She holds medical license issued by Serbian Medical Chamber. https://www.intrinsequehealth.com/. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. Our customized and scalable solutions improve the quality and execution of clinical trials while mitigating costs and allowing clients to retain strategic control. Dont miss out; join us in Burlingame on March 1st& 2nd2023! Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. Meet Inspiring Speakers and Experts at our 3000+ Global Events with over 1000+ Conferences, 1000+ Symposiums and 1000+ Workshops on Medical, Pharma, Engineering, Science, Technology and Business. www.bsi-lifesciences.com. Current topics in the Medical Device Regulatory Landscape, Presented by the FDA. Exploring incentives for the community if not financial what else can you offer? Taking a Data Science approach to gain financial oversight of clinical trials. He has supervised the management of a clinical portal, eTMF, CTMS, RTSM, EDC, Coding and Grants solutions. To learn more , please visit our website - To learn more , please visit our website - Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. Arena International are delighted to announce the Outsourcing in Clinical Trials Southern California Event will be returning to California's La Jolla on September 26th & 27th 2023! Evolve our technology to improve the study experience for patients, site, and sponsors with the move towards more decentralized trial models, Software will be more heavily relied upon to keep patients connected, informed, and engaged, Explore the importance of utilizing user-focused research on software design and implementation of eCOA and eConsent in clinical trials, Define the role of leadership in cultivating a Quality and Compliance culture, Establish key considerations for implementation, Explore best practices for ensuring sustainability, Operational analytics including enrollment, protocol compliance and safety, Risk-based analyses and insights with elluminate RBQM, Operational knowledge for data-driven development with elluminate CTMS, Centralized issue management across roles in operations, data and medical review, Sample tracking, data forecasting and financial performance indicators, See how Curebase can design a flexible site model to address specific study concerns, Learn about the features Curebase can incorporate based on Sponsor needs, Witness how virtual sites can be deployed to collect high-quality patient data in real-world settings, Strategies for global patient recruitment, Supplies management and shipping challenges. With her unique blend of business acumen and technical expertise, Rebecca Lin is a dynamic leader with many years of success in the healthcare industry. As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. Dr. Cunningham came from academic background. Medrio is the leading provider of eClinical technology for pharma, biotech, device, diagnostics, and animal health clinical trials. Previously, Bruce held leadership roles at Alkahest, Celerion and Allon Therapeutics, and works closely with the Michael J Fox Foundation, chairing one of their scientific review panels. Combined, our clinics offer over 200 beds. 8th Edition of Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PHARMA 2023) Mon, 13 . I went into industry for post-doctoral studies at the biotechnology research center at Ciba-Geigy Corp. (Novartis) and have over three decades of academic and industrial research and senior management experience in protein and metabolic engineering, bio-based manufacturing, and drug discovery / development. He held senior level positions with Relypsa (acquired by Galenica for 1.52B US$), Anacor (acquired by Pfizer for 5.2B US$) and Transcept Pharmaceuticals (revers merger with Paratek). She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. Intrinseque Health is an EN ISO 13485 certified Global Clinical Supply Chain organisation, building & executing complex Clinical Supply Plans for Ancillary, Medicinal products, Clinical Supplies, Equipment and Services required by Pharmaceutical & Biotech companies and CROs for their Clinical Trials. www.ledgerrun.com/, To learn more , please visit our website - This, exclusive event brings together attendees from established pharma, large and small, alongside with biopharmaceutical companies and gives opportunity to dive into the operational challenges and innovations in clinical development found within the UK & Ireland region. Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck. Our mission is to optimize the Clinical Trial Ecosystem, applying industry experience and the latest technology to streamline, secure, and enhance the interactions between sponsors, sites, CROs, and others involved in administering and operating clinical trials. Emmes acquired Casimir in March 2022, and the . Our Sponsor Edition includes dedicated applications for clinical study planning and budgeting, outsourcing and forecasting. Agilex Biolabs operate a fully quality-assured, FDA-inspected laboratory (ISO/IEC17025 and OECD GLP). Catalyst Clinical Research is a new generation Clinical Research Organization, serving the unique needs of small-to-medium sized biopharmaceutical companies. In addition to her deep understanding of the unique dynamics of developing novel treatments for rare and complex diseases, Dr. Raymond also leverages her combination of training and experience leading the Gene Therapy Think Tank at Worldwide Clinical Trials. For more than 20 years, Axiom has delivered data-driven, powerful and cost-effective eClinical Solutions and Services dedicated to small-to-medium life science companies. Funwie strives to do meaningful work that combines and applies her bioethics background while prioritizing and addressing health equity in the context of clinical studies, patient experience, and policy. http://www.labconnectllc.com/. To learn more , please visit our website - Global Player in eClinical Solutions . He is also President of SBS Medical Management, a healthcare economic consulting firm for investment banks and Expert Medical Reviews, including the California Medical Board. He also conducted undergraduate research on osteoporosis progression and has authored several papers, abstracts and a book chapter on protein signal transduction. At Trilogy, medical writing is our passion. Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. Post doctoral research studies in Human Behavior. Dr. Debashish Niyogi is currently Vice President, Product Management at Anju Software, where he is responsible for the vision, strategy, and roadmap for the companys eTMF and CTMS solutions. http://www.heartcorsolutions.com. Dr. Cunningham came from academic background. Prevail InfoWorks improves the probability of clinical trial success by providing stakeholders real-time actionable intelligence to effectively manage endpoints and key deliverables with the Single Interface, its patented cloud-based tool that aggregates, reconciles, analyzes and single-view reports/visualizes all clinical, operational and project accounting data, regardless of the source or format. She is a career FDA federal service veteran with vast experience in technical and managerial positions across multiple commodities. She is currently the Founder and CEO of Strategikon Pharma, developer ofClinical MaestroTM, the industrys only end-to-end cloud-based platform for clinical trial budgeting, sourcing and budget management including strategic alliance/partnership management. This session examines how scientific rigor can be applied to clinical outcome assessments (COAs) even though they are subjective. Fusion eClinical Suite is the most adaptable, unified platform that serves as the Connected Hub for all your Clinical Trial and operational data and reporting. Subsequently, Arun lead the Gastric-Immuno-Oncology Rare Disease Bispecific-T cell-Engager portfolio at Amgen on various aspects of clinical research operations. In 2010, he became a Supervisor Consumer Safety Officer (SCSO). August 29-31, 2016 Atlanta, USA. Making progress of a complex Interventional device study during covid. To learn more , please visit our website - To learn more , please visit our website - She currently serves as Vice President of Clinical Affairs at Endogenex, a medical device company developing innovative solutions for the treatment of Type 2 diabetes. dpocentre.com. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. Spaulding Clinical operates a 200-bed Clinical Pharmacology Unit, a Full Service Biometrics Group and Cardiac Core Laboratory. info@caidya.com. He worked as a Research Associate to improve recruitment metrics in the Million Veterans Program genomic biobanking initiative for Loma Linda VA Medical Center where he developed a novel Point of Care recruitment solution in outpatient clinics. Outsourcing In Clinical Trials East Coast 2022 User Dashboard. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. Previously, Arvinder has worked at CV Therapeutics and Gilead Sciences where she led various projects from early discovery to clinical development. Alexis Garelli has over 15 years of diverse healthcare information and pharmaceutical software technology experience. www.allucent.com. ProTrials works with sponsors in the pharmaceutical, biotechnology and medical device industries to deliver high-quality clinical development services in a wide range of therapeutic areas. For more information, visitwww.eclinicalsol.com, or contact us atinfo@clinicalsol.com. The therapeutic areas include: Cancer, CV, CNS and infectious diseases. Our experienced team has been in this niche of clinical research with deep domain experience for decades and client solutions has been our passion for over two decades. 21 - 22. Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. To learn more , please visit our website - Chemistry degree from Punjab University, Institute of Chemistry, Executive Director, Global Digital Quality Management Systems and Business Intelligence BeiGene, Executive Director, Global Medical Affairs Study Management, BioMarin Pharmaceuticals, Inc. Wendi Carroll received her Pharm D from the University of the Pacific. Kristina leads the Patient Insights team at Parexel and is dedicated to bringing a thorough understanding of the patient journey, and the patient voice to the entire spectrum of research services. To learn more , please visit our website - Prior to starting SageMedic, he was an Associate Professor at UCSF. Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. FDAs role in maintaining a secure and resilient supply chain. Fun fact: Ndidi was born and raised in Sierra Leone, and is a descendant of the Krio people who were freed slaves that returned to Freetown from Africa, America and The West Indies. Meghan received her Masters Degree in Human Biology at San Francisco State University and her Bachelors Degree in Economics at University of North Carolina, Chapel Hill. Rhonda Mecl recently became the Deputy Program Director after serving as the Program's Operations Staff Director for the previous five years. Peachtree BioResearch Solutions is an Atlanta-based Clinical Research Organization that provides clinical development support services and innovative resourcing solutions to medical device, pharmaceutical, and biotech companies. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals. http://www.premier-research.com/, To learn more , please visit our website - With locations in the US and EU, Catalyst offers highly flexible and customized, customer-centric solutions from Global Resourcing and FSP, to Full Service Managed Solutions, with a focus on oncology product development. Working closely with the CRO and giving your site the freedom to breathe, Communication is key- how can the sponsor/CRO help and support as a partner, Trends in clinical development across the globe over the last 5 years, Pre and post covid impact on the clinical trial global economy, Patterns in investment and clinical trial equity. Hang Nguyen brings over 20 years of medical device clinical research and is currently the Sr. Director of Clinical Affairs at Materna Medical, a novel OBGYN platform company defining a $6B market in the most common pelvic conditions women face. TransPerfect Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. CA; X-Mine, CA; Delphian Pharma, CA and Certum LLC, CA). Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. Global Clinical Trials Connect 2023 2022 London United Kingdom. Review and assess the selection criteria sponsors face when selecting Phase I jurisdiction. http://catalystcr.com/. CLOSING KEYNOTE: FDAs role in maintaining a secure and resilient supply chain. To learn more , please visit our website - https://www.anjusoftware.com/. In 2010 she became the Deputy Director of ORAs Southeast Region, and in 2012 she assumed the responsibilities of Acting Director for the Southeast Region. She is a Nurse Practitioner by training and spent over 10 years caring for patients before coming to industry. Genentech Chief Diversity Office, Patient Inclusion And Health Equity. What can we do to take advantage of high prevalence of disease in populous countries but systems are either rudimentary or non-existent? The DIA's Digital Technology in Clinical Trials Conference discovers how digital technology is transforming the drug, device, and diagnostics development process in clinical trials. Founded in 1976, ACRP is a Washington, DC-based non-profit organization with more than 13,000 members who work in clinical research in more than 70 countries. Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORAs Office of Import Operations. The DPO Centre has assisted over 600 clients globally, including a broad range of bioscience, genomics, therapeutics, healthcare and pharma companies to comply with EU data protection laws such as the GDPR, the EU Clinical Trials Regulation and specific member state requirements. Where do the opportunities lie for further acceleration in clinical development? https://lnkd.in/gEJj4yXX Please come and visit us at stand http://www.altasciences.com/, To support the acceleration of drug development, over the last 12 years, ARENSIA Exploratory Medicine GmbH (www.arensia-em.com) has built up its own research clinics, with full Phase I infrastructure, entirely dedicated to the performance of sophisticated FIRST-in-PATIENT Phase IB, IIA and PROOF OF CONCEPT clinical trials with novel compounds. Wendi is currently the Executive Director, Global Medical Affairs Evidence Generation COE at BioMarin Inc. where she oversees global operational strategy and execution for programs in the post-approval setting. Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables. Our full service offering includes clinical program management, biometrics services and regulatory affairs. In his role as BD lead, he is responsible for many aspects of the companys planning and operations. Clinical ink is the global life science company that brings data, technology, and patient science together. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone. Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. Her background in Biotechnology and proficiency in Data Management solidified her proven ability to identify data integrity risks, and problem solve the most complaint path to drug submissions and approvals. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry. Dr Morimoto has over 25 years of industry experience in leading project teams in the development of innovative medicines, providing guidance in the design and execution of preclinical, clinical and regulatory strategies with a therapeutic focus in Parkinsons, Alzheimers and frontotemporal dementias. Henry earned his B.S. Does it offer a solution? Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. It is a 2 day event organised by Arena International Events Group and will conclude on 24-May-2023. United States, 94010, To learn more , please visit our website - November 28-30, 2016 San Antonio, USA. Chief Executive Officer, Agility Pharmaceuticals, Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American Association for Precision Medicine ( and chair of ACT AAPMs Coronavirus Taskforce He is leading research efforts focused on preventing curing chronic diseases not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company committed to revolutionizing drug discovery development through technology, big data, robotics, and artificial intelligence He is a serial entrepreneur who founded his first company after graduating high school, and his second company during his Ph D Since then, he has accumulated a wealth of experience by building, investing, and advising numerous other companies He is an investor, co founder/ board member of a few corporations, focused on accelerating drug discovery/ development, data analytics, robotics, mental health, and digital health He is also the founder of AAPM Angels and Investors AAi an investment group focused on investing in drug discovery, diagnostics, precision medicine, technology healthcare companies He is also the founding investor and advisor to Barcelona Ventures and serves as an advisor to a 100 M private equity fund Widely recognized as a thought leader in the field of technology and healthcare, Dr Mishra has keynoted, chaired, curated, and organized numerous successful international conferences He served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where he participated in several drug discovery project teams Moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic His research work has been recognized globally by over 40 prestigious awards and honors Due to his unique perspective selfless service, he is a highly respected sought after mentor to many The companies that he has advised have raised multimillion dollars Notably, he serves as a mentor and advisor to several VC funds and startup accelerators, including IndieBio HIMSS/Health 2 0 s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture, UCSF Invent Fund, and California Life Sciencess FAST program, to help grow Californias life sciences innovation ecosystem, Chief Executive Officer, Strategikon Pharma. To learn more , please visit our website - www.Clario.com. Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. Meghan joined a CNS-focused start up in RTP and has spent the last 15+ years working in the life science technology industry. www.assistek.com, To learn more , please visit our website - He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv. After 3 years as a patent lawyer at Apple Computer, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through successful acquisition in 2005. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionalscollaborateswith biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.

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