Dr. Niyikiza's Biography
Dr. Clet Niyikiza
Founder, President and CEO
Dr. Clet Niyikiza is the Founder, President and CEO of L.E.A.F. Pharmaceuticals LLC (L.E.A.F.) after serving as the Executive Vice President of Development at Merrimack Pharmaceuticals, Inc. from 2009 until 2014 where he was involved in the development and approval of ONIVYDE®, for the treatment of advanced pancreatic cancer.
In October 2016, Dr. Niyikiza and his team at L.E.A.F. received the 2016 Health Care Innovator Award in recognition of the company's leadership and innovation in the fight against cancer. The award honors the people and companies who are disrupting the health care and biotechnology industries and solidifying Greater Philadelphia's reputation as a center for innovation.
Dr. Niyikiza also served from 2005 to 2009 as a Vice President and Medicine Development Leader at GlaxoSmithKline where he oversaw global anti-cancer assets medicine development strategy. Prior to that, Dr. Niyikiza joined the pharmaceutical industry in January 1991 with Syntex Corporation (since acquired by Roche Holding AG), in Palo Alto, California, working on the discovery and development of the pain medication, ALEVE®. He then held multiple high level positions at Eli Lilly from 1993 to 2005. At Lilly, Dr. Niyikiza was credited for groundbreaking research in the field of antifolates. He developed, over those years, a strong international network of investigators and regulatory authority policy makers that resulted in effective development and efficient registration of 10 New Drug Application indications on many of Lilly medicines, including EVISTA® and the two popular anticancer drugs GEMZAR® and ALIMTA®. Dr. Niyikiza’s landmark scientific achievements that led to the successful development of ALIMTA® were the subject of a front page Wall Street Journal article on April 21, 2004.
Since 2005, Dr. Niyikiza has been a member of President George H. W. Bush’s C-Change national forum dedicated to the advancement of cancer research, treatment and prevention. He is a member of the American Association for Cancer Research and the American Society of Clinical Oncology. A native of Rwanda and father of three children, Dr. Niyikiza holds a doctorate in Mathematics from Indiana University-Bloomington, Indiana, U.S.A., and is currently a member of the Presidential Advisory Council of Rwanda.
In addition to his passion for cancer research, Dr. Niyikiza’s other interests are designing and building homes for his family, and empowering and developing young scientists through research and collaborative initiatives.
Dr. Moyo's Biography
Dr. Victor Moyo
SVP, Chief Medical Officer and Head of Research and Development
Dr. Moyo is an Oncologist/Hematologist with substantial experience in the development of novel therapeutic and companion diagnostic approaches to cancer.
Prior to joining L.E.A.F. Pharmaceuticals, he served as Vice President of Clinical
Investigations at Merrimack Pharmaceuticals, providing clinical support for oncology
programs including Pre-IND programs, First-in-Human, Phase 1 multi-arm safety and tolerability, and Phase 2 proof of concept studies involving multiple programs.
Dr. Moyo has also supported registration studies with the USFDA and other regulatory agencies. Most recently, he was involved in the development and approval of ONIVYDE®, for the treatment of advanced pancreatic cancer. Prior to Merrimack Pharmaceuticals, Dr. Moyo’s experience includes service as Medical Director for Centocor-Ortho Biotech (Johnson and Johnson) and service as Assistant Professor in the Department of Medicine, Division of Hematology/ Oncology, University of Connecticut Medical Center, in Farmington, CT.
Dr. Moyo holds an MBChB (MD) degree from the School of Medicine, University of
Zimbabwe, and did internships at Mpilo Central Hospital, Bulawayo Zimbabwe and The George Washington University Medical Center, Washington, D.C. where he also completed his Residency in Internal Medicine. He also completed a fellowship in Hematology and Oncology at Johns Hopkins Hospital in Baltimore, MD.
Dr. Moyo also has experience conducting clinical research in central and southern
Africa and has published on various other topics including iron overload disorders and malaria. He is also a co-inventor of several patents involving the treatment of several cancers.
U.S. Mickey Gill's Biography
U.S. Mickey Gill
Mr. Gill is a partner in the law firm of Nixon & Vanderhye, P.C., located in Arlington, Virginia, a close-in suburb of Washington, D.C.
For the past 25 years, Mr. Gill has been practicing as an intellectual property (IP) attorney specializing in IP law. Most recently, Mr. Gill has been primarily involved in providing general corporate, management and strategic counseling and support, in addition to providing strategic IP procurement and planning to various clients. Mr. Gill has been involved in numerous complex and high value licensing and procurement transactions involving various technologies and aspects of IP, representing some of the world’s largest consumer electronics companies. Some of these transactions also involved litigation before U.S. District Courts and the International Trade Commission.
