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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NFL Players Host Concussion Summit Week Before Super Bowl, Despite Ongoing Litigation

Real innovation is often driven by those who think outside the box; those who take the obvious and make it an actionable reality. The week leading up to Super Bowl XLVIII, a group of entrepreneurs created a unique and transformative meeting of the minds. At the Coalition for Concussion Summit (#C4CT), Brewer Sports International and Amarantus BioScience Holdings, Inc. joined forces at the United Nations’ (UN) New York headquarters to bring scientists, biotech companies and professional athletes together, with the goal of building awareness and advancing scientific and medical opportunities for traumatic brain injury (TBI), chronic traumatic encephalopathy (CTE) and concussions. Add in the weight of immediate policy implications of the National Football League facing litigation for not properly informing or protecting players and Northwestern University’s football team attempting to unionize in hopes of improving athlete’s rights, and a perfect storm is created to demand change. Collectively, the week of the Super Bowl developed into an ideal time, location and platform for changing standards of health care and promoting developments in mental medical care that are patient-centric.

NFL Litigation

In the months preceding the 2014 Super Bowl, the NFL and the NFL Players Association (NFLPA) found themselves in a heated battle over the allegations that the NFL withheld information from the players about the depth and breadth of research indicating that concussions, memory loss and memory deterioration are linked. The NFL has since agreed to a $765 million settlement, which was recently denied by Judge Anita Brody who claims that the in the suit, “not all retired NFL football players who ultimately receive a qualifying diagnosis, or their related claimants, will be paid.”

While that decision is pending, more lawsuits are beginning to surface from individual players. Last Tuesday, former Detroit Lions running back Jahvid Best sued the NFL and helmet maker Riddell, claiming that concussion problems contributed to ending his career early

However, according to Robert Griffith, a 13-year veteran of the league, it doesn’t take a career-ending hit to significantly impact long-term functioning. “Guys suffer the same symptoms even after a few years in the league, including, sleep deprivation, depression, mood swings, addictions and self worth problems.”

The same week of the Super Bowl, the Northwestern University football team also dropped a bomb on the sports world, despite efforts from the National Collegiate Athletic Association (NCAA) to curb player concussions. The team wants to change the way university’s view, treat and educate student athletes, claiming more players’ rights are needed. This comes in tandem with a more than two-year long effort by several college players to sue the NCAA for failing to protect student athletes from concussions. An irony, pointed out by Chris Nowinski, author and former professional wrestler with World Wrestling Entertainment (WWE), who noted that “We have pitch counts for shoulders, even in high school, but we don’t have hit counts.”

Health Policy at the Forefront

When the NFL, the United States’ most powerful sports league, is on the hot seat for neglecting players’ mental and physical health, it is only a matter of time before public outrage requires policy change. Not only does the NFL itself have the ability to change health policy for the better, but the trickle down impact could save many young athletes around the country the trauma that current and past players have suffered.

Ultimately, a new standard of care is possible in the near future. Because, as Jermichael Finley told me, “100% or 50%, it doesn’t matter how one steps on the field. It isn’t if you get hurt, it’s when you’ll get hurt.” Further, as one conference goer attested, “We are speaking on the floor of the United Nations about brain trauma. This has never before been possible.”

With that in mind, researchers and clinicians such as Andrew Maas, MD, PhD, Robert Stern, PhD, Kim Heidenreich, PhD and Jay Clugston, MD came together with patients and biotech companies to discuss the current state of trauma, neuroscience, degenerative diseases, sports medicine and public policy.

Meeting Of The Minds

Despite the exorbitant power of the NFL, surprisingly little has been done to advance the conversation between athletes and the scientists who work diligently to understand and protect our brains. Until now.

As the nation’s best football players ascended upon New York and New Jersey, Brewer Sports International and Amarantus BioScience Holdings, Inc. gathered a room full of athletes and scientists to educate one another and discuss the real world of traumatic brain injury, concussions and memory loss.

“As a former NFL player, I am passionate about making strides to improve the health and safety of my fellow professional athletes, both former and current,” said Jack Brewer, CEO of Brewer Sports International. “Instead of pointing fingers, we have put together a world class panel of researchers to discuss TBI-induced neurodegeneration and CTE with those directly affected by and equally passionate about the cause as we strive to enhance awareness and work to find viable treatments.”

Gerald Commissiong, President and CEO of Amarantus reinforced the originality of the idea saying that, “The true innovation in #C4CT lies in bringing all of the stakeholders on the concussion issue into one forum. Conferences that are medical in nature almost always overlook key groups such as patients, caregivers and advocates. By allowing patients to be part of the process, we are creating a paradigm shift that we hope will galvanise the broader community into action.”

