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Decisions made in Phase II trials can have an impact on the development and marketing program for new products, and experts say Phase II is becoming a critical stage for planning the potential launch and marketing of products. Bringing agencies in earlier in the process makes a lot of sense, says Abby Mansfield, senior VP and creative director at Topin & Associates. “We’re often brought in to the process at the end of Phase III to begin strategy, positioning, and branding work,” she says. “Even at the end of Phase II, market research targeting prescribers can uncover issues the brand team may not be aware of, allowing enough time to either address them in Phase III trials or at least know how to work with them once the brand comes to market.” Brand strategy and positioning work can begin during Phase III,” Ms. Mansfield says. “This is a time-consuming process that often gets rushed when backed up against an assumed approval date,” she says. “The investment in agency resources at this point doesn’t have to be huge, just enough to get the right partner on board, up to speed, and working on the elements critical to a successful launch.” One key issue is that companies don’t have a commercial operation or resources on board early enough to be able to help guide the clinical process, says Ken Ribotsky, president and CEO of The Core Nation. “Millions of dollars can be wasted if a developer does not thoroughly understand what the market requires as proof of concept,” he says. “Another concern is that advisory boards are being relied upon too heavily. These healthcare professionals are often not in sync with the reality of a practice and interactions with patients. They have become far too accustomed to saying what some developers may want to hear as opposed to what they need to hear.” Chris Garabedian, president and CEO of AVI BioPharma, says a large part of formulating the commercialization process is understanding the market and the key prescribers and influences that treat the particular disease a product is targeting, as well as the patient community and advocacy groups that have a vested interest in the success of the program. “This feedback and understanding of what will be most important to a given disease community will help guide the advanced development of the program, while shaping the most relevant and salient clinical data and outcomes that are meaningful to the various stakeholders in the market,” he says. “It is always a balance to invest heavily with an assumption of success and risking a lot of dollars on a program that may fail vs. waiting until absolutely sure that the product will be on a path to NDA filing and approval.” Mr. Garabedian adds that the more a development-stage product creates high expectations, the harder it may be for a company to withstand a failed program from a public relations or investor relations perspective. “A failed study will have a bigger impact on a company if it has been touted as a breakthrough, high-potential product before a sufficient dataset is available,” Mr. Garabedian says. Jennifer Brice, life-sciences global program manager at Frost & Sullivan, says the industry can start educating patients, physicians, and stakeholders about the disease and drug class/mechanism of action, as long as there is no brand marketing. “This can be done at conferences via brochures, TV/magazine ads, social media, etc.,” she says. “Advantages are that when the drug comes to the market, patients will have a better understanding of the disease and how to treat it. The disadvantages could include the risk of wasting marketing efforts/money if the drug fails during clinical trials and does not reach the market.” Pharmaceutical companies are beginning to consider this in some areas, according to research done by Best Practices. For example, about 89% of surveyed companies start engaging diabetes thought leaders and key investigators in clinical trial protocol development at Phase II or before, with the largest response groups signaling Phase II as the kickoff to most thought leader services. Engaging thought leaders and key investigators in clinical trial protocol development is rated by 94% of companies as one of the most important thought leader education activities. Ms. Mansfield says technology keeps evolving, which can be challenging as well. “The keys are flexibility and depth,” she says. “Pharma marketing has always been multichannel to some degree, and creative teams are accustomed to thinking about how ideas live beyond a print ad. The other aspect is depth. Pharma marketing is evidence driven, so it inherently has a level of depth other categories don’t. But now, creative teams have to understand how to adapt ideas much more dramatically than in the past — from print to Web to iPad to newsletter. With all the added communication vehicles, campaigns have to be deep enough to generate enough content to keep all these channels full. And that takes a pretty big idea.” Creating the Message in Phase II Trials Experts say the industry needs to start looking at the commercialization process for a compound when a product is still in Phase II clinical trials. Companies outsourced 63% of their Phase II clinical budgets in 2011, up from 36% in 2008. Source: Cutting Edge Information Phil Birch is Corporate Brand Manager, Aptiv Solutions, a full-service international CRO that supports global clinical trials for biopharmaceutical and medical-device companies. For more information, visit aptivsolutions.com. “The efficiency of Phase II trials can be enhanced by the use of adaptive design approaches. The opportunities at Phase II are significant where different adaptive approaches can provide better information on dose, endpoint, and patient sub-population (enrichment). In addition, it is possible to combine Phase II and Phase III studies into seamless trials. Enrichment designs offer a significant step forward in the identification of patient sub-groups that respond more effectively to the drug treatment under evaluation. This has significant implications for the design of confirmatory Phase III trials, for health technology assessment, and ultimately for pricing and reimbursement. The key to success is the use of an integrated technology platform and specific processes that enable adaptive design trials to be implemented and executed in a manner that does not undermine trial validity and integrity.” Joel Scherer, M.D., is Managing Director, Chorus, Eli Lilly and Company; Chorus is a small, multidisciplinary drug development group within Lilly that conducts early-stage development work using a virtual model. For more information, visit lilly.com. “An efficient Phase II clinical study starts with a robust Phase I approach. Phase II technical probability of success is the single biggest productivity lever in pharmaceutical R&D, while Phase I cost and cycle time are not. Creating a more robust Phase I proof-of-mechanism (POM) package may modestly increase Phase I cost and time, but is a wise investment. In defining an appropriate, focused Phase II/proof-of-concept study, one size does not fit all. Where there is limited ability to demonstrate POM in Phase I, or target validation is low, a smaller Phase IIa/POC with reduced statistical power or limited dose-ranging may be warranted. For assets that have strong clinical validation or deliver successful Phase I/POM data, a more robust Phase II/POC study including dose ranging may be preferred. In a learn-to-POC approach, some chemical development and manufacturing work, biopharmaceutical and chronic toxicology studies are deferred. An efficient approach to avoid delays for potentially promising assets is to stage and trigger these as buy-up options based on successfully passing the POM hurdle and based on interim analyses in the POC trial. It’s important to recognize that not all targets and indications are suitable for a learn-to-POC approach. Promising molecules with high levels of biological and clinical validation, molecules advancing in very competitive spaces, and molecules strongly aligned to an existing commercial strategy typically should be advanced in a fast-to-market, traditional model with full parallel processing.” Best Practices for Phase II Efficiency Abby Mansfield n Topin “At the end of Phase II, market research targeting prescribers can uncover issues the brand team may not be aware of, allowing enough time to address in Phase III trials or once the brand comes to market. ” Chris Garabedian n AVI BioPharma “A large part of formulating the commercialization process is understanding the market, the key prescribers, and the influences that treat the particular disease being targeted.” Ken Ribotsky n The Core Nation “Millions of dollars can be wasted if a developer does not thoroughly understand what the market requires as proof of concept.” Experts Jennifer Brice. Life Sciences Global Program Manager, Frost & Sullivan, which provides research and best-practice models to drive the generation, evaluation, and implementation of growth strategies. For more information, visit frost.com. Chris Garabedian. President and CEO, AVI BioPharma Inc., which is focused on the discovery and development of novel RNA-based therapeutics for rare and infectious diseases, as well as other select disease targets. For more information, visit avibio.com. Abby Mansfield. Senior VP, Creative Director, Topin & Associates Inc., a healthcare marketing agency that specializes in strategic marketing for healthcare, medical, and pharmaceutical clients. For more information, visit topin.com. Ken Ribotsky. President and CEO, The Core Nation, a family of healthcare marketing and medical communications companies (Core-Create, Brandkarma, and Alpha & Omega) that offers strategic, branding, and creative consulting services. For more information, visit thecorenation.com.