#1 Raise Life Expectancy
One of our specialties is helping companies raise capital for new drug discovery, to develop medical devices and to repurpose promising medical IP. A pharmaceutical startup business plan - or innovative medical device pitch deck - requires a very different approach to very different kinds of investors. Here’s how we go about it!
A pharmaceutical business plan, or an investment proposal for new medical device development are some of the most satisfying projects Unicorn works on.
They’re unashamedly trying to change a lot of people’s lives for the better by preventing illness, raising life expectancy and enhancing people’s quality of life
The investor relationships they foster are some of the most committed and longest lasting - they have to be!
When clinical trials are successful, and FDA approval is achieved the rewards for our clients are staggering - ‘blockbuster’ drugs achieve revenues of more than $1 Billion a year. That’s what most of our clients are trying to achieve
If unsuccessful, it’s not necessarily necessarily the end of the road for the business. Many highly regarded treatments are sold over the counter as supplements - there are major investors waiting to get involved in this too.
With great potential, comes great responsibility.
By the time a client first approaches us, they’ve usually completed successful preclinical stage. That means the drug has shown enough promise in non-human trials to justify the millions of dollars and many years it’ll take to get through Phase I and Phase II Clinical Trials and apply for FDA approval.
“Only 10% of the drugs that enter Phase I trials - the studies in which scientists evaluate dosing and basic safety in humans - ever make it to pharmacy shelves.
"The FDA typically requires more and larger clinical trials for drugs than it does for devices; it takes 12 years, on average, to bring a new drug to market, compared with three to seven years for a new medical device. The expense therefore tends to be much higher for drugs.”
- Emily Athnes - Bloomberg Business Week.
To gain FDA approval, new drugs and devices really have to work. In fact, they really have to work better than anything that’s come before. It makes a lot of sense - lives are on the line. It sets a high bar.
An investor needs to see the benefit of hanging in for a relatively long time… but also, they’ll ultimately need to be willing to let go - as will the development team. Once Phase I and Phase II Clinical Trials are successful, and FDA approval granted, it’s likely that the team that proved the drug’s effectiveness won’t have the ability to bring it to market in the best possible way.
Launching a new pharmaceutical drug or medical device is the work of skilled political operators with a global footprint, regulatory know-how and rock solid relationships spanning dozens of territories, legal jurisdictions and healthcare methodologies. It takes deep pockets and worldwide marketing experience. Long story short: it takes Big Pharma.
Interestingly, the big pharmaceutical companies have identified that their ability to overcome regulatory hurdles and bring new drugs to market is their core business. That means that they’re happy to leave new drug R&D to smaller, nimbler operations, then acquire them for a fortune once they’re successful.
Strategic partnerships have long been a major feature of the pharmaceutical industry. There’s a proliferation of arrangements with and between bio-pharmaceutical companies and academic research institutions involving in-licensing, out-licensing, joint research, and co-development.
“[Johnston & Johnston] says about half of its drug-development pipeline is from outside, versus about 20% in 2002. Six of its nine new drugs approved since 2011 come from outside.” Jonathan D. Rockoff Wall Street Journal
According to Vantage Partners’ recent alliance benchmarking study, over 80% of biopharma respondents report increased alliance activity compared to five years ago. Here’s an interesting LinkedIn blog about it by Andrii Buvailo
“Many branded drugs are moving off patent, and pharmaceutical companies are competing to bring new, patented drugs to the market. This activity has also included increased acquisition activity, as companies with branded drugs look to buy companies with a complementary pipeline as well as to license or acquire emerging technology or innovation techniques such as drug-delivery technology.” Kim Lawson - BCC Research
Your Pharmaceutical Startup Business Plan Should Have an Exit Plan
The process for new medical devices is the same, but different. Because devices are often used on humans for a much shorter period of time - think a heart monitor versus cardiac medications - there’s a slightly lower bar to approval, but a higher barrier to entry: Basically, you can’t even get permission to test a new medical device unless it demonstrates potential to be better than the best option currently available.
So if you want to introduce a CPR device to the market, before you can test it on humans it has to demonstrate laboratory non-inferiority to the current standard of care - in this case that's manual CPR.
The goal of a new medical device is to become the FDA-approved ‘standard of care’.
If your proprietary medical device becomes standard of care, it basically becomes required equipment for whoever needs to use it - hospitals, medical facilities and emergency medical services. As a standard of care device, NOT having it, if it were available, could constitute prima facie medical malpractice.
So with IP protection, regulatory approval and that kind of obligatory market penetration, competitors will have a very difficult time achieving regulatory or market approval for an alternative device - because your device becomes the control against which they have to demonstrate superiority.
So it’s a high stakes, high reward game. 90%+ of Phase I and Phase II Clinical Trials don’t deliver the results a company was hoping for. But don’t despair - it’s not over yet. That time, money and effort isn’t a total write-off. As long as your new drug or medical device can be demonstrated not to be harmful to humans, there could still be an serious investor, and serious rewards for you.
You know those vitamin and health supplements you can buy off the shelf? Those ones that have thousands of people swearing by them? They’re the drugs that didn’t make the FDA medical use grade. Of course, they made human grade - they’re not going to kill you, but they’re not proven to make you any better either. Not that you’ll hear that message from the marketing, or the anecdotal ‘evidence’ of legions of devoted users. These are the products that come into the complementary medicine sphere. Medicinal marijuana is one of them. For all the buzz (pun intended) no strain or delivery method of marijuana has received FDA approval as an effective medicine (not quite true...). That’s not to say we don’t think it can happen - my word, If you’ve got the cannabis-based drug that’s ready to be the first to nail its Phase I and Phase II Clinical Trials - get in touch! The point is that many people swear by the medicinal effects of cannabis. It’s led to law changes, and the development of a multibillion dollar industry. The lack of proven efficacy isn’t deterring investors.
Most office chair back supports and computer risers probably started life trying to become standard of care. If they did, they’d retail for $15K a pop. As it is, you can pick them up for $30 on Amazon. Their inventors are doing just fine.
Complementary medicine is a multibillion dollar industry. As long as your drug or medical device is not doing harm, someone will be able to demonstrate how it might do some good.
If you’re in the situation that you’ve got some interesting IP, or a drug or a device that blew out in clinical trials but has potential in the sphere of complementary medicine, we’ll help you revamp your pitch deck and get it in shape for a whole new kind of investor.
If you’re working on new drug development, or innovating a medical device, or trying to repurpose the best bits of an almost-ran - get in touch. We’ve been there, done that, and seen a lot of it before.
If you’re looking to present a compelling business plan or pitch deck, we’ll make sure that your investors aren’t wasting their time with you, and that you're not tripping over nickels to pick up pennies. We love helping our inspiring clients put their best foot forward.