Leadership
John Simard, Chairman, President and Chief Executive Officer
Mr. Simard was founder and chief executive officer of CTL ImmunoTherapies Corp., a developer of therapeutic vaccines, headquartered in Los Angeles with over 100 scientists and support staff. Mr. Simard also founded AlleCure Corp., of Valencia, California, a developer of immune-modulating therapies. In 2001, Allecure and CTL ImmunoTherapies were merged with a third company, forming MannKind Corp. (NASDAQ:MNKD), where Mr. Simard served as Corporate Vice President and Board Member. Mr. Simard has invented several core technologies that form the basis for commercialization programs. Operationally, he has championed an integrated approach to drug development, undertaking R&D, pre-clinical development, manufacturing, and clinical regulatory programs under one roof—which he has used as an effective means to conserve capital and control timelines. Mr. Simard attended graduate studies in Medical Biophysics, University of Toronto and studied biochemistry, at the University of Saskatchewan. He has numerous issued and pending patents related to cancer therapy, therapeutic antibodies and vaccines, as well as substantial peer-reviewed scientific publications and the textbook “Immune Response Genes”.
Dr. Stanley Kim, Ph.D., J.D., Vice President of Corporate Development and Intellectual Property
Dr. Kim has been responsible for engineering XBiotech’s intellectual property portfolio since 2007. Dr. Kim focus has been creating and managing an evolving a strategic and tactical program to strengthen XBiotech’s patent position with respect to True Human antibodies, and the treatment of chronic inflammation. Dr. Kim also acts as counsel on technical legal and business matters such as clinical trials, in- and out-licensing, vendor agreements, collaborations, and finance. Prior to joining XBiotech, Dr. Kim was a partner at a law firm where he led the firm's patent and life sciences practices. A registered patent attorney, Dr. Kim has considerable experience in procuring domestic and foreign patents, licensing and joint ventures, intellectual property opinions and due diligence, strategic patent portfolio development, and intellectual property litigation matters. Dr. Kim is himself an inventor of several patents, has published several legal articles, has been an invited speaker in numerous forums, and has founded or co-founded several different technology companies. Dr. Kim holds a bachelor's degree in Biology from Bowdoin College, a Ph.D. in Microbiology and Immunology from the University of Miami, and a law degree from Suffolk University.
Dr. Michael Stecher, M.D., Medical Director
Dr. Stecher started with the Company in December of 2009 as a medical safety officer. In 2010, he joined XBiotech as a Medical Director, where he is the principle medical expert overseeing the clinical trial program. Dr. Stecher oversees the Company’s in-house clinical regulatory department which implements and monitors all clinical trial programs. Dr. Stecher also works to develop and design clinical protocols and supporting rationales, working closely with leading medical experts in the various disciplines of the Company’s clinical programs. He is in charge of all reporting to the FDA and other regulatory agencies and providing medical oversight for all clinical trials. Dr. Stecher is board certified in Family Medicine, and practiced medicine in the Austin area for 6 years prior to joining XBiotech. He received his medical school training at the University of Kansas, and completed his family practice training in Austin at Brackenridge Hospital (Austin Medical Education Program), where he ultimately served as chief resident of Family Medicine.
Norma I. Gonzalez, Vice President Quality
Ms. Gonzalez was one of the first employees to join XBiotech’s operation in Austin, Texas in 2008. She played a crucial role in launching XBiotech’s manufacturing program and establishing the company’s bioreactor system for the production of clinical trial drug product. Ms. Gonzalez transitioned to developing a full quality program, to enable cGMP compliance and growth of the company’s manufacturing program. Ms. Gonzalez continues to prepare the company to enable pivotal study and commercial scale production. Before joining XBiotech, Ms. Gonzalez was Director of Quality at a world-leading leading manufacturer of heart valves, Carbomedics. During her tenure at Carbomedics, Ms. Gonzalez held various roles including Director of R&D, Director of Manufacturing Mechanical Heart Valve, and Director of Tissue valve and Quality. Prior to Carbomedics, Ms. Gonzalez worked for Shiley Caribbean as a Quality Control & Manufacturing Manager as well as Baxter-Travenol as a Microbiology/QC Supervisor. Ms. Gonzalez holds a B.Sc. in Biology from University of Puerto Rico.
