It is striking just how much the past year has dramatically changed our lives. Today we casually talk about our life experiences as ‘pre-COVID’ or ‘post-COVID’. Mass availability of multiple, effective vaccines against the SARS-CoV-2 novel coronavirus (COVID-19) has been met with both excitement and trepidation. For many, it has brought about a general sense of relief that we are finally one step closer to a return to normalcy after an undeserved and rather abrupt disruption to our lives.
Quality has always been the cornerstone of safe and effective drug products and therapies. Yet, this year in light of the pandemic, the focus on quality against a backdrop of warp-speed vaccine delivery, has been put into overdrive. Pharmaceutical manufacturers recognize that the only way to keep quality on track, proactively mitigate risk and deliver breakthrough drugs in a post-COVID-world is to require a unified quality management approach.
Biopharma executives have leveraged technology to navigate the global pandemic: using it to collaborate on research and development, to conduct clinical trials virtually and reconfigure supply chains. They’ve leveraged science to enable multiple COVID-19 vaccines to be developed in record time despite the remote working environment.
Naturally, safety event reporting and pharmacovigilance (PV) should be subject to detailed regulatory scrutiny as evidenced from the Food and Drug Administration (FDA) overseeing the protection of human subjects and improving trial conduct by ensuring appropriate safety procedures are in place. It's critical that the right information reach the right constituents for reporting adverse events in a clinical trial.
Pfizer conducted the first randomized virtual clinical trial under an investigational new drug application in 2011.1 Introducing inventive protocol modifications, the Pfizer trial shipped all study drugs to the patients’ homes, required no in-person visits, and data was collected via cell phone and web-based technology.
Cell and gene therapies promise life-changing outcomes for patients facing debilitating and rare diseases. Immunotherapies and stem cell treatments have given new hope to cancer patients, while gene therapies have the potential to cure by targeting the root cause of disease.
A clinical trial's path from initial study design to execution and completion is long, arduous, and often riddled with obstacles. Patients experience emotional, financial, and logistical burdens, negatively affecting patient recruitment and retention rates.
The use of dry powder formulations for administering drugs to the lungs has long been a strategy for the treatment of respiratory diseases such as asthma and chronic obstructive pulmonary disorder (COPD). Delivering the active drug via a dry powder inhaler (DPI) allows patients to breathe the medicine directly into the lungs quickly, allowing rapid, systemic delivery of the drug to the bloodstream.
“Patient centricity” has long been a guiding principle of clinical trial design and conduct, and it has become even more critical in the COVID era as trial sponsors and regulatory authorities have had to adapt to a continually shifting landscape. Pandemic-related restrictions have prompted substantial changes in how clinical trials are developed and implemented, requiring sponsors to comply with new guidance and processes designed to promote speed and efficiency while remaining mindful of patient safety.
The International Council for Harmonisation (ICH) establishes industry-wide standards for clinical trials - and those standards are undergoing a complete rewrite, affecting the ways trial data is monitored, analyzed, and de-risked. These changes are being developed both at the behest of and with extensive input from a wide range of industry insiders; and they are explicitly aimed at helping eliminate complexity, enabling sponsors and researchers to take advantage of exciting new technologies and the innovative trial designs they make possible. Yet, changing standards will inevitably require changing processes and procedures to meet those standards; it will pay to be prepared.
We are seeing a growing demand of CBD-based therapies and treatments for a wide range of illnesses and diseases globally. According to a Transparency Market Research report in 2020, the CBD market was valued at US$1.4bn and expected to grow at a CAGR of ~21% from 2020-2030 to ~US$11.3bn.
We are now into our second year of dealing with the impact of the COVID-19 pandemic and there are several questions on our mind such as, how is the COVID-19 crisis influencing pharma supply chains for the future? Is the global pharma supply chain under sustained threat? And what has been the impact of moving manufacturing to Asia and its resulting dominance in the supply chain? These are all valid questions considering recent and current events across the world as we have managed through the worst of this pandemic.
Advanced therapies - including gene-, cell-, and tissue-based products - offer groundbreaking new opportunities for the treatment of disease. As of the end of 2020, there were 1,085 active developers of these therapies and 152 ongoing Phase 3 trials worldwide. According to the Alliance for Regenerative Medicine, regulatory decisions are expected on a record eight new advanced therapy products in 2021
This quarterly review of New Drug Applications (NDAs) contains data for applications approved during the second quarter of 2021. A total of 36 applications were approved by FDA during these three months. Interestingly, only six NDAs (16.7%) were approved in the month of April and 12 and 18 NDAs in the months of May and June 2021, respectively.
As human beings I think we have evolved (well, most of us) to a state where we have gotten used to (or at least tolerate) many things in our lives. We have gotten used to the changing seasons – and even embrace them. We tolerate lines at movie theaters, concerts, etc. (at least we did pre-COVID).
At Pfizer CentreOne we aspire to be the CDMO partner of choice. Over the last several years our team has been working to expand our development services offerings so we can truly be an end-to-end CDMO, from development through to commercial manufacture.
As the world continues to adapt to the changes required to minimize the spread of COVID-19, scientists around the globe are working to develop both vaccines and antiviral drugs. With new strains of the SARS-CoV-2 virus emerging, it may only be a matter of time until vaccine-resistant strains surface. Therefore, it is likely that we will need both approaches to successfully combat this disease and overcome the pandemic.