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Prior to her current role, she was a Director of Global Regulatory Policy at Merck, advocating for incentives to spur antibiotic Khyati leads regulatory policy advocacy efforts for the U. She joined AbbVie in and has over 25 years of regulatory experience. Khyati has also provided regulatory advice to the biopharmaceutical industry on product She started her career in the pharmaceutical industry and joined EMA in She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product This sessions aims to provide a broad and comprehensive picture in order to draw a comprehensive picture of the activities within our mandates.

Learning Objectives Describe the health system in Canada and the place of the regulator within that system; Discuss the most current regulatory innovations. Agnes V. Klein trained in Endocrinology at UofT and has interests in multiple aspects of drug development and medical bioethics. Klein is As part of this discussion, panelists will also consider how digital health policies are shifting and where additional work could be done to facilitate innovation. Join us for an interactive discussion among a diverse set of stakeholders. Fox Foundation for Parkinson's Research.

Learning Objectives Discuss how artificial intelligence has matured over time. He has more than 10 years of experience in Regulatory Affairs. Prior to joining Bayer, Patrick led international science and regulatory She has extensive experience conducting research on biopharmaceutical industry practices and trends affecting contract research organizations and investigative Dave Meyers is National Director - US Life Sciences at Microsoft; focused on strategy, business development, and the solutions portfolio in pharma, genomics and precision medicine.

He joined Microsoft in - held various technical, program management, and product development positions This forum will discuss the regulatory aspects and experience with regenerative medicine. Learning Objectives Discuss regulations governing implementation or use of specific medical technology, examination, laboratory testing and medical devices; Describe the management of regenerative pharmaceutical products; Describe the experience of reviewing regenerative medicine affairs.


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From to , he was the head of Bureau of Medical Affaires that oversees the health care system and leads the health care reform including the programs addressing Since joining in the regulatory science field in , Dr. Tang has been involved in various projects. She is an experienced medical reviewer in evaluating market Now she is in charge of the overall policies. Under Dr. He has a broad international experience working across various cultures and geographies leading Prior to joining Olivia has extensive multi-disciplinary program management and policy experience in the biopharmaceutical and biodefense industries, ranging from pre-clinical Discover the latest data visualization use cases for safety and how dynamic data exploration yields meaningful data review, better patient outcomes and trial efficiency.

Learning Objectives Discuss various data visualization examples that can be applied to the area of clinical trial safety analysis; Outline key benefits and efficiencies statisticians, medical monitors, and others in charge of safety can achieve through data visualizations that are being used in this area of clinical trials today. Prior to joining eClinical Solutions she held leadership roles in biostatistics He is co-chairing the ASA safety working group, and is a deputy topics-leader Component Type: Workshop Level: Basic This session will focus on strategies to create a more memorable presentation, one that draws in the audience and holds its attention.

We will explore the use of steamlined slides, images, and storytelling as well as specific presenting techniques to grab and hold the attention of an audience. Attendees will leave with plans for how to approach their next presentation. Learning Objectives Discuss how to create more impactful presentations; Explain how to present with confidence and flair; Identify how to engage and inform audiences.

Chair Robin Whitsell. Founder and president of Whitsell Innovations, Inc. Prior to founding WI, Ms. Whitsell was the assistant director of preclinical Current thinking in more closely involving patients throughout the medicines lifecycle will be presented and audience feedback sought. Learning Objectives Discuss the latest developments in patient involvement and engagement in the medicinal product lifecycle from development to post-marketing, pharmacovigilance and risk management; Describe current progress of the CIOMS XI WG in terms of involving patients and patient groups or associations more closely with medicines addressing medical needs.

Marc M. He has been a leading voice for greater patient involvement at every stage of the health care continuum. Boutin has been actively involved in patient advocacy organization management, health advocacy I am now the National Development Manager responsible for overseeing the Family Support Service and I work closely with our medical teams in Birmingham, UK to support the highly specialised Herve is Professor of Pharmacology. He is an hepatologist by training and has a PhD in Pharmacogenetics.

