Outsourcing in Clinical Trials New England 2022

Biography: Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors.  Craig is Co-Chair for the Decentralized Trials & Research Alliance, Vice Chair of the MedStar Health Research Institute, and Vice President of the Foundation for Sarcoidosis.  He is Adjunct Assistant Professor in Health Informatics at Rutgers University. Craig was previously the Head of Clinical Innovation and Venture Partner at Pfizer, and on the founding management teams for two successful startup ventures.

Session Details: KEYNOTE Democratizing Decentralised Trials: How Innovative Solutions Can be Accessible for All 13-10-2022, 1:45 pm View In Agenda

Biography: Shaheen Lakhan, MD, PhD, FAAN, is a physician-scientist, biotech executive, and biopharma board director with over 20 years of experience in healthcare, academia, and industry focusing on neuroscience research and development. He is board-certified in both neurology and pain medicine, with clinical training from Cleveland Clinic and Massachusetts General Hospital. As an expert in patient-empowering clinical development from drugs to devices, Dr. Lakhan is keen on transforming medicine and democratizing health care through prescription digital therapeutics (Chief Medical Officer, Click Therapeutics) and novel drug-delivery platforms (Board Director, SpineThera). He continues to serve patients as a practicing neurologist and pain specialist (Mount Auburn Hospital, Cambridge Health Alliance) and is professor of neurology and neuroscience (Western University, Virginia Tech). Previously, Dr. Lakhan served as faculty of leading institutions (Harvard Medical School, Case Western Reserve University), founding department chair and curricular dean (California University of Science and Medicine), institutional review board chair (Arrowhead Regional Medical Center), chief of pain management (Virginia Tech - Carilion Clinic), and executive/leadership positions in biopharma (Sage Therapeutics, Zogenix) and biotech (The Learning Corp, Fern Health).

Session Details: OPENING KEYNOTE: Enabling Innovation in Spite of Barriers 12-10-2022, 8:30 am View In Agenda

Biography: Marissa Fayer is a 22-year medtech executive, innovator, entrepreneur, investor, and philanthropist. She is the CEO and founder of social enterprise / non-profit HERhealthEQ, President of DeepLook Medical, VP of Operations at Ultrasound AI, and US Partner at Goddess Gaia Ventures. Her mission is to move innovation and the health of women forward throughout the world. Marissa has previously served as an executive at Hologic, Olympus (formerly ACMI), Maquet-Getting (formerly Atrium Medical), Providien Medical, and Accumed Innovative Technologies.  Her consulting clients include many of the Top 500 healthcare companies and innovative start-ups including Pfizer, Boehringer Ingelheim, Nuvasive, the National Institute of Health (NIH), Oerlikon Medical, Lonza Precision Medical, Emit Imaging, and others.   Marissa sits on the board of medtech companies Welwaze Medical and DeepLook both focused on improving the diagnosis of breast cancer; Ultrasound AI focused on predicting Preterm birth, and PMD Medical focused on urinary incontinence; Marissa graduated from Boston University with a BS in Manufacturing Engineering and from University of Connecticut with an MBA. Marissa is a TEDx Speaker (2019 at TEDxLugano), a UCSC Miller Center Social Entrepreneur Fellow, and has been listed as one of the Top 100 Women in Medtech in 2018, a Top Woman Activist to Watch, awarded the 2018/9 Africa Development Award, a Wonder Women in Medtech, and has delivered keynote discussions at the World Alliance Forum, MedExec Women, Lithuanian Biotechnology Association, Leading Entrepreneurs of the World, Women’s Health Innovation Summit, DeviceTalks, HER.Talks, and others. Marissa has appeared in several online and print publications such as Medical Design & Outsourcing, BloombergLaw, FemTech Analytics, the Maven Collective, Med Device Online, and TheStreet.com.  Marissa leads the #wealththroughhealth and #healthequityforwomen movements and is dedicated to innovative solutions for global operations and improving women’s health throughout the world. Marissa lives in New York City and can be found at www.marissafayer.com

Session Details: PANEL DISCUSSION Overcoming the Barriers to Trial Innovation and Technology Access from a Small Company’s Point of View 12-10-2022, 2:45 pm Global Women’s Health Innovation and Diversity 13-10-2022, 10:00 am View In Agenda

Biography: John Seman is a Pharmaceutical Executive with a consistent track record of building teams, solving problems, adapting to changing markets, and establishing long term growth strategies.     Mr. Seman began his career in global life science corporations working for E. R. Squibb & Sons and multiple divisions of Johnson & Johnson, holding various management positions in sales, marketing and business development.  During his tenure at Squibb, he was a team member responsible for the introduction a new cardiovascular drug that achieved highest first year sales in company history.  At Johnson & Johnson, he managed a portfolio of eight biotech products in various stages of pre-clinical and clinical development, and actively participated in the licensing and acquisition of anti-infective pharmaceutical products.  He served as Vice President of Marketing at the central laboratory division of Corning Pharmaceutical Services where he was responsible for expansion of services into the European market, and for developing an innovative marketing strategy to increase profitability with a growing base of top tier pharma customers.     For the past 20 years, Mr. Seman has been a serial entrepreneur involved in multiple startups including:  A Founder of AVANTEC, an innovative technology based company focused on accelerating the receipt of clinical trial data from investigator sites, where he secured over $10M from multiple rounds of financing; CEO at HealthBridge, a reimbursement services company, where he tripled revenue and successfully positioned the company for a sale; CEO at PhysioGenix, a preclinical research company, where he secured seed funding from angel investors; and most recently licensed technology from universities for commercialization with ZOETIC Pharmaceuticals and REVITALE Pharma focused on expanded use of anti-virals.     Mr. Seman’s non-profit experience includes executive leadership of the Alosa Foundation, an independent medical education organization, where he secured multi-year contracts from the Commonwealth of Pennsylvania, the Commonwealth of Massachusetts and the District of Columbia public health departments for the dissemination of evidence based treatment strategies to primary care physicians.  He also served as the Founding CEO of Launch NY, an economic development organization serving the 27 counties of upstate New York, raising $7 million from the federal government and regional foundations.     Mr. Seman holds a Bachelor of Science degree in Pharmacy, and received a Master of Science degree with honors in Pharmaceutical Economics and Business Administration, from the Massachusetts College of Pharmacy. He is an active participant in industry associations, and continues to be sought after to present at national and regional life science conferences.  Mr. Seman also volunteers as a coach and mentor to aspiring life science entrepreneurs from the University at Buffalo, McMaster University, and Syracuse University to support their efforts to build companies, win business plan competitions, and secure financing.