Dr. Sushma Shivaswamy, Ph.D., Director of Research and Development
Dr. Shivaswamy joined XBiotech in 2009 as a senior research scientist and quickly advanced to lead the research and development. The multidisciplinary R&D group has pioneered development of the Company’s technology platform for discovery of True Human™ antibodies. Dr. Shivaswamy has lead the group in the development of new approaches for screening human blood for novel True Human™ antibodies based on super-high-stringency mining technology. She has also led the group to establish the Company’s new molecular cloning and proteomics strategies for identifying the True Human™ therapeutics. Dr. Shivaswamy’s program has also included development of the high-output manufacturing cell lines, for producing antibodies in mammalian cells for large-scale commercial production. Dr. Shivaswamy has an academic background in regulation of eukaryotic gene expression, and is an expert in molecular genetics. Prior to joining XBiotech, Dr. Shivaswamy was a postdoctoral researcher at the Center for Systems and Synthetic Biology at the University of Texas at Austin. She has a Ph.D. degree in Molecular Biology from the Center for Cellular and Molecular Biology, India.
Dr. Seema Kumar, Ph.D., Director of Quality Control
Dr. Kumar has grown XBiotech’s quality control program since early 2008. Dr. Kumar leads a multidisciplinary team engaged in testing quality and stability of drug product during manufacturing, and as final product, in compliance with cGMP and regulatory guidelines. Under her direction is also clinical pharmacokinetics analysis of drug product in compliance with CLIA regulations. Dr. Kumar brings an extensive background in development, implementation and optimization of bioanalytical, biochemical & biophysical methods for the characterization therapeutic antibodies. Dr. Kumar earned a Ph.D. in Biophysics/Biophysical Chemistry from Johns Hopkins University. In her scientific career, she developed state-of-the-art biophysical and bioanalytical methods, authored internationally recognized scientific articles, and has lectured on the subject at numerous international conferences.
Dr. David J. Combs, Ph.D., Director of Manufacturing
Dr. Combs oversees a team that manages all aspects of the manufacturing program—from initiation of cell culture process to fill and finish of drug product. Dr. Combs also oversees a team of research scientists working on both upstream and downstream process development, including media development and product purification technology. In addition, he heads up efforts to develop a custom bioreactor system that will reduce XBiotech’s capital requirements for manufacturing expansion. Dr. Combs previously worked for The Cancer Research Institute at Scott and White Memorial Hospital where he served as Senior Scientist, in charge of pre-clinical development, process development, manufacturing and formulation of immuno-toxins used for clinical trials. While at Scott and White, Dr. Combs was involved in the design and set up of a cGMP facility and has extensive experience designing and running bioreactors used for the production of therapeutics. Dr. Combs has a B.Sc. in Biology from Tarleton State University and a Ph.D. in Cellular and Molecular Biology from The University of Texas at Austin.
Dr. Prasant Mohanty, MD, MBBS, MPH, CCRP, Director of Biostatistics
Dr. Mohanty is a medical statistical expert and is responsible at XBiotech for creating statistical models, sample size and power calculation, experimental design and analysis of clinical trials. As a key member of the Copmany’s clinical and regulatory team, Dr. Mohanty analyzes and interprets data from individual trials, determines strategy and development of internal guidelines, as well as providing statistical expertise for issues in preclinical and clinical research. Dr. Mohanty spent several years with Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, TX as a clinical biostatistician, and five years with Texas Medicaid Healthcare Partnership, Austin TX, as Healthcare Policy Analyst, and three years as an Epidemiologist with Texas Healthcare Information Council (a state agency under Texas Health and Human Services Commission). Dr. Prasant is a SAS Certified Professional, and also holds a Clinical Research Professional certification. Dr. Mohanty has had more than 20 peer-reviewed publications within only the last three years. Dr. Mohanty received his medical degree from S.C.B. Medical College, Orissa, India. He completed his Master of Public Health degree in epidemiology and biostatistics from the University of North Texas Health Science Center, Fort Worth, Texas.
