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Exclusive Life Science Feature LEAD BY EXAMPLE treatment alternatives, including the To become a successful spokesperson AIDS community." As a result, Celgene or industry advocate, Hugin believes leadership was willing to take the risk you have to speak from experience of bringing back THALOMID and develand lead by example — something oping next-generation therapies with which Celgene has most certainly been improved features and greater clinical doing. The company has been recogbenefit — a challenging endeavor requirnized as one of the most innovative in ing multiple collaborations between the world by Forbes. A recent entrant the FDA, patient advocacy groups, and into the Fortune 500, Celgene's excepinsurance payers. Facing this unique tional stock performance over the past situation forced Celgene to ask the 10 years, +1,778%, is the envy of following types of questions of its many of its peers. Some experts are leadership team that ultimately led predicting Celgene to be the bestto the evolution of a more innovative performing biotech in 2013. Hugin environment. attributes Celgene's success to a posi• How do we create a mindset to look tive policy environment, collaborations at things in creative ways? with multiple constituencies, and an • What can we do to challenge the conBob Hugin, Chairman and CEO, Celgene internal company culture he describes ventional wisdom internally? as entrepreneurial, challenging, and • How can we work in areas that are innovative. It's those success stories and industry credibility that going to make transformational change for patients and he's bringing to his new spokesperson role as chairman of the change the way science and medicine are practiced? Pharmaceutical Research and Manufacturers of America (PhRMA), • How can we revolutionize processes so that we are looka position he assumes in April, replacing Eli Lilly's John Lechleiter. ing to do things in a way that has the highest probability But Hugin can't do it alone. He is looking to all stakeholders to of creating great outcomes and doing things that have the step up as spokespersons for medical innovation to spread the most efficiency? message — a healthy U.S. medical innovation R&D; engine is an • What are we doing to focus on operational excellence interintegral component of a healthy U.S. economy. nally so that every dollar saved can be put back into creating more opportunities? CREATE A CHALLENGING • How can we improve access to drugs for patients? ENVIRONMENT WITHIN YOUR ORGANIZATION • Are we really committing our resources to advance science When it comes to touting the importance of a healthy pharmaand medicine? ceutical R&D; industry, Hugin suggests you first look at your own Having a more innovative and challenging environment at company. For instance, do you have a challenging environment Celgene improved R&D; productivity. For example, Hugin notes internally geared toward innovation? For Celgene, the process of that the company has nearly halved the time it takes from discovcreating an entrepreneurial, challenging, and innovative environery, when a development candidate is first identified, to entering ment all began with getting the FDA to allow the company to clinical trials. Since FDA approval of THALOMID in July 1998 for bring back a drug that had been withdrawn from the market over treatment of erythema nodosum leprosum (a severe and debili50 years ago. tating condition associated with leprosy), Celgene has not only When Celgene's REVLIMID (lenalidomide) first received FDA gained approval of REVLIMID worldwide, which had sales of $3.77 approval in 2005 as a viable treatment for blood cancer, it was no billion in 2012, but also recently won regulatory approval for use small feat. That's because the drug is a derivative of THALOMID in China. A next-generation oral immunomodulatory therapy, (thalidomide), which was withdrawn from the market in 1962 after POMALYST (pomalidomide), was approved by the FDA in February being linked to birth defects. Given the tragic history associated for the treatment of relapsed or refractory multiple myeloma in the with this drug, the decision to try to launch a new drug derived U.S. It is important to note that survival rates for patients with mulfrom it certainly created a challenging environment at Celgene. tiple myeloma have soared to well over 50% as a result of the introMany might think that the politically correct thing to do would duction of novel therapies including REVLIMID and POMALYST. In have been to not even try. But would that have been the right addition, REVLIMID is up for FDA priority review for a new use in thing to do? According to Hugin, "The drug had positive attributes patients with mantle-cell lymphoma with an expected decision in which were beginning to be understood by people who had no June. One of the keys to Celgene's success has been its commit- "Generics are invented by branded innovative companies. They aren't invented by generic companies." 26 LifeScienceLeader.com April 2013