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19 – Partnering Supplement Covid 19Covid – Partnering Supplement

TOGETHER BEYOND COVID-19 Dr. Jürgen Hönig, Senior Director; Lisa Pascoe, Associate Director

We find ourselves in one of the most challenging situations in history. In a very short time, the world has been consumed by a virus that has proved to be both ruthless and deadly. Countries all over the world are battling an invisible enemy and yet remain resolute in the face of such adversity. Whilst challenges create opportunity, never has such a spotlight been put on the pharmaceutical industry to react quickly and effectively and develop a cure or vaccine for COVID-19. However, despite the current crisis, product development continues and regulatory compliance, quality management and ongoing pharmacovigilance must be maintained. As a leading provider of specialised services for the pharma, biotech and medical device industries, PharmaLex’s expertise can really make a difference and we are committed to going above and beyond to fight this as an industry. We are proud that we continue to support our clients and provide the necessary backbone which allows our industry to deliver. In this article we explore some of the key topics our clients are facing, and how the pharmaceutical industry is coming together to use this as an opportunity to learn, grow, innovate and increase in flexibility. A Global Problem Requires a Global Effort Historically more associated with academia and smaller pharma companies, there have been a number of prominent research and development (R&D) collaborations announced since the start of the pandemic, with stakeholders of all sizes understanding that working together will be key. R&D collaboration facilitates pooling of complementary skills, learning from the partner as well as sharing risks and costs. Companies are forced to innovate at a faster rate to maintain their competitiveness in the market and, as a result, they see R&D alliances not as an option, but as a strategic need. Typically small and medium-sized pharma companies tend to benefit from collaboration through access to a broader and more diversified knowledge base. However, during these times, no single company 26 COVID – 19 PARTNERING SUPPLEMENT

is going to be able to solve this crisis alone, irrespective of their size, and so we are seeing collaboration at the highest level. PharmaLex as a full-service provider offers its customers the possibility to access a broad network of independent R&D institutes. In more than 25 years PharmaLex has been involved in various stages of the development process of innovations and has gained extensive experience in different areas, be it galenic or clinical development. We are currently working with a number of clients to ensure they can continue vital research, as they face practical issues such as laboratories closing for safety reasons. In one case PharmaLex supported the transfer of analytical method development studies to an alternative laboratory. The methods involved identification of co-compounds for a biologic medicinal product and were crucial in obtaining approval of a Phase I clinical study. PharmaLex was also recently approached by a small biotech company seeking support for the identification of alternative laboratories for the qualification of non-genotoxic impurities (NGIs) regarding biological safety. During the search for a suitable partner for this very specific request, it became apparent that the client did not have sufficient capacity and, above all, experience to work efficiently with existing external partners. Subsequently the client requested PharmaLex take over the coordination and management of all external partners to enable their internal resource to focus on their core business.  The COVID-19 Clinical Trial Challenge, Today and Tomorrow   In response to the pandemic, clinical studies are emerging at an unprecedented rate with the EMA advising that, as of 14th May, they have been in discussion with the developers of around 115 potential COVID-19 treatments and 33 potential vaccines. However, when it comes to clinical trials, companies are facing challenges on numerous fronts. On one hand, clinical trials are needed for development of these potential treatments and vaccines, yet typically take many months or even years to set up. On the other hand, the development of pipeline products cannot be stopped, yet sponsors must safeguard the safety of trial participants, and research and regulatory affairs resource are being redeployed to frontline care.  Fortunately, health agencies have been quick to support in facing these challenges. Whilst the scientific and ethical evaluations are as stringent as ever, a number of initiatives have been launched for acceleration of development support

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