Outsourcing in Clinical Trials West Coast 2022

Biography: Mr. Solis is a recognized expert in FDA import operations who has served as the acting assistant commissioner and director of ORA’s Office of Enforcement and Import Operations (OEIO) since March 29, 2020. During this time, he has provided leadership and direction to all OEIO field import divisions as well as the Division of Food Defense Targeting and Division of Import Operations at FDA HQ. He brought about the leadership and stability needed during the COVID-19 Pandemic. Mr. Solis was selected as the Assistant Commissioner for Import Operations on November 22, 2020 and prior to that 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 that includes working at the FDA lab in Irvine, Ca. as a Microbiologist, HQ 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 is an experienced collaborator who has played an integral role in FDA operational activities with other federal agencies, partnering with Customs and Border Protection, Homeland Security Investigations, U.S. Department of Agriculture, U.S. Fish and Wildlife Service, Drug Enforcement Agency, and state and local law enforcement agencies. Additionally, he conducts local and national training on imports, is a member of the National Leadership Development Workgroup at FDA’s Office of Training and Education Development, and has served as a mentor for the Federal Executive Board in Los Angeles and ORA’s Potential Supervisors Program. In his new role, Mr. Solis serves as the principal advisor to Associate Commissioner for Regulatory Affairs and report to the Deputy Associate Commissioner for Regulatory Affairs (DACRA) on all import matters. This includes providing direction and oversight to FDA field import operations, reviewing prior notice and intelligence data on human and animal food, and leading the development and implementation of new import programs and procedures. Mr. Solis has had many accomplishments within FDA and these are a few notables: Implementation of PREDICT at all ports in the US, the implementation of electronic communications and paperless transactions initiatives with the Trade Associations, formation of the CBP/FDA Teams including the Opioid Task Force, formation of the West Coast Import Advisory Council, formation of Federal and State Task Forces, conducting Federal Operations, streamlining the refusal process in the Ports of LA, San Francisco and Seattle, and development of strong partnerships with the filers, brokers and importers in the Pacific Region. Mr. Solis is nationally recognized as a subject matter expert in the program area of Import Operations and gives local, as well as, national training on Imports Investigations. He is a member of the National Leadership Development Workgroup at FDA’s Office of Training and Education Development, has served as a mentor for the Federal Executive Board in Los Angeles and the Potential Supervisor Program within FDA. He also has had integral roles in FDA Operations with other Federal Agencies, working with CBP, HSI, USDA, FWS, DEA and State and local law enforcement agencies. Currently, aside from his duties at the port, Mr. Solis is also a member of the FSMA – Foreign Supplier Verification Program (FSVP) Implementation Team as well as the Associate Commissioner’s IT Advisory Workgroup, the Associate Commissioner’s Import Advisory Panel, member of AFDO, WAFDO, ASQ, OCRA and the Pacific Island Health Officers Association (PIHOA). Mr. Solis holds a Masters Degree (MS) in Healthcare Administration from the University of LaVerne and a Bachelor’s Degree (BS) from University California of Irvine.

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Biography: Dr. Ravi Kiron based in California, USA is an experienced pharma/biotech executive with decades of experience in discovery R&D through late-stage clinical development, intellectual property and regulatory, technology & business development, M&A, strategy and product commercialization, negotiating and executing partnerships by leveraging his extensive global business development networks in CVMD, Oncology, CNS, Wound Healing, Microbiome and Diagnostics. He was a tenure-track faculty member at Cornell University Medical College and adjunct faculty at University of Rhode Island. Dr. Kiron served in various operational & management roles at Pfizer Inc., and J&J/ALZA, in Cardiovascular R&D, Oncology clinical development (Tarceva), strategic business development and M&A (acquisition of WLA, PHA & other biotech).  Dr. Kiron has consulted for several dozen global biotech & pharma companies, founded and led multiple companies/new ventures, served as an Entrepreneur In Residence (EIR) at SRI Ventures, ShangPharma Innovation and advises company and non-profit boards. ​ Currently, Dr. Kiron is Head, BioPharma External Innovation at the Merck KGaA/EMD Serono’s Silicon Valley Innovation Hub in Menlo Park, California and is exploring cutting edge game changing technologies (Artificial Intelligence & Machine Learning, Microbiome, Electroceuticals etc.) to have an impact on pharma/biotech research, product development and launches.

