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5 Potential Research Priorities and Opportunities in Therapeutics
Pages 49-60

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From page 49...
... • Learning from different complex chronic illnesses is key, and it is important to know how they are similar and different in order to properly train clinicians and improve precision and personalized treatment approaches. (Putrino)
From page 50...
... While drug development is typically a very long process, the process for nirmatrelvir, the antiviral component of Paxlovid, took less than 2 years from concept to treating patients. Pfizer made a few innovative changes to expedite the process in an emergency situation, he said, including expedited drug design and manufacturing of the drug product, at-risk investment in commercial batches, and rapid internal decision making and regulatory interactions.
From page 51...
... Pfizer used an innovative "first in human" study design, which efficiently informed and accelerated the launch of the clinical trial.3 Ritonavir, a protease inhibitor, was added after determining that it significantly increased the half-life of nirmatrelvir. Next, the team developed and used population PK and quantitative structural pharmacology models to project drug concentration and effect on the viral load in the blood to determine appropriate dosage and duration of treatment.
From page 52...
... They collaborated across the world to obtain drug repurposing libraries, which contain large numbers of small molecules originally developed to combat other pathogens. The largest class of approved antivirals resemble human nucleosides, the building blocks used to make RNA, which block viral replication when incorporated by the virus.
From page 53...
... They found that Paxlovid and interferon beta retained activity in the human intestinal cell line, while molnupiravir had decreased activity. Furthermore, prophylactic treatment by all three compounds showed antiviral activity in preventing infection, but there was significantly reduced activity with single-dose treatment regimens after the infection is established.
From page 54...
... When this pathway is upregulated the tight junctions are disrupted and there is uncontrolled antigen trafficking from the gut lumen into the bloodstream. Fasano shared the first study they did in children with MIS-C, where they found an elevation of serum zonulin, and participants had systemic symptoms including microbiota dysbiosis and tight junction disruption (Yonker et al., 2021)
From page 55...
... . Simply having the altered zonulin pathway and having the viral spike protein in your bloodstream does not necessarily mean that the individual will develop long COVID, he clarified, as a genetic predisposition is also needed.
From page 56...
... OPPORTUNITIES FOR PREVENTION AND TREATMENT OF LYME DISEASE ASSOCIATED CHRONIC ILLNESSES Given the overlap in symptoms between chronic Lyme and other autoimmune disease, Kim Lewis, Northeastern University, wanted to investigate whether there was also an overlap between alterations in the microbiome in these disease states. Looking at different subgroups of patients compared with healthy controls, his team identified distinct signatures in the gut microbiomes for each group.
From page 57...
... CLINICAL CARE ACROSS ILLNESSES David Putrino, Mount Sinai Health System, started a clinic primarily focused on long COVID, but recognizing the overlap with so many other complex chronic illnesses, his team has also started to treat patients with other conditions, such as Ehlers-Danlos syndrome, myalgic encephalitis/ chronic fatigue syndrome (ME/CFS) , and Lyme disease.
From page 58...
... The next stage of the pipeline is "prehab," which includes symptom management resources and conversations and lessons on how to best avoid symptom flare-ups, as well as breath work programs specifically focused on improving blood carbon dioxide balances. In conducting internal research, Putrino said his team found that 90 percent of patients who used their breath work platform for at least 3 months had improvement across indicators such as sleep quality and stress control.
From page 59...
... Sinai model of informed, compassionate, patient-centric clinical care can be exported and developed elsewhere for more people to access. Putrino replied that they are working to build curricular and training materials and will also be creating a complex chronic illness medical curriculum through Icahn School of Medicine.


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