Lessons Learned from the COVID-19 Pandemic and its Impact on Bioanalysis and Drug Development

Abstract

The COVID-19 pandemic challenged pharmaceutical and bioanalytical communities at large, in the development of vaccines and therapeutics as well as supporting ongoing drug development efforts. Existing processes were challenged to manage loss of staffing at facilities along with added workloads for COVID related study support including conducting preclinical testing, initiating clinical trials, conducting bioanalysis and interactions with regulatory agencies, all in an ultra-rapid timeframes. A key factor of success was creative rethinking of processes and removing barriers – some of which hitherto had been considered immovable. This article describes how bioanalysis was crippled at the onset of the pandemic but how innovative and highly collaborative efforts across teams within and outside of both pharma, bioanalytical labs and regulatory agencies worked together remarkably well.

Synthetic Approaches to the New Drugs Approved During 2021

“…Imeglimin hydrochloride (23), discovered by Poxel and co-developed with Sumitomo Dainippon Pharma Co., was approved for use in Japan as a key treatment for T2D. 216 Imeglimin is the first approved tetrahydrotriazine-containing class of oral antidiabetic agents known as the glimins.…”

“…20,21 As the severity of the pandemic may be waning (with great credit to the heroic vaccine development efforts), questions have been raised about how the pandemic experience may impact the future of drug development, in which a higher degree of collaboration, a greater extent of data sharing, improved patient access, as well as accelerated avenues for regulatory review and approval may accelerate development of drugs for patients in need. 22,23 Despite the challenges that the COVID-19 pandemic brought to the pharmaceutical industry and to many facets of life, the approval of 33 small-molecule drugs and 2 antibody−drug conjugates (ADCs) for the treatment of diseases is a significant accomplishment and attests to the continued importance of synthetic chemistry in the field. As in previous years, the drugs presented in this review will be categorized into treatment for diseases in 11 therapeutic areas: anti-infective, cardiovascular, central nervous system, genetic, inflammatory and immunologic, metabolic, oncology, and reproductive system (Figure 1).…”

“…This year’s review features 35 NCEs that were approved during 2021, including two treatments for coronavirus disease 2019 (COVID-19) (nirmatrelvir and molnupiravir) that were advanced through development in record time to respond to the global pandemic and urgent need for medical treatment. , As the severity of the pandemic may be waning (with great credit to the heroic vaccine development efforts), questions have been raised about how the pandemic experience may impact the future of drug development, in which a higher degree of collaboration, a greater extent of data sharing, improved patient access, as well as accelerated avenues for regulatory review and approval may accelerate development of drugs for patients in need. , …”

Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and Implementation

“…With limited options for outpatient pharmacokinetic (PK) sample collections, a PK dataset in patients can be supplemented by self‐collection because venous blood collection could only be performed around the site visit when patients were either on‐site to receive the investigational product or to fulfill other required study monitoring activities. To enrich the PK dataset, an option for patient self‐collection using microvolumetric capillary blood collection device (e.g., Tasso‐M20) at home during the week‐long treatment provided a valuable alternative 4,5 …”

“…To enrich the PK dataset, an option for patient self-collection using microvolumetric capillary blood collection device (e.g., Tasso-M20) at home during the week-long treatment provided a valuable alternative. 4,5 Compared with traditional venous collection by a phlebotomist at clinical site, self-collection or caregiver-assisted collection methods using capillary blood at-home offers convenience, flexibility, and decreases trial burden for patients. 6 There are multiple at-home PK-sampling options and tools 7,8 primarily utilizing two types of collection devices.…”