Pharm Exec at 40 (2018-2021)

Mayhem took center stage early in 2018, with news of the Valentine’s Day mass shooting at Marjory Stoneman Douglas High School in Parkland, Fla., which killed 17. Gun violence persisted nationwide, and 2021 is on pace to overtake 2020 as a record year. California suffered its deadliest and most destructive wildfires in 2018. The #MeToo movement also was ongoing, with a focus on the sexual misconduct of filmmaker Harvey Weinstein and actor Bill Cosby.

The lighter side of 2018 included the wedding of Prince Harry to Meghan Markle. The Winter Olympics were held in Pyeongchang, South Korea. In Brazil, the FIFA World Cup culminated in France’s 4-2 win over Croatia.

In 2019, Boris Johnson became British prime minister; the first all-woman spacewalk occurred; and more than 50 privileged parents were accused of college admissions bribery, including actresses Felicity Huffman and Lori Loughlin. President Donald Trump’s ties to Russia regarding the 2016 US presidential election also were under investigation; he was eventually impeached in 2019 and again in 2021. His stance on immigration and a US-Mexico border wall were hot topics. Meanwhile, millionaire Jeffrey Epstein, who had ties to many notable politicians, died in prison in 2019 while awaiting trial on sex trafficking charges.

The same year, FDA approved a record number of generics—a step toward improved access. However, many questioned access to Zolgensma, a newly approved gene therapy targeting spinal muscular atrophy. Priced at $2.125 million a year, it became the most expensive drug ever. Pharma mega mergers were also noteworthy, topped by the $74-billion acquisition of Celgene by Bristol Myers Squibb, AbbVie’s $63-billion acquisition of Allergan, and Takeda’s takeover of Shire for $62 billion.

At FDA, Commissioner Scott Gottlieb stepped down in April 2019 and was replaced by Norman Sharpless, who served until November 2019. Stephen Hahn then took over until January 2021; Janet Woodcock has been acting director since. At the EMA, Emer Cooke replaced Guido Rasi as executive director in November 2020. These agencies soon would be challenged with bringing much-needed therapies to the world faster than ever.

As catastrophe loomed around the world in 2019, a fire engulfed Notre Dame Cathedral in Paris; the Bahamas sustained the worst natural disaster in its history, Hurricane Dorian; and Australian wildfires raged. These events were only a harbinger of the disaster to come, however, as the first case of COVID-19 was reported in Wuhan, China, in December. Amid the threat of COVID and murder hornets, the UK had its official Brexit from the European Union in January 2020. Harry and Meghan likewise made an exit, moving to Canada, then Los Angeles—a city still reeling from the January helicopter crash that killed former NBA star Kobe Bryant.

COVID became a pandemic in 2020, and the world went into lockdown as people juggled hybrid learning and work from home. Living amid uncertainty, they pondered the future of a “new normal.” FDA’s emergency use authorization of remdesivir for severe COVID in May brought a sigh of relief. The murder of George Floyd the same month also shifted the societal status quo. This intensified the Black Lives Matter movement, which became pivotal for racial equity.

The race for a vaccine and the race for US president dominated the second half of 2020. Hope was ignited with the authorization of Pfizer/BioNTech’s vaccine in December, followed by shots from Moderna (EU and US), and AstraZeneca/Oxford (EU). The use of mRNA in the Pfizer and Moderna vaccines held additional promise as a novel platform for drug development. In February 2021, a single-dose J&J shot was authorized by FDA. Additional vaccines continue to be developed.

Joe Biden beat Trump with record voter turnout in the election, and Kamala Harris became the nation’s first female, Black, and Asian-American vice president. But a mob of people who believed the election had been stolen stormed the US Capitol in January 2021—a scene longtime Supreme Court Justice Ruth Bader Ginsburg, who died in September 2020, would not have condoned.

Around the world, people sought COVID vaccines in 2021. Though waves of infection continue to ebb and flow, the world presses on in the shadow of a pandemic, not knowing what the future holds.

Elaine Quilici is a Senior Editor for Pharm Exec. She can be reached at equilici@mjhlifesciences.com.