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Welcome to our Clinical Research Cohort.
Clinical Research Update: Lowering Risk & Leveraging Covid Lessons
October 21, 2021 9:00 am-12:00 pm EST (Online, Free of Charge)
As we address COVID - impacted clinical research, what have we learned about collaboration, the regulatory environment, and patient centricity? How have thought leaders leveraged technology and fresh understanding to accelerate acceptance
of patient treatments?
Together we will share findings, and discuss formal process changes, in light of International Issues, Inclusive Approaches, and Building Flexibility/Safety in a Shifting Environment.
Register for free to receive full access and join our growing Clinical Research Cohort.
Thank You To Our Gold Partner
Denise Albitz
Research Associate
Staff Liason, Clinical Research Roundtable
dalbitz@westchesterbiotechproject.org
Speakers:
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Marne Garretson, MPH
Clinical Research Scientist
Vireo HealthAs Vireo’s Clinical Research Scientist, Marné Garretson leads the development and execution of innovative Real-World Evidence (RWE) analytic products leveraging epidemiological research methods to advance the evidence base for medical cannabis. Prior to joining Vireo’s Clinical Research team, Ms. Garretson’s variety of professional experiences in the applications of epidemiological research methods, biostatistics, and project management provided her with opportunities to serve as an analytical thought leader within NYC hospital systems and at the NYC Department of Health & Mental Hygiene. Receiving her MPH in Epidemiology from Columbia University’s Mailman School of Public Health, Ms. Garretson's primary research interests include cannabinoid science, epidemiology, data science, and health equity policy research.
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Adam Brown
Founder & Chief Executive Officer
ClinArk Inc.Adam obtained his Bachelor of Arts from Wittenberg University in Biology. He holds the title and serves as the Chief Executive Officer at ClinArk and advisory board member at the Wittenberg Institute for Public Humanities and Science. Adam spent his career developing clinical trial strategies at some of the largest contract research organizations (CROs) in t he world leading to the founding of ClinArk. Adam has a continued passion for increasing clinical trial awareness and access.
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Jonathan Bandel
Chief Innovation Officer
White Plains HospitalHe oversees strategy, programmatic growth and development, an institutional venture fund, and startup incubator. Jonathan is responsible for establishing the innovation entity’s vision, goals, strategic imperatives, and investment theses. Jonathan has over 16 years of healthcare strategy and operations experience, and previously raised a $5M venture fund. Jonathan has a BA from the University of Pennsylvania, a MPA from New York University, and a MS in Finance from Baruch College, in addition to being a Fellow in the American College of Healthcare Executives, certified Six Sigma Green Belt, and Project Management Professional. He was recently named a 2021 Top 25 Emerging Leader by Modern Healthcare.
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Nini Fan
Founder and CEO
MaMome Inc.Nini Fan is a microbiome researcher with expertise in genomic sequencing, bioinformatics, clinical trial, intellectual property, product development, and business administration. She earned her BS in Human Biology from SUNY Albany, MS in Molecular Biology, and an MBA candidate from Long Island University.
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Dalfoni Banerjee
Principal Consultant & CEO
3Sixty Pharma SolutionsDalfoni Banerjee is an award-winning, solution-focused consultant and entrepreneur. Beginning her career over 25 years ago in academic, pharmaceutical, and start-up biotechnology research laboratories – including Centocor and Merck – she went on to lead inspection-readiness efforts, drive clinical research and clinical operations, manage relationships between pharma and key opinion leaders, develop marketing strategies/tactics, and launch new drug products – across 12+ therapeutic categories. In 2011, she founded 3Sixty Pharma Solutions, with a mission to partner with start-up and established pharmaceutical and biotechnology companies to accelerate & support global drug development, boost marketing communications, and drive product launch – while harnessing the power of a multicultural approach. Dalfoni is a board member and advisor to life-science organizations, an invited speaker and moderator at conferences and via virtual channels on a variety of industry-related and consulting topics, has authored and co-authored several publications, and has received over 30 awards.
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Romina Marazzato Saparano
President
Plain Language International
Plain Language Translation And Localization
Language CompassMs. Romina Marazzato Saparano is a plain language expert, translator, and educator with over 20 years of experience working with private firms and public agencies on medical localization and health literacy. With studies in biochemistry and linguistics, she is passionate about science communication and pursues research in this area.
She designed the Master of Arts in Translation/Localization Management program at the Middlebury Institute of International Studies at Monterey and co-founded the multilingual Plain Language Academies. She has contributed as board member and in other capacities to several professional organizations, including ACES, American Medical Writers Association, American Translators Association, Spanish Editors Association, International Alliance of Spanish Editing Associations, and the Center for Plain Language—where she now serves as judge for the ClearMark Awards. She is currently a board member at Plain Language Association International. She contributes to language standards development at ASTM International and ISO, the International Organization for Standardization. -
Demet Sag
Dr. Sag has impacted the full medical product life cycle from innovation to market and post market. Her diverse expertise ranges from the genome to diverse clinical applications. She brings experiential knowledge of biomanufacturing, the clinical research process, and regulatory affairs for drug and device development. As a scientist, she is comfortable to use any living system and modeling in functional transgenomics, stem cells, single cells as discovery vehicles based on a thorough understanding of signaling cascades and comparative molecular physiology. Clinical data analysis and clinical evaluation reflects her cross-functional scientific strength in regulatory submissions and global market entry strategies.
