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QuintilesIMS Blog

Fresh ideas and insights from our experts around the globe

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Brazilians flock to pharmacies: How healthcare companies can bolster sales by embracing this shifting shopper trend
PeterLassoff
When I first started working in regulatory affairs a few decades ago, nothing mattered but the science – or so we believed. If the submission was written on onion-skin paper with a fountain pen that was fine as long as the benefit-risk ratio was shown to be positive and every point of the proposed label was well defended. We focused exclusively on the science and ensured that we had the right combination of expertise on the team to make the best decisions. It was a balancing act of ex-agency personnel and industry veterans who together could achieve ‘win-win’ negotiation with agencies, most of whom were in Europe, the US and Japan -- other regions were still considered ‘export’ markets at that time. Over the years, this approach to regulatory affairs hasn’t changed too much. Science...
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PaulSutton
We have talked before about the importance of outcomes audits as part of an integrated market access strategy . Outcomes audits give biopharma highly detailed insight into how a care pathway for a specific patient population is functioning in the real world, and we believe that along with simulation modeling, health informatics and specialist market access services, outcomes audits are an essential tool for biopharma. By combining centralized analysis of national data sets with hugely detailed local data, information can inform an action plan that can help identify and bridge gaps in a pathway, discover where stronger messaging needs to reach clinicians, and where adherence could be improved by providing additional patient support. What makes outcomes audits so powerful is that...
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Michael Klein
Conducting clinical research in Africa can be fraught with risk. From overcoming basic infrastructure obstacles and finding reliable talent, to addressing personal safety issues for your team, these projects require an entirely different level of management and oversight. But Africa also offers tremendous opportunities for biopharmaceutical companies interested in doing research into a wide range of prevalent and neglected diseases, including Malaria, HIV, Tuberculosis and sickle cell anemia. Over the last eight years, global funding for neglected diseases has grown substantially, reaching $3.165 billion in 2012, and much of this research is being done in Africa.  Biopharma companies who want to participate in these philanthropic endeavors need to overcome their fears about working...
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Michael Klein
Conducting clinical research in Africa can be fraught with risk. From overcoming basic infrastructure obstacles and finding reliable talent, to addressing personal safety issues for your team, these projects require an entirely different level of management and oversight. But Africa also offers tremendous opportunities for biopharmaceutical companies interested in doing research into a wide range of prevalent and neglected diseases, including Malaria, HIV, Tuberculosis and sickle cell anemia. Over the last eight years, global funding for neglected diseases has grown substantially, reaching $3.165 billion in 2012, and much of this research is being done in Africa.  Biopharma companies who want to participate in these philanthropic endeavors need to overcome their fears about...
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KellyMcKee
The ongoing Ebola crisis has become one of the greatest public health challenges of modern time. Thousands of people are dead, communities are devastated, families have been torn apart, and national economies and healthcare systems brought to their knees. It has also been a powerful catalyst for the healthcare industry, causing competitors to set aside their differences and join forces, working together create a vaccine with the potential to save millions of lives and putting a stop to this devastating epidemic. While media coverage has focused (quite rightly) on the human toll of Ebola, biopharma companies, regulators and global health organizations have been collaborating in the background to rapidly develop, test, and validate vaccines and anti-viral drugs that will combat the Ebola...
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CynthiaJackson
Although there is no question that pediatric clinical trials are essential to demonstrating the safety and efficacy of treatments for children, conducting these can be frustratingly difficult. They are especially challenging to recruit for, in part because researchers have had little insight into what motivates parents to enroll their children in trials – until now. At the recent American Academy of Pediatrics National Conference , we presented the results of a survey of US parents and caregivers to understand what influences their willingness to enroll their children in clinical trials. The results suggest that our assumptions may need to change: 73% of parents say they are interested in having their child participate in an appropriate clinical trial – yet 96% of them say they have...
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Nathalie Horowicz-Mehler
Even when biopharmaceutical teams engage with payers early and often through the development process, payers may still balk at the projected price of a new treatment especially if cheaper options are on the market or if the target population is large. That can be the death knell for an innovative asset. But there is a solution. If payers won’t embrace your pricing strategy, consider risk-sharing as a way to get them on board. When agreement cannot be reached on price or on the reimbursement terms, risk-sharing agreements allow less restrictive access in exchange for the manufacturer bearing incrementally greater financial risk, thus ensuring the asset is prescribed and used. Some examples of risk sharing models include: Outcomes-based risk-sharing: These agreements...
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RickSax
If you want quality outcomes from a clinical trial program, you have to focus on quality goals when you design the program. That is the essence of Quality by Design (QbD) principles. Yet the biopharmaceutical industry hasn’t invested enough time or thought into building that level of quality into their design process.  Part of the problem is that teams tend to be formed on the basis of technical or therapeutic expertise, not on the basis of well-honed design skills. Furthermore, teams tend not to be incentivized to foster open approaches to design or to use structured design methodologies that lead to high quality and performance.  Following a QbD approach, can help solve this problem.   The biopharma manufacturing industry has used QbD principles for decades – making the efficient...
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Aggressive Transparency, Data Privacy and the Opt-in Movement
In the era of big data, the most effective organizations are seeking ways to combine disparate data sets to generate new insights. This should be the goal of every biopharmaceutical company today. By linking clinical trial data with electronic health records and other data sets we can inform social and clinical research and generate innovative solutions that could lead to new treatments and marketable products that will improve outcomes for patients around the world. But the industry must be cautious, particularly in the way we use patient information. Data privacy is a major issue for patients and other industry stakeholders, and the idea of linking databases for biopharma research makes many groups skittish. Research shows that in general people don’t mind having their data...
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Michael Klein
Conducting research into neglected tropical diseases can be a tough sell for biopharmaceutical companies. The investments are significant, the risks are great, and the payoff is primarily philanthropic. But the need is clear. One billion people are affected by neglected tropical diseases worldwide, and each year neglected diseases disproportionately kill or disable millions of poor people primarily in tropical and subtropical areas of the world. For many biopharma companies, addressing these deadly diseases has become a core goal of their philanthropic efforts. But even with unwavering executive commitment, the many obstacles these companies face managing research in the most remote parts of the world can feel insurmountable. Though it doesn’t have to be. The key to approaching...
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