Sanaria's Leadership and Advisors


Management

Stephen L. Hoffman MD, DTMH, DSc (hon), FASTMH, FIDSA, FAAAS, FAAM, CAPT, MC, USN (RET)

Chief Executive and Scientific Officer

Dr. Hoffman has over 40 years of experience building and managing large, successful research and development programs. From 1987-2001 he was malaria program director, Naval Medical Research Center, where his team were leaders in subunit malaria vaccine development and sequencing the Plasmodium falciparum genome and published the first studies in the world showing DNA vaccines elicited killer T cells in humans. In 2001 he joined Celera Genomics as Sr. VP biologics and created a program to utilize genomics and proteomics to produce biopharmaceuticals, begin the field of personalized (precision) medicine, and sequence the genome of the mosquito, Anopheles gambiae. He has held several professorships, chairs or serves on multiple advisory boards, is past president of the American Society of Tropical Medicine and Hygiene, authored > 500 scientific publications, and has > 65 patents. He is the most highly cited author in the world for scientific papers on malaria published between 1995 and 2005, was listed as the third most influential person in the world vaccine industry in 2015 when he received the Vaccine Industry Excellence Award for Best Biotech CEO. He received his BA from Penn, MD from Cornell, and Diploma in Tropical Medicine and Hygiene from London School of Hygiene and Tropical Medicine, and did residency training at UC San Diego. He was elected to membership in the National Academy of Medicine in 2004, and received the Distinguished Alumni Award from Weill Cornell Medical College in 2016.

B. Kim Lee Sim, PhD, FASTMH

Executive Vice President Process Development and Manufacturing

Dr. Sim has led all process development and cGMP manufacture of Sanaria’s aseptic, purified cryopreserved Plasmodium falciparum sporozoite (PfSPZ)-based products that have been assessed in > 36 clinical trials in the U.S. and 10 European and African countries, and will soon enter phase 3 development. She is also president and CSO of Protein Potential, LLC (proteinpotential.com), which she founded in 2003. Protein Potential is currently focusing on a vaccine for shigellosis, ETEC diarrhea, and typhoid fever. Dr. Sim did her undergraduate (B.Sc., Honors, First Class) and graduate studies (M.Sc., Ph.D.) at the University of Malaya. After a post doctoral fellowship in molecular biology at Harvard School of Public Health, she was a research scientist at the Walter Reed Army Institute of Research and adjunct faculty at the Uniformed Services University of Health Sciences, a research assistant professor at Johns Hopkins School of Public Health, and an Expert at NIAID, NIH. In 1993 she joined EntreMed Inc. as research director of molecular biology, and in 1999 was appointed VP pre-clinical R&D. At EntreMed, Dr. Sim established a development program for anti-angiogenic proteins for cancer therapy, and developed the process that led to cGMP manufacture of tens of kilograms of Angiostatin and Endostatin, anti-angiogenic proteins that entered phase 2 clinical trials. Dr. Sim has extensive experience with yeast and bacterial expression systems and recombineering technologies. She has >148 published scientific papers, and 29 issued and > 7 pending patents.

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Peter F. Billingsley, PhD, FASTMH

Vice President of International Projects and Strategy

Dr. Billingsley has been a senior member of the team, developing and testing, the PfSPZ product portfolio since 2006. After consulting for Sanaria, he came on board as the Senior Director of Entomology and Quality Systems, using his knowledge to advance the methodologies for aseptic mosquito rearing and to develop the Quality System for the early phase work through to the first clinical trials of PfSPZ Vaccine, and working with clinical sites around the world to be fully prepared for vaccine and CHMI studies.  As VP, he has catalyzed international interactions with clinical sites and particularly fostered the major program to test PfSPZ Vaccine in an elimination demonstration project in Equatorial Guinea; in this regard he interacts closely with the teams in Equatorial Guinea, including the government. He has led successful grant applications to support Sanaria’s mosquito research aimed at reducing cost of goods.  Prior to working at Sanaria, Dr. Billingsley led a well-funded medical and veterinary entomology research team at the University of Aberdeen in Scotland, where he was also director of postgraduate studies for the life sciences and head of zoology. His research centered around mosquito biology and malaria transmission both in the lab and the field.  He was awarded a prestigious Royal Society University Research Fellowship in 1988 which he held at Imperial College, London and prior to that held a Royal Society NATO at the Swiss Tropical Institute (now Swiss Tropical and Public Health Institute) in Basel where he began his research endeavors into mosquito biology and malaria transmission. He earned his PhD in Biology from Queen’s University (Kingston, Canada) and his BSc in Agricultural Zoology from the University of Leeds (UK). He has over 100 publications and is or has been on editorial boards for numerous international journals.

