DISQUS

Jens · 2 years ago

The key aspect that differentiates the human therapeutics industry from all others is the extensive regulatory environment. Just imagine that every new semiconductor that was developed had to undergo a 5-10 year testing process in which the developer had to proof that it was:

- safe to use (because something people drop dead when they come in contact)
- it worked better than any other semiconductor in the same field (maybe you just made it up?)
- it still worked when you gave it to a lot of people who used it in a near real life environment (strange thinsg happen when you give new stuff to a lot of people in an uncontrolled environment).

After you have done all that successfully, you still needed to:
- convince the regulatory committee that it is really a good idea to approve this semiconductor (BTW, this step alone would take about one year)
- then you have to manufacture the semiconductor (actually, you probably need to build the fab first)
- then you can sell it (you hope that people really want it).

If you think this through, you will understand why therapeutics is different in many respects from all other industries.

Michael Martin · 2 years ago

Speaking of bridging the gap and translational research in the pharmaceutical area -- has Venture Beat ever covered what Paul Capital is doing with its Paul Royalty Fund?

Michael Martin · 2 years ago

Speaking of bridging the gap between basic science and commercialization -- has Venture Beat ever covered what Paul Capital is doing with the Paul Royalty Funds I and II?

Joey h. · 2 years ago

Another crucial and equally important issue facing new drugs is the deviation between IP protection and the realized protected time on market. Assuming a drug actually clears regulatory hurdles, it has to quickly recoup its invested money plus a healthy gain to foster new innovations. Better aligning the regulatory process with the patent process would motivate companies to not only develop new drugs, but commercialize known discoveries.

Mr. Gunn · 2 years ago

You know, if they were dumping money onto small biotech start-ups like they used to do in web tech back in the 90s, things might very well be different, but the main thing, as JENS, points out, is that the regulatory environment is so different, and rightly so.

I have first-hand experience in this, because I worked as a science advisor to a biotech startup(currently in stealth mode). The former company of the founder of this startup was a technology company, and the biggest adjustment they had to make was realizing how much of a difference the regulatory environment makes.

David Gong · 2 years ago

Maybe Andy is right: why shouldn't Pharmaceutical industry have a similar Mohr's Law? It's going to happen for sure. But before anything can be done, many of us have to dare to question existing assumptions and so called Rules of Law. Many of us might have heard story of Roger Bannister. Within ten years after he broke the four-minute-mile track-and-field record, 336 other runners had broken the four-minute-mile record as well. But before him,for hundreds of years, nobody ran a mile in less than four minutes. We have to break out from our mind barriers and begin to make impossible possible.

Greg · 2 years ago

Andy Grove is dead wrong. The real problem in the pharmaceutical industry is precisely what he claims is lacking today... time to money. The drive for profit is what causes these companies to concentrate entirely on treating the symptoms of a disease rather than forging further ahead to find a cure. In an environment where profit is paramount, if I can create a drug that a patient will need to use the rest of their life, why on earth would I want to continue further down the path to a drug that will elimiate that patient's need for my product. This paradox is why the pharmaceuticals is one of those rare industries that are completely broken when operating in a capitalistic system. Creating wat the customer, and society, ultimately need, works agains the interest of the creators.

Venu Madhav Dubagunta · 2 years ago

Since I work in semiconductor industry I can certainly see Dr.Grove's approach;however also agree with the differences that Mr.Hamilton pointed out.
To be able to scale up to the expectations set by Dr.Grove we need more collaboration between pharma companies and simulation and modeling Engineers to generate models that can mimic specimens.

Clinical trials are expensive and I am wondering if there is no machine based system that can replicate clinical specimens. Agreed that system building is expensive and time seeking but that's a challenge for computer scientists. And,if machine based system is not a good idea why not legislate more funding for tissue cell research that can probably replace clinical specimens?