Session Details: KEYNOTE REUNION DEBATE, 1 YEAR ON: How long will we feel ripples of the pandemic? 15-02-2022, 8:30 am View In Agenda

Biography: David Larwood is a founder, the CEO, and chief chemist for Valley Fever Solutions, running the manufacturing process for a novel antifungal headed for Phase 2a trials in 2022. In his role as BD lead, he is responsible for many aspects of the company’s planning and operations. Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis), for which NikZ will transform the standard of care. NikZ shows promise against other important fungal diseases. Mr. Larwood co-invented his first two commercial molecules before age 30. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today. At UCSF he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. Earlier as a bench chemist, he was the first to make Iotrolan, a CT X-ray contrast agent, generic for decades, replaced in about 2005 by newer agents. Moving to law, in leading law firms he advised major companies on patent matters. After 3 years as a patent lawyer at Apple Computer, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through successful acquisition in 2005. Mr. Larwood is the third of his family to be involved in Valley Fever.  His father was a physician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever.

Session Details: All Things Enrolment 15-02-2022, 12:30 pm View In Agenda

Biography: 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.

Session Details: PANEL DISCUSSION: Decentralized/Hybrid Trials: Discussing the current challenges and debating best practises for a successful virtual study 15-02-2022, 12:30 pm PANEL DISCUSSION: How to successfully Outsource while focusing on Data Integrity? 15-02-2022, 3:00 pm View In Agenda

Biography: Few people with a cause walk the talk as boldly and graciously as Christine Von Raesfeld, founder and CEO of People with Empathy. Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. Through the lens of her lived experiences in healthcare, she has become a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. Christine has brought her unique perspective and honed expertise to countless roles as a featured speaker for numerous conferences dedicated to the rare disease community and disease awareness initiatives. Wherever possible, Christine generates momentum toward progress along her patient advocacy interests and stimulates dialog on a range of topics relevant to patients, clinicians, and industry. As a patient advisor, Christine has assisted several initiatives including the Stanford "Humanwide" Precision Medicine Program, All of Us Research, and the 23andMe Lupus initiative. For her many contributions to her field, she has been named one of the top 100 Women of Influence by Silicon Valley Business Journal, a member of the 2021 HIMSS Future 50, and one of Medika Life's medikal life 50 most influential voices in healthcare 2022  among other distinctions. With her guidance and support, we will continue to optimize the patient journey for people worldwide.

Session Details: QUICK FIRE ROUNDS: The Patient Perspective 15-02-2022, 11:30 am PANEL DISCUSSION THE PATIENT IMPACT: Patient recruitment, patient centricity & virtual trials… Navigating the ‘New Normal’ 15-02-2022, 3:00 pm View In Agenda

Biography: Stephanie Molteni, JD, Director, Site Budgets & Contract Management, Clinical Operations, Ultragenyx Pharmaceutical Inc. Stephanie Molteni is the Director, Site Budgets & Contract Management, Clinical Operations, at Ultragenyx Pharmaceutical Inc. where she oversees a team who manages the global investigator site budgets and contracts.  Stephanie is also responsible for the strategic development of the group, focusing on process refinement, key performance indicators and change management.  Stephanie has worked with contracts and budgets for more than 20 years, 10 of which at a large medical device company.  Prior to entering the biotech industry, Stephanie spent several years in compliance, contracts and operations within the insurance industry.

Session Details: A Fireside Chat on…. The Budget Conundrum 16-02-2022, 10:00 am View In Agenda

Biography: Dr Morimoto has over 25 years of industry experience in leading project teams in the development of innovative medicines, providing guidance in the design and execution of preclinical, clinical and regulatory strategies with a therapeutic focus in Parkinson’s, Alzheimer’s and frontotemporal dementias.  Previously, Bruce held leadership roles at Alkahest, Celerion and Allon Therapeutics, and works closely with the Michael J Fox Foundation, chairing one of their scientific review panels.  He is an advisor to several biotech companies. Bruce started his career on the faculty in the Chemistry Department at Purdue University where his independent research focused on neuronal signal transduction.  Bruce earned his doctorate in biochemistry from UCLA and completed a postdoctoral fellowship at the University of California Berkeley.

Session Details: KEYNOTE REUNION DEBATE, 1 YEAR ON: How long will we feel ripples of the pandemic? 15-02-2022, 8:30 am View In Agenda

Biography: Michael’s background spans contract and proposal development; contract negotiations in multiple languages; set up and management of vendor oversight and governance programs; and related change management. He has worked for CROs as well as small and large biotechnology companies. Over the course of his career, he has worked on clinical development of 23 compounds currently marketed in 1 or more therapeutic indications.

