Archives: Speakers

Isaac Blum has served as Senior Manager of Clinical Supply at ALX Oncology since June 2021. Previously, Isaac served in operational roles of increasing responsibility at BioMarin Pharmaceutical, Sangamo Therapeutics and Puma Biotechnology. Isaac is excited about developing global supply strategies and systems to help advance innovative, life-saving treatments. He has used his expertise to launch multiple global oncology clinical trials, and has shared his expertise at numerous speaking events. Isaac holds a B.A. from the University of Puget Sound.

Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.

David Chang is a supply chain compliance specialist at Boehringer Ingelheim’s Fremont site. He prepares the supply chain department for audits, serves as a training coordinator, and is one of the primary investigators for deviations on his team.

He has investigated deviations for the procurement, planning, systems, and warehouse teams in his department. Cold chain related deviations he has worked on include deviations on temperature excursions during shipments as well as missing temperature data. 

Patrick is a Logistics and Trade Compliance professional with an advanced degree and a U.S. Customs Brokers license. He is experienced in U.S. Customs, FDA, USDA, FWS, APHIS, BIS and other government agency regulations for the biotech sector, including sanctioned and denied party screening, export licensing, and duty drawback process and procedures.  Patrick is also, familiar with GMP and GDP guidelines, application to the movement and storage of drug substance, drug product and key intermediates.

Phil is a supply chain professional working exclusively in the clinical space for over 15 years.  He has managed all aspects of clinical supply, packaging and labeling and distribution, IXRS setup and management.  He has worked with the following companies:

• Rainier Therapeutics
• Aimmune Therapeutics
• Myovant Sciences
• Onyx Pharmaceuticals
• Elan Pharmaceuticals

Bei Li has a Ph.D. in Pharmaceutical Chemistry with 10+ years of experience in pharmaceutical industry and hands-on experience in a wide spectrum of drug development stages ranging from discovery support, preformulation, to phase III formulation and process development. She has extensive experience in formulation development with expertise in a variety of dosage forms including solid and liquid oral formulation and parenteral (i.v., topical, subcutaneous, transdermal) formulations.

She also has an-depth experience in GMP manufacturing of tablets, capsules, and iv solutions and managing contract research and manufacturing organizations, IND and CTA filings, and dealing with a wide range of drug delivery techniques including supersaturation, amorphous formulation, liposomes, and nanoparticles.

A Public Heath Service Officer with 25 years of active duty service assigned to the Food and Drug Administration (FDA). Maintains regulatory oversight of compliance operations conducted in the Western 13 States and rest of world compliance activities for operations performed by investigators in Division IV. Supervisory oversight of Compliance Officers in Seattle, Portland, Alameda, Irvine and Denver to accomplish the work of the Compliance Branch. A recognized pharmaceutical regulatory subject matter expert that is frequently consulted in the review and implementation of national policy and guidance. Reviews and evaluates evidence and findings gathered by FDA investigators and laboratory analysts and microbiologists indicating a possible lack of compliance with Agency enforced laws and regulations. Acts as a liaison to other Federal and State Agencies for advisory and judicial cases. Coordinates the issuance of Warning Letters and other official correspondence to regulated industry that is appropriate for documented violative conditions and initiates import alerts on violative import products. Promotes voluntary compliance through local, regional, national and international outreach to academia, regulated industry and trade organizations.

Jasmine Dow is a outsourcing professional at Nektar Therapeutics and has 10+ Pharmaceutical and Biotech experience in procurement, contracting, strategic sourcing and operational process development.  She holds a Masters of Business Administration in Leadership and Health Care Management from the University of Saint Mary.  Jasmine is passionate about strong business relationship development, strategic negations and  effective communications.  Her experience and passion uniquely qualifies her to advocate for strong business practices for the benefit of the patients, this community and clinical research.

With over ten years in the big pharm and biotech industry, Santana currently serves as Senior Manager, Clinical Contracts and Outsourcing at Cytokinetics. Santana has combined her legal education and training with industry experience to create foster collaborative relationships between sponsors and vendors.  She believes that robust specifications, partnership, intent toward value and clear communications lead to quality deliverables and effective sponsor vendor relationships.

Santana is an organizational coach and speaker with attention to communication, personal and professional growth and start-up strategies.