The fittest model

May 11, 2021
Is it time for pharma to evolve its drug development ways?

Part anecdote about natural selection, part myth, part heartwarming tale about how humans snacked a species into extinction — the dodo bird has gotten a lot of press.

But the part that doesn’t get enough attention is how the dodo bird was actually pretty adept at evolving. Facing no known predators on the tropical island of Mauritius, the birds grew larger than their pigeon relatives. They began nesting on the lush forest ground and gradually became flightless. Their beaks adapted to available food sources and became big and curved. They developed robust legs to support their weight and help them maneuver through the brush.

In short, dodos had evolved to be quite well-suited to the small island’s ecosystem. All was well in dodoland until ships of sailors with a hankering for bird-BBQ arrived, bringing with them rats, pigs and other predators. As an added extinction whammy, humans turned the island into an agricultural plantation, destroying the birds’ habitat and leaving them vulnerable.

And just like that, the dodos’ once-helpful survival adaptations weren’t working in their favor.

While on the topic of things that aren’t really working, let’s talk about pharma’s drug development models. The industry itself acknowledges that there are flaws in its methods — specifically, the use of animal models in preclinical testing. It’s commonly understood that biological differences between animals and humans make animal testing an inefficient way of modeling drug effects.

But acknowledging inefficiencies doesn’t mean drug discovery and development hasn’t evolved. Research has come a long way since ancient Greeks were learning about human anatomy by performing vivisections on live animals. The passing of the 1938 Food, Drug, and Cosmetic Act marked the start of mandated safety testing of drugs on animals and since then, pharma has continuously evolved its methods.

For example, with the advent of genetically engineered models in the latter part of the 20th century, mice and other species were modified to better reflect the specific disease pathways that were being studied. When combined with later advances in genome sequencing, animal models became even more efficient and targeted.

And yet, even with technological and scientific advancements, close to 90% of drugs still fail in human trials despite showing positive responses in animal trials. Most of these drugs flop for reasons that were not detected in animals.

Has the industry stagnated in terms of evolving its drug development models? Not quite. Emerging technologies including computational modeling, organ-on-a-chip and advanced cell culture assays offer alternatives to animal testing. 

Of course, when it comes to these emerging technologies, there are still limitations and barriers to adoption. And while it is unlikely that alternative models will ever entirely replace animals in pharma, many estimate that technology is five to 10 years away from being developed enough to replace “most” animal models.

I’d argue any day that drug discovery and development are among the most crucial scientific activities when it comes to human health. As such, failure to improve the industry’s methods is a risk to the future well-being of humanity. And while evolution by definition involves gradual developments, you never know when a party boat of sailors will pull up and force your hand — and in that scenario, it’s good to have a better plan because without it, you risk extinction.

Read our cover story about how animal models are on the brink of extinction in pharma drug development.

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.' 

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