What keeps a drug development company busy?
By Pekka Simula 23 Mar 2016
Herantis develops three distinct drug candidates for the treatment of several diseases. Our team is 7-person strong, which means roughly two persons per drug candidate. Now I’ve been told this is ridiculous for two reasons. One: “Even a company with two drug candidates needs a team of at least 50 people!” Two: “Your CRO does all the work. What do you need 7 people for?”
I’m sure those comments are valid in some scenarios! Let me elaborate on what keeps our team of 7 busy.
Two of our drug candidates, CDNF and Lymfactin®, are advanced biologicals, each based on leading science in their fields, aiming to be first-in-class drugs. This means there are simply no subcontractors who know anything about them. How to manufacture them in sufficient quantity and quality for human use? How to characterize the manufactured substances, to prove to authorities that it is functional, free of any impurities, and safe? What’s their shelf life? How and in which models to test the substance to justify a safe dosing window, route of administration, frequency of dosing? How to optimize those for efficacy? How to eventually design an optimal clinical study based on all we know about the underlying science?
Behind each question there are countless new questions. And with an innovative drug candidate even regulatory guidelines can fall short. You may need to discuss with head-scratching authorities and negotiate your way through regulations, which didn’t think about something so advanced. Safety of the patients always remains the #1 priority.
This all keeps our 6 very smart experts extremely busy – sometimes even I get to help with some simple paperwork. Our team is a great match of medical, scientific, regulatory, and manufacturing expertise in drug development. Sure we also outsource a great deal of work to CROs! That’s just not automatic. First we need to decide what to do. Then we need to identify the best group in the world capable of doing that – options are often few. We’ll audit them and educate them. Then, in close collaboration, they’ll do the work for us. And this all continues through clinical development: We learn, the authorities learn, regulations change, development continues.
Of course we could at times do with extra hands. We’re trying to be smart and use temporary help as appropriate. With our excellent network of partners we definitely don’t need a team of 50 for the time being. Anyway, I’m proud to say that it takes a superb team to run clinical development of novel, innovative drug candidates by average two employees per compound.
On top of all that there are of course many tasks related to business development, financials, public company’s administration etc. Trust me, they are a piece of cake compared to development of novel first-in-class drugs.
Herantis intends to start patient treatments in a clinical study with Lymfactin® in breast cancer associated lymphedema in H1/2016. This will be the first time in the world when repair of the human lymphatic system is attempted by gene therapy. Lymfactin® is based on research at a national centre of excellence at the University of Helsinki, lead by professor Kari Alitalo.