Scientific Advisory Board

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Bioniz’s Board of Directors and Scientific Advisors bring decades of experience to help us realize the full potential of multi-cytokine therapies.

Robert C. Gallo, M.D.

Director, Institute of Human Virology
at the University of Maryland School of Medicine

Dr. Gallo is the eminent scientist who became world famous in 1984 when he co-discovered HIV as the cause of AIDS. Dr. Gallo and his team pioneered the development of the HIV blood test, which enabled health care workers for the first time to screen for the AIDS virus – leading to a more rapid diagnosis while simultaneously protecting patients receiving blood transfusions. In 1996, his discovery that a natural compound known as chemokines can block HIV and halt the progression of AIDS was hailed by Science magazine as one of that year’s most important scientific breakthroughs. Prior to the AIDS epidemic, Dr. Gallo was the first to identify a human retrovirus and the only known human leukemia virus – HTLV – one of few known viruses shown to cause a human cancer.

In 1976, he and his colleagues discovered Interleukin-2, a growth regulating substance now used as therapy in some cancers and sometimes AIDS. And in 1986, he and his group discovered the first new human herpes virus in more than 25 years (HHV-6), which was later shown to cause an infantile disease known as Roseola and currently is hypothesized as a strong suspect in the origin of multiple sclerosis.Prior to becoming director of the Institute of Human Virology in 1996, Dr. Gallo spent 30 years at the National Institutes of Health’s National Cancer Institute, where he was head of its Laboratory of Tumor Cell Biology. A Connecticut native, his interest in science and medicine was first stirred by the loss of his 6-year-old sister to leukemia when he was just 12 years old. The physicians who cared for her made a lasting impression and Gallo would later make scientific research – and the opportunity to help put an end to deadly diseases – his life’s work.

Dr. Gallo’s research has brought him international recognition as well as election into the National Academy of Sciences and the Institute of Medicine. He has been awarded honors for his contribution to science from countries around the world and holds 29 honorary doctorates. Dr. Gallo was the most referenced scientist in the world in the 1980s and 1990s, during which he had the unique distinction of twice winning America’s most prestigious scientific award – the Albert Lasker Award in Medicine – in 1982 and again in 1986. Dr. Gallo is the author of more than 1,200 scientific publications and the book “Virus Hunting – AIDS, Cancer & the Human Retrovirus: A Story of Scientific Discovery.”

Bana Jabri, M.D., PH.D

Director of Research, U. of Chicago Celiac Disease Center

My laboratory investigates the mechanisms underlying the development of complex inflammatory disorders. We combine human ex vivo studies, in vitro human model systems, and mouse models to determine the role of tissue and microbial signals in the regulation of tissue resident effector T cell responses. In human, we focus on the study of celiac disease, inflammatory bowel disease and type-1 diabetes. In early studies we identified a regulatory loop whereby stressed or infected tissue epithelial cells arm cytolytic T cells to kill them through the interplay of the cytokine IL-15, activating receptors of the natural killer (NK) family, and the stress-induced MHC-like ligands MIC and HLA-E. This innate tissue-mediated control of effector CTL constitutes a new layer of immune regulation with implications for disease mechanisms and treatments.

We further characterized the innate signaling pathway regulating NK receptor and IL-15-mediated regulation of effector cytolytic T cells. These discoveries have led to the initiation of clinical trials aimed at targeting IL-15 in refractory celiac disease. In parallel, we characterized the role played by tissues and bacteria in the regulation of T helper cell responses. In particular, we demonstrated that retinoic acid acquired adjuvant properties under conditions of sterile inflammation associated with IL-15 overexpression in the lamina propria. More recently, my laboratory is developing new lines of investigations aimed at addressing the role of host-viral interactions in the loss of tolerance to dietary antigens and the role of epigenetic in the shaping of T cell responses by the tissue environment in which they reside.

Thomas P. Loughran, JR., M.D.

