Outsourcing in Clinical Trials West Coast 2022

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: Christina’s breadth of experience and understanding of clinical research comes from working throughout healthcare and clinical research in academics, medical institutions, local government (public health), and the medical device industry. She is the Director of Clinical Affairs at ReCor Medical, a Palo-Alto based company studying an ultrasound-based renal denervation technology to treat hypertension. She thrives on being challenged, creative and innovative while building highly effective and impactful clinical teams. She enjoys mentoring and leading others positively through her actions and energy. Areas of Interest: Leadership, Clinical Research, Trial Management, Monitoring, Health Education, Project Management, Lecturer, Epidemiology, Public Health, Certified Clinical Research Associate, Leading remote and in-house teams.

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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 summer 2020. 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). Their NikZ will transform the standard of care. 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, where he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. As a bench chemist, he was the first to make Iotrolan, a CT contrast agent, now generic. Moving to law, he advised well known companies on patent matters, later moving to Apple Computer. Later, 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 acquisition in 2005. Mr. Larwood is the third of his family to be involved in Valley Fever.  His father was a clinician 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 about 1998 and raised some $20M for research into vaccines against Valley Fever.

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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.

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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.

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Biography: Elise Brownell, PhD. has spent the last 35 years in the bio/pharmaceutical arena where she has played key roles in Discovery, Development and Opportunity Assessment to drive innovation. After completing her doctorate at Yale University, Elise’s career started at SUNY Stony Brook. She continued her interest in comparative molecular biology during her tenure at Frederick Cancer Research Facility and expanded her facility with molecular genetics while in various functions at Bayer Healthcare. Her efforts were widely recognized by promotion to Director, Project Management, where she led global cross-functional teams. Elise also became a member of the founding team of a venture-backed spin out (Aerovance, Inc), where she became head of project management. Dr. Brownell serves in Interim Executive capacities for a number of emergent and highly innovative companies in the Life Science sector, and as a mentor to the entrepreneurs who run them. Elise received her MS, MPhil and PhD from Yale University, and her BS from Allegheny College

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Biography: Revati Tatake currently serves as a Global Director of Databases and Analytics at GlobalData, where her primary responsibilities are to lead the development and continuous enhancement of integrated databases and analytical tools for providing competitive and business intelligence for pharmaceutical and biotechnology sectors Revati has more than 20 years’ experience, both in academic research and the healthcare industry, during which time she focused on basic and clinical research, drug discovery and competitive intelligence projects across many therapeutic areas.  After academic career at Tata Cancer Research Institute and the University of Connecticut Health Center, she began her healthcare industry career at Boehringer Ingelheim Pharmaceuticals, where she led drug discovery projects involving small molecules, gene therapy and cell therapy for cardiovascular diseases, Rheumatoid arthritis and Diabetes.  In addition to leading drug discovery projects, Revati co-chaired novel target identification group, scouted novel technologies for enhancing drug discovery efforts, established collaborations with experts in academic institutions to complement internal projects and evaluated in-licensing opportunities for their scientific and technical merit.  She is a co-inventor on several issued US patents and applications related to the projects on cell and gene therapies. Before joining GlobalData, Revati worked at Citeline, where she was involved in competitive intelligence and analytics of clinical trials and pharmaceutical products. Revati holds a PhD in Tumor Immunology from Tata Cancer Research Institute. She was a post-doctoral fellow at the University of Connecticut Health Center.

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Biography: Gale McCandlish is an experienced Quality Assurance professional with an extensive background in GCP and GLP compliance for both pharmaceutical companies and CROs. In her current role as Associate Director, Vendor Compliance at Gilead Sciences, Ms. McCandlish is accountable for GCP vendor risk management and audit strategy.  During the COVID-19 pandemic, Gale authored a remote audit process to ensure the continuation of vendor audit oversight responsibilities when onsite audits are not feasible. Gale holds a BS in Biology from Bemidji State University and completed graduate work towards an MS in Biology from The George Washington University

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Biography: Over 25 years of pharmaceutical industry experience of increasing responsibility that includes strategic input at the clinical development team level, clinical operations, clinical trials management, CRO and vendor management, and personnel management. • Adjunct Faculty, San Francisco State University College of Extended Learning, Clinical Trials Design & Management, Ethical and Legal Issues in Clinical Trials (2008 to present) • Allied health professional experience as a Registered Nurse in clinical nursing including, critical care, AIDS, oncology, and hematology as well as clinical trials coordination.