Session Details: PANEL DISCUSSION: Decentralized/Hybrid Trials: Discussing the current challenges and debating best practises for a successful virtual study 15-02-2022, 12:30 pm Considerations and best practices in direct-to-patient (DTP) / decentralized clinical trials (DCT) –lessons learned from past trials 15-02-2022, 4:45 pm View In Agenda

Biography: Nanomed, with the headquarter at Cupertino, CA, applies innovative microfabrication technology to make a delivery tool for skincare actives. This is a new way of overcoming skin barrier and delivering actives without needle injection. The product successfully went through two clinical trials and got into the finals of Asian Innovation Award together with IBM Healthsolution Lab's product sponsored by the Wall Street Journal and won Silver Prize in 2010. Nanomed's antiblemish product was successfully launched at AAD, the largest dermatology annual meeting in US. Together with Sephora's product, Nanomed's delivery product got into the top three for the International Package Design Award (tool category) at 2012 HBA Global in New York City.

Session Details: A Fireside Chat on… Regenerative Medicine as a future trend 15-02-2022, 2:00 pm View In Agenda

Biography: Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.

Session Details: VIDEO: Digital Transformation in Pharma – the evolving future of work 15-02-2022, 3:00 pm View In Agenda

Biography: Toby Odenheim is the former Director of Technology and Governance at the Parker Institute for Cancer Immunotherapy (PICI). He is now Senior Vice President, Research & Development Technology at ProPharma Group. Committed to accelerating the development of new medical treatments through effective technology adoption and continual process improvement.

Session Details: Cloud Migration: From server room to cloud 16-02-2022, 11:15 am View In Agenda

Biography: 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.

Session Details: Fireside Chat: Planning for success in an evolving regulatory landscape 16-02-2022, 12:15 pm View In Agenda

Biography: Jennifer Lee is Senior Vice President of Clinical Operation, Biostats, and Data Management at Elevar Therapeutics. Jennifer brings over 25 years of industry expertise in clinical strategies, asset evaluation, and advancing novel and innovative clinical programs spanning phases I-IV across therapeutic areas, including oncology, infectious disease, inflammation, urology, CNS, cardiovascular, rare disease, and stem and cell therapies. She is an invited speaker at international conferences and has successfully submitted market applications leading to seven NDA approvals. Previously, Jennifer worked at G.D. Searle, Pharmacia, Pfizer, Astellas Gilead Sciences, and other mid- and micro-cap companies. Jennifer holds a BS in Biochemistry from the University of Illinois and an MS in Clinical Research and Regulatory Administrations from Northwestern University. She is an active mentor, Women in Bio supporter, and board member.

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Biography: 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

Session Details: TECH KEYNOTE 16-02-2022, 9:00 am View In Agenda

Biography: 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.

Session Details: Optimizing CRO Success: Relationship, contribution and oversight 15-02-2022, 4:45 pm PANEL DISCUSSION Defining your outsourcing strategy to contain costs and accelerate drug development time-to-market: what should you consider in the new COVID-19 era 16-02-2022, 1:45 pm View In Agenda

Biography: Laurin Vincent most recently held the position of Sr. Director/Head, Supplier Performance Management at Roche/Genentech, located in South San Francisco. In this role, she was responsible for the supplier oversight, sourcing and the governance ecosystem for vendors used in late phase studies. She has over 20 years of clinical development experience in various roles and companies. She has managed diverse and global teams, focusing on strategically collaborating and maximizing supplier relationships and organizational transformations in clinical operations. Prior to joining Roche/Genentech in 2013, she worked at Amgen in clinical operations as well as at technical vendors/ CRO’s.

Session Details: PANEL DISCUSSION Defining your outsourcing strategy to contain costs and accelerate drug development time-to-market: what should you consider in the new COVID-19 era 16-02-2022, 1:45 pm View In Agenda

Biography: 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.

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Biography: 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.

Session Details: QUICK FIRE ROUNDS: The Patient Perspective 15-02-2022, 11:30 am PANEL DISCUSSION THE PATIENT IMPACT: Patient recruitment, patient centricity & virtual trials… Navigating the ‘New Normal’ 15-02-2022, 3:00 pm View In Agenda

Biography: Uber Health provides a modern, tech-enabled logistics platform that is designed to expand access to reliable transportation, deliveries, and meals. Our mission is to enable patients from all demographics to have equal access to healthcare, and to reduce work for staff by giving them tools that optimize their time. Our partnerships arm focuses on engaging organizations that are looking to improve recruitment, retention, and overall experience for both patients & medical staff.