Director, University of Virginia Cancer Center

Thomas P. Loughran, Jr., MD, is the director of the UVA Cancer Center, F. Palmer Weber-Smithfield Foods Professor of Oncology Research and professor of medicine. Loughran’s career as a physician scientist is a testament to translational research beginning with his discovery of large granular lymphocyte (LGL) leukemia. He has published numerous articles in high-impact peer-reviewed journals including The New England Journal of Medicine, Annals of Internal Medicine, Lancet, Journal of Clinical Investigation, Journal of Clinical Oncology and Blood.

From July 2003 to August 2013, he served as the founding director of the Penn State Hershey Cancer Institute and professor of medicine at the Penn State College of Medicine. He previously served as program leader of hematologic malignancies at the H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida, associate director of the Bone Marrow Transplant Program at SUNY Health Science Center and chief of hematology at the Syracuse Veteran’s Affairs Medical Center in Syracuse, N.Y.

Loughran completed his fellowship in medical oncology at the Fred Hutchinson Cancer Research Center under direction of Nobel Prize recipient Dr. E.D. Thomas and remained on the faculty there for seven years.

Yutaka Tagaya, M.D., PH.D.

Professor, Institute of Human Virology
at the University of Maryland School of Medicine

For the past 15 years, Dr. Tagaya has been studying T cell- and cytokine-biology. He started his work as a post-doctoral fellow at the NCI in Dr. Thomas Waldmann’s group. After several years of successful research advances, Dr. Tagaya found the opportunity of establishing his own research group consisting of dedicated post-doctoral fellows and students in the same branch. Dr. Tagaya’s group has made seminal discoveries on the unique functions of cytokine IL-15 (trans-presentation paradigm) and used this model to study the development and functional differentiation of NK and T cells. His group has also generated several cytokine transgenic mice (IL-15, IL-7, and IL-2 transgenic mice, IL-2-GFP knock-in mouse in collaboration) and studied the immunological and pathological consequences of the overproduction of these cytokines. Recent work has also revealed a special and unique function of a transcription factor IRF-8 in the development of effector/cytotoxic CD8 T cells.

Since Dr. Tagaya joined the Institute of Human Virology at the University of Maryland as a faculty member (assistant professor), Dr. Tagaya has been running his own research lab focusing on the development of unique multi-cytokine inhibiting peptides for Bioniz’s BNZ class technology targeting autoimmune and inflammatory disease. These investigations have also involved the study of T cell transformation mechanism caused by HTLV-1 in the context of a human leukemia (ATL; adult T-cell leukemia).

At the same time, Dr. Tagaya has been in charge of creating and running the IHV flow-core which helps the IHV community to run polychromatic flow-cytometry as well as conducting various types of cell-sorting, supervising the entire operation of the core. Dr. Tagaya’s core has special permission to sort infectious (such as HIV-1 and HTLV-1) cells and is the only flow lab in the University of Maryland Baltimore which is capable of conducting such sorting.

Having originally started his research under the influences of his first mentor (Dr. Junji Yodoi) who was a hematology-resident when he discovered the first case of ATL (Yodoi et al. 1974, New Engl J Med), Dr. Tagaya’s drive to address cancers and immune cell proliferation come from a deep desire to find an effective cure for this deadly leukemia.

In memoriam of THOMAS A. WALDMANN M.D.

Renowned Immunologist, NIH investigator, and mentor to Company’s founders

Thomas A. Waldmann, M.D. received his M.D. from Harvard Medical School. He joined the NCI in 1956, and has been Chief of Metabolism Branch since 1973. Over his 59-year career he defined the IL-2 receptor subunits, IL-2R beta and IL-2R alpha using the first-ever reported anti-cytokine receptor monoclonal antibody (anti-Tac, daclizumab, Zenapax). These studies culminated in the definition of the IL-2 receptor as an exceptionally valuable target for monoclonal antibody mediated therapy of leukemia, lymphoma, and multiple sclerosis. He co-discovered IL-15, elucidated its role in persistence of NK and CD8 memory T- cells and completed the first in-human trial of IL-15 in patients with metastatic malignancy.

