|
Date
of Presentation
|
Sponsor
|
Conference
and Presentation Title
|
Presenter(s)
|
| January
28-29, 2008 |
International
Pharamceutical Academy (IPA) |
FDA
Pre-Approval Inspections
"FDA
approval processes and combination device and biologics inspections"
|
John
R. Godshalk, MSE, MBA |
| January
21-23, 2008 |
Institute
for International Research |
5th
Annual Formulation & Forced Degradation
"Implementation
of a flexible yet cGMP complaint Stability Program for Phase
I, II and III Studies"
|
Nanda
Subbaro, Ph.D. |
| December
13 - 14, 2007 |
IBC
China |
US
FDA Biological Approval Process |
Lei
Zhang, MD, Ph.D. |
|
Past
Presentations...
|
| November
12-15, 2007 |
AAPS
(American Association of Pharmaceutical Scientists) |
AAPS
Annual Meeting
“Critical
Stability Evaluation of Biopharmaceuticals During Clinical
Development”
|
David
T. Lin, Ph.D. |
| November
5-7, 2007 |
Informa
Life Sciences
|
Medical
Device Regulations: Essential Training in Present and Pending
Medical Device Regulations
"Introduction
to US FDA Regulations"
|
Stuart
Portnoy, MD
|
| October
23, 2007 |
Second
Annual FDA Inspections Summit |
Getting
it Right the First Time, Every Time
"Combination
and Device Inspections" Godshalk
"Essential
Documents: Auditing Trial Master Files" Anderson
|
John
R. Godshalk, MSE, MBA
Carl
Anderson
|
| October
2 - 3, 2007 |
IVT
Lab Week |
Capturing
the Science of Stability Testing
"Out-of
-Specification Investigations for Stability Samples"
|
Nanda
Subbaro, Ph.D. |
| October
2 - 3, 2007 |
|
2007
International Symposium on Regulation of Human Cell and Tissue-Based
Products
"FDA
Regulations and Practices for Human Cell and Tissue-Based
Therapies/Products"
"Biosafety and Manufacturing Considerations for Clinically
Cell-Based Therapies"
|
Darin
Weber, Ph.D. |
| October
20 - 23, 2007 |
AABB
(American Association of Blood Banks) |
Annual
Meeting & TXPO 2007
“New
Technologies in Cellular Product Testing”
|
Ellen
M. Areman, MS, SBB |
| October
23, 2007 |
Second
Annual FDA Inspections Summit |
Getting
it Right the First Time, Every Time
"Combination
and Device Inspections"
|
John
R. Godshalk, MSE, MBA |
| September
23- 26 , 2007 |
Regulatory
Affairs Professional Society (RAPS) |
Annual
Conference & Exhibition
"Regulatory
Considerations for Starting a Gene Therapy Trial in the US"
(Miller)
"Facility
Design Considerations for Biologics" (Godshalk)
"Addressing
Immunogenicity of Biotechnology-Derived Therapeutic Products:
Preclinical, Clinical and Analytical Considerations"
(Subbarao)
"Quality
Expectations for Product Development CMC Activities: R&D,
GLP or GMP" (Weber)
|
Speakers
Andra
Miller, Ph.D.
John
R. Godshalk, MSE, MBA
Nanda
Subbaro, Ph.D.
Darin
Weber, Ph.D.
