menu

QuintilesIMS Blog

Fresh ideas and insights from our experts around the globe

distribution
Brazilians flock to pharmacies: How healthcare companies can bolster sales by embracing this shifting shopper trend
Rachel McCorkle
Enrollment planning is always a challenging aspect of a clinical trial, but, for acute conditions, like COPD exacerbations, acute thrombosis, or the flu, the challenge of recruitment planning is even more difficult. One of the biggest challenges in recruiting patients for these trials is connecting with them at the right point in their care to make them relevant candidates for the research. There is a narrow window for enrollment, and acute care patients enter the healthcare systems at a variety of touch points making it difficult to catch them at exactly the right moment in their care journey. If researchers can’t figure out when and where to engage with these patients, they will miss opportunities to recruit them into their trials. In my DIA presentation this year, I shared a number...
Read More
Ianriches
The success of healthcare outcomes largely depends upon patients’ adherence to medical treatment. While non-adherence can put the patient at risk of unnecessary further health complications such as relapse or hospitalization, it can also carry a significant economic burden. With the healthcare system facing mounting financial pressure, biopharma must demonstrate its commitment to improving adherence for supporting the local health economy.  While local pathways are vital to the success of healthcare outcomes, the patient also has a role to play in improving adherence. Physicians can support the patient by assessing their knowledge and understanding of the regimen, creating clear communication channels, and developing trust. Collaboration is key to helping patients make positive choices...
Read More
Brad Smith
Immunotherapy is one of the most promising avenues of research in the battle against cancer. This treatment path uses small molecules and biologics to harness a patient’s own immune system to fight the tumor – a novel approach that is poised to revolutionize cancer treatment. This promise has been a long time coming. Scientists in the cancer research world have been working on immunotherapy treatments for decades, since the first observations were made about how important the immune system is in modulating and potentially killing cancer. These early realizations where made nearly a century ago, and we are only now beginning to harness the immune system in cancer therapies. Although there is no conclusive evidence that immunotherapy will be a “magic bullet” for all cancer indications...
Read More
Helena Zhang
Over the past decade, China has demonstrated that it has the potential be a major player in global marketplace. But it is still facing some obstacles that must be addressed, and soon. As healthcare expenditure rises and disease burden increases, status of the local drug development ecosystem makes it difficult for Chinese companies to compete on a global scale. Even though a number of Chinese companies are pursuing innovative drug development, capabilities in the local talent pool are still weak due to lack of medical teams familiar with overall clinical development strategy in the country. This  increases drug lag and adds risk to the clinical development process, which ultimately hampers launch of new drugs to market. Recent data shows that Category 1 applications (drug not yet...
Read More
Q&A with Simon Denegri: How to Engage Patients in Clinical Research
Simon Denegri is the National Director for Patients and the Public at the National Institute for Health Research (NIHR) , and Chair of INVOLVE – the national advisory group for the promotion and support of public involvement in research funded by NIHR. In honor of International Clinical Trials Day, Mr. Denegri met with Quintiles to discuss his work with NIHR, and his efforts to raise awareness of clinical research among patient populations with its ‘OK to ask’ campaign.  Q: Why is it so important to talk to patients about clinical research opportunities?   People usually become interested in participating in clinical trials when they are first diagnosed, but they don’t know how or where to look for opportunities. Nor has our current healthcare system been very good at...
Read More
Judith Beach
Quintiles recently provided input to the U.S. Food and Drug Administration regarding the issue of patient engagement in drug development.  The FDA requested comments as part of their ongoing efforts to ‘develop and implement strategies to solicit patient perspectives during the medical product development process and in regulatory discussions‘, as directed by the Section 1137 of the 2012 FDA Safety and Innovation Act (FDASIA). We were excited to share our thoughts on this important topic. Engaging patient feedback in the drug development process has long been a priority for Quintiles, and we have derived extensive insight from the more than 100,000 successful trial designs and 110 product launches we’ve supported. Working with experts from multiple perspectives, we made the following...
Read More
Nigel Rulewski
March 6, 2015 was a landmark day for the biosimilar manufacturers. It is the day that U.S. Food and Drug Administration (FDA) approved a biosimilar version of filgrastim, making it the first biosimilar product to enter the U.S. market. The approval was no great surprise. An abbreviated licensure pathway for biosimilars approval in the U.S. was established in 2010 as part of the Affordable Care Act, and filgrastim offered an attractive package of attributes making it a prime candidate for FDA’s first step into this new product category. A biosimilar version of filgrastim has been on the European market for years, and the makers can provide hundreds of thousands of days of patient outcomes data, post approval, which provides FDA with deep assurances around its safety and efficacy. I...
Read More
Kimberly Robasky
If your employer is interested in identifying new biomarkers for oncology and immunology therapies, you should be investigating HLA-typing of new and legacy data. There is considerable insight to be gained from these exciting new research opportunities. Human Leukocyte Antigen (HLA) typing has long been a standard tool for tissue matching in transplant medicine, however the HLA region also has significant applications for oncology biomarkers, disease association and pharmacogenomics. And with the recent advent of next-generation sequencing technology and advances in statistical phasing, there are now multiple, cost-effective options to HLA-type individuals in addition to the current “gold standard” technology of “Sequence-Based Typing”, or SBT. Some of these innovations are also...
Read More
Karen Knecht
U.S. hospitals and physicians have made significant progress in adopting electronic health record (EHR) technology since the inception of the federal EHR incentive program . According to the Robert Wood Johnson Foundation, at least 58.9% of all hospitals and almost 50% of all physicians had a basic EHR in 2013. As the broad range of disciplines in the provider community continue to become more engaged with HER technology, progress has been made not only in collecting data and automating workflows, but we’ve also seen the EHR data help enable some early decision support functions such as concomitant medication checking and drug-allergy checking as well. However, as indicated by this report as well as by other industry analysts, there is much more work to be done. To date, there...
Read More
Helena Zhang
China’s recent surge in higher income families, its growing aging population and steady growth in biopharmaceutical sales suggest significant market potential in the future. The current landscape for biopharmaceutical development in China is certainly emerging, but challenges remain. It creates opportunities for local biopharmaceutical companies to establish dominance in the global marketplace if they can overcome several hurdles such as early phase development, regulatory oversight, biomarker driven studies and clinical trial data quality. This has been a difficult journey. In the past, Chinese biopharmaceutical industry has suffered under the perception that they are better at following than innovating, which has limited their impact on global research and their ability to bring new...
Read More