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Thomas L. Richie, MD, PhD, CAPT MC USN (ret)

Chief Medical Officer

Dr. Richie is an internationally recognized expert in vaccine development. He received his MD and PhD (evolutionary biology) from the University of Pennsylvania, did his internal medicine residency training at Massachusetts General Hospital (Harvard), and his infectious diseases training at Johns Hopkins Hospital. Before joining Sanaria in 2014, he directed the Malaria Program and headed the Department of Clinical Studies at the U.S. Naval Medical Research Unit #2 (NAMRU-2) in Jakarta (1992-1998), served as the Director of Clinical Research in the Malaria Department, Naval Medical Research Center (NMRC) and the Director of the Clinical Trials Center in Bethesda, Maryland (1999-2003), and directed the U.S. Navy’s Malaria Program (2004-13) and the U.S. Military Malaria Vaccine Program (USMMVP) at NMRC and the Walter Reed Army Institute of Research in Silver Spring (2010-13). Dr. Richie chaired the Interagency Working Group for Molecular Vaccines (Executive Branch, U.S. Govt), was on the Scientific Advisory Board and Clinical and Development Subcommittees of the International AIDS Vaccine Initiative has served as an expert consultant on controlled human infections and has >125 scientific publications and 5 issued patents. Dr. Richie joined Sanaria to lead the clinical development program for PfSPZ vaccines and other Sanaria products and has since directed Sanaria’s sponsorship of over 30 clinical trials of these products since 2014, including 18 trials in Africa and Asia.

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Alexander D. Hoffman, JD

Chief Legal Officer

Mr. Hoffman is responsible for corporate legal matters, business development, insurance, and information technology.  He has negotiated the hundreds of contracts, research agreements, collaborations, and other types of partnerships that have taken the PfSPZ Vaccine from a concept to a reality and continues to ensure that these partnerships and collaborations remain strong.   Mr. Hoffman received his JD from the University of Denver and his BA from Tulane University.  In addition to his role at Sanaria, he also sits on the Board of the Akumaning-Brewu Foundation, a non-profit that provides educational support for under-resourced elementary school children in Ghana, and is General Counsel for Protein Potential, LLC.

Board of Directors

Stephen L. Hoffman MD, DTMH, DSc (hon), FASTMH, FIDSA, FAAAS, FAAM, CAPT, MC, USN (RET)

Chairman

Dr. Hoffman has over 40 years of experience building and managing large, successful research and development programs. From 1987-2001 he was malaria program director, Naval Medical Research Center, where his team were leaders in subunit malaria vaccine development and sequencing the Plasmodium falciparum genome and published the first studies in the world showing DNA vaccines elicited killer T cells in humans. In 2001 he joined Celera Genomics as Sr. VP biologics and created a program to utilize genomics and proteomics to produce biopharmaceuticals, begin the field of personalized (precision) medicine, and sequence the genome of the mosquito, Anopheles gambiae. He has held several professorships, chairs or serves on multiple advisory boards, is past president of the American Society of Tropical Medicine and Hygiene, authored > 500 scientific publications, and has > 65 patents. He is the most highly cited author in the world for scientific papers on malaria published between 1995 and 2005, was listed as the third most influential person in the world vaccine industry in 2015 when he received the Vaccine Industry Excellence Award for Best Biotech CEO. He received his BA from Penn, MD from Cornell, and Diploma in Tropical Medicine and Hygiene from London School of Hygiene and Tropical Medicine, and did residency training at UC San Diego. He was elected to membership in the National Academy of Medicine in 2004, and received the Distinguished Alumni Award from Weill Cornell Medical College in 2016.