|
| September
17 - 21, 2007 |
University
of Wisconsin-Madison |
10th
Annual Land O'Lakes Conference on Drug Metabolism/Applied Pharmacokinetics |
Melanie
Hartsough, Ph.D. |
| August
21 - 24, 2007 |
Cambridge
Healthtech Institute |
Target
Immunotherapeutics and Vaccine Summit
"Selecting
a Study Population"
|
Stephen
Litwin, MD |
| June
27 - 28, 2007 |
Pharmaceutical
Training Institute |
“Design
and Implement Effective Stability Programmes for Biotechnology
Products” |
Nadine
Ritter, Ph.D. |
| June
19 - 20, 2007 |
IVT
Method Validation Conference |
"Test
Method Qualification or Test Method Validation: What is the
Difference?" |
Nadine
Ritter, Ph.D. |
| June
18 - 20, 2007 |
BIO
|
VentureForum
East 2007 |
Wilson
W. Bryan, M.D. |
| June
18-21, 2007 |
Drug
Information Association (DIA) |
43rd
Annual Meeting
“The
Impact of FDA's Quality-by-design Initiative on Biologics
Development”
|
David
T. Lin, Ph.D. |
| June
12 - 13, 2007 |
IBC
Life Sciences Training Academy |
"Best
Practices for Biotechnology Product Comparability and Stability
Studies -
Protocols, Test Methods and Quality Practices" |
Nadine
Ritter, Ph.D. |
| May
30 - Jun 3, 2007 |
ASGT
(American Society of Gene Therapy) |
10th
Annual Meeting |
Maritza
C. McIntyte, Ph.D. |
| May
7 - 9, 2007 |
Pharmaceutical
Education Research Institute (PERI) |
Effective
Planning and Management of Clinical Trials |
Wilson
W. Bryan, M.D. |
| Mar.
23-27, 2007 |
AABB
|
Spring
Cell Therapy Conference
Moderating
session on Novel Cell Therapies
|
Ellen
M. Areman, MS, SBB
John
R. Godshalk, MSE, MBA
(speakers)
|
| Mar.
19 - 22, 2007 |
Terapinn |
World
Vaccine Congress 2007
Agenda
|
Peter
Patriarca, M.D.
(chairman)
Julia
Barrett, M.D., MPH
David
Pepperl, Ph.D.
Nadine
Ritter, Ph.D.
Keith
Wells, Ph.D.
(speakers) |
| Mar.
14 - 17, 2007 |
Mayo
Clinic |
Oncolytic
Virus Conference |
Maritza
C. McIntyte, Ph.D. |
| Mar.
8 - 10, 2007 |
American
Society for Experimental NeuroTherapeutics (ASENT) |
Annual
Meeting |
Wilson
W. Bryan, M.D. |
| Feb.
28 - Mar. 2 |
Cambridge
Healthtech Institute |
2nd
Annual Commercial Implications of Stem Cell Research
Track
6 at Molecular Medicine Tri-Conference; Panel Expert on Regulatory
Issues for Neural Regeneration
|
Darin
Weber, Ph.D. |
| Feb.
12-13, 2007 |
International
Pharmaceutical Academy (IPA) |
Effective
Management of Stability Programs
“Stability
Design Considerations for Global Regulatory Filings”
|
David
T. Lin, Ph.D. |
| Jan
9-10, 2007 |
Cambridge
Healthtech Institute |
PepTalk:
Optimizing Protein and Antibody Therapeutics |
David
T. Lin, Ph.D. |
| Dec.
6-7, 2006 |
PTI
(Pharmaceutical Training Institute |
Stability
Testing for Biotechnology Products |
Nadine
Ritter, Ph.D.
|
| Nov.
6-8, 2006 |
Williamsburg
BioProcessing Foundation |
WilBion
Viral Vectors and Vaccines Meeting
"WilBion
Viral Vectors and Vaccines Meeting"
|
Maritza
C. McIntyte, Ph.D. |
| Oct.
29 - Nov. 2, 2006 |
AAPS
|
2006
AAPS Annual Meeting
“The
Impact of FDA Initiatives on the Development of Biological
Products”
|
David
T. Lin, Ph.D. |
| Oct.
21-22, 2006 |
AABB
|
Annual
Meeting
"Regulation
of Cell Therapy Products for Cardiac Disease"
|
Ellen
M. Areman, MS, SBB |
| Oct.
19-20, 2006 |
SWE
Enterprises |
Stability
Testing for the FDA Regulated Industry
“Cost
Efficient Design of Stability Studies”
“In-Use
Testing of Biotechnological and Biologic Products”
|
David
T. Lin, Ph.D. |
| Oct.
