Science Exchange

CERSI Exchange Award Conferences 2012 - 2017

* Notes attendance including online participants.

October 27, 2017
Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design and Endpoints
Event Info & Registration
Dr. James Polli ** **
May 15-17,2017
Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development
Final Report
Dr. James Polli 250 281 (3 days)
April 17, 2017
MAMNA 2017 Symposium-Small Sensors Going Big Places
Final Report (.pdf)
Dr. Didier Depireux 80 72
March 7, 2017
Medical Device Innovation in Maryland
Final Report  | Program (.pdf)
Dr. William Bentley 135 118
January 27, 2017
America's Got Regulatory Science Talent Competition
Final Report
Dr. James Polli 25 25
December 5, 2016
Protein Aggregation Measurement in Biotherapeutics: Established and Emerging Techniques
Final Report (.pdf)
Dr. Bruce Yu
Dr. Ewa Marszal
130 94
September 23, 2016
Pediatric Master Protocols
Final Report (.pdf)
Dr. Jill Morgan
Dr. Gil Burckart
276 499*
June 8 & 9, 2016
Formulation Science and Strategy to Facilitate Development of Pediatric Drug Products
Final Agenda (.pdf)
Dr. James Polli
Dr. Jian Wang
85 75
June 1, 2016
Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics
Final Report (.pdf)
Dr. Lily Mulugeta 800 702
March 25, 2016
Material Advantage: Pioneering Devices Enabled by Material Breakthroughs
Final Report (.pdf)
Dr. Didier Depireux 75 71
March 24, 2016
Building the National Evaluation System for Medical Devices: Using Real-World Evidence to Improve Device Safety and Effectiveness
Final Report (.pdf)
Dr. Fadia Shaya
Dr. Gregory Pappas
213 153
February 5, 2016
"Americas Got Regulatory Scient Talent Competition"
Final Report (.pdf)
Dr. William Bentley
Dr. James Polli
29 29
September 11, 2015
Exploring Mobile and Social Media Informatics for Regulatory Decision-making: Methods, Opportunities and Challenges
Final Report (.pdf)
Dr. Ritu Agarwal 118 84
August 21, 2015
Evidentiary Consideration for Integration of Biomarkers in Drug Development, Co-sponsored with Critical Path Institute (C-Path)
Final Report (.pdf)
Dr. Shashi Amur
Dr. Ruth Barratt
Dr. Jia Bei Wang
521 329
June 5, 2015
Mass Spectrometry Imagery Analysis System for Medical Applications
Final Report (.pdf)
Dr. David Kilgour
Dr. Michael Boyne
54 37
May 4, 2015
Using Big Data to Inform Drug Safety and DER: Novel Solutions to Reduce Confounding in Administrative Databases 
Final Report (.pdf)
Dr. Fadia Shaya
Judy Staffar
Simone Pinheiro
Dr. Efe Eworuke
162 263
April 6, 2015
Low Budget/High Payoff: Techniques and Resources for Innovative Micro/Nano Research Johns Hopkins
Final Report (.pdf)
Dr. Didier Depiereux 78 69
March 9, 2015
Patient Focused Drug Development
Final Report (.pdf)
Dr. Eleanor Perfetto
Elisabeth Oehrlein
Theresa Mullin
Ashley Slagle
Pujita Vaidya
Dr. Sara Eggers
228 162
January 30, 2015
“America Got Regulatory Science Talent” competition
Dr. James Polli 24 23
January 22, 2015
Pediatric Drug Development: How can Exposure Matching and Exposure-Response be Utilized to Improve Pediatric Study Programs?
Final Report (.pdf)
Dr. Jill Morgan
Dr. Lily Mulgeta
Robert Nelson
Kevin Krudys
Jian Wang
218 437
December 13-16, 2014
