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EXCLUSIVE LIFE SCIENCE FEATURE leaders LIFESCIENCELEADER.COM JUNE 2014 36 genuine. I never approached it as I just want to get something out of it. I've actu- ally struck up some beautiful friendships through the years of meetings. So that's part of the value add; it doesn't show up in a department, it doesn't show up on a balance sheet, but it pays dividends for the business." Another side of relationships for a growing company is staffing. At the top of Achar's list was a chief scientific offi- cer and a chief operating officer, along with heads of regulatory affairs and clin- ical development. "We are a lean organi- zation in the sense that we don't main- tain our own facilities with bench-level scientists; we contract with our CRO. But having the high-level oversight of those key areas was what we needed." Achar says Genzum is lucky to have a CSO who has 30 years of experience in Big Pharma and worked on more than 100 generic products, as well as a co- founder turned COO who is "extremely diligent, and scrappy when he needs to be." Achar also emphasizes the critical role of regulatory affairs, "because that determines everything from where we buy our material to what the clinical trial design looks like." EXECUTING THE MODEL IN SCALE-UP Relationships in business nat- urally lead to commitments to deliver as promised, which was the next, antic- ipated step in Genzum's construction. Once a topical generic is formulated, it goes straight into a Phase 3 trial to prove its equivalency to the original. "In some of our study designs, we're doing very direct, head-to-head comparisons," says Achar. "In our ophthalmic studies, to con- trol variability, we are dosing patients in one eye with the original drug, perform- ing surgery, extracting fluid, and a week later, we're doing the same procedure in the other eye, but dosing with our drug." The Phase 3 trials are large; accord- ing to Achar, the smallest has been 500 patients and the largest planned cur- rently will be 3,000. At the same time, because topicals tend to age faster than dry powders, the generic must demon- strate stability on the shelf for two years. Not many small companies can say they have accomplished that level of execu- tion within a few years of start-up. Achar believes more could, if they thought far enough ahead from the beginning. "There are a lot of start-ups that have one asset, maybe one partnership that they start on, and they just stay there. The difference for us is that we are a post- start-up company — scaling up followed after start-up. Proving ourselves, execut- ing on the model, establishing a track record to the point where companies now want to work with us on identifying the next set of products — that is the scale-up portion. That was a big change for us. And it hinged a lot on relationships, then going out and filling out the remaining portion." Whenever I finish a story full of lessons for up-and-coming life sciences compa- nies, I am always struck by the seeming obviousness of the principles illustrated therein. Yet, it is equally apparent that many if not most start-ups in this indus- try are stillborn, or nearly so, because of their science-driven but business- lacking agendas. Achar and his company Genzum highlight three basic business axioms that unfortunately seem lost on too many life sciences enterprises: Build a solid business model, form genuine relationships, and execute on the model with a well-planned scale-up. All other details aside, those are the essential tools of the art. L it was really a lesson that my father taught me, is that business, no matter what the industry, depends greatly on relationships. That was my skill, and I knew it was something I could build this business around. If I could put together all the pieces necessary to make a com- mercial partner interested in the prod- uct, then the rest of it would be relatively easy to go figure out. This is the art in building a business." Going at a business the other way around — focusing on the product dream and leaving the practical details for later — will hamstring the company's own development, in Achar's belief. "If you say, I want to do this product, let me go do it, and then try to figure out the rela- tionship with a partner, you risk every- thing," he says. "You work out of pocket; you don't even know whether there's a pathway to the market. Do the potential commercial partners even want it? Are there too many competitors already? "We started the business working from the market backwards — was there inter- est, who wants it, how much are they willing to pay for it? Knowing those three things, I understood the boundaries within which I had to operate. I had my budget for the rest of this go-figure-it-out portion. Go figure out who supplies the ingredients, whether we could develop it, or if not, who else could do it, the size and cost of the clinical studies, the raw materials, and so on. You put all of that together and a large portion is then focus- ing on execution." Most of Achar's current networking is with the portfolio teams and the execu- tive management of the potential part- nering companies. "Once we actually figure out the partnership details, then we work down to their commercial ops and their regulatory, technical, and R&D.; Understanding what they want — the decision process and steps on their end — is a huge component, so I can prepare and serve up what they need to push an opportunity internally." When Achar reached the point of nar- rowing and focusing his networking encounters, the results added up, but not only in quantity of business deals, he says. "All the relations that I have are A POST-GENESIS STORY – GENZUM PLIES THE ART & SCIENCE OF SCALING UP By W. Koberstein C H R I S A C H A R CEO of Genzum We started the business working from the market backwards — was there inter est, who wants it, how much are they willing to pay for it? 0 6 1 4 _ F e a t u r e _ G e n z u m . i n d d 4 0614_Feature_Genzum.indd 4 5 / 2 1 / 2 0 1 4 1 : 1 9 : 5 6 P M 5/21/2014 1:19:56 PM