16-17, 2006 |
DIA |
First
International DIA Workshop on “Developing Probiotics
as Foods and Drugs – Scientific and Regulatory Challenges”
“Environmental
Assessment and Impact” and “Product Development
for Probiotics as Biologic Drugs”
|
Ann
Sutton |
| Oct.
15-18, 2006 |
Regulatory
Affairs Professional Society (RAPS) |
Annual
Conference & Exhibition |
Speakers
Ellen
M. Areman, MS, SBB
Bette
A. Goldman, RN, MPH
Stephen
Litwin, MD
Maritza
C. McIntyte, Ph.D. |
| Sept.
2006 |
Institute
for International Research |
Cost
and Contract Management for Clinical Trials.
"Finding
your match: what service provider is right for you?"
|
Bruno
Gagnon. B.Pharm, MSc |
| July
20-21, 2006 |
CaSSS
|
WCBP
CMC Strategy Forum
"Changing
Paradigms in Process Validation"
|
Nadine
Ritter, Ph.D.
|
| June
28-29, 2006 |
IBC
Life Sciences |
IBC
Life Sciences Training Academy 2006
"Best
Practices for Biotechnology Product Comparability and Stability
Studies: Protocols, Test Methods, and Quality Products"
|
Nadine
Ritter, Ph.D.
|
| June
20-23, 2006 |
IVT |
Stability
Testing: Implementing Effective Processes for Stability Program
Development
"Cost
Efficient Design of Stability Studies"
"Stability
Requirements for Global Regulatory Filings"
|
David
Lin, Ph.D.
|
| June
19-21, 2006 |
American
Association of Pharmaceutical Scientists' (AAPS) |
2006
National Biotechnology Conference
"Regulatory
Issues in Developing New Vaccines"
|
Peter
Patriarca, M.D.
|
| June
17-19, 2006 |
IBC
Life Sciences |
IBC
International Analytical Summit: Implementing Process Analytical
Technologies (PAT) for Bioprocessing
"Overcoming
Challenges for the PAT Implementation Team"
|
Nadine
Ritter, Ph.D.
|
| June
11-12, 2006 |
IIR |
Chemistry,
Manufacturing & Control (CMC)
“Clarifying
and Understanding ICH Guidance to Help Meet International
Requirements for Submissions”
|
David
Lin, Ph.D.
|
| June
8-9, 2006 |
CBI
(Center for Business Intelligence) |
Stability
Programs: New Approaches to Test, Analyze and Document Data
for Improved Program Design and Global Compliance
"In
Use Testing of Biotechnological and Biological Products"
|
David
Lin, Ph.D.
|
| May
24-25, 2006 |
IBC
Life Sciences |
IBC
Life Sciences Training Academy 2006
"Best
Practices for Biotechnology Product Comparability and Stability
Studies: Protocols, Test Methods, and Quality Products"
|
Nadine
Ritter, Ph.D.
|
| May
16-18, 2006 |
IVT
(Institute for Validation Technology) |
Annual
Method Validation Conference
"What
is Test Method Qualification"
|
Nadine
Ritter, Ph.D.
|
| May
10-11, 2006 |
PTI
(Pharmaceutical Training Institute |
Stability
Testing for Biotechnology Products |
Nadine
Ritter, Ph.D.
|
| May
4, 2006 |
University
of Maryland, Baltimore County |
Department
of Chemical and Biochemical Engineering Course, ENCH 662 -
Good Manufacturing Practices for Bioprocesses
"Assay
Development and Validation"
|
Nadine
Ritter, Ph.D.
|
| May
1-4, 2006 |
IBC
Life Sciences |
TIDES
2006:
Oligonucleotide and Peptide ® Technology and Product Development
-Practical Considerations for Saving Time and Money while Ensuring
Quality
"Stability
Considerations and Testing for Oligo- and Peptide-Based Therapeutics"
|
David
Lin, Ph.D.
|
| Apr.
26-27, 2006 |
IBC
Life Sciences |
IBC
Life Sciences Training Academy 2006
"Best
Practices for Biotechnology Product Comparability and Stability
Studies: Protocols, Test Methods, and Quality Products"
|
Nadine
Ritter, Ph.D.
|
| Apr.
