2021 was a big year for pharma.
From Biogen’s wild ride with its controversial Alzheimer’s drug, Aduhelm, to cyberattacks to the explosion of mRNA drugs onto the marketplace, there has been a lot to keep up with.
But worry not — here are summarized highlights from our cover stories published in the last year, as well as memorable quotes from each one.
January/February: CDMOs with vision
The onset of the COVID-19 pandemic thrust the pharmaceutical industry into the spotlight, bringing changes with it. One such change was drugmakers choosing CDMOs close to home, especially when it came to vaccine manufacturing — bucking past trends of outsourcing production to China and India.
Several CDMOs stepped up to the challenge of coronavirus vaccine and therapeutics production. Simultaneously, contract manufacturers must continue to meet global, non-pandemic needs. Many ramped up to respond to the growing demand for cell and gene therapies — novel and complex biologics at the forefront of innovation for the treatment of severe diseases, such as cancer — that have suffered from supply delays.
March: The Alzheimer’s approval maze
When the news broke in March 2019 that Biogen was abandoning development for a drug targeting Alzheimer’s disease, the reaction was one of predictable disappointment — but not surprise. That October, in a move that sent shockwaves through the pharma world, Biogen announced that it would file for approval of aducanumab with the U.S. FDA — a decision that teed up the first new drug approval for Alzheimer’s in 18 years.
Confusion, controversy and conflicting beliefs have been swirling around the drug ever since.
April: A state of flex
But once we pull back the curtain, what exactly does this “flexvana” entail?
Ultimately, a flexible facility is one that is agile enough to adapt to change — whether it be a shift in capacity needs, regulatory demands, manufacturing processes, technologies, products or some combination thereof.
May: The next phase of drug creation
Animal testing has been an integral phase of preclinical trials for every major drug on the market today, with FDA requiring drugs to be tested on animals before humans. But ethical concerns and biological differences have dated the practice.
But with no viable alternative, animal testing has persisted. The market for animal testing was valued at $10.74 billion in 2019 and is expected to grow.
Technological advancements, like organ-on-a-chip, may hold the key to replacing animal testing. OOCs can model organ functions and companies are looking for a way to incorporate the technology into drug testing.
June: Rising tides of orphan drugs
The niche rare disease space has long been pushed forward by the advocacy of patients and caregivers needing treatments that don’t quite exist. Notably absent in the scrappy history of orphan drugs are multinational pharma giants.
But 35+ years after the passage of the pivotal Orphan Drug Act, the tides may be changing. The pharma industry is becoming increasingly more adept at developing drugs for small patient populations and financial incentives are attracting more companies to the industry.
Multinational pharma companies are becoming more and more visible in what is now a swelling rare disease space.
A deeper dive into the factors motivating this shift reveals a pharma industry that, if willing to stay true to the core values of the once niche space, can realize countless benefits — for both their bottom lines and the 300 million patients worldwide suffering from rare diseases.
July/August: mRNA takes off
mRNA has finally met its moment — after years spent lingering in clinical trials the technology has found success in COVID-19 vaccines. With its potential realized, drug developers are now rushing to get in on the action, scaling up and investing in mRNA technology.
The new technology comes with several benefits. Manufacturers are able to make higher yields of high potency vaccines, shrinking their manufacturing footprint. Modifying sequences to address new strains is much easier and production and manufacturing procedures can be reused for other types of mRNA vaccines.
As mRNA’s popularity grows, there are still a few things to smooth out. Manufacturers are exploring methods of improving the purification process. Several risks still need to be addressed, like the risk of inflammatory heart conditions, and the risks associated with the unregulated raw materials suppliers that are necessary for the technology. The frozen temperatures that the vaccines must be stored at pose another challenge for distributors.
Despite the bumps, mRNA technology is sure to be an explosive new area of the pharma industry.
September: Cyber scares
Cyberattacks on the biotech and pharma industry are on the rise, becoming more frequent and more sophisticated. Pharma companies hold trade secrets and massive amounts of personal health data in their systems – and cybercriminals know its value.
The COVID-19 pandemic made attacks more prevalent, when suddenly thousands of employees were sent home to work. As industry develops cybercriminals do too, using new ransomware attacks and supply chain attacks to get what they want.
The best way to prevent an attack? Making cybersecurity a top priority. Companies that are proactive and aware are less likely to fall victim to an attack. As attacks become more prevalent, the industry’s continued success depends on pharma’s ability to kick its cyber vigilance into high gear.
October: Legal unease
A dramatic case between Teva Pharmaceuticals and the U.S. Department of Justice is shedding light on what some say are shady practices by generic drugmakers.
In August 2020, the DOJ formally charged Teva with conspiring to fix prices, rig bids, and allocate customers for generic drugs. According to the DOJ, consumers were overcharged at least $350 million, and unless Teva ultimately settles, the indictment has set up an eventual showdown in court.
In an unusual move, Teva chose not to settle, opting instead to fight the case. Further investigation prompted the DOJ to bring five more companies into the case based on allegations of collusion and price fixing between the manufacturers.
The charges speak to deeper problems that have boiled beneath the surface of the generics landscape for decades. Now, as the industry takes stock of how the various lawsuits are unfolding, generics companies may find themselves adjusting business practices to avoid further allegations. And the situation is opening up the door to talk about larger issues that could be creating the perfect environment for price-fixing schemes
December: Minding the gap
But the burning enthusiasm for psychopharmacology solutions that came to a head in the 90s has seemingly grown dim. Faced with the daunting realities of high development costs, high failure rates and a still-incomplete understanding of the underlying pathophysiology, a once vibrant therapeutic sector has seen pipelines thin and a multitude of big players quietly back away. And yet, the need to find faster-acting, longer-lasting, and more effective treatments for mental health has never been greater.
Can the pharma companies that remain dedicated to minding the ever-growing treatment gap find a way to fill the voids?
