Outsourcing in Clinical Trials West Coast 2023

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: PANEL DISCUSSION: The concept of DCT, is it the future? 01-03-2023, 10:45 am View In Agenda

Biography: Wendi Carroll received her Pharm D from the University of the Pacific.  She has 20+ years of diverse global experience in the biotechnology industry including roles within Clinical Development, Medical Affairs, and Risk Management.  During her career she has advocated for critical partnerships with vendors supporting integration with internal stakeholders.  Wendi is currently the Executive Director, Global Medical Affairs Evidence Generation COE at BioMarin Inc. where she oversees global operational strategy and execution for programs in the post-approval setting.

Session Details: Developing successful communication pathways in a more remote world 02-03-2023, 12:00 pm View In Agenda

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: PANEL DISCUSSION: The concept of DCT, is it the future? 01-03-2023, 10:45 am THE 2023 AI UPDATE AI & disruptive technology: Harnessing the future of Artificial Intelligence to transform clinical trials 02-03-2023, 10:00 am View In Agenda

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: Not just ticking a box: Outreach to minority groups is improving but the focus now is on establishing trust and relationships 01-03-2023, 10:45 am View In Agenda

Biography: Dr. Chris Apfel is the founder and CEO of SageMedic Corp., an early-stage clinical diagnostics company to assist oncologists in selecting the most effective treatment for their patients. Dr. Apfel is also the Chair of Life Sciences at the Keiretsu Angel Investment Forum, where he invests in life-science companies that have the potential to positively impact patients with serious conditions. Prior to starting SageMedic, he was an Associate Professor at UCSF.  Dr. Apfel is an internationally known authority on designing, conducting, and publishing highest quality clinical trials with thousands of patients that have changed medical practice with over 100 peer-reviewed publications.  Dr. Apfel is a California licensed physician with 20+ years of clinical experience in anesthesiology, critical care medicine, and emergency medicine. He received his medical degree (MD) and his doctoral degree (PhD equivalent) from Justus-Liebig-Universität Giessen, Germany, and his Master of Business Administration (MBA) from the Wharton School of Business, University of Pennsylvania, PA

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Biography: Currently, Audrey Funwie works in the Patient Inclusion and Health Equity team of Genentech’s Chief Diversity Office. In this position, she focuses on initiatives for employee development or training and topics to advance health literacy for underserved communities as it relates to clinical trial access. Additionally, Funwie collaborates with colleagues to co-create educational resources as a part of the core team of the Advancing Inclusive Research Site Alliance, which focuses on addressing disparities in clinical research.  Prior to working at Genentech, she graduated from the Johns Hopkins Bloomberg School of Public Health with a Master of Bioethics. Funwie strives to do meaningful work that combines and applies her bioethics background while prioritizing and addressing health equity in the context of clinical studies, patient experience, and policy.

Session Details: INTERACTIVE SESSION Data matters in health outcomes and equity: Collecting and understanding Social Determinants of Health (SDOH) data in clinical trials and beyond 01-03-2023, 12:00 pm View In Agenda

Biography: Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. Solution-oriented professional, with strong problem solving capabilities.

Session Details: Simplifying the problem: What 5 things can you change today to build and improve your CRO relationship? 01-03-2023, 12:00 pm Bridging the gap between sponsor and site when negotiating site budgets 02-03-2023, 11:00 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: KEYNOTE 01-03-2023, 8:30 am PANEL DISCUSSION: Reversing the Conversation: What the clinical trial industry really wants from its service providers 02-03-2023, 2:30 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: GENENTECH CASE STUDY 01-03-2023, 2:00 pm View In Agenda

Biography: Isabel Brown (she/her/hers) is currently working in Genentech’s Research and Early Development Clinical Operations Group in Inclusive Research and Health Equity. In her current role, she creates and centralizes inclusive research strategies for Genentech's early phase studies. She is involved in Genentech’s Advancing Inclusive Research Site Alliance, where she works as a core member with a focus on patient and healthcare provider education initiatives. Isabel leads strategies related to LGBTQ+ Health Equity and Social Determinants of Health, both relating to how the ethical collection of patient data can impact clinical trial design and address health inequities.