3-5, 2006 |
PERI
(Pharmaceutical Education and Research Institute ) |
Biologics
Drug Development: An Integrated Overview of Manufacturing,
Nonclinical, Clinical, and Regulatory Requirements
"Key
CMC Biopharmaceutical Product Development Studies"
"Key
CMC Biopharmaceutical Process Development Studies"
"Overview
of Clinical Trial Design"
|
Nadine
Ritter, Ph.D.
Ruth Wolff, Ph.D.
Barbara
G. Matthews, MD, MPH |
| Mar.
21, 2006 |
Carilion
Biotech Association |
|
John
Jessop, MPH, Ph.D.
|
| Mar.
8-9, 2006 |
PTI
(Pharmaceutical Training Institute |
Stability
Testing for Biotechnology Products |
Nadine
Ritter, Ph.D.
|
| Feb.
22, 2006 |
Molecular
Medicine Tri-Conference |
Commercial
Implications of Stem Cell Research
Lost
in Translation? - Addressing Regulatory Concerns While Bridging
from Research to Clinical Applications of Stem Cells
|
Darin
Weber, Ph.D.
|
| Jan.
25, 2006 |
CaSSS
|
WCBP
2006: 10th Symposium on the Interface of Regulatory and Analytical
Sciences For Biotechnology Health Products
Workshop:
Co-Chair: A New Class of “Live” Therapy
|
Darin
Weber, Ph.D. |
| Dec.
8, 2005 |
Harris
Nesbitt |
Harris
Nesbitt Focus on Healthcare 2005
"Stem
Cells Panel Presentation"
|
Darin
Weber, Ph.D. |
| Nov.
14 - 15, 2005 |
IBC |
Symposium
on Well-Characterized Biologicals
"Considerations
for Host Cell Protein Assays from Product Development through
Product Approval"
|
Nadine
Ritter, Ph.D. |
| Nov.
6-10, 2005 |
American
Association of Pharmaceutical Scientists (AAPS) |
2005
AAPS Annual Meeting and Exposition
"Stability
Testing Requirements for Global Product Registrations"
|
David
Lin, Ph.D. |
| Oct.
17 - 20, 2005 |
. |
BioLOGIC
USA 2005
"Clinical
aspects of trial design for biodefense vaccines"
|
Julia
Barrett, M.D., MPH |
| Oct.
16-19, 2005 |
Regulatory
Affairs Professional Society (RAPS) |
Annual
Conference & Exhibition |
Andra
Miller, Ph.D. |
| Oct.
10-11, 2005 |
GTCbio |
Therapeutic
Strategies Against Neurodegenerative Conditions
"The
Regulatory Product Development Process”
|
David
Lin, Ph.D |
| Sept.
29 - 30, 2005 |
Barnett
conference |
Immunogenicity
Testing for Therapeutics
"Issues
and challenges with Preclinical Immunogenicity testing"
|
David
Pepperl, Ph.D. |
| Sept.
26 - 27, 2005 |
Organized
by Pharmaceutical Education Associates |
The
Second Annual Toxicology Study Directors and Monitors Conference
"Regulatory
Compliance of Analytical Methods during Preclinical Development
and GLP Studies"
|
Rajesh
Gupta, Ph.D. |
| Sept.
25-27, 2005 |
Vectech
Pharmaceutical Consultants, Inc. |
4th
RMUG™ Conference |
Robert
G. Darius |
| Sept.
