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Transforming R&D

It was noted in your ­November/December Year in Preview ­article “Transforming R&D” that life-sciences companies are experiencing “the perfect storm.” I believe it’s more like a tsunami. Tsunamis are typically generated by a massive disturbance such as an earthquake, volcanic eruption, underwater explosion, or landslide, which then results in the displacement of an immense volume of water and energy. Life-sciences companies are still experiencing a series of “massive disturbances.” The economic crisis, globalization, new business models, the transition to personalized medicine, and healthcare reform are just a few. This is on top of internal challenges, such as chronic project slippage, declining success rates, and slashes in R&D expense and personnel. Now, life-sciences companies are experiencing the tsunami after-effect and have a proverbial flood of change coming across their organizations, as most are reinventing their business and operational strategies to set a course for profitable growth. I agree with the notion in the article that says executives understand the problems, but they have not diagnosed the problem. One item not mentioned in the article is that many companies are reacting to their tsunami by adopting the “latest” techniques to improve performance, like AcPOC and Lean Sigma. AcPOC is a practice that has been around for 30 years, yet it is being introduced as new. Also, it has been proven that Lean Sigma is applicable to only about 4% of a company’s processes. My view is that the new imperative for “R&D Transformation” is to create a new integrated framework to diagnose R&D productivity and truly identify the improvement levers, their priority, and the appropriate way these opportunities should be addressed. The key characteristics of a new R&D productivity diagnostic include the following: n Create the Right Frame to Prevent Strategic Myopia: Frame and isolate the problems and/or opportunities that should never be identified on just a “bottoms-up” or “tops-down” basis; create a portfolio of issues that must be addressed; prioritize the problems. n Select the Right Tool to Fix the Problems: Determine the correct tool to address the problem area. For example, Lean Sigma cannot fix and won’t uncover a bad contract or a bad business model. Also, select an improvement method that has the highest probability of gaining the right recommendation. n Comprehensiveness: Construct a comprehensive diagnostic across the whole life-sciences company, as 40% to 60% of the root causes in poor R&D productivity lie outside of the R&D domain. Layer-deep rigor, risk assessments, leading practices, insights from multiple perspectives, and so on from within the industry, as well as those outside of the industry, to inform the understanding of the challenge as well as the recommendations. n Durability: Understand the sustainability of the improvement option. Be aware of dynamic vs. static improvements. If a “patch” is required for a short-term problem, make an explicit decision that it is just a temporary fix, but longer-term solutions will be required to ensure sustainable performance improvement. n Timeliness: Achieve desired results in a timely manner, so recommendations are actionable. Rosemarie Truman Executive VP, Solutions Advanced Clinical { Ms. Truman can be reached at rtruman@advancedclinical.com. Do Not Track Legislation There was a lot of buzz in Washington, D.C., late December around the FTC’s proposal for “Do Not Track” legislation. If, and that is a big if, the proposal becomes legislation, it may have a significant impact on interactive marketing. The components of the proposal — from the FTC press release — are as follows: 1. Companies should “bake” certain privacy protections into their operations, like data security and accuracy (sometimes this is called Privacy By Design). They should collect and retain data only if they have a legitimate business need. We’re encouraged by companies that have created a culture of privacy protection; others should follow their lead. 2. Privacy choices should be presented to consumers — and in a simpler, more streamlined way. The most practical method would likely involve the placement of a persistent setting on the consumer’s browser, signaling the consumer’s choices about whether or not to be tracked. A “Do Not Track” browser setting would serve as an easy, one-stop shop for consumers to express their choices, rather than on a company-by-company or industry-by-industry basis. 