Laura Shawver, PhD
Chief Executive Officer
Dr. Shawver is an experienced Biotech executive with more than 25 years of experience in the development of small molecule drugs for cancer and other serious diseases. Prior to joining Cleave Biosciences as Chief Executive Officer and driving the $54M Series A financing, she was an Entrepreneur in Residence for 5AM Ventures beginning October 2010. From 2002 - 2010, Dr. Shawver was the Chief Executive Officer of Phenomix Corporation where she also served on the Board of Directors. Phenomix was a venture-backed company that developed dutogliptin through a successful Phase 3 clinical trial and attracted collaborations from Forest Laboratories and Chiesi Farmaceutici. Previously, Dr. Shawver was the President of SUGEN Inc. from 2000 after holding various positions since 1992. SUGEN focused on understanding key molecular pathways of cancer cells and developed the drugs Sutent™ and Palladia™. The company was acquired by Pharmacia in 1999. Prior to SUGEN, she was employed at Berlex Biosciences, formerly known as Triton Biosciences. She is an active member of the American Association for Cancer Research and also a member of American Society for Clinical Oncologists. Dr. Shawver is the Founder of The Clearity Foundation, a nonprofit organization providing access to molecular profiling for ovarian cancer patients to improve their treatment options. Shawver received her PhD in Pharmacology and a BS degree in Microbiology, both from the University of Iowa.
Chief Business Officer
Tim Smith has more than 15 years of experience in the life sciences industry, consisting primarily of roles in equity research, investor relations, and business development. Prior to joining Cleave, he was executive director, business development at Celgene Corporation. In this role, he led numerous M&A, in-licensing and strategic equity investment transactions. Mr. Smith joined Celgene in 2009 as director, investor relations and subsequently led the business planning and analysis function. Prior to joining Celgene, he was director, investor relations at MGI PHARMA, Inc. He spent the majority of his early career in equity research covering the biotechnology sector at RBC Capital Markets, Lazard Capital Markets and Citi Research. He began his career as a research technician at the Skirball Institute of Biomolecular Medicine. Mr. Smith holds a B.S. in biology from the University of Texas at Arlington, an M.B.A. in finance from Fordham University and an M.A. in biotechnology from Columbia University.
Kanya Rajangam, MD, PhD
Chief Medical Officer
Dr. Rajangam has 8 years of oncology drug development experience including successful regulatory submissions leading to drug approval. Prior to Cleave, Dr. Rajangam worked at Onyx therapeutics on late stage clinical development and at Exelixis on early stage clinical development. At Onyx, Dr. Rajangam was involved in the NDA submission, including ODAC interactions, which lead to the accelerated approval of carfilzomib (Kyprolis™) in relapsed and refractory myeloma based on a single arm Phase 2 study. She was the lead physician responsible for submitting the confirmatory Phase 3 studies as a sNDA, an MAA and creation of a global clinical dossier to support worldwide Kyprolis regulatory submissions by Amgen affiliates. After Onyx, she was the executive director at Nektar Therapeutics leading their oncology and immuno-oncology clinical development program. At Exelixis, Dr. Rajangam worked on multiple early phase studies targeting oncology drivers in various therapeutic areas including studies in cabozantinib (Cometriq™) and cobimetinib. She worked closely with pharmaceutical partners including Sanofi-Aventis, Bristol-Myers Squibb and Genentech/Roche in moving compounds to the next stage of development. Dr. Rajangam earned a medical degree from St. John’s Medical College, India, completed a surgical residency at PGIMER, India and earned a Ph.D. in biomedical engineering from Northwestern University, Evanston IL for a doctoral thesis on self-assembling biomaterials that promote angiogenesis.
Brian Baker, CPA
Vice President, Finance
Brian Baker is a licensed CPA with over 19 years of progressive senior accounting and finance experience, primarily with venture-backed, biotechnology, drug discovery and development companies. He obtained "Big Four" public accounting experience during his tenure at Price Waterhouse where he was a senior assurance advisor. In addition to Price Waterhouse, Mr. Baker has held senior financial positions with Phenomix Corporation, and Cengent Therapeutics. He has significant fundraising experience in excess of $150 million in equity and $25 million in debt. Mr. Baker earned a Master's of Science degree in Business Administration - Information Systems from San Diego State University, and a Bachelor's of Science degree in Business Administration - Accounting, also from San Diego State University.