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Biography: Clinical Executive who sponsors, oversees, and leads teams to develop and improve processes and capability to efficiently execute clinical studies. Applies strong knowledge of clinical research and regulatory requirements to select, implement, and manage best-fit systems and vendors, train sponsors and site personnel, and optimize compliance / inspection readiness. Focused on aligning and setting strategic direction, ensuring high-quality compliant results, meeting goals, and improving performance metrics. Adept at overcoming conflict, creating a positive, trusting, and enthusiastic team culture, and with developing direct reports.

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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.

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Biography: Jasmine Begin, M.S. RAC is the Director of Regulatory Affairs and Quality Assurance at Zosano Pharma.  She has worked on small molecule and drug/device combination products for over 15 years as a regulatory and quality assurance professional. In her current position, she manages the regulatory department providing strategic and operational guidance for investigational and filed products. Prior to Zosano Pharma, she has worked in small to large companies such as Depomed, Carbylan Therapeutics and IQVIA. Previously, her role in IQVIA was client facing to facilitate and deliver regulatory strategy to support new and lifecycle products.

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Biography: Experienced biopharmaceutical executive with more than 20 years of clinical drug development and medical affairs experience in small to large pharmaceutical and biotechnology companies. I currently apply my scientific knowledge and experience to the development of molecules modulating the Wnt pathway. Trudy served on the board of Insys Therapeutics from April 2018-February 2020 and is open to new board positions that leverage her R&D and corporate development experience.

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Biography: Eighteen years of commended performance in the pharmaceutical and biotechnology industries focused on clinical operations, compliance and inspection readiness. In-depth knowledge of clinical trial methodology, with experience leading cross functional, cross-cultural teams Success leveraging both a strong communication skill-set and the ability to influence key stakeholders in managing internal and external team personnel. In-depth experience managing vendors including CROs, clinical technology vendors, and laboratories Knowledge of project management best practices, drug development processes including clinical trial methodology and change management methodology

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Biography: Toby Odenheim is the Director of Technology and Governance at the Parker Institute for Cancer Immunotherapy (PICI). Committed to accelerating the development of new medical treatments through effective technology adoption and continual process improvement.

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Biography: Jennifer has a comprehensive background in managing global clinical development programs spanning from phases I-IV across multiple therapeutic areas in Oncology, She has expertise in Transplantation, Urology, Infectious Disease, Cardiovascular, CNS, and personalized cellular immunotherapies and rare disease. Seasoned in managing external CROs and vendors. Sound regulatory experience. Excellent verbal & written communicator. Strong track record of building, leading and motivating clinical teams.

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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.

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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.

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Biography: Connecting LEO Pharma with startups, hi-tech companies and best-in-class research teams in Silicon Valley. I have more than 10 years of experience in different sectors -Consulting, Banking, Petroleum, Insurance, Consumer Goods, Health Care and Technology, and strong international exposure (LATAM, North America, Europe and Middle East). I learn fast and enjoy interacting with people in problem solving situations with high uncertainty. I am constantly interested in helping to solve business problems as well as mixing practices from different industries to solve innovation challenges.

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Biography: Karrie Hilsinger is  Director, Clinical Operations at Immunomedics. She has been in the pharma industry for 20+ years, spanning numerous therapeutic areas, phases and roles supporting clinical trial conduct at several large pharmaceutical companies, CROs and Medical Device organizations. Her recent roles have focused on cross functional operational oversight of global programs. Karrie has been crucial to leading organization through SOP development, Inspection readiness and successful agency inspections.

