In 2019, only 1.2 percent of global clinical studies included India, even though the country is estimated to bear 20 percent of the global disease burden. One reason for the slow growth of clinical research in India has been its...
Expertise: Consulting 225 results
Technology transfer is a critical step in any drug development program, occurring for various reasons and at different development stages. A sponsor may be looking for a contract development and manufacturing organization (CDMO) for clinical trial manufacturing; to transfer a...
Emerging biopharma companies play a big role in overall drug development—the percentage of new therapies both originated and launched by these companies has increased over the last decade, in an industry that is growing at the same time. As drivers...
Preparing to meet with the FDA can be challenging and stressful for sponsors, especially when they do not know what to expect. Many have misunderstandings about how meetings should be conducted and what constitutes success. Others find themselves needing to...
This is the second installment in a four-part blog series highlighting FDA designations for products with rare disease indications: orphan drug designation (ODD), rare pediatric disease designation (RPDD), and humanitarian use device (HUD) designation. Part 1 compared these designations, and in...
Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug...
Comparing Orphan Drug, Rare Pediatric Disease, and Humanitarian Use Device Designations The FDA offers sponsors a variety of special programs to incentivize development of therapies to treat unmet patient needs, including fast track, breakthrough therapy, and qualified infectious disease product designations. This blog...
In the first half of 2020, as a direct consequence of the ongoing pandemic, China issued a ban on the export of non-human primates (NHPs), including those used for pharmaceutical research. As this affected COVID-19 research, the NIH later issued a Notice of...
Most people know someone who uses an inhaler to prevent or relieve shortness of breath after exertion or during allergy season. Medicine has been delivered by inhalation for decades to treat human respiratory diseases such as asthma, chronic obstructive pulmonary...
You’ve determined that you need to perform juvenile animal toxicity studies as part of your nonclinical program. The next step is understanding why these studies are required and how they should be designed. Why are juvenile nonclinical studies needed? Drug...