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This podcast presents a session on planning for and addressing missing data form the 2019 Mobile in Clinical Trials conference. When a protocol dictates a set period of time for data collection, what happens when there's a gap in the data due to technical glitches or human error? What are the regulatory and operational implications? Discussion points include: How to prepare for missing dataHow do we handle missing data?How to rewrite protocols so that you avoid the trapForewarning and communicating with regulatorsRegulatory advice on how to address missing data Moderator: Jennifer Goldsack, MBA, Executive Director, Digital Medicine Society (DiMe) Panelists: Ariel Dowling, PhD, Associate Director of Digital Clinical Devices, Data Sciences Institute, Takeda Pharmaceuticals Marie McCarthy, MBA, Senior Director of Product Innovation, Information Technology, ICON plc Carrie Northcott, PhD, Project Team Lead, Early Clinical Development, Digital Medicine, Pfizer Shyamal Patel, PhD, Director of Data Science, Digital Medicine & Translational Imaging, Pfizer The 2020 Mobile in Clinical Trials event will take place on September 21. Learn more here.

In this podcast, first recorded at the 2nd annual Drug Delivery West conference, Dr James Cunningham, Allergan leads a panel on exploring other routes of administration for ophthalmology. Discussion points include: Barries/challenges associated with drug delivery to the back of the eyeProlonging delivery & reducing frequency of administrationAlternative/less invasive routes of administration for delivery to the back of the eyeDelivery for emerging modalitiesImpact of delivery system design choices on development/scalabilityHow to effectively assess novel delivery approaches Panelists include: Dr James E Chastain, Novartis Institutes for BioMedical Research, IncDr Susan Crowell, GenentechDr Viral Kansara, Clearside Bio To learn more about the 3rd annual Drug Delivery West conference happening May 17-18, 2021 in San Francisco, CA please visit www.drugdeliverywest.org

This 5 minute podcast summary helps prepare listeners on what they can expect at the4th Annual Patients as Partners Europe event, taking place January 27th and 28th in London. The venue is the Millennium Gloucester Hotel. In a nutshell, Patient as Partners is the first conference in Europe dedicated to understanding how working with patients can drive greater clinical trial efficiencies throughout the entire medicines development process. It is ultimately about how to reduce risk in the development of hugely, costly clinical trials through working with patients. It is a wonderful opportunity for pharma and biotech and patient disease advocacy groups to come together and learn from each other. The 2020 Summit is chaired by Claire Nolan, of Charities Research Involvement Group, GSK’s Andrew Garvey and Parexel’s Rosamund Round. Our patient keynote guest is Lesley Gosden. Lesley is a Parkinson’s patient and advocate who participated in the GDNF clinical trial, which was featured on the BBC. For more information, visit the conferenceforum.org.

In this podcast from the 2018 Mobile in Clinical Trials conference, Dr Paul Glimcher, Julius Silver Professor of Neural Science and Physiology at NYU alongside Dr Daniel Karlin, CEO at Healthmode presented on the future of mobile data in clinical trials. Drs Glimcher and Karlin discussed this rapidly evolving space with an emphasis on the barriers and opportunities in the mobile health arena. More specifically: • What are the Barriers to gathering an incorporating Mobile data into clinical trials? • What are the most important new datatypes that are evolving in the Mobile Health space? • How can we use Real World Measurements to identify new classes of clinically relevant endpoints to go beyond Billing Codes? • Can we expect to see large-scale Mobile databases for synthetic use on the model of EMRs and ICD codes? • How should we think of these new classes of data, are they just novel bioindicators or something else? Dr Karlin is returning to Mobile 2019 as co-chair. Speakers: Paul Glimcher, PhD, Julius Silver Professor of Neural Science and Physiology, NYU Daniel Karlin, MD, CEO, Healthmode

About This Episode: What is the future of drug delivery for patients, and how do we get there? In this episode, Dr Shawn Davis, who leads the Drug Delivery team of the Biopharmaceuticals Development organization at AstraZeneca, lays out a bold vision discussing how the future of drug delivery is patients interacting less with their disease, and what steps we can take to make that future a reality. Key Takeaways: How companies can de-risk drug delivery innovationsHow the current moment in drug delivery is shaping our long-term visionBalancing the competitive landscape, portfolio and patient needs About the Speaker: Shawn Davis, PhD is an Executive Director at AstraZeneca and leads the Drug Delivery team of the Biopharmaceuticals Development organization. The team improves patients’ lives by ensuring AZ’s therapies are as safe, effective, and convenient as possible using technologies that target the delivery of medicines to the site of action and optimizing their effective half-life. This requires the evaluation, development, and commercialization of drug delivery technologies across a wide range of modalities in the biopharmaceutical space. Areas of program delivery include: intracellular delivery of nucleic acids, controlled release of antibodies for less frequent dosing, novel routes of administration for therapeutic benefit, and co-delivery of multiple therapeutic molecules. Dr Davis also serves as the CMC leader for early stage assets in the portfolio. For more information about drug delivery, click here.