@AndrewDBailey Not the evening the whole playoffs. Naz, OKC and now Knicks. Can only assume he’s favored because he and Adam Silver arrived on same spaceship
@_Biotech_iQ Agree! Problems caused by excessive regulation are not solved by more regulation. Australia has shown over 30 years that local IRBs are sufficient for INDs - get the FDA out of way. For approval benefit/risk is askew and killing patients. Fix FDA instead of protectionism.
@cwebs21@ethanjweiss@LocasaleLab initial trials of imatinib in blast crisis CML were similar to what is being seen here for panc. approximately doubling survival from 4 to 9 months. its when the agent went first line that it had the dramatic effect of restoring patients to essentially full lives.
This is the silent part that people wouldn't know.
Behind closed doors inside a medical conference, a large group of clinicians and researchers giving a standing ovation to another group of clinicians and researchers who found a way to increase survival in patients suffering from one of the, if not the, worst cancer in humans.
Metastatic pancreatic cancer.
They'll do this and then be on their way to see their patients the next day as if nothing happened.
And then work on something new to better what they did in this room.
That is how medical science works.
Value it and value its practitioners.
Key results of the randomized trial:
—At 5-years, 69% of patients getting vaccine plus pembrolizumab (Keytruda) were cancer free compared with 49% in the pembrolizumab group alone,
—Distant metastasis was also reduced by 59% by vaccine addition
—Overall survival 92 vs 71% (vaccine vs no vaccine)
@MelindaBChu1@G17Esiason@RuxandraTeslo@JTLonsdale Is being an author on clinical trial papers not viewed as a positive? The colleagues I know who are active trialists are sought out by patients. Maybe its because they are in poorly served TAs, but their patients seek new & better therapies.
@RichardHanania One disadvantage US has versus China is an obstructionist regulatory attitude at FDA. To your point, problems caused by excessive regulations aren’t fixed by introducing more regulations.
@adamfeuerstein@AppleHelix Very encouraging data. Data is in MM but real and massive opportunity is deep B cell depletion in autoimmune. 1 shot “cures” for lupus, MS, RA, etc.
2/ America should be the fastest, safest place in the world to deploy clinical AI & get promising cures to patients.
Instead, we are suffocating innovation with a top-down, Soviet-style bureaucracy.
Here are some table stakes for the next FDA leader: https://t.co/yEmQLiTr4n
1/ US biotech is in crisis, right before AI should be saving millions.
China is stealing away our industry and has surpassed the US in blockbuster pharma deals.
The next FDA Commissioner must be a fighter, and have a plan to overhaul the agency, beat China, and unleash cures.
@daphnezohar Simply put, we currently have an unreliable FDA that is prolonging time and expense in clinical trials while the Fed is shrinking exclusivity period to recoup costs. Reversing all those trends is necessary to save the industry and benefit patients.
good post from @JTLonsdale on what could be done by the FDA to increase American biotech competitiveness. Top of the list: streamline Phase I regulations.
Our current Phase 1 trial regulations require 12–18 months of preclinical work that Australia’s version of an IND (in Australia called a CTN) have shown unnecessary; the US regulations are a top-down, Soviet legacy of the mid-20th century that is straitjacketing us and delaying innovation. If we implement the Australian learnings, including 3rd party or medical center trial oversight (who review the IND instead of the FDA) we can speed up patient access to novel drugs while saving FDA reviewers’ time and taxpayer dollars.
The leading research institutions of the world like MD Anderson Cancer Center and Memorial Sloan Kettering should be empowered to decide when and how they launch Phase 1 trials, within regulatory frameworks.
https://t.co/blVgJWyz5i
@AppleHelix@Papa_Heme While acknowledging Papa’s point, that kind of protocol change would take a year or more to get approved at FDA and IRBS and amount to restarting trial with great cost and delay. And there is high potential a different approval will happen after restarted trial.