18-23, 2005 |
Liquent |
Horizons
Users Conference
"FDA
Electronic Submissions Gateway"
|
Daniel
Offringa |
| July
27 - 29, 2005 |
IIR
|
2nd
Annual Symposium on Stability Indicating Assays and Forced Degradation
Studies for Proteins |
Nadine
Ritter, Ph.D. |
| July
25 - 27, 2005 |
CaSSS
|
8th
CMC Strategy Forum - Design and Successful Implementation of
a Stability Program for Biotechnology-Derived Products |
Nadine
Ritter, Ph.D. |
| July
13-15, 2005 |
. |
NIAID
Product Development Workshop |
Keith
Wells, Ph.D. |
| June
28, 2005 |
DIA |
DIA
Annual Meeting
"Essential
Tools and Strategies for Overcoming Developmental Challenges
for Cell-based Products "
|
Darin
Weber, Ph.D. |
| June
1, 2005 |
AABB |
AABB
Audioconference Series
Presentation
Topic: Facility Requirements for a Cell Therapy Laboratory
|
Darin
Weber, Ph.D. |
| May
18, 2005 |
Wound
Healing Society |
Wound
Healing Society - 15th Annual Meeting and Exhibition
"Understanding
the FDA's Regulatory Pathway for Regenerative Wound Healing
Products"
|
Darin
Weber, Ph.D. |
| May
6, 2005 |
ISCT |
11th
Annual ISCT Meeting
Presentation
Topic: Ancillary Materials Used in Cell-Based Therapies
|
Darin
Weber, Ph.D. |
| April
25-27, 2005 |
IBC |
IBC's
2nd Annual Early Development of Biotherapeutics Symposium
"Early
In-Process Analytical Methodologies - How Early Should Analytical
Get Involved?"
"Impact
of “Annex 13” on Manufacturing Materials for Clinical
Trials"
|
Nadine
Ritter, Ph.D.
Karin
Sewerin, Ph.D.
|
| April
18 - 20, 2005 |
PERI |
Project
Management in the Research- Based Pharmaceutical Industry
"World-Wide
Regulations: An Overview"
|
Jim
Ackland |
| April
12 - 13, 2005 |
IBC |
IBC
European Conference
"Process
Validation Protocol"
|
Karin
Sewerin, Ph.D. |
| April
11, 2005 |
GTCbio
|
Stem
Cells Research & Therapeutics, The Dana on Mission Bay
"Practical
Insights on Understanding the FDA's Expectations for Stem
Cell-based Therapies"
|
Darin
Weber, Ph.D. |
| March
7-8, 2005 |
.. |
International
Pharmaceutical Academy (IPA) Course/Workshop
“Designing
a Comprehensive OOS Investigation Strategy”
|
Tom
Gerteisen, Ph.D. |
| March
2-4, 2005 |
International
Pharmaceutical Federation (FIP) |
Harmonizing
Clinical Trial GMP and Quality Requirements across the EU
and Beyond
“The
US Investigational New Drug (IND) System”
|
David
Lin, Ph.D. |
| February
11, 2005 |
University
of Washington Engineered Biomaterials (UWEB), the UW Department
of Bioengineering, and the UW Tech Transfer |
The
2005 UWEB Industry Symposium
"Keys
to Understanding the Regulatory Approval Pathway for Engineered
Tissues"
|
Darin
Weber, Ph.D. |
| February
9-10, 2005 |
DSM
Biologics |
The
Crossroad of Biotechnology 2005, Biomanufacturing:
Innovative BioProcessing Technologies and Strategies |
Nadine
Ritter, Ph.D. |
| January
24-26, 2005 |
Phacilitate |
Cell
and Gene Therapy Forum 2005
"Processing
autologous cell products- discussing the regulatory
and commercial impact of patient-specific therapies"
|
Andra
Miller, Ph.D. |
| October
10-13, 2004 |
Regulatory
Affairs Professional Society (RAPS) |
RAPS
2004 Annual Conference & Exhibition
"FDA
Enforcement Basics: 483 to Consent Decree"
|
Steve
Masiello & Julia Lukas (session
leader) |
| October
1-3, 2004 |
ISCT
(International Society for Cellular Therapy) |
4th
Annual Somatic Cell Therapy Symposium |
Darin
Weber, Ph.D. |
| September
8-10, 2004 |
Barnett
International |
Biopharmaceutical
Comparability and Follow-On Biologicals Summit
"Comparability
Requirements During the Product Development Path"
|
Elizabeth
Leininger, Ph.D. |
| July
28-30, 2004 |
Institute
for International Research (IIR) |
Identification
and Validation of Stability - Indicating and Forced Degradation
Assays for Proteins |
Nadine
Ritter, Ph.D.
