About a week before Christmas 1996 I got the flu. A few days later my wife got the flu.
Jean-Noel David
Audits are a fact of life in drug development. And, as drug developers increasingly outsource manufacturing, it’s important that the raw materials used in their final products are monitored to ensure that they are safe, effective, free of excessive impurities and sourced from quality suppliers. But while Contract Development & Manufacturing Organizations (CDMOs) are usually responsible for auditing raw material suppliers, it’s the sponsor’s job to audit the CDMO.
Scott Connor
No one needs to be reminded of how COVID-19 has changed our world, and what it has cost us all. Moments with friends and family. Job stability, especially for small businesses and restaurants. Anxiety, isolation, and mental health. A nearly impossible challenge for teachers, students, and parents. And far, far too many lives.
Andrew Lees, PhD, Libo Wang, PhD
Conjugate vaccines are developed by linking molecules that are poorly immunogenic to a carrier protein to improve immunogenicity. They can be highly effective, as exemplified by the Haemophilus Influenzae b (Hib) and Prevnar 13® (which prevents infections from pneumococcal bacteria) vaccines, both of which are conjugates. However, conjugate vaccines are complex to formulate and costly, with very few carrier proteins licensed for use.
Kristin Mauri
Without clear-cut evidence that clinical trial results are reliable – and that treatments are both safe and effective - billions of dollars and years of hard work are rendered moot. Yet as trials grow in complexity, acquiring unequivocal proof becomes equally complex. Risk-Based Monitoring (RBM) grounded in Risk-Based Quality Management (RBQM) can streamline the process. Using these strategies, researchers proactively incorporate quality into study design rather than retroactively, and painstakingly, monitoring results.
Priyanka Gupta
Among the many lessons learned during the COVID-19 pandemic is the need for large biopharma companies to be able to pivot quickly to meet emerging threats and demand for novel products. While this redirection typically costs time and money, there is significant room for efficiency if the right tools are in place. Many of these fall under the umbrella of Process Intensification (PI). While PI may not be the right decision for every company, we aim to provide some of the key considerations to determine if this is the right approach for you.
For the past few years, sponsors and CROs have moved steadily towards decentralized clinical trials. These shifts apply new approaches and technologies to clinical trials with the goal of reducing or eliminating the need for subjects to physically visit clinical research sites.
Bernard Vrijens, PhD
Non-adherence to medication in general medical practice is a long-standing problem, and its impact on health outcomes has been well documented.
David Williams, Dominic Hyde
As we eagerly begin 2021 and prepare this year’s cold chain industry predictions, we reflect on the events of 2020. Nowhere leading into the year did we predict a global pandemic. Yet its impact crosses all facets of business, causing companies to pivot and adapt. Some were able to harness new opportunities to serve our ever-changing way of life and others struggle to stay the course.
Andreas Eschbach
As biopharma companies race to develop drugs and vaccines at “pandemic speed,” quality control strategies and shift-to-shift communications must keep pace. It is all about managing people, processes, and technology. With the increasing number and complexity of drug products – including biologics, sterile injectables, cell therapies and vaccines, it has become evident that pharmaceutical and biotech companies are experiencing extraordinary challenges arising from disruption in supply chains and the need to change business processes to accommodate social distancing, remote working, and quarantining.
Torkel Gren
The drug market has changed a lot over the last 10 years, particularly when it comes to the way medication is administered to either overcome challenges related to the drug substance or enhance useability and make it easier and more pleasant for patients to use. But what about the future? What does the next decade have in store for drug dosage forms?
Mark White
Gene therapies have the potential to bring about the greatest change in medicine since the advent of antibiotics. In 2017, the US Food and Drug Administration approved a gene therapy for the first time, an adeno-associated vector (AAV)-mediated gene replacement therapy that returns sight to those affected by biallelic RPE65 mutation-associated retinal dystrophy.
Neelam Sharma, MS,, Hemant N. Joshi, Ph.D., MBA
This quarterly review on New Drug Applications contain data for applications approved during the fourth quarter of 2020, which includes New Molecular Entities (NMEs), new biologics, etc.