Session Details: GENENTECH CASE STUDY 01-03-2023, 2:00 pm INTERACTIVE SESSION Data matters in health outcomes and equity: Collecting and understanding Social Determinants of Health (SDOH) data in clinical trials and beyond 01-03-2023, 12:00 pm View In Agenda

Biography: Esther Marfo, is a Project Leader within the Health Equity and Population Sciences department at Genentech. With over 15 years’ experience in the industry, Esther has predominantly worked in clinical trial management and data management roles across Europe, North America and South Africa. Her passion for ensuring that clinical trials are reflective of our society drove her to her most recent work in Health Equity, where she works with a group of committed and passionate individuals to successfully develop and implement scalable and sustainable strategic interventions for the recruitment of underrepresented patient populations.

Session Details: Uncovering how Deconstructed Patient Navigation can enhance patient support 01-03-2023, 2:00 pm View In Agenda

Biography: Abby Kennedy received her BS in chemistry from Allegheny College and a Ph.D. in organic chemistry from the University of Arizona.  She started her career in drug discovery and development as a medicinal chemist at Exelixis, Inc.  After completing her Clinical Trials Design and Management Certification at San Francisco State University Extension, Abby moved downstream in the drug development process at Exelixis.  As a Senior Clinical Trials Manager, she managed oncology trials supporting the successful filing of cabozantinib for the treatment of medullary thyroid cancer.  In 2011, she moved to XOMA in Berkeley as a Sr. Manager of Clinical Operations where she built a high-functioning team of trial managers focused on bringing monoclonal antibodies to market.  Abby joined Genentech, a member of the Roche family, in 2014 as a Sr. Clinical Program Manager of immunology programs within Genentech Research & Early Development (gRED).  From there, Abby became Sr. Director of Clinical Operations at Principia Biopharma in 2018, where she led the late phase program for Principia’s lead molecule, rilzabrutinib.  Abby joined CymaBay Therapeutics in 2021 as VP of Clinical Operations, leading a team focused on bringing seladelpar to market for patients with a rare liver disease, primary biliary cholangitis.  Abby volunteers for the American Chemical Society, the Association for Clinical Research Professionals, and serves as President of the Oakland Girls’ Softball League.

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Biography: 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

Session Details: PANEL DISCUSSION: The concept of DCT, is it the future? 01-03-2023, 10:45 am What can we do to take advantage of high prevalence of disease in populous countries but systems are either rudimentary or non-existent? 02-03-2023, 1:30 pm 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: Registration and Refreshments 02-03-2023, 8:30 am FIRESIDE CHAT: Is the pharma industry still too conservative with disruptive innovations in clinical operations and technology? 02-03-2023, 11:00 am Exploring the need for a dedicated regulatory pathway for antibacterial/antimicrobial drugs 02-03-2023, 1:30 pm View In Agenda

Biography: I move business forward, faster! I'm a firm believer that business alliances and partnerships and nurturing relationships with new clients paves the way to market share acceleration and brand awareness. I'm also a creative powerhouse when it comes to building a brand image and taking innovative healthcare IT solutions from a vision, to a valuable partner in delivering scientific discovery. I'm a scientist and an artist and this gives me a unique perspective when crafting market approaches that drive disruption. My most exciting work to date focuses on impacting the lives of patients and the people who care for them - who seek to discover new treatment protocols and pharmaceutical applications. My results are evidenced in the impact I make on how complex decisions and discoveries are made using our technology to improve patient lives at the bedside and beyond.

