ELITE 2020 Uber Winner Syed M. Shah of IM HealthScience LLC

Syed M. Shah, PhD

Chief Innovation Officer

IM HealthScience LLC

Photo Credit: Valerie Noell

It all started with cow’s milk. While attending the Illinois Institute of Technology in Chicago, Syed M. Shah, PhD, got a part-time job at Beatrice Foods Research Center. While working as a lab technician, he discovered and isolated the natural emulsifier in milk that would prove to be a pivotal component in making salad dressings, whipped toppings, and other food formulations. It was Syed’s first patent.

Almost 50 years later, Syed is the co-inventor on 77 U.S. patents, with the vast majority within the pharmaceutical and healthcare space. In his 20 years in Big Pharma R&D (including roles at Pfizer, Wyeth, and Lederle Labs), he played a key leadership role in the science behind four blockbusters: Pristiq, Zosyn, Tygacil, and Protonix. Currently, as the Chief Innovation Officer at IM HealthScience, Syed is working on harnessing natural products and their oils to solve issues in neuroscience and gastrointestinal (GI) health that pharmaceuticals have yet to address.

“My approach for most of my inventions is to address unmet need—find ways to improve on molecules, their delivery, and how they can become more effective and tolerable,” Syed explains. “Innovation builds upon the molecular discovery process. Usually in R&D, the sexy part is discovering the new compound, and just showing it works on a limited patient population. But molecules are only as good as their targeted delivery and absorption, and I have repeatedly succeeded in expanding the reach of molecules to new patients by changing how they work in the body.”

The Tale of Four Blockbusters

That strategy is behind some of Syed’s most successful products. For example, Zosyn (piperacillin plus tazobactam) was already an antibiotic used to treat pneumonia, but it could not be administered to patients with high-blood pressure or diabetes. By discovering a formulation of Zosyn that could be administered to those patients, Syed helped more people to be treated with this life-saving drug.

In the case of Pristiq (desvenlafaxine), Wyeth had already developed another serotonin-norepinephrine reuptake inhibitor (SNRI) in Effexor (venlafaxine). However, since Effexor metabolized differently in each patient, it required patients to be individually titrated by gradually increasing their dosage until the patient’s health stabilized. Furthermore, it couldn’t be used in the Japanese population and a significant percentage of the general U.S. population who have a different liver function. In inventing Pristiq, Syed created a treatment option with a fixed dose, which could be taken just once-per-day, and used in any patient population.

And as the world saw an increase in antibiotic resistance, Tygacil (tigecycline) showed promise in rescuing patients from infections that other antibiotics did not work on. The one problem: Tygacil would degrade while giving it to the patient. Syed developed a form that would not degrade, which also made it safer since the effects of degrading products are unpredictable.

Pantoprazole (discovered by Altana Pharma) was showing effective results for patients with nocturnal GERD. The big drawback was the initial tablet formulation could get held up in the stomach where the acidity would destroy the formulation’s active ingredient. Syed helped develop a multi-particulate formulation, which meant delivering the active ingredient in a bead form that would readily get past the stomach and into the intestines. This not only provided faster efficacy, but also allowed easier dosing for both elderly patients and children—ultimately leading Protonix to become a $2 billion product in the U.S.

Unlocking the Power of Natural Products

“After 20 years in pharma, I noticed patients were getting very concerned about adverse events and side effects of pharmaceutical products, and were increasingly gravitating towards natural products” Syed says. “I saw the opportunity to deploy my pharmaceutical sciences learnings to make natural products much better, so that they could be patented as new entities.”

Syed has used his serial success in both food and pharmaceutical R&D to unlock the power of essential oils to be used within the body. While herbal extracts from natural products have been used on the skin or through aromatherapy, they could not be effectively delivered orally because humans have difficulty absorbing oils directly and doing so can cause side effects such as heartburn. Syed solved this issue of essential oil oral delivery and helped to develop several game-changing products now on the market.

For IBgard, the powerful bioactive extract L-menthol from peppermint oil was put to good use in managing Irritable Bowel Syndrome (IBS). Studies have shown IBgard can provide relief of GI symptoms, especially abdominal pain, within two hours after dosing and without the typical issue of heartburn seen with conventional peppermint oil products. Once again, Syed developed the product to work in all IBS patient sub-populations (IBS-D, IBS-C, IBS-M), which is not the case for all IBS treatments.

Syed also developed FDgard, which uses caraway oil and L-menthol to treat the symptoms of functional dyspepsia. While this meal-triggered indigestion disorder affects 40% to 50% of the Asian population and about 25% to 30% of the European and American populations, there were no approved treatments before FDgard.

Another of Syed’s natural products is REMfresh, launched by IM HealthScience’s sister company Physicians Seal. This product solved an issue many companies and universities struggled with for years: How to deliver a flat-topped melatonin profile in the blood and thus to the brain, for seven hours, in order to help people who struggle to sleep.

A Future of More Innovation

Syed is not remotely done. One of his most recent patents involves using CBD to treat pain around the GI tract in the same way people can take something orally to treat a headache. Syed developed a bead formulation (much like he did for Protonix) that allows CBD to get past the acidity in the stomach and deliver it within the GI tract to treat pain often felt by people with IBS, ulcerative colitis, Crohn’s disease, diverticulitis, and similar disorders. Currently, no products on the market offer patients this kind of relief. While the product and its patent are still in development, a locally acting CBD should surprise the GI community with its efficacy and safety.

Syed’s next big ambition: Help tame Alzheimer’s and dementia. Watching his own mother suffer from Lewy Body dementia, he knows the effect those diseases have on patients and the people who care for them.

“Within the last 10 years, we filed a lot of patents in regards to dementia and Alzheimer’s,” Syed explains. “We are examining potential products with an aging population in mind, how to help keep the challenges of senescence at bay especially mental acuity, as well as mobility, muscle pain, low energy, etc. We have been so busy pursuing breakthroughs in GI and sleep that we haven’t gotten to this huge area of unmet need. This could be our most exciting challenge yet.”

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