Jim Ferguson, Senior Director of CMC Compliance
Jim Ferguson joined XBiotech in 2008 and has played several roles in the Company. As Sr. Director of Chemistry Manufacturing and Controls (CMC) Compliance at XBiotech, Jim oversees regulatory compliance throughout the development cycle and is primary author of all CMC regulatory submissions. He also plays an important role in providing scientific and technical expertise in the areas of pharmaceutics, process development, assay development and instrumentation. He has worked in the area of GMP biologics development for 12+ years, and previously for 10+ years as a bench-level biochemist. Mr. Ferguson studied biochemistry at the University of Toronto and operated the biotechnology core facility at the Ontario Cancer Institute in Toronto. He then worked in various capacities at CTL ImmunoTherapies (MannKind Corporation) in Los Angeles, starting as formulation chemist, and ending as Director of Clinical Manufacturing. Mr. Ferguson graduated from the University of Toronto with a B.Sc. in Biochemistry.
Board Members
Thorpe McKenzie, Board Member
Mr. McKenzie is Managing Director of Pointer Management Company, Chattanooga, Tennessee, which he co-founded in 1990 to invest in hedge funds and similar types of partnerships utilizing a fund of funds approach. From 1982 until 1990, he was a private investor in New York City, and a director of several public and private companies. From 1980 until 1982, he was founding general partner of TIGER, a global hedge fund. From 1971 until 1980, he was a Vice President of Kidder, Peabody & Co., Inc. in New York. Mr. McKenzie is a graduate of the University of North Carolina in Chapel Hill, and the Wharton Graduate division of the University of Pennsylvania in Philadelphia.
Hector MacKay-Dunn, LLB, QC, Board Member
Mr. MacKay-Dunn is a senior partner at Farris, Vaughan, Wills & Murphy LLP based in Vancouver with over 25 years of experience advising early stage and high growth private and public companies in a broad range of industries on domestic and cross border public and private securities offerings, mergers and acquisitions, tender offers and international partnering transactions. Mr. MacKay-Dunn advises clients in a variety of commercial industries, including biotechnology, technology, cleantech, new media, mining, transportation, personal and health fitness. Mr. MacKay-Dunn was named in the 2011 Lexpert/American Lawyer Guide to the Leading 500 Lawyers in Canada and listed in The Best Lawyers in Canada. Mr. MacKay-Dunn is immediate past Chair of the BC Innovation Council, a director of LifeSciences BC, BC Leading Edge Endowment Fund, and Tennis Canada and is also a member of the University of British Columbia Industry Liaison Advisory Council and Faculty of Science Dean’s Advisory Counsel.
Advisory
Dr. Alexander Knuth
Dr. Knuth is Chief of Oncology, University of Zurich, Switzerland. He is also scientific advisor for the Ludwig Institute for Cancer Research, where he was formerly head of clinical research, overseeing operations for an organization comprising 2,780 medical researchers.
Ernst Bütler
Mr. Bütler is a Member of the Board of Bank Frey & Co AG, Zurich; Chairman of the Board of Alegra Capital Ltd., Zürich; Member of the Board, Solarfun Holding Ltd., China; Chairman of the Board of AA-Capital Ltd., Zurich; and Member of KPMG’s Audit Committee Institute and of PricewaterhouseCooper’s Audit Committee Forum. Mr. Bütler was formerly a Partner and Head of Business Unit for Partners Group, Zug; Managing Director and Co-Head Investment Banking, Credit Suisse First Boston, Zürich/London; and Managing Director & Head Multinational Division, Credit Suisse.