martin wrote:foosballnick wrote:The only concern I have is that Pharma Companies may opt to terminate future potential drug programs in order to focus on what will be profitable over what will be beneficial. Takes about 10 years and ~$1 Billion to bring a drug to market with probably 80% more wasted on targeted programs in development that do not move forward beyond clinical trials because they are either not effective or not safe.
To be fair, that could be true but it probably isn't.
That is the sales line the pharma industry keeps repeating to get away with the galactic sized profits they do today.
There is no reason why the gov't shouldn't be able to negotiate drug prices. We are a capitalistic country, right? And if those costs for program development are too high, perhaps this should be taken over and then subsidized by a gov't entity, right?
It's the same as filing taxes. The gov't already knows the tax amount for like 80% of the normal filers and could VERY easily just have those people electronically upload their info/payment without cost but companies like Intuit had enough lobbyists to block that simple feature. As does/had the pharma industry with Medicare-D negotiations.
I know you may not have intentionally intended to do so but you just passed along a well lubricated sales pitch from the pharma industry.
Was that your intention?
Do you have a background in this industry that perhaps you could share with us? I'd love to be better informed on this topic.
Apologies - took me a while to respond (been pretty swamped at work so I've just been browsing quickly here on ultimateknicks the past few weeks).
To your last question - I've had about 20 years total experience with various companies in Pharma and Biotech development including R&D, Drug Product Development, Contract Manufacturing and clinical specialty laboratories.
In my experience R&D costs are somewhere between 20% - 25% of total gross revenue. So when you think about "big" pharma think in the $10 - $20 Billion dollar range annually. To successfully launch a product these days it takes passing a high degree of regulatory, safety and quality scrutiny. Note that this is not limited to the FDA, but rather each region or country may have it's own regulatory requirements that need to be evaluated and met. Most pharma rely on outsourced partnerships or suppliers for Central Clinical laboratories (to recruit potential patients, run the trials as well as analyze efficacy data), Analytical Laboratories (potentially hundreds of different assays related to product quality, chemical and structural analysis, packaging testing, release/stability testing etc), Contract Manufacturing, Formulation, Chemical Synthesis, Drug Safety, Purification steps, Process Development etc. Every new drug candidate has somewhat custom processes and custom test methods that will be analyzed and need to be approved by the various regulatory bodies. There are 4 Stages of Drug Development after Basic Chem and Bio Research.....clinical phases 1-3 and a 4th for lifecycle management. Each clinical program can take an average of 9-10 years to go through a cycle from Basic to Drug Filing for approval. Note also that each program (drug candidate) will have multiple studies within each development phase and may also have multiple trial streams going on at once based on different formulations, dosage level or regimens etc. The trials produce safety and efficacy data which could impact forumalation changes or bump a program forward, back or to termination based on results. If a Pharma company has ~100 Pre or Clinical Programs in development at any given time, if just 1 or 2 make it to regulatory approval in any given year - it is considered a success. Perhaps over 90% of the programs in development never make it to approval. Pharma can terminate programs for a variety of reasons even beyond safety/efficacy. Sometimes for instance drug formulations work in a laboratory setting but cannot be scaled up successfully. Drug Development is leaning more and more towards biologics, cell and gene therapy programs which can be extremely expensive. For instance - I recently worked on a Phase 1 drug candidate that is projected to cost $1M per dose for a clinical patient. It is likely that such formulations will be too expensive to commercialize - but hopefully this type of activity sheds some light on the expense basis in Pharma Development.
The mRNA Covid vax was very fast tracked. It can certainly happen in emergency situations but note that it required a high degree of government alignment/intervention with regards to Warp Speed alignment of manufacturing & supplies as well as available Patient population. Also the mRNA technology was leveraged from already in development SARS vaccine work which started in the early 2000's.
9/3/2023 1:27 PM