Session Details: PANEL DISCUSSION Exploring Repurposing Off-Patent Drugs as an Effective Clinical Trial Strategy 13-10-2022, 11:00 am View In Agenda

Biography: James L. Sherley, M.D., Ph.D. is the founder, President, and CEO of Massachusetts stem cell biotechnology company Asymmetrex, LLC. Asymmetrex develops and markets technologies for advancing stem cell medicine, including the first method achieving specific and accurate certification of the dosage of therapeutic tissue stem cells, called kinetic stem cell (KSC) counting. Asymmetrex’s kinetic stem cell counting platforms are also used to optimize manufacturing of therapeutic stem cells and for evaluations of drug effects on tissue stem cells. Dr. Sherley is a graduate of Harvard College, with a B.A. degree in biology, and the Johns Hopkins University School of Medicine, earning joint M.D. and Ph.D. degrees. Prior to founding Asymmetrex, he held academic research appointments at the Fox Chase Cancer Center, Massachusetts Institute of Technology, and Boston Biomedical Research Institute. Dr. Sherley’s professional awards include Pew Biomedical Research Scholar, Ellison Medical Foundation Senior Scholar in Aging Research, and NIH Director’s Pioneer Award.

Session Details: Impact of Dosage Standardization Innovation on Stem Cell Clinical Trials Operations and Support Needs 12-10-2022, 12:15 pm View In Agenda

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

Session Details: Chair’s opening remarks 12-10-2022, 8:25 am Outsourcing & Clinical Operations 12-10-2022, State of the Biopharmaceutical Industry – 2022 13-10-2022, 12:15 pm View In Agenda

Biography: Oliver has more than 20 years of experience in pharmaceutical, diagnostics and medical technology solution. He joined in 2022 Roche to lead a regulatory team focusing on especially oncology companion diagnostics. Till end 2011 he was the Vice president Clinical and regulatory affairs in Imagion Biosystems, a FDA-Breakthrough status clinical stage medical device company combining transformative, high-sensitivity imaging and nanomedicine for better, safer diagnosis and therapy delivery in cancer and other diseases. Previously, Oliver served as Vice President R&D at TransCode Therapeutics, dedicated to microRNA-targeted, image-guided, personalized cancer detection and treatment solutions. Before, he held at PHILIPS the positions of Senior Director Clinical Research Board, governing the North America clincial innovation program, moving several products through human trials and approval, further as Senior Director Biomolecular Engineering leading diagnostic/interventional imaging and drug-device combination developments. Oliver started in various R&D positions at ALTANA Pharma AG building the Functional Genomics Group and entrepreneurial ALTANA Research Institute. He received his Ph. D. degree in biochemistry from the University of Tuebingen, Germany

Session Details: OPENING KEYNOTE Doing your first Proof of Concept Study in “Down Under”: Lessons learned from Clinical Trials Outside of the United States 13-10-2022, 9:00 am View In Agenda

Biography: Amanda Murphy is the Director of Product Management at GlobalData, a company that focuses on research, data analytics and consulting that provide actionable insight into the pharmaceutical and medical device sectors.  She has 10+ years of experience working in pharmaceutical data science and web platform development (including BioPharm Insight, Lead Sheet, and the Pharma Intelligence Center).  She has developed models and solutions to support Clinical Operations & Feasibility teams plan and optimize trials, including an e-feasibility questionnaire tool resulting in 4x faster response rates from sites.  Amanda also has many years of experience supporting business development at CROs through data-driven lead delivery and CRM integration solutions.

Session Details: Clinical Trial Technology & Innovation 12-10-2022, PANEL DISCUSSION Overcoming the Barriers to Trial Innovation and Technology Access from a Small Company’s Point of View 12-10-2022, 2:45 pm Decentralized, Remote and Virtual Trials 13-10-2022, View In Agenda

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Biography: Adrian Orr is the Executive Director of Clinical Affairs at Anika Therapeutics, Inc in Bedford, MA. Adrian has previously worked in a range of small to medium-sized medical device and biologics companies including Gyrus Medical, Serica Technologies, and Haemonetics. He has focused on re-structuring and developing clinical teams to tackle technically challenging surgical and biologics trials. Adrian’s current focus is on joint preservation and tissue regeneration in orthopedics. His talk today will center on the use of eDiaries in clinical research.

Session Details: Delving into Strategic and Functional Activities to Budget and Execute Clinical Trial Launch 13-10-2022, 11:00 am View In Agenda

Biography: Dr. Missling, President and CEO of Anavex, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex®, he served as the Chief Financial Officer of Curis and ImmunoGen. In addition, at Aventis (now Sanofi),  Dr. Missling worked as head of financial planning on all aspects of financial strategy and M&A. His career experience also includes working as an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, as well as serving as the head of healthcare investment banking at Brimberg & Co. in New York. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.

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Biography: Strategic & technical leader applying machine learning, data mining, visualization and analytics skills to solve key data science problems. Data science is a hybrid field integrating computer science, visualization, statistics, and business knowledge. The standard skill set emphasizes breadth over depth yet both are critical: ● Advise and guide the technical direction of Pfizer's machine learning, deep learning and AI entries into natural language processing, image processing, and predictive modeling ● Harvard University lecturer teaching the Master's software engineering capstone and the graduate level, machine learning and data mining courses ● Analytics researcher: developed ~30 novel visualization and analytical tools in use at Pfizer ● Ph.D. in computer science emphasizing artificial intelligence and machine learning ● Master's degrees: software engineering, applied statistics, applied linguistics, image processing and biology ● Statistician: primary site statistician for 10 years supporting up to 200 scientific researchers ● Broad industry experience including pharmaceuticals, defense, text mining, and education

Session Details: Harnessing the Benefits of clinicaltrials.gov to Improve your Access to Clinical Trial Data and Movement Towards DCTs 13-10-2022, 10:00 am View In Agenda

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Session Details: Facing up to Increased Trial Costs: Top Tips for Staying in Budget 12-10-2022, 12:15 pm View In Agenda

Biography: Former R&D Sr. Project Manager at LifeMine Therapeutics, Oscar is an innovative Program Manager and Lean 6 Sigma Black Belt, specializing in the strategy, planning, and execution of program and project specific goals across functional departments while utilizing historical data and operational trends to analyze potential risks and create program level efficiencies. His 12 year career began in academic research (oncology, regenerative medicine, and microbiology), before transitioning into the pharma and biotech industry. For the last several years Oscar has worked as a Program, Project, and Alliance manager in R&D and Commercial organizations. He is currently working with pharma and biotech teams to understand and improve their workflows through Lean 6 Sigma practices.

