Do I really need to detail how the last 12 months have changed our lives?
Ed Price
The API manufacturing business can be a risky one – especially when dealing with chemical substances that will be consumed by humans. But it’s not only potent drugs that create risk for API manufacturers. Risk also can come from project delays or problems in the lab or plant that can derail projects and their timelines and result in cost over-runs.
Rossana Della Ventura
The ways of working across the globe continue to change. Emerging markets are starting to flourish and play a more significant role in global economics and there are growing demands for more localized control, rather than taking direction from more centralized, global influences.
Amos Dor
Digitalization of the pharmaceutical industry has been underway for some time, with many companies looking to benefit from the Pharma 4.0 evolution using experience gained from the automotive and electronics/semiconductor industries. Integrated data solutions and digital tools combined with the use of inline sensors, process automation, advanced analytics, and model predictive control help to optimize production processes for higher quality and yields.
Mahesh Veerina
With 25 named storms, 2020 is currently the second most active Atlantic hurricane season on record, causing considerable damage to the nation’s supply chains.
John Price
Pharmacovigilance (PV) automation could be achieving so much more, according to the findings of research involving pharmaceutical organizations in the UK and US. The sector’s use of technology to capture adverse event data is immature and automation strategies are still very much stuck at first base. Dr John Price, life sciences regulatory and safety consultant and advisor to Arriello, digs deeper into the findings. He discovers the extent to which life science companies are failing to maximize the opportunities for automation – and highlights the next steps necessary for more sophisticated and effective automation.
Yourway is a single-source packaging and supply chain partner that offers a full range of services including primary and secondary clinical packaging, temperature-controlled logistics, and storage and distribution services for the global pharmaceutical and biotech industries.
Rafik H. Bishara, Ph.D., Chuck Forsaith, Henry Moran
In recent years, global pharmaceutical supply chains have increased in complexity and scrutinization, due to the involvement of many players with new guidance, regulation and compendial requirements. For example, compliance with the European Good Distribution Practice (GDP) of Medicinal Products for Human Use guidelines will ensure control of the distribution chain and consequently maintain the quality and integrity of the medicinal product as it is being handled by many different players.
Ed Ikeguchi
As with the rest of the world, clinical trial sponsors and those that help facilitate trials have experienced unprecedented change over the last year as a result of the COVID-19 pandemic. At the beginning of the pandemic, when social distancing mandates were widespread and at their most strict, the industry was faced with many questions around the ability to continue studies or start new studies in an environment where patients’ ability to visit clinical trial sites was greatly reduced if not wholly eliminated.
As the COVID-19 pandemic continues to rattle economic markets it is becoming apparent that the pharmaceutical industry’s overreliance on APIs coming from China is turning into a major supply chain issue.
Gary Hutchinson, Daniel J. Littlefield
The race for safe, efficacious COVID-19 vaccines is on, with an estimated 66 vaccine candidates in the clinical trial phase and many more in the
preclinical drug development phase worldwide.
The field of cell and gene therapy (CGT) is rapidly developing, with the number of therapies in development greatly increasing over the last five years. The application of CGT provides the promise of significant long-term health benefits to people suffering from a wide range of diseases, from ophthalmological disorders to cancer.
Adam Lohr
As another wave of the COVID-19 pandemic surges across the globe, patients are flooding into hospitals, economies are returning to lockdown and supply chains again face restrictions. This second wave has renewed fears of drug and medical device shortages, and given new life to conversations in the United States about national security and overreliance on manufacturing in other countries.
Karen Ooms
The COVID-19 pandemic is an unparalleled global event that caught all businesses off-guard. This is especially prevalent in the pharmaceutical industry as on-going clinical trials are disrupted due to lockdown measures and social distancing requirements. In many existing trials, subjects simply cannot get to site, visits are being missed, data are not being recorded and clinical monitoring is challenged as Clinical Research Associates (CRAs) experience travel restrictions.
Jon Bardsley
In past decades, innovation in biotherapeutics has led to significant advances in the biopharmaceutical industry. These medicines are similar in structure to molecules produced naturally in the human body and can seek out highly specific targets in their treatment of disease. As a result, they hold promise in treating a range of acute and chronic conditions.
Neelam Sharma, MS,, Hemant N. Joshi, Ph.D., MBA
This quarterly review on New Drug Applications (NDAs) contains data for applications approved for the first-time during July-September 2020, which includes New Molecular Entities (NMEs) and new biologics. A total of 36 applications were approved by the FDA during these three months.