Session Details: UBER HEALTH KEYNOTE How strategic technology partnerships can improve health outcomes for vulnerable populations 15-02-2022, 11:30 am View In Agenda

Biography: Ndidi Rickert is an experienced Quality Assurance leader with over 20 years of experience in the Pharmaceutical/Biotechnology industry. She is acknowledged for her expertise and passion in Data Integrity and Vendor Oversight, and has been recognized as a thought leader in process optimization and standardization as they relate to Inspection Readiness. After completing her education in England, Ndidi began her career working for Parexel followed by Merck Sharp & Dohme. She then ventured across the pond to the United States where she worked for Novartis, Pfizer, Johnson & Johnson and Aeras (one of the Bill Gates Foundation companies specializing in TB and Malaria). An opportunity at Gilead Sciences sparked her move to the West Coast, and she is now settled in the San Francisco Bay Area. Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. Her background in Biotechnology and proficiency in Data Management solidified her proven ability to identify data integrity risks, and problem solve the most complaint path to drug submissions and approvals. Ndidi also leads the X2 Women in Biotech Group speaker series and is one of the founding members of the UltraMosaic Employee Resource Group. In her spare time, Ndidi enjoys creative writing and interior decorating. She intentionally injects laughter and authenticity into everything she does, and is an advocate for kindness, diversity and inclusion, as well as issues impacting women and children. Fun fact: Ndidi was born and raised in Sierra Leone, and is a descendant of the Krio people who were freed slaves that returned to Freetown from Africa, America and The West Indies. #DareGreatly – T. Roosevelt LinkedIn Bio: https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/

Session Details: PANEL DISCUSSION: How to successfully Outsource while focusing on Data Integrity? 15-02-2022, 3:00 pm View In Agenda

Biography:

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.

Session Details: PANEL DISCUSSION THE PATIENT IMPACT: Patient recruitment, patient centricity & virtual trials… Navigating the ‘New Normal’ 15-02-2022, 3:00 pm View In Agenda

Biography:

Tara Safakish is a Software Engineer with over 15 years of experience in different roles such as Software Developer, Software Quality Engineer and Quality Computer System Validation specialist in medical device and biotechnology/pharmaceutical industries. She is also a Certified Medical Device Auditor (CMDA) and Six Sigma Green Belt (CSSGB).

She started her career as a software developer and after a few years found her passion in software quality engineering field.  She worked for several medical device and biotechnology companies in North America including, CryoCath, enLabel Global Services, Sciex, Avalanche Biotechnologies. Presently, Tara is the Associate Director, QA Computer System Validation at Ultragenyx Pharmaceutical Inc. where she has worked for over 5 years.

The combination of her education and experience as a software quality engineer involved in all aspects of software development life cycle, including risk management, gives her a unique perspective to identify and assess data integrity risks through its life cycle.

Session Details: PANEL DISCUSSION: How to successfully Outsource while focusing on Data Integrity? 15-02-2022, 3:00 pm View In Agenda

Biography: Jacqueline Lee has been working in the clinical research industry for over 30 years.  She brings a unique perspective in that she has worked in several different capacities, including at the site level, the CRO level, and the Sponsor side of this industry. For the past 17 years, Jacqueline has been working at Cytokinetics, a biopharmaceutical company located in South San Francisco, California.  She is currently the Senior Director of Clinical Operations and has provided strategic planning, leadership, and oversight for over 35 clinical trials, the majority of which were conducted internationally.

Session Details: Why designing patient-centric clinical trials is so important during a pandemic 16-02-2022, 11:15 am View In Agenda

Biography:

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Biography: Amy is the Sr. Director and lead for Information Technology (IT) Research and Development (R&D) at Ultragenyx Pharmaceutical. Amy leads teams as they build IT strategies, develop innovative and efficient technology portfolios, implement best in class and emerging technologies, and enable business capabilities through technology enablement. She has promoted technology advancements across the Life Sciences, from building the nation’s most successful private health insurance exchange platforms, to improving state Medicare & Medicaid technology solutions, and growing the technology portfolios of both biotechnology and pharmaceutical companies. Amy promotes strong partnership and collaboration across IT and functional stakeholders, as it has proven to promote speed and efficiency in pre-clinical drug development and clinical trial execution. With experience in IT consulting at the nation’s leading strategy consulting firm, as well as a background in International Public Health, Amy combines deep analytical approaches with a desire to save the world one patient at a time. Amy spends her free time learning about new cultures as she travels across the globe, with her knitting needles always along for the ride.

Session Details: PANEL DISCUSSION: How to successfully Outsource while focusing on Data Integrity? 15-02-2022, 3:00 pm View In Agenda

Biography: Jeff Lewis is the Sr. Director of QA Computer Systems & Data Integrity for Ultragenyx Pharmaceutical, which focuses on bringing life-changing medications to patients with rare and ultra-rare genetic diseases.  Prior to Ultragenyx, Jeff consulted for more than fifteen years for a wide range of life sciences companies, where he provided quality systems, computer system validation, software development and data integration services.  Jeff served on the ISPE Data Integrity Special Interest Group, which produced a series of GAMP Data Integrity Good Practices Guides.  He lives in Oakland with his wife and three children.

