Archives: Speakers

Vinaya Kapoor, PhD, is currently Vice President, Regulatory Affairs at Tricida, Inc. Vinaya is an experienced regulatory leader with over two decades of experience at both small and large companies in the biotechnology/pharmaceutical sector, at West and East Coast locations. She has contributed to over 20 development programs, in small molecules, biologics, vaccines and cell therapies. Prior to Tricida, Vinaya worked for over 10 years in Global Regulatory Affairs at Janssen Pharmaceuticals (a division of Johnson and Johnson) , at Merck & Company, and Iovance Biotherapeutics, a cell therapy company. Her experience includes CMC drug development and regulatory affairs across therapeutic areas and development phases. Vinaya has a PhD in Chemical Engineering from the University of Notre Dame. Vinaya serves as a Stanford SPARK advisor, a CASSS Associate Director and is actively involved with American Association of Pharmaceutical Scientists (AAPS). She is passionate about furthering interest in careers in science, technology, and the environment, particularly among women and youth and volunteers her time towards this.

Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. He was Senior Director of Clinical Operations at Pharmacyclics from 2012 to 2017 where he was responsible for the development, implementation and maintenance of the Clinical Operations infrastructure, as well as the GCP inspection hosting platform and processes, and regulatory authority marketing approval inspection hosting. From 2008 to 2011, he was Senior Clinical Trial Manager at Seattle Genetics where he was responsible for the oversight of multiple oncology clinical trials, as well as support for the development of the Clinical Operations infrastructure and regulatory authority marketing approval inspection hosting. From 1990 to 2008 he held various Clinical Operations positions at Abgenix, Pharmacyclics, Quintiles, Covance and Syntex. Mr. Luciano earned a B.A. in Psychology and Biology from the University of California at Santa Cruz.

20+ years of experience in drug discovery and clinical development including management of phase I, II, and III studies. Expertise in Early Development including developing strategy for 15+ IND/FIH submissions. Developed strategy for execution of over 200 clinical pharmacology studies to support Phase II/III and NDA filings Experience with large international Phase 3 studies (up to 5400 patients) implementing novel approaches to meet development program goal of accelerated NDA submissions. Participated in sponsor and investigational site inspection readiness activities as part of scheduled and potential regulatory agency inspections Member of Development Operations leadership team to develop strategy and goals to drive higher capabilities, productivity and quality levels. Participated in R&D Quality and Compliance routine audits to identify process gaps, develop corrective actions plans, and implement training plans Created a highly motivated teams through effective leadership, coaching and people management ensuring an objective and performance-led management culture.

Estela Mata is the President and co-founder of Looms for Lupus, a non-profit organization that provides Lupus, Fibromyalgia and Mental Health Awareness, advocacy, and support to those living with these conditions, their loved ones, and caregivers. Estela has worked in healthcare for over 30 years, currently supporting private practices with electronic medical records, office workflows to help the practice and patients for a top leading healthcare organization. In 2011 she co-founded Looms for Lupus when her sister almost lost her life to Immune thrombocytopenia and Lupus; she is alive today because she advocated for herself. Estela has supported her sister and her passion to help others has evolved to “iLOOMinating”, Engaging, Empowering and Supporting the community as a whole to take control of their healthcare. For the past 10 years, Estela has co-facilitated support groups, led, and participated in educational symposiums, advocated locally and nationally. As a community leader and healthcare advocate she partners, collaborates with initiatives including the U.S. Department of Health and Human Services’ Office of Minority Health and the U.S. Food and Drug Administration’s Office of Minority Health and Health to increase awareness on the need for diversity in lupus clinical trials, All Of US Research, Scripps Digital Trials Center and Congresswoman Grace Napolitano’s Mental Health Consortium. Estela is an exceptional community engagement liaison for both English and Spanish speakers.

Ms. Lea is the Director of Global Patient Engagement and Advocacy for Acceleron, a wholly-owned Subsidiary of Merck. She is a Nurse Practitioner by training and spent over 10 years caring for patients before coming to industry. She has an extensive background including several years of experience in field medical as well as over 6 years in medical affairs. She is driven by listening and incorporating the patient voice and by finding innovative ways to improve the patient experience.

Paolo Diana is a Mechanical Engineer, he graduated at the Università di Pisa in 2016. He got the Professional Master’s Program in Infrastructures and Railway Systems Engineering in 2017. He works in Trenitalia as Fire safety Engineer. He is currently involved in new projects of firefighting systems and HVAC systems on Trenitalia trains. He is member of: · CEN/CENELC TC 256 WG1 · UNI Fire Safety CT 50

Dan Solis is a recognized expert in FDA’s import operations and is the Assistant Commissioner for OII’s Office of Import Operations. Prior to this position he was the Division Director for the Division of West Coast Imports since February 9, 2018. He started his career with FDA in 1998. Prior to working in FDA, Mr. Solis worked in the Bioresearch field focusing on Medical Device and Drug Application Products after graduating from the University California of Irvine and the University of La Verne. Mr. Solis has held many positions within FDA, including work at the FDA lab in Irvine, Ca. as a Microbiologist, headquarter position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer, and working in the FDA Los Angeles District Office as a Director of Import Operations Branch. Mr. Solis brought leadership to the Office of Import Operations in March 2020, during the Covid-19 pandemic and became permanent Assistant Commissioner for Import Operations in November 2020.

Mark Milberg has over 27 years of management and operational experience in the biopharmaceutical, medical device, and healthcare industries. He currently works as Senior Director, Clinical Outsourcing at Ultragenyx Pharmaceutical Inc., supporting all of the clinical programs in this clinical-stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases. He worked at Medtronic previously for 8 years in increasingly responsible positions, including leading the contract function for the entire company. Mark’s career has included work in medical and dental practice management as well. He has both a MSW and a MBA. He was appointed to his local community’s Citizen Finance Oversight/Advisory Committee. Mark has presented at numerous industry conferences and is a well-respected collaborator and influencer in his field.