Vlad Ratziu and Mazen Noureddin join the Surfers to explore some of the key lessons learned and issues uncovered in 2020. Vlad Ratziu provides a 10-minute overview of a fast-paced year of successes (and occasional failures) in clinical trials and novel diagnostics. Mazen Noureddin discusses the expanding role of non-invasive liver tests in diagnosis, patient treatment and monitoring and drug development. Stephen Harrison updates our knowledge about the use of clinical endpoints in obtaining conditional drug approvals. Finally, Roger Green places the entire year in a systems context with an eye toward the Law of Unintended Consequences and why the obeticholic acid Complete Response Letter was not the death knell many observers feared.
listen to each segment…
New Podcast Series Surfing the NASH Tsunami
Hep Dynamics LLC announces the launch of a new podcast series. “Surfing the NASH Tsunami”, focused on challenges, solutions and news in NASH drug development.
Ep. 1 COVID CHAOS
Navigating NAFLD/NASH clinical trials through the pandemic
Ep. 2 FIVE $IMPLE PIECES
What investors want to know about NASH development during the pandemic.
Ep. 3 C-SUITE COVID-19 CHALLENGES
Critical considerations for companies developing NASH drugs
Ep. 4 WHEN YOU GET TO A FORK IN THE ROAD
Three possible scenarios for development of the NASH market.
Ep. 5 WILD TIMES IN NASH-VILLE: PART 1
Clinical trial results that are changing how we look at NASH
Ep. 6 “WHAT’S IN A NAME?”
Exploring the controversy over the name(s) to use when describing Fatty Liver disease(s)
Ep. 7 WILD TIMES IN NASH-VILLE PART 2
Reviewing press releases reporting preliminary findings from six recently announced Phase 2 trials
Ep. 8 Diagnosing Diagnostics – Part 1
Room for improvement
Ep. 9 International NASH Day is here!
SurfingNASH celebrates a growing and increasingly important global event for the Fatty Liver community.
Ep. 10 Diagnosing diagnostics II – tools vs. teaching
What would create greater value for patients and providers?
Ep. 11 Crystal ball tells us the most important story of the summer
CONSENSUS: the big story will be the regrowth of COVID-19 in the US and its implications
Ep. 12 What does “No” mean to FDA?
Decoding the message of Intercept’s Complete Response Letter
Ep. 13 Diagnosing diagnostics 3
FOCUS: Three sets of tools that will improve NASH disease understanding
Ep. 14 Respect for the liver
NASH is not merely a byproduct of obesity.
Ep. 15 – Previewing EASL: Part 1
FOCUS: Some of the presentations that will make NASH/NAFLD news next month
Ep 16 – Nurses Helping NASH Patients
How passionate providers (nurses, dieticians, and physicians) can motivate patient lifestyle changes.
Ep. 17 – Previewing EASL: Part 2
FOCUS: More of the presentations that will make NASH/NAFLD news at the Digital International Liver Congress later this month
Ep. 18 – What Do Patients Want from the Healthcare System?
Patient advocates discuss how doctors and other providers can serve patient needs better
Ep. 19 – What NASH patients want from outside the healthcare system
Patient advocates envision future digital technologies that can provide tremendous benefit to them and how government agencies provide support for better disease knowledge and care
Ep. 20 – How will Digital ILC be different from past conferences
The group discusses the plusses and minuses of digital conferences compared to traditional in-person events.
Digital ILC Day One Highlights: Much to Think About – Ep 21
Day One into EASL Digital ILC 2020
Digital ILC Day Two Highlights: A Fork in the Road – Ep 22
Day Two into EASL Digital ILC 2020. Drugs in development and diagnostics show promise but healthcare has far to go in identifying and treating patients in need.
Digital ILC Day Three Highlights: Late breakers, COVID and more – Ep 23
Day Three into EASL Digital ILC 2020
Episode 24 – EASL Digital ILC 2020 Wrap-Up: A Complicated Picture Emerges
Professors Joern Shcattenberg and Vlad Ratziu join the Surfers to discuss the lessons and findings we can take away from Digital ILC 2020
What Exactly Are We Trying To Achieve In Early-Stage NASH Therapy? Ep 25
The Surfers and guest Joern Schattenberg consider the implications of a Digital ILC presentation stating that the liver, not cardiovascular disease, is the leading cause of death for NAFLD patients.
“Beyond the Biopsy”— How NASH Therapy Will Improve When Non-Invasive Tests Become The Standard – Ep 26
The Surfers discuss the Global Liver Institute’s campaign to educate and motivate key stakeholder groups on the value of non-invasive liver testing.
Crystal Ball Tells Us The Most Important Stories Of Autumn – Ep 27
The Surfers discuss four issues that are likely to affect how our thinking about NASH diagnosis, education, and treatment might evolve over the next three months.
Episode 28 – Wild Times in NASH-Ville Part 3: Better Days ARE Ahead!
Stephen Harrison leads the Surfers through a review of FGF-21s and other exciting drug development news
Episode 29 – COVID-19 and The Liver… “It’s Complicated”
Matt Kelly, Chief Innovation Officer at Perspectum, Ltd., joins the Surfers to the discuss early findings from the COVERSCAN study which looks at the relationship between COVID-19 infection and major end organ systems.
