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Every year in America, roughly 23,000 people undergo a Bone Marrow Transplant (BMT). These procedures are typically last-line interventions to save cancer patients. When successful, the therapy is often curative.

Despite its value, a BMT is an arduous procedure with significant drawbacks. The transplants can fail to engraft, have extreme side effects even when successful, and if rejected can ultimately result in death. The most pernicious issue is that BMTs cannot scale to the multitudes of patients who need them. BMT standards of care have been in place since the 1950s, with minimal progress in safety, efficacy, or reach.

Orca Bio is solving these issues by developing a novel cell-transplantation therapy that replaces conventional BMTs. Their work draws upon fundamental innovations in both engineering and biology. The engineering innovation is a proprietary cell-sorting method that surpasses incumbent technology in both throughput and precision. The biological innovation is the identification of a precise cocktail of immune cells that balances the trade-off between transplant rejection and therapeutic efficacy. Together, these advances allow Orca to generate therapies with the potential to reduce rejection, increase survival, expand the patient pool, and treat new diseases. …


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Imagine you have an incurable disease — maybe Alzheimer’s or multiple sclerosis. Though you might be willing to take a chance on science, you would nonetheless face a difficult decision in choosing whether to volunteer for a clinical trial. While you could potentially receive a better treatment, it’s equally likely that you would instead receive a placebo as part of the control arm of the study, used to verify the efficacy of the experimental drug. Despite bravely seeking to improve your life, you might end up as just a baseline comparator. That system doesn’t seem right.

What if, instead, there was a 100% chance you’d get the new therapy, because the trial didn’t need a placebo arm? …


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This was originally written as an op ed on March 25th, 2019. Prominent papers were considering publishing it, but we were told at least one worried about their relationship with the FDA and that they did not want to criticize them directly at this time and risk losing contact during a crisis.

The FDA does not have an easy job — but it’s well known that the FDA is overly risk averse, causing far more damage with what they do not allow than the lives saved. Its insular, bureaucratic decision-making is not set up for a pandemic. …

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