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Biography: Tormey has more than 44 years of Sales and Marketing, and Executive experience in the global pharmaceutical market. 2017-2020, Mr. Tormey held the position of Chief Executive Officer at Kibow Biotech, where the company developed product a novel treatment for Chronic Kidney Disease. Prior to Kibow, he was a Member of the Board, and Vice-Chairman of Prevention Pharmaceuticals Inc, where he previously held the position of President/CEO beginning July 2010. From 1985 to 1990, Tormey lead Medical/Hospital/Industrial Sales with Wyeth. From 1990 to 2003, Tormey was with Nelson Communications Worldwide. First, as VP at PDN, and then as President of The Medical Phone Company®, and later as President/COO of Nelson Communication’s flagship company, Nelson Professional Sales (later known as Publicis Selling Solutions), Publicis, S.A., Paris. From 1976 to 1985, Mr. Tormey held Sales & Sales Management positions at Ortho Pharmaceuticals, and then as Director of Sales Staff Management with McNeil CPC (Johnson & Johnson).

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Biography: Behtash Bahador is an Associate Director at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

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Biography: Meraf Eyassu is a Senior Director of Clinical Operations at FibroGen.  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.

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Biography: Highly successful Executive Sales Leader, Coach and Mentor with over 20 years experience in the Biopharmaceutical and Healthcare Industry who loves to help people achieve their fullest potential!!

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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.

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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.

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More than 25 years of hands-on experience and working knowledge in clinical development and operations in both diagnostics and therapeutics at the Senior Director and Vice President capacity.  Track record includes delivering supportive clinical data culminating in multiple NDA/BLA and PMA/510(k) product approvals in the US and EU.  Experienced in leading highly motivated in-house clinical and cross-functional teams, vendors and CROs in strategic planning and execution of early to late phase clinical trials in oncology, immunotherapy, CNS, CVD and upper respiratory disorders in a cost-effective and timely manner.  Experienced in planning and executing complex, hard to recruit, large global studies across 5 continents.  Authored publications, protocols, study documents, training material and mentored direct reports.

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Biography: Stephanie Molteni, JD, Associate Director, Site Budgets & Contract Management, Clinical Operations, Ultragenyx Pharmaceutical Inc. Stephanie Molteni is the Associate 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.

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Biography: Highly motivated individual with an extensive scientific & clinical background. Worked in multiple environments and many different companies. Enjoys being part of a team but highly independent. Wears multiple hats all the time. Seeks challenge. Delivers on time. Loves travelling and interacting with site personnel. Very detail oriented. Problems solver, good negotiator.

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Biography: Haley is a clinical research professional with over 15 years of experience in drug development.  While currently focused on rare disease feasibility and operational strategy Haley is experienced in clinical operations, regulatory affairs and project management across a wide range of therapeutic areas.  Areas of special interest include pediatric clinical trials, gene therapy and decentralized trial implementation.

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Biography: Experienced pharmaceutical professional with more than 22 years in industry working in Clinical Operations and Medical Affairs, managing development programs from early phase through post marketing. His recent roles have focused on global program strategy development and oversight, partnership development, and operational quality improvement. Michael is currently head of Clinical Operations at Surrozen, focusing on department infrastructure and outsourcing strategy development to support planned clinical studies.

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Biography: Alicia has over 20 years of experience in software design and information systems management. She has a Mechanical Engineering Degree from Syracuse University and from Boston University with a Masters of Information Systems and an MBA.  At Medidata, Alicia works to infuse the patient perspective throughout the product development lifecycle and help engage patients in novel ways. Alicia is also a three-time cancer survivor, first diagnosed with Hodgkin’s disease as a sophomore during college. Over the past 10 years, she's applied her engineering background to improve the patient experience for those dealing with cancer.  With an extensive network of patient advocates and non-profit organizations, she collaborates with a wide range of stakeholders to help improve processes and policies that impacts cancer care. An early adopter of social media, she co-founded #BCSM, which attracts over 1,000 global participants each week to its scheduled online discussions. Since its launch, #BCSM has been showcased at SXSW in 2013, 2014, 2015, and 2017 and is recognized as the gold standard for disease-specific social media networks.  She’s co-led numerous research studies on how patients share information in online forums As a champion of patient advocacy and engagement, she understands the critical issues facing patients seeking to engage in clinical research.  With a keen focus on improving access to clinical trials, Alicia is passionate about making a difference for patients seeking clinical trials.