Session Details: Keynote: Deep dive into Wearables 01-03-2023, 12:00 pm 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: FIRESIDE CHAT: Is the pharma industry still too conservative with disruptive innovations in clinical operations and technology? 02-03-2023, 11:00 am View In Agenda

Biography: Experienced Clinical Operations and Clinical Data Management professional with over 20 yrs of Biotech/ Pharma industry, and Study Site experience. Phase I through Phase IV clinical studies experience in various therapeutic areas, e.g. infectious disease, oncology, GI, and HIV AIDS. Evaluated and managed CROs for both Clinical and CDM activities. Monitored and co-monitored national and international study sites (India and Thailand). Led implementation of, and worked with various software systems like DataFax, Oracle Clinical, ClinTrial, Clinical Trial Management system, and Document Management. Experienced in managing clinical trial process from inception to reporting and submission. Specialties: Management of CROs, study sites (US, Asia), and Clinical Data Management. Establishing Data Management Dept and implementing software systems and processes that are well integrated with Clinical, Biostat/Programming, QA/QC, and Research.

Session Details: WORKSHOP: Identifying and overcoming the hurdles associated with global studies including longer timelines, drawn-out budgets and remote teams 02-03-2023, 9:00 am View In Agenda

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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: Top tips for starting up trials in the Rare Disease space 01-03-2023, 3:00 pm 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: FIRESIDE CHAT 01-03-2023, 3:00 pm View In Agenda

Biography: Extensive Outsourcing and Contracts experience in the area of Clinical Development primarily at small to mid-size biotech organizations. Includes management of the RFP process for outsourced services as well as contract/proposal and budget negotiations, vendor selection, and vendor oversight/relationship management. Previous roles within both CRO and Sponsor organizations which provide valuable perspective from both sides of the industry.

Session Details: INTERACTIVE SESSION: Establishing strong CRO/sponsor relationships and building trust in a more virtual landscape- What 5 things do our panellists say we should focus on right now? 01-03-2023, 4:00 pm View In Agenda

Biography: Clinical Operations leader with extensive bio-pharmaceutical and CRO industry experiences (20+years) *Develop and implement strategic Clin. Ops components of various FIH studies and global P1-P3 drug development programs and post-marketing studies in Oncology, Hematology-Oncology, Immuno-Oncology, Infectious Diseases, Immunology, Metabolic Diseases, Ophthalmology, and Critical Care conducted in North America, Europe, Africa, Central and South Americas, Asia-Pacific regions including Japan, China, So Korea, and Australia *Lead cross-functional teams and successfully contributed to several INDs, NDAs, FDA, EMEA, TGA, and NMPA regulatory filings and approvals of marketed products within HIV/Virology Therapeutic Area *Mentor, motivate, and develop clinical operations teams and direct reports *Strong, flexible, strategic team leader with extensive change management successes *Track record to develop, problem-solve, and execute creative and innovative process improvements and quality efficiencies within development operations *Motivated and driven to continue contributing to drug development in transformative medicines with a focus on unmet medical needs

Session Details: ClinOps team focus: Managing relationships, retention and hiring in the new world 01-03-2023, 5:00 pm 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: Executing clinical trials on a shoestring: Optimizing the CRO Functional Service Provider model 02-03-2023, 10:00 am View In Agenda

Biography: Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. She has led clinical development in dermatology and medical aesthetics for pharma/biotech, CROs, medical device and cosmetic companies including RAPT, Innovaderm, Premier Research, Allergan, Leo Pharma, and Murad. She has driven program strategy and planning, including implementation of 300+ clinical study protocols in 25+ indications, by leading global cross-functional teams towards successful regulatory submissions, product launches, and innovative lifecycle management. As an international key opinion leader in dermatology clinical development, Dr. Jankicevic has served as advisor to multiple companies on their path to global regulatory and commercial success. Dr Jankicevic holds Doctor of Medicine degree, Master of Medical Sciences degree, and Board-certification in Dermatology and Venereology from the University of Belgrade, Serbia. She holds medical license issued by Serbian Medical Chamber. She is also a Certified Clinical Research Professional, and a trained journalist. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals.

