Program

1st Day

8:30 am to 9:30 am
WELCOME

BMBF
Federal Ministry of Education and Research| State Secretary

Axel Pries & Christopher Baum
Charité – Universitätsmedizin Berlin| Dean & BIH| Chairman

Orla Smith & Georg Duda
Science Translational Medicine | Editor & BIH Center for Regenerative Therapies | Deputy Speaker

9:00 am
PANEL: STREERING vs. FREEDOM of TRANSLATION – lessons learned

Moderator: Georg Duda | BIH Center for Regenerative Therapies
What are experiences with gate keeping in translational research hubs? If de-risking is the strategy, what risks are we ready to take from bench to bedside? How is the culture of project selection? How do I end the project of my boss? Experiences from large translational-science oriented institutions

How to gate translational progress? 
Angelika Fretzen | Wyss Institute Harvard 
How to measure impact of science?
Robert Guldberg | Phil and Penny Knight Campus for Accelerating Scientific Impact, U Oregon
Building a Culture that Promotes and Accelerates Translation
Louise Jones | Medical Research Council, GB
How Can Translational Research be Empowered?
Hildegard Buening | MHH

10:30
COFFEE BREAK

11:00
SESSION: DATA SCIENCE AND STEWARDSHIP

Moderator: Caitlin Czajka | Science Translational Medicine 
Massive collection of personalized data by wearables (Project Baseline). Who is vetting quality of data collected en masse? Veracity of collected human data from telemetric sensing could be a big problem. What technologies are available for managing vast datasets in the cloud? How will this be useful and traceable? Difference between medical coding and data for medical mining: using data for unintended purpose. Commercial or government use; role of regulation/law. Cry out for registries as ultimate solution vs. how can we predict outcome from historical data in a fast-evolving scientific setting

Jennifer Goldsack | Digital Medicine Society (DiME)
Data Governance and Privacy in the Age of Digital Medicine
Christoph von Kalle | BIH Berlin
How to boost translation by data sciences – cancer as a role model?
Christine Manta | Elektra Labs
Digital Medicine, Biomarkers, Diagnostics, and Therpaeutics
Eric Dishman | NIH
All of Us Research Program – accelerating precision health

12:30 pm
LUNCH BREAK / Poster Session

1:45 pm
How to judge translational progress and performance

Moderator: Orla Smith | Science Translational Medicine 
Need for new metrics: not just counting impact factors or patents. National funding schemes (Germany uses impact factor for €€) use performance-oriented budgeting based on papers. Max Planck – content/quality, not quantity. How to judge translational progress? How much competition between basic vs translational science is helpful? How much rote discovery/serendipity “blue-sky” open basic research can we afford? How much risk do we take in translational-oriented research? How do we rank and track translational research efforts? How do we ensure high quality in international endeavors of translational sciences? Are Translational Readiness Levels a solution (TRL EARTO doc)? What benchmark expectations are set prior to funding approval or intermediate reporting? 

Hans-Dieter Volk | BIH-CRT, Charité
Translational Readiness Levels – a feasible strategy to judge on progress? 
Hans-Gustaf Ljunggren | Karolinska Institutet 
The value of creating well-organized biobanks for translational research: The Karolinska Covid-19 case
Jeffrey Bluestone | UCSF School of Medicine 
Challenges of Ranking progress in Translational Academic Research

3:15 pm
GUIDED TOUR FUTURIUM

Umbau des Forums für Break Out-Sessions

4:00 pm OFFEE BREAK & PARALLEL BREAKOUT SESSIONS
15 MIN INTRODUCTION BY SESSION CHAIR

In these breakout sessions, participants are broken up into smaller groups for the purpose of discussing specific topics. This session is particularly important in developing, in detail, action items for high-priority areas of translational medicine. The focus lies on synthesizing new ideas and presenting a consensus on Day 2 from the group on how to move forward in three distinct areas.

