
Program
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25 Jan 2021 | 1st Day
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Welcome
5:00 pm
GEORG DUDA | BERLIN INSTITUTE OF HEALTH (BIH) | CHARITÉ – UNIVERSITÄTSMEDIZIN BERLIN
ORLA SMITH | SCIENCE TRANSLATIONAL MEDICINE -
Opening Statements
5:05 pm
AXEL RADLACH PRIES | DEAN, CHARITÉ – UNIVERSITÄTSMEDIZIN BERLIN
CHRISTOPHER BAUM | CEO, BERLIN INSTITUTE OF HEALTH (BIH) -
Steering vs. Freedom of Translation – Lessons Learned
5:10 pm
MODERATOR GEORG DUDA | BERLIN INSTITUTE OF HEALTH (BIH) | CHARITÉ – UNIVERSITÄTSMEDIZIN BERLIN
Co-MODERATOR: C. CZAJKA | SCIENCE TRANSLATIONAL MEDICINEAre 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
Louise Jones | Medical Research Council
Assessing Translational Progress within Peer Review Processes
Hildegard Büning | Hannover Medical School (MHH)
How can Translational Research be Empowered? -
Data Science and Stewardship
6:00 pm
MODERATOR: CAITLIN CZAJKA | SCIENCE TRANSLATIONAL MEDICINE
Co-MODERATOR: G. DUDA | BERLIN INSTITUTE OF HEALTH (BIH) | CHARITÉ – UNIVERSITÄTSMEDIZIN BERLIN
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.
Jennifer Goldsack | Digital Medicine Society (DiME)
Data Governance and Privacy in the Age of Digital Medicine
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
Andrew Morris | The University of Edinburgh
Maintaining the Integrity of a Trustworthy Health Data Ecosystem -
How to Judge Translational Progress and Performance
6:55 pm
MODERATOR: ORLA SMITH | SCIENCE TRANSLATIONAL MEDICINE
Co-MODERATOR: J. SCHULZ | RWTH AACHEN
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-Dieter Volk | Berlin Institute of Health (BIH) | Charité – Universitätsmedizin Berlin
Translational Readiness Levels – a Feasible Strategy To Judge on Progress?
Hans-Gustaf Ljunggren | Karolinska Institute
The Value of Creating Well-Organized Biobanks for Translational Research: The Karolinska COVID-19 Case
Jeffrey Bluestone | The University of California, San Francisco (UCSF)
Challenges of Rewarding Entrepreneurship in Translational Academic Research -
Measuring Translation – What Works, What Does Not?
7:50 – 8:10 pm
Report on Consensus Process I
Measuring Translation – What Works, What Does Not?Contribute to a conference consensus statement to guidance on metrics that better inform translational progress and rank success.
Glenn Prestwich | Washington State University
Hans-Dieter Volk | Berlin Institute of Health (BIH) | Charité – Universitätsmedizin BerlinBrenna Rauw | 12Bridge LLC, Portland
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The Role of Data Reproducibility in Translation
8:10 – 8:30 pm
Report on Consensus Process II
The Role of Data Reproducibility in TranslationContribute to a conference consensus statement on improving biomedical data stewardship, veracity, validation and confidence, and how this might be enforced to improve translational efficiency.
Ronenn Roubenoff | Novartis Institutes for Biomedical Research
Ulrich Dirnagl | Berlin Institute of Health (BIH) | Charité – Universitätsmedizin Berlin
Petra Reinke | Berlin Institute of Health (BIH) | Charité – Universitätsmedizin Berlin -
Digital Labs: A Unique Translation Engine for Digital Health in Research Hospitals
8:35 pm
KLAUS NITSCHKE | BERLIN INSTITUTE OF HEALTH (BIH)
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Challenge@Translate
8:50 pm
GEORG DUDA | BERLIN INSTITUTE OF HEALTH (BIH) | CHARITÉ – UNIVERSITÄTSMEDIZIN BERLIN
26 Jan 2021 | 2nd Day
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Warm up & Summary of First Day
5:00 pm
DAVID GRAINGER | UNIVERSITY OF UTAH
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RADx – Unexpected Opportunity Under Unexpected Circumstances With Unexpected Consequences
5:05 – 5:40 pm
BRUCE J. TROMBERG | NATIONAL INSTITUTE OF HEALTH (NIH) -
Regulatory Sciences for Novel Therapies – From Cells, Devices and Apps
5:40 pm
MODERATOR: DAVID GRAINGER | UNIVERSITY OF UTAH
Co-MODERATOR: O. SMITH | SCIENCE TRANSLATIONAL MEDICINE
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 | University of Oxford
New Approaches to Value-Driven Device Developments
Stefan Schreck | DG SANTE C European Commission
From Creating New Knowledge To Its Application: A New Approach at EU Level
Caroline Paunov | Organization for Economic Co-Operation and Development (OECD)
Inclusive Innovation in the Digital Age and University-Industry Collaboration in Innovation -
Translational Hubs – Infrastructures to Boost Translation
6:30 pm
MODERATOR: JÖRG SCHULZ | RWTH AACHEN
Co-MODERATOR: HD. VOLK | BERLIN INSTITUTE OF HEALTH (BIH) | CHARITÉ – UNIVERSITÄTSMEDIZIN BERLIN
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?
Susanne Herold | University Hospital of Gießen and Marburg (UKGM)Translation in Times of COVID-19 – and Beyond
Andre Terzic | Mayo Clinic
Practice-Centric Translation Strategy
Stephen Kern | Bill and Melinda Gates Foundation
Essential Characteristics for Effective Translational Research
Wolfgang Wick | Heidelberg University Hospital
Neurooncology – Translating Novel Concepts Into Clinical Application -
Accelerated Translation in Times of Global Crises
7:25 pm
MODERATOR: HANS-DIETER VOLK | BERLIN INSTITUTE OF HEALTH (BIH) | CHARITÉ – UNIVERSITÄTSMEDIZIN BERLIN
Co-MODERATOR: G. DUDA | BERLIN INSTITUTE OF HEALTH (BIH) | CHARITÉ – UNIVERSITÄTSMEDIZIN BERLIN
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 Product Development and Approval
Katja Brose | Chan Zuckerberg Initiative
A Basic Science Perspective on Translational Challenges in Times of Global Challenges
Klaus Cichutek | Paul-Ehrlich-Institute (PEI)
Accelerated Approval Process in Times of Crises -
Measuring Translation – What Works, What Does Not?
8:15 pm
Discussion on Consensus Paper Draft IRefine the conference consensus statement for guidance on metrics that better inform translational progress and rank success.
Glenn Prestwich | Washington State University
Hans-Dieter Volk | Berlin Institute of Health (BIH) | Charité – Universitätsmedizin BerlinBrenna Rauw | 12Bridge LLC, Portland
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The Role of Data Reproducibility in Translation
8:35 pm
Discussion on Consensus Paper Draft IIRefine the conference consensus statement on improving biomedical data stewardship, veracity, validation and confidence, and how this might be enforced to improve translational efficiency.
Ronenn Roubenoff | Novartis Institutes for Biomedical Research
Ulrich Dirnagl | Berlin Institute of Health (BIH) | Charité – Universitätsmedizin Berlin
Petra Reinke | Berlin Institute of Health (BIH) | Charité – Universitätsmedizin Berlin -
Closing Remarks and Announcement of Winning
8:55 pm
PitchCAITLIN CZAJKA | SCIENCE TRANSLATIONAL MEDICINE
GEORG DUDA | BERLIN INSTITUTE OF HEALTH (BIH) | CHARITÉ – UNIVERSITÄTSMEDIZIN BERLIN