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She oversees the Divisions of Pharmacovigilance 1 and This systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future. Learning Objectives Identify evidence-based techniques for better defining causal factors in system failure; Recognize that those techniques which can be used now; Appraise how we should best develop these concepts, identify best practice and engage all stakeholders; Discuss how to volunteer to join the team aiming to improve the safety of the system for clinical research.

Nichola has worked at a strategic level in a variety of healthcare settings spanning primary and secondary care. Her roles have included professional nurse leadership and mentoring of nursing teams, mobilisation of new services including service and workforce redesign, and training He is a Clinical Pharmacologist with education and experience in chemical engineering Outsourcing services to emerging regions continue to grow especially in the realm of risk based monitoring, data management, clinical trial management and site management.

On the scientific arena, innovative research activities in countries like Korea, China, and Singapore to name a few have developed biomedical, biotech and clinical research infra structures with the ultimate goal of attracting big pharma to partner with them to co-develop their discoveries. However, capability, capacity, credibility and overall quality remain to be sticking points.

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In this session, current trends, issues, challenges and opportunities will be discussed by experts who work in these emerging regions. Their hope is that by sharing experiences and information the global pharma and biotech industry would have better understanding of the huge opportunities and untapped potential these emerging regions can provide. Learning Objectives Discuss the current environment of clinical research in emerging regions; Identify strategic advantages in conducting clinical trials in emerging regions; Identify solutions to challenges in conducting clinical research activities and trial management in these emerging regions.

Prior to that, he worked with two successful startups and is a Founding Board member at iKure, a healthcare startup. He is passionate about Global Professor Asita de Silva has held many positions in academic medicine over the last 25 years.

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He is also Director of the Clinical Trials Learning Objectives Describe using data analytics, machine learning, and precision medicine, how to distinguish, analyze, and reclassify disease based on subgroups; Identify the best prognosis for patients using these tools; Describe how to better predict disease progression and pinpoint individual treatments.

His passion lies in challenging the status quo, mobilizing teams to harness technology and championing change. Since , Dwight has helped lead a precision medicine Learning Objectives Describe FDA's activities to promote patient voice in outcome measurement; Describe FDA resources to support the science of patient input in medical product development. The Patient Science and Engagement Program fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies.

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Under her leadership, CDRH is making Robyn T. In this role, Robyn is responsible for the development of innovative strategies to evaluate meaningful outcomes to patients and consumers She joined FDA to implement the use of Bayesian statistics for the regulation of medical devices and led the Decision Analysis initiative including Bayesian statistics, benefit-risk determinations, and New methods of data collection and usage also bring new challenges.

This forum will model the journey of data in a virtual trial, identify key challenges, and offer solutions for sponsors and CROs. Learning Objectives Recognize data collection and usage challenges at all stages of virtual trials; Design successful data practices in a virtual trial. Popat is the OND lead on biomedical informatics issues in areas such as staff training on the use of new review tools to make the evaluation of pre-marketing data Isaac R. He is a biomedical leader with expertise in Virology, Microbiology, Immunology, Vaccinology, and Oncology.

Past positions in the last 20 years In this new environment, pharmaceutical companies are evaluating different channels for communicating information to their customers.

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This session will explore delivery different channels pharmaceutical companies are using and present case studies on new methods that companies are using to share information with healthcare professionals.. Learning Objectives Identify and evaluate the different channels of medical information delivery currently used in the pharmaceutical industry, including cost effectiveness, usage, healthcare professional preference, and future delivery channels; Discuss specific case studies of pharmaceutical companies successfully implementing new communication channels with healthcare professionals.

As Director of Operations, David supports global medical information for pharmaceutical, biotechnology and medical device clients. He has a background in pharmacy, with a Doctorate of During his studies, Walter Frank worked as a consultant in the specialty pharmacy industry, helped to establish Learning Objectives Identify useful guidelines and regulations regarding special populations in various countries; Discuss useful models of patient engagement that focus on special populations; Discuss case studies that show how some clinical trials have attracted special groups of patients.


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  • Chair Deborah E. Deborah Collyar has applied a wealth of leadership skills from her successful IT business career to help create patient-centered medical research and healthcare, after her first cancer diagnosis at the age of She is responsible for the development and implementation of a peer education program in which prospective lupus clinical trial patients are matched with a trained In her role she is responsible for building relationships with industry that help amplify the voice of the clinical research site.

