Biopharma Excellence’s push for African vaccine equity is among 200+ successful vaccine-related projects to date

  • In late June, PharmaLex’s Biopharma Excellence team was invited to observe the signing of a Memorandum of Understanding (MoU) beween Rwanda FDA and Ghana FDA, in recognition of its trailblazing work in accelerating global access to critical vaccines and pioneering treatments. This has included laying the foundations for localised vaccine manufacture in Africa.
  • Biopharma Excellence’s profound expertise in vaccine and other biopharmaceuticals regulation is not only helping its clients to get to market efficiently; it is also shaping the regulatory landscape – through the development of new concepts and solutions, eg for regulation of mRNA technologies.

Frankfurt, Germany – November 30th,  2022. PharmaLex Group’s Biopharma Excellence service line, launched last year, has seen large-scale take-up of its vaccine expertise across more than 200 projects already delivered internationally. These have included creating an optimum environment to enable localised vaccine manufacturing in Africa, with a view to enabling greater equity in vaccine access across the continent. In June, linked to this, Biopharma Excellence was invited to witness the signing of a new Memorandum of Understanding (MoU) between Rwanda FDA and Ghana FDA, around the provision of reciprocal technical assistance related to medicines and vaccines manufacture regulatory oversight.

Since inception, the deeply experienced Biopharma Excellence team has successfully worked on a vast array of vaccine-related projects, working closely with clients including large and mid-sized pharma organizations and biotech startups, state institutions, non-profit organisations and academia, to streamline the path to market for these critical products.

The Biopharma Excellence team comprises specialist virologists, vaccinologists, molecular biologists, and leading ex-regulators with a rich understanding of the aetiology of infectious agents, as well as public health/health policy needs and expectations.

This impressive pool of in-house knowledge has enabled Biopharma Excellence to hone a precise vision of how the CMC, non-clinical and clinical development of novel vaccine technologies can be optimally blended with smart regulatory solutions worldwide. “We’re in a very comfortable position to share our knowledge and to support interested developers to rapidly provide their solutions to the market,” commented Dr. Michael Pfleiderer, lead scientist at Biopharma Excellence.

Against the backdrop of the still present SARS-CoV-2 (COVID-19) pandemic, demand for Biopharma Excellence’s vaccine insights has been acute. The first vaccines were licensed with unprecedented

speed – in a matter of months rather than years – supported by adapted, fit-for-purpose regulatory approaches. “Given this rapidly-evolving situation, fast, flexible, and innovative solutions have been – and continue to be – paramount,” Dr Pfleiderer noted.

Since the onset of the pandemic, Biopharma Excellence has been deeply involved in all aspects of regulatory oversight of pandemic vaccines, and has developed comprehensive regional and global regulatory strategies for more than 20 SARS-CoV-2 vaccines, including novel platform technologies such as mRNA vaccines.

It has also supported pharma/biotech clients at all stages of development- from securing funding, partnering, CMC, non-clinical, clinical development all the way to successful fast-track approvals.

Its work to help establish vaccine manufacture and establish vaccine equity in Africa stems from an engagement with a major global brand, exploring how to localise vaccine manufacturing in Africa. The concept developed by Biopharma Excellence, which it dubbed Reg and Tech Transfer, has been accepted by pan-African organisations, and led to a contract to explore opportunities to enhance regulatory systems in the region. This is just one of a number of initiatives the team has been working on across the continent.

Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence, under the PharmaLex brand. The global team of 70+ scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services geared to developers of biopharmaceuticals such as cell & gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars. It is headed up by Dr. Christian K. Schneider, formerly Chief Scientific Officer at the UK’s MHRA, who is also its Chief Medical Officer.

Biopharma Excellence, which has already brought big business to Pharmalex, has shared its expertise and insights widely via published thought leadership on relevant issues ranging from Accelerated development and licensure of Coronavirus vaccines to Vaccine Development in Paediatric Populations – How to Proceed for SARS-CoV-2 Vaccines?.

Its expertise around vaccines has seen particularly pronounced demand, because of the field’s unique characteristics. “This is a highly dynamic field at the forefront of science,” Dr. Pfleiderer said. “It is subject to new technology, scientific progress, and new epidemics around the world, and it’s inevitable that there will be a lag in the regulators’ ability to adapt. That’s why there’s a need for experts like us who can adapt to these rapidly-changing situations. We understand that the procurement of vaccines is very different to any other product. They could be given to entire populations in a country or geographic region, so safety and clear communication about the science is paramount. Vaccines are paid for by governments too, which means that the entire infrastructure around it is different to other pharma categories.”

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