Drug Development vs Making a Drug

How does a small company move from drug discovery to drug development? The answer is in partnering with people who know what to do. A handful of PHds from MIT who start up a biotech company based on some clever cloning vector do not have the proper experience to begin developing upstream and downstream processes that can be scaled to a GMP facility. They must seek help. This is difficult for any PHd.

What is happening to biotechnology today is similar to what happened during the dot com era. Initially people were very excited and money was not hard to find. After too many empty promises the money has dried up. Investors are looking for more advanced programs. In biotech that means they want a drug in phase II or III. In order to get there you have to have a drug to put into people. How do you do that? Biotech start ups only know how to get to the drug discovery phase. After this they must either outsource or learn new skills. The former is more desirable.

Big Pharma wants the little guys technology. Like the zillions of little companies that went out of business in the last 20 years, big pharma has also had a tough time discovering new drugs. They must look outside of their organization. They look to people who most often have never actually made a drug, small biotechs. They don't know the rules and there are lots of them. Still, big pharma and biotech partner up and roll the dice.

One group that doesn't gamble in this process are the contract manufacturing organizations. They accept the job, develop the methods and produce the drug. No further research will be required.

Does biotech understand the bottleneck of manufacturing? Do they understand clinical trials? That is another story. Once again, we clump the companies into a population. Some are better than others. Some are great at science but horrible at engineering issues. But go to a biotech company website and seek out the information that touts their ability to perform necessary routine development work. It's just not sexy. Without that expertise however, they won't even know who to call to get help. If you want money, you have to get smarter. There is now a new question start ups must answer besides "do you have a drug"? "Can you make it"?