Steering vs. Freedom of Translation – Lessons Learned
Are translational research hubs allowed to pursue their translational opportunities freely? What does this control matrix look like? If de-risking occurs, what risks are considered moving from bench to bedside? What is the culture of project prioritization and selection? How are pet projects and politics avoided? Listen to experiences from large translational science oriented institutions.
Angelika Fretzen | Wyss Institute at Harvard University
How to Gate Translational Progress?
Robert Guldberg | University of Oregon
Building a Culture that Promotes and Accelerates Translation
Data Science and Stewardship
Society is now being tapped to provide new real-world data, often in real time. Massive collections of personalized health data by wearables are increasing. But, who vets the quality of data collected en masse? How are such vast datasets collected, curated, and managed in the cloud? How will all of this be verified and protected to be used appropriately and remain traceable? Many published preclinical and clinical studies lack reproducibility and consistency in their messaging. How does the biomedical research enterprise enhance credibility and data veracity in both fundamental and translational forums? Experts will describe the current issues, policies and procedures with stewarding massive medical data sets and better reproducing biomedical studies to improve reliability.
Christof von Kalle | Berlin Institute of Health (BIH) | Charité – Universitätsmedizin Berlin
How To Boost Translation by Data Sciences – Cancer as a Role Model?
Christine Manta | Elektra Labs
Digital Medicine, Biomarkers, Diagnostics, and Therapeutics
How to Judge Translational Progress and Performance
Common metrics used to assess real world translational success include impact factors, publications and patents for academics, and product launch, marketing and publicity for industry. Many national funding incentives use performance leveraged budgeting (e.g., impact factors or publication production based research awards). Synergies between basic and translational science are often advocated as essential, but how much rote discovery/serendipity “blue-sky” fundamental research is proper? How much risk is allocated to translational-oriented research? How are real world translational research efforts ranked and assessed to ensure high quality global translational sciences? Are Translational Readiness Levels a solution? What benchmarks for success are appropriate?
Hans-Gustaf Ljunggren | Karolinska Institute
The Value of Creating Well-Organized Biobanks for Translational Research: The Karolinska COVID-19 Cases
Regulatory Sciences for Novel Therapies – From Cells, Devices and Apps
Regulatory agencies can enforce new regulations in unpredictable ways, creating risks in translation. Globalization of regulatory policy is inconsistent and defaults to country-specific enforcement. Regulatory sciences are now being developed to produce quantitative research specific to regulatory requirements. Other developments (adaptive clinical trial designs, digital twins, Nobel Prizes) are changing translational perspectives and approval opportunities. Experts present models, metrics and experiences for translating biomedical products in different global environments.
Setsuko Hashimoto | CellSeed Inc.
Accelerating Translational Research in Advanced Technologies
Andrew Carr | Oxford University
New Approaches to Value-Driven Device Developments
Translational Hubs – Infrastructures to Boost Translation
Academic cultures and structures are seen to both limit and boost translation – often steering innovation from the bottom up through a labyrinth of barriers inconsistent with translation. New translationally oriented institutes are now acting independently of their academic hosts (e.g. Zuckerberg/Stanford; Gladstones/PICI/UCSF) whereas others are enabled by their institutional directives (e.g. Mayo Clinics, Scripps Institutes). How much entrepreneurial excellence, innovation and translation can be expected in modern academic settings? Can they evolve?
Andre Terzic | Mayo Clinic
Patient-Centric Translation Strategy
Accelerated Translation in Times of Global Crises
Many global regulatory agencies have recently developed fast-track approval processes in response to clinical needs, commercial demands, and researcher inputs. Can this same strategy be further adapted for more general approaches to biomedical translation?
Zami Aberman | Pluristem Therapeutics Inc.
Allogeneic “Living Drugs” Treatments: Translation From Acute (Muscle) Injury and Chronic Ischemia to Treatment of Acute Respiratory Distress Syndrome (ARDS) Resulting From COVID-19.
Peter Marks | U.S. Food and Drug Administration (FDA)
Accelerated Approval Processes in Times of COVID-19 From a US Perspective