Session Details: PANEL DISCUSSION: How to successfully Outsource while focusing on Data Integrity? 15-02-2022, 3:00 pm View In Agenda

Biography: Andy Lipetz has 19 years of experience in clinical research including time at PPD and IQVIA where he held a broad range of roles across operations, sales, analytics, and strategy. Andy is now the head of CRO Partnerships at Castor where he collaborates with customers to build long-term relationships and to deliver decentralized and hybrid clinical trials. Andy holds an economics degree from UCLA and an MBA from UNC Chapel Hill.  

Session Details: Getting started with DCT: Strategies and considerations for meaningful patient engagement 15-02-2022, 12:00 pm View In Agenda

Biography: Aryana Hosseinkhani is the Director of Patient Cloud at Medidata, a Dassault Systemes Company. She completed her education at University of California, Davis in Genetics and shortly after began working as a bench scientist in stem cell research. Aryana began her clinical research career at Science 37 around 7 years ago, as the third employee and a founding partner.  At Medidata she focuses on product and patient communications in patient facing technologies.  She believes that when sponsors, sites, and patients have optimized experiences, drug development timelines can be expedited and clinical research can become an option for more people.  Aryana is passionate about the value of  research and seeing it through from the bench to the real world. Over her career, she has focused on disruptive and innovative technologies that can simplify clinical trials for patients, sites and sponsors.

Session Details: How a turn-key DCT approach benefits sponsors, sites, and patients by improving access, awareness, and experiences 15-02-2022, 9:45 am View In Agenda

Biography: Mike Keens leads operational performance and growth strategies for Anju Software. Mike brings more than two decades of experience in drug development clinical and commercial operations at organizations that include ADial Pharmaceuticals, Syneos, Firma Clinical Research, and Icon PLC. His expertise includes driving the rapid growth of Clinical Trial and DCT business units supporting studies in more than 60 countries. Keens holds an M.S. in Public Health Sciences and a B.S. in Biology & Psychology and has been recognized by PharmaVOICE magazine as one of the Top 100 Inspiring People in Pharma. He also holds memberships in the American Society of Clinical Oncology (ASCO) and the Association of Clinical Research Professionals (ACRP).

Session Details: DCT Trials – What do we have and where are we going? Structuring your current options for success and predicting the next 24 months 15-02-2022, 2:30 pm View In Agenda

Biography: As Vice President, Business Development at Curebase, Wayne leverages more than a decade of experience in clinical research across both clinical operations and strategic sales to identify new areas for growth within the company. He is a key member of the leadership team responsible for defining the company's go to market strategy and value proposition across the many segments of the pharmaceuticals and device research industry. Before joining Curebase, Wayne served as Vice President at mid-sized Florida based CRO Biorasi, where he helped to lead that company to a successful acquisition by a private equity partner in 2018. Wayne holds an MBA and B.S. degree in Neurobiology and is the author of several peer-reviewed papers in prostate cancer and premature ovarian failure. Wayne resides in Miami, Florida.

Session Details: Virtual site operations demo in a real RCT dermatology drug study 15-02-2022, 4:15 pm View In Agenda

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Biography: Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv.  

Session Details: KEYNOTE REUNION DEBATE, 1 YEAR ON: How long will we feel ripples of the pandemic? 15-02-2022, 8:30 am Acceleration of clinical development in the world’s fastest growing region 15-02-2022, 9:15 am View In Agenda

Biography: Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side.  She is currently the Founder and CEO of Strategikon Pharma, developer of Clinical Maestro^TM, the industry’s only end-to-end cloud-based platform for clinical trial budgeting, sourcing and budget management including strategic alliance/partnership management. Previously she served as Head of Clinical Outsourcing and Analytics for BioMarin Pharmaceuticals, where she was responsible for vendor contractual, relationship and financial management. She also had several leadership positions with PharmaNet Development Group (now Syneos Health), ICON Clinical Research and eMetagen Corporation.

Session Details: Stream B: Clinical Innovation & Technology 15-02-2022, PANEL DISCUSSION: Decentralized/Hybrid Trials: Discussing the current challenges and debating best practises for a successful virtual study 15-02-2022, 12:30 pm Registration and Refreshments 16-02-2022, 8:30 am A Fireside Chat on…. The Budget Conundrum 16-02-2022, 10:00 am PANEL DISCUSSION Defining your outsourcing strategy to contain costs and accelerate drug development time-to-market: what should you consider in the new COVID-19 era 16-02-2022, 1:45 pm View In Agenda

Biography: Ellen Weiss joined PCM Trials in April 2019 as Vice President, Business Development. Ms. Weiss has worked to deliver patient-centric services to patients since 2014, including previous roles with CMed Clinical Services and Symphony Clinical Research. Additionally, she has driven the advancement of hospice services at Rainbow Hospice and Palliative Care, a non-profit hospice in Chicago, as both a board member and an on-staff patient advocate. She began her career in the financial services sector and has been an active volunteer for the Healthcare Businesswomen’s Association since 2005, where she works to foster communication across the healthcare industry

