Gordon Chu is the Director of Investigations Branch at the Food and Drug Administration (FDA) Division of West Coast Imports (DWCI) within the Office of Enforcement and Import Operations (OEIO).

In this role, Mr. Chu develops, manages, and evaluates inspectional matters for DWCI covering all FDA import activities associated with air and sea port operations in the States of Hawaii, California, Nevada, Oregon, and Washington. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. He works cooperatively and collaborates with Federal, State, and local agencies to ensure appropriate consumer protection.

Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. In 2010, he became a Supervisor Consumer Safety Officer (SCSO). As a supervisor, he had the opportunity to manage an Import Field Operation Team, an FDA team in the Centralized Examination Stations (CES), and the Los Angeles International Mail Facility. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018.

Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. He also served on multiple FDA Headquarter working group and committee related to Food Safety Modernization Act (FSMA), import process improvement, strategic framework, rapid screening technology, and partnership agreements. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine.

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.

Ryan is a versatile, results-oriented Supply Chain professional with 15+ years experience across multiple industries and roles.

His top skills include: Supply Chain Strategy; Forecasting and Demand Management; Supply and Capacity Planning; Risk Management; Data Analytics; Business Process Design and Optimization; ERP Implementation; Team Leadership; Program and Project Management; Career Development

Brittney is currently Senior Director, Technical Operations & Supply Chain at Aligos where she is responsible for the supply chain department and external vendors accountable for packaging, labeling and distribution of clinical trial materials to investigational sites.

Brittney has more than 15 years of experience working in both technical development and supply chain organizations in the consumer products and pharmaceutical/biotech industries.  Prior to Aligos, she was at Tricida, Intarcia, and Genentech where she managed all aspects of supplying 40+ clinical trials across the world in over 30 countries for thousands of patients. She also managed the commercial supply chain for the Clorox Disinfecting Wipes business, dealing with un-precedented demand changes through the H1N1 flu outbreak.

Results-oriented, motivational strategic leader with extensive experience in developing, launching, and managing global projects. Adept at managing CMC activities from initial product development stages, supporting regulatory submissions, product launch, and ensuring stable commercial supply. Capacity for communication, collaboration, and leadership, establishing relationships with multidisciplinary teams internally and externally engaging business development partners and contract manufacturing sites for outsourced work to facilitate project goals.

Dedicated Quality Assurance Leader who excels at phase-appropriate development/redevelopment, management and strengthening of an organization's Quality Culture to ensure a constant state of Inspection Preparedness & Readiness by:

- establishing/re-aligning a current state feedback loop which utilizes close to real-time data, Quality metrics & Key Performance Indicators (KPI's);

- creating robust assessment and evaluation programs that builds sensitivity, accountability, transparency and awareness collaboratively to constantly reduce Cost of Quality;

- developing a strategic approach of continuous improvement to a Company's Quality Management System Elements which remain in a state of control.

Experienced Project Manager in Product Development, Supply Chain, Business Operations and Logistics, and Change Management

High performing, excellence-driven, end-to-end Clinical Supply Chain Professional carrying over 20 years of industry experience in pharmaceuticals and biotechnology. Over 10 years of clinical and commercial supply chain experience. Proven success in leading study teams, including external partners, to target milestones on time and on budget. Highly skilled at supply and demand planning, developing distribution strategies, scenario planning and risk mitigation, troubleshooting, streamlining processes, saving on costs, and increasing the speed to clinics and to markets without compromising product quality.

Paul is an experienced Clinical Supply Chain Professional with a 25-year career in the BioPharmaceutical industry.  His extensive career includes roles at major companies like Amgen and Thermo Fisher Scientific, where he honed his skills and made a significant impact.  He has served in varied roles from basic research and contract manufacturing to client services and account management.  He is a Principal Consultant and Co-Founder of Beacon BioPharm Associates, a clinical supply chain consulting firm, providing variable staffing solutions to small and mid-sized BioPharm clients.  Paul is an industry veteran and respected leader known for his expertise in clinical supply chain.

Supada manages a team of Product Leads to bring cell and gene therapies from acquisition to manufacturing readiness. They work on a growing portfolio of targeted and personalized medicines for oncology and ocular diseases that span from early clinical development to preparation for commercial launch.  Her responsibilities include due diligences, process development, system stakeholder, and contract manufacturer selection.

Tom is currently serving as a Senior UAT Analyst for Bristol Myers Squibb. Most recently, he worked in clinical systems role for Ultragenyx Pharmaceutical, overseeing IRT, CTMS, eCOA, eConsent, CGM, and wearables systems and processes. Previously, he worked as an IRT senior project manager at Amgen, built and managed international technical support and data management teams, and worked as an IRT project manager, both at endpoint clinical. He has managed projects in the therapeutic areas of hematology & oncology, pain, bone, cardiovascular, and dermatology, from early-phase oncology through post-marketing studies. He graduated summa cum laude with a B.A in Philosophy and History from Florida Gulf Coast University, where he also earned an M.A. in English. He has published several articles on process improvement, change management, and making IRT concepts more accessible to sponsor study management personnel.

Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. He held senior level positions with Relypsa (acquired by Galenica for 1.52B US$), Anacor (acquired by Pfizer for 5.2B US$) and Transcept Pharmaceuticals (revers merger with Paratek). He played a pivotal role in the development and commercialization of Veltassa® (USA and EU), a treatment for hyperkalemia, Intermezzo® for MOTN insomnia, Kerydin® for onychomycosis, and Eucrisa® for atopic dermatitis. Dr. Hayat is managing partner of Revive Pharm USA. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. He received M.Sc. Chemistry degree from Punjab University, Institute of Chemistry

A highly motivated, experienced IT Product Management professional with over 26 years of experience in the biopharmaceutical service industry. Executes product strategy, defines product vision and roadmaps, develops customer-driven product requirements incorporating human-centered design, drives product release cycles using Agile methodologies, and collaborates with cross-functional teams to deliver high quality solutions on time. Prior roles include IT Product Owner, IT Business Partner, Integrated Processes and Technologies POC Project/Product Manager, Predictive Analytics Lead SAS Developer, Biostatistics Senior SAS Statistical Programmer, Statistical Programming Manager, Clinical Data Programmer, and Associate Biostatistician.

Chris Varner is the Senior Director of Solutions Consulting at Endpoint Clinical, where he brings over 15 years of experience in the clinical trials industry. Joining the company in May 2024, Chris has over 8 years of expertise in site and clinical project management and more than 7 years in technology supporting clinical trials. He has successfully led a global team of 30+ project managers, focusing on designing and implementing DCT and eCOA solutions across various therapeutic areas and study phases. Throughout his career, Chris has developed effective operating models and cultivated strong relationships with major pharmaceutical companies, ensuring long-term delivery partnerships. His strong operational leadership is complemented by his collaboration with the sales team, where he helps ensure that proposals feature the most effective strategies at scale.

Mary Zhang – National Account Manager since 2009, at the Center of Excellence and Expertise for the Pharmaceuticals, Health and Chemicals (PHC-CEE) with U.S Customs and Border Protection (CBP). Ms. Zhang's previous experience includes serving as a Senior Import Specialist for the Trade Operations Division in the Port of New York/Newark, and Chicago. Previously she worked for the Revenue Management at the United Airlines.

Experienced outsourcing professional with passion for clinical technology and clinical research in the oncology field.

Samit manages Myonex’s growing Clinical Trial Patient Solutions (CTPS) in North America and Europe. Samit and his team are responsible for the innovation and execution of CTPS to provide value to Myonex’s clients in addition to enhancing clinical trial sites and patient experience. He brings over 12 years’ experience in managing successful formulary status and relationship management with payers, a significant understanding of healthcare contracts, and knowledge of medical and pharmacy benefits including specialized knowledge across different therapeutic areas. Samit holds both a Doctor of Pharmacy degree and an MBA from Drake University.

Jan Pieter (JP) Kappelle, VP of Clinical Services at Inceptua, is a Supply Chain Executive with 30 years of industry experience, of which 15 years were spent leading clinical trial supplies departments in global pharmaceutical and biotech companies.

Trained as an Electronic and Quality Engineer, JP has a strong financial background and brings a methodical, analytical and process-oriented approach to his work. Coupled with his MBA and MSc in Supply Chain Management, JP has the unique ability to switch between strategic and operational discussions.

JP also serves as the Global Clinical Supplies Group (GCSG) Master of Ceremony where he connects clinical supply professionals for the purposes of education,
knowledge sharing and the development of industry best practices.

Sascha held numerous positions in business development and operations, most notably in global Commercial Operations AMERICAS & EMEA at Marken and VP Business Development at Sharp Clinical Services, where he formed a new business development team and implemented novel services. Sascha is a subject matter expert of a broad range of services along the clinical supply chain such as Direct-to-Patient, labelling & packaging, cell & gene therapies , and global distribution strategies. Sascha studied economics and holds a MBA in International Management and Leadership. He has been a long-term member of the ISPE Investigational Product community, contributed to the development of several Good Practice Guides and was a member of the European IP Steering Committee. At SanaClis Sascha is leading global business development and acts as Country Head Germany.

Experienced healthcare editor with a demonstrated history of B2B journalism covering drug development, manufacturing, and the pharma industry. Skilled in editing, news writing, KOL interviews and financial journalism. Special focus on pharmaceutical manufacturing, clinical trials, rare disease and women's healthcare. Bilingual Glasgow/London-based English and French-speaking media professional with a Master of Arts (M.A.) in English from the University of Bristol.

Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman, speaker, moderator, and facilitator for many life-sciences and drug development events.