Session Details: FIRESIDE CHAT: Wearables, ePRO, eConsent, Big Data: Are We Prepared for the Digital Transformation? 12-10-2022, 3:45 pm View In Agenda

Biography: Dr Daniel Klamer, Vice President of Business Development and Scientific Strategy of Anavex, has more than 15 years of experience in neuroscience and the orphan disease space, with acquisition, partnering and R&D experience in Europe and the USA. Prior to Anavex he worked at Retrophin and Neurosearch Sweden. At Neurosearch Sweden, Dr Klamer led and evaluated multiple discovery-phase neuropharmacological research products with an emphasis on strategic evaluation of preclinical and clinical development. Dr. Klamer earned his PhD in Pharmacology at The Sahlgrenska Academy at University of Gothenburg, Sweden, his MBA at Fordham Gabelli School of Business, and his Post-Doctoral training at the Department of Psychiatry, Yale University School of Medicine. In addition, Dr. Klamer holds a position as an Associate Professor at the Department of Pharmacology at The Sahlgrenska Academy at the University of Gothenburg.

Session Details: Top Tips for Starting up Trials in the Rare Disease Space: Best Practices and Considerations 12-10-2022, 11:15 am View In Agenda

Biography: Andrea Bottkova, Director of Vendor Management and Contracts at Karyopharm Therapeutics Inc.  Andrea has been negotiating contracts for little over fifteen years.  In 2019 Andrea has helped established Karyopharm’ s vendor management and procurement department to support vendor oversight, strategic sourcing and maximize financial savings. Andrea is passionate about building partnerships and negotiating business terms of contract resulting in several million dollar saving annually. She believes that she has perfected her negotiations skills while learning from her very curious 5-year-old son Barton.

Session Details: Facing up to Increased Trial Costs: Top Tips for Staying in Budget 12-10-2022, 12:15 pm View In Agenda

Biography: Michael Patel is a Senior Scientist II at Novartis Institutes of BioMedical Research in Cambridge, MA. There, he is involved in biomarker planning and implementation on early phase clinical programs and studies across a wide range of therapeutic areas. Specifically, he has been heavily involved in identifying and evaluating near patient sample collection and analysis technologies. This includes engaging and collaborating with internal and external partners on progressing to the ultimate goal of applying these to future decentralized and patient-centric clinical studies.   Michael received a bachelor’s degree from Rutgers University and a doctorate in pharmacy from the University of North Carolina.

Session Details: Partnering with central lab vendors on continuous improvements 12-10-2022, 1:45 pm View In Agenda

Biography: Michael Breen, PhD, is the Senior Director of Infectious Diseases and Oncology at GlobalData in Boston. He has over eight years of experience in market analysis, business intelligence, and providing strategic insight for the pharmaceutical industry. Prior to his current role, he was a Senior Analyst for Decision Resources Group, where he gained extensive experience writing in-depth reports and developing forecasts for a variety of indications, including rare and infectious diseases and vaccines. Michael has a BA in biology and biochemistry from Hunter College, and a PhD in biochemistry from Boston University School of Medicine.

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Biography: Hollie Schmidt is the VP of Scientific Operations at Accelerated Cure Project for Multiple Sclerosis. She co-chairs the Research Committee of iConquerMS™, a research cohort established to perform and support patient-centered research in MS. She also founded and leads the MS Minority Research Engagement Partnership Network, a multi-stakeholder initiative aimed at increasing racial and ethnic diversity in MS research studies.

Session Details: Mind the Gap: Improving the Diversity and Inclusion of Under-Represented Groups in Clinical Research 12-10-2022, 11:15 am View In Agenda

Biography: Dr. Kathryn Duschean is a post-Doctoral fellow in Biomarker Development at Novartis Institutes for Biomedical Research in Cambridge, MA. She is currently involved in biomarker operational planning, implementation, and validation of novel patient-centric sampling techniques, in early phase clinical programs across a variety of therapeutic areas. Her deep personal passions and former research in autoimmune and related conditions heavily influence and progress her interests and projects in this area. She believes that engaging with internal and external partners is critical to advancing toward the ultimate goal of fully decentralized clinical trials in these spaces. Kathryn received both bachelors in English, and in Health Sciences from the University of Iowa, and her Pharm.D from the University of Colorado. She is also currently an adjunct faculty member at the Massachusetts College of Pharmacy and Health Sciences, focusing on teaching various elements associated with the innovation and operational consideration in clinical trials.

Session Details: Patient Centric SMART Blood Sampling 12-10-2022, 1:45 pm View In Agenda

Biography: Amanda McEwen has over 14 years of experience in clinical research that spans work in academia, contract research organizations, and several Boston-area small-to-mid-size biotechnology companies. Throughout her career, Amanda has held roles of increasing responsibility within the Clinical/Regulatory Development space across a range of therapeutic areas including rare, neurodegenerative, respiratory, infectious, and metabolic diseases.  Her experience includes a variety of therapeutic product types, including combination products, most notably a novel dry powder inhalation therapy to treat motor issues in Parkinson’s patients, Inbrija™, approved by the FDA and EMA.  Amanda has a particular affinity for early phase work and has played pivotal roles in shepherding several programs from the bench to the clinic, most recently in her previous role as Vice President of Clinical Development of Nocion Therapeutics, where she successfully led the efforts to complete Nocion’s first Phase 1 study amidst the backdrop of the emerging SARS-CoV-2 pandemic. In addition to her work in industry, Amanda serves as an adjunct faculty member for Northeastern University’s Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices, specializing in courses on the strategic and technical considerations for IND and NDA/MAA submissions and Pharmacovigilance regulations and best practices. Amanda holds a BA in Psychology from the College of the Holy Cross and a Master of Research Methods in Psychology degree from the University of York.

Session Details: The Future of Rare Disease Trials: How can we Encourage Innovation Whilst Protecting Affordability? 12-10-2022, 12:15 pm View In Agenda

Biography: Behtash Bahador is the Director of Health Literacy 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.  