Her faculty positions have ranged from Bahcesehir University, Istanbul, Turkey; to University of North Carolina, and University of California, San Diego.
Her company, Functional TransGenomics, LLC provides support for researchers engaging in precision medicine, translational programs, and regulatory clinical operations. She is a linker between academic and industrial collaborations for a largely accepted commercial product stem from integration of science and medical needs to sales/business effectively. She has a rich portfolio, thus, provides a 360 full-product-life-cycle management through well managed translational medicine approach from idea to the market with precision under regulatory requirements for safe and effective clinical applications.
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Stephen Dahmer, M.D.
Chief Medical Officer
Vireo HealthDr. Stephen M. Dahmer is a board-certified family physician whose passion for health and healing has taken him around the globe. A fellow of the Arizona Center for Integrative Medicine, for over a decade he has studied the relationships between plants and people and has served as the Chief Medical Officer at Goodness Growth Holdings since 2015 – a physician-led medical cannabis company. He leads medical research partnerships which are helping inform the development of new, pharmaceutical-grade products with evidence-based outcomes. He is Assistant Clinical Professor of Family Medicine Community Health at the ICAHN School of Medicine, co-chair of the US Cannabis Council Medical Research
Subcommittee, and practices in Westchester. -
Dr. Paloma Lehfeldt, MD, MA
Director of Medical Education
Vireo Health
Co-Chair Diversity Equity & Inclusion Council
Vireo Health
Dr. Paloma Lehfeldt, MD, MA, is a lifelong cannabis student and advocate who serves as the Senior Director of Clinical Science and Partnerships for Goodness Growth Holdings. Dr. Lehfeldt brings to Goodness Growth more than ten years of experience in psychiatric research, community outreach, and teaching. She has expertise in neuroscience with a keen interest in mental health and the endocannabinoid system. At Goodness Growth, Dr. Lehfeldt is the direct line of communication with providers and organizes outreach events, conferences, continuing education, and lectures for both providers and patients. Paloma is also the Chair of the company’s Diversity, Equity, and Inclusion Council where she leads the company's expungement efforts across the country. Additionally, Dr. Lehfeldt Vice Chairs the National Cannabis Industry Association’s Scientific Advisory Committee. She is passionate about the use of cannabis as medicine and cannabis health equity and looks forward to advocating its healing properties throughout her career. -
Nora Diaz
Consultoría Lingüística Profesional
Montero Language ServicesNora Díaz's experience in clinical research translation ranges from patient-facing materials to clinical trial documentation, research papers and linguistic validation of international questionnaires and instruments. Nora leads teams of translators, editors and proofreaders from Mexico, South America and Spain working together on large projects. She is a published English to Spanish translator, editor, and proofreader for international medical, technical and scientific texts.
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Fritz Handtke
External Relations, VP
Montero Language ServicesFritz is an international sales, marketing and operations top executive with a 37-year successful track record in leading business development and business strategy . An experienced business leader with a deep understanding of consumer markets and retail channels across the globe. Proven multi-functional management skills to develop and implement strategic business & go-to-market launch plans for consumer products & services. Leadership, strategic thinking, multi-cultural and people skills needed for success in a fast-changing, technology-driven international business environment are his competencies.
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María del Sagrario Velasco García
Professor, Translation and Interpreting of Indigenous Languages
Universidad Autónoma Benito Juárez de Oaxaca UABJO- MexicoMaria has a master’s degree in translation and interpreting from UABJO. Her teaching experience has focused on translation, interpreting and foreign languages (English and Spanish). She is a freelance translator. She has collaborated with CEPIADET A.C. (Indigenous Professional Center for Consulting, Defense and Translation) as a consultant in a number of projects of translation into indigenous languages in Oaxaca.
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Ellen Bedenko, RN, CCRC
Clinical Trial Educator
Ellen Bedenko is a seasoned clinical research professional with knowledge and perspectives on the clinical trials process developed while working at sponsor, CRO, and vendor levels. Her areas of interest are patient recruitment and retention, inclusion of patients with limited English proficiency, inpatient clinical trials, and biobanking for both investigator-initiated and industry-sponsored trials.
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Daria Crean, RN, BSN
Clinical Site Liaison, Medical Sciences Summit Clinical Research, LLC
With a diverse, 30-year background as a champion of change, Daria actively implements her creative and innovative ideas in clinical research. Her ongoing focus is the constant need for bridging the gap between clinical practice and research during this evolving time. She has built deep understanding and knowledge through a variety of roles and settings. As a clinical operations consultant at Huron Consulting Group, she initiated the rebuilding infrastructure of clinical research programs. At a US-based CRO she created successful model for Phase III medical device trial sites as a patient recruitment specialist.
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Denise Albitz
Research Associate
Westchester Biotech ProjectMs. Albitz is an innovative, results-driven manager with more than 24 years of experience in pharmaceutical and biotechnology companies. She has successfully launched new US and global drug products, including in both Europe and Latin America.
With her unique experience leading effective cross-functional teams, she is adept at overseeing the logistics of scientific advisory boards and the strategic creation and tactical execution of multi-channel marketing campaigns.
At Westchester Biotech Project, she coordinates the Clinical Research Cohort and conducts outreach to the larger community for thought leader input.
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