|
June
6-9, 2004
(11:00-12:15)
|
|
|
Julia
Lukas |
June
6-9, 2004
(9:30-10:45)
|
|
BIO
2004
"Emerging Technologies in the Downstream Manufacture
of Bio-Materials"
|
Jim
McIver, Ph.D. |
| June
6, 2004 |
American
Diabetes Association |
64th
Scientific Sessions
"FDA
Licensing for Pancreatic
Islet Transplantation in Type I Diabetes" |
Darin
J. Weber, Ph.D. |
| June
5, 2004 |
Italian
Trade Commission |
Antibody
Therapeutics: from discovery to application
"Regulatory Considerations for the Development of Antibody
Therapeutics" |
Elizabeth
Leininger, Ph.D. |
| June
2, 2004 |
International
Society for Cell Therapy (ISCT) |
AABB-ISCT
Audioconference Series
" Good Tissue Practice" |
Andra
Miller, Ph.D. |
| May
24-26, 2004 |
Regulatory
Affairs Professional Society (RAPS) |
|
Elizabeth
Leininger, Ph.D. |
|
May
24-26, 2004
|
|
|
|
| May
16-19, 2004 |
2004
AAPS National Biotechnology Conference |
Pre-Approval
Inspection, Are You Ready? |
Julia
Lukas |
|
March
11-12, 2004
|
|
|
|
| January
16, 2004 |
Williamsburg
BioProcessing Foundation in Coronado, CA |
"Characterization
and Comparability of Complex Biological Products" |
Darin
J. Weber, Ph.D. |
| November
2003 |
Well
Characterized Biologicals |
"Changes
and Comparability: What is Needed for Regulatory Approval" |
Elizabeth
Leininger, Ph.D. |
| October
2003 |
Process
Validation for Biopharmaceutical Manufacturing |
"Process
Validation Regulatory Requirements for Biologics" |
Elizabeth
Leininger, Ph.D. |
| October
2003 |
RAPS
2003 |
"CMC
Development for New Products" |
Ann
Sutton |
| October
2002 |
IBC's
5th International Well Characterized Biologicals |
"Comparability
for Biotech, A European Perspective" |
Karin
Sewerin, Ph.D. |
| August
2002 |
BioTaiwan
2002
Taipei, Taiwan
|
"FDA
Regulation of Cell and Tissue Products" |
James
Kenimer, Ph.D. |
| June
2002 |
British
Institute of Regulatory Affairs meeting |
"Current
Issues at CBER" |
James
Kenimer, Ph.D. |
| April
2002 |
Regulatory
Affairs Professional Society, RA/QA 101 course |
"Drugs
and Biologics Submissions" |
James
Kenimer, Ph.D. |
| .. |
.. |
"Post
Approval of Biologics License Application" |
Ann
Sutton |
| .. |
.. |
"The
Process Determines the Product" |
Ann
Sutton |
| .. |
.. |
"Documentation" |
Ann
Sutton |
| .. |
.. |
"Vaccine
Manufacture - Downstream" |
Ann
Sutton |
| .. |
.. |
"Vaccine
Manufacture - Upstream" |
Ann
Sutton |
| .. |
.. |
"Nonconformance" |
Ann
Sutton |
| .. |
.. |
"Process
Control for Biologics - Defining Terms" |
Ann
Sutton |
| .. |
.. |
"Process
Control for Biologics - Product Characterization, Specifications,
and Process Control" |
Ann
Sutton |
| .. |
.. |
"Process
Control for Biologics - Biologics License Application and Post-Approval
Activities" |
Ann
Sutton |
| .. |
.. |
"Quality
and Compliance" |
Ann
Sutton |
| June
2001 |
Food
and Drug Law Institute meeting |
"The
Investigational New Drug (IND) Process" |
James
Kenimer, Ph.D. |
| June
2001 |
Food
& Drug Law Institute meeting |
"The
Biologics License Application (BLA)" |
James
Kenimer, Ph.D. |
