Archives: Speakers

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.

Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American Association for Precision Medicine ( and chair of ACT AAPM’s Coronavirus Taskforce He is leading research efforts focused on preventing curing chronic diseases not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives

He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company committed to revolutionizing drug discovery development through technology, big data, robotics, and artificial intelligence He is a serial entrepreneur who founded his first company after graduating high school, and his second company during his Ph D Since then, he has accumulated a wealth of experience by building, investing, and advising numerous other companies He is an investor, co founder/ board member of a few corporations, focused on accelerating drug discovery/ development, data analytics, robotics, mental health, and digital health He is also the founder of AAPM Angels and Investors AAi an investment group focused on investing in drug discovery, diagnostics, precision medicine, technology healthcare companies He is also the founding investor and advisor to Barcelona Ventures and serves as an advisor to a 100 M private equity fund

Widely recognized as a thought leader in the field of ‘technology and healthcare’, Dr Mishra has keynoted, chaired, curated, and organized numerous successful international conferences He served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where he participated in several drug discovery project teams Moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic

His research work has been recognized globally by over 40 prestigious awards and honors Due to his unique perspective selfless service, he is a highly respected sought after mentor to many The companies that he has advised have raised multimillion dollars Notably, he serves as a mentor and advisor to several VC funds and startup accelerators, including IndieBio HIMSS/Health 2 0 ’s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture, UCSF Invent Fund, and California Life Sciences’s FAST program, to help grow California’s life sciences innovation ecosystem

Thiago Favano serves as Senior Director, Program Operations, leading MiNK’s clinical operations and portfolio strategy. Over 17 years of extensive experience across clinical development and operations, clinical research, market access, project management and strategic business projects on a global scale. with a remarkable ability to navigate complex regulatory landscapes and drive operational efficiency. He previously served as Senior Director of Clinical Development and Operations, and Senior Strategic Advisor for Orphan DC. He also served various positions in the Pharmaceutical industry, including Clinical Operations Consultant at Atea Pharmaceuticals, and roles at Alexion Pharmaceuticals. He is fluent in English, Spanish, French, and Portuguese, and received a PharmD and MBA from Universities in Brazil.