Session Details: The Shifting Paradigm: The Impact of Patient-Centricity Across the Lifecycle of Treatment Development 13-10-2022, 12:15 pm View In Agenda

Biography: Dr. Sherris has over 30 years’ experience in translational medicine involving basic research, pharmaceutics and diagnostics.  Dr. Sherris has been a successful serial entrepreneur developing biotechnology companies from the ground up, devising corporate strategy, enacting programs and carrying companies through funding and acquisition.  Dr. Sherris prides himself as a “roll up your sleeves” CEO, entrepreneur, business development officer, drug developer and scientist, not simply a delegator. Dr. Sherris has worked with venture capital companies, investment banks and angel investors where he has advised and raised well over $100 million for biotech companies.  Dr. Sherris has been employed by pharmaceutical and biotechnology companies to manage external (academic groups and contract research organizations) and internal (directly manage, augment and expand internal scientific programs) research and development. Dr. Sherris has been a frequently invited guest speaker at biopharmaceutical business and scientific conferences, a published author and holder of patents in a wide range of therapeutic areas including oncology, ophthalmology, dermatology, neurology, gene therapy and infectious disease.  Dr. Sherris has held positions of increasing responsibility in public and private companies.  Dr. Sherris has developed drugs from the bench to the clinic, partnered technologies to pharmaceutical companies and raised capital for companies at the triple digit million dollar levels.

Session Details: PANEL DISCUSSION Overcoming the Barriers to Trial Innovation and Technology Access from a Small Company’s Point of View 12-10-2022, 2:45 pm View In Agenda

Biography: Laura is the Director of Clinical Quality Assurance at Syros Pharmaceuticals. Strategic clinical research compliance business continuity leadership in COVID-19 environment. Expert knowledge of GCP Quality Operations and Compliance in the Pharmaceutical and Biopharmaceutical industries focusing on risk-based environments.

Session Details: Who is Quality and what do they do? How can we invite Quality into the Clinical Operations conversation and into the partnership? 12-10-2022, 2:45 pm View In Agenda

Biography: A strong proactive leader of groups within the Data Analysis and IT disciplines in the Healthcare industry sector. A managerial style based upon vast global experience, which incorporates a pragmatic approach to issue management together with a progressive attitude to create and successfully implement business driven strategic change initiatives within multicultural environments. Recent key achievements (1) Led a team that developed and implemented a Strategic systems approach to capitalise on the Clinical Data assets own by the Roche Product Development Group (2) Optimising the global sourcing solutions within the group by taking advantage of CRO, Contractors and Offshoring solutions. (3) Transitioned the programming group from being heads down programmers to Analysts who proactively provide and develop solutions for partners and customers

Session Details: A Deep Dive into Decentralised Trials: Managing the Moving Parts to Result in a Successful Trial 12-10-2022, 11:15 am View In Agenda

Biography: Josh has over 20 years of experience working in the as a clinical operations and regulatory affairs professional. Working both as an consultant and leading teams in-house, his career has focused on getting novel medical technology to the market through the design and execution of robust clinical trials, and the preparation of quality regulatory submissions to regulatory authorities in the US and abroad.  Through creativity and collaboration, he has helped several medical device start-ups progress towards commercialization across a variety of therapeutic areas, including cardiovascular, diagnostics, orthopedics, and women’s health.

Session Details: PANEL DISCUSSION Overcoming the Barriers to Trial Innovation and Technology Access from a Small Company’s Point of View 12-10-2022, 2:45 pm OPENING KEYNOTE Preparedness for FDA Audit for Devices: What Should you be Focusing on Right Now? 13-10-2022, 9:00 am View In Agenda

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Session Details: Targeted Personalized Cancer Therapy: The Holy Grail of Cancer Treatment 12-10-2022, 2:45 pm View In Agenda

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Session Details: PANEL DISCUSSION Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers 12-10-2022, 4:45 pm View In Agenda

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Session Details: Facing up to Increased Trial Costs: Top Tips for Staying in Budget 12-10-2022, 12:15 pm View In Agenda

Biography: Ms. Zahora is Sr. Director, Global Quality Systems & Process Improvement with Agenus and is responsible for the Quality Management System (QMS) including document control, vendor management, training, process improvement initiatives, risk/quality issue management, and establishing quality systems analytics. She has a MBA from St. Joseph’s University, a Six Sigma Black Belt, and is PMP certified. Ms. Zahora has developed and implemented an organizational QMS, compliance metrics to assess performance of global quality standards, and has created and implemented: (1) enterprise wide Root Cause Analysis training supporting CAPA effectiveness, (2 ) process review methodology with a Process Scorecard enabling a consistent method for corporate wide process review, (3) Data Trending including visibility of audit findings/quality issues by Key Core Process, SOP, and Corrective/Preventive Actions, and (4) Regulated documentation standards to ensure clear, concise, and compliant process documentation fit for purpose. Ms. Zahora is an instructor for Society of Quality Assurance (SQA) Quality College, Past President of NERCSQA, Past Chair of the Beyond Compliance Specialty Section (BCSS) and is on Nahant’s Advisory & Finance Committee.

Session Details: FIRESIDE CHAT: Wearables, ePRO, eConsent, Big Data: Are We Prepared for the Digital Transformation? 12-10-2022, 3:45 pm Outsourcing & Clinical Operations 13-10-2022, View In Agenda

Biography: Laura Taraboanta, MS is a clinical strategy and development professional with a demonstrated history in health care and clinical trials. She is currently the of Head Clinical Innovation at Click Therapeutics, with a focus on improving speed, efficiency, and cost of prescription digital therapeutics discovery, development and implementation. Prior to Click, Laura was leading clinical operations at Woebot Health, a mental health company focused on delivering evidence-based treatment through an AI chatbot. Laura has been part of two successful FDA Breakthrough Designations for software as medical devices and has overseen numerous research projects in CNS and oncology, tapping into the potential of virtual trials to empower patients. Laura is keen on tackling health disparities by accelerating digital therapeutic development so that clinically-proven, safe and effective solutions can be universally available to patients and their providers.

Session Details: OPENING KEYNOTE: Enabling Innovation in Spite of Barriers 12-10-2022, 8:30 am View In Agenda

Biography: Hyun has been a part of AOBiome’s clinical pipeline leadership since 2016. Hyun brings over 24 years of drug development experience in the pharma and biotech industry. Prior to this, Hyun has led Clinical and R&D programs and departments at Pfizer, Anika Therapeutics, Transport Pharmaceuticals, and Olympus Biotech. He started his career at Genetics Institute and Wyeth, where he developed biologics for tissue repair. He attended Brown University where he studied Biomedical Engineering and completed a PhD in Medical Science.

