He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. She has over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules. www.clincierge.com. Our leading clinical show will focus on providing delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials, this is an [] Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 3rd-4th May 2023! Medocitys platform captures valuable real-time clinical insights & real-world data, while engaging patients, sites, and sponsors. Where do the opportunities lie for further acceleration in clinical development? Wayne holds an MBA and B.S. ICACB 2023: Applied Clinical Biostatistics Conference, Rio de Janeiro (Feb 16-17, 2023) ICAHIPHIM 2023: Advanced Healthcare Informatics and Public Health Informatics Management Conference, New York (Feb 16-17, 2023) ICCPP 2023: Clinical Psychiatry and Psychology Conference, Barcelona (Feb 16-17, 2023) ICEPNR 2023: Exercises for Pediatric . www.orbisclinical.com. Currently he is the CEO of Certum Bio in San Francisco Bay area and honors the co-appointment as the Member of the Board of Advisors, UC Berkeley Postdoc Entrepreneurs Program (BPEP). https://www.sdcclinical.com/. https://www.intrinsequehealth.com/. He is an advisor to several biotech companies. To learn more , please visit our website - http://www.novotech-cro.com/. Meraf has over 20 years experience working in biotech, health and the pharmaceutical industry. I am passionate about the life sciences and the clinical and commercial potential of novel therapeutics and applications of synthetic biology. Worldwide is changing how the world experiences CROs in the best possible way. How data mining clinical trial costs and benchmarks can lead to operational efficiencies, The impact of macroeconomic factors on clinical trials and how to best combat changes, How to reimagine financial stability and planning for clinical trials, Clinical Trials: Success & attritions. Looking forward to another great conference! We work With HeartTMevery day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. We proactively plan, coordinate and write clinical documents to meet timelines, with a readability that reduces the time for review and approval. PANEL DISCUSSION: Optimizing oversight & governance: What does oversight mean to you? Wednesday, 28th Sep 2022 - Thursday, 29th Sep 2022 . To learn more , please visit our website - http://www.clinicalink.com/, To learn more , please visit our website - Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc. Were doing more than streamlining your processes. Her passion for ensuring that clinical trials are reflective of our society drove her to her most recent work in Health Equity, where she works with a group of committed and passionate individuals to successfully develop and implement scalable and sustainable strategic interventions for the recruitment of underrepresented patient populations. Clinical Outcome Assessments (COAs): Applying scientific rigor and good instrument design. To learn more , please visit our website - http://www.yprime.com/, Curebase leads decentralized clinical research using a sophisticated eClinical software platform that manages all site/patient data capture, along with a fully virtual site that acts much like a traditional site, but with greater flexibility and reach. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. Weve all had to sit through several pitches from vendor companies telling us what they can do for us, but now its time to reverse the conversation! Previous roles within both CRO and Sponsor organizations which provide valuable perspective from both sides of the industry. Last year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, [] www.harborclinical.com/. Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. To learn more , please visit our website - Conference series LLC Ltd Organizes 3000+ Global Events Every Year across . . She has managed and overseen large global clinical trials in various therapeutic areas and multiple phases of development. Frances has an undergraduate degree in Physiology and a PhD in medical science from the University of Sydney. deep6.ai, To learn more , please visit our website - Any Device. Technology as a methodology: Accelerating Clinical Development timelines. Hear from the trial industry as they discuss the services they would like to see from their solution providers, including: Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Dr Jankicevic holds Doctor of Medicine degree, Master of Medical Sciences degree, and Board-certification in Dermatology and Venereology from the University of Belgrade, Serbia. The "Global Clinical Trial Outsourcing Market by Clinical Trial Phase, Therapeutic Area, End-user and Region: Competition Forecast and Opportunities to 2027" report has been added to . The news service . Chris has dedicated his 16-year career to the services side of the Phase I clinical drug development industry, including both operational and business development roles. 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. Since 1996, ARA has supported 700+ clinical trials worldwide across all therapeutic areas. Our Sponsor Edition includes dedicated applications for clinical study planning and budgeting, outsourcing and forecasting. www.precisionformedicine.com. 