He introduced blockade of the IL-15/IL-15 receptor and its Jak/STAT signaling pathway for leukemias and autoimmune diseases where gamma-c cytokines including IL-15 play a pathogenic role. His honors include: the Ehrlich Medal, Abbott Laboratories Prize, Bristol-Myers Squibb Award for Distinguished Achievement in Cancer Research, Milken Family Medical Foundation Distinguished Basic Scientist Award, Artois-Baillet Latour Health Prize, AAI-Dana Foundation Award in Human Immunology Research and election to the National Academy of Sciences, The SAMMIE Life Time Achievement Award, identification as an NIH Distinguished Investigator, American Academy of Arts and Sciences, Institute of Medicine of the National Academy of Sciences and Royal Society of the Medical Sciences (UK).

Leadership: We are led by energetic senior research leadership with decades of experience in cytokine biology, peptide therapeutics, and drug development. Our business leadership team also has a long track record of financing biotech companies via both equity issuance and business development.

Nazli Azimi, Pharm.D., PH.D.

Founder & Chief Executive Officer

Nazli Azimi, Pharm.D, PhD, is Chief Executive Officer and Founder of Bioniz Therapeutics. Dr. Azimi is co-inventor of the company’s Next Generation of Cytokine Directed Therapies that covers over 45 patents. With over 15 years in life sciences, startups, and investments, she has a proven track record of leading and managing the cross-disciplinary activities of drug development. Prior to founding Bioniz, Dr. Azimi served as founder and CEO of Dermaheal USA, a privately held dermatology company. She is responsible for raising capital to finance the discovery and development of the Bioniz technology and led the company’s efforts in M&A deals.

Dr. Azimi’s deep scientific knowledge fuels her ability to guide discovery teams and prioritize efforts to identify attractive targets for highly valuable drug candidates. After earning her doctorate degree from the University of Tehran with high honors, she completed a post-doctoral fellowship program in immunology at the National Institutes of Health (NIH). During her tenure at the NIH, she was part of a leading group that discovered and characterized IL-2, IL-15, and their receptors and developed therapeutic monoclonal antibodies against these cytokines. She made seminal contribution to the understanding of disease pathogenesis of IL-2 and IL-15 in several viral, neurological and oncological diseases. Her intimate knowledge of this family of cytokines, led her to the conceptualization of Bioniz platform technology. After NIH, she joined the faculty at the Fred Hutchinson Cancer Research Center, where she collaborated with other groups studying peptide therapeutics. Dr. Azimi has authored more than 30 peer-reviewed publications in the areas of immunology, oncology, virology, and neurological disease. She has been recognized as a leading innovator and business person in several media outlets including EY Entrepreneurial Winning Women and Women in Business in Orange County. She also contributes back to the scientific and community as an advisor to the Chapman University Dean of Pharmacology and a mentor for the entrepreneurial program at the University of California in Irvine.

Kevin Green, M.B.A.

SVP of Corporate Development

Kevin brings over 20 years of experience in operations, finance, business administration and corporate development in the biotech, healthcare, and entertainment industries. At Bioniz, Kevin is responsible for corporate development, operations, strategy, and finance to support the growth of our platform technologies.

Prior to Bioniz, Kevin was Vice President of Corporate and Business Development at Aivita Biomedical, where he was responsible for corporate development, public and investor relations, and venture capital fundraising. At Aivita, Kevin was instrumental in leading the company’s venture raises and securing international licensing and distribution deals to build the dermatology business. Prior to Aivita, Kevin was running his own multinational consulting practice and spent 18 months working on various strategy, corporate, and business development initiatives in biotech and medical devices.

In addition to his consulting experience, Kevin spent almost 12 years at Allergan in business development and finance. During his tenure at Allergan, Kevin was successful in closing over $2 billion in acquisitions and over $750 million in licensing transactions. In addition to biotech and pharmaceuticals, Kevin brings a breadth of healthcare operations and finance experience starting his career working for PacifiCare Health Systems (now United Healthcare) and the Walt Disney Company.

Kevin received his MBA from University of California, Irvine with emphasis in marketing and finance.

Alex Kaoukhov, M.D.

