Specialist
Associate Professor at Fred Hutchinson Cancer Research Center (Fred Hutch)
Agenda
- COVID-19 characteristics and epidemiology
- Vaccine trial design for phases 2-3 and clinical results from COVID-19 vaccines, including Moderna's (NASDAQ: MRNA) mRNA-1273 and AstraZeneca's (LON: AZN) AZD1222
- COVID-19 vaccine implementation scenarios – different efficacy profiles, side effects, disease severities and population characteristics
- Outpatient treatment for early stages of COVID-19 – use of convalescent plasma, hydroxychloroquine, dexamethasone, favipiravir, lopinavir-ritonavir and emtricitabine-tenofovir
- Peaks and troughs of viral loads in COVID-19 patients and implications on diagnostic testing
Questions
1.
When thinking about epidemiology modelling of the COVID-19 disease, what are your expectations on a secondary spike and how might it vary by geography, especially in the hotspot vs non-hotspot areas? What factors are driving these assumptions?
2.
What are some of the pathology drivers for the optimal therapeutic projections around optimal therapy in the physician community around COVID-19? How is this driving use of the available therapeutics and what are your thoughts around pipeline and why there is such paucity in data?
3.
Why do you think there was such difficulty identifying and enrolling the right population size and type in the trials? Does it come down to issues in finding and building smaller studies, and do you think that is a function of wasting time on some of the more politicised and generic options? You also said there are potentially better repurposed agents than hydroxychloroquine, for example, that have yet to be enrolled in trials, or are in preliminary trials. Which of those do you think could hold more promise?
4.
Do you think the hope around the Merck EIDD-2801 agent in collaboration with Ridgeback Bio is that it’s more of a novel formulation and an oral antiviral targeting to treat COVID-19? Similar to medications for the common cold or flu – it’s almost prophylactic or very early-stage. What are your thoughts on potential remdesivir usage given the mixed feedback around the New England Journal publication data and the later- stage administration and extended study? Is this just filling the gap before something more hopeful, such as the antiviral out of Merck and Ridgeback Bio? Could there be some meaningful survival benefit where a standalone could be administered in the earlier stage of the disease?
5.
Could you outline the trial designs around the later-stage vaccines of the AstraZeneca-Oxford adenoviral vaccine? What are your thoughts about the trial designs, vaccine implementation and the different scenarios when comparing with the mRNA platforms out of Moderna, CureVac, BioNTech and the DNA segment vs traditional vaccines? How are you assessing timeline and which one would you be most optimistic about?
6.
Has the prolonged vaccine timeline been impacting therapeutic research and focus around COVID-19? Is there anything to consider about the biopharma hesitancy and lack of infectious disease expertise, as you mentioned, to fully invest in therapeutic advancement beyond repurposing drugs to target the COVID-19 strain?
7.
What are your thoughts around the UK data around dexamethasone? Could it be another hydroxychloroquine scenario where it floods the market? Is there anything comparably better from a trial design standpoint, to at least alleviate a certain patient subsegment?
8.
Otezla, the PDE4 has historically focused on psoriasis but is an interesting option, especially around pulmonology. Do you have any thoughts around that agent used as one of the medications in chronic lung disease and in an advanced COPD [chronic obstructive pulmonary disease] patient? Could it be a differentiating formulation when thinking about repurposed drugs?
9.
What are your thoughts on plasma, which is emerging as a short- to immediate-term preferred solution across divisions? How are you factoring plasma into your optimal therapy modelling? Where do you think it stands as it pertains to other formulations, antivirals and immunomodulators?
10.
What are your projections in spikes, measures and a general worst- or best-case scenario? Would it be fair to assume that there will not be as big of a spike in New York, New Jersey, Connecticut and areas that were previously hotspots? Are we approaching herd immunity, and how should this be factored when assessing mitigation strategies? What is working and what isn’t?
11.
How are you modelling flu severity and scenarios coupled with how COVID-19 could unfold? Should we anticipate further lockdowns into the spring of 2021?
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