Ndidi also leads the X2 Women in Biotech Group speaker series and is one of the founding members of the UltraMosaic Employee Resource Group. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. 2023. Deep 6 eliminates months of manual data validation, to de-risk and accelerate clinical trials, because clinical trials should be a gatekeeper (accelerator), not a bottleneck to innovation. He is a key member of the leadership team responsible for defining the company's go to market strategy and value proposition across the many segments of the pharmaceuticals and device research industry. Dr. Apfel is also the Chair of Life Sciences at the Keiretsu Angel Investment Forum, where he invests in life-science companies that have the potential to positively impact patients with serious conditions. To learn more , please visit our website - 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. Outsourcing In Clinical Trials East Coast 2022 - HealthManagement.org Learn more atwww.clinone.com. Scout Clinical, part of the Meeting Protocol Family, provides stress-free, confidential and personalized travel, expense and compensation management services to clinical trial participants on a global scale. She has authored or co-authored 10 publications and has been an advocate for STEM education throughout her career. Partnerships in Clinical Trials Europe 2022 - ntradeshows.com She is a Registered Respiratory Therapist, holds the CPPS (Certified Professional in Patient Safety) credential from IHI and has a Masters degree from Johns Hopkins in Patient Safety and Healthcare Quality. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. To learn more , please visit our website - 2023 edition of Outsourcing in Clinical Trials East Coast will be held at King of Prussia starting on 23rd May. Join Premier Research at Outsourcing in Clinical Trials Southern California 2022 as it returns for its 9 th annual event. To learn more , please visit our website - Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs. 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. 2 nd Clinical Case Reports Conference. From 2 to 4 November 2020. Visit our website to learn more about how we deliver a Better Clinical Experience. With over 15 years experience in the industry, Esther has predominantly worked in clinical trial management and data management roles across Europe, North America and South Africa. 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. To learn more , please visit our website - Project Leader, Health Equity And Population Sciences, Hoffman La Roche. What can small biotech ClinOps teams learn from large Pharma, and vice versa? The event is a must-attend for people from the clinical trials . 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. Despite the ongoing disruptions from COVID-19, 2021 saw some major results from clinical trials. ARENSIA is trusted by Leading Pharmaceutical and Biotechnology organizations worldwide. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. 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 . Esther Marfo, is a Project Leader within the Health Equity and Population Sciences department at Genentech. http://citlabels.com/. As an international key opinion leader in dermatology clinical development, Dr. Jankicevic has served as advisor to multiple companies on their path to global regulatory and commercial success. Our Ergomed team is looking forward to exhibiting at Outsourcing Clinical Trials - Texas 2022, December 7th & 8th . Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences. Pharma/Medical Device/Biotech Delegate - Complimentary Pass Register Now. Our latest enhancements include patient genetic and biomarker matching to promote swift site identification and patient enrollment. To learn more , please visit our website - The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today. Partnerships in Clinical Trials Europe 2022. 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. Clinical Trials Innovation Programme 2023 is the only platform to . Tickets. Dr Frances Rubenstein has worked in clinical data management for more than 20 years in both medical device and pharmaceutical companies. Outsourcing Clinical Trials New England - BURG Translations Arena International are delighted to announceOutsourcing in Clinical Trials West Coastwill be returning to Burlingame for the annual event onMarch 1st& 2nd2023! Cliniacal Trials 2023 | 13th International Conference on Clinical To learn more , please visit our website - http://www.pcmtrials.com/. http://www.mlm-labs.com. Or has the noise around DCT quietened? She is currently managing a Ph3 program in rare liver disease. To learn more , please visit our website - Taking a Data Science approach to gain financial oversight of clinical trials. ICON plc is a world-leading healthcare intelligence and clinical research organisation. ARENSIA is based with its headquarters in Dsseldorf, Germany, and operates with 400+ talented employees in 7 countries, To learn more , please visit our website - 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. dpocentre.com. To learn more , please visit our website - He was Senior Director of Clinical Operations at Pharmacyclics from 2012 to 2017 where he was responsible for the development, implementation and maintenance of the Clinical Operations infrastructure, as well as the GCP inspection hosting platform and processes, and regulatory authority marketing approval inspection hosting. ), both from Duke University where I was also an undergraduate. 