its services and footprints?
8.
How do you anticipate a CRO such as Iqvia competing with Science 37 in the decentralised trial sector? For example, we have a model where a customer might go to PPD and use Medable on the side for software or go directly to Science 37, which is smaller than Iqvia, though Iqvia is beginning to expand its decentralised trial capabilities. How are you assessing the type of customers that will go towards each model?
9.
How difficult is it for a CRO or another software player to adopt an all-in-one model that combines all software offerings needed for a trial in one place? Historically, there have been many e-clinical verticals and, as a result, many vendors, although that’s starting to somewhat consolidate, particularly when considering players such as Veeva and Iqvia. What are your expectations for the risk for other players to adopt similar models? How is the actual software, particularly with the telemedicine component, different? What moats do Science 37 or Medable have, comparatively?
10.
What traction would you expect for software as a standalone vs services as a standalone vs both combined? You mentioned earlier the value a player such as Science 37 has largely depends on the sponsor, and to what extent they’re searching for software first or a potential services partner after. As integration and consolidation in the industry continues for a CRO and CDMO [contract development and manufacturing organisation] or a CRO and software, we’ve noticed that value is very dependent on the client type. The smaller the sponsor is, the more overlap in responsibility in selecting a partner there is, whether it’s software, whether it’s services. Of course, that’s a little bit more difficult in pharma, where different people are responsible for selecting different partners.
11.
What are your expectations for Science 37 becoming the one-stop shop who can be accountable for a whole project a sponsor would hope for? Do you think the company has the scale and expertise to do so? Or do you think it’ll ultimately be won out by a player such as Iqvia, who also has services and software but at a significantly different scale?
12.
Science 37 announced in August 2020 a partnership with ERT. It also has partnerships with Foundation Medicine, Syneos, Signant and others. Could you discuss the partnerships you consider most encouraging, particularly given the other gaps that need to be filled in order to have a fully-run decentralised or hybrid trial? What is your outlook for partnerships for Science 37?
13.
What do you think is important for Science 37 to prioritise in the shorter term to make the most of those partnerships and the overall increase in demand for decentralisation? What avenues would you explore for adding scale or other verticals?
14.
You mentioned CRO players need to tighten up their operations execution. Even players such as Iqvia and larger CROs are all experiencing some of the ramifications from a labour shortage and increasing price. How much read-through is there between the two? Is Science 37 in a position where it can potentially get that expertise in-house when competing against players such as PPD, Iqvia and Icon-PRA?
15.
Science 37 has expanded to Europe, LATAM and APAC, particularly when considering investments in nurses and investigators networks. How are you assessing the firm’s global footprint, and are some of those challenges particularly acute in any geographies?
16.
How do you expect the regulatory landscape for decentralised trials to impact potential adoption? Are there potential catalysts you’re monitoring as indicators, both in the US and abroad, that Science 37 and peers have an opportunity to continue to grow their industry and overall positioning?
17.
What are your longer-term expectations for Science 37, particularly the value the company offers as a standalone business vs it potentially being acquired? Before Science 37 went public, it was long speculated it would be acquired by Verily or PPD. What are your expectations for a potential acquisition when considering its strengths in both software and services, but also some of the limitations that come with that?
18.
Who would make the most sense as a potential acquirer for Science 37? You mentioned some of the same limitations working with PPD where there would be a conflict because the company also offers the same services as PPD. However, PPD is now under the Thermo umbrella and Thermo is aiming to have a very clear end-to-end offering. Do you think Thermo makes sense as a potential acquirer or someone else?
19.
What are your best- and worst-case scenarios for Science 37 in the next 2-3 years? You mentioned the company needs to address its relationship with CROs and gaps in its software. What would happen if a player such as Medable or Thread were to fully overtake it in the international market?
