Covid-19 pandemic gives an opportunity for the BioPharma industry to transform its image. Can the initiatives and learnings from Covid-19 be applied to other critical therapy areas? Can the time and cost of development be significantly reduced such that the pharma companies can launch the products at affordable prices to ensure that every patient gets access to the medicines?
Emerging markets are gaining more importance than ever, led by China, considering the scales of volumes they offer. With time and cost of development significantly reduced, the pharma companies can launch the products at affordable prices.
According to a market research expert, most people do not have any real opinion on the biopharma industry, for them it just exists; and the ones who have an opinion, it is not a positive one. This is counter-intuitive, especially for an industry that works on the premise of saving lives and impacts each and every individual several times throughout their lifetime.One reason for the negative opinion is the growing distrust due to high costs of available therapies and lack of transparency in the market place and the overall healthcare system, contributed by cost intensive new drug development and conservative regulatory guidelines.
With all negative impacts, COVID-19 pandemic gives an opportunity for the biopharma industry to transform its image. It is the only industry that can deliver a solution and the timing of the pandemic is propitious as the science has substantially matured and put into practice. The scale of such a united response from biopharma against COVID-19 is something that has never been witnessed in history.
At least 240 new or repurposed drugs are under various stages of development, involving more than 50 companies across the US, EU, China, Japan and India. Biopharma has demonstrated a collaborative approach with ~90 deals announced between January and April 2020 for COVID-19 therapies, involving ~120 groups across a dozen countries, the highest one has ever seen in a single quarter. The deals aim towards expediting the drug development, leveraging key expertise of various partners from pre-clinical discovery, to clinical development to manufacturing.
At the end of this pandemic, biopharma will emerge as one of the most important industries critical to the sustenance of mankind. An intelligent consortium of key stakeholders, the government, regulators, biopharma and healthcare, combined with IT tools has the potential to transform the future drug developments, of course, with a patient-centric approach.
Regulators can justify accelerated new product development cycles. Advances in science have enabled next generation therapies to target a specific gene or a mutation, with minimal off-target effects along with companion diagnostics to select the patients. A tailor-made phase I study in pre-selected patients will establish the safety and a further continuation of the same set of patients for a phase II study will establish the efficacy at an acceptable level. Therefore, it is now possible to approve the drugs based on phase II, while combining phase III and phase IV post approval. Of course, not all the drugs will qualify, but a robust framework will enable the selection.
Combining this approach with IT platforms to ensure the recall of every packet within 48-72 hours will ensure further risk mitigation in case of any unexpected adverse events. This will lead to a significant reduction in the overall time and cost taken to put a drug to the market. The patients will ultimately benefit from more number of available and customized therapies, that too with affordable cost. Data sharing between the pharma companies and the regulatory agencies will not only reduce the failure rates at an early stage, but also the burden of clinical development, of course, within the boundaries of protecting the IP.
Every patient can access and afford the therapies. Emerging markets are gaining more importance than ever, led by China, considering the scales of volumes they offer. With time and cost of development significantly reduced, the pharma companies can launch the products at affordable prices. Active collaborations with government and public health organizations will maximize the market penetration. Moreover, data sharing at a public health level will be the ultimate testimony to the drug’s efficacy and will increase its overall acceptance. Such a pioneering initiative from a set of key stakeholders in one part of the world will ultimately have a ripple-effect on the global biopharma landscape. With the patient at the centre of the ecosystem, biopharma will be known as the industry that does the right thing and the society will embrace it with open hands.
This column originally appeared on BioSpectrum Asia, June, 2020.