Kerry Kelly, Esq
Vice President, Legal Affairs
Kerry Kelly is a highly experienced lawyer, licensed to practice in California for the past 30 years, with over 15 years in the biotechnology industry. Most recently, Ms. Kelly has been representing a number of small biotechnology and biopharmaceutical companies, primarily in the Bay Area. In this capacity, she provided broad legal and business services to support research, pre-clinical and clinical development, intellectual property, fundraising, and human resources. Ms. Kelly previously served as the General Counsel of Ambit Biosciences, where she was a member of the executive team and responsible for legal and G&A functions, and was involved in the company’s financings and pharma collaborations. Before her role at Ambit, Ms. Kelly was the Associate General Counsel at The Scripps Research Institute, overseeing conflicts of interest, corporate compliance, and advising the technology transfer group. Prior to joining Scripps, she served as Senior Director and Head of Corporate and Legal Affairs for SUGEN (later acquired by Pharmacia/Pfizer), where she was responsible for business development and strategic alliances, oversight of IP, and general legal matters. Earlier in her career, Ms. Kelly was a partner in a California commercial law practice. Ms. Kelly received her J.D. from Santa Clara University and her B.A and M.A. from Stanford University.
Han-Jie Zhou, PhD
Sr. Director, Chemistry
Dr. Zhou has over 15 years of experience in pharmaceutical research and development of small molecule drugs in oncology, immunology and other diseases, medicinal and process chemistry and early discovery and development projects. Currently Dr. Zhou is a Senior Director of Chemistry at Cleave Biosciences and responsible for discovery chemistry and global outsourcing, and he also serves as a project leader and a member of the leadership team. Dr. Zhou has made a substantial contribution to its lead drug candidate, CB-5083, a first-in-class, oral inhibitor of p97, a critical enzyme that controls various aspects of protein homeostasis.
Prior to joining Cleave Biosciences in 2011 as Director of Chemistry and participating in the Series A financing, he was an Associate Director at PPD. Dr. Zhou oversaw multiple projects and managed 60+ scientists. From 2004 - 2009, Dr. Zhou worked at Proteolix as a Group Leader. Dr. Zhou played substantial role in the discovery of Carfilzomb. He also served as a Program Leader to lead the discovery of oprozomib, a novel oral proteasome inhibitor and oversaw the chemistry effort that leads to the discovery of ONX0914, an immunoproteasome-selective inhibitor. Prior to Proteolix, Dr. Zhou was employed at Cytokinetics and contributed to the discovery of Omecamtiv mecarbil.
Dr. Zhou was trained as a Postdoctoral Associate in Professor Robert Holton's laboratory at Florida State University and earned his Ph.D. degree in organic chemistry from the University of Fribourg, Switzerland and M.S. degree from Nankai University, China. He is a named inventor and author on +30 patents and publications.
Daniel Anderson, PhD
Dr. Anderson has over 7 years of experience in cancer drug discovery and early-stage research. Prior to joining Cleave in early 2012, Dr. Anderson contributed to a number of oncology-focused small molecule drug discovery programs at Genentech. During this period he led a group responsible for developing novel cellular assays to report on drug activity and mechanism of action. His group contributed key mechanistic insights into the function of clinically approved drugs targeting the MAPK pathway and apoptosis. Dr. Anderson received a PhD in cell biology and biochemistry from the University of California, San Diego in conjunction with the Salk Institute where he was awarded the Martin D. Kamen Cell Biology Thesis Prize. He earned his BS degree in Biology from the University of Pittsburgh. Dr. Anderson has authored 19 scientific publications including several in top-tier journals.
