Clinical Development Operations Leader with over 20 years of drug development and clinical project management experience.
I am very passionate about drug development process and bringing new therapies to patients in need. My expertise benefits small and large biotech and pharmaceutical companies with all stages of drug and medical device development programs. I have worked in the following therapeutic areas: Alzheimer’s disease, oncology (hematologic malignancy T- cell therapy, and solid tumors), cardiology (stem cell therapy), infectious diseases, endocrinology and rare diseases.
Specialties: Clinical Operations department head (team structure and assignments), Clinical Study strategy and management (CRO/vendor selection, management and oversight) cross-functional team leader, global phase 3 studies, study sites selection, management and monitoring, study Protocol and other document writing, GCP and FDA regulations, budget management, risk management
As a Practice Leader in Advanced Analytics and Data Science for Life Sciences Commercialization, I specialize in navigating the complexities of data and technology strategy to drive impactful business outcomes. My expertise spans Life Sciences Commercialization from pre to post-launch, crafting robust Data Strategies, defining KPIs and BI Strategies, and leveraging Advanced Analytics for a comprehensive understanding of the Patient Journey. I also bring a rich and diverse experience of guiding 20+ large bio-tech, emerging pharma, and med-tech companies involved with their product launches, growth trajectory, and M&A scenarios
With a deep focus on Customer Strategy and Segmentation, Opinion Leader Intelligence, Omni Channel, and CRM Experience, I deliver actionable insights that drive organizations towards success. I bring deep expertise around diverse commercial and market access data, to help deliver insights for key account planning, payer targeting and various other operational and analytics use cases
Leveraging a diverse skill set, I excel in Cross-Functional Partnerships, Team Building, and Coaching, driving data science, engineering, and architecture initiatives. Proficient in Cloud Architecture and tools for CRM/CDP/MDM, I bring an Agile mindset to strategy and execution.
Dr. Spear has been working in oncology and gene therapy research and development for over 30 years. He received a B.A. degree from the Johns Hopkins University and an M.D. degree from Stanford University. Post-graduate training was in the Massachusetts General Hospital / Harvard University program. He has served as an Associate Professor on the faculty of the USC Keck School of Medicine, and the UCSD Medical School / UCSD Cancer Center where he managed a clinical practice, drug discovery/gene therapy research, and clinical trial programs for cancer. Dr. Spear led multiple oncology clinical development programs at Pfizer. He subsequently served as Chief Medical Officer and Senior Vice-President at Nereus Pharmaceuticals, followed by Head of Oncology and Head of Biotherapeutics at Sunovion Pharmaceuticals, then as a Vice-President at Incyte and Sangamo Therapeutics, and Chief Medical Officer at Poseida Therapeutics developing multiple CAR-T cell and gene therapy products. He is currently Chief Development Officer / Chief Medical Officer at Denovo Biopharma. He has also served as a CIRM CAR-T cell principal investigator, NIH / NCI study section, CPRIT grant review panel, biotechnology and pharmaceutical advisory boards, IRB/SRC, and scientific journal editorial review committees related to cancer and gene therapy, as well as authoring numerous scientific papers and patent applications.
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.