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. Outsourcing In Clinical Trials East Coast 2022. Bruce earned his doctorate in biochemistry from UCLA and completed a postdoctoral fellowship at the University of California Berkeley. Pharmapack is the European event focal point for the pharma packaging and drug delivery device industry. To learn more , please visit our website - www.pro-ficiency.com. To learn more , please visit our website - Dr. Yunis is a scientist with multidisciplinary training and experience in the mechanism of diseases. www.ACMGlobalLab.com. As a supervisor, he had the opportunity to manage an Import Field Operation Team, an FDA team in the Centralized Examination Stations (CES), and the Los Angeles International Mail Facility. Conversis is built on one goal: To provide you with the highest-quality clinical trials translations. http://www.pcmtrials.com/, To learn more , please visit our website - Oversight with less presence how to make this work, Effectively building strong working relationships remotely, Strategies to deliver training and upskill your team, Handling hard discussions with your CRO/partner when you cant meet in person, Optimizing communication channels/effectiveness with your CRO partner and team, Maintaining a positive working relationship prioritizing and building strategies from the outset, Clinical trial timelines are lengthy and on average a Phase 3 trial can take between 1-4 years. http://greenphire.com/. LabConnects unique combination of state-of-the-art technology, world-class laboratories, easy access to emerging markets and extensive specialized testing expertise means the drug development industry can rely on a single provider for all of their central lab needs. Our mission is to eliminate the barriers to clinical trials by bringing access to people where they live, work and are willing to engage. Exploring new science and a futuristic perspective on AB/AM drug development, Exciting growth of artificial intelligence in medicine, A framework on development of artificial intelligence in medicine, The power of public attention and funding, Business opportunity of artificial intelligence in medicine, What they like to see in an outsourced partner organization, What they would like a partner to know about them / how they work. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services. Previously, Arvinder has worked at CV Therapeutics and Gilead Sciences where she led various projects from early discovery to clinical development. Drivers of failures, Flawed clinical study design leading to failures, Diagnostic indicators and early Go/No-Go decisions in proceeding further during clinical study phases. Our performance is built on years of experience staffing the competitive biopharma job recruitment landscape, leveraging our deep networks to source the most highly sought-after candidates in the industry. Clinical Trials 2023. www.advanceresearch.com. Ndidi Rickert is an experienced Quality Assurance leader with over 20 years of experience in the Pharmaceutical/Biotechnology industry. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. https://www.chillipharm.com/. Long term solutions: could reducing the site certification process be a realistic solution? Clinical Trials 2022 will discuss various disciplines involved in the pre-clinical research, conduct of clinical trials; it will educate health care researchers about design, operation, organizing, research computing . Axiom Exhibiting at Outsourcing in Clinical Trials Southeast 2022. BS in Human and Organizational Behavior, and Communication Studies and authored numerous trade articles and frequently present on behalf of Parexel at trade conferences. This conference will focus on topics such as bioethics, regulations, patient recruitment, site selection, data integration & strategy, and many more. TransPerfect Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Learn more about and Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp. Are Hybrid trials the more realistic and practical approach compared to full DCT agree or disagree? Were your solution. Previously she served as Head of Clinical Outsourcing and Analytics for BioMarin Pharmaceuticals, where she was responsible for vendor contractual, relationship and financial management. www.flexdatabases.com. Imaging endpoints are often used to support go/no-go decision-making in early phase trials. YPrimescloud-based technology streamlines clinical trial data collection and management. September 28-29, 2022. Acceleration of clinical development in the worlds fastest growing region, Biotech Market Performance and the impact on Clinical Trials and Operations. Advantages of working alongside grass root organisations and PAGs what groups are out there? These conferences closely focus on the advancements in clinical research and trials. http://www.mlm-labs.com. 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. Today she serves as the Chief Strategic Officer for Potrero Medical, a Hayward, California-based predictive health company developing the next generation of medical devices with smart sensors and artificial intelligence. 