OCCAMPOINT - Key Persons

Job Titles:

• Regulatory Reform and Policy, Trial Innovation, and Decentralization Risk Mitigation / Click for Bio

In her more than 20 years of experience working in a variety of roles in clinical research, Beth Brinsdon has developed a valued, thorough, and nuanced understanding of investigational product development and what it takes to execute clinical trials, including the complexity of data sources and their interface with clinical databases, data monitoring, the CRO landscape, and Good Clinical Practice. Her therapeutic area expertise includes oncology, CNS, and clinical pharmacology studies. The president and founder of Trialwise, a boutique CRO, Ms. Brinsdon regularly consults with and directs clinical research activities for small-to-midsize biotech companies and startups. Ms. Brinsdon views her work as collaborative, and has developed strong working relationships with other CROs, government agencies, as well as academic research centers, such as UT MD Anderson Cancer Center, and Memorial-Sloan Kettering Cancer Center. Ms. Brinsdon's CRO, Trialwise, focuses on planning and execution of phase 1 and phase 2 studies for a small number of private and government clients. Prior to founding Trialwise, Ms. Brinsdon provided operational oversight for early and late phase programs for Fortune 500 companies, including global submissions of blockbuster products. She is a frequent speaker and trainer on topics including Good Clinical Practices and optimized clinical study workflow at national conferences. Ms. Brinsdon studied psychology and zoology at Brigham Young University and holds an MBA from the C.T. Bauer College of Business at the University of Houston.

Job Titles:

• Clinical Trial Design, Clinical Outcome Assessments, Biometrics / Click for Bio

Job Titles:

• Quantitative Sciences and Development Operations / Click for Bio

Dr. Sanders has over 25 years of experience in global Pharma and Biotech Research and Development including senior executive roles overseeing diverse aspects of early-to-late development programs in both large and small organizations. Her experience spans the therapeutic areas of oncology, immunology, pulmonary, rheumatology, respiratory, neurology, ophthalmology, cardiovascular, inflammatory bowel disease, endocrinology, and infectious disease. Her primary focus areas are in Strategic and Development Operations, Portfolio Strategy, and Quantitative Sciences. Most recently Dr. Sanders served on the Executive Committee of Juno Therapeutics' CEO, as the Executive Vice President of Strategic and Development Operations, before transitioning to the strategic advisor to the Celgene office of the CMO, upon Celgene's acquisition of Juno. At Juno Therapeutics, she led multiple corporate-level organizations, including corporate project leadership and management, development operations, quantitative sciences, operational excellence, and CAR T patient operations. Prior to joining Juno, Dr. Sanders was Senior Vice President at Hoffman-La Roche, as global head of clinical operations and industry collaboration, and before that, as global head of biometrics and development innovation. She was a member of the late stage portfolio committee, co-chair of the Roche-Chugai joint portfolio management committee and vice-chair of the Board of Directors of TransCelerate Inc. At Genentech, Inc. Dr. Sanders served in several senior leadership roles, including oversight of biostatistics, epidemiology, health economics and outcomes research, data management, medical writing, development information technology, bio-sample management and development innovation. Dr. Sanders and her teams made significant contributions to programs across the early-to-late development portfolio. She was instrumental in the development and submission of Herceptin and its companion diagnostic, Herceptest. Dr. Sanders also directly contributed and/or led the planning and execution of Claritin, Rituxan, TNKase, Cathflo, Xolair, Avastin, Tarceva, Lucentis, Zelboraf, Perjeta, Erivedge, Gazyva, Kadcyla, Ocrevus, Hemlibra, and JCAR017, a CAR T cell therapy for NHL. Dr. Sanders currently serves on the Board of Trustees of the Fred Hutchinson Cancer Center Research Center. She is also on the Board of Directors of Molecular Templates, a biotech company developing Engineered Toxin Bodies to create novel drugs for cancer, and AbGenomics, a pioneering organization with scientists seeking new and innovative ways to prevent, diagnose, and treat cancer, HIV/AIDS and other life-threatening diseases. She is also on the Life Science Council of Springboard Enterprises, a network of innovators, investors, and influencers, helping women build and lead big businesses. Dr. Sanders holds Bachelor's and Master's degrees in Statistics from the University of the Philippines. She received a Master's degree and Doctorate in Statistics from the Wharton School at the University of Pennsylvania.

