Covid and consultancy – combating a global health crisis with unprecedented scientific and regulatory solutions

Michael Pfleiderer

by Michael Pfleiderer

Retrospectively, it already became apparent in the beginning of 2020 that this year will become very different from the years and decades before. Chinese doctors and scientists discovered a novel respiratory virus causing a novel and diffuse clinical picture of severe lung disease while spreading rapidly from small local hotspots to the entire world. The causative agent was swiftly identified and categorized as SARS-CoV-2, a member of the family of Coronaviridae.  SARS-CoV-2 is the third spillover of an animal coronavirus to humans within just two decades. SARS-CoV-2 can be grouped into a sister clade to two previously circulating human coronaviruses also causing severe acute respiratory disease, namely SARS-CoV-1, identified in 2003 and MERS, identified in 2012. Unlike the latter two coronaviruses only causing local outbreaks that could rapidly be confined, SARS-CoV-2 has developed unique features resulting in an extremely quick transition from epidemic to pandemic scale as declared accordingly by WHO on 11th of March 2018.

As an immediate response to this outbreak governments around the globe decided on a wide range of shutdown or lockdown measures aimed at confining the virus in a way that hospital resources would not be overwhelmed by a too high number of severely ill Covid-19 patients. Those measures varied widely depending on a range of factors including political constellation, infrastructure, geographic location, economic as well as cultural and societal conditions, etc. Restrictive measures are largely perceived as unavoidable by a majority, however, although transient in duration, measures imposed are also perceived as too restrictive by a considerable minority. Nevertheless, the necessity to adhere to those measures as a token of responsibility for those individuals being most susceptible for acquiring severe Covid-19 disease is mostly acknowledged.


Initial and repeated imposition of confinement measures also made clear that none of the approaches chosen by governments turned out to be suitable to fully control further spread of SARS-CoV-2. Depending on the rigorousness of measures imposed, cases and number of hospitalized patients were remarkably reduced. However, as those measures, for numerous obvious reasons, cannot be maintained for an unlimited period of time, lifting of confinement measures finally resulted in the onset of another pandemic wave after a lag period of several weeks or months which, as we are currently experiencing, manifests more vigorously than the first one.

As such, what was known from previous pandemic events has been confirmed for the ongoing SARS-CoV-2 pandemic, namely that local or global spread of a new pathogen with pandemic potential can only be retarded by non-interventional measures, it can, however, not be stopped.

Becoming increasingly aware of that major dilemma has sparked global research and development activities in an unprecedented pace to deliver and deploy preventive and therapeutic medicinal products to better control the disease burden caused by SARS-CoV-2. While short term solutions are focussed on mitigating symptoms of severely ill Covid-19 patients, long-term solutions reach out for the availability of highly protective vaccines.

As regards the former, two active substances were rapidly considered useful for the treatment of early and late Covid-19 disease, namely remdesivir and dexamethasone, respectively, and were licensed following a very short clinical research period under specific regulatory conditions defined by applicable drug legislation [1, 2]. Numerous other therapeutic approaches are currently in late-stage development providing an optimistic prospect that the arsenal of therapeutic options might expand and improve in the near future. In this respect therapeutic approaches based on SARS-CoV-2 specific monoclonal antibodies are most promising and have recently already been licensed or are under review elsewhere for licensure in the near-future [3].

In this context it should, however, not go unmentioned that the majority of therapeutic approaches currently investigated is likely to have only limited or no efficacy in the treatment of Covid-19 disease. Therefore, it is important to highlight the enormous progress that has been made in vaccine development. According to the WHO landscape document on SARS-CoV-2 candidate vaccines, 51 candidate vaccines are in early and late clinical development and another 163 constructs are in the pre-clinical development stage [4].

Basically, any imaginable technology is applied, and some frontrunners are already in use or expected to be licensed very soon. It is encouraging and fascinating to see that a number of breakthrough technologies are amongst those frontrunners which will sustainably pave the way for subsequent innovative vaccines.

It is also amazing to see how efficient Regulatory Agencies handle these innovative concepts. Although most of them are certainly overwhelmed with requests for scientific advice, clinical trial applications and licensing procedures, it is remarkable to learn how quickly the right balance between pragmatism, flexibility and in-depth evaluation has been defined and is effectively applied. Also, the currently applied regulatory strategies for SARS-CoV-2 vaccines are to a great extent harmonized globally [5,6], adequate and sufficient to ensure that the current pandemic finds its end through the availability huge quantities of numerous highly effective and safe vaccines available in any region of the world [7].

Biopharma Excellence as a consultancy is deeply involved in the proceedings outlined above and has collected ample experience on how to “navigate the uncharted” [8]. During the past 9 months we have developed a fundamental understanding on the epidemiology and virology of SARS-CoV-2. We also developed a precise vision on how the CMC, non-clinical and clinical development of these vaccine constructs and antibody-based product candidates should be merged with smart regulatory solutions, world-wide. As such, we are now in a very comfortable position to share our knowledge and support interested developers to rapidly provide their solutions to the market – contact us at any time in case you wish to learn more.










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