BIO 2024 – A Look into the Future
Last week I had the opportunity to attend the 2024 BIO International Conference. This conference is hosted by the BIO Innovation Organization, which is the world’s largest advocacy association representing biotechnology companies, academic and research institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. Biologics are a type of medicine that is drawn from living organisms rather than the more common chemically derived small molecule medicines. Most drug manufacturers develop and produce both types of medicine. This conference brings together over 20,000 people from all parts of the BIO technology business. That’s a lot of people. I’ve attended this conference 8 or 9 times in the last 15 years and have found it a great place to see what the future holds for our healthcare.
This time was kind of a new experience because I attended as a member of the press/media. It offered me the chance to interview some of the participants, attend seminars and panels and listen to experts as they discussed where the development of new medicines is headed and how our business structure and government oversight will work to support future research and development.
The overarching theme that I detected in almost every aspect of BIO technology was personalization. The focus was squarely on how the developers can tailor the medicine and treatments so they will best treat each individual patient’s specific needs. Diversity has become the catch phase and with good reason. We are finally recognizing that sex, race and ethnicity, socioeconomic status, etc. need to be part of the guiding determinants as we develop new cures. I could feel the excitement in how the strides in understanding RNA (ribonucleic acid) have opened the doors to discovering new medicines for a number of diseases. The COVID pandemic spurred expanded research, especially in how messenger RNA (mRNA) can communicate a template at the cell level to spur our body's defense against a particular virus or adverse cell-level event. More than once, I heard how we are at the cusp of exciting new medicines in this arena.
One particular person I interviewed discussed their company’s research into how to overcome the manufacturing and distribution problems faced during the pandemic. As you might remember, the vaccines had to be manufactured in large batches and then had special cold storage requirements as they were shipped. This limited distribution, especially to third-world countries. This company is developing a washing machine-sized machine that can produce mRNA vaccines close to where they would be administered. It just needs to be programmed with the formula for the vaccine, and it can begin producing the required vaccine. It is like a personal vaccine manufacturing unit. It’s this type of research that can overcome the problems of getting medicines to everyone.
I talked with another team whose company was developing and doing initial clinical trials on a medicine that could help calm Alzheimer’s patients who had aggressive behavior. I’ve read reports of instances where Alzheimer’s patients were kept in overly drugged states, almost to the point of being unresponsive, to overcome the aggression or, worst case, to make them less work for the attendants. This medicine will focus only on the aggression aspect of the disease. Again, personalized treatment for a particular symptom of a disease.
While the possibility of real breakthroughs was exciting, the current environment of the business structure and government oversight to support this research and development was not exciting. In fact, many aspects were depressing. One panel talked about how new and proposed government regulations will likely hinder these breakthroughs. This was a panel of experts in drug research and development, pharmacy benefit managers (PBMs), and providers. Throughout the hour-long panel, they discussed the likely effects of price-setting provisions in the Inflation Reduction Act, the proposed government use of the Bayh-Dole Act to set prices, and the limits of price increases in the Part D prescription drug program. Here are some quotes from my notes from that panel.
The IRA was a “needless shot across the bow” of innovation. It will crater the brands of the 10 selected drugs.
Since manufacturers can’t depend on price increases, they will raise the launch price.
If you squeeze the balloon at one spot it will pop out somewhere else.
It was curious that half of the 10 selected drugs were going off exclusivity in 2026.
Will CMS set the price of this first batch of drugs at:
A modest increase to kind of ease everyone into the program and not make it too painful, or
Dramatically lower the prices to have election-year fodder to tout.
Will the patient see any change?
It is this last statement that raised a big red flag with me. We finally passed the $2,000 yearly cap on out-of-pocket costs; this will certainly benefit patients with high drug costs. Will the IRA price fixing approach have any effect on you and me at the pharmacy counter? The panel’s consensus was – it would not. They did state that there certainly will be pressure on raising premium rates, lowering benefits in Medicare Advantage plans, and increasing the utilization management oversight to control costs.
My own prediction on the effects of the IRA price fixing approach is – they moved the fences back so far that the chance of hitting a new drug home run will be almost impossible, and the investment in innovation will drop as a result.
As you can see, this is a complicated and often hard-to-understand arena. I will continue to watch and explain how these government intrusions into our healthcare will affect you. It was an eye-opening conference that gave me both hope and trepidation.
Best, Thair