1. The culture of translation/diverse valleys of death
What can we learn from many different global systems? National cultures of translation grown from within each country based on customs?
Chair: NN | NN Co-Chair: Mohamed Abou EL-Enein | BIH Center for Regenerative Therapies 

2. Role of Data Integrety in Translation
There is a commercial belief that academic research cannot be reproduced (Bayer study, DG’s Verily Google talk). Need independent validation of academic research but who does it?  Who pays)
Chair: Ronenn Roubenoff | Novartis Institutes for Biomedical Research Co-Chair: Ulrich Dirnagl | BIH & Charité - Universitätsmedizin Berlin 

3. Measures of translation on the bench test – what works, what does not?
Chair: Glenn Prestwich | University of Utah Co-Chair: Petra Reinke | BIH Center for Regenerative Therapies

6:00 pm
POSTER and APPERO

(with vote for best poster/poster pitches)

7:30 pm
DINNER WITH SHORT TALKS, POSTER AWARDS

RADx - unexpected opportunity under unexpected circumstances with unexpected consequences Bruce Tromberg | National Institute of Health

9:00 pm
END OF FIRST DAY

2nd Day

8:45 am
WAKE UP & SUMMARY OF FIRST DAY

David Grainger | University of Utah

9:00 am
SESSION: REGULATORY SCIENCES FOR NOVEL THERAPIES – FROM CELLS, DEVICES AND APPS

Moderator: David Grainger | University of Utah
Approval agencies seem to react to new regulations rather than shaping them. Globalization of regulation vs country specific. FDA is trying to stay up to date via regulatory science. Industry: J&J, Stryker Europe. How is regulatory science engaged in the process engaged…funding on regulatory sciences

Setsuko Hashimoto | Cellseed Tokyo
Accelerating Translational Research in Advanced Technologies
Andrew Carr | Oxford University
New Approaches to Value-Driven Device Developments
Stefan Schreck | Head of DG SANTE C11 European Commission, Brussels
From creating new knowledge to its application: A new approach at EU leve
Caroline Paunov | Organization for Economic Co-operation and Development (OECD), France
Inclusive Innovation in the Digital Age and University-Industry Collaboration in Innovation

10:30 am
COFFEE BREAK

11:00 am
PANEL: SUMMARIES OF BREAKOUT SESSIONS

Moderator: David Grainger | University of Utah

1. The culture of translation/diverse valleys of death
NN | NN

2. Role of Data Reproducibility in Translation
Ronenn Roubenoff | Novartis Institutes for Biomedical Research

3. Measures of translation on the bench test – what works, what does not?
Glenn Prestwich | University of Utah

12:00 pm
POSTERS: WINNERS PITCH THEIR STORIES

12:30 pm
LUNCH BREAK

2:00 pm
PANEL DISCUSSION HOSTED BY DFG: TRANSLATIONAL HUBS – INFRASTRUCTURES TO BOOST TRANSLATION

Moderator: Jörg Schulz | RWTH Aachen & DFG SGKF
Academic structures to boost translation – complementing but also steering the bottom up; Translational oriented institutes that can act independent from their academic university backbone (e.g. Zuckerberg/Stanford) vs. strategic measures within institution (e.g. Mayo); How much entrepreneurial habit is possible in an academic setting?

Podium discussion with potential speakers:
Susanne Herold | Uni Giessen
Andre Terzic | Mayo Clinic
Stephen Kern | Gates Foundation
Wolfgang Wick | Uni Heidelberg

3:30 pm
SESSION: ACCELERATED TRANSLATION IN TIMES OF GLOBAL CRISES

Moderator: NN | NN
Both EMA/PEI as well as FDA have recently developed fast track approval processes. First lessons learned from the side of the authorities as well as from companies and researchers who went through this. What can we take from such examples for general strategies in translation?

Zami Abermann | Pluristem Inc., Haifa
A stem cell based product for COVID-19 treatment
Peter Marks | FDA
Accelerated approval processes in times of COVID-19 from a US perspective
Katja Brose  | Chan Zuckerberg Initiative
Translational efforts in time of global challenges
Klaus Cichutek | PEI
Regulatory support of translational medicine: Covid-19 vaccine development and other examples

5:00 pm
CLOSING REMARKS

Orla Smith | Science Translational Medicine
Georg Duda | BIH Center for Regenerative Therapies (BCRT)