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. David Hadden is the pioneer of AI-driven Virtual Patient Simulation technology. Focusing on life sciences, Datacubed offers software and services driven by behavioral science to improve patient retention and compliance, resulting in better data and positive health outcomes. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine. Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. theactigraph.com. Amsterdam RAI. Spaulding Clinical Research is a global CRO providing Phase I IV drug development services to pharmaceutical and biotechnology companies. Reem holds a PhD in genetics from the Hebrew University of Jerusalem. AbbVie reports rise in full-year 2022 net revenues; Teva Pharmaceutical reports 5% fall in Q4 2022 revenue; Merck reports 2% increase in worldwide sales in Q4 2022; Companies. http://www.spauldingclinical.com/, To learn more , please visit our website - December 07-09, 2015 Atlanta, USA. This is the unmissable event that the pharmaceutical, biotechnology, and medical device communities need to come together and discuss strategies for operational success in clinical trials. In partnership with customers, we build solution-driven teams working for a healthier future. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. 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. Emvenio Research is transforming how patients and care-givers engage in and experience clinical research, To learn more , please visit our website - To learn more , please visit our website - Our latest enhancements include patient genetic and biomarker matching to promote swift site identification and patient enrollment. THREAD provides key platform features such as eConsent, eCOA/ePRO, sensors, reminders, and telehealth Virtual Visits to support remote data capture, hybrid virtual studies, and fully decentralized studies in key therapeutic areas. 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. The 2023 programme will offer a fresh insight into the latest regulatory updates, global clinical trials, advanced technologies such as digital health and connected devices space, and more. 5 th Clinical Nutrition Conference. They have fewer surprises, faster outcomes, and stronger data integrity. Vice President, Clinical Operations, Corvus Pharmaceuticals Inc. Assistant Commissioner for Import Operations, U.S. Food and Drug Administration, Director, Global Patient Engagement and Advocacy, Acceleron Pharma, Associate Director, Site Contracts & Budgets Deciphera Pharmaceuticals, LLC, Program Director, Office Of Medical Device And Radiological Health Operations, FDA. With a dual clinical appointment in Robotic-Surgery at the Institute, Arun focused on post-surgical outcomes of Da-Vinci Robotic Prostatectomy for Hormone Refractory Patients. Date: January 18 - February 17, 2023. Frontageis a CRO providing integrated, scientifically-driven research, analytical and product development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals. www.medocity.com, To learn more , please visit our website - Whether you require ad hoc support or a team to partner with on audit programs, we have the people, the expertise and the experience to provide the assistance you need. www.medpt.com. ARENSIAs speed and data quality provide our Partners/Sponsors with a strategic advantage across the entire lifecycle of a project, as they can progress their novel compounds much faster to later phases of research. Over the years, Lin has achieved success at both large corporations and startups. Ops components of various FIH studies and global P1-P3 drug development programs and post-marketing studies in Oncology, Hematology-Oncology, Immuno-Oncology, Infectious Diseases, Immunology, Metabolic Diseases, Ophthalmology, and Critical Care conducted in North America, Europe, Africa, Central and South Americas, Asia-Pacific regions including Japan, China, So Korea, and Australia *Lead cross-functional teams and successfully contributed to several INDs, NDAs, FDA, EMEA, TGA, and NMPA regulatory filings and approvals of marketed products within HIV/Virology Therapeutic Area *Mentor, motivate, and develop clinical operations teams and direct reports *Strong, flexible, strategic team leader with extensive change management successes *Track record to develop, problem-solve, and execute creative and innovative process improvements and quality efficiencies within development operations *Motivated and driven to continue contributing to drug development in transformative medicines with a focus on unmet medical needs, CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world. Basel, Switzerland. ), pharmacovigilance and safety solutions, translation and language services, and call center support. Sandy Mohan is the VP of Quality at Iovance Biotherapeutics. http://www.peachtreebrs.com. http://www.iconplc.com/, To learn more , please visit our website - With 2,000 annual trials and projects, around 200 active clients and global access to source drugs in over 60 countries,Myonex is your complete partner around clinical trials around the globe reliable, trusted and by your side. Alton Sartor completed a combined MD/MBA from Tulane University. Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem.
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