In addition, Mr. Gill has served on the Board and as a Scientific Advisory Board member for a pharmaceutical analytics company focused on bringing big data to bear on complex issues surrounding patient pharmaceutical adherence and improving patient adherence based on predictive analytic tools and patient medical histories. In addition to providing strategic business and corporate counseling, Mr. Gill is also involved in developing complex IP procurement strategies in this particularly fluid area of technology and the law.
In addition to the above, over the years, Mr. Gill has concentrated his practice on complex patent litigation and prosecution, bringing his educational background and extensive industry experience to bear on complex technical issues faced by his clients. Mr. Gill has extensive experience in all aspects of patent and trademark prosecution, litigation and strategic counseling, including inter partes practice before the U.S. Patent and Trademark Office. He also has experience in trade secret, common-law trademark, copyright and intellectual property licensing matters. Mr. Gill is a registered patent attorney and is admitted to practice in a number of state and federal courts. Mr. Gill also has an active Inter Partes Review (IPR) practice representing both petitioners and patent owners before the Patent Trial and Appeal Board.
Mr. Gill has acted as lead counsel and has played a major role in numerous complex patent infringement litigations representing both plaintiff and defendant. Mr. Gill has participated in over 30 patent litigations since 1993. In addition to his active litigation practice, Mr. Gill maintains an extensive prosecution practice focusing on high-tech electrical, electronic, computer and communications related technologies. In addition to drafting original patent applications and prosecuting applications in a wide variety of technologies, Mr. Gill regularly provides clients with opinions involving infringement, validity, freedom to operate and general due diligence. Mr. Gill also actively counsels clients regarding complex intellectual property issues and related strategies to assist clients in making informed business and legal decisions.
Dr. Dhindsa's Biography
Ms. Friday's Biography
Dr. Navreet Dhindsa
VP of Global Research and Development Operations
Dr. Navreet Dhindsa is the Vice President for global Research and Development Operations for L.E.A.F. Pharmaceuticals (L.E.A.F.). She has extensive drug development experience in the pharmaceutical industry that spans over more than 16 years, at the Indian Affiliate of Eli Lilly, Merrimack Pharmaceuticals and Ipsen Biosciences. Prior to joining L.E.A.F., Dr. Dhindsa served as the Global Project Leader for liposomal irinotecan (Onivyde®) program at Ipsen Biosciences, following Ipsen’s over $1 billion acquisition of Onivyde® from Merrimack Pharmaceuticals. Dr. Dhindsa had lead, for over 4 years, the clinical operations for the global registration of Onivyde®.
Following her tenure at Lilly India, Dr. Dhindsa moved to the United States and joined Merrimack Pharmaceuticals in Cambridge MA, in 2010. During her 7-year tenure at Merrimack Pharmaceuticals, Dr. Dhindsa lead the clinical operations for the Development and Registration business unit, and oversaw the implementation of registration programs for multiple molecules. Most notably, she was involved in the development and approval of Onivyde®, for the treatment of advanced pancreatic cancer. She was directly responsible for the execution of the Onivyde® NAPOLI-1 registration program globally across 15 countries and over a 100 clinical trial research sites.
Dr. Dhindsa started her industry career at the Indian Affiliate of Eli Lilly and Company in March 2002, where she worked for close to 8 years in clinical operations. She led clinical operations for the first ever Lilly translational research trial of anti-cancer drug gemcitabine (Gemzar®), which became the model approved by FDA for future Lilly translational research efforts. In 2005, Dr. Dhindsa was promoted to lead the Lilly India oncology clinical operations team. During her tenure at Eli Lilly India, Dr. Dhindsa established and managed Lilly regional clinical research office in Bangalore, India. She was also a clinical research subject matter expert for the Eli Lilly Asian region. In addition, she was involved in rolling-out Lilly’s key clinical research and development initiatives in the region, that included risk based monitoring of clinical trials, as well as key project management initiatives.
Dr. Dhindsa is a Dentist by training and holds a BDS (DDS) degree from the College of Dental Sciences in India. She is a co-author on several publications in cancer research, and is a co-inventor on patents and patent applications involving the treatment of various forms of cancer, including the FDA approved Onivyde® regimen for treatment of pancreatic cancer.
