Archives: Speakers

Stanley Kim is an entrepreneur with a passion for innovation. His colleagues warmly refer him as an eclectic or parallel entrepreneur having founded several technology (healthcare and software) companies that develop products which enhance or better people’s lives. Stanley has been fortunate enough to work with leading technologists and research institutes in the world which act as the foundation for his companies.

Result-driven professional in the life sciences industry with 25 years of combined vendor outsourcing/selection, proposal/RFI development, contract management, process improvement, and team leadership expertise. Resourceful and proficient in problem solving and risk mitigation, negotiating cost savings, vendor relationship management, contract and change order negotiations, and streamlining processes to support clinical outsourced services.

Experienced pharmaceutical professional with proven leadership of clinical development and operations teams

Allan Camaisa is a serial entrepreneur, investor, and technologist, with proven leadership skills in bootstrapping startups. He has had four successful exits, which were sold to publicly traded Fortune 1000 companies. Mr. Camaisa has always created a tremendous return for his shareholders. He has proven operational experience in recruiting the right team as well as creating a culture of trust, and collaboration. Since taking over as Chairman and CEO of Calidi Biotherapeutics, he signed an agreement with National Institute of Health (NIH), recruited top immunologists to the Scientific Advisory Board, and entered license negotiations with large pharmaceutical organizations.

Before entering business, Mr. Camaisa served eight years as a surface warfare officer in the United States Navy. He currently owns seven U.S. patents and has received many personal awards including the Deloitte FAST 50, the Governor’s Small Business of the Year Award and the Ernst and Young Regional Entrepreneur of the Year. He also received awards from the San Diego Asian Business Association and many other awards.

Biotech executive driving progress to urgently create new medicines for people suffering from neurological diseases with significant unmet medical need.

Proven organizational leadership and management of cross-functional teams in a rapidly-growing matrix environment. Track record of delivering robust development plans tailored to each CNS disease indication. Experience across preclinical development, IND-filing, Phase I-IV studies, clinical trial design and operations, biomarker strategy, PK/PD, and regulatory submissions. Previous roles at Travere Therapeutics, BioMarin, Sangamo Therapeutics, and Harvard Medical School.

– Clinical development leader with a passion for science and broad range of experience across modalities and therapeutic areas, including small molecules, biologics, AAV-based gene therapy and engineered cell therapy.

– Board-certified physician with expertise across CNS diseases, rare diseases, internal medicine, pediatrics, immunology, and infectious diseases.

– Believer in the innovation economy and disruptive potential of big data/AI to radically improve drug development.

Effective project manager with broad experience in pharmaceutical development, including preclinical research, clinical development, and commercialization. I specialize particularly in late-stage clinical development (Ph2 to NDA). Demonstrated flexibility in a variety of corporate cultures from small biotech to big pharma, startup to mature, and in several therapeutic areas. Strong working knowledge of many project management tools, techniques, and methodologies. Demonstrated ability to align team to project goals and objectives and work with stakeholders and team members to achieve success.

• Over 20 years of experience in Biologics CMC, both in large biopharma and startup biotech companies, providing operational and strategic leadership for process development, analytical development, manufacturing, and supply chain for clinical and commercial
• Broad experience in selecting, partnering and managing the external service providers (CDMO and CRO) for tech transfer, process characterization, scale up/out, cGMP manufacturing, process validation (DS/DP PPQ), as well as analytical transfer, method validation, QC for release and stability, extended characterization (PTM, MAM, HCP by Proteomic MS, HOS, PS20/80 Degradation, Charge Variant Characterization, Cell-Based Assay), and comparability study
• Deep understanding of regulatory requirements: FDA guidance, USP Pharmacopeia, Ph Eur, EMA, and ICH guidelines
• Experience in co-authoring and reviewing CMC sections (Quality Module 3 DS and DP) for IND/IMPD
• Strong expertise in GMP best practices (used to practice GMP at Catalent Biopharma Solutions for 5 years), applying “GMP principle” to non-GMP data integrity (good documentation practice and data verification) for global regulatory filings
• Chairing specification committee on patient-centric specification setting and justification for in-process and final product QC release/stability
• Experience in responding to the regulatory queries from health authorities worldwide

Senior manager with over 25 years experience in clinical research and the CRO industry and proven abilities in clinical project management, strategic business development, and FSP alliance leadership.

Specialties: Strategic CRO Business Development, Alliance/FSP Leadership, Clinical Project Management & Planning, Budget & Expense Control,Team Leadership & Consensus-Building, Contract & Price Negotiation,Project Resourcing, Financial & Resource Forecasting, 
Staff Development & Motivation, Line Management, Operations Process Improvement

I contribute to protocol development, protocol medical writing, conceptual development per FDA guidance, background research, QC/QA, compilation of TMF, and briefing and supporting documents. I am experienced in writing/reviewing ICFs, CSRs, NTF/MTF, IRB material, data tables, data spreadsheets, and briefing documents. I am responsible for the development and execution of clinical study plans and budget analysis. I am skilled in MS Office, SAS and SPSS, EDC, public speaking, and team building.

I am a clinical research operations specialist with two decades of experience with CRO’s, startups, research sites, and small consulting firms. I am creative, efficient, effective, and a problem solver. I am able to identify with the challenges of research from many different perspectives.