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Biography: Kelly McKee is the Vice President of Patient Registries and Recruitment at Medidata with 20 years of experience in clinical trial operations, patient recruitment and innovation. She is a proven clinical trial leader and trailblazer in operationalizing global patient-focused solutions across organizations including innovations in clinical trial awareness, access, and improvements in patient experiences. Kelly is passionate about celebrating the role that clinical trial participants bring in making new medicines and vaccines possible and was named one of PharmaVoice’s 100 Most Inspiring Leaders in 2020, Centerwatch’s Top 20 Innovators of 2018, and PharmaTimes’ Clinical Researcher of the Year, Clinical Research Teams, in 2012.

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Biography: Jess has 15 years of clinical research experience, with much of that time uniquely focused on rare and orphan diseases.  Most recently, Jess oversaw clinical operations at the University of Pennsylvania’s Orphan Disease Center and Gene Therapy Program, both housed within the Perelman School of Medicine. While at Penn, Jess worked closely with biotech companies to implement strategic clinical development initiatives and with thought-leaders to foster collaboration within the rare disease community. She oversaw vendor partnerships to create patient registries and natural history studies, and, most impactfully, she worked hand-in-hand with patient advocacy groups, providing rare disease patients and their families with data-driven guidance while accelerating the clinical research process. Prior to Penn, Jess spent eleven years in the CRO industry with Syneos Health, formerly INC Research, where she held director level positions growing their therapeutic business units, with a specific focus in global rare disease and pediatric trials. Jess earned bachelor’s degrees in both Molecular Biology and Psychology from Meredith College in Raleigh, NC.

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Biography: Shannon Macquarrie has over 20 years of experience building and growing global clinical development teams.  Within this realm she has developed processes that have implemented technologies that have been applied to strategy implementation through all phases of clinical development from start-up through site close out.  Ms. Macquarrie has been responsible for development and roll-out of full operational and risk oversight of clinical programs and product portfolios.  She regularly serves on client executive steering and joint oversight governance committees.  She is a focused leader and articulate communicator capable of building long lasting relationships with key stake holders at all levels.  Ms. Macquarrie’s therapeutic experience is broad and has extensive experience in the oversight of pediatric and cell therapy operating models and has designed initiatives to improve the delivery of oncology and immune-oncology programs.

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Biography: E.B. McLindon is an accomplished senior executive with proven ability to build, develop and manage businesses.  Utilising a background in finance and technology, he helped create Accelovance, a CRO that owns and operates clinical research sites.  E.B. is  passionate about engaging patients – either directly through outreach or through site development, and simplify the research journey for both patients and sites.

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Biography: Louis-Pierre Marcoux likes to think of himself as a regulatory minesweeper, clearing the path of obstacles for the commercialization of medical devices. He has spent the last 20 years bringing innovative medical technologies to new markets, and currently serves as Sr. Director of Regulatory Affairs for NeoTract | Teleflex Interventional Urology. Prior to joining NeoTract, Marcoux served in various leadership roles in at ZELTIQ (now AbbVie), Coapt Systems (now MicroAire) and Stryker. His expertise is in Regulatory, Quality, and Compliance, and he has lectured at various industry conferences and events on Regulatory Affairs, Quality Management and Supplier Quality.

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Biography: Nick Damiano is a serial entrepreneur with broad experience in medical devices and digital health. He has 15 years of experience as a healthcare entrepreneur, innovator, and leader. He is currently Co-Founder & CEO of Zenflow, which is developing a novel office-based therapy to relieve symptoms of benign prostatic hyperplasia (BPH), a urologic condition that impacts quality of life over 500 million men globally. The company has raised over $60 million in funding and conducted successful clinical trials in five countries. Zenflow is backed by leading venture firms including Invus and F-Prime and was one of the first medical device companies funded by Y Combinator, the world’s leading startup accelerator. Prior to Zenflow, Nick was an Innovation Fellow at Stanford University. Before Biodesign, he co-founded Avail MedSystems (f.k.a. Nurep), a company developing telemedicine solutions for medical device procedures that has raised over $100 million in venture funding. In this role, Nick led the successful technical development effort to bring the company's product to market and also played key roles in strategy, sales, and fundraising. Prior to Avail, he worked in engineering roles for several small medical device companies, including developing critical algorithms for the world’s first leadless cardiac pacing system at EBR Systems. Outside of Zenflow, Nick plays an active role in mentoring and advising medtech and healthcare entrepreneurs and startups. He has served as an advisor in various capacities at StartX, Y Combinator Startup School, Stanford Byers Center for Biodesign, and the Rosenman Institute. He is also a Venture Partner at Pioneer Fund, a venture fund led by Y Combinator alumni. Nick grew up on the east coast and earned his M.S. and B.S. with Distinction in Management Science & Engineering from Stanford University.

