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Daily Archives: September 23, 2014

The Most Interesting Man Revolutionizing The Health World

He wrote his first world-renowned book at the age of 26. On weekends he recites love poems (ghazals) on Voice of America. He casually – and humbly – references his more than 70 patents that range from aging wine to chewing gum to bioreactors to air scrubbing systems at his infamous Chicago wine parties. And his mustache rules his twitter feed. In 2013 he was awarded the Star of Distinction, the highest civil award by the Government of Pakistan, for his inventions that are making significant impact in developing countries. He has written over 50 books, well over 100 research papers, and hundreds more articles in the field of science, philosophy, rhetoric, poetry and religion, drawing thousands of hits per day on his blog. Dr. Sarfaraz Niazi might just be the most interesting man in the world, but he is certainly the most interesting man pursuing biosimilars in the United States.

Throughout his career his driving principle has been to make things simpler. He did this while at Abbott Labs, as a former tenured professor at the University of Illinois at Chicago (UIC), in developing countries, and presently in his independent career at Therapeutic Proteins International, LLC (TPI) where he is working on biosimilars – or “copies” of current biologic pharmaceuticals that are about to lose their patents. Although only 17 biosimilars have been approved to date worldwide, though none in US, Dr. Niazi and TPI have nine in the pipeline to transform the entire market.   According to photographer Steve Huff, Dr. Niazi is, “An amazing man, in fact the most interesting man in the world!”

Flexibility Is Key To Innovation

When asked his advice to other inventors in a recent interview, Dr. Niazi explained his philosophy that, “You should never get enamored by your thoughts. If the idea does not solve a problem or move the quality of life farther, there are many more things to be invented.” With that mentality, he is filing two products this year alone, similar to Amgen Inc.’s $6 billion molecule white blood count product, due to its expiring patent in the cancer market. Next year, the two molecules he plans to take to market are similar to AbbVie’s expiring $12 billion product Humira.

With movement like that, it’s no wonder Dr. Niazi claims that the U.S. Food and Drug Administration (FDA) is his “friend.”Nevertheless, he notes extreme complications with the rolling submission model, which can cost up to $4 million per submission in fees alone. Additionally, the four levels of the FDA’s “analytical similarity” benchmarking can be troublesome if one has a new biologic entity. This benchmarking, however, allows scientists and the FDA to work together in a predictable, step-wise fashion to move products to market quickly that have fingerprint-like similarity to existing US-licensed biologic products.

Dr. Niazi’s strategy is to create an analytical and clinical equivalent to biologics with expiring patents, which is preferred even over a Phase 3 clinical trial. By doing this, the cost of production is reduced drastically and the speed of development increases by 2-3 times. Dr. Niazi estimates an overall reduction in production costs for his biosimilars of up to 50% or higher compared to market competitors.

By being flexible, his products are proving to be bio-revolutionary.

Can The United States Catch Up?

Additionally, thanks to the Affordable Care Act (ACA), a shorter licensing path for lower-cost versions of cell-derived drugs is now possible, giving inventors like Dr. Niazi another pathway for approval and distribution.

While he claims that the ACA will not reduce health costs, he does believe that independent shocks to the health market will. By this, he believes that making biosimilars easier, faster, cheaper and better translates directly into his mission of making all things simpler. Further, cost-effectiveness in the US and European Union (EU) can directly convert into worldwide distribution and scalability that is safe.

Although a friend of the FDA, Dr. Niazi is not hesitant to note the tough decisions US-based companies face to stay in the states. Having FDA approval carries weight around the world, but the financial and regulatory burden can be great for inventors and business owners. In contrast, he asserts that the EU has moved ahead of the rest of the world, with the most established and advanced regulatory framework for the authorization and marketing of biosimilars, which has since been adopted by the World Health Organization (WHO).

Additionally, Dr. Niazi says that it is difficult to raise money in the US. Venture capitalists and corporate investors are less likely to take risk and have notoriously poor track records with the health sector

Investing In The Windy City

In 2003, the TPI founder committed that his work and company would stay in Chicago.  He believed that from creation to manufacturing and testing to going to market, that TPI would excel in the Midwest due to Chicago’s health care ecosystem, experts and manufacturers.

Through a focus on creating “generic equivalents,” Dr. Niazi is proving that TPI can be wildly successful in the Midwest, and further, that in the same way generics revolutionized how people access pharmaceuticals, biosimilars can revolutionize the way those around the world access lifesaving treatments.

As his biosimilars enter the market with FDA approval, the ability of Dr. Niazi to impact the entire health sector grows because his biosimilars can be substituted for its reference product without provider or patient intervention. However, the FDA has not yet finalized these guidelines, and only 17 biosimilars have been approved internationally to date, of which none are by the FDA.

Ultimately, with numerous billion-dollar biologics coming off patent over the next six years, and the exorbitant cost for specialty drugs, the nine biosimilars TPI has in the pipeline stand to make a huge impact in the health sector. While Dr. Niazi could be doing many interesting things these days as an international man of mystery, he has devoted his research, time and energy to bringing high quality, cost-effective treatments to the US, and beyond. So long as he maintains his wine parties and poetry readings, its certain no one will complain.

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Expanding Insurance May Not Mean Long Lines and Trouble Seeing the Doctor

When health reform made it on the agenda in 2008-9, it took almost no time to hear the old familiar line that government-run health care will mean rationing, with crowded waiting rooms and the dreaded prospect of it taking months or years to get seen by the doctor or have an important surgery performed. It didn’t matter when Brits and Canadians chimed in to say “Actually, it’s not like that here at all.” Americans succumbed to the combination of logic and fear. The logic is apparent: If more people have the ability to go to the doctor, and there isn’t suddenly a corresponding increase in doctors, then either doctors are going to have to see more patients in less time (potentially reducing quality), or patients are going to have to wait to be seen (and we don’t like to wait). Given my parenthetical explanations in the preceding sentence, do I even need to elaborate on the fear aspect?

There’s just one important question: Is that really what will happen? This is where the good folks at Harvard who do health policy and health services research are so lucky. In Massachusetts, which basically implemented ObamaCare at the state level years before ObamaCare came into being, we have a nice policy laboratory to investigate this question. That’s precisely what Karen Joynt and colleagues did, as they report in a recent article in Health Services Research.

The very short version of what they did is this: Using Medicare data, they looked to see if people with chronic diseases like diabetes and hypertension had fewer outpatient visits to the doctor after the Massachusetts health reform was enacted, compared to the number of visits they had before the reform. They also looked at some quality metrics in the same way. That is, did the patients get the treatments we know they are supposed to get? And they also looked at health care costs. The cool thing about this is that they were able to use patients in other New England states that didn’t have health reform as controls. That means that their study design is really able to attribute any changes they see in Massachusetts above and beyond what they see elsewhere in New England to the health reform in Massachusetts.

The very short version of what they found is this: There was no decrease in health care visits or health care quality in Massachusetts because of health reform, but there was an increase in costs. Now, there are some limitations to what they did, but the authors acknowledge these nicely. The biggest issue is that Massachusetts had a low rate of uninsured persons to begin with, so their health care system was less flooded with newly insured than other places–like Kentucky–might be thanks to the ACA. The other big issue is that the study only examined the Medicare population age 65 and up, so we have no idea if the under-65 disabled Medicare population and everyone else may have experienced issues getting seen by a doctor. Still, despite these limitations, the study offers a ray of hope that our health care delivery system is responsive enough to adapt to an increase in demand without making us suffer lengthy waits to be seen for outpatient care, and that the ACA may well end up doing more good than harm.

 
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Posted by on September 23, 2014 in "Rationing", Recent Research

 

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