Life Science Leader Magazine

NOV 2014

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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27 LIFESCIENCELEADER.COM NOVEMBER 2014 market-driven paradigm that held sway for so long in the industry. "We now have the freedom to discover on the basis of science, which makes it possible to make surprising new discover- ies rather than the ones we wished and expected to discover. You have to build new medicines from what is scientifically credible, rather than go where you see simply a big market. Of course, the sci- entific line must be linked to a vision of patient need, but if you are completely focused on the market from day one, you close things down — and if you start by aiming at where you see the biggest dol- lar sign, you will end up in a weird place scientifically and medically." THE TRACK OF CHANGES As the mechanics of GSK's R&D; reorgani- zation continued to evolve, all the related efforts conformed to the two key prin- ciples employed by the DPUs, according to Vallance — personal accountability and openness to external collaboration. Both principles were reflected in progressive structural changes. " We had to reintroduce personal accountability and individual leadership so that we didn't end up with everything being a total team effort and nobody really taking accountability for projects," he says. Personal accountability called for smaller, integrated teams. It was not always as painless as it sounds. Teams that underperformed were cut, with their funds, and often their personnel shifted to new teams. Some long-term people pros- pered; others found themselves demoted or worse. With the startup of the DPUs, the com- pany eliminated some therapeutic areas in R&D;, such as some late-stage neurosci- ence work, and reportedly made around 3,000 R&D-related; job cuts worldwide. Besides respiratory, the company's largest market area, GSK's current pharmaceuti- cal pipeline lists candidates in oncology, respiratory, cardiovascular/metabolic, immuno-inflammation, infectious dis- eases, ophthalmology, neuroscience, and various rare diseases. DPUs are also sub- ject to periodic pruning. In 2012, following a review of all DPUs, the company cut LYNN MARKS: ACCELERATING GSK'S R&D; INNOVATION Reporting to Patrick Vallance, GSK's head of phar- ma R&D;, Lynn Marks is a senior vice-president in charge of a group called Projects Clinical Platforms and Sciences (PCPS). His group's responsibilities cover the conduct of all of the Pharma R&D; Phase 1 through Phase 4 clinical trials, with rare excep- tions. PCPS has a staff in more than 40 countries and is one of the company's "platform" organi- zations. In addition to clinical trial operations, its functions include business IT support pro- vided by a PCPS subgroup, Business Planning and Performance. In parallel to PCPS, a closely related nonclinical platform group covers clinical trials drug formulation and supply. Marks also sponsors the company's "Simplifying Clinical Development Change Initiative" and is corporate secretary for TransCelerate Biopharma, the trans-company col- laboration to improve efficiency and productivity in clinical development. "All of the companies in this industry realized five to 10 years ago that they were spending way too much money for the deliverables of a new medicine launched into the world," says Marks. "All the change initiatives that companies did — we called ours Simplifying Clinical Development — was to look at ways to reduce costs, increase quality, boost efficiency, and simplify the pro- cesses across clinical development. So we put our program in place about five years ago, and we have tracked the magnitude of savings and moni- tor the quality of our trials." Having accomplished its mission, with projected savings of "hundreds of millions of pounds across that time frame," the initiative comes to an end later this year. But Marks says initiatives such as Simplifying Clinical Development also helped spark the thinking that led Global R&D; Chief Moncef Slaoui, along with Patrick Vallance and other industry R&D; leaders, to begin building what turned out to be TransCelerate Biopharma — and attract 18 other, mainly midsize and large pharma companies into the not-for-profit collaboration to date. Marks worked with R&D; executives from other companies to get TransCelerate up and run- ning, initially chaired the operations committee, and now serves as secretary of the organization. "Dr. Slaoui was very keen on the idea that we could work in collaboration in a precompetitive way on how to increase quality, decrease costs, and increase efficiency in the clinical develop- ment space. So I was brought in very early in those conversations in regard to how my organi- zation could participate," he says. One area TransCelerate took on was data stan- dards, with CDISC, a dictionary of terms associ- ated with therapeutic standards that all member companies use when they report their infor- mation into regulatory agencies. The member companies have since put additional resources into CDISC to accelerate the development of therapeutic standards, according to Vallance. "Our goal was '55 in Five,' or introducing 55 new therapeutic area standards in five years. We didn't want to re-create something that was already in place but rather get our resources aligned and make clinical development move faster and more efficiently." The obvious and oft-asked question about TransCelerate is why collaborate with a set of companies that are otherwise competitors in the industry? Marks describes the dynamics of collaboration. "We are fiercely competitive, and we have to be ever-conscious of anti-trust issues, so we make sure we're clear of all that by having active involvement from our colleagues in Legal. We look for areas where we want to advance something and believe, as a group, if we work together, we can actually advance it faster. Good clinical practice training was one example in which we could make the lives of our investigators around the world simpler. We decided to train them with an agreed set of fundamentals on good clinical practices, which each of us would have done independently and redundantly in the past." TransCelerate is also working to build an electronic portal through which all 19 companies would communicate with investigators globally. Comparator drugs for clinical research is another area the group took on — to the surprise of doubters, Marks adds. "In the old world, if we wanted to run a clinical trial using another company's marketed product, we would often go through a third party that would buy it in various countries and ship it to us. Now we have multiple agreements among companies to buy directly from each other, so we know the pedi- gree and the characteristics of the product and can ensure a high-quality, reliable source of the clinical trial material. I am particularly proud of the team for this because many people thought we couldn't do it." This industry "League of Nations" gives new meaning to the popular term "partnering." No longer is a partner just a license holder or trusted supplier; now the term may apply to a lengthening list of collaborations, including the "precompetitive" tide that lifts all boats. "The space of where we can go is only lim- ited by our imagination and our appetite for precompetitive collaboration as an industry," Marks says. As an infectious disease special- ist, he sees antibacterials as a key example that such cooperation can have a big impact. "It is one of those areas in which we will have to call on the collective leadership of govern- ment, academia, and industry, and we will have to break down the barriers across com- panies to improve our response to the growing threat of antimicrobial resistance. How can we advance that kind of collaboration across the industry collectively?"

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