Life Sciences Queensland Limited (LSQ) have teamed up with Ground Zero Pharmaceuticals, Inc. to bring you the CTN to IND: Maximising your initial data to move to IND and attract investors webinar.
Presenter Dr Siegel will discuss how many Australian small molecule and biotechnology programs begin with the relatively straightforward and low-impact movement from laboratory data through initial clinical trial under Australian CTN. However, bridging these data and early clinical results through movement into a US IND is part art and part focused on data quality and strategy. To provide guidance for academics and industry professionals, Dr Siegel will discuss in detail:
- Preparation and presentation of laboratory data into reviewable reports
- Early interactions with the FDA to validate these data
- Bridging CTNs into US INDs, including nonclinical and clinical strategies
- Informing investors and securing their further support for your development program
About the speaker – Evan B. Siegel, B.S., M.S., M. Phil., Ph.D.
Dr. Siegel founded Ground Zero Pharmaceuticals, Inc. in 1999 from his consulting firm, Ground Zero Strategics, Ltd. and serves today as the company’s President and CEO. The company is located in Irvine, California and provides Regulatory Affairs and Product Development Consulting services to Pharmaceutical, Biologics, Biotechnology and Medical Device firms worldwide.
Dr. Siegel served as Chief Executive Officer of OXO Chemie Inc. from 1997 to 1999. Before he joined OXO Chemie, he was the Vice President, Regulatory Affairs and Bioethics for Medical Science Systems, Inc. Prior to that he was Director of Regulatory Consulting Services and Principal Regulatory Scientist for Quintiles, Inc., in Research Triangle Park, North Carolina. He has served in regulatory affairs and executive positions in the pharmaceutical (Astra, Syntex, and OXO Chemie), Genetics Testing Industries (Medical Science Systems); and trade association environments.
He has is also an Adjunct Professor at the University of Queensland and the Centre for the Study of Preclinical Drug Development, Brisbane, Australia, and a member of the California Lieutenant Governor’s Biotechnology Advisory Group to the California Council for Economic Development. He also acts periodically as an expert witness in patent and drug development litigation cases.
About Life Sciences Queensland
Life Sciences Queensland Ltd (LSQ) is a Member based organisation that is working for the life sciences industry in Queensland. LSQ recognises and supports the Queensland Government’s commitment to work with industry, to build infrastructure and attract world-class individuals to form the basis of a life sciences industry in Queensland. As an industry-led vehicle, which promotes and supports all segments of the life sciences industry, LSQ works to enhance Queensland’s national and international reputation as a centre of commercial and research excellence in life sciences.
About Ground Zero Pharmaceuticals Inc.
Ground Zero Pharmaceuticals, Inc. (GZP) focuses on bringing medical product programs through the FDA regulatory process, from late discovery through final approval and postmarketing. GZP’s philosophy of doing what is necessary and sufficient and no more at each stage of development aids clients via clean, cost-effective, targeted and accelerated development plans. With emphasis on completing each portion of a product’s lifecycle in a rapid and resource-sparing manner (while maintaining acceptable quality for FDA review), GZP adds value to our client programs by enabling accomplishment of important milestones.