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    She has been integrally This forum explores reasons for low adoption from the viewpoints of scientists, drug developers and regulators and explores solutions. Learning Objectives Describe the value of precision medicine trials PMCT as an innovative approach to drug development; Identify the regulatory, scientific, operational and technical challenges and barriers to the execution of these trials. Edward Abrahams, Ph. Representing innovators, scientists, patients, providers and payers, PMC promotes the understanding and adoption of personalized medicine concepts, services and products for the benefit of patients and After receiving her Ph.

    He is actively involved in cancer genomic research, using circulating tumor DNA, for lung and gastrointestinal cancers. His primary area of interest Anita has more than 20 years of experience in the pharmaceutical industry and 29 years of experience in pharmacogenetic, human and molecular genetics research in roles including bench scientist, manager, and business leader.

    This forum will discuss successful and less successful strategies for integration across various healthcare organizations. Learning Objectives Describe the different components that lead to the successful integration of acquired assets or companies; Compare and contrast different strategies for strategic integration and discuss best practices from a business development, project and portfolio management perspective to promote streamlined integration of an asset or company.

    In this role, she engages throughout all phases of business development and licensing activities to lead and manage the execution of strategic She specializes in the management of large-scale, complex collaborative projects in Discovery and Early Development. Prior to her transition to Project Management, she In addition to accountability for the ID TA, she manages a team focused on Discovery collaborations which leverages her experience managing complex cross functional drug development Learning Objectives Demonstrate how periodic screenings are an important part of inspection readiness; Discuss where hidden challenges lurk and how mock inspections can bring these items to light; Identify appropriate remediation plans that are organizationally focused and not study specific.

    She is active in industry participating in forums such as the Society Barbara Maley Sr. Consultant, The Avoca Group. Barb Maley is a Quality Assurance professional with 29 years of research experience including 26 years within the pharmaceutical industry GLP and GCP and 17 years hands-on experience within Quality Assurance and Continuous Improvement. Barb has extensive experience providing quality Other responsibilities include inspection support as well as the QA therapeutic lead for Her current role includes providing GCP strategic direction for Immuno-oncology programs at AstraZeneca including providing quality and compliance advice during study conduct, submission Analyze how existing regulatory frameworks apply to the emerging field of digital health technologies including case examples, and discuss issues to be addressed to promote advancement of digital DDTs.

    Learning Objectives Describe the EMA, industry, and consortium views on digital drug development tools DDTs ; Discuss the growing value of digital health tools as part of the drug development process including key learnings from sponsor experience; Evaluate case example s in the development of digital DDTs. His work has focused on the development of functional measures using scalable research-grade tools and consumer devices in a Zahra Hanaizi joined EMA in as Product Team Leader, managing centralised medicinal products initial marketing authorisation applications, maintenance and life-cycle activities, mostly in the therapeutic area of Oncology.


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    • Since , she has been working on the creation, implementation In her time at Biogen she launched a widely used Food and Drug Administration and the pharmaceutical Su has over 25 years of experience in drug regulatory and development. He had worked in the Chinese regulatory agency Wendy Yan is Senior Vice President, Global Head of Regulatory Affairs, for BeiGene, a commercial-stage biotechnology company focused innovative molecularly-targeted and immuno-oncology drugs for treatment of cancer.

      She has more than two decades of regulatory affairs experience, having The session will be delivered by members of ICMRA and conclude with a panel discussion of questions raised by the audience. Jefferys, MD. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was Ms Nolan joined the HPRA in and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances.

      Prior to assuming He is a physician who practiced as a paediatrician prior to working in the pharmaceutical industry in clinical research and development. Future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization and industry efforts.

      This session will present an overview of the landscape for innovative modalities and emerging technologies in the field of human therapeutics, and the regulatory CMC challenges associated with their product development and approval. Learning Objectives Discuss the landscape for innovative modalities and emerging technologies in the field of human therapeutics; Describe the regulatory CMC challenges associated with their product development and approval.

      Chair Nina S. Puri, MD, PhD. Nina S. Christopher Love is the Raymond A. Love received his Ph. His research centers on Raj K.