Session Details: From the frontlines, incorporating home visits - not just for rare diseases: How home visits allowed a neurodegenerative disorder study to happen 15-02-2022, 2:30 pm View In Agenda

Biography: In his over 20-year career, Skip has had responsibility for formulating and executing strategies for drugs, vaccines, diagnostics and medical devices with broad global drug development knowledge including medical affairs, clinical trial design, pharmacovigilance, clinical operations, investigator site selection, patient advocacy and product commercialization. Skip most recently served as the Chief Medical Officer for Selecta Biosciences, a life sciences start-up headquartered in Watertown, Massachusetts, where he had responsibility for all clinical activities, including clinical strategy and development of drug candidates, clinical study designs, protocols, and CRO selection. He held a similar CMO role at Targacept, Inc. a biopharmaceutical company, and at Plasma Surgical, Inc., a medical device company.  Prior to these roles, Skip held senior leadership roles including U.S. Head of R&D for Solvay Pharmaceuticals which was incorporated into Abbott Laboratories/AbbVie, as well as Procter and Gamble Pharmaceuticals.  Skip started his career in Obstetrics/Gynecology in both the hospital and community setting and is a principal investigator himself.

Session Details: Essential steps for making your CRO relationships more successful 16-02-2022, 9:30 am View In Agenda

Biography: Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used.   Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

Session Details: Decentralized Clinical Trials/Hybrid Trials: What you need to understand to run them successfully 16-02-2022, 11:45 am View In Agenda

Biography: Donald Kellerman is the Vice President of Clinical Development and Medical Affairs for Zosano Pharma.  Dr. Kellerman has more than 30 years of experience working in several areas of the pharmaceutical industry, primarily clinical development.   Dr. Kellerman has led registration trials in a number of therapeutic areas, including respiratory, allergy, ophthalmology, cardiovascular, and neurology.  From 2008 to 2013, Dr. Kellerman served as Senior Vice President, Clinical Development and Medical Affairs at MAP Pharmaceuticals, Inc., where he led the development of Semprana for migraine.  Prior to joining MAP, Dr. Kellerman held management positions at Inspire Pharmaceuticals, Inc. Glaxo Wellcome, plc, Sepracor, Inc., Ciba-GEIGY Corporation, and E.R. Squibb and Sons, Inc.  He has served as project leader on multiple development teams including those working on Flovent,® Advair,® and Xopenex®. Dr. Kellerman received his Bachelor of Science and Doctor of Pharmacy from the College of Pharmacy at the University of Minnesota.  He has authored major sections of eight NDAs, created labelling strategy for several pharmaceutical products, and has co-authored over 80 publications related to the results of clinical development activities.

Session Details: Chairman’s Opening Remarks 15-02-2022, 8:25 am KEYNOTE REUNION DEBATE, 1 YEAR ON: How long will we feel ripples of the pandemic? 15-02-2022, 8:30 am Stream A: Outsourcing & Clinical Operations 15-02-2022, What’s the ‘New Normal’ for the clinical trial industry? 15-02-2022, 12:30 pm Chairman’s Closing Remarks & Drinks Reception 15-02-2022, 5:15 pm Registration and Refreshments 16-02-2022, 8:30 am View In Agenda

Biography: Meraf Eyassu is a Executive Director of Clinical Operations at Terns Pharmaceuticals.  Meraf has over 20 years experience working in biotech, health and the pharmaceutical industry.  She has managed and overseen large global clinical trials in various therapeutic areas and multiple phases of development.

Session Details: PANEL DISCUSSION Defining your outsourcing strategy to contain costs and accelerate drug development time-to-market: what should you consider in the new COVID-19 era 16-02-2022, 1:45 pm View In Agenda

Biography: Claudia Berrón is Avantor’s Senior Vice President, Clinical Services. Claudia has over two decades of experience in B2B strategic marketing covering ideation, value proposition strategies, market segmentation, marketing and sales planning through product launch, and has been working with Avantor since 2015. She holds an MBA from the University of North Carolina Kenan-Flagler Business School in Chapel Hill, North Carolina, and a bachelor’s degree from Monterrey Institute of Technology in Mexico City.

Session Details: How will the Supply Chain need to adapt to support the growth of Decentralized Clinical Trials? 15-02-2022, 4:15 pm View In Agenda

Biography: Business executive, advisor and entrepreneur Paul's career includes nearly 20 years of leading companies, product development, global operations, design and adoption of technology in the most difficult of sectors: healthcare and drug development. As Senior Director Paul leads THREAD Consulting in ensuring customers are successful in the strategic design and deployment of technologies throughout the course of their clinical trials.