Session Details: A Beginner’s Guide to Decentralizing your Trials from a Small Company’s Point of View 13-10-2022, 11:00 am View In Agenda

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• Former Associate Vice President, Global Clinical Trial Management at Allergan
• Former Executive Director, Global Clinical Trial Management at Actavis plc
• Former Executive Director, Clinical Operations at Warner Chilcott
• Former Senior Director, Technical Services at Consumer Product Testing Company
• Former Section Head, Toxicology at Leberco Testing
• A., Biology, Rutgers University

Session Details: PANEL DISCUSSION Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers 12-10-2022, 4:45 pm View In Agenda

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Session Details: Accelerating Digital Trials to Improve Outcome Success While Keeping Patient Experience at Heart 13-10-2022, 12:15 pm View In Agenda

Biography: Harry Barnett Harry is the co-founder and Executive Chairman of Lubris BioPharma, a clinical-stage biotech company developing a proprietary version of the novel, ubiquitous human protein, PRG4, for use in multiple indications.  Novartis owns rights to Lubris’ technology for ophthalmology. Harry’s two-decade life science career includes: (i) co-founding and executive management roles at three life science companies and two CROs; (ii) incubating, partnering and licensing successfully a wide array of pharmaceutical products and technologies including Pepcid Complete®, the OTC hearburn remedy sold by J&J, and; (iii) innovating multi-center, clinical trial processes using techniques that have been adopted as industry standard.  Prior to his transition to life science and biotech, Harry was a transactional business lawyer in private practice at DLA Piper in San Diego, and later at Faneuil Advisors, Inc., an investment advisory firm based in Boston where he served as General Counsel and Executive Vice President.

Session Details: PANEL DISCUSSION Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers 12-10-2022, 4:45 pm Speaker Hosted Roundtables 13-10-2022, 3:45 pm View In Agenda

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Session Details: Sharing Experiences of Being on Both Sides of a Rare Disease Trial; Focussing on the Move Towards Decentralization and the Patient Journey 12-10-2022, 1:45 pm View In Agenda

Biography: Chris Fourment, MD, has a passion for advancing science and medicine, and is an expert in inflammatory bowel disease (IBD), NASH, clinical trials, and medical education. Dr. Fourment is the SVP of Clinical Strategy at Iterative Scopes, and the president and CEO of Clinical Research Strategy Group (CRSG) and Precision Research—two clinical-trial-optimization companies focused on streamlining and accelerating the drug-development process for IBD. In 2022, Iterative Scopes acquired both CRSG and Precision Research. Dr. Fourment is the founder and has served as the director of the Department of Clinical Research & Education at Texas Digestive Disease Consultants/ GI Alliance. He received his medical degree from St. Matthew’s University School of Medicine.  He has also authored numerous abstracts and publications on IBD and is a member of the American College of Gastroenterology, the Texas Society of Gastroenterology & Endoscopy, and haserved as chair on the Chapter Medical Advisory Committee for the Crohn’s & Colitis Foundation.

Session Details: The Dynamic Duo of Clinical Trial Recruitment 12-10-2022, 3:45 pm View In Agenda

Biography: Holly John, Senior Director, Patient Advocacy at Agios is an innovative and strategic leader with a passion for elevating the patient voice and ensuring patient insights are woven into all activities across the lifecycle. With experience spanning multiple disease areas within the biotech and pharmaceutical industries, Holly has led and built advocacy functions and teams organized around the patient, bringing value to activities across the business while delivering better outcomes for patients.  Holly has a strong record in achieving exceptional results, through cross-functional collaboration on complex initiatives and through creating and fostering strong partnerships with patients, patient advocates and clinicians. Since joining Agios in 2020, Holly has spearheaded a project to define an ambition for patient-centricity that goes beyond words, driving meaningful action & change.  Ultimately, the goal is to raise the bar and set a new standard for patient engagement across the pharmaceutical industry

Session Details: OPENING KEYNOTE Creating More Patient-Centric Trials, What Role Can Patient Advocates Play? 13-10-2022, 9:00 am TOPIC TBC Creating More Patient-Centric Trials, What Role Can Patient Advocates Play? 13-10-2022, 9:00 am View In Agenda

Biography: Mac Winslow is the Senior Director of Global Customer Development for Clinical Services at Avantor, which maximizes clinical trial efficiencies across the globe, providing scalable, end-to-end service capabilities including biorepository and sample management, custom kitting, and clinical trial equipment and ancillary solutions. Mac has more than 20 years of sales experience, including a decade of specialization in biorepository services and sample management sales. Prior to joining Avantor, Mac spent eight years at BioStorage Technologies, Inc., where he oversaw North American and European sales teams. Mac earned a BS in Agricultural Business Management from North Carolina State University.

Session Details: How will the Supply Chain need to adapt to support the growth of Decentralized Clinical Trials? 12-10-2022, 11:45 am View In Agenda

Biography: Tim Curry joined MedPoint Digital in 2006 and in his current role leads an elite team focused on strategic global program development. Tim has extensive experience consulting with biopharma clients on effective applications across a broad suite of digital platforms and services. Tim holds an MBA from the University of Chicago.

Session Details: Are We There Yet? Gaps in Automation of Clinical Trials 13-10-2022, 2:15 pm View In Agenda

Biography: Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. He brings over 25 years of product management, consulting, and engineering experience across verticals such as life sciences, enterprise software, healthcare, government, entertainment and manufacturing. Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. He has supervised the management of a clinical portal, eTMF, CTMS, RTSM, EDC, Coding and Grants solutions. Jay has also created and managed products for eCTD submission publishing and review, enterprise quality management, document management, computer validation, as well as mobile apps for physicians, sales reps, and music and sports fans.   Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College.

Session Details: Three Practical Use Cases to Improve Clinical Trial Efficiency with Technology 13-10-2022, 9:30 am View In Agenda

Biography: Akiko has over 10 years of experience in the life sciences industry, previously at McKinsey & Company advising pharmaceutical clients in strategy, digital and advanced analytics.  She holds an MBA from London Business School and a BA in Law from the University of Tokyo.

Session Details: Harnessing Data to Improve Study Operations and Outcomes 12-10-2022, 9:30 am View In Agenda

Biography: Ken Hamill is the Senior Director, Clinical Operations Portfolio, at Medidata, a Dassault Systèmes company. Ken works across the organization and with customers in their adoption of clinical operations technologies that help automate trial quality workflows. Ken also leads the development and execution of strategic marketing programs for Clinical Operations at Medidata. Prior to Medidata, Ken had over 15 years of experience in life science product management, most recently at PerkinElmer where he led the strategy team for drug discovery assay development. Ken holds an MBA in Health Sector Management from Boston University, and an BS in Chemistry from Tufts University.