2014 TERMIS-Americas (TERMIS-AM) Conference & Exhibitions: TERMIS-AM Industry Committee One-Day event with the FDA
Dr. John P. Fisher 900 850
December 2, 2014
The Role of Standards and Regulatory Science in the Characterization of Biopharmaceuticals
Final Report (.pdf)
Dr. Marueen Kane
Dr. David Goodlett
Dr. Michael Boyne
Ann Gray Waters
50 45
June 20, 2014
Top Down Analysis of Antibodies
Final Report (.pdf)
Dr.Young Ah Goo
Dr. David Goodlett
80 64
May 21, 2014
Standards for Phantoms for Optical Medical Imaging
Final Report (.pdf)
Dr. Yu Chen 69 58
May 12, 2014
Questioning the Bioequivalence Standards for Antiepileptic Drugs: Implications for Regulations of Narrow Therapeutic Index Drugs
Final Report (.pdf)
Dr. Tricia Ting 76 82
May 5, 2014
Innovative Approaches to Pediatric Drug Development and Pediatric Medical Counter Measures: A Role for Physiologically-Based PK?
Final Report (.pdf)
Dr. Thomas Dowling
Dr. Jian Wang
Dr. Gilbert Burckart
98 245
April 8, 2014
MALDI Mass Spectrometry Imaging of Drug Metabolism
Final Report (.pdf)
Dr. Maureen Kane 61 53
March 6 & 7, 2014
AIMBE/NIH Workshop on Validation and Qualification of New in Vitro Tools and Models for the Pre-clinical Drug discovery Process
Final Report (.pdf)
Dr. William Bentley 300 250
March 10, 2014
Regulatory Aspects of Micro/Nanosystems Technologies Applied Away from the Central Lab
Final Report (.pdf)
Dr. Ian White 95 73
February 11, 2014
Leveraging Big Data II-What does it Mean for Improving Product Development and Health Care? 
Final Report (.pdf)
Dr. Eleanor Perfetto 95 80
January 30, 2014
“America Got Regulatory Science Talent” competition UMB
Final Report (.pdf)
Dr. James Polli 25 23
September 12, 2013
Leveraging Big Data in Support of Outcomes Research: A Community Focus on the Potential for Medicine
Final Report (.pdf)
Dr. Eliot Siegel 45 32
September 5, 2013
CERSI Day Year 2
Final Agenda (.pdf)
Dr. William Bentley
Dr. James Polli
182 85
September 3, 2013
Regulatory Issues in Personalized Medicine and Pharmacogenomics
Final Report (.pdf)
Dr. Alan Shuldiner 106 81
August 26, 2013
Human Reliability Analysis Applied to Medical Device Use-Related Hazards
Final Report (.pdf)
Dr. Monifa Vaughn-Cooke 35 15
May 23, 2013
Control Strategies for Pharmaceutical Manufacturing: Real Time Release Testing (RTRT) and Design Space Determination
Final Report (.pdf)
Dr. Stephen Hoag 65 51
May 21, 2013
Topical Bioequivalence and Bioavailability Summit
Final Report (.pdf)
Dr. Audra Stinchomb 64 50
May 8, 2013
Workshop on Improved Characterization of Mesenchymal Stem Cell for Clinical Trials
Final Report (.pdf)
Dr. Curt Civin
Dr. Steven Bauer
121 115
April 15, 2013
Degree and Educational Programs in Regulatory Science or Regulatory Affairs
Final Report (.pdf)
Dr. Dr. Keith Herold
Dr. James Polli
49 35
March 14 & 15, 2013
AIMBE/NIH Workshop on Validation and Qualification of New In Vitro Tools and Models for The Pre-clinical Drug Discovery
Final Report (.pdf)
Dr. William Bentley   170
December 17, 2013
CERSI Scientific Exchange Meeting
Dr. William Bentley
Dr. James Polli
50 40
September 2012
CERSI Day Year 1
Final Agenda (.pdf)
Dr. William Bentley
Dr. James Polli
173 145

Total Attendees: 5103