Dr. Hoover's Biography
Ms. Friday's Biography
Dr. Kenley Hoover
Intellectual Property Counsel
Dr. Hoover is a partner in the law firm of Nixon & Vanderhye, P.C., based in Arlington, Virginia. With over 20 years of experience representing pharmaceutical and biotechnology companies, Dr. Hoover provides L.E.A.F. with the benefit of his deep knowledge and insight as an intellectual property attorney. His experience includes all aspects of IP law, including patent prosecution, litigation, opinions, interferences, oppositions, licensing and complex technology driven transactions.
As a thought leader in the pharmaceutical, biotechnology, and life science industries, Dr. Hoover provides in-depth strategic counseling and support on all matters relating to the development, transfer, and strategic management of patents and other intellectual property assets for biopharmaceutical companies in all stages – from nascent start-ups to multi-billion dollar international conglomerates. Dr. Hoover also regularly provides counsel on IP matters relating to all phases and aspects of drug development, from early research and development, through clinical trials, and commercialization.
Dr. Hoover has extensive patent prosecution experience having directed the preparation and prosecution of more than 10,000 domestic and international patent applications and he has prosecuted more than 1,000 drug-based U.S. patents to issuance. He also regularly advises on intellectual due diligence, infringement and validity issues.
Dr. Hoover’s in-house experience extends from a tenure of more than a decade at Human Genome Sciences Inc. (now part of GlaxoSmithKline), during which he led the IP Group and oversaw all aspects of HGSI’s intellectual property including IP strategy, prosecution, inter partes matters, and technology transfer. In this capacity, he served as intellectual property strategist, business tactician, and technical expert for assessing intellectual property, implementing portfolio management strategies, structuring technology driven agreements, and evaluating freedom to operate and risk management. Dr. Hoover held positions including Associate General Counsel, Intellectual Property; Executive Director of Technology Assessment and Licensing; and Executive Director of Scientific Assessment. Kenley was an integral member of HGSI’s cross-departmental teams responsible for characterizing the company’s lead targets and he contributed to the preclinical and clinical development of over 30 therapeutics including the approved drugs raxibacumab and BENLYSTA™ (belimumab).
Dr. Hoover received a B.S. from Duke University, an M.S. in cell biology from the University of Michigan, a Ph.D. in Development Biology from The Johns Hopkins University, and a J.D. from the University of Maryland School of Law.
Mr. Ogden's Biography
Ms. Friday's Biography
Vice President of Finance and Controller
Richard Ogden holds the roles of Vice President of Finance and Controller for L.E.A.F. Pharmaceuticals LLC. Mr. Ogden has more than 30 years of experience in the financial management of growing companies spanning several industries.
Prior to joining L.E.A.F., Mr. Ogden spent 25 years as Chief Financial Officer of J&C Resources LLC and he held that same role for several operating companies that J&C owned or controlled. J&C Resources was a private investment firm that funded, operated and controlled several medical and technology companies until 2017 when its owner retired and its operating entities were sold. Among J&C’s recent operating subsidiaries was UltraClenz LLC which developed and marketed health care products for hospitals. Mr. Ogden led the effort to divest UltraClenz from the J&C portfolio by writing an offering document, managing the due diligence process and eventually negotiating the terms and conditions of the company sale to the healthcare division of Ecolab in 2016. Mr. Ogden performed those same functions for the sale of three other operating subsidiaries owned by J&C.
In his role of Chief Financial Officer for J&C and its operating businesses, Mr. Ogden was responsible for managing financial reporting, implementing financial controls, managing the audit process, addressing tax matters, developing budgets, and creating financial analysis to drive informed business decisions. He negotiated agreements with U.S. and foreign suppliers and with customers. For many of J&C’s operating businesses, Mr. Ogden was responsible for building the accounting department and financial infrastructure from inception through divestiture. Two of the companies that J&C controlled were publicly traded and for those companies, Mr. Ogden managed all SEC filings.
Prior to joining J&C, Mr. Ogden spent 6 years with ISI Systems Inc, a business that developed software solutions for the insurance industry. At ISI, he held various accounting and financial management positions and was instrumental in the company’s IPO which was led by Merrill Lynch. While at ISI, Mr. Ogden reported to the CEO and worked on the preparation of SEC filings, generated financial analysis, and managed treasury functions.
Mr. Ogden has worked as an instructor at Merrimack College where he taught financial management courses part-time in both the undergraduate program and the graduate level business school.
Mr. Ogden is a licensed CPA. He earned an MBA from Babson College and a Masters of Taxation degree from Bentley University. He holds an undergraduate degree in Finance from Bentley University.