Session Details: Harnessing Data to Improve Study Operations and Outcomes 12-10-2022, 9:30 am PANEL DISCUSSION Overcoming the Barriers to Trial Innovation and Technology Access from a Small Company’s Point of View 12-10-2022, 2:45 pm View In Agenda

Biography: Edyta Korzuch - Edyta is a Sr. Director of Project Management at TFS HealthScience. She has over 20 years of experience in clinical research industry within global and cross-cultural environment where she successfully managed studies from Phase 1 first in human to Phase 3 registrational trials. Her current focus is on innovative solutions for early phase oncology and hematology clinical development. Edyta was educated at Silesian Medical University in Katowice, Poland and Oxford Brookes University, UK. She is based in Paris, France.

Session Details: Internationalize Your Early Phase Clinical Trials 13-10-2022, 11:45 am View In Agenda

Biography: Bin Pan - Bin is an Executive Director of Program Strategy at TFS HealthScience where she interfaces with global, multifunctional teams from business development to project delivery. Bin has over 20 years of clinical research experience in Asia and North America. Bin was educated in Beijing, China and the United States. She is based in Colorado, US.

Session Details: Internationalize Your Early Phase Clinical Trials 13-10-2022, 11:45 am View In Agenda

Biography: Sarah R. Anderson is an Executive Director, Oncology Strategy Lead at Worldwide Clinical Trials.  Ms. Anderson has dedicated the past 17 years to building and advancing innovative oncology clinical trial concepts through development execution. Her passion is leading therapeutic strategy development along with a strategic thoughtfulness on advancing clinical trial options to patients in a local community setting.

Session Details: Tackling the Challenges of Operational Delivery in Rare Oncology Studies 12-10-2022, 11:45 am View In Agenda

Biography: Ian Greenfield helped transform Oregon’s healthcare delivery system while serving in Governor John A. Kitzhaber, MD’s administration. He has held leadership positions in numerous companies and non-profit organizations, including the world’s leading death with dignity advocacy group, Compassion & Choices. His marketing work has earned both an International Association of Business Communicators’ Bronze Beacon Award and a Public Relations Society of America Award of Excellence.

Session Details: Tell Me Why Not: Leveraging Consumer Engagement in an eClinical World 13-10-2022, 11:45 am View In Agenda

Biography: Christine McSherry founded Jett Foundation in 2001, when her son now 24-year-old Jett was diagnosed with Duchenne Muscular Dystrophy. As head of the Jett Foundation, Christine co-founded the International Duchenne Alliance, a partnership of over 40 independent organizations that has funded nearly $15 million dollars in research to date. Christine has advocated for the patient perspective to be considered by the FDA when reviewing safe and potentially effective treatments for Duchenne. In April of 2016, Christine presented the Jett Foundation's Patient Centered Outcomes report at the FDA's meeting of the Peripheral and Central Nervous System Drugs Advisory Committee.

Session Details: The Importance of Patient Advocacy Through a CRO 12-10-2022, 10:45 am View In Agenda

Biography: Kris O’Brien is an Executive Director in Program Strategy, specializing in Rare Disease and Pediatrics, at Premier Research. Ms. O’Brien has been conducting clinical research for more than 35 years and has covered multiple functions during that time. Her experience in a multitude of therapeutic indications has led to an acute knowledge of study conduct and execution with a keen focus on protocol dynamics. This experience has allowed her to understand the nuances that set rare and pediatric studies apart from routine clinical studies and develop proper strategies for clients to execute their studies in real world settings.

Session Details: The Importance of the Patient Journey in a Rare Disease Clinical Trial 12-10-2022, 2:15 pm View In Agenda

Biography: I'm an innovation catalyst and entrepreneurial leader skilled at commercializing inventions and ideas to address customers’ unmet needs and to generate enterprise growth. I bring a unique combination of experiences in business & innovation strategy, startups, venture capital, business development, and university technology transfer. Using innovation as a lever for growth and value creation is a common thread in my career. In some cases this involves finding or building pathways to enable the translation of new technologies and ideas into viable products and solutions; in other cases it involves the discovery of customers' unmet needs that can be addressed with innovations such as new products and services or even simply with more finely-tuned messaging. My innovation expertise is industry and product agnostic - for example, most recently I've applied it in early-stage biotech, performance fabrics, and specialty plastic films. In prior years I helped bring products to markets in materials science and industrial instrumentation.

Session Details: PANEL DISCUSSION Exploring Repurposing Off-Patent Drugs as an Effective Clinical Trial Strategy 13-10-2022, 11:00 am View In Agenda

Biography: Michael G. King, Jr. is Managing Director, Equity Research at HC Wainwright & Co., LLC. Prior to joining H.C. Wainwright, Mr. King was Entrepreneur in Residence at Fortress Biotech, Inc., where he worked for approximately three years. Before joining Fortress, Mr. King had a distinguished 25 year career as a senior biotechnology research analyst, most recently as a Managing Director at JMP Securities. Earlier in his career Mr. King held senior positions at a number of investment banks including Rodman & Renshaw, where has was Director of Research and led the Healthcare team, Banc of America Securities, Dillon, Read & Co., Vector Securities and Robertson Stephens. Mr. King has been recognized by The Wall Street Journal (Best on the Street 2014) and Institutional Investor (Home Run Hitter 2000) during his career for his research in the sector. He holds a BA in finance from The Bernard M. Baruch College of the City University of New York.

Session Details: PANEL DISCUSSION Exploring Repurposing Off-Patent Drugs as an Effective Clinical Trial Strategy 13-10-2022, 11:00 am View In Agenda

Biography: Senior Vice President of Integrated Customer Solutions and Trial Oversight As Senior Vice President of Integrated Platforms and Trial Oversight at Clario, Tim is responsible for delivering solutions that bring together the Clario portfolio of products to provide exceptional experiences for patients, sites, and sponsors.  His team focuses on minimizing the burden for patients and sites through the delivery of intuitive streamlined applications by uniquely combining traditional eCOA, Respiratory, Cardiac Safety and Imaging interactions in a harmonized ecosystem. Tim has 25 years’ experience of working in healthcare, with a focus on the medical imaging industry. He has held many executive positions, including Product Line Executive, CTO, CSO, and also as President and CEO at ImageIQ, where he led the company’s deployment of software engineering, high-resolution imaging and custom-tailored image analysis, to support the delivery of high-quality imaging data for clinical research

Session Details: Train the trainer: How to train patients in an era of decentralized clinical trials 12-10-2022, 4:15 pm View In Agenda

Biography: Mac Winslow is the Senior Director of Global Customer Development for Clinical Services at Avantor, which maximizes clinical trial efficiencies across the globe, providing scalable, end-to-end service capabilities including biorepository and sample management, custom kitting, and clinical trial equipment and ancillary solutions. Mac has more than 20 years of sales experience, including a decade of specialization in biorepository services and sample management sales. Prior to joining Avantor, Mac spent eight years at BioStorage Technologies, Inc., where he oversaw North American and European sales teams. Mac earned a BS in Agricultural Business Management from North Carolina State University.