B. Kim Lee Sim, PhD, FASTMH

Executive Vice President Process Development and Manufacturing

Dr. Sim has led all process development and cGMP manufacture of Sanaria’s aseptic, purified cryopreserved Plasmodium falciparum sporozoite (PfSPZ)-based products that have been assessed in > 36 clinical trials in the U.S. and 10 European and African countries, and will soon enter phase 3 development. She is also president and CSO of Protein Potential, LLC (proteinpotential.com), which she founded in 2003. Protein Potential is currently focusing on a vaccine for shigellosis, ETEC diarrhea, and typhoid fever. Dr. Sim did her undergraduate (B.Sc., Honors, First Class) and graduate studies (M.Sc., Ph.D.) at the University of Malaya. After a post doctoral fellowship in molecular biology at Harvard School of Public Health, she was a research scientist at the Walter Reed Army Institute of Research and adjunct faculty at the Uniformed Services University of Health Sciences, a research assistant professor at Johns Hopkins School of Public Health, and an Expert at NIAID, NIH. In 1993 she joined EntreMed Inc. as research director of molecular biology, and in 1999 was appointed VP pre-clinical R&D. At EntreMed, Dr. Sim established a development program for anti-angiogenic proteins for cancer therapy, and developed the process that led to cGMP manufacture of tens of kilograms of Angiostatin and Endostatin, anti-angiogenic proteins that entered phase 2 clinical trials. Dr. Sim has extensive experience with yeast and bacterial expression systems and recombineering technologies. She has >148 published scientific papers, and 29 issued and > 7 pending patents.

Judith L. Harris, JD

Ms. Harris is a former Partner in the Regulatory Litigation Group, Reed Smith LLC. She is former Managing Partner of the D.C. office, and has practiced with the firm since 1974, with the exception of two periods of government service. Most recently, Ms. Harris served during the Clinton Administration as Director of the Office of Legislative and Intergovernmental Affairs at the Federal Communications Commission. In that capacity, she was the Commission’s primary interface with Capitol Hill, with the Administration, and with all Executive Branch and independent government agencies. Before entering the government, Ms. Harris’ practice primarily focused on antitrust and trade regulation counseling, civil and criminal litigation, and administrative law, handling regulatory and APA matters before a wide array of federal agencies and in the courts, with a particular emphasis on the healthcare and telecommunications industries. Since returning to private practice, Ms. Harris has continued to work in the healthcare and telecom sectors, concentrating on matters before the FCC, the Justice Department, the Federal Trade Commission, in the courts and on Capitol Hill. In addition to her recent government position, Ms. Harris served as a senior trial attorney with the Antitrust Division of the Department of Justice, both in Washington, D.C. and in San Francisco, and was a law clerk to the Honorable James A. Belson, now of the D.C. Court of Appeals. Ms. Harris is a 1973 graduate of the Yale Law School and a 1970 graduate (Phi Beta Kappa, with highest distinction) of the University of Michigan. She resides in Washington, DC with her husband, Norman Ornstein.

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James E. Schrager, MBA, CPA, JD and PhD

James E. Schrager is a Clinical Professor of Entrepreneurship and Strategy at the University of Chicago Booth School of Business. In addition, he has an active strategy consulting firm in South Bend, IN, and is founding editor of the Journal of Private Equity, published by Institutional Investors, New York, NY. His educational background includes MBA, CPA, JD and PhD degrees. He previously completed deals and turned around businesses for Chicago’s Pritzker family interests, where the largest business he turned around was $500 million in revenue. He also led the first private USA company to go public in Japan in 1989. His articles have appeared on the op-ed pages of the Chicago Tribune, the Wall Street Journal, and other publications, he has appeared on the NBC Nightly News, the PBS Business Report and other television shows, and has been widely quoted in many publications.

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Address:

Sanaria Inc.
9800 Medical Center Drive, Suite A209
Rockville, MD 20850

Phone:

+1.301.770.3222

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