Bruce F. Scharschmidt

Scharschmidt was born in East Cleveland, Ohio. He now lives in San Francisco, California with his wife, Peggy S. Crawford M.D.[1]

Scharschmidt graduated from Shaw High School in East Cleveland[2] and completed his undergraduate and medical education in Northwestern University’s Honors (6-year) Program in Medical Education.[3] After completing his residency training in Internal Medicine at the University of California, San Francisco (UCSF) in 1972, Scharschmidt worked for three years as a Clinical Associate at the National Institutes of Health, where he was a founding member of the Liver Disease Research Branch of NIDDK.[4]

Scharschmidt returned to UCSF in 1975 for subspecialty training in gastroenterology, and in 1977 joined the UCSF faculty. In 1985, he became a Professor of Medicine and, in 1990, was named Chief of the Gastroenterology division.[5]

While at UCSF, for two decades Scharschmidt led an independent NIH-funded research laboratory focused on liver physiology and the pathophysiology of liver disease. His research team elucidated cellular mechanisms of bile formation, including characterization of the hepatic uptake of organic anions such as bilirubin,[6] demonstration that hepatic update of bile acids is sodium-coupled and electrogenic,[7] identification of the presence on the basolateral hepatocyte membrane of a sodium-coupled bicarbonate transporter critical to intracellular pH regulation,[8][9] and reporting of the initial evidence that hepatic bile acid secretion is mediated by an ATP-dependent transporter (later identified and shown to be mutated in progressive familial intrahepatic cholestasis type 2).[10] His team also collaborated in the identification of the gene that is responsible for progressive familial intrahepatic cholestasis type 1, previously known as Byler's disease, as well as benign recurrent intrahepatic cholestasis.[11]

Scharschmidt was an invited speaker at the 1982 NIH Consensus conference on Liver Transplantation,[12] he reviewed and presented the results of liver transplantation, which at that time was carried out in only four centers worldwide, and authored the then definitive article on liver transplantation outcomes.[13] The NIH Consensus Conference concluded that liver transplantation was no longer experimental, which paved the way for its reimbursement and availability at centers throughout the US and worldwide. Subsequently, with his UCSF colleagues in surgery, Scharschmidt helped launch the UCSF liver transplant program.[14][15] As a member of the Training and Workforce Committee of the American Association for the Study of Liver Diseases,[16] he worked with his colleagues to set current standards for training in hepatology.

More than 15 individuals trained directly with Scharschmidt, several of whom became gastroenterology division chiefs,[17] and/or deans [18] and dozens more completed the UCSF gastroenterology training program for which he was responsible.[19] He authored an invited article on the topic of mentoring for Gastroenterology.[20]

In 1996, Scharschmidt moved to Chiron Corporation,[5] where he served as Corporate VP responsible for the clinical development of both therapeutics and vaccines until its acquisition in 2006 by Novartis, where he remained for two years. While at Chiron and Novartis, his team was responsible for the successful clinical development and approval of therapeutics, including interleukin 2 for melanoma.,[21] Scharschmidt also played a central role in the early development of several new vaccines subsequently approved in the US and/or Europe, including the first influenza vaccine manufactured using mammalian cell culture rather than the traditional fertilized chicken eggs, the first adjuvanted flu vaccine,[22] the meningococcal C vaccine[23] used to help curb deadly outbreaks in Canada and the UK, a tetravalent meningococcal vaccine effective against A, C, Y & W strains,[24] and the first vaccine against meningococcus B.[25]

In April 2008, Scharschmidt left Novartis to join Hyperion Therapeutics, a bay area biotech startup which was in early phase development of an ammonia lowering agent for patients with urea cycle disorders (UCDs).[26] Within a month of his arrival, Hyperion was downsized. As a member of Hyperion's management team, he was closely involved in taking the company public in 2012 (HPTX, NASDAQ) [27] orchestrated Hyperion's successful secondary stock offering in 2013,[28] and completed the sale of the company to Horizon Pharma in May 2015.[29]

Scharschmidt currently serves as Board Member and/or consultant to several biotechnology companies in the US and abroad.[30][31]

Scharschmidt was elected to membership in the American Society for Clinical Investigation (ASCI) at age 36[32] and was subsequently elected ASCI President.[33] He served from 1987-1992 as Editor-in-Chief of the Journal of Clinical Investigation (JCI),[34] the official publication of the ASCI. He was also elected to the Association of American Physicians.

Scharschmidt served as Associate Editor of Gastroenterology (1981-1986),[35] Associate Editor of the textbook Gastrointestinal and Liver Disease, (5th, 6th and 7th Editions)[36] and as Editor of the Pocket Clinician textbook on Internal Medicine.[37] He has received the Western Gastroenterological Association Research Award (1988), the University of Toronto Sheila Sherlock Research Award (1991),[38] was 1998 Honoree of the American Liver Foundation Northern CA Division's Salute to Excellence,[39] and was named 2010 Distinguished Northwestern Feinberg School of Medicine Alumnus of the year.[40]

Scharschmidt is inventor or co-inventor on multiple US (Patent Nos. 5,308,833,[41] 8,404,215,[42] 8,642,012,[43] 9,095,559,[44] 13,610,580,[45]) and international patients with multiple patents pending.

Scharschmidt has authored over 200 research and review articles. The clinical trials designed under Scharschmidt have resulted in over 20 publications.[46] They address not only with the performance characteristics of RAVICTI,[47] but also the use of blood and urine metabolites for drug dosing and the optimal timing and target levels for blood ammonia in patients with urea cycle disorders so as to minimize the risk and frequency of hyperammonemic crises,.[48][49] Bruce's team at Hyperion also designed and executed a large randomized, double-blind placebo controlled trial which demonstrated that lowering ammonia in patients with cirrhosis complicated by hepatic encephalopathy (HE) decreases the risk and frequency of HE episodes.[50] These findings, which were presented at the plenary session of American Association for the Study of Liver Disease, established that ammonia is not just a correlate, but a cause of HE and, as with UCDs, established the optimal timing and target levels for blood ammonia in cirrhotics so as to minimize their risk and frequency of HE episodes.[51] He also helped define the natural history of HE [52] as well as methodology for its diagnosis [53]

As ASCI President, Scharschmidt initiated and obtained industry and NSF funding for a High School Science Teacher Summer Scholarship Program,[54] which paired science teachers with ASCI mentors so as to enable them to teach science as the exciting discipline of discovery. Bruce has served on the National Board of Directors of the American Liver Foundation,[55] on the External Advisory Board for the Clinical Translational Science Award at Northwestern/Feinberg School of Medicine, where he also served as President of the Medical Alumni Association Board from 2015 to 2017.[56] He has chaired the Translational Team of the Gladstone Institutes, where he is also a member of the President's Council.[57] He ran in the 2005 and 2006 Boston Marathons [58] and participated in the 2008 Mt. Shasta Climb [59] to raise funds for the American Liver Foundation, organized with his son in 2009 the “Biking For Burma’s Malnourished” bike ride from Central Thailand to the Burma Border to raise money for Global Health Access Program,[60] and in 2010 co-founded the ‘Cure the Cycle Challenge’ for the National Urea Cycle Disorders Foundation [61] in which he participated as a rider from 2010 through 2015.