Session Details: How will the Supply Chain need to adapt to support the growth of Decentralized Clinical Trials? 12-10-2022, 11:45 am View In Agenda

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

Session Details: Decentralized clinical trials and hybrid trials: what you need to understand to run these successfully 12-10-2022, 10:45 am View In Agenda

Biography: Robert Loll is the SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies with award-winning creative and superior execution. Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 15 years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare. Robert received a BA from the University of Iowa and completed the Athletic Training Curriculum Program within the Department of Exercise Science and Physical Education. Post-graduate courses include exercise science and Clinical Pharmacology, Drug Development, and Regulation with the Center for the Study of Drug Development at Tufts University. Robert is an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP) an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

Session Details: Rare Diseases 12-10-2022, Technology, Innovation & Devices 13-10-2022, View In Agenda

Biography: Dawn has over 20 years of experience in the pharmaceutical industry. She have worked within every level of clinical data management, from Data Coordinator to Senior Director where she participated in or had oversight for more than 250 clinical trials. During her time in the industry, she has provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter as well as Co-Chair of the annual conference (2018-2021) and serves on the SCDM Board of Trustees. Dawn is involved as a member of the CDISC-CDASH core team, Diabetes sub-team, CDASH CFAST Expanded Leadership Team and former Co-Chair of the CRF Library project. Dawn currently holds the position of Vice President, BD Operations, where she supports business development as a Clinical Subject Matter Expert for both software and data services as well as overseeing the Proposals and Solution Consulting departments.

Session Details: 15min Tech Spotlight: Data-Driven Operations and Oversight with elluminate 13-10-2022, 11:45 am View In Agenda

Biography: Tom has worked in the life sciences industry for over 20 years, initially as a pharmaceutical representative and then as a pharmaceutical product manager. Over the past 10 years Tom has become an expert in providing sponsors and CRO’s with an innovative clinical supply process that is patient centric, saves clinical operations and supply management teams time and saves sponsors money.

Session Details: Innovative Processes to Better Address Todays Trial Dynamics 12-10-2022, 11:45 am View In Agenda

Biography: Desmond Cabrera serves as Executive Director, Cell & Gene Therapies and brings over 15 years of experience in the CRO industry. In his current position, Desmond is the Global Therapeutic Operations Lead for Allucent’s Cell and Gene Portfolio in which he leads the strategy and team executing trials for sponsors who are developing CAG Therapies. Desmond has gained extensive experience in the execution and management of clinical trials in all phases throughout his career and has worked at large CROs including ICON, IQVIA, Labcorp, and Parexel. He has led multinational teams and projects overseeing trials for oncology, pediatric, CNS and large-scale cardiovascular studies that involved 1,000+ sites and 25,000 patients. Desmond has overseen several early phase cell and gene therapy (CGT) projects involving feasibility and safety assessments, first-in-human studies, and dose escalation and expansion for oncology indications including breast and lung cancer, acute myeloid leukemia, and myelodysplastic syndrome.

Session Details: Operationalizing Long Term Follow-up for Cell and Gene Therapies 13-10-2022, 9:30 am View In Agenda

Biography: Dr. Ahmar U. Zaidi is a pediatric hematologist who spent the last several years at the Children’s Hospital of Michigan, where he helped care for over 800 patients with sickle cell disease. He currently serves as Medical Director, Clinical Development for Agios Pharmaceuticals. Along with numerous publications and clinical trial experience, he has worked tirelessly as an advocate for sickle cell disease patients, fueled by a belief that medical misinformation and disinformation steadily contribute to poor outcomes in sickle cell disease patients.  He co-founded and hosts the sickle cell educational podcast, Cheat Codes; and has been an advocate for social media as a tool for patient and physician education.  He currently serves as the Chair of the Hematology Anti-Racism Task Force for the American Society of Hematology and the Chair of the Board for The Sickle Cell Reproductive Health Directive.

Session Details: OPENING KEYNOTE Creating More Patient-Centric Trials, What Role Can Patient Advocates Play? 13-10-2022, 9:00 am TOPIC TBC Creating More Patient-Centric Trials, What Role Can Patient Advocates Play? 13-10-2022, 9:00 am View In Agenda

Biography: Steve Brandao has spent more than 30 years in research and development.  His experience includes time with a major pharmaceutical company, work with two leading SMO’s, and business development positions with large global CRO’s, a medical device CRO, and an EDC technology company.  He is currently the US Regional Director of Business Development for Novotech, an Asia-Pacific centered CRO with global capabilities.  Steve has a graduate degree in psychology and worked as a psychotherapist before starting his career in biopharma research and development.

Session Details: Biotech Market Performance and the Impact on Clinical Trials and Operations 12-10-2022, 9:00 am View In Agenda

Biography: Helen Yeardley is Global Clinical Operations Head at ICON. In this role, she oversees the timely and quality delivery of a team of approximately 4,000 staff in areas including clinical and hub monitoring, clinical risk management and trial master file services. With over 25 years’ experience in monitoring and managing clinical trials, in both CROs and large pharma companies, Helen has held numerous senior positions in the areas of feasibility, site identification and start-up, clinical trial management and project management. She started her career as a CRA, and her therapeutic background is oncology as well as internal medicine. Helen is also actively involved in ICON’s Diversity, Inclusion and Belonging operations, with a particular focus on the company’s Disability Awareness Network, DAWN. DAWN is one of ICON’s community groups and is focused on developing and fostering a mind-set towards creating an inclusive workplace and working environment where everyone is treated equally with respect and dignity, irrespective of any visible or hidden disabilities.

Session Details: Inception and Sustainability of a Remote Monitoring Hub 12-10-2022, 10:45 am View In Agenda

Biography: An expert in clinical trial operations, Camila Matheny works closely with Pharma, Biotech and CRO customers to clearly articulate the value of adopting digital technologies to deliver decentralized and hybrid clinical trials. A member of the SCDM eSource Consortium and DTRA, Camila leads with data - the driving force behind bringing new therapies to market. With over 15 years of clinical trials experience, a background in data management and a passion for the latest cutting-edge technologies, Camila provides a unique combination of expertise to help guide the industry towards the future state of patient-first clinical trials.