SVP and Head of Clinical Development

Dr. Kaoukhov is the Head of Clinical Development Senior Vice President (SVP), at Bioniz Therapeutics Inc. Dr Kaoukhov is a physician with 20 years of drug development experience. Prior to joining Bioniz he served as Head of Global Development at Almirall a global company specializing in the development of dermatological therapies. At Almirall he was responsible for non-clinical development, global clinical development, pharmacokinetics and statistics. Prior to Almirall, Dr. Kaoukhov was at Allergan where he was Associate Vice President of Clinical Development with oversight of the medical dermatology pipeline. Prior to that, he served in clinical development leadership roles at Novartis (Switzerland) and Galderma (France). During his career, Dr Kaoukhov has driven a number of product approvals of global programs as well as multiple early stage programs under IND and CTA. Prior to joining industry, Dr Kaoukhov conducted clinical research at Saint Louis Hospital in Paris. Dr Kaoukhov earned an MD Degree with Honors from First Moscow State Medical University and was trained in dermatology at Saint Louis Hospital in Paris.

Sunil Shah, PH.D., RAC

Head of CMC

Dr. Sunil Shah is the Head of CMC at Bioniz. His passion for drug development is the hallmark of his professional career, which spans over 30 years across multiple biopharmaceutical companies. Sunil’s formal training started at The University of Iowa. After graduating with a Ph.D. in Pharmaceutics, Sunil has held scientific and managerial leadership positions with progressively higher responsibilities at Spectrum Pharmaceuticals, Granules, Kemwell, Amylin, Pfizer/Warner-Lambert and Searle.

Dr. Shah’s industry experience includes in-depth understanding in product development, clinical supply manufacturing and associated quality and regulatory considerations. He has authored several publications as well as CMC sections of the US regulatory submissions with working knowledge of ICH requirements including QbD.  During one of his previous tenures, he executed remedial action plans negotiated with the US FDA during a consent decree. Dr. Shah obtained a Regulatory Affairs Certification (RAC) in 2013.

Dr. Shah has had the privilege of leading many cross-functional scientific teams, with expertise in drug substance, drug product, analytical methods, quality, and regulatory affairs. With this leadership experience, he has developed a profound interest in identifying, building, and guiding cross-functional project teams. He understands the intricate balance associated with development of phase appropriate formulations, processes & analytics, robust sourcing strategies and foreseeing regulatory hurdles to achieve the on-time target for development and launch of new drug products.

Simon Daggett

VP, Clinical Operations and Project Management

Simon brings more than 25 years of global drug development experience. Most recently as Associate Vice President of Clinical Operations at Allergan, he was responsible for a wide variety of therapeutic operations including dermatology, neurology and psychiatry. Prior to that position, Simon held various leadership roles at Allergan, including early phase clinical development and team leader roles. In addition, Simon was the workstream lead for the cross industry Transcelerate Patient Technology initiative. Prior to Allergan, Simon also worked at Amgen, Bayer and Covance.

Yutaka Tagaya, M.D., PH.D.

Scientific Co-Founder

Dr. Yutaka Tagaya is the scientific co-founder of the company and a leading expert in the field of cytokine biology. He is currently a faculty member at the Institute of Human Virology, University of Maryland School of Medicine where he also serves as the Head of the Flow Cytometry Core and the Laboratory of Cell Biology.

Prior to this, Dr. Tagaya spent over 15 years as an independent investigator at the National Institutes of Health (NIH) where he collaborated with Dr. Nazli Azimi on several research projects including the conceptual idea underlying the Bioniz platform technology.

Dr. Tagaya has made seminal contribution in the field of Immunology including characterization of cytokines IL-2 and IL-15. He also discovered the unique property of IL-15 that is referred to as trans-presentation paradigm. He has published over 80 original publications and review articles in high impact, peer-reviewed journals, and is an inventor of several scientific patents. Dr. Tagaya was won numerous scientific awards and is a sought after speaker at scientific conferences.

Dr. Tagaya received his M.D. in 1986 and PH.D. in 1990 from Kyoto University in Japan.

Bioniz’s Board of Directors and Scientific Advisors bring decades of experience to help us realize the full potential of multi-cytokine therapies.

David Pyott, PH.D.