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Biography: Tracy MacNeal is an engineer, healthcare entrepreneur, and MedTech investor.  She is CEO of Materna Medical, a Series B startup focused on transforming the standard of care in women’s pelvic health.  As an investor in Portfolia’s FirstStep fund, she supports the commercialization of high-growth segments typically undervalued and overlooked by traditional investing approaches.  Tracy serves as the national Chair of Advamed’s Women’s Executive Network, connecting and amplifying the top women leaders in the MedTech industry. She previously served as President of Diagnostics and Digital Health for Ximedica, held by SV Life Sciences, a private equity healthcare firm, after serving in Chief Strategy Officer and Chief Financial Officer roles at two successful medical devices companies.  Tracy received a Bachelor of Chemical Engineering with full scholarship at the Cooper Union in New York City and an MBA from Duke’s Fuqua School of Business, graduating summa cum laude as a Fuqua Scholar.

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Biography: Vice President of Clinical Operations: Reporting to the COO and 4th employee of the company, built a clinical operations team and led re-design, enrollment and completion of the pivotal (IDE) trial of the Jada System for abnormal postpartum uterine bleeding and hemorrhage. Strategic leadership for all U.S. and O.U.S. clinical operations. In this role Kathryn has; • Led 15-center US pre-market pivotal IDE study, enrolling the maximum of 107 subjects in a challenging recruitment setting. Developed site relationships, negotiated favorable study contracts and budgets with each site, led training program that certified over 700 site team members as investigators and research staff, drove enrollment programs that approached >16,000 patients and secured informed consent from >7,000 in under 15 months. • Built clinical study team from 0 to maximum of 6 team members including the roles of Director, Prof Ed Manager, In-house, Field-based and Contract CRAs and Clinical Coordinator. Recruited key talent to executive and adjacent teams. • Designed and executed “Continued Access” program to ensure extended data collection after close of pivotal study, including successful FDA approval of IDE. • Presented Clinical Operations updates to quarterly BOD Meetings and investor presentations. • Developed relationships and key interactions with OB/GYN and Maternal Fetal Medicine specialist KOLs for understanding and advancement of the Jada System.

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Biography: Ms. Verma is Director of Global Clinical Affairs with Natus Medical, founder and President of ClinVitals and Advisory member with Wai Technologies bringing extensive expertise in Medical Device clinical research and product development. A recognized health care and life science leader with more than 20 years of mentoring experience, leadership skills, strategic thinking in multi-therapeutic acumen. Ms Verma has served several start-up and public firms encompassing all phases and types of Medical Device clinical research.

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Biography: Judy Skroback is the former Director of Clinical Research at SynCardia Systems, LLC, where she spent 10 years overseeing medical device trials and continues as a Consultant. She is a Certified IRB Professional, a Certified Clinical Research Contract Professional and an Affiliated IRB Member at Advarra. She previously served for 16 years in the Human Subjects Protection Program of a major research university

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Biography: Hal has over 25 years of Clinical Research experience ranging in perspective from the Study Site, small and large CRO’s, large Pharma, and large Diagnostics companies.  During his 15 years with GlaxoSmithKline, Hal spent six years designing and conducting Clinical Trials before focusing on outsourcing and supplier management.  In 2013, Hal joined Roche Molecular in Pleasanton, CA where he oversees Clinical Contracting, Outsourcing, Process Excellence, eClinical Solutions and Logistics.

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Biography: Louisa Roberts is VP Corporate Development and Partnerships at PRA Health Sciences. Her role focusses on the identification of capabilities and go to market strategies partner organizations can provide, to accelerate PRA’s transformation from a CRO into a Healthcare Intelligence Organization. She works with product, scientific and operations leadership to develop partnerships that accelerate growth of both existing and new offerings. Throughout her career Louisa has enjoyed applying data and technology/ AI to adress biopharma’s most pressing drug discovery and development needs. She has a Masters in Chemistry from the University of Edinburgh and developed her business acumen through receiving her MBA from the Tuck School of Business at Dartmouth.  Louisa lives in New Jersey with her husband and spends her free time trying to keep up physically and intellectually with her two daughters.

