The Technology track will seeKimberley Ferguson(Commercial Head of Personalized Healthcare Partnerships, Genentech) discussing all thingsWearables. Register. Erin has over 20 years of clinical trial and pharmaceutical software technology experience . Meghan joined a CNS-focused start up in RTP and has spent the last 15+ years working in the life science technology industry. 1333 Bayshore Highway, Burlingame, To learn more , please visit our website - http://kpslife.com/. Additionally, Funwie collaborates with colleagues to co-create educational resources as a part of the core team of the Advancing Inclusive Research Site Alliance, which focuses on addressing disparities in clinical research. From 2 to 4 November 2020. 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. This presentation will discuss: With increasing site staff/physician burnout and sites taking on less projects, we are still feeling the ripple effect of this on trials. https://www.advancedclinical.com/. Francis is an expert in clinical system regulatory compliance with over 20 years pharma experience spanning R&D, manufacturing and clinical research. To learn more , please visit our website - RT1 Conducting a study when there is minimal education, Hang Nguyen, Sr. Director, Clinical Affairs, Materna Medical, RT2 Navigating the complex spiderweb of multiple vendor relationships, Sarah Mullen, Vice President of Clinical, HeartFlow, RT3 Training Strategies for a Novel Therapeutic Medical Device, Ann Louise Armstrong, Senior Manager of Clinical Affairs and Field Operations, Ancora Heart, - How the process started and steps taken, - Assessment of eligibility and submission, - Lessons learnt - how it helped and what we did, what we companies can learn and do better, Discussion focusing on Real World Data; an overview of opportunities and challenges in working with RWD/RWE, Ted Chun, Director, Global Clinical Shared Services, Stryker Neurovascular, RT2- Navigating the complex spiderweb of multiple vendor relationships, RT3- Training Strategies for a Novel Therapeutic Medical Device, Ann Louise Armstrong, RN, MSN, CCRC, CCRA, Senior Manager of Clinical Affairs and Field Operations, Ancora Heart. Our Provider Edition offers a CRO costing module and bid benchmarking. A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. The 15th Annual Outsourcing in Clinical Trials New England event will bring together clinical trial professionals from big and small biopharma to uncover new technologies and processes, to optimize their clinical and outsourcing operations. A visual cognitive neuroscientist by training, Dr. Anderson has over a decade of experience developing both hardware and software to evaluate behavioral and neural mechanisms of attention, working memory, and visual perception. Extensive Outsourcing and Contracts experience in the area of Clinical Development primarily at small to mid-size biotech organizations. To learn more , please visit our website - How best to go about educating the patient community? Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget Join us for a two day event filled with case studies, panel discussion and face to face networking opportunities around clinical operations, technology and innovation, and data management. Through Inspire you will access a unique blend of data longitudinally across patients health journey to draw insights that accelerate medical progress and improve healthcare. https://www.nucleusnetwork.com/au/, To learn more , please visit our website - 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. Login; Register now; Toggle navigation. Ms. OBrien has been conducting clinical research for more than 35 years and has covered multiple functions during that time. Aug 16 International Conference on Clinical Trials in Cardiovascular Medicine (ICCTCM) - Barcelona, Spain. Dr. Cunningham came from academic background. Join us in Philadelphia, May 10th-11th, to shape best practice on: Refining patient recruitment strategy. Featuring solutions for automated referrals, eConsent, patient engagement, connected devices, eCOA, and eSource, ClinOne makes participating in a clinical trial a little easier, every day. ProTrials Research, Inc., is a full-service clinical research organization (CRO) and woman-owned business headquartered in San Jose, CA, with clinical operations personnel located throughout North America and across the world. Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. . By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. 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. How applying behavioral science insights can better inform the way we do patient engagement. He also served on multiple FDA Headquarter working group and committee related to Food Safety Modernization Act (FSMA), import process improvement, strategic framework, rapid screening technology, and partnership agreements. Exploring the idea of adopting a medical device-like regulatory philosophy/strategy for bringing drugs forwards, with a focus on antimicrobials, Industry is on high alert for bacterial outbreak, with parallels to the covid pandemic. Dan Solisfrom TheFDAwill give the closing keynote. Partnerships in Clinical Trials Europe 2020. Anju Software is a customer-first organization providing adaptable life science solutions for clinical research, medical affairs, and data science. 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. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. Aug 09 International Conference on Drug Development, Clinical Trial Phases and Technology (ICDDCTPT) - Lagos, Nigeria. Dr. Cunningham came from academic background. Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck. Formed through the merger of IMS Health and Quintiles, IQVIA has more than 58,000 employees worldwide. She leads the scientific development of digital clinical measures and the modernization of clinical development models under the banner Technology As Methodology. With this expertise, global scale and the broadest endpoint technology platform, Clario will continue to lead the way in clinical trial technology that will transform patients lives. OMDRHO is one of five programs in the Office of Medical Products Operations within FDAs Office of Regulatory Affairs. 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. http://www.peachtreebrs.com. Also within Genentech, she is a core member of the Advancing Inclusive Research Site Alliance and leads the company's LGBTQ+ Health equity strategies. 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. . 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. At Pro-ficiency, Dave has transformed clinical research training into a powerful study resource and analytics tool, and Pro-ficiency has become the leader in the proactive, metric-driven approach to training that contradicts the traditional, check-it-off-the-list approach. Dr. Hsu is anesthesiologist and pain management physician, but also a serial entrepreneur. 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. Consulting Dermatologist, Clinical Development & Medical Affairs RAPT Therapeutics, Inc. 