Getting Male Birth Control To Market
Our mission is to get new male contraceptives to market. Specifically, we’re talking about reversible, non-hormonal methods that act during later stage sperm development. This pickiness sidesteps avoidable side effects and makes for a birth control method that works much faster.
So how do we get male contraceptives to market? The first step is getting them far enough along in clinical development.
Typically, funding sources appear more readily once research gets to human clinical trials. So you’re aware, there are three phases of these human clinical trials before a drug is eligible for FDA application. After that, it can go to market. Even then, just 10% of drugs, on average, make it from Phase I to market. But pharma companies and investors are fine stepping in here around Phase I. That’s because they expect to make back much more than ten times their investment should there be a success. Hence, it’s financially wise for them to step in.
But before a drug like a contraceptive makes it to a Phase I human clinical trial, there’s some early work that needs to be done. And that work is riskier. In fact, it’s so risky, this phase is called the “valley of death”.
This “valley of death” phase involves a lot of preclinical work. After discovering a candidate molecule, you do a process called high throughput screening. This is a high volume screening process to make sure that you wind up with a drug that is highly selective. That is, the drug only does what you want it to do.
In this phase you have some other parts as well. You test for toxicity, make sure your drug is absorbable by the body, and assure that the drug lasts long enough and is potent enough to be practical. If any of these doesn’t work out, then you either have to backtrack or give up. Investors and large pharma companies have stayed out of this “valley of death” for male contraceptive research. And that’s why we’ve focused on this area.
The nice part about this “valley of death” stage is that — depending on how far along the research is — it only costs a mere millions of dollars to get it to the next phase. Compare that to the higher costs that pharma companies and investors take on once human clinical trials start. This “mere millions” doesn’t count the cost of adding in all the failures.
This is expensive, and so it’s important to make good decisions on what to fund. The way MCI works to maximize our odds of success is by having the best experts in the world review our male contraceptive research proposals.
How do we fund all this?
We fund this work through very generous donors who recognize the importance and impact of getting a new male contraceptive to market. A donor’s concern could be human welfare, educational prospects, gender equity, or even issues related to population. In any case, adding a new male birth control method has a high impact. To the degree that we can fund worthwhile research (or shift others’ funding in the right direction), the more likely we can have a male contraceptive reach the market sooner.
So what do these chances look like?
Imagine that each time we get a promising male contraceptive past the “valley of death” and to human clinical trials that we get a chip. We’ll say for simplicity that each chip gives a 10% chance of getting a male contraceptive to market. You can imagine this chip as just like one you’d see in a Plinko game in The Price Is Right. That’s the one where you try to get the chip to randomly fall in the right slot. We can’t guarantee that our chip will turn out to be a winner, but each chip has a certain chance. If we can move enough candidates to Phase I human clinical trials, then we increase the chance that at least one of those male contraceptives will get to market.
In the meantime, we’ll keep working to get the attention of contraceptive research teams and counting on generous large donors for support. To the degree that we can fund and identify promising research successfully, the more likely the world will get its new — and long-overdue — male birth control method.
Originally published at www.malecontraceptive.org on September 1, 2017.
