Archives: Speakers

Dr. Missling, President and CEO of Anavex, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex®, he served as the Chief Financial Officer of Curis and ImmunoGen. In addition, at Aventis (now Sanofi),  Dr. Missling worked as head of financial planning on all aspects of financial strategy and M&A. His career experience also includes working as an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, as well as serving as the head of healthcare investment banking at Brimberg & Co. in New York. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.

Hollie Schmidt is the VP of Scientific Operations at Accelerated Cure Project for Multiple Sclerosis. She co-chairs the Research Committee of iConquerMS™, a research cohort established to perform and support patient-centered research in MS. She also founded and leads the MS Minority Research Engagement Partnership Network, a multi-stakeholder initiative aimed at increasing racial and ethnic diversity in MS research studies.

Brandy Porter is the Assistant Center Director for Enforcement, of CBP’s Pharmaceutical, Health, and Chemicals Center of Excellence and Expertise (PHC CEE). PHC CEE oversees imports of pharmaceuticals, healthcare, medical equipment, and chemicals into the United States. Prior to her work at PHC CEE, Ms. Porter was the Deputy Assistant Director for the Center for Intelligence, Targeting, and Enforcement, located in the New York Field Office.  She began her career with CBP in 2009, as an analyst.

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

Accomplished Quality and Regulatory professional with 25 years of progressive experience in pharmaceuticals, biologics, medical devices, and combination products from early stage to late stage and commercialization.
Proven track record of significant contributions in quality management, pre-approval inspections, commercial launch, regulatory submissions, process improvement, supplier management, regulatory compliance, and implementation of quality management systems in a wide range of organizations that previously had no/minimal quality programs in place.
Established clinical quality assurance function in clinical trials globally. This includes QA review of clinical trial documents, data integrity assurance, GCP compliance at investigator sites, clinical vendor (CRO) qualification, management and audit, independent GCP quality audits and supporting clinical CAPA.

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.

• Education: BS Mechanical Engineering 1997, MS Engineering Management 2004, EdD 2027.
• 20 years in the Life Sciences: Operations Management and Supply Chain Management leadership roles in Biotechnology, Clinical Diagnostics, Medical Device, Cell & Gene Therapy, and synthetic Biology companies (former Genentech, Bio-Rad Laboratories, Amgen).
• Functional and Digital Supply Chain experience: Plan, Source, Make, Deliver, ERP, Master Data Management and Governance, Analytics, Supply Chain and Supplier Risk.
• Global experience: Americas, Western Europe, and Asia-Pac.
• Operations Management and Supply Chain Management Adjunct Lecturer and Faculty Advisor at Santa Clara University, University of San Francisco, UC Davis, and Golden Gate University.
• Board positions and Advisory roles have included the Bio Supply Management Alliance, American Association of Precision Medicine, Santa Clara University Bronco Venture Fund.
• Patents in Supply Chain Digital Twin and AI-based scenario analysis.