Latin America, a region of more than 640 million people, is experiencing significant outbreaks of COVID-19 since its first confirmed case on February 25, 2020. Health regulatory authorities are required to adapt to new challenges as the regions face medical supply shortages and halted clinical trials. “In our region, governments will learn even more the value of an independent regulatory authority that does regulation based on science and scientific evidence,” says Cammilla Horta Gomes, Latin America Regulatory Policy Lead at Roche, Brazil. She discusses the outbreak’s impact on the region’s regulatory landscape and the solutions that have been implemented to improve regulatory efficiencies in the face of the outbreak.
The South African Health Products Regulatory Authority (SAHPRA) is responsible for regulating health products intended for human and animal use, the conduct of clinical trials, and other duties in South Africa. “Around the COVID-19 pandemic, as regulators, we are having to work very closely with each other because in some jurisdictions clinical trials are ongoing, and we need to access that data. In some jurisdictions, products have been registered and we need to access that data,” explains SAHPRA CEO Dr. Boitumelo Semete-Makokotlela. “It's been humbling to be part of the broader health sector where we contribute to not only saving the lives of South Africans but contribute to the knowledge base across the world and to averting this pandemic.”
Scientific advancements in pharmaceutical R&D are simultaneously benefiting patients and challenging industry and regulatory frameworks throughout Europe. “The pharmaceutical R&D of today is driven by groundbreaking innovation which has the potential to transform patient treatments and improve patient outcomes, as we move more and more from treating symptoms to really treating the underlying cause of diseases,” explains Dr. Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA). “Developing this new generation of treatments raises new and challenging questions of our regulatory system, underlying the need for evolution to adapt to such advanced technologies.”
New drugs are getting through the FDA approval process faster. According to a study published in January 2020, the review time for standard drug applications has decreased from more than 36 months in 1983 to approximately ten months in 2018. “It can be a good thing for drugs to reach the market faster, if those drugs offer large benefits. But often drugs offer only very small benefits over existing treatments,” says Dr. Jonathan Darrow, pharmaceutical policy expert and Assistant Professor at Harvard Medical School in Boston. “The system we have is a patchwork of various policies,” explains Dr. Joshua Sharfstein, former FDA Principal Deputy Commissioner, now Vice Dean and Professor at Johns Hopkins Bloomberg School of Public Health in Baltimore. “We should take a step back and say, ‘Are there ways to align incentives more so we have more money to spend for treatments that make a huge difference for people who need them?’”
Digital tools that revolutionize information and communication technology are increasingly employed to transform the quality and quantity of clinical trial data. “The ability for us to reach patients in geographic locations and in demographic groups that the current system is missing is arguably the most important role of these technologies,” suggests Lauren Oliva, Global Regulatory Policy Lead for New Technologies, Biogen. “With the increased quantity of data, you do increase the quality to some extent in terms of your reach and the types of things that you could measure now that you wouldn't be able to measure in the past,” explains Josh Cosman, Principal Engineer, Digital & Quantitative Medicine, Biogen. Lauren will Chair the Drug Development Tools in a Digital Era session at DIA Europe 2020.
FDA’s Center for Biologics Evaluation and Research (CBER) is responsible for assuring the safety and efficacy of biological products including vaccines, allergenic products, blood and blood products, and cellular tissue and gene therapies. “This area of advanced therapy medicinal products (ATMPs) is just an incredibly exciting one to be working in right now,” explains Center Director Dr. Peter Marks. “We have our work cut out for us here, but to me it's wonderful work to have to do because it shows how fast the science is advancing, how fast hopefully the technology will advance, to bring these medical benefits to patients.”
The DIA Europe 2020 Keynote Address will focus on the intersections of science and business as explored by a scientist turned investor, Mr. Joep Muijrers, who currently serves as CFO of PureTech, a listed biopharmaceutical company that focuses on developing medicines for devastating diseases including cancer, CNS disease, and immunological disorders. “What is the value of a product that, quite often against the odds in this sector, makes it and gets to patients and then doesn't make a dent whatsoever – it's not being used. What's the relevance of that?” he asks. “Put it this way: In this industry, we tell the end user what's good for them. Isn't that crazy?”
Dr. Steven Murray, Group Vice President & Principal Engineer in the Electrical & Data Sciences Group for Exponent, assesses and analyzes potential risk and failure of products from underground lateral piping to surgical heart catheters. “In drugs and medical devices, developers really need to consider where their product lies on the scale of risk: Is this a product where it is impossible to disentangle the benefits from some other risk? Or is this a product that, if anything is even a little bit wrong, the benefit doesn't justify it?” he asks. “We're much more accepting to risks in things like cancer drugs or AIDS drugs, where the risk of death is highly present and you're averting it.”
Telematics has evolved since the first joint HMA/EMA Telematics strategy in 2014. “The vision for EU telematics is an IT collaboration that will deliver cost-effective, efficient, and interoperable services to the European regulators and to its stakeholders,” suggests Bernd Misselwitz, Director and Regional Head, Regulatory Submission Management, Bayer AG (Germany). “Maybe from an IT perspective, it was the technical problem first and business was second; now that you've seen how people want to get value out of it, it's starting to shift where the business problem comes first,” explains Vada A. Perkins, Executive Director, Regulatory Policy & Intelligence at Bayer Pharmaceuticals (Global). Vada and Bernd will help lead the DIA Europe 2020 session Telematics Strategy in the EU: Global & Regional Considerations for 2020-2025.
As drug development and market approval grow more connected and complex, effective regulatory information management (RIM) is more essential than ever. “The ideal state would be to leverage regulatory data as a corporate asset,” suggests Venkatraman “Bala” Balasubramanian, Senior Vice President of Life Sciences, Orion Business Innovation. “Regulatory teams will be able to better advise portfolio teams on probability of regulatory success in any given market, so you’re going to have higher success rates from a regulatory perspective going forward,” concurs Patterson Shaffer, Managing Director of Regulatory Compliance & Quality, Grant Thornton LLP. Bala and Pat serve in the Working Group developing the Regulatory Information Management reference model discussed at DIA's 2020 Regulatory Submissions Information & Document Management Forum.