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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Community Benefit: Holding Non-Profit Hospitals Accountable

With all of the recent scrutiny of Mitt Romney’s tax returns, here’s something you might not know: non-profit hospitals are exempt from paying any federal income taxes. The rationale behind this is that these hospitals deserve a break because they provide significant benefits to their communities. This community benefit can be thought of as consisting of the sum total of a number of things like the amount of uncompensated care the hospital provides, the number of lives it saves, the number of jobs it provides, and the impact it has on residents’ quality of life. If a hospital is creating jobs, restoring people’s health, saving people’s lives, and providing a health care safety net for the community, then perhaps it shouldn’t have to pay federal taxes. Similar to the case for making employer-based health insurance tax-free, this is a way for the federal government to effectively subsidize something that it considers to be beneficial to the public.

Hospitals certainly enjoy their tax exemption, but the bigger question is: Do they deserve it? For more than 40 years, the rhetoric of community benefit has been bandied about without actually defining what it includes, establishing criteria for the amount of community benefit that must be provided to merit non-profit status, or evaluating the extent to which non-profit hospitals are doing so. What has been done is research showing that more often than not, non-profit hospitals behave a lot like for-profit hospitals. And who can blame them? After all, why not take the tax break with one hand and attempt to maximize profits with the other hand? In fact, the former bolsters efforts at the latter.

Since 2009, however, the IRS has required non-profit hospitals to document the dollar amount of the community benefits they provide. In the February issue of the American Journal of Public Health, Karen Principe and colleagues consider what effect health reform may have on the provision of community benefit. For example, as more Americans are covered by insurance, the amount of uncompensated care a hospital provides can be expected to decrease. The authors report that some have called for an end to non-profit status for hospitals. One way to think about this is that the federal government would be shifting its subsidy from the hospitals to the individuals as it helped them to purchase insurance. The authors disagree, however. They argue that hospitals will still need to provide uncompensated care for individuals who move in and out of coverage, and that coverage expansions under the Affordable Care Act will strengthen the financial position of hospitals, leading hospitals to allocate community benefits differently. That is, they will provide less uncompensated care, but more of the “other” stuff that constitutes community benefit.

I like their optimism, but without strong enforcement to hold non-profit hospitals accountable, I think hospitals are about to win big: They’ll keep their tax-exempt status, provide even less uncompensated care, see their revenues increase, and laugh all the way to the bank. And who can blame them? After all, they’ve no incentive to do otherwise.