Specialist
Former SVP at Vineti Inc
Agenda
- TAM, regulatory framework and demand outlook for advanced therapies supply chain orchestration software solutions including potential impact of the shift from autologous to allogeneic cell therapy
- In-house vs third-party software platforms, competitive landscape for third-party incumbents and review of overlapping services from different players across the value chain
- Vineti vs Trakcel case study – software platform analysis, economics, scalability and KPI benchmarking
- Outlook for new market entrants and consolidation
Questions
1.
Can you give a brief introduction to the end-to-end supply chain orchestration software, such as the platforms offered by Trakcel and Vineti? Why do they exist? What are the problems they want to solve and where do they add value for their customers?
2.
Could you expand on what these platforms typically offer, whether it’s end-to-end or point services, and perhaps even delineate across clinical vs commercial end markets?
3.
What are the different platform requirements across a clinical stage software platform vs commercial stage? As we’ll discuss later, I believe Trakcel is particularly ingrained in the clinical trial segment and less experienced in commercia, so I’m curious to understand what is needed to succeed across the two.
4.
On the topic of customers, presumably, biopharma players such as Kite, Novartis and J&J are the core customer bucket, but what about the healthcare providers who have to administer the patients with these advanced therapies?
5.
What would it take for the manufacturers and HCP [healthcare professional] to consolidate everything onto the one platform? What would that platform end up resembling?
6.
As you note there’s a certain payer pressure as they aim to drive down costs. What about regulatory pressure? What are the regulatory requirements around supply chain orchestration software?
7.
The key currently approved party therapies are Abecma [idecabtagene vicleucel], Breyanzi [lisocabtagene maraleucel], Kymriah [tisagenlecleucel], Tecartus [brexucabtagene autoleucel] and Yescarta [axicabtagene ciloleucel]. What regulatory requirements has the FDA put around those regarding supply chain orchestration software requirements, patient tracking and so on? Are they homogeneous or is there a clear lack of standardisation across the different approved therapies?
8.
Are there any other regulatory requirements stipulated by the FDA, beyond identity and chain of custody?
9.
Does the FDA mandate that you need to follow up on patients receiving cell therapies after administration?
10.
How should we think about TAM for supply chain orchestration software platforms? We’ve drawn the battle lines between the supply chain and the EHR [electronic health record] software.
11.
You opened up the Interview today by walking us through why these businesses exist, and you noted that its due to the complexities of this one-to-one relationship between the autologous therapy and the patient. The therapy is unique to the individual. What happens when the market shifts away from autologous cell therapies and towards allogeneic or, off-the-shelf, cell therapies which don’t have as complex a supply chain? What does that mean for the demand of these software orchestration platforms?
12.
To be provocative, to what extent would the allogeneic cell therapy supply chain problem not merit an entirely dedicated software from Trakcel or Vineti? Could this not be managed by other supply chain software? I appreciate the clear value proposition in managing all the moving parts for an autologous therapy.
13.
Do at-scale biologic supply software companies exist, so those who only really operate in the mAb [monoclonal antibody] field? Is there a Trakcel or Vineti equivalent that focuses on off the shelf mAbs?
14.
How significant is the adoption of GDP [good distribution practice] standards, outside of advanced therapy? Could regulators drive an industry-wide uptake in standardised supply chain and logistic software with robust track-and-trace capabilities, hand-in-hand with the rapidly maturing cell and gene therapy pipeline?
15.
How much of the autologous cell therapy market – and advanced therapeutic market more broadly – is captured by third-party players such as Trakcel and Vineti vs in-house software solutions from biopharma such as Novartis, or even the large CDMOs [contract development and manufacturing organisations]?
16.
There are five approved on-market cell therapies from BMS Celgene, Juno, Novartis, Gilead and Kite. How many of those are using in-house vs third-party software? I believe Vineti has publicised a Kite partnership for commercial runs.
17.
Considering the pipeline, could you give me a rough sense for the split of clinical trials that are using a third-party software platform vs proprietary in-house?
18.
How are you thinking about the competitive threat from a digital consulting shop, such as Deloitte, that has historically developed a customised platform building an off-the-shelf platform? I think Iqvia is also in the mix.
19.
What about the threat from CDMOs such as Lonza, which are very active in developing and manufacturing cell therapies? We discussed how biotechs don’t have many resources, hence why they often outsource to a CDMO, so how significant a threat might Lonza be as it seeks to build out a one-stop shop?
20.
Who are the major competitors for third parties selling gene therapy supply chain orchestration software platforms? You mentioned that the competitive landscape extends beyond Trakcel and Vineti.
21.
How should we think about the barriers to entry for new entrants going forward? Obviously, we’ve discussed the complexities of this market, especially for autologous cell therapies. Presumably, that’s one barrier to entry and the regulatory requirements would be another.
22.
Circling back to our earlier discussion around the respective clinical-stage market shares, you noted that roughly two-thirds of the market would work with an outside provider. Are you including the consultancies in that two-thirds, or is that included into the in-house third?
23.
Perhaps I’m misunderstanding, but seems there are many overlapping services from other tangential players. For example, Cryoport has built its own fleet of cryogenic shippers, which Trakcel and Vineti don’t have, but, interestingly, Cryoport has its own software applications supporting it. Vineti and Trakcel have supply chain software, but they obviously don’t have the cold chain fleet that Cryoport does…
24.
Are the cold chain logistics players and other integrators platform-agnostic, in that they work with Vineti and Trakcel, or only one or the other?
25.
Returning to our earlier discussion around what the healthcare professionals want, you have competitors like the Lash Group, which is part of AmerisourceBergen, which provides patient service hubs or patient access programmes. You have Sonexus, which is part of Cardinal, too.
26.
Do you think Vineti and Trakcel could be acquisition targets for a player such as Cryoport or even a large distributor such as McKesson?
27.
I’m very conscious of time, so I compare Vineti vs TrakCel specifically. Starting off at the top, can you walk me through the respective strengths and weaknesses of the PTM vs Occelos platforms?
28.
You mentioned Trakcel has greater expertise in preclinical and clinical trials and is less experienced in commercial. On balance you noted Vineti has better cell and gene therapy expertise more broadly and that biotechs would typically gravitate towards Vineti over Trakcel. Forgive me if I am being slow, but why then does Trakcel have greater penetration with pipeline players?
29.
Could you quantify Trakcel and Vineti’s respective market shares or penetration in the preclinical and clinical stage segments? We discussed that roughly 60% of all pipeline candidates work with a third-party platform. Could you delineate further across Trakcel vs Vineti?
30.
As it stands today, which platform offers the most rounded set of features a customer wants vs representing somewhat more of a minimal viable product?
31.
How does the revenue model work for these TrakCel or Vineti platforms? Is it a fixed subscription with variable components based on the number of patients treated or the modules added?
32.
How many patients do you need to treat to cover the software cost?
33.
How does the cost compare for Vineti’s PTM vs Trakcel’s Ocellos platforms? Is one priced at a premium vs the other?
34.
You mentioned that the subscription fee is tied to the number of patients. Just as we think about the future revenues for these platforms as and when the cell therapies scale, would you be able to help me understand the magnitude of annual spend from someone such as Kite and Yescarta and how changes as more patients are treated? What does that sliding scale look like?
35.
How easy is it to scale the Vineti platform vs the Trakcel one, because clearly that’s of paramount importance? Is one better set up to scale than the other?
36.
How sticky are Vineti and Trakcel’s existing customers? How easy would it be for a pharma or a biotech company to switch platform?
