he Coronavirus Disease 2019 (COVID-19) caused by the coronavirus SARS-CoV-2 (previously known as 2019-nCoV), first identified in Wuhan City in the Hubei Province of China, has led to more than 79,000 cumulative confirmed cases of human infections and at least 2,900 deaths in China (as of March 1, 2020). It has also spread quickly to more than 60 countries beyond China. In China, a series of powerful measures were taken to contain the spread of COVID-19, including the early identification and quarantining of infected patients. Chinese health authorities, pharmaceutical companies, and healthcare professionals are also responding quickly and working around the clock to accelerate the research and development of products for the identification, prevention, and treatment of COVID-19.

ompanion diagnostics are a class of diagnostic devices that has become important not only in personalizing therapy for patients, but also for developers of therapeutic products, who must now consider not only development of the drug or biologic, but also development of a diagnostic test to identify or manage patients who use the therapeutic product.

IA’s 2020 Pharmacovigilance and Risk Management Strategies Conference included thirteen sessions that describe the current regulatory environment as well as primary sources of risk. The sessions, together with a keynote talk by Steven Murray (Exponent), provide a foundation for making informed and up-to-date decisions in a pharmacovigilance program.

Key Takeaways

• New ICH and CIOMS programs are underway to address evolving issues related to patient engagement and safety data collection.
• The global regulatory framework for pharmacovigilance has evolved in different regions independently and consequently exhibits a regional focus on different areas of safety and pharmacovigilance practice.
• The regulatory context surrounding risk management tools, such as REMS and RMPs, continues to evolve in a regional manner, making global risk management a challenging endeavor.
• Current research findings on topics such as DILI and alloCAR-T therapies will have an impact on the benefit-risk analysis associated with these therapies.
• Several pharmacovigilance approaches are being pursued to help address the growing concern of medication errors.
• Regulatory safety assessment is making growing use of real-world evidence using novel approaches.

IA’s recent Pharmacovigilance & Risk Management Strategies Conference 2020 opened with experts providing Asia Region Updates from India, Japan, and China, in a session chaired by DIA Fellow E. Stewart Geary and summarized in this report.

he significance that sponsors place on soliciting input on their development projects from regulators is evidenced by the steadily growing number of Scientific Advice procedures given by, for instance, the European Medicines Agency (EMA) or US Food & Drug Administration (FDA). Indeed, EMA reported they granted 466 Scientific Advice and follow-up requests in 2018 (the 2019 report has not yet been published) compared to 264 in 2008.

he development of regenerative medicines such as cell and gene therapy products was accelerated in Japan by new regulatory and legal systems that came into effect in 2013 and it continues to attract considerable international attention in not only scientific journals but in more general publications. Reports on these development advancements have revealed numerous challenges in the development, distribution, and post-market management of these products.

IA is launching a new Advanced Therapy Community for cross-functional discussion of advanced therapy product development from experimental inception through pre-clinical and clinical development, marketing, and beyond. These promising therapies face unique challenges that are often a combination of issues at different functional levels of the overall development program.

t the beginning of 2019, I walked into the most challenging and intimidating presentation of my life. At that time, I was vying for a fellowship in the pharmaceutical industry and competing against hundreds of pharmacy students from across the country. I was almost at the finish line: After going through four grueling rounds of interviews, I was one of the top candidates. My last and most important step was to deliver a 30-minute presentation.

This was my golden opportunity to distinguish myself and my abilities among some of the top leadership in the company. This could clinch the fellowship of my dreams and jumpstart my career.

But my excitement for this opportunity was also couched by fear: How am I going to stand out? How can I make sure people will remember me?

As I found myself seeking answers to these questions, I searched for guidance from well-known motivational speakers, leaders across all major industries, and most importantly, friends and mentors with considerable leadership experience.

Here’s what I found.