Ep 30 – Six Months In: How COVID-19 Has Changed Our World!
On the six-month anniversary of SurfingNASH’s first episode, the Surfers stop to consider how much has changed for NASH stakeholders since April
Episode 31 – How Have The Events of 2020 Affected Patient Treatment In The Clinic?
Guest Surfer and regular listener Dr. Ian Rowe joins the Surfers to discuss how everyday patient treatment in the clinic once was and how COVID-19 and the news we discuss weekly on SurfingNASH have changed practice.
Episode 32 – Previewing The Digital Liver Meeting (TLMDx from AASLD): Part One
Louise Campbell, Donna Cryer and Naim Alkhouri identify pivotally important presentations and posters from The Digital Liver Meeting 2020
Episode 33 – Previewing The Digital Liver Meeting (TLMDx from AASLD): Part Two
Stephen Harrison, Roger Green and our guest Surfer, Dr. Manal Abdelmalek, identify pivotally important presentations and posters from The Digital Liver Meeting 2020
Episode 34: Why NASH Drug Trials Fail: A Thoughtful, Challenging Theory
Prof. Dr. Jörn M. Schattenberg joins the Surfers to discuss his recent article in Expert Opinion on Investigational Drugs dissecting recent drug trial failures.
Ep 35 – Saturday at TLMdX 2020 from AASLD: Lean NASH, exciting Diagnostics and Patient-Reported Outcomes as an Endpoint
Manal Abdelmalek joins the Surfers to review some of Saturday’s most exciting presentations and posters from AASLD 2020, followed by a discussion of an exciting new hand-held diagnostic
Ep 36 – Sunday at TLMdX 2020 from AASLD – The Future Looks Bright!
Reviews of Phase 2 drug trials and diagnostic strategies reveal that NASH is close to multiple breakthroughs
Ep 37 – Monday at TLMdX 2020 from AASLD: Getting Better at Diagnostics and Drugs, Not Education
Mary Rinella joins the Surfers for a final day of AASLD 2020 reviewing focusing equally on lessons in drug development and the crying need for social and dietary education, particularly for parents and children.
Episode 38 – The Day After TLMdX 2020: Wrapping Up with The View from Across the Atlantic
Vlad Ratziu and Joern Schattenberg join the Surfers to wrap up our conversation about this year’s AASLD meeting
COVID CHAOS: The 2nd Wave – Ep 39
Guest Ian Rowe and Kris Kowdley join the Surfers to discuss how the 2nd COVID wave and arrival of the vaccine are likely to affect patient treatment and clinical development
Links between NAFLD and Cardiovascular Disease
Dr Ian Rowe and Prof. Dr. Jörn M. Schattenberg joins the Surfers to explore the relationship between NAFLD and CVD in light of recent work questioning the strength of links between the two
Episode 41- Policy 1: The Liver Policy Agenda Has Experienced Surprising Success in the Last Four Years
Donna Cryer and Global Liver Institute Director of Policy Andrew Scott join Stephen, Louise and Roger to discuss the policy progress liver disease and NASH have made in the last four years.
Episode 42 – Policy 2: Credibility, convergence and the 2021 Global Liver Institute Action Plan
Donna Cryer and Global Liver Institute Director of Policy Andrew Scott return to discuss their 2021 US NASH Action Plan, garnering support for the new COVID-19 vaccines and the importance of aligning stakeholders with Stephen, Louise and Roger.
2020 Year-End NASH Review 1: Drugs and Diagnostics
The Surfers and guests Vlad Ratziu and Mazen Noureddin discuss key lessons learned in 2020 about Drugs and Diagnostics
43.1 – 2020 Year in Review: Advances in Fatty Liver Disease Drugs and Diagnostics
Vlad Ratziu discusses a “boiling hot” field of emerging NASH drugs and “particularly rich” data coming from no-invasive diagnostic testing
43.2 2020 Year In Review: Emergence of Non-Invasive Tests and Testing Strategies in Fatty Liver Disease
Mazen Noureddin describes a year in which biopsy’s shortcomings are revealed at the same time as non-invasive testing becomes better and produces more robust data
43.3 2020 Year in Review: Progress in developing clinical endpoints necessary to support drug approvals
Stephen Harrison summarizes a year of progress in improving the tests and analyses used to derive clinical endpoints necessary to initial drug approvals
43.4 2020 Year in Review: The Law of Unintended Consequences Blesses NASH Drug Development
Roger Green discusses why despite widespread concerns, FDA’s Complete Response Letter to Intercept did not cripple progress in NASH drug development.
2020 Year-End NASH Review 2: Patient Treatment and Perspectives
Guests Ian Rowe, Joern Schattenberg and Wayne Eskridge join the Surfers to discuss key lessons learned in 2020 about Patient Treatment and Perspectives
44.1 – 2020 Year in Review with Ian Rowe: Simplifying NASH Diagnostics Saves Money, Improves Satisfaction
Ian Rowe discusses how streamlined use of ELF, FIB-4 and FibroScan improves cost effectiveness and patient satisfaction associated with NASH screening
