Specialist
Former executive at Thermo Fisher Scientific Inc
Agenda
- Recent developments in cell and gene therapy market, focusing on outsourcing trends to CDMOs (contract development and manufacturing organisations)
- Potential disruptions to supply chain following coronavirus restrictions and inefficiencies to operations
- Competitive positioning of large vendors across product offerings
- Industry M&A dynamics and growth expectations, highlighting potential gaps in large players’ offerings and Danaher’s (NYSE: DHR) outlook after August 2021 acquisition of Aldevron
Questions
1.
What are some of the most important trends and developments you’ve been following in the cell and gene therapy space since our previous Interview [see Cell & Gene Therapy – Outsourcing Trends & Market Update –1 October 2021]?
2.
What’s your updated perspective on the cell and gene therapy supply chain dynamics? How would you balance improvements in the coronavirus situation with any geopolitical tensions or other macroeconomic backlogs?
3.
How does the demand split break down geographically? Is it predominantly in the US, where ability to pay is high? How do you see demand developing from higher-growth areas such as APAC?
4.
How are you assessing the industry’s ability to scale and meet the rise in demand? What are players doing to optimise supply chain efficiencies or accelerated scaling to meet this growing demand?
5.
How exposed are some of the major players to rising prices for materials and other costs over the near term? You mentioned some of the raw materials costs spiking due to inflationary pressures and supply chain inefficiencies.
6.
You mentioned we’re seeing some trends in the insourcing vs outsourcing of gene therapy services. Could you expound on what you’re seeing in either direction, perhaps delineating by cell manufacturing and viral vector manufacturing?
7.
How are you viewing the continued efficiencies in the manufacturing and sourcing process industry-wide? What potential is there for further cost reduction from optimising workflows or introducing innovative technologies? Could you elaborate on some use cases here?
8.
What are your thoughts on the market opportunity in electroporation? Why do you think this area has been relatively under-penetrated by some of the larger life sciences players?
9.
What are your thoughts on Thermo Fisher’s ability to carve out market share against Chemometec’s NC-202 counter and the Beckman Vi-cell offering? Does the company have any material ability to penetrate this market?
10.
Do you have any thoughts on MaxCyte and its relative growth prospects in electroporation vs other techniques, including viral vectors for transfection?
11.
What are some of the other adjacencies that might be attractive for MaxCyte to expand into, to diversify offerings and reduce reliance on electroporation?
12.
Could you quantify any downward pricing pressure or margin erosion for a first mover such as MaxCyte? What are the main reasons that could drive down profitability, other than increasing competitive saturation?
13.
What are your thoughts on the benefits and drawbacks of an end-to-end strategy such as a Thermo Fisher vs more of a point solution offering for cell and gene therapy? Could you juxtapose the benefits that could be leveraged from vertical integration vs having more gaps or weaknesses in a portfolio offering?
14.
How seamless of a fit is Aldevron under the broader Danaher umbrella? How do you assess the ability to integrate such a large acquisition into the fold and manage any subsequent integration challenges?
15.
Could you expound on some of the attractive synergies between life science tools and services that could be leveraged for a name such as Danaher with its August 2021 Aldevron acquisition? What are some synergistic use cases here?
16.
How do you assess Danaher’s continued acquisitive appetite relating to broadening its cell and gene therapy footprint? You mentioned you didn’t think the company was finished with M&A. What might be some strategic tuck-in acquisitions to further augment its offerings, and does the Aldevron acquisition’s size temper its capital spend at all?
17.
How broad of an application do you think mRNA technologies can present as it relates to cell and gene therapeutic manufacturing? We’ve seen significant demand uptick over the past couple of years. Are there any potential limitations to widespread adoption?
18.
Why do you think we haven’t seen a greater focus on mRNA? Is it the limited application to infectious disease and oncology, as you’ve mentioned? What are some of the pros and cons financially for players to increase their exposure and focus on mRNA manufacturing capabilities?
19.
How might some of the industry-wide consolidation dynamics evolve in 2022? What strategies do you expect from large players to capitalise on some of the margin expansion and portfolio diversification opportunities?
20.
How are you viewing the general regulatory landscape as it relates to FDA approvals of new therapies? What might this mean for accelerating the innovation curve for cell and gene therapies and creating efficiencies for manufacturers?
21.
What are some of those important distinctions between regulatory bodies in the US, EU, APAC and so on? Do you expect increasing harmonisation between regulatory bodies across regions?
22.
Are there any other regulatory developments you’re monitoring, perhaps regarding GMP [Good Manufacturing Practice] standards, CMC [chemistry, manufacturing and controls] or other compliance frameworks for cell and gene therapy players? How might evolving regulatory dynamics impact the operating environment over the near term?
23.
How do you assess some of the major cell and gene therapy players, including Danaher, Thermo Fisher and Catalent? How do they compare in breadth of offerings, innovation and market share? Who are some leaders and laggards in addition to those names?
24.
How much of a competitive threat do you see from clinical CROs [contract research organisations], such as Charles River, expanding their cell and gene manufacturing capabilities? How defensible is the positioning of some of the incumbents, given their greater size and scale?
25.
Is there anything else that you think would be important to highlight around the cell and gene therapy space?
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