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.
Throughout his 25+ year career in GMP production of biopharmaceuticals, biologics, bulk chemicals, and medical device consumables, Rob has led scientific, engineering and manufacturing teams across diverse geographic locations; introduced continuous improvement cultures to maximize manufacturing efficiency; gained recognition as a problem solver with an inherent ability to come up with on-target solutions to tough challenges and updated legacy production processes to modern GMP and analytical standards. Utilization of core competencies in LEAN processing, large-scale manufacturing, ERP implementation/optimization, project management, 3rd party management, production finance, inventory management and supply chain management have driven operational success.
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.