Job Titles:

• Systems and Infrastructure for Clinical Data Acquisition, Aggregation, and Governance / Click for Bio

The focus of Dean's 30+ years experience in clinical development has been building enterprise-level systems and infrastructure solutions for data acquisition, aggregation and governance in small and large pharma and device companies, as well as Clinical Research Organizations (CROs). His therapeutic development experience includes oncology, CNS, ophthalmology, infectious diseases, and endocrinology. Dean's interests and passion are on data-driven, adaptable data flow operations that help move the industry towards rational implementation of risk-based monitoring and paperless (eSource) clinical trials. He is driven to materially contribute to helping to achieve quantum improvements in addressing the longstanding industry challenge, namely, that clinical trials take too long and cost too much. He has published, and presented on the topic of how to combine real-time data collection and near-real time risk-based monitoring at national industry forums, and implemented the paradigm of data-driven fast and quality decision-making across all his corporate roles and customer engagements. Dean's focus on creation of organizational structures that optimize speed and quality of pharmaceutical data flows enabled successful achievement of regulatory filing milestones. As the Head of Biometrics at Vertex Pharmaceuticals, Dean led Biostatistics, Statistical Programming, and Clinical Data Management to deliver its first NDA filing for hepatitis C. While at Meadox Medicals, Dean built a Data Management function and infrastructure, and successfully defended two PMAs during advisory panel reviews. At ICOS, Dean established clinical information systems governance that supported global regulatory filings, and introduced the use of electronic data capture (EDC). As a Head of global Data Management at Genentech Roche, Dean was instrumental in establishing a data science approach towards collecting, storing, and interrogating clinical trial data to enable achievement of critical development milestones. Dean holds a BA in Biology from Rutgers University, and an MS from Fairleigh Dickinson University that combines computer science and MBA, with emphasis on database technologies.

Job Titles:

• Aggregate Safety Assessments, Cross - Disciplinary Engagement / Click for Bio
• Safety Data Scientist, ASAPprocess

Greg has 38 years of strong leadership, managing people and projects; including 13 years as a traditional Statistician (MD Anderson, Applied Logic Associates, Quintiles, and Astellas) and 11 years as a Safety Data Scientist (AbbVie, Merck, and ASAPprocess). He served in the Navy and taught high school math and physics before earning his MS in Statistics from Purdue and PhD in Biostatistics from the University of Texas. He co-led a company initiative at Merck between Clinical Safety and Safety Statistics to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). To advocate for aggregate safety assessments and cross-disciplinary scientific engagement, Greg partners in leading the following groups some of which he established: the PHUSE Safety Analytics working group; the ASA Biopharm Safety Monitoring working group; and the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group.

Job Titles:

• Program Development and Management, Process Design and Optimization / Click for Bio

Jenny Chaplin has more than twenty years of experience in program management and corporate operations. Her expertise includes planning and execution of drug development programs from research through late-stage development; portfolio and scenario analysis; managing alliances and partnerships; and building solutions for efficiency across R&D and G&A. Jenny's experience spans large pharma to smaller, early-stage biotech. She was most recently Vice President, Strategic Operations, at Bellicum Pharmaceuticals before founding Saffyre Consulting. Prior to this she held positions of increasing responsibility at Pfizer, Vical Inc, and Diversa Corp. Her drug development expertise spans cell therapies, vaccines, other biologicals, and small molecules. Jenny has a strong track record of organizational excellence and translating strategy into execution. She has delivered multiple projects on target, managed challenging global alliances, and successfully taken on diverse operational leadership roles. Jenny has an enthusiasm for working with early-stage companies and setting them up for success with integrated and adaptive development plans. She provides guidance on the development pathway, product selection, target product profiles, and opportunity and risk assessment. She also plays a key role in managing partner and vendor relationships and establishing stage-appropriate workflows within early-stage companies to improve productivity and support future growth. Jenny holds a B.Sc (Hons) from the University of the Witwatersrand. She has published several papers and has held >5 patents. She is a former Chapter President for AWIS-San Diego, has served as a mentor for both HBA and WIB programs, an advisor for Chico State University's Women in Leadership Program and for SpringBoard Enterprises.

Job Titles:

• Innovation Startup Coaching Clinical, and Medical Affairs / Click for Bio

Job Titles:

• Product Strategy and Management, Cloud Computing, and AI / Click for Bio

Job Titles:

• President, Clindata Insight Inc.

Peng has spent 20 years supporting clinical trial projects, with extensive biometrics experience in all phases of clinical development and medical affairs within the pharmaceutical and biotechnology industry. In 2013, she founded Clindata Insight Inc, a niche consulting business in biometrics and grew the business into a premier data service provider, winning numerous awards, including the Top 100 Women Owned Businesses in the Bay Area in 2019 through 2022. She attracted and developed a team of experts who provide the gold standard of consulting services in CDISC implementation, clinical data management, biostatistics, statistical programming, and CRO oversight. Before founding Clindata Insight, she worked for pharmaceutical companies in various management roles. She was the Head of Statistical Programming and Data Management at Santen Inc, where she built the statistical programming functionality from the ground up. She was also the Manager of Statistical Programming and Global Product Lead Programmer at Amgen, where she led a global programming team to support the GCSF franchise. Peng is a member of American Statistical Association (San Francisco & BIOP chapter) and Women Presidents' Organization (WPO). She is also a co-founder of the non-profit data science focused organization DahShu in the Silicon Valley. She has given numerous talks on career development and entrepreneurship. Peng holds a Master's of Science in Computer Science from the University of Texas at Dallas and a Master's of Science in Genetics and Developmental Biology from the University of Texas Southwestern Medical Center in Dallas. She received her Bachelor's of Science in Biotechnology from Peking University.

