is a privately-held consulting firm specializing in development solutions and global regulatory strategies and submissions for investigational medicinal products in early development stages through Phase 3. The Conventus team includes full-time expert personnel, and expert affiliates with deep expertise in multiple technical disciplines, who together comprise an integrated team with successful experience in a broad range of therapeutic areas and vaccine indications.

STEVEN A. KRADJIAN, RAC
President and Principal Regulatory Consultant

Mr. Steven Kradjian is a veteran regulatory leader, drawing from his more than 25 years of experience in biopharmaceutical regulatory affairs and development, ranging from product candidate selection through late stage clinical development with cellular and gene therapies products, small molecules, recombinant proteins, monoclonal antibodies and combination products in a wide range of therapeutic areas, and investigational vaccines in populations at risk for infectious disease vaccines. He trained in regulatory affairs at Amgen while working on EPOGEN and other development programs, and later, as Executive Director of Regulatory and QA at Vical Inc., he gained experience as product development team leader in the Phase 2 and Phase 3 settings. As a consultant since 2004, he has served as regulatory strategy advisor to Sponsors in the U.S., Europe, and Asia, and has successfully filed 27 IND/CTAs and managed numerous formal and informal meetings with regulatory agencies. Mr. Kradjian earned a Bachelor's degree in Chemistry from Occidental College, with a thesis on reduced specificity of aminoacylation during protein synthesis in aging rats. He was Board certified in Regulatory Affairs in 2000 and completed the Executive Development program for Regulatory Professionals at the Kellogg School of Management.

WILLIAM H. COVER, PhD, JD, RAC
VP of Technical Consulting & Business Development

Dr. William H. Cover is an accomplished Scientist, Regulatory Affairs Professional and a recognized CMC/Quality expert with more than 25 years of proven leadership experience in the pharmaceutical, biotechnology, and medical device industries. Dr. Cover has worked for both large and small start-up companies holding positions in functional areas that include regulatory affairs, drug development, validation, quality assurance/control, production, process development, and research. He has both domestic and global regulatory affairs experience with commercial products and product candidates in development (proteins, small molecules, gene therapy products, medical devices, and combination products). Dr. Cover has participated in or directed numerous CMC and Clinical FDA face to face meetings that include pre-IND, pre-NDA, EOP2 and Type C meetings in addition to a vast number of formal communications with regulatory agencies around the globe.

ZENAIDA A. ORTEGA, MBA, CQE, CQA
Director of Quality Assurance

Zenaida Ortega is an accomplished Quality Professional with more than 25 years of proven management experience in pharmaceutical, biotechnology, and medical device industries with expertise in design, development, and implementation of Quality Systems. She has provided strong leadership and quality oversight of domestic and foreign contract manufacturers/service providers/suppliers for Phase I, Phase II, Phase III, and commercial products, ensuring compliance to regulatory requirements and Quality Agreements. She has effectively managed Quality Operations, including timely review and approval of master and batch production records, change control requests, raw material and product specifications, deviations, SOPs, formulation and test methods, investigations, CAPAs, stability, analytical and manufacturing data, complaints, protocols and reports, CMC submissions, final packaging, labeling, and distribution documentation. She is an experienced GMP trainer and has successfully managed and hosted client audits and regulatory inspections.

FRANCISCO X. ROSAS, MS, RAC
Senior Regulatory Associate

Francisco Xavier Rosas is a Regulatory Affairs Professional with more than 10 years of experience in the pharmaceutical and biotechnology industry. Mr. Rosas has experience working with both clinical stage products and marketed products. He has operational expertise and has contributed technically to a variety of regulatory submissions including IND Amendments, NDA Supplements, IND and NDA Annual Reports, Meeting Request and Meeting Packages. Mr. Rosas also has been successful implementing FDA's requirements governing Risk Management Programs and Risk Evaluation and Mitigation Strategies (REMS). Mr. Rosas has demonstrated team leadership by heading cross-functional groups and interacting with CROs. Mr. Rosas' scientific training encompasses research in molecular biology and cellular immunology as well as research in in vivo animal models.

LISA KRADJIAN
Writer and Administrator

Lisa is a professional writer and editor with credits in multiple local and national publications including the Los Angeles Times and the San Diego Union Tribune and NPR/KPBS Public Radio. Her work includes writing and editing annual reports, grant proposals, speeches, company newsletters, direct mail campaigns, articles, and web and social media content, for both corporations and nonprofit organizations across various industries. She also has administrative management experience at companies including MetLife Insurance, The Music Center Inc. of Los Angeles County, and the Museum of Contemporary Art and has served on numerous boards. Lisa is a graduate of Stanford University (BA English with Honors, 1992).