Session Details: Increasing Patient Choice in Oncology Trials using Remote Consent 13-10-2022, 9:30 am View In Agenda

Biography: Kathlyn Tilley is Director of Business Development for Nucleus Network, Australia’s largest Phase 1 clinical research organization and the only Phase 1 specialist globally with facilities in the USA and Australia.  She has over 15 years of experience working in the CRO industry, supporting clinical development efforts in the US, China, and Australia.  Kathlyn has successfully served clients in biotech, pharma, and academic institutions to discover the strategy and tools they need to reach their clinical development milestones.  Kathlyn holds a BS in Biology from the State University of New York at Geneseo and MS in Clinical Research Management from Drexel University.

Session Details: Fast-Track Your Phase 1 Clinical Trial in Australia 12-10-2022, 2:15 pm View In Agenda

Biography: THREAD Research is a leading provider of Decentralized Clinical Trial (DCT) technologies for life sciences. In her role, Esther oversees THREAD’s oncology strategy and collaborates directly with clients to help them build the best oncology solution in a DCT design that integrate with THREAD’s platform. Esther is committed to the mission of improving the lives of cancer patients, globally. She has twenty years of experience in the healthcare and clinical research industry, primarily in oncology drug development at PRA Health Sciences (now ICON) and Labcorp Oncology. For the past 5 years Esther has been working hard to find a path to bring clinical research as a care option to cancer patients and is now working with THREAD and THREAD’s customers to design and innovate to achieve this mission.  

Session Details: Establishing and Conducting an Oncology Decentralized Clinical Trial (DCT) 12-10-2022, 4:15 pm View In Agenda

Biography: Helen brings over 17 years of deep expertise from the clinical research industry and significant global experience working with various CROs, supporting clinical operations teams across, Asia, Middle East, Europe and US.  Her expertise includes Clinical monitoring, Project management, Regulatory affairs, and Clinical technologies such as IRT and eCOA. Helen has been a part of IQVIA /Cenduit leadership team since 2015, She has recently taken on responsibility as IRT eCOA customer success lead and supporting North America Project Management team at Cenduit. Prior to her stint at IQVIA, Helen held several positions across various global CROs. Helen is based out of IQVIA headquarters in Durham, North Carolina.  

Session Details: IRT eCOA Orchestration Case Study: Building integrations that reduce site and sponsor burden and improve the patient journey 12-10-2022, 2:15 pm View In Agenda

Biography: Maria joined the clinical trials field as a Clinical Trial Assistant for one of the top 10 CROs supporting Clinical Research Associates (CRA) with the management of the trial documentation, focusing on Oncology phases II and III trials. After a Master in Clinical Trial Monitoring and some experience, Maria changed to a CRA role monitoring trials phases I-IV in different therapeutical areas: oncology, respiratory, rare diseases, hematology, etc. Five years later, Maria joined Teckro to help bring technological innovation to clinical sites.

Session Details: 15min Tech Spotlight: Herding Cats: Why Can’t Clinical Trial Collaboration Be Easier? 13-10-2022, 12:00 pm View In Agenda

Biography: Ms. Lewis is an experienced and versatile professional with over 25 years in the clinical research industry across a variety of therapeutic areas using a range of methodologies and strategies. Her experience includes the design and implementation of phase 3 and 4 studies as well as large-scale global safety and effectiveness registries, clinical trial simulations and digital app experience workshops. She has led numerous qualitative research projects involving patients, caregivers and healthcare professionals.  In addition, Ms. Lewis has spearheaded the development of educational materials and communications for patients and physicians, as well as oversight of several large-scale longitudinal survey-based projects. In addition, she has created content for and scripted multiple Investigator Meetings as well as Study Team launch meetings.  She has held positions within the healthcare sector, CROs and pharmaceutical industry, as Project Director, Director of Late Phase Research, Director of Health Economics and Outcomes Research, Senior Project Manager, and Senior Clinical Administrator for a research foundation.

Session Details: Train the trainer: How to train patients in an era of decentralized clinical trials 12-10-2022, 4:15 pm View In Agenda

Biography: Dr Daniel Klamer, Vice President of Business Development and Scientific Strategy of Anavex, has more than 15 years of experience in neuroscience and the orphan disease space, with acquisition, partnering and R&D experience in Europe and the USA. Prior to Anavex he worked at Retrophin and Neurosearch Sweden. At Neurosearch Sweden, Dr Klamer led and evaluated multiple discovery-phase neuropharmacological research products with an emphasis on strategic evaluation of preclinical and clinical development. Dr. Klamer earned his PhD in Pharmacology at The Sahlgrenska Academy at University of Gothenburg, Sweden, his MBA at Fordham Gabelli School of Business, and his Post-Doctoral training at the Department of Psychiatry, Yale University School of Medicine. In addition, Dr. Klamer holds a position as an Associate Professor at the Department of Pharmacology at The Sahlgrenska Academy at the University of Gothenburg.

Session Details: Top Tips for Starting up Trials in the Rare Disease Space: Best Practices and Considerations 12-10-2022, 11:15 am View In Agenda

Biography: Mary Jo Lamberti is Director of Sponsored Research at Tufts Medical School. She has extensive experience on benchmarking drug development operating practices. Her research focuses on a variety of areas including outsourcing and partnerships, clinical supplies, investigative site initiation and management, patient recruitment and retention, and the use of technologies and digital solutions in clinical trials. She has been a frequent speaker at global industry conferences and has published extensively. She holds a B.A. from Wellesley College and a Ph.D. from Boston University.

Session Details: Discussing the Results of a Tufts Survey on the Impact of Decentralized Clinical Trials on Sponsor-CRO Collaborations 12-10-2022, 4:45 pm View In Agenda

Biography: Dr. Arkady Gusev is Global Head of Laboratory Excellence and Operations in Biomarker Development / Translational Medicine of Novartis Institute for Biomedical Research. In his current role he is responsible for the scientific and operational leadership of clinical biomarkers, assay outsourcing, sample operations, central laboratory set up and vendor management.  Previously, Arkady Gusev led the Business and Technology Operations units in the Department of Pharmacokinetics, Dynamics and Metabolism in Pfizer Global Research Division.   Arkady Gusev received his PhD (1992) in mass spectrometry from Institute of Space Research, Russian Academy of Sciences. Following his PhD, he joined the Department of Chemistry, University of Pittsburgh as a postdoc and held a Research Assistant Professor position in the Department of Chemistry at Vanderbilt University before joining the industry in 1997. Arkady Gusev is the author and co-author of 50+ peer-reviewed publications in different areas of bioanalytical technologies, bioanalysis, biomarkers and clinical operations.

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