Chairman of the Board

Dr. David Pyott has served as our Chairman since June 2016. From 1998 to 2015, Dr. Pyott served as CEO of Allergan Inc., where he was recognized by the Harvard Business Review as one of “The 100 Best Performing CEO’s in the World.” Under his 17-year tenure, Allergan was transformed from a small eye care business with approximately $1 billion in sales to a global specialty pharmaceutical and medical device company, with sales over $7 billion in 2014 and more than 10,000 employees.

Prior to Allergan, Dr. Pyott served as the Head of the Novartis Nutrition Division and as a member of the Executive Committee of Switzerland-based Novartis AG. Dr. Pyott is a member of the Board of Directors of Avery Dennison Corporation, a member of the Board of Directors of BioMarin Pharmaceutical, Alnylam Pharmaceuticals, and a member of the Supervisory Board of Royal Philips in the Netherlands. He is a member of the Governing Board of the London Business School, President of the International Council of Ophthalmology Foundation, and a member of the Advisory Board of the Foundation of the American Academy of Ophthalmology.

Dr. Pyott holds a Diploma in International and European Law from the Europa Institute at the University of Amsterdam, a Master of Arts degree and an Honorary Degree in Medicine from the University of Edinburgh, and a Master of Business Administration degree from the London Business School.

Nazli Azimi, Pharm.D., PH.D.

Founder & Chief Executive Officer

Nazli Azimi, Pharm.D, PhD, is Chief Executive Officer and Founder of Bioniz Therapeutics. Dr. Azimi is co-inventor of the company’s Next Generation of Cytokine Directed Therapies that covers over 45 patents. With over 15 years in life sciences, startups, and investments, she has a proven track record of leading and managing the cross-disciplinary activities of drug development. Prior to founding Bioniz, Dr. Azimi served as founder and CEO of Dermaheal USA, a privately held dermatology company. She is responsible for raising capital to finance the discovery and development of the Bioniz technology and led the company’s efforts in M&A deals.

Dr. Azimi’s deep scientific knowledge fuels her ability to guide discovery teams and prioritize efforts to identify attractive targets for highly valuable drug candidates. After earning her doctorate degree from the University of Tehran with high honors, she completed a post-doctoral fellowship program in immunology at the National Institutes of Health (NIH). During her tenure at the NIH, she was part of a leading group that discovered and characterized IL-2, IL-15, and their receptors and developed therapeutic monoclonal antibodies against these cytokines. She made seminal contribution to the understanding of disease pathogenesis of IL-2 and IL-15 in several viral, neurological and oncological diseases. Her intimate knowledge of this family of cytokines, led her to the conceptualization of Bioniz platform technology. After NIH, she joined the faculty at the Fred Hutchinson Cancer Research Center, where she collaborated with other groups studying peptide therapeutics. Dr. Azimi has authored more than 30 peer-reviewed publications in the areas of immunology, oncology, virology, and neurological disease. She has been recognized as a leading innovator and business person in several media outlets including EY Entrepreneurial Winning Women and Women in Business in Orange County. She also contributes back to the scientific and community as an advisor to the Chapman University Dean of Pharmacology and a mentor for the entrepreneurial program at the University of California in Irvine.

Eric Carter, M.D.,PH.D.

Former CMO of Allergan

Eric Carter, M.D., PH.D. is a pharmaceutical industry executive with more than 2 decades of global pharmaceutical and device research and development experience in multiple therapeutic areas with significant people, portfolio, business development and budget responsibilities. Dr. Carter has demonstrated leadership in large, mid and small pharma settings and has a proven record of success in the introduction of new candidates into clinical development, in the introduction of new therapies into clinical practice to address unmet medical needs and in value-adding activities in support of commercialized medicines.

Dr. Carter served as Senior Vice President, Chief Medical Officer, Global Head of Clinical and Non-clinical Development of Allergan, Inc from 2011 through its acquisition by Actavis Pharmaceuticals in 2015. At Allergan he was responsible for non-clinical development, global clinical development and operations, safety, pharmacovigilance and epidemiology and R&D QA in ophthalmology, dermatology, urology, CNS and plastic surgery for small molecule and biologics, drugs and devices. He led the organization through a period of global growth and transformation and played a key role in Allergan’s independent recognition as a highly successful global R&D organization.