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Biography: Mark has work in the Clinical Trial Supply Chain field for 10+ years, previously as a Supply Chain Manager at a leading Contract Manufacturing Organization, delivering the service for multiple sponsors across a wide range of Clinical Trials. Since joining Cenduit’s Drug Supply Center of Excellence team he has been working on delivering innovative solutions for clinical supply challenges. Mark has a BSc in Mathematics from Queen’s University Belfast

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Biography: Tom has worked in the IRT industry for 11+ years and has been with Cenduit since 2014. His experience encompasses various roles in Quality Assurance and Project Management. Currently, Tom specializes in a highly consultative role to support business growth, oversee system capabilities, develop processes and tools and develop client specific standards.   Tom holds a Master of Business Administration (MBA) from Rider University

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Biography: Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific. Novotech has been instrumental in the success of over a thousand Phase I - IV clinical trials for biotechnology companies and has a unique capability in offering expert global product development and regulatory affairs consulting to support global programs.

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Biography: As Senior Vice President and Chief Digital Officer, Technology Solutions at IQVIA, Nagaraja Srivatsan is responsible for driving growth and leading product development of Clinical Technologies. Srivatsan was recognized as the top 100 most inspiring people in the life sciences by PharmaVOICE publication and regularly speaks at industry conferences. Srivatsan holds a Bachelors Degree in Electrical Engineering from B.I.T.S. in India and a Masters degree in Electrical Engineering & Computer Science from Northwestern University.

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Biography: Catherine (Cat) Hall started her career as an academic scientist in Molecular and Cellular Biology before finishing her MBA and transitioning into Pharmaceutical Supply Chain Management. During her career, she developed notable expertise not only in clinical supplies but also in training development, process improvement, managing partnerships, and the design and implementation of technologies such as Interactive Response Technology (IRT).  She is well-known for focusing on bridging the GMP/GCP gap by bringing supply chain customer service through the last mile to patients. Cat joined endpoint in 2019 as VP of Product Strategy to help continue to bring the customer voice forward into shaping the future of IRT. She was recently promoted to VP of Clinical Innovation and Quality where she will have oversight of the Testing Organization as well as Product Strategy and QTC ensuring that endpoint’s Quality by Design strategy is implemented successfully and proven with every project.

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Biography: Brandi Lute, MBA, CPM, Senior Director of Project Management, Clinical Pharmacology, has worked in research and development for 28 years. Her experience includes laboratory expertise in immunological assays in support of vaccines for infectious diseases, single and multiple site clinical pharmacology trials in healthy participants and managing multi-country trials in renal and hepatic impaired patients. She has 20 years’ experience in project management over services from protocol concept through clinical study report and developing professional project manager teams specializing in early clinical research at leading CROs.  She is currently heading the global full service delivery team in the Clinical Pharmacology Project Management group at Covance.

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Biography: Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific. Novotech has been instrumental in the success of over a thousand Phase I - IV clinical trials for biotechnology companies and has a unique capability in offering expert global product development and regulatory affairs consulting to support global programs.

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Biography: Executive intrapreneur turned digital health entrepreneur, my career includes 18+ years leading global drug development, clinical research and decentralized trials for life science organizations. As CEO of THREAD, I lead our efforts to change the way clinical research is conducted focused on decentralized approaches, enabling the use of our one platform for conducting modern research studies and leading partnerships with our customers. After launching and growing THREAD, we were acquired in 2019 by JLL Partners and Water Street with strategic investment for continued growth and focus on accelerating drug development for our customers. Named one of the Top 100 Influencers in Digital Health, I also provide expertise and execution experience in digital health, clinical trials and decentralized, remote, virtual, community-based clinical research. I enjoy being a keynote speaker at global industry events, guest lecturer at Duke University on digital health/innovation/entrepreneurship and a published author featured in various conferences, journals, articles and media outlets.

