Review

Published on 12 Jun 2017

Advancing Public Health Using Regulatory Science to Enhance Development and Regulation of Medical Products: Food and Drug Administration Research at the Center for Biologics Evaluation and Research

in Regulatory Science

Marc Kusinitz
Emily Braunstein
Carolyn A. Wilson

Frontiers in Medicine

doi 10.3389/fmed.2017.00071

4,936 views
5 citations

Review

Published on 29 May 2017

Adaptation through Collaboration: Developing Novel Platforms to Advance the Delivery of Advanced Therapies to Patients

in Regulatory Science

Magdalini Papadaki

Frontiers in Medicine

doi 10.3389/fmed.2017.00056

6,456 views
13 citations

Original Research

Published on 16 May 2017

Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe

in Regulatory Science

Andreas M. Farkas
Segundo Mariz
Violeta Stoyanova-Beninska
Patrick Celis
Spiros Vamvakas
Kristina Larsson
Bruno Sepodes

Frontiers in Medicine

doi 10.3389/fmed.2017.00053

9,117 views
23 citations

Review

Published on 20 Jan 2017

Public–Private Partnerships in Cloud-Computing Services in the Context of Genomic Research

in Regulatory Science

Palmira Granados Moreno
Yann Joly
Bartha Maria Knoppers

Frontiers in Medicine

doi 10.3389/fmed.2017.00003

8,560 views
18 citations

Mini Review

Published on 19 Jan 2017

The European Lead Factory: A Blueprint for Public–Private Partnerships in Early Drug Discovery

in Regulatory Science

Anna Karawajczyk
Kristina M. Orrling
Jon S. B. de Vlieger
Ton Rijnders
Dimitrios Tzalis

Frontiers in Medicine

doi 10.3389/fmed.2016.00075

5,949 views
28 citations

Perspective

Published on 14 Nov 2016

Challenges for Relative Effectiveness Assessment and Early Access of Cancer Immunotherapies in Europe

in Regulatory Science

Mira Pavlovic

Frontiers in Medicine

doi 10.3389/fmed.2016.00056

3,016 views
3 citations

Review

Published on 14 Oct 2016

Prediction of the Carcinogenic Potential of Human Pharmaceuticals Using Repeated Dose Toxicity Data and Their Pharmacological Properties

in Regulatory Science

Jan Willem van der Laan
Wenny H. W. Buitenhuis
Laura Wagenaar
Ans E. M. F. Soffers
Eugene P. van Someren
Cyrille A. M. Krul
Ruud A. Woutersen

Frontiers in Medicine

doi 10.3389/fmed.2016.00045

6,731 views
20 citations

Technology Report

Published on 12 Oct 2016

Distributed Cognition and Process Management Enabling Individualized Translational Research: The NIH Undiagnosed Diseases Program Experience

in Regulatory Science

Amanda E. Links
David Draper
Elizabeth Lee
Jessica Guzman
Zaheer Valivullah
Valerie Maduro
Vlad Lebedev
Maxim Didenko
Garrick Tomlin
Michael Brudno

Frontiers in Medicine

doi 10.3389/fmed.2016.00039

3,525 views
2 citations

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Articles

Advancing Public Health Using Regulatory Science to Enhance Development and Regulation of Medical Products: Food and Drug Administration Research at the Center for Biologics Evaluation and Research

Adaptation through Collaboration: Developing Novel Platforms to Advance the Delivery of Advanced Therapies to Patients

Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe

Public–Private Partnerships in Cloud-Computing Services in the Context of Genomic Research

The European Lead Factory: A Blueprint for Public–Private Partnerships in Early Drug Discovery

Challenges for Relative Effectiveness Assessment and Early Access of Cancer Immunotherapies in Europe

Prediction of the Carcinogenic Potential of Human Pharmaceuticals Using Repeated Dose Toxicity Data and Their Pharmacological Properties

Distributed Cognition and Process Management Enabling Individualized Translational Research: The NIH Undiagnosed Diseases Program Experience