Session Details: Decentralized or Traditional Design: Differentiate your study through participant co-creation and design 16-02-2022, 12:15 pm View In Agenda

Biography: Dave is an entrepreneur and technology innovator. He is known for pioneering the fields of A.I.-based medical decision-support, Training Analytics, and Virtual Patient Simulation (VPS). Dave’s last company, TheraSim, launched the world’s first successful online VPS system for physicians and trained over 500,000 doctors in every country on Earth. TheraSim built the world’s largest network of computer-based clinical simulation sites in Africa in support of the USAID and the CDC’s HIV-treatment effort. TheraSim was acquired by WebMD in 2014. Since then, he has focused his passion for technological innovation and learning systems in the field of clinical trials, helping sponsors make their studies more accurate and efficient through finding the right technology mix such as virtualization, performance management and applied behavioral sciences to produce the most effective, lasting, and engaging results for clinical trials. Dave has always valued the interconnectedness of our vastly changing world, and has traveled to over 70 countries for his global health work and for cultural development outreach through music.

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Biography: Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience.  His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality.  He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

Session Details: KEYNOTE REUNION DEBATE, 1 YEAR ON: How long will we feel ripples of the pandemic? 15-02-2022, 8:30 am Remote Monitoring: Lessons learned during a pandemic 16-02-2022, 10:00 am View In Agenda

Biography: Since 2002 Jorge has been involved in pharmaceutical, biotech, and biologics research in a variety of roles including clinical, operations, finance, market Intelligence and business development at the site level, SMO, CRO, and now for clinical supply solutions and access at TrialCard.  Past employment includes Sarkis Clinical Trials, Radiant Research, Covance, Interventional Concepts,  MedPrimo Research as an independent consultant, FutureLife LLC advisory board member, and the University of Florida/VAMC Department of Neurology.  Cumulatively he has been involved in over 350 clinical trials including Phase I-IV, PK/PD, vaccine, 510k submission, vaccine research, and has conducted both pediatric and adult trials. Mr. Franceschi completed his undergraduate work at the University of Florida in Food Science & Human Nutrition and completed his Masters of Science in Health with emphasis in nutrition at the University of North Florida in Jacksonville.  A majority of his clinical trial work has been within the CNS realm supporting major depressive disorder, anxiety, bipolar, ADHD, and PTSD research but most recently he is learning about and supporting clinical teams needing oncolytic co-therapy medications.

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Biography: Dr. Greene is a seasoned pharmaceutical research professional with success both in large pharmaceutical companies and in CROs.  He has a PhD and post-doctoral training in psychology and neuroscience, with a focus on the neuroanatomical and neurochemical bases of learning and memory.  His career has spanned the full range of clinical development from preclinical pharmacology through late-stage clinical development, successful NDA and MAA submissions, and post approval commitments and label extensions.   Dr. Greene has published numerous manuscripts and over thirty abstracts, all focused in CNS research from the bench to clinical work.   With over 25 years of experience in the pharmaceutical industry, first as a Lilly Fellow at the Universitè Louis Pasteur in Strasbourg, France, Paul has obtained roles of progressing responsibility at major pharmaceutical companies and CROs.   He has experience across a range of CNS disease states with very deep concentrations in mood disorders and schizophrenia. He has worked extensively in pediatric and elderly populations including special institutional environments. At GlaxoSmithKline Dr. Greene led the clinical team through the creation and execution of a clinical development plan for a major marketed product for bipolar disorder.  He also led the submission team for a successful NDA and MAA for that product and wrote the Integrated Summary of Efficacy and the Integrated Summary of Benefits and Risks. Having led global project management teams, a rater training enterprise, and  large customer relationships at Syneos Health, Dr. Greene brings scientific, operational, and partnership expertise to the relationships in his remit.  Paul is Senior Vice President, Global Client Solutions at Syneos Health.

Session Details: The growing constellation of asset development partnerships 15-02-2022, 12:00 pm View In Agenda

Biography: Derek Ansel, CCRA, has more than 8 years of experience in clinical laboratory research, monitoring, and project management in Phases I-IV. He has a wide breadth of therapeutic experience including non-malignant hematology, vaccines, infectious diseases, and nephrology. He is a 4-time US PharmaTimes Clinical Researcher of the Year finalist and is currently pursuing a master's degree in pharmacology and toxicology from Michigan State University. He is a writer for the Vaccine Education Center at the Children's Hospital of Philadelphia, an active consultant for several start-ups in the eClinical software space, and serves on the institutional review board (IRB) at Thomas Jefferson University in Philadelphia, PA. He is also a contributing member of Cochrane, a non-profit organization that promotes evidence-based decision making in healthcare