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. Triomics is a technology company offering an enterprise-grade platform for clinical trial sites to automate data collection practices. In this position, she focuses on initiatives for employee development or training and topics to advance health literacy for underserved communities as it relates to clinical trial access. 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. Our platform allows site staff to pull data from various sources such as EHR and legacy systems automatically into their eCRFs (Fully agnostic) hence helping significantly reduce the double-data entry efforts (demographics, labs, vitals, adverse events, allergies, medications) and time spent with CRAs during monitoring visits. pril 28-29, 2016 Dubai, UAE. Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry. His drive to improve healthcare is based on passion, compassion and hope. https://www.anjusoftware.com/, To learn more , please visit our website - TrialMaster, IRMS MAX, and TA Scan, the companys flagship products, lead the way in reducing complexities in the drug and device discovery and commercialization process. Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster. Previously, he has led and worked on data science teams across different functions at Janssen Pharmaceuticals, Johnson & Johnson Medical Device Companies and Roche Pharmaceuticals. To learn more , please visit our website - Altasciences helping sponsors get better drugs to the people who need them, faster. A healthy discussion on different disciplines in pre . 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. API Services & Chemical Development. November 28-30, 2016 San Antonio, USA. To learn more , please visit our website - Pharmapack is the European event focal point for the pharma packaging and drug delivery device industry. eurofinscentrallaboratory.com/biopharma-services. 8 th Pharmaceutics and Novel Drug Delivery Systems Conference. 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! Dr. Parapiteva is an experienced regulatory professional with over 24 years in the pharmaceutical industry/clinical research organizations. Moving to law, in leading law firms he advised major companies on patent matters. Kris OBrien is an Executive Director in Program Strategy, specializing in Rare Disease and Pediatrics, at Premier Research. Partnerships in Clinical Trials Europe 2021. Outsourcing Clinical Trials New England 2022. Tactical clinical operations in digital health studies, First-hand learnings, breakthrough device system, a case study. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. At Trilogy, medical writing is our passion. To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com. Prior to working at Genentech, she graduated from the Johns Hopkins Bloomberg School of Public Health with a Master of Bioethics. 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. The DPO Centre isEuropes leading life science experts, providing Data Protection Officer (DPO) and Data Protection Representative (DPR) services. Before joining Curebase, Wayne served as Vice President at mid-sized Florida based CRO Biorasi, where he helped to lead that company to a successful acquisition by a private equity partner in 2018. www.allucent.com. Estela has worked in healthcare for over 30 years, currently supporting private practices with electronic medical records, office workflows to help the practice and patients for a top leading healthcare organization. Clincierge reduces barriers to trial participation by employing patient-centric strategies to enhance the patient experience, increase patient retention, and improve clinical trial performance. Vial is a next-generation CRO that leverages the nationwide Vial site network to ensure faster, higher-quality trial outcomes for sponsors. To learn more , please visit our website - Wed, 25 May 2022, 18:00 WebSite. Session Reserved for Worldwide Clinical Trials, Data Management: Programming and metrics in medical device studies, Vast experience of over 20 years in Quality, Regulatory, Processes Improvements and leading cross organization projects, VP Quality Assurance, Regulatory Affairs and Clinical at IceCure Medical, since September 2020, leading the company compliance and clinical affairs, Prior to joining IceCure Medical, held a position of Director of Quality, Regulatory and Customer Support at Applied Spectral Imaging (ASI) and Several positions at Carestream Health (formerly Orex Computed Radiography). Outsourcing in Clinical Trials Europe 2023. Meghan started her career as a Masters level psychologist working within a medical care team treating patients with ALS and traumatic brain injury. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. Esther Marfo, is a Project Leader within the Health Equity and Population Sciences department at Genentech. To learn more , please visit our website - http://www.iconplc.com/. Clinical ink is the global life science company that brings data, technology, and patient science together. Study sponsors and contract research organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. Held annually in Paris and online, this event unites 5,000 attendees and 360 exhibitors centered around innovation, networking, and education. She has executed a variety of clinical trials involving therapeutic areas including autologous breast reconstruction, heart failure, hypertension, arrhythmia management and erectile dysfunction. http://www.datacubed.com/. We have access to a population of over 10.5 million people across all 3 sites, and the ability to offer a multi-site solution in recruiting participants and patients to our clients. THREAD is a leading provider of a proprietary, decentralized research platform and suite of supporting services used by biopharma, CROs and life science organizations to remotely capture data from participants and sites during, in-between and in lieu of in-clinic visits. The Digital Transformation of Clinical Trials the Importance of Data Accuracy. www.advanceresearch.com. He is a member of DIA, ARVO and CDISC. To learn more , please visit our website - Many biopharmaceutical trial sponsors rely on or scientific leaders to help design and optimize their protocols and statistical analysis plans. To learn more , please visit our website - The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. ClinOne, a leader in virtual clinical trial management, provides a single platform technology experience to accelerate clinical trial enrollment and remote patient care, compliance and retention. 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. 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. Advance Research Associates is a premier provider of biostatistical and data management services to the pharmaceutical, biotech, and medical device industries. He has worked for CROs as well as small and large biotechnology companies. Rho, a contract research organization (CRO) located in Chapel Hill, NC, provides a full range of services across the entire drug development process. Discuss a pathway to extend biotech cash burn runway while still meeting Phase I objectives and meeting investor expectations! We are a certified Minority Business and always do the right thing.