STEVEN A. KRADJIAN, RAC
Founder and Owner
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.
CHRISTINE M. WOODS, MA
Vice President, Regulatory Affairs
Christine M. Woods is an agile Vice President of Regulatory Affairs at Conventus Biomedical Solutions. She has held several positions in Regulatory Affairs at various pharmaceutical companies. She has over 30+ years’ experience in progressive professional experience in the pharmaceutical, biologic & device industries in RA, quality and R&D positions. Thirty years of regulatory experience with a broad understanding of product development. Over 30 years of experience hiring, supervising, developing & mentoring technical and administrative professionals. Experienced with start-ups and building organizations, trials & facilities. Responsibilities range from strategic planning to development of department infrastructures. Manage changing priorities, multi-task and successfully operate within abbreviated timeframes, while still maintaining excellent productivity, quality, teamwork & high group morale. Product development experience includes small molecules, cell therapies, proteins/peptides and medical devices, with several fixed-dose combination and drug/device & biologic/device combination products, and spans from feasibility through commercial lifecycle management. Dosage form experience encompasses solid/oral (IR & MR), parenteral, pulmonary aerosol, nasal spray, transdermal patch, topical gel and liposomal. Oncology is a therapeutic area of special interest.
Regulatory Operations Manager
Thiru Vodnala is a Regulatory Operations Manager at Conventus Biomedical Solutions. He has held several positions in Regulatory Operations at various multi-national pharmaceutical companies focused on eCTD and Advertising and Promotional Material submissions. He has over 4 years’ experience in preparing and submitting eCTD submissions for applications such as INDs, NDAs, BLAs, ANDAs and DMFs using various publishing tools as per USFDA guidelines. He has extensive experience and knowledge in submission planning, document publishing and eCTD publishing for all types of submissions such as Original Applications, Amendments, Supplements and other types of submissions related to FDA pharmaceutical drug applications. He has assisted and lead filings of Original and major eCTD submissions. He has submitted various Advertisement and Promotional Materials to OPDP as per guidelines in both CD and eCTD format.
KURT NORTON, MS
Regulatory Affairs Senior Associate
Kurt Norton is a Regulatory Affairs Senior Associate at Conventus Biomedical Solutions. He is an accomplished Scientist and Regulatory Affairs Professional. Kurt has held multiple Scientist positions in biotechnological companies developing and manufacturing in vitro diagnostic assays, medical devices and biologics. Kurt has regulatory affairs experience with product candidates in development and commercial products. He has experience with IND, NDA and DMF submissions. He has extensive regulatory operations experience publishing documents for submission. Kurt has prepared summary reports, addressed information requests, and amended product inserts and SOPs. He has completed a product name change for Health Canada. Kurt has hosted an on-site BIMO inspection. He has prepared Customs Letters and performed Product Holds, Document Revisions and Change Requests.
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).
CONVENTUS BIOMEDICAL SOLUTIONS, INC.
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.