Session Details: Getting started with DCT: Strategies and considerations for meaningful patient engagement 15-02-2022, 12:00 pm View In Agenda

Biography: Michael is a Managing Partner of Medidata’s Patient Cloud solution sales team, providing leadership and subject matter expertise in decentralized clinical trials and patient centric technologies.  Over the last decade, Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world to pioneer the use of decentralization technologies for hybrid and virtual clinical trials. He was involved in providing solutions for the first decentralized clinical trial with FDA oversight in 2011 as well as PCORI’s ADAPTABLE study with more than 15,000 patients, and many other fully decentralized and hybrid clinical trials.  His 33-year career in medical research includes nearly a decade with the US government conducting and supporting surgical & preclinical research and more than two decades working in the commercial sector to provide technology solutions that improve and support preclinical and clinical research.  Michael is a decorated veteran of the United States Navy and resides in Brushy Creek, Texas where he is also an elected official serving his community.  

Session Details: PANEL DISCUSSION: Decentralized/Hybrid Trials: Discussing the current challenges and debating best practises for a successful virtual study 15-02-2022, 12:30 pm View In Agenda

Biography: Irfan Khan, MD, the Founder and CEO of Circuit Clinical®, is a cardiologist who has served as a principal investigator on both therapeutic and device clinical trials for more than a decade. Delivering on his company’s mission, Dr. Khan is passionate about improving access and equity in clinical trials, increasing community engagement, and fostering the patient experience through education and empowerment. Over the last six years, he has overseen Circuit Clinical’s growth to more than 2.5 million patients, which involve 30+ partner locations including multi-specialty physician practices, Accountable Care Organizations, and Federally Qualified Health Centers. His work at Circuit Clinical has also included the creation of TrialJourney™, the first-ever ratings and reviews platform for clinical trial participants and people seeking clinical research as a care option.

Session Details: How a turn-key DCT approach benefits sponsors, sites, and patients by improving access, awareness, and experiences 15-02-2022, 9:45 am View In Agenda

Biography: Research operations professional with over 19 years of experience in Basic, Translational and Clinical Research focusing on Hematology/Oncology, Infectious Diseases, and Type 2 Diabetes/Metabolic Syndrome. Impacting human health globally while working with and leading diverse teams to execute phase 1-4 trials.

Session Details: PANEL DISCUSSION: Decentralized/Hybrid Trials: Discussing the current challenges and debating best practises for a successful virtual study 15-02-2022, 12:30 pm View In Agenda

Biography: Meghan has over 20 years of clinical research experience in Phase 1 to 3 Clinical trials in oncology, ophthalmology, immunology, neurology, and infectious disease.  Her vision includes developing strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical research and to support the optimal use of Genentech medicines.   Gaining patient insights early in program development is integral to developing what is important to patients but just as important is getting access to medicines and treatments for all patients, regardless of race/ancestry, sexual orientation, gender identity, socioeconomic status and ability/disability.   Her prior positions include Clinical Program Director. Clinical Program Leader, Trial monitor, Data manager, Research Coordinator and NASA Research associate. She has a Bachelor's degree in Behavioral Economics from UNC-Chapel Hill and a Master's degree from San Francisco State University in Human Biology.

Session Details: KEYNOTE Improving inclusion & diversity in clinical research: Reaching under-represented patient populations 15-02-2022, 11:30 am View In Agenda

Biography: Dr. Isaac R. Rodriguez-Chavez is a biomedical leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, and Vaccinology. His experience covers the entire life cycle of medical products from basic, preclinical, interventional clinical research (phase I – IV), non-interventional clinical research, and post-marketing studies. Currently, he is a Senior Vice President,  Scientific & Clinical Affairs, and Head, Global Strategy Center of for DCTs and Digital Medicine at ICON plc. Past positions include FDA, CDER Senior Officer for Clinical Research, Regulatory Compliance, and Policy Development modernizing clinical research through DCTs enabled by DHTs. He published numerous articles and has been an invited speaker in 100+ global conferences. He holds leadership roles at DiME, IEEE, DTRA, HCMA, Global Genes, and DIA Global Forum. He is also involved with and a member of 14 professional associations. He has a Ph.D. in Virology and Immunology; a M.S. in Microbiology; a M.H.S. in Clinical Research; and a B.S. in Biology. He completed two postdoctoral training specialties in viral immunology and viral oncology combined with clinical research at the National Institute on Aging and the National Cancer Institute of the National Institutes of Health.

Session Details: Driving Innovation in Decentralized Clinical Trials Using the Digiverse and Unique Digital Prints 15-02-2022, 12:00 pm View In Agenda