Brain Function

Despite Super Bowl caliber athletes having athletic abilities that are superior to most, the brains and vulnerabilities of these athletes are comparable to all others. The impact of one hard hit or one concussion can disrupt brain function forever. A point that resonates with Mixed Martial Arts (MMA) fighters as well. Just yesterday, boxing rivals met on Capitol Hill with Senators to support efforts of the Cleveland Clinic in studying brain health. They were backed by more than 400 of their peers who wanted to maintain their profession, but ensure that the future is brighter for other athletes.

Even veteran players such as Clinton Portis assert that he does not have regrets about his career but that he, “will not let my sons play contact football until at least high school,” due to the limited research that exists on TBI and concussions.

Those downstream effects, many at the summit contend, are highly linked to neurodegeneration, memory loss and long-term functioning. However, this is exceptionally hard to prove given how hard apples-to-apples comparisons are of brain damage and functioning. This association is further limited by the ability to compare impact enumeration and force due to the small sample size that are athletes.

Events such as the Coalition for Concussions Summit are becoming imperative to change health policy. When organizations, individuals, researchers and policymakers cannot fight the battle alone, it takes a meeting of the minds to advance a message. Hopefully, assembling key stakeholders to address health care problems will become a norm to improve health and care in the US.

 

As They Age: Women Know What They Do Not Know

The need for health care varies greatly over a lifespan, with older adults having significantly more health-related needs and costs than younger individuals. Women, in particular, often face a myriad of health problems as they transition through menopause. Sadly, despite the fact that every woman will go through menopause, very little is understood about the physical and mental changes that occur during this period of life. In addition, women may struggle to find pharmaceutical solutions, which can safely provide proven relief without the worry that those available will increase their likelihood of other health and mental complications.

Much is misunderstood about menopause and the changes that are associated with the hormonal fluctuations. This is largely due to the fact this inevitable transition is rarely apart of the conversation, particularly in the context of health care. Further, menopause is expected to be merely “bothersome”; not something one could attribute real health problems to. Although maternity care and issues related to younger women are required in the Affordable Care Act as essential health benefits, nothing of legislative note will improve the knowledge and acceptance of this natural life progression.

Most insurance companies do not even cover basic mediations associated with menopausal symptoms, and conflicting research has women scared about the potential long-term effects associated with hormone replacement therapy. Negative press, little medical literature and low financial assistance often leaves women to suffer through menopause silently, many of whom worry constantly about memory deficits they experience and potential long term changes.

A recent study focused on the memory complaints of midlife women has been receiving a lot of attention. The study, conducted at the University of Illinois- at Chicago (UIC), attempted to determine if women who are experiencing hot flushes during menopause were able to accurately predict their own memory performance.

According to the principal author, Lauren Drogos, “We found that a one-item question: ‘How would you rate your memory in terms of the kinds of problems that you have?’ was the best predictor of verbal memory performance on a list-learning task. We also found that many complaints were related to mood symptoms.”

In the US, the average woman becomes postmenopausal around the age of 51. Common symptoms that occur include hot flushes, sleep disturbances, mood changes and memory problems. However, until recently it was believed that women were unable to accurately describe the current state of their memory and the changes they experience as they progress through menopause.

Despite the difficulty in being taken seriously about the physical and mental challenges that menopause presents, this recent study from Drogos, along with other research, shows that woman are able to accurately describe their current memory abilities. Specifically, a group of sixty-eight women performed a series of memory tests and were then asked, to detail the types of memory problems they were experiencing. The study concluded that women were able to accurately rank themselves on a scale from no memory problems to severe problems.

Using recall of a short story, the deficits seen in memory did not indicate that women were suffering from dementia, nor were they experiencing shortfalls in memory that were impacting daily life. Instead, it was simply indicative that women who experienced memory deficits often recognized the changes occurring.

Previous research focusing on women’s transitions through menopause also found that hot flushes during the nighttime were the best predictors of memory performance in women. This leads researchers within the Women’s Mental Health Research Program at UIC, to believe that sleep disturbances and stress hormones may play integral roles in memory and hot flushes.

The good news for women concerned about the transition through menopause is that the cognitive decline that occurs appears to only be temporary, with performance rebounding early into post-menopause. Further, for those who want to keep both their minds and bodies at peak performance, research indicates that leading a non-sedentary lifestyle, keeping mentally active, and having a healthy diet can be the best preventers of cognitive decline.