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LIFESCIENCELEADER.COM MARCH 2015 29 Integrity, Service & Dedication Ash Stevens has over 50 years of experience developing, registering and manufacturing Active Pharmaceutical Ingredients (APIs) for clients of all sizes, from Large Pharma to virtual startups. At our state-of-the-art cGMP facility in Michigan, we provide batch sizes from grams to hundreds of kilograms, including highly potent APIs (HPAPIs). We have a very successful track record moving projects forward to commercialization, achieving customer satisfaction through high quality science, regulatory excellence, safety and integrity. Call our team +1 734 282 3370 www.ashstevens.com Another hurdle Cubist learned to over- come was the typical, relatively slow ramp-up of sales for new antibiotics. "Despite investors anxious for the next quarter's earnings, we had patience and stayed the course," Gilman says. "With hard work and good products, you make the appropriate return, and shareholders will ultimately be satisfied. Sometimes it comes quickly, and sometimes it doesn't. But our science is about patients and patience — the actual patients, who are treated with our drugs; and patience, the persistence and perseverance it takes to develop our drugs. Our focus on science, patients, and patience has helped us build a now 20-year-old company." Gilman sees the work of Cubist as trail- blazing for companies, large or small, traversing the field with a new generation of antibiotics. "The whole industry has benefited, not only because of our success as a company acquired by another company, which generates a certain amount of buzz in the industry. We have spent a lot of time and effort working very closely with the FDA to create new policies and guidances that have streamlined some antiquated regulation, so now all compa- nies' ability to develop antibiotics going forward is clearer and more defined." He notes Cubist's active role in contributing to the GAIN (Generating Antibiotic Incentives Now) Act of 2012, which offers incentives to stimulate overall industry growth in new antibiotics R&D.; LOOKING OUT Contrary to the stereotype of a life sciences start-up lacking a sophisticated business team and inwardly focused only on its technology or product, Cubist needed to be outwardly focused only on its therapeutic area from the beginning, if it were to have any chance of being successful in the antibiotics space. Besides reaching out to the regulators, the company took time looking at the actual medical needs in the practice arena — not only of patients and practitioners, but also payers, key opinion leaders, and policy- makers. Similarly, as Cubist settles into its new subsidiary status, Gilman sees shared challenges for Merck and other new- antibiotics developers. The first set is scientific. "Only two novel classes of antibiotics have been discovered, both of which are represented in our portfolio: daptomycin is a lipopeptide, and tedizolid phosphate [Sivextro] is an oxazolidinone. We are trying to find