Whats holding back biopharmaceutical research in the USA?

Wow what a week.. If you were a fly on my wall in my virtual science office you would be blown away. My email has seen it all, my phone conferences have been blistering. But I am about to join the dots – and please give me some leeway, I may have stumbled on to why biopharmaceutical research is in such sad shape in the USA. Its a combination of people, facilities and money.

So the names and affiliations have been totally removed to avoid any red faces. Here are the  observations from a week when I have spent 5 x 15 hr days writing grants, working on paper resubmissions and just generally trying to clear the backlog after a week at the ACS in San Diego. Here goes:

First off when you spend 2+ years working with terrific world class academic collaborators on a project which you are the PI, wrote some of the 2 NIH grants, wrote all the commercialization documents, general champion, wrote the first draft of the provisional…. Do not at any point expect an external set of patent lawyers to assume that you or any of the inventors are actual inventors.  But that is not all, they missed off the key researcher from the lab who did the biology… Do not expect the collaborating tech transfer office to even have any rational sense to disbelieve the said patent lawyers when they completely decide on an incomplete set of inventors. I am using the term loosely. A poor job was done and it took 3 months and at what cost. After many emails and one phone call things might get put right. No promises here because this legal team has no clue.

Second you collaborate over a year with another set of terrific collaborators, clinicians, with no lab space of their own. They have a brilliant idea to do drug discovery you help them find some new molecules that work on a horrific disease that affects millions. They unsuccessfully apply to their institute for seed funding. They then obtain funding from an outside foundation and do the in vitro work to show the idea works. Can they get internal support to file a provisional  ? Not a sure thing. We decide to write an STTR to put the molecules in animal models before going to the clinic..we need to have an internal champion, we need a lab, no support from the institute is provided. In fact they almost shut down our attempts to put the grant together. What next, do we remove them from the equation and just outsource? And here comes the rub.

Three, outsourcing preclinical animal models in the USA is not cheap. Outsourcing anything here either ends up in Europe or China and that’s a problem because NIH grants will not fund this work abroad. Doh. So if you do not have the facilities to do the work, e.g. a lab of your own, how on earth do you get the work done. If the institute of the collaborators’ does not support them with space while adding on a hefty overhead, what gives? You are stuck and that my friend is one of the many reasons why the innovators in biopharma will continue to struggle.

This reminds me of my interactions with a major University / hospital on the east coast. Again a long term collaboration with a bright young researcher who works tirelessly and is underappreciated by said university. I am fortunate to consult on a grant and get to invoice for my relatively small check. I have to wait six months for them to pay me. No apology. I was made to feel as though I should be happy I was paid at all. I am a self employed consultant. One year on, the second time I invoice I remind them how long it took the first time. Three months pass by after many reminders, no check. I decide to email the president of the University. Within 1 hr a senior finance figure calls and says a check is in the mail. It arrives in a day. Now if I really needed the money what would happen, I would still be waiting. This is a university with gazillions in federal funding which clearly is a sorry bureaucratic mess and just swimming in a massive amount of overhead. Scientists & research clinicians are losing out because the bean counters are running the show and doing so badly.

So whats needed? As a small company trying to translate some of the ideas you come up with alongside collaborators, call them inventions.. well its an uphill battle to just go beyond the idea, when you actually make progress you get slapped by some patent lawyer or tech transfer group, or you hit the administrators that want their favorite people as co-investigators on your grant “to ensure success”.  I would say quite honestly this smacks of corruption. An old boys network comes into play. I could not make this stuff up. HBO will be making a drama out of this next. Game of Biopharma.

I get to collaborate 24/7 and everywhere I see the same thing, it does not matter if its a big university or a small research institute. You can work with the scientists but ultimately they are being held back by the very fabric which should be giving them the support needed to make discoveries, to cure disease, to invent and to patent. Its sad to see for all the billions the NIH puts into these institutes, a great percentage is being thrown away.

The only ray of light I have seen in this is the fact that there are some very small foundations that are willing to give out $10K here or $30K there to researchers or clinicians with a great idea to help get it off the ground. We need more walk up or flexible lab space where scientists or clinicians can actually do experiments that could serve as a foundation for something bigger. Whats needed after that are US based CROs that can do the preclinical work well and at a fair price, and not ship it off to China. Beyond that there needs to be better ways that the NIH can directly fund the scientists without overhead  going to the bricks and morter- just ban it, let these administrators work to earn their money instead of riding on the backs of the fortunate grantees. There needs to be better help for patenting and generally translating and helping when an outside group comes in and is willing to write grants to fund the research. We should not be holding back the ideas, we should be testing them and making sure if they work they reach the patient.




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