Prior to Allergan, Dr. Carter served as Chief Science Officer, Head of R&D and Chief Medical Officer of King Pharmaceuticals from 2007 until the company was acquired by Pfizer in 2011. Prior to King, Dr. Carter worked for Glaxo Wellcome and GSK where he held positions of increasing responsibility in global clinical development and medical affairs. Dr. Carter started his career in industry at Pharmacia which he joined from academic medical practice at the University of North Carolina, Chapel Hill with board certifications in Internal Medicine, Gastroenterology and Hepatology and Clinical Nutrition. He received his M.D. from the University of Miami, FL and his PH.D. from the University of Cambridge, England.

Joe Kiani

Founder, Chairman,
and CEO of Masimo Corporation

Joe Kiani is the Founder, Chairman, and CEO of Masimo Corporation, a global medical technology innovator credited with revolutionizing pulse oximetry and noninvasive patient monitoring for more than 20 years.

Kiani founded Masimo in 1989. Under his leadership, Masimo has grown from a “garage start up’ into a successful publicly traded company (NASDAQ: MASI) employing over 2,000 people worldwide and providing its market-leading measure-through motion and low perfusion pulse oximetry technology to leading OEM patient monitoring manufacturers such as GE Medical and Medtronic.

Masimo Rainbow SET® Pulse CO-Oximetry™—the first noninvasive blood constituent monitoring platform to measure multiple blood constituents that previously required invasive procedures and help reduce risky blood transfusions.

Masimo’s innovative technology pioneered products such as Masimo Patient SafetyNet™—the first remote monitoring and wireless clinician notification system designed to help hospitals improve patient safety and clinical outcomes by dramatically decreasing rescue events and costly ICU transfers; and Masimo Rainbow SET® Acoustic MonitoringTM—the first noninvasive and continuous acoustic respiration rate (RRaTM) monitoring technology.

Kiani and Masimo have over 575 issued and pending patents worldwide. Kiani and Masimo have garnered more than 50 awards and honors, including the Frost and Sullivan CEO of the Year Award, the Society for Critical Care Medicine Technology Excellence Award, and the Ernst & Young (Orange County) Entrepreneur of the Year Award. In addition to his role as Chairman and CEO at Masimo, Kiani serves on the board of SABA (a publicly traded software company, and previously served as Chairman of the Medical Device Manufacturers Association (MDMA).

Kiani is active in efforts to reform U.S. health care and encourage medical innovation. In 2010, Kiani established the Masimo Foundation for Ethics, Innovation, and Competition in Healthcare, which is dedicated to encouraging and promoting activities that improve patient safety and deliver advanced healthcare worldwide.

Kiani earned both his bachelor’s (B.S.E.E) and master’s (M.S.E.E) degrees in electrical engineering from San Diego State University.

Michael Martin, PH.D.

Founder, Chairman,
President, Takeda Ventures

Dr. Michael Martin is President of Takeda Ventures, Inc. (TVI) and he is based in San Diego, CA. His professional background includes venture capital, pharma business development and broad R&D experiences with an integral role in the discovery and development of 17 innovative investigational drugs and 2 commercial products. Prior to joining TVI, Dr. Martin was most recently a member of Global Licensing and Business Development at Takeda, heading efforts for sourcing and transacting technologies and early stage pipeline programs.

Dr. Martin has held executive and scientific roles with Intellikine (acquired by Takeda), TargeGen (acquired by Sanofi-Aventis), Arena Pharmaceuticals and Monsanto Corporation.

Dr. Martin is currently a director at ArmaGen, Avidity Biosciences, BioMotiv, Bioniz, Cortexyme, FutuRx, Hookipa Biotech, OrphoMed, Univercells and an advisory to Arix Biosciences, Atlas Ventures and UK Dementia Discovery Fund. Dr. Martin earned his doctorate in Medicinal Chemistry from the University of Illinois and holds a M.S. degree in analytical chemistry and B.S. degrees in Chemistry and Mathematics.