Job Titles:

• Data Mining, Endpoint Development, and Statistical Methods / Click for Bio

Dr. Landin has over 25 years of drug development experience ranging from preclinical to post-commercialization. His therapeutic areas of expertise include precision medicine, oncology, asthma and allergy, migraine, insomnia, depression, general anxiety disorder, multiple sclerosis, lupus, and rheumatoid arthritis. During his time in the industry, Dr. Landin has established a history of building, managing and leading Biometrics organizations in large R&D (Marion Merrell Dow, Eli Lilly, Biogen), small-to-midsize-pharma (IDEC, Neurocrine), as well as pre-commercialization (Ambit, Ignyta, La Jolla Pharmaceuticals). In addition, he has served and led cross functional, multi-corporate teams, leading to regulatory submission and approval of multiple products. Dr. Landin holds a Ph.D. is Statistics from Texas A&M University. Since graduating from Texas A&M, Dr. Landin has been committed to the practical application of statistical theory for the advancement of drug development, with successes including the following: development of the Theory of Selective Score Inflation to redesign depression studies, the creation of innovative endpoints for the measure of Sleep Maintenance, innovative data presentation of QTc data, and most recently serving as a catalyst in the development of a precision medicine toolbox based on advances in applied math/machine learning. In 2018 Dr. Landin co-founded Presagia.AI, an advanced precision analytics company that uses predictive statistical modeling and machine learning to optimize planning, executions and inference from drug development programs.

Job Titles:

• Statistical Methods Biomarker, IVD / LDT, Clinical Development / Click for Bio

Job Titles:

• Commercial Strategy, New Product Planning, Life Cycle Management, Payer Strategy / Click for Bio

Susan Gibson has 30 years of commercial leadership experience in Pharma/Biotech and medical device industries encompassing marketing strategy, new product planning, market research, competitive intelligence, and managed care. She has successfully launched nine products and performed commercial assessments and forecasted commercial potential for over 30 products. Her areas of expertise include trends in healthcare, orphan drugs, lifecycle management, forecasting, and commercial assessments in the therapeutic areas of CNS, cardiovascular, sleep disorders and Alzheimer's disease. Ms. Gibson's career path spans both entrepreneurial and corporate spectrum. She is currently the Founder and President of Vivolor™ Therapeutics Inc., creator of the revolutionary nutraceutical, Glory Day™ Brain Booster - an all-natural product designed to address the underlying cause of brain decline and memory loss in dementia. Prior to founding Vivolor, Ms. Gibson was the Head of Commercial Development and Market Intelligence at Jazz Pharmaceuticals®, as well as the Commercial Lead for SUNOSITM (solriamfetol). Ms. Gibson's past career roles include leadership positions in managed care at Genentech, Vice President of Marketing at EndoGastric Solutions, and Founder and President of Eve Group Inc. a marketing strategy consulting firm. Ms. Gibson received 2019 Top 100 Healthcare Leaders award from the International Forum for Advancements in Healthcare. She serves on the Board of Directors of Linnet Pharmaceuticals and two non-profit organizations. Ms. Gibson holds a Pharmacy degree from Purdue University and an MBA from Harvard Graduate School of Business.

Job Titles:

• Executive
• Fellow of Regulatory Affairs Professionals
• Regulatory & Clinical Strategy, Innovative Products, Policy / Click for Bio

Winifred Wu is a seasoned executive with over 30 years of experience in medical companies. Ms. Wu founded Strategic Regulatory Partners, LLC in 2011 to bring together an integrated regulatory and clinical advice on innovative product development. Examples of her current and past engagements include due diligence for M&A and joint ventures, opportunity analysis, talent management and coaching, and support of commercial readiness activities. Her clients range from multi-national pharmaceutical and medical devices corporations to private equity investors and start-ups. In her most recent corporate role, Ms. Wu was a VP of Regulatory and Medical Affairs in the Neuromodulation Sector at Medtronic, responsible for strategic and tactical oversight of 13 therapeutic development programs and several product platforms. During her 16-year tenure as a part of the Neuro sector management team, the organization grew from a venture to $1.6B global business in 2011. Throughout her corporate career, Ms. Wu held positions of increasing responsibility in regulatory, clinical, biostatistics and compliance groups. She served on Portfolio Management Boards, R&D steering Committees, Business Development Council, Clinical Research Boardand Regulatory Talent Management Committee. She led industry working groups at AdvaMed to advance positive regulatory policy changes and also served on nonprofit boards. Ms. Wu's technical expertise includes combination products and first-of-a-kind NME and innovative medical technologies. Her record includes a 3-year appointment on an FDA medical device advisory panel, and membership on advisory committees for academic start-up accelerators and patient advocacy groups. Ms. Wu is a Fellow of Regulatory Affairs Professionals Society. She has received multiple awards from the FDA, Medtronic, and 3M. She holds a B.S.in Pharmacy from the University of Minnesota, an MBA from the University of St. Thomas, and has completed executive training programs at Harvard, Kellogg School of Management, and Tufts Medical School.

Job Titles:

• Early - Stage Fundraising and Business Operation, Data Analytics, Business Development, Public Health / Click for Bio