Trio’s lead compound TML-2 is the acetyl prodrug of TML-1, a novel, well tolerated G-protein coupled receptor antagonist which shows clinical promise but has limited bioavailability owing to low solubility. Trio turned to Catalent for help.
At the early stages of product development, pharmaceutical development scientists are under increasing time pressure to select the right molecule form, the right formulation and the right final dose form.
When it comes to dealing with and interacting with the FDA, attitude plays an important part in ensuring the agency is on your side. How do you do this?
The patent cliff and a reducing drug pipeline are the two biggest challenges faced by innovator companies today. With the expiry of blockbuster drugs and early entry of generics, the pharmaceutical industry has lost about $157 billion in sales between 2010 and 2015. This is hampering the industry’s ability to fund drug development programs. Until about two decades ago, most drugs had an effective patent life of about 17 years, but changes to regulatory requirements and challenges by generic companies has resulted in only about 7 to 11 years of market exclusivity for innovators’ drugs.
Until about 30 years ago, “process R&D” in the pharmaceutical market meant just making a chemical process scalable. Most of the brightest chemists chose to spend their time “discovering” molecules rather than studying how to make them on scale, both efficiently and safely. Adequate attention was not paid to critical aspects of scale-up like safety, waste management, or energy efficiency. The pharmaceutical industry even justified their methods by hypothesizing that the benefit of the end product (life-saving medicines) far outweighed the concerns over the amount of waste that was generated. As a result, the pharmaceutical industry became one of the worst-performing sectors in terms of waste produced per unit of product made. Over the years, the pharma industry has recognized the need to change and develop more efficient processes. Thus a new field of chemistry called process research was born.
In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progression of stages ranging from drug discovery, product development, clinical trials to full-scale commercialization or it is the transfer between development and commercialization at different sites within or outside an organization.
Ozonolysis is a widely used reaction in organic synthesis. The reaction was invented by Christian Friedrich Schoenbein in 1840. Alkenes and alkynes are the most common substrates for the ozonolysis reaction. Ozonolysis was an important diagnostic tool for the determination of the position of unsaturation in unknown molecules before the invention and development of spectroscopic techniques for identification and characterization of organic molecules. The reaction was used for structure elucidation work because it provided chemists with smaller and more readily identifiable carbonyl compounds.
Biotech firms often have tight timelines to prove the concept of their NCE. As a result, modern clinical development pathway requires rapid manufacturing of the “first Kilo”.
The $330 bn global sterile market is expected to reach $525 bn by 2020, growing at a CAGR of 11% -with North America contributing 48% while APAC is expected to record highest CAGR of 13%.
In January, UC San Francisco announced a research alliance with AbbVie, Amgen, and BMS supporting the collection and analysis of at least 500 tumor samples from more than 10 different forms of cancer to ultimately improve patients’ responses to cancer immunotherapy.
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