Dr. Raymond completed her doctoral training in molecular biology at University of California San Diego and post-doctoral training in molecular biology at Memorial Sloan-Kettering in New York City, New York, USA. Acceleration of clinical development in the worlds fastest growing region, Biotech Market Performance and the impact on Clinical Trials and Operations. They have fewer surprises, faster outcomes, and stronger data integrity. Currently, Audrey Funwie works in the Patient Inclusion and Health Equity team of Genentechs Chief Diversity Office. In his role as BD lead, he is responsible for many aspects of the companys planning and operations. Improving the patient experience through user-focused design. 11 th International Conference on Clinical Trials is scheduled to be held during November 09-10, 2023 at London, UK. OMDRHO is one of five programs in the Office of Medical Products Operations within FDAs Office of Regulatory Affairs. In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners. August, 2023. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact by driving quality, mitigating compliance risk, and enhancing patient engagement. Prior to her work at Potrero, she was the VP of Business Development at Theranova and led marketing initiatives for C. R. Bard (now owned by Becton Dickinson), in both Shanghai and the U.S. She has also worked as a Board Fellow at the American Red Cross Bay Area, currently serves as a guest lecturer at the University of California, San Francisco and Berkeley, and spent several years in sales and training at Johnson & Johnson. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. Currently, Arvinder is VP of Clinical Development at Rani Therapeutics, where she is responsible for Clinical and Regulatory functions for all programs. It was through this privileged relationship with patients facing devastating diagnoses that Meghan witnessed first hand the life-saving and life-enhancing effects of medical and therapeutic intervention thus piquing her interest in the drug development process. MaxisITs clinical data analytics platform is a purpose-fit solution developed to improve clinical trial performance, mitigate risk, and optimize clinical outcomes. Why drugs fail in clinical trials? Optimizing CRO Success: Relationship, contribution and oversight, PANEL DISCUSSION Defining your outsourcing strategy to contain costs and accelerate drug development time-to-market: what should you consider in the new COVID-19 era, Executing clinical trials on a shoestring: Optimizing the CRO Functional Service Provider model. www.medocity.com, To learn more , please visit our website - Clinical Trial Supply New England . Prior to working in FDA, Mr. Solis worked in the Bioresearch field focusing on Medical Device and Drug Application Products after graduating from the University California of Irvine and the University of La Verne. Making progress of a complex Interventional device study during covid. Founded and operated as a more customer centric and nimblealternative to traditional CROs, KPS offers a full range of services leveraging the latest clinical technologies. This conference intends to focus on the global health and clinical trials around the world. . https://lifesciences.transperfect.com/, To learn more , please visit our website - For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. She facilitates policy and procedure development within OMDRHO and collaborates with medical product partners in the Office of Medical Product and Tobacco Operations, and with peers throughout CDRH during daily operations and on special projects. Dr. Richard Abelson, President & CEO of Statistics & Data Corporation (SDC), founded the company in November of 2005. To learn more , please visit our website - In her role at Nevro, Frances is responsible for leading the data management team, driving the adoption of new technologies and innovative data management processes to bring new treatments to patients. We offer customizable specimen collection kits, specialty testing capabilities, dedicated project management and trial site support, biostorage, and real-time data management and reporting. 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. ), both from Duke University where I was also an undergraduate. 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. Liza has extensive experience in managing and overseeing phase I-IV clinical trials globally as well as building and growing clinical operations teams in oncology, cardiovascular, metabolic and liver diseases, HIV and trials in gene therapy. 2023. 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. Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. CROMSOURCEis unparalleled in offering an end-to-end guarantee covering trial timelines, enrollment, and price. Flex Databases platform is a secure, unified and compliant system for clinical trials. Clinical Technologies. Taking a Data Science approach to gain financial oversight of clinical trials. Following its virtual success over the COVID lockdowns, we are pleased to forecast the 2022 live edition will attract even more, with a great speaker line up and up to date content. Ndidi also leads the X2 Women in Biotech Group speaker series and is one of the founding members of the UltraMosaic Employee Resource Group. Finding patients is a challenge. INTERACTIVE SESSION: Establishing and maintaining strong CRO/sponsor relationships and building trust in a more virtual landscapeWhat have we learned and what should we focus on? 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. He has been a visiting professor at Catholic U., Louvain, Belgium and U. Pittsburgh, Pittsburgh, PA and visiting speaker at Humboldt U. in Berlin, Germany. Local vendor oversight vs global provider oversight how would you manage this differently? Executive Director, Program Strategy, Rare Disease and Pediatrics, Premier Research, https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/, https://eurofinscentrallaboratory.com/biopharma-services/, eurofinscentrallaboratory.com/biopharma-services, Hyatt San Francisco Airport, Burlingame, San Francisco, Best practices for engaging the patient community and growing that relationship using real life case studies. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets. In her spare time, Ndidi enjoys creative writing and interior decorating. The global clinical trials outsourcing market size is expected to reach USD 67.62 billion by 2030, according to a new study. Axiom Exhibiting at Outsourcing in Clinical Trials Southeast 2022. Join us in April 2023 to learn from the best in the drug development industry and have an opportunity to learn from their experiences. www.saama.com. Founded in 1985, Promedica International, a woman-owned corporation, is headquartered in Orange County, California. Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis), for which NikZ will transform the standard of care. https://medrio.com/, To learn more , please visit our website - Bruce earned his doctorate in biochemistry from UCLA and completed a postdoctoral fellowship at the University of California Berkeley. After completing her education in England, Ndidi began her career working for Parexel followed by Merck Sharp & Dohme. To learn more , please visit our website - The two day, in person conference, Outsourcing in Clinical Trials will deliver top-quality content from industry experts covering all aspects of operational . Dr. Parapiteva is an experienced regulatory professional with over 24 years in the pharmaceutical industry/clinical research organizations. Parexel Recognized by Frost & Sullivan with 2022 Global Customer Value Leadership Award . The Patient Engagement track will be chaired byEstela Mata-Carcamo(Healthcare Advocate) and will delve into topics such as,outreach to minority groups,social determinants of health, and best practices forengaging the patient community. 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. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. Despite the ongoing disruptions from COVID-19, 2021 saw some major results from clinical trials. Medocitys platform captures valuable real-time clinical insights & real-world data, while engaging patients, sites, and sponsors. www.emmes.com, Emvenio Research is a leading decentralized research organization (DRO) providing scalable and hybrid decentralized trial solutions improving clinical trial access to underserved and high-risk populations. Topics: Our standard products and services include patient recruitment, eConsent, ePRO/eCOA, interactive digital support and symptom monitoring with the capability to provide an end to end clinical to commercial solution. http://www.labconnectllc.com/. Dr. Cunningham has over 15 years experience in clinical leadership position in medical device industry, overseeing a full spectrum of clinical development programs ranging from FIM to pivotal to post-market phases. To learn more , please visit our website - His clinical trial experience spans from set-up to delivery across all phases in a wide variety of disease and therapeutic areas. PANEL DISCUSSION: Decentralized/Hybrid Trials: Discussing the current challenges and debating best practises for a successful virtual study, Considerations and best practices in direct-to-patient (DTP) / decentralized clinical trials (DCT) lessons learned from past trials, PANEL DISCUSSION: Reversing the Conversation What the clinical trial industry really wants from its service providers, KEYNOTE A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around, A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around. 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. Eurofins BioPharma Services, Laboratory Testing is a group of Eurofins companies with dedicated testing facilities for global Central Laboratory Services, Bioanalytical Services, and Specialty Virology and Oncology Services. Mr. Larwood is the third of his family to be involved in Valley Fever. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. We're here at the Outsourcing in Clinical Trials & Clinical Trial Supply East Asia conference. Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality helping them bring life-changing therapies to our families and communities around the world. In addition, 30% of trial participants drop out of the study, Innovation should strive to maximize the synergy of all three variables: safety, efficacy, and speed. 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. http://www.clinicalink.com/, To learn more , please visit our website - 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. TICKETED. Conversis is built on one goal: To provide you with the highest-quality clinical trials translations. La Jolla, CA. He investigated mechanisms by which active ingredients in cumin seeds halt Prostate Cancer progression and metastasis at the Vattikutti Urology Institute, Henry Ford Hospital. To learn more , please visit our website - She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. . as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch. Learn more about and Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp. He works cooperatively and collaborates with Federal, State, and local agencies to ensure appropriate consumer protection. There, he employed a broad range of methodologies, including: visual psychophysics, neuropsychological and computer-based cognitive assessments, eye tracking, electrophysiology, and structural imaging. He has worked for CROs as well as small and large biotechnology companies. Meghan started her career as a Masters level psychologist working within a medical care team treating patients with ALS and traumatic brain injury. Our Ergomed team is looking forward to exhibiting at Outsourcing Clinical Trials - Texas 2022, December 7th & 8th . 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. 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! PANEL DISCUSSION: The concept of DCT, is it the future? Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). David Larwood is a founder, the CEO, and chief chemist for Valley Fever Solutions, running the manufacturing process for a novel antifungal headed for Phase 2a trials in 2022. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv. Conference series LLC Ltd Organizes 3000+ Global Events Every Year across . To learn more , please visit our website - Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 3rd-4th May 2023! Advance Research Associates is a premier provider of biostatistical and data management services to the pharmaceutical, biotech, and medical device industries. Partnerships in Clinical Trials Europe 2022. Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence. In a separate article, Manasi Vaidya discovers that, fuelled by the successful use of mRNA vaccines in Covid-19, RNA therapeutics are expected to make larger strides in 2022.. Based on available data, there are emerging trends . CROMSOURCE is an international contract research organization providing a comprehensive services to the pharmaceutical and biotechnology companies. 