Ed Price
Earlier this year the news that big pharma was raising the price of more than 1,000 drugs created outrage nationwide.
Caitlin Bancroft, JD
The Premarket Notification (510(k)) pathway for medical device approval presents challenges for device manufacturers, FDA reviewers, and patients.
Bikash Chatterjee
One of the inevitable consequences of political change is disruption to the global economic engine. Disruption can result from political instability, regulation, or even innovation. Now, from the portent of the coming Brexit storm, to the enactment of major provisions of the Drug Quality Security Act (DSCA), to the promise of blockchain and artificial intelligence (AI), the requirements for modern supply chain management are in evolution, as are the efforts underway to safeguard supply chain integrity.
Mike Greene
In the era of increased automation, a yawning gap often exists in the training cycle for standard line manufacturing production operators, who often find themselves caught in a “neither here nor there” loop of skills accruement that leaves them familiar yet not wholly proficient. This disconnect can be remedied through integrating continuous improvement tools into equipment training agendas.
Brad Sanderson
Research suggests that 20% of oncology trials do not recruit enough participants. Data also suggests that only three percent of patients with cancer participate in clinical trials. Considering the stats, it’s clear that there is significant work to be done to improve accessibility to clinical trials for cancer patients.
Charlie Johnson
The scale of patient demand has fuelled an overarching healthcare market need to expand the drug development pipeline to generate more biologics to treat multiple diseases and innovative new biopharmaceuticals to further enhance the treatment of cancer. The effectiveness of antibody drug conjugates (ADC) and checkpoint inhibitors in combating cancer is having a massive impact on the ADC R&D market; additionally, new and exciting uses of antibody drug conjugates are also being actively researched. Data analysis by Beacon Targeted Therapies highlights this significant ADC market trend.
Becky Griffiths
In recent years, the pharmaceutical industry has seen tremendous changes in the way it is expected to deliver new drugs to market: being under increasing pressure to expedite the development of new therapies, to decrease clinical study duration, and to drive new treatments through their clinical phases as quickly, safely and cost efficiently as possible.
Narine Baririan, PharmD
One of the major challenges when undertaking a first-in-human (FIH) clinical trial is how to appropriately plan and analyze the pharmacokinetics (PK) of a new drug. Although PK assessment in the earliest stages of clinical development provides valuable dosing recommendations for further development, only limited recommendations are available in the European Medicines Agency and US FDA guidelines, or in scientific publications, about how to view the statistical analysis and interpretation of PK data and results.
Jin Seon Park
Biologics have unique developmental challenges on their pathway to becoming a commercial product. Today’s biologics are developed utilizing a wide variety of modalities, including antibodies, peptides, enzymes, fusion proteins, antibody-drug conjugates, gene therapies and cellular therapies (e.g. CAR-Ts). While this breadth of modalities has opened up biologic development to new possibilities, it has also required innovation to overcome developmental hurdles. In biologics development, one of the most promising innovations is engineered micro- or nano-particle technology.
Many issues that the pharmaceutical drug development industry face not only affect oral solid dose manufacturing and one of the constant challenges is the scalability of new molecules emerging from the drug development pipeline.
This quarterly review on New Drug Applications contain data for applications approved for the first time during the first quarter of 2019, which includes New Molecular Entities (NMEs) and new biologics.