3. We need to improve transparency. Privacy notices should be clearer, shorter, and more standardized, so people understand what’s happening with their information and who’s watching what they do online and off. The report proposes additional measures for promoting transparency. The current plan is for the FTC to accept public comment through January before finalizing the report. Of course the FTC proposal is not industry specific, though we expect any hearings will be colored by a complaint filed in early December by The Center for Digital Democracy, U.S. PIRG, Consumer Watchdog, and the World Privacy Forum asking the FTC to investigate unfair and deceptive advertising practices that consumers face as they seek health information and services online. The detailed 144-page filing identifies a number of interactive techniques that ostensibly pose threats to consumers, such as: n The practice of medical “condition targeting,” covering such illnesses as depression, COPD, diabetes, and asthma, based on a person’s use of online health information services and digital behaviors. n The eavesdropping on online discussions of health consumers via social media data mining, enabling pharmaceutical companies to hone marketing campaigns for drug brands. n The collection of data on a consumer’s actions related to health concerns via online profiling and behavioral tracking in order to target them for medical advertising. n The use of viral and so-­called word-­of-­mouth techniques online to drive interest in prescriptions, over-the-counter drugs, and health remedies. n The use of “unbranded” websites and video channels to promote connections to pharmaceutical brands, which are sponsored by drug companies. n The lack of clear separation between what is supposed to be editorial content and promotional material by sponsors and advertisers. n The influencing of subconscious perceptions via pharma-­focused “neuromarketing.” The complaint also asks the FTC to address the impact of “e-­detailing,” in which physicians, nurses, and other healthcare professionals are the target of highly focused digital marketing campaigns for specific drug brands and treatments. Among the companies named in the complaint are Google, Yahoo, Microsoft, AOL, WebMD, Quality Health, Everyday Health, and Health Central. We are consulting with key stakeholders, including Quality Health, Google, and others to determine the shape of the industry reaction both to the FTC proposal as well as the complaint and will keep you updated with any developments. Elizabeth Izard Apelles CEO Greater Than One Inc. The Future of Science A recent national survey shows large percentages of science teachers and parents strongly agree that demonstrating real-life applications in science (87% and 72%, respectively) can help make science education more interesting for U.S. students. Almost all science teachers (99%) and nine in 10 parents (90%) feel that science education is important, if not very important for a child’s future, but that it needs to be more engaging to capture the attention of children in America today (97% and 96%, respectively). The survey, conducted online by Harris Interactive on behalf of iBIO Institute and Astellas Pharma US, Inc. included a sample of 235 science teachers and 300 parents with school-age children in kindergarten through 12th grade. To spur student interest in science, the survey also shows science teachers and parents feel very strongly that using outside mentors (46% and 51%, respectively) and leveraging technology resources like the Internet (73%, 56%) can play an important role. Earlier this year Astellas launched Science WoRx, a mentoring program and online resource network designed to help science teachers inspire the next generation of scientists. Astellas is expanding its mentoring efforts through a program called the Virtual Science Pro. Through video lessons and online resources, such as Skype, teachers can bring a real-world scientist into their classrooms to work with students and conduct experiments that demonstrate the impact of science. The Virtual Science Pro can be found at youtube.com/AstellasUS or scienceworx.org. PharmaVOICE wants to know what other ­companies are doing to develop the next generation of scientists. { Send your responses to feedback@pharmavoice.com. And we will feature your ­company’s ­program in a future issue. Should the life-sciences industry do more to ­reinvigorate student ­interest in science education? Poll Yes / No / Maybe { Reply to feedback@pharmavoice.com with your response. PharmaVOICE would like to set the record straight, or rather photos straight. In our November/ December issue we inadvertently mixed up several photos of our thought leaders. Rob Vollkommer, Principal CSC’s Global Health Informatics ­Practice “Biopharmaceutical companies, now more than ever before, need to ­continuously demonstrate ­comparative effectiveness and ­safety throughout a product’s ­entire life cycle in real world ­conditions.” (Page 32, November/December 2010, “The Regulatory ­Environment”) Stephen Webb, President North America, Registrat-MAPI “Regulatory agencies are probably more than any time in recent history open to collaboration with ­manufacturers to perform better early life cycle planning, clinical ­development, and risk ­assessment.” (Page 32, November/December 2010, “The Regulatory ­Environment; and Page 64, “Healthcare Reform) John White, R.Ph., Director, MSL Programs The Medical Affairs Company “It is critical for companies to truly ­distinguish themselves from the ­current model providing a ­representative who exactly meets the providers’ needs.” (Page 58, November/December 2010, “The Sales Force of the Future) Our sincere apologies for mixing up these industry thought leaders and their companies and any ­inconvenience or confusion we may have caused. Pardon Us…

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