Archives: Speakers

My professional career spans three decades in the pharmaceutical industry. My journey began as a law firm paralegal for several years before entering the pharmaceutical industry through Blis-tech, where I held a range of roles and responsibilities, including Quality Assurance, Technical Design, Project Management, Distribution, and Contracts Management.  Upon that success, I established a consulting role at Jeiven Pharmaceutical Consulting, overseeing a project management group for three years. Since then, I have been an integral part of the Otsuka company for over 20 years.  Currently, the Director of Clinical Supplies Operations, overseeing the Clinical Supply Operations for global packaging, labeling, and logistics, directs the RTSM/IRT, and the overall various integration programs, on the use of seamless, integrated systems for superior trial management and results.

Michael MacNeir is the VP of Business Development at Sharp Clinical Services, where he leads commercial strategy and client partnerships across clinical trial supply chain solutions. With a long-standing career in the clinical supply services industry, he works closely with his team to support pharma and biotech sponsors to build integrated packaging, manufacturing, and global distribution solutions that support clinical development from early phase through late stage.

Steve Jacobs, R.Ph., is the President of Global BioPharm Solutions and a veteran executive with 30+ years of experience in clinical supply chain and global logistics. He is a trainer and consultant, on both the R&D supply chain and commercial operations enhancement, to Biotech and Pharmaceutical organizations worldwide. Steve previously led clinical operations for Johnson & Johnson. He currently serves on the Board of the Global Clinical Supplies Group (GCSG), specializing in operational excellence and high-performing team leadership.

Karen is Senior Director of Clinical Pharmacology Solution Consulting for Parexel. She has over 20 years of progressive experience in the CRO industry with a strong background in early drug development and clinical pharmacology.

With a comprehensive understanding of Phase I study design, feasibility, clinical execution, regulatory requirements, and non-clinical services, she brings a straightforward, analytical and solution-orientated approach to strategy and proposal delivery.

Enthusiastically supporting drug development from first-in-human through proof-of-concept across a global clinical site network, she crafts compelling operational, technical and business strategies; showing innovation, financial acumen and general management competencies to support current and future client needs.

Chris Takimoto, MD, PhD, is the Global Chief Medical Officer of The START Center for Cancer Research. Chris has worked in oncology drug development for over three decades. He has extensive experience in early phase oncology trials both as a clinical investigator and as an industry sponsor.

Before joining START, Chris was the CMO for IGM Biosciences, a clinical stage, public biotechnology company, and he also was a Senior Vice President in Oncology at Gilead Sciences. Prior to that, he was the CMO at Forty Seven, Inc., a biotechnology company that was acquired by Gilead in 2020, and he was also a Vice President at Johnson & Johnson/Janssen R&D overseeing Oncology Experimental Medicine Early Development.

Chris was one of the original Phase 1 Investigators at START when it was founded in 2007, and he has held faculty positions at the Cancer Therapy and Research Center, the University of Texas Health Science Center San Antonio, the National Cancer Institute, and the Uniformed Services University in Bethesda, MD.  He completed fellowships in Medical Oncology and Clinical Pharmacology, and he is a graduate of the Yale University School of Medicine where he received his MD and a PhD in Pharmacology. Chris also holds an undergraduate degree in Chemistry from Stanford University.