At PAREXEL, we frequently get asked questions about protocol optimization – what it is, how it works, and trends in…
PAREXEL helps position emerging Biopharmaceutical companies by providing them with advice and capabilities. We provide them with advice regarding clinical research strategies, regulatory strategies, as well as expedited approval pathways, to give a few examples.
In terms of capabilities, we provide them with all capabilities required to successfully complete a clinical study, and this includes everything from clinical, regulatory, technology, logistics and a large number of additional capabilities.
Biopharmaceutical companies will remain one of the major sources of innovation also in the future. For the large global pharmaceutical companies, this means that they will continue to partner and heavily invest in these clients to be able to acquire some or all of that innovation. From the perspective of a venture capital investor, this presents a very attractive opportunity. It includes risk, but the upside of getting - on having funded an approved drug on the market is enormous.
When a global pharmaceutical company or an investor is evaluating a biotech company they are typically looking for innovation, IP, and quality. In terms of innovation, the company needs to have novel science, typically around a new disease target. IP is the ability to protect this innovation with patents, and quality involves both quality of the science as well as the quality of the execution of the clinical studies that, if successful, lead to drug approval.
The investing trends we are seeing on the current Biopharm landscape include an increasing emphasis on oncology, which has been the largest area for the last 10 years. We are also seeing a lot of investment interest in autoimmune diseases. We are seeing targeted therapies, that is, pursuing sub-populations of larger disease areas such as cardiovascular disease being an additional area of interest, and finally a lot of interest in novel devices, either for drug delivery such as inhalation devices, as well as devices that are attributed to better patience adherence, i.e., that the patient is actually taking the drugs they are supposed to take.
The BioPharm unit is a business unit that is fully dedicated to collaboration with small to medium size companies. Our…
Bringing a medicinal product to market is a lengthy and expensive process associated with high risks and narrow time…
BioPharm Business Trends
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Regulatory and Market Access
Roland Andersson, SVP, CRS, on how PAREXEL benefits emerging biopharmaceuticals.