Session Details: Seeing your site as a partner and identifying best practices for reducing site-burden 01-03-2023, 4:00 pm PANEL DISCUSSION: The concept of DCT, is it the future? 01-03-2023, 10:45 am View In Agenda

Biography: Sandy Mohan is the VP of Quality at Iovance Biotherapeutics.  Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck. She has worked at several companies in positions of increasing responsibility including VP of Quality at InterMune (acquired by Roche) and Director of Quality at CV Therapeutics (acquired by Gilead).  She has over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules.  She has extensive experience in building quality organizations, overseeing Phase 3 global clinical trials, supporting marketing authorization applications in the US and EU, and managing pre-approval inspections leading to multiple product approvals and launches.  She received her MS and PhD in Microbiology from New York University and did a postdoctoral research at Merck Research Laboratories.

Session Details: GxPs in Cell Therapy and key considerations for Quality and Project Management 02-03-2023, 12:00 pm View In Agenda

Biography: Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. Proven ability to organize and manage late-stage development cross-functional teams completing projects on time with meticulous attention to detail.

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Biography: Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. Currently he is the CEO of Certum Bio in San Francisco Bay area. Over the past 30 years his focus has been in the areas of drug substance as well as drug product R&D, manufacturing and outsourcing the small molecules as well as biologics. The therapeutic areas include: Cancer, CV, CNS and infectious diseases. He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. CA; X-Mine, CA; Delphian Pharma, CA and Certum LLC, CA). He has been actively involved on both sides of the business in managing CDMOs and CROs. Of the several programs he worked at Pharma and Biotech companies, three culminated in making to the market [PaclitaxelTM – Bristol-Myers Squibb; SensiparTM – Amgen and DuexisTM - Horizon Therapeutics). As the Founder and Chairman, he spearheaded the ACS ProSpectives international conferences on, ‘Process Chemistry in the Pharmaceutical Industry’, and as the chair, speaker and the moderator at numerous national and international conferences on API Process Chemistry and Drug Discovery & Development. He has been a visiting professor at Catholic U., Louvain, Belgium and U. Pittsburgh, Pittsburgh, PA and visiting speaker at Humboldt U. in Berlin, Germany. In addition to several peer reviewed publications and patents he published two volumes on, ‘Process Chemistry in the Pharmaceutical Industry’ and currently is working on the third volume entitled, ‘Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry’ jointly with the bio-process leaders at Pfizer. Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia.

Session Details: Why Drugs Fail in Clinical Trials? - Cognizing & Mitigating….Does AI-ML offer a solution? 01-03-2023, 3:00 pm View In Agenda

Biography: I am the CEO at OrPro Therapeutics, a biotechnology company in San Diego, CA developing biologic drug solutions to unmet needs in serious epithelial diseases including cystic fibrosis. My training is in genetics (Ph.D.) and mechanical/biochemical engineering (M.S.), both from Duke University where I was also an undergraduate. I went into industry for post-doctoral studies at the biotechnology research center at Ciba-Geigy Corp. (Novartis) and have over three decades of academic and industrial research and senior management experience in protein and metabolic engineering, bio-based manufacturing, and drug discovery / development. I am passionate about the life sciences and the clinical and commercial potential of novel therapeutics and applications of synthetic biology.

