PharmaTalkRadio

In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Johnson & Johnson's Dr Martine Lewi discusses the evolution of their use of Real-World Data in their clinical programs. Including:

What is the state of the art in real-world data and how is patient data being used today?Innovation initiatives at J&JAccelerating the drug development cycle

Speaker: Martine Lewi, PhD, MBA, Janssen Clinical Innovation, Scientific Director, Johnson & Johnson

The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.

In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Sanofi's Laura Kling discusses developing a digital endpoint for Parkinson's Disease using wearables. 

Speaker: Laura Kling, Director, Digital Innovation, Sanofi

The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.

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 presented at the 9th annual DPharm: Disruptive Innovations conference, Merck's Mark Travers presents a cornerstone discussion on Balancing Innovation with Solid Common Sense to Deliver Innovative Medicines.

Merck is walking the walk in disrupting how to restore best practices for people, products, and productivity. With a clear vision on output, their remarkable team mapped a plan to an enterprise to change operational delivery. In this R&D Leadership session hear the story on how they are delivering what they promise:

How to plan upfront once and do it properlyGetting the basics right and what do you need to disrupt to get thereSignificant changes on greatly improving monitoringThe use of iPad technology to monetize CRA visitsHow monitoring reports got reduced from 8 to 2Building a stable workforce with strong employee engagementBehavior, structure, systems and toolsScaling it

Speaker: 

Mark Travers, PhD, MBA, VP, Head of GCTO Regions, Monitoring Excellence, Global Operations, Merck & Co.

 

The 10th Annual DPharm: Disruptive Innovations conference is scheduled for September 22-23, 2020. Learn more here.

This podcast presents a panel discussion from the 2019 Mobile in Clinical Trials conference on what we are striving for and measurements of success in virtual trials. Discussion points include:

How is it getting our of pilotville?What is the barrier to adoption?Factors that impact success: Risks and Patient Preferences

Moderator:

Adama Ibrahim, EMBA, Associate Director, Performance Operational Capabilities, Global Clinical Operations, Biogen

Panelists:

Christopher Ceppi, Chief Product Officer, Science 37

Jamileh Jamison, MD, Head of Clinical Development, HealthMode

Hassan Kadhim, Director, Clinical Trial Business Capabilities, GCO, BMS

Casey Orvin, President, Society for Clinical Research Sites (SCRS)

John Reites, Chief Product Officer, THREAD Research

 

The 2020 Mobile in Clinical Trials event will take place on September 21. Learn more here.

This podcast presents a session from the 2019 Mobile in Clinical Trials conference on Escaping Pilotville: How to Scale Mobile/Digital Deployment in Clinical Trials. Discussion points include:

What KPIs are used to evaluate success/failure of a pilot?What are the barriers to scale, even when a pilot is a success?What are the operational models used by innovation teams to support deployment?Which models are working?Are study teams equipped to take on deployment efforts?What resources must be made available?How to position for scaleHow can industry remove the fear and transition from addition to the replacement of traditional efforts?Show good evidence of what works at scaleWhat should this include?

Moderator:

Michelle Shogren, Director of Innovation, Pharma R&D Clinical Operations, Bayer

Panelists:

Arthur Combs, MD, FCCP, FCCM, CMO, MC10

Ken Thoelke, EVP, Chief Scientific Officer, PRA Health Sciences

 

The 2020 Mobile in Clinical Trials event will take place on September 21. Learn more here.

This podcast presents a session from Merck on Mobilizing Mobile Efforts and Engineering for Scale at the 2019 Mobile in Clinical Trials conference. 

Mobile tool/device implementation has been widely accepted, tested, and piloted in clinical research. With the bar set, Merck looks to challenge it and create an ecosystem that continues to set the bar higher with a scalable model. In this session, Kai Bode walks the audience through their approach to coordinating and prioritizing digital efforts, building a  prototype to test devices, mobilizing their mobile devices, mobile patient screenings, finding a workaround to perceived barriers and/or premature acceptance of timelines/processes and lessons learned.

Speaker: Kai Bode, Director, Digital and Analytics Technologies, Merck

The 2020 Mobile in Clinical Trials Conference will take place on September 21. Learn more here.

This podcast presents a panel discussion on What a Successful Digital Trial Looks Like from the 2019 Mobile in Clinical Trials conference. Including:

What is a digital trial?Is a common definition needed in order to scale for success?What does success look like? Fully remote, data sharing, device/tool implementation?How do we measure success? And when?What about

accessibility?patient/investigator experience?tool/device effectiveness?data quality and usability?did digital help answer the necessary clinical question?did it ensure representative patients in the study?

Moderator:

Craig Lipset, Former Head of Clinical Innovation, Pfizer

Panelists:

Jennifer Goldsack, MBA, Executive Director, Digital Medicine Society (DiMe)

Jacob LaPorte, PhD, Co-founder & VP, Global Head of Novartis Biome, Novartis

 

The 2020 Mobile in Clinical Trials event will take place on September 21. Learn more here.

In the third episode of our series highlighting rare diseases, Conference Forum reporter Danny McCarthy sits down with Fernando Albertorio, PhD, to discuss Hermansky-Pudlak Syndrome. 

Dr Albertorio is co-founder of Sunu, Inc, which creates wearable, IoT and mobile technology that empowers independence for people who a blind and visually impaired. Dr Albertorio is also an advocate for increasing awareness and treatments for managing Hermansky-Pudlak Syndrome (HPS). 

HPS is an extremely rare autosomal recessive disorder, characterized by albinism, visual impairment, and a platelet dysfunction that results in prolonged bleeding. There are currently 10 known types of HPS. 

In the episode, Dr Albertorio mentions several websites for more information: HPSNetwork.org, GlobalGenes.org and Sunu.com.

The COVID-19 pandemic has meant that, more and more, clinical trials are being disrupted or interrupted completely. Without the continuous momentum and contact, trials will lose patients as gaps in studies lengthen. 

To combat that, Be the Partner designed “Bridge,” a new solution on their Patient Portal specifically for continuing secure, ongoing connectivity with trial patients during any temporary pauses in trials as a result of COVID-19. The end goal of “Bridge” is to maintain patient engagement throughout the trial’s indefinite pause and aid in a successful relaunch at the appropriate time.

For more information go to or contact www.bethepartner.com.