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. We have five years of clinical trial experience and capabilities around the globe in over 90 countries and across any therapeutic area whether for decentralized, hybrid or fully virtual studies. Tickets. Scalable clinical analytics platforms built within core engineering frameworks are the only way to ensure the integrity, repeatability, and value of data standards and insights. Read more . http://www.iconplc.com/, To learn more , please visit our website - To learn more , please visit our website - To learn more , please visit our website - http://www.pcmtrials.com/, To learn more , please visit our website - Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. Headquartered in Sydney since 1996, Novotech has come to be recognised as the CRO of choice for many US and European biotechnology firms in the Asia Pacific. RadMD, a Medica Group Company, is your full service imaging core lab solution. This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. Visit our website to learn more about how we deliver a Better Clinical Experience. Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. Philips BioTel Research is an industry leader in medical imaging and cardiovascular safety testing for clinical trials. www.flexdatabases.com. Prior to starting SageMedic, he was an Associate Professor at UCSF. Find out about the events you can meet the Caidya team at and stay updated about the latest conferences and clinical research events. What is critical to get right to make a digital QM System work? 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 . Keeping them can be an even bigger challenge. Richard holds a Ph.D. in Industrial Engineering with a focus on applied statistics, quality, and reliability engineering from Arizona State University (ASU), a Master of Science in Industrial Engineering focused in Operations Research and Production Systems (ASU) and a Bachelor of Science in Engineering in Industrial Engineering (ASU), and is certified as a Six Sigma Black Belt. He is a member of DIA, ARVO and CDISC. The 2014 event will focus on how companies from the region can implement effective clinical outsourcing strategies. To learn more , please visit our website - Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. TFS demonstrates scientific and medical competence across populations and therapeutics, with industry-leading capabilities in: -Dermatology, Immunology and Inflammatory Diseases, -Internal Medicine including Neurology & Respiratory, -Pediatrics, Rare Diseases and Orphan Drugs, Detailed information about TFS, and its business offerings can be obtained through. We are committed to delivering high-quality, cost-effective services according to sponsor timelines and specifications. Francis has lead supplier oversight responsibilities for sponsors, CROs and clinical system vendors. To learn more , please visit our website - Genentech Chief Diversity Office, Patient Inclusion And Health Equity. Lin, who has been with the company since October 2016, previously served as the Senior Vice President of Sales and Marketing. Communities. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. For the past 10 years, Estela has co-facilitated support groups, led, and participated in educational symposiums, advocated locally and nationally. Based outside Philadelphia, Pennsylvania, we pride ourselves on being boutique by design and always customer focused. Ellen brings decentralized clinical trial visits to patients with PCM Trials experienced Certified Mobile Research Nurses. Precision medicine is in our blood, our cells, our genes, and our name. 4240 La Jolla Village Drive. THE 2023 AI UPDATE AI & disruptive technology: Harnessing the future of Artificial Intelligence to transform clinical trials, FIRESIDE CHAT: Overcoming the barriers to trial innovation and technology access from a small companys point of view. We are now in the position now to share our practical experiences with Decentralized & Hybrid Clinical Trials; The bedrock of a successful trial is a well-designed protocol with reliable measurements of biomedical and health-related outcomes to satisfy regulatory standards. Proven ability to organize and manage late-stage development cross-functional teams completing projects on time with meticulous attention to detail. Anne came to FDA in 1990 with an undergraduate degree in Biochemistry and a masters degree in Food Science and segued into FDAs laboratory science regulatory operations. Vendor/CRO Paid Ticket . TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem. CA; X-Mine, CA; Delphian Pharma, CA and Certum LLC, CA). This session examines how scientific rigor can be applied to clinical outcome assessments (COAs) even though they are subjective. Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. Prioritizing patient diversity. She has a wealth of knowledge and experience having served more than 24 years in ORA managing staff and operations focused on medical devices, radiological health, and MQSA. Phase 1 Trials: How to globalize to accelerate value inflection. The therapeutic areas include: Cancer, CV, CNS and infectious diseases. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. She has worked at several companies in positions of increasing responsibility including VP of Quality at InterMune (acquired by Roche) and Director of Quality at CV Therapeutics (acquired by Gilead). To learn more , please visit our website - http://www.clinicalink.com/. 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 . ACM performs more than 20 million laboratory tests each yearspanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more. His thesis was on the role of the Androgen Receptor in Hormone Refractory Prostate Cancer. In another exclusive data-led investigation, Andrew and Reynald Castaeda investigate which diseases are set to have an increase in clinical trial activity this year. deep6.ai, To learn more , please visit our website - www.rad-md.net. Altasciences full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, data management and more, all of which can be tailored to specific sponsor requirements. Lin holds a Master of Science in management from the Stanford University Graduate School of Business and a master's in marine biology from Sun Yat-sen University in Guangdong, China. . His expertise is in regulated content management, and he is a member of the TMF Reference Model Project Team. This is a great opportunity to network and share knowledge with regions leading pharmaceutical firms, biotechs and med device companies, discuss operationally efficient, specifically targeted clinical trials. Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. His father was a physician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. Quickly upscaling digital technologies. Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management.
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