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. During her career she has supported Class 1-3 devices through the entire product lifecycle. Philips BioTel Research is an industry leader in medical imaging and cardiovascular safety testing for clinical trials. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. Prioritizing patient diversity. DCT was previously done out of necessity but are we seeing it as a new world order? 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. In partnership with customers, we build solution-driven teams working for a healthier future. We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. www.pro-ficiency.com, To learn more , please visit our website - Additionally, our tech-enabled trial management system, streamlined study startup processes, centralized pre-screening call center, and unparalleled approach to patient recruitment will successfully deliver a superior CRO experience. Medical Writing and Healthcare Communications Conference. Conduct of clinical trials are increasingly becoming expensive. The Technology track will seeKimberley Ferguson(Commercial Head of Personalized Healthcare Partnerships, Genentech) discussing all thingsWearables. Why expert partners and staff matter; what metrics dont tell. Alton Sartor completed a combined MD/MBA from Tulane University. Outsourcing In Clinical Trials - Texas 2022 - Ergomed PLC Cultural consideration - translations, typical distance from site, etc. We help teams bring order, trust, and predictability to protocol execution and automation. Conduct of clinical trials are increasingly becoming expensive. Clinical Trials conferences 2023 are large-scale multidisciplinary events well attended by clinical researchers, media partners, renowned speakers, sponsors, scientists, exhibitors, and other attendees. For more information please contact Graig Daley Business Development Manager and Jackson Young Business Development Associate atsales@citlabels.com. 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. Myonexis a global complete clinical trial solutions provider. Clinical research professional with 25 years of experience in clinical and medical affairs, most recently as Director of Clinical Affairs and Associate Director of Medical Affairs for a global medical device manufacturer focusing on endovascular and surgical repair of aortic disease. In 2011 she co-founded Looms for Lupus when her sister almost lost her life to Immune thrombocytopenia and Lupus; she is alive today because she advocated for herself. Analytical & Solid State Services. Outsourcing Clinical Trials New England 2022 - Almac To learn more , please visit our website - http://www.medable.com/. Parexel is among the worlds largest clinical research organizations (CROs), providing the full range ofPhase I to IV clinical development services to help life-saving treatments reach patients faster. Applied Clinical Trials Online Dr. Karl McEvoy has over a decade of industry experience in both the vendor and sponsor sides. Precision for Medicine (PFM), the full-service global CRO, is purpose-built to accelerate clinical research and development processes to bring life-changing therapeutics to those who need them most. In 2010, he became a Supervisor Consumer Safety Officer (SCSO). By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. 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. The 2014 event will focus on how companies from the region can implement effective clinical outsourcing strategies. The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. To learn more , please visit our website - She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. November 13-14, 2023 Dubai, UAE. Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. in Psychology and Biology from the University of California at Santa Cruz. For more information, please contact us at 262-334-6020, or via email at Daniel.Selness@spauldingclinical.com. Dr. Yunis is a scientist with multidisciplinary training and experience in the mechanism of diseases. 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. 25 people interested. 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. Meraf has over 20 years experience working in biotech, health and the pharmaceutical industry. To learn more , please visit our website - September 28-29, 2022. An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps. Promedica International is a privately held, full-service CRO providing clinical trial services for the medical device, biotechnology and pharmaceutical industries. Dr. Hayat is managing partner of Revive Pharm USA. Henry earned his B.S. http://www.conversis.com/, To learn more , please visit our website - For over 30 years, we have been the leading global clinical trial supply company and we have expanded our service portfolio to offer complete solutions around clinical trials for our partners. Since 1996, ARA has supported 700+ clinical trials worldwide across all therapeutic areas. Clinical Trials Outsourcing Global Market Report 2022: Rising Best practices for managing CRO governance for small/start-up companies with limited resources or large companies with competing priorities, Driving success in either unexplored settings or in saturated market settings, Maintaining Chain of Identity/Chain of Custody, Evolving Technologies & Regulatory Guidance documents, Roel of Project Management in helping to drive and streamline cross functional communication, Key considerations for communicating timelines and milestones, Maintaining focus on Quality centric culture, Using machine learning to increase efficiency, Leveraging interoperability to streamline operations. To learn more , please visit our website - Novotech is an Australia based clinical CRO operating across Asia and South Africa. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, To learn more , please visit our website - https://www.medidata.com/. Versiti Clinical Trials Services support biopharma and cell therapy companies through central laboratory, logistics, biomaterials provision, and IRB services. 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. Events | 4G Clinical The elluminate Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. Michaels background spans contract and proposal development; contract negotiations in multiple languages; set up and management of vendor oversight and governance programs; and related change management. 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. Aug 16 International Conference on Clinical Trials in Cardiovascular Medicine (ICCTCM) - Barcelona, Spain. It offers its clients a global reach through a network of 38 processing laboratories. 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. She has managed and overseen large global clinical trials in various therapeutic areas and multiple phases of development. Are you planning to attend the upcoming Outsourcing in Clinical Trials New England, November 9-10th, 2021? Outsourcing in Clinical Trials Europe 2023. Taking place in Boston, 17 - 19 October 2022. He is a member of DIA, ARVO and CDISC. To learn more , please visit our website - Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry. Login; Register now; Toggle navigation. To learn more , please visit our website - Outsourcing in Clinical Trials (OCT): Medical Devices Europe 2022 Arena International are delighted to announce Outsourcing in Clinical Trials West Coast will be returning to Burlingame for the annual event on March 1st & 2nd 2023! Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. Mr. Larwood is the third of his family to be involved in Valley Fever. We are a certified Minority Business and always do the right thing. Brandi has participated in numerous regulatory inspections as the Management representative, authored HHEs for all levels of products and issues and prides herself on being a patient advocate. 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. Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem. 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). Prior to working at Genentech, she graduated from the Johns Hopkins Bloomberg School of Public Health with a Master of Bioethics. He is an advisor to several biotech companies. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals. The two day programme will take a holistic approach to the latest challenges and innovations in clinical operations, such as, the [] To learn more , please visit our website - https://www.threadresearch.com/. August 29-31, 2016 Atlanta, USA. 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. View Event. Chris deep knowledge of the global early phase drug development industry strengthens the tradition of success of Nucleus Network, our customers and partners in Advancing Medicines, Improving Lives. GENENTECH CASE STUDY LGTBQ+ Health Inequities & SOGI collection Why collecting this data is important in your study, Uncovering how Deconstructed Patient Navigation can enhance patient support. To learn more , please visit our website - LinkedIn Bio: https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/, Enhancing a responsible quality mindset and culture. OCT Europe 2022 | SGS - SGSCorp 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. www.versiticlinicaltrials.org, Viedoc designs engaging software for the life science industry. https://www.nucleusnetwork.com/au/, To learn more , please visit our website - Practiced Neuro-Oncology and General Neurology at the VA and Boston Medical Center. www.gobio.com/clinical-research/. 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. NikZ shows promise against other important fungal diseases. 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. Her experiences in academia, biotech, and CROs confirm that meeting the needs of all stakeholders payers, regulators, patients, families, and sites is a critical success factor for efficient development programs. mediantechnologies.com, Medocity is a leading digital health technology company that has been serving the pharmaceutical and life sciences industry for almost a decade. This conference intends to focus on the global health and clinical trials around the world. The elluminate Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. News and Events - Ergomed PLC Gordon Chu is the Director of Investigations Branch at the Food and Drug Administration (FDA) Division of West Coast Imports (DWCI) within the Office of Enforcement and Import Operations (OEIO). Our innovative model brings a global network of sites, decentralized trials, Sites On Demand, Virtual PIs, and Mobile Sites to previously-unreachable patient populations to expand the impact of clinical research. Meghan started her career as a Masters level psychologist working within a medical care team treating patients with ALS and traumatic brain injury. 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. Per the FDA, Decentralized Clinical Trials (DCT) hold promise to reduce patient and sponsor burden and increase accrual and retention of a more diverse trial population, Designing clinical trials with technology in mind can empower and power studies. 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.
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