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Biography: Alex is a Business Development professional with over 3 years of biotech experience working in the Contract Research Organization space. She is strongly passionate about improving patient education and outcomes, boosting the industry reputation amongst the general public, increasing efficiency and quality in clinical trials and bringing more effective and safer treatment options to patients.  

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Biography: Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific. Novotech has been instrumental in the success of over a thousand Phase I - IV clinical trials for biotechnology companies and has a unique capability in offering expert global product development and regulatory affairs consulting to support global programs.

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Biography: Radha is a cross-functional biopharmaceutical executive with expertise in leading business transformation projects driving process excellence, cost synergies and technological innovation in the management of Clinical trials/Biobanking. Her in-depth understanding of Central lab operations coupled with experience in financial planning and strategic pricing enabled the successful implementation of various technologies supporting the central lab process delivery and optimization.

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Biography: Kim joined Anju Software with the acquisition of OmniComm Systems, which he had been at since 2017, managing the eClinical Suite's product development. His expertise in clinical operations software is driving Anju’s products to new levels of innovation. Prior to Anju, Kim gained about 20 years of experience at Oracle Corporation as Vice President of Development for many clinical research applications, including systems for electronic data capture (EDC), clinical trials management, data management, medical coding, and data warehousing. Kim holds a Bachelor's degree in Informatics from the Aarhus Business College in Denmark.

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Biography: Heather DiFruscia is the Associate Director RTSM / IWRS and is responsible for managing and overseeing the RTSM department operations, strategy, processes, and software product development

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Biography: A dynamic leader with 20+ years experience in Pharmaceutical Research, including 16 years in Project Management and Clinical Operations. A strategic thinker with strong industry perspective in an expansive range of therapy areas across the full drug development lifecycle. Have successfully directed a variety of complex global programs ranging from CMC drug development/manufacture to Phase I and bioequivalence studies, Phase II proof of concept studies, Phase III clinical trials and Phase IV/peri-approval, observational, health economic studies. Serving as the primary liason between global operational stakeholders, very proficient in leading cross-functional teams in the planning, executing, and monitoring of drug development research projects against scope, budget, timeline, resource, and quality metrics. Work effectively across multiple divisions to direct the delivery of projects/programs. Provide direct supervision, support, and training to full clinical operations and data technology staff. Responsible for developing and maintaining effective stakeholder relationships. Very experienced in commercial/business aspects of research operations. (business & proposals development). Collaborating with senior executives and as liaison with business development, responsible for operational strategy, budgets, and acquisition of new business.

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Biography: Krista Bradley joined PCM TRIALS as the Executive Vice President in January 2020. She brings over 20 years of healthcare and clinical research expertise from The Cleveland Clinic, University of Colorado Cancer Center, and most recently as the National Vice President of Research for Common Spirit Health (Catholic Health Initiatives). Ms. Bradley’s career has been focused on team building, improving operational efficiency, and organizational leadership. She is passionate about the value of research, its potential impact on the lives of patients, and its role in shaping the future of medicine. Ms. Bradley is currently completing her MBA in Healthcare Management at Western Governor’s University. She retains an active license as a Registered Nurse in the state of Colorado and received her certification as a clinical research professional in 2010.

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Biography: Julie has been with PCM TRIALS since its inception in 2008, working in all facets of the business including project management, human resources, quality, marketing, business development and is now spearheading the site relations efforts to provide support to the sponsors and CROs in outreach and education of sites.  

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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 Head of Global Medical Affairs Study Management at BioMarin Inc. where she oversees global operational strategy and execution for programs in the post-approval setting.

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Biography: Jeff Lowry leads UBC data warehousing team and serves as the product owner of UBC Real World Infrastructure.  Mr. Lowry has been at UBC since 2015 where he as utilized 25 years of data modeling, development, and architecture experience to play a key role in the design and build out of UBC Mosaic platform.  Jeff started his career at NCR Teradata working in their Professional Services as a consultant where we worked on accounts for multiple fortune 500 clients.  After Teradata Jeff spent 15 year at an international insurance company where he served as Director of Data Processing and operations.  In this role Jeff lead the organization responsible for data processing and interfaces.  Along with a strong technical acumen Jeff also possess an extensive understanding of data privacy and processing laws for over 60 countries including all developed nations in North America, Central America, South America, Europe, Middle East, and Asia

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