Upcoming appearances

Consultants of the Biologics Consulting Group, Inc. attend several conferences every year during which they are available to provide company information or consulting expertise. BCG consultants often participate in continuing educational conferences and product/service focused seminars. Below are some conferences that BCG consultants will be attending in the near future, or have attended in the past. Please feel free to contact the attending consultant either before, or during the conference for company information or to discuss a business opportunity. Also, please see our Presentations page to view a copy of BCG conference presentations.

Date of Conference
Organization sponsoring conference
Conference & Presentation Title
BCG Consultant(s) Attending/Speaking
Conference Location
Jun. 21-23, 2009 DIA 45th DIA Annual Meeting

Louise Johnson
David Lin, Ph.D.
Michael Salgaller, Ph.D.
Annie Zurbay, RN, MSN, ND

San Diego, CA
Jun. 22-24, 2009 American Association of Pharmaceutical Scientists (AAPS)

AAPS 2009 National Biotechnology Conference

"Phase I INDs for Biologics: How Much Data is Adequate"

Ron Marchesani
(speaker)

Seattle, WA
Jun. 25-26, 2009 IIR-PTI

CMC Analytical, Comparability and Stability Studies for Biotechnology Products

"Current Expectations, Practical Considerations” 

Nadine Ritter, Ph.D.(speaker) London , UK
July 29-30, 2009 PDA

PDA Cell Substrate Workshop

T.W. Tanaka (speaker) Bethesda, MD
Aug. 17-18, 2009 Cambridge Healthtech Institute

Production & Manufacturing of Vaccines (part of the ImVacs Immunotherapeutics & Vaccine Summit)

"Essential Quality Considerations for Today’s Manufacturing of Vaccines: The Do’s and Don’ts for Successful Audits and Inspections"

Ron Marchesani
(speaker)
Providence, RI
Aug. 19-21, 2009 IVT

Laboratory Compliance Week

"Develop Effective Stability Testing of New Drug Substances and Products"

David Lin, Ph.D.
(speaker)
Philadelphia, PA
Sept. 8-9, 2009 IIR Stability Testing for Biologics

"Stability Testing Performed Over A Product Lifecycle"
David Lin, Ph.D.
(speaker)
Prague, Czech Republic
Sept. 12-13, 2009 SEAK, Inc.

National Non-Clinical Careers For Physicians

"Networking Your Way Into a Non-Clinical Career: Industry, Government & Consulting"

Stuart Portnoy, MD
(speaker)
Chicago, IL
Oct. 24-27, 2009 AABB  Annual Meeting & TXPO Joseph Fratantoni, MD New Orleans, LA
Dec. 5-8, 2009 American Society of Hematology 51st ASH Annual Meeting and Exposition Joseph Fratantoni, MD New Orleans, LA
Past Conferences Attended...
Jun. 11, 2009 ACRP Northern California Chapter “Emerging Markets: Clinical Trials in India” Louise Johnson (speaker) South San Francisco, CA 
Jun. 10, 2009 BenAstrum “Comprehensive Forced Degradation Studies to Validate Stability-Indicating Methods for Biotechnology Products” Nadine Ritter, Ph.D.(speaker) webinar
Jun. 8-11, 2009

Seton Hall Law School

Health Care Compliance Certification Program

"Advertising & Promotion of Medical Devices"

Stuart Portnoy, MD
(speaker)
Newark, NJ
June 2, 2009 BenAstrum Regulatory Expectations for Biologics Facilities: an ex-FDA Inspector's Outlook John R. Godshalk, MSE, MBA
(trainer)
webinar
Time: 1:00 PM EST
May 27-29, 2009 Cambridge Health Institute Biomarker World Congress 2009 Ron Salerno, PhD Philadelphia, PA
May 21-22, 2009 Prescription Pharma Support

CMC Analytical, Comparability And Stability Studies For Biotechnology Products: Current Expectations, Practical Considerations

“Analytical and Stability Studies for Biotechnology Products”

Nadine Ritter, Ph.D.(speaker) Signapore
May 18-21, 2009 BIO

BIO 2009 (booth #5232)

Michael Salgaller, PhD

Jim Kenimer, PhD

Wilson W. Bryan, MD

 

Atlanta, GA
May 18-19, 2009 Prescription Pharma Support

CMC Analytical, Comparability And Stability Studies For Biotechnology Products: Current Expectations, Practical Considerations

“Analytical and Stability Studies for Biotechnology Products”

Nadine Ritter, Ph.D.(speaker) Bangalore, India
May 11-13, 2009 Pharmaceutical Education and Research Institute (PERI)

Clinical Trial Planning and Management

"Trial Design for Efficient Drug Development "

Wilson W. Bryan, MD
(co-director)

Arlington, VA
May 6, 2009 UMBC Graduate Program in Biotechnology "Laboratory Quality Practices:  R&D, GLP and GMP” Nadine Ritter, Ph.D.(speaker) Baltimore, MD
May 4-6, 2009 Society for Clinical Trials Annual Meeting Wilson W. Bryan, MD Atlanta, Georgia
May 3-6, 2009 International Society for Cellular Therapy (ISCT)

Annual Meeting

Pre-Conference Symposium: Translation of Stem Cell Therapies Symposium
"Product Development Challenges for Stem Cell Therapies"

"Quality and Manufacturing Considerations - From Concept to Pre-BLA"

Session: Balancing Regulatory Expectations and Industry Realities in Proof of Concept Studies and Preclinical Data

"Nonclinical Development of Cell Therapy Products – Reconciling FDA Expectations with Industry Realities"

Darin Weber, Ph.D. (speaker)