Director, Project Management
Michael Longhi brings over 20 years of industry experience, including 18 years in clinical operations and study management. Prior to joining Cleave, Michael was a Senior Clinical Research Manager for Medtronic, Inc. from 2007-2012, where he led a clinical operations team and managed several clinical trials for a variety of product lines and spine disorders. Previous experience includes study and team leadership positions at MAP Pharmaceuticals, overseeing early phase clinical trials for Asthma and Migraine indications, and VaxGen, Inc. supporting late phase studies in HIV and infectious disease. From 1992-1999 Michael was at SUGEN, Inc. where he worked on a variety of preclinical models and monitored early phase oncology studies. His career began at Berlex Biosciences in 1990. Michael received his MS in Biology in 1990 and a BS in Biology, Cum Laude, in 1987, both from Wake Forest University.
Shanna Stopatschinskaja, MD
Medical Director, Clinical Science
Dr. Stopatschinskaja has more than 10 years of oncology experience, primarily in clinical research and medical affairs. Prior to joining Cleave Biosciences, Dr. Stopatschinskaja worked at Medivation on the enzalutamide signal finding studies in breast cancer. Previous experience includes the US launch of ALK-inhibitor crizotinib (Xalkori ®) at Pfizer Inc., and global life cycle management of the oncology portfolio at Schering-Plough, where she led global cross-functional teams and managed company sponsored and investigator initiated phase IV trials. Dr. Stopatschinskaja has led global cooperative group trials, including the CALYPSO trial with PEGylated liposomal doxorubicin in recurrent ovarian cancer. Her career began at Essex Chemie AG, Switzerland in 2005. Dr. Stopatschinskaja earned her medical degree from Heidelberg University Medical School, Germany and completed her residential training in Urology at University Hospital Basel, Switzerland. Dr. Stopatschinskaja has a specialist accreditation in Pharmaceutical Medicine from the European Center of Pharmaceutical Medicine (ECPM).
Director, Clinical Operations
Sujatha Venugopal-Prasad brings over 17 years of experience in drug development, including 15 years in clinical operations. Prior to joining Cleave, Ms. Prasad led study execution teams for multiple clinical trials including ASPIRE, the confirmatory Phase 3 study in relapsed and refractory multiple myeloma, leading to global approval of Kyprolis™ at Onyx Pharmaceuticals. Previous experience includes operational leadership positions at Global Blood Therapeutics, Novacea, Nuvelo Inc., and Scios Inc., overseeing early and late phase clinical trials in solid tumors, hematologic oncology, vascular disease and autoimmune disease. From 2008-2011, as a Quality Assurance auditor, Ms. Prasad provided her services to Bay Area biotech companies performing GCP audits of study sites, CROs and other vendors in US, Europe and Australia. Her career in drug development began at Covance in 1998. Ms. Prasad received her M.Sc. in Botany from Bharathiyar University, India.
Ronan Le Moigne, PhD
Associate Director, Pharmacology
Dr. Le Moigne has been working in oncology drug development for over 8 years. Prior to joining Cleave in 2012, he was laboratory head in the pharmacology oncology group for Sanofi from 2006-2012. In Paris and Boston, MA, Dr. Le Moigne led groups that participated in target validation efforts of new kinase inhibitors, advanced small molecules and antibodies to preclinical development and supported the progression of Aflibercept, a VEGF Trap biologic, during its clinical development. During his years at Sanofi, Dr. Le Moigne actively participated in several very diverse projects including those targeting mitosis, apoptosis, stress responses, angiogenesis, MAPK signaling, p53 and the PI3K pathway. He received his PhD in pharmacology from the University Paris XI, France and earned his BS degree in cellular physiology from the University of Bretagne Occidentale, France.
Associate Director, Finance
Tanya Bowman has more than 15 years of accounting and administrative leadership experience. Since joining Cleave in January 2012, she has facilitated the development of accounting systems, controls and infrastructures that has helped Cleave scale from a research organization to a clinical stage company. Prior to joining Cleave, she held management positions at private companies where she was responsible for all aspects of the accounting and administrative functions. Mrs. Bowman earned her Bachelor of Science degree in business administration with a concentration in accounting from San Francisco State University.