Session Details: Speaker Hosted Roundtables 02-03-2023, 3:45 pm View In Agenda

Biography: Arun Sivanandam has more than 12 years of experience in clinical research at site and sponsor side. He investigated mechanisms by which active ingredients in cumin seeds halt Prostate Cancer progression and metastasis at the Vattikutti Urology Institute, Henry Ford Hospital. With a dual clinical appointment in Robotic-Surgery at the Institute, Arun focused on post-surgical outcomes of Da-Vinci Robotic Prostatectomy for Hormone Refractory Patients. He worked as a Research Associate to improve recruitment metrics in the Million Veterans Program genomic biobanking initiative for Loma Linda VA Medical Center where he developed a novel Point of Care recruitment solution in outpatient clinics. To understand site-side difficulties in trial recruitment and conduct, Arun served as a Senior Clinical Research Coordinator for Cardiology Phase 4 trials at the Loma Linda VA Medical Center, and as a Lead Clinical Research Specialist for Investigator-Initiated and Phase 0 – 3 Gastric Neuroendocrine Rare Disease trials at Stanford Cancer Center. Subsequently, Arun lead the Gastric-Immuno-Oncology Rare Disease Bispecific-T cell-Engager portfolio at Amgen on various aspects of clinical research operations. More recently, Arun headed to Santen, with a focus on driving operational excellence in Ophthalmology clinical research as Associate Director Global Clinical Development and Operations, where he oversees Phase 1 – 4 clinical trial conduct. Arun received a Bachelor’s degree in Biological Sciences from University of California-Riverside, a Master’s degree in Biomedical Sciences from Wayne State University and completed Doctoral degree coursework from Michigan State University College of Human Medicine. His thesis was on the role of the Androgen Receptor in Hormone Refractory Prostate Cancer. He received a Certificate for Graduate Biostatistics at Harvard University Extension. He also conducted undergraduate research on osteoporosis progression and has authored several papers, abstracts and a book chapter on protein signal transduction.

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Session Details: TECH MEETS QUALITY: Empowering excellence in supply through digital quality management systems 02-03-2023, 2:00 pm View In Agenda

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Session Details: ClinOps team focus: Managing relationships, retention and hiring in the new world 01-03-2023, 5:00 pm View In Agenda

Biography: Ann Louise Armstrong is Senior Manager of Clinical Affairs and Field Operations for Ancora Heart, a device company involved in research and development of a novel therapy to improve the quality of life for heart failure subjects. Ann Louise graduated from the University of North Carolina at Chapel Hill and earned her Masters in Clinical Trials at Drexel University.  She started her nursing career in the CCU at Duke University Medical Center.  She became a Research Coordinator and an ICU nurse at Duke in a hybrid position.  Following a move to Tennessee, she was a Research Coordinator rising to  Director of Research at Cardiovascular Associates in Kingsport. She transitioned to being a Clinical Research Associate following a move to South Carolina with a strong focus on cardiovascular drugs, then devices.

Session Details: Speaker Hosted Roundtables 02-03-2023, 3:15 pm View In Agenda

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Session Details: Speaker Hosted Roundtables 02-03-2023, 3:15 pm View In Agenda

Biography: Alton Sartor completed a combined MD/MBA from Tulane University.  Subsequently completed a Neurology Residency at Columbia University with additional Fellowship training in Neuro-Oncology at the Mass General Brigham program.   Practiced Neuro-Oncology and General Neurology at the VA and Boston Medical Center.  Joined industry with a goal of developing digital and devices to improve patient care.  Currently a Medical Director/Patient Safety Physician Digital & Devices at Astrazeneca.

Session Details: Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence. 02-03-2023, 1:30 pm View In Agenda

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Session Details: Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence. 02-03-2023, 1:30 pm View In Agenda

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Biography: Dr. Cunningham has over 15 years’ experience in clinical leadership position in medical device industry, overseeing a full spectrum of clinical development programs ranging from FIM to pivotal to post-market phases. She has a unique perspective in leading clinical programs in a dynamic startup environment. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. She currently serves as Vice President of Clinical Affairs at Endogenex, a medical device company developing innovative solutions for the treatment of Type 2 diabetes.    Dr. Cunningham came from academic background. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China.  

Session Details: Making progress of a complex Interventional device study during covid 02-03-2023, 10:00 am View In Agenda

Biography: Dr. John Hsu worked 29 years as an anesthesiologist and pain management physician.  In his practice he often found it difficult to monitor medication adherence and was always concerned about misuse and diversion.  To solve this problem in his practice, he founded iPill Dispenser for medication adherence monitoring, secure storage, active control dispensing, and destruction of unused pills. In his past, Dr. Hsu founded QuivivePharma, a drug development company that combined an opioid with a respiratory stimulant.  After receiving a NIDA NIH grant,  he is working with the Cleveland Clinic on a clinical study.   QuivivePharma has gone from an FDA 505(b)2 PreIND meeting to an FDA drug filing.  He also founded Fentavive, an abuse deterrent Fentanyl patch that has will have a commerical product in about a years time.  He co-founded   NAOMI systems, a digital software platform integrating digital X-rays devices, practice management, EMR and RCM billing systems. He currently holds 8 granted patents in digital medicine, medical devices and drug development.

Session Details: The Digital Transformation of Clinical Trials – the Importance of Data Accuracy 02-03-2023, 11:00 am View In Agenda

Biography: Dr Frances Rubenstein has worked in clinical data management for more than 20 years in both medical device and pharmaceutical companies. She has extensive experience in leading data management activities for multiregional clinical trials in all phases and several therapeutic areas. Frances has an undergraduate degree in Physiology and a PhD in medical science from the University of Sydney. Frances has been working at Nevro Corp, a medical device company for the past 12 years as Director, Database Management. In her role at Nevro, Frances is responsible for selecting and managing vendors and technology to deliver quality clinical trial data to support decisions that bring new treatment to patients.

Session Details: Data Management: Programming and metrics in medical device studies 02-03-2023, 12:00 pm View In Agenda

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Session Details: Speaker Hosted Roundtables 02-03-2023, 3:45 pm Speaker Hosted Roundtables 02-03-2023, 3:15 pm View In Agenda

Biography: Vast experience of over 20 years in Quality, Regulatory, Processes Improvements and leading cross organization projects VP Quality Assurance, Regulatory Affairs and Clinical at IceCure Medical, since September 2020, leading the company compliance and clinical affairs Prior to joining IceCure Medical, held a position of Director of Quality, Regulatory and Customer Support at Applied Spectral Imaging (ASI) and Several positions at Carestream Health (formerly Orex Computed Radiography)

Session Details: First-hand learnings, breakthrough device system, a case study 02-03-2023, 2:00 pm View In Agenda

Biography: Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORA’s Office of Enforcement and 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 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.  

Session Details: CLOSING KEYNOTE: Session Reserved for FDA 01-03-2023, 5:00 pm View In Agenda

Biography:

Session Details: Tactical clinical operations in digital health studies 01-03-2023, 2:00 pm View In Agenda

Biography:

• Kristina leads the Patient Insights team at Parexel and is dedicated to bringing a thorough understanding of the patient journey, and the patient voice to the entire spectrum of research services.
• Over 20 years in clinical research, including patient  innovation, feasibility, strategy, patient recruitment, retention, site engagement. 12 years at Parexel.
• Lead on the diversity and inclusion team, and member of DTRA, CISCRP and other industry consortiums aimed at improving access to clinical research and providing clinical research as a care option.
• Post doctoral research studies in Human Behavior. BS in Human and Organizational Behavior, and Communication Studies and authored numerous trade articles and frequently present on behalf of Parexel at trade conferences.
• Experienced in research methodologies and conducting qualitative and quantitative research in a variety of therapy areas including respiratory, cardiology, oncology, immunology rare diseases and emerging therapy areas.

Session Details: How understanding the person behind the patient can improve engagement 01-03-2023, 12:30 pm 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: Chairman’s Opening Remarks 01-03-2023, 8:25 am Stream A: Outsourcing & Clinical Operations 01-03-2023, FIRESIDE CHAT 01-03-2023, 3:00 pm Registration and Refreshments 02-03-2023, 8:30 am PANEL DISCUSSION: Reversing the Conversation: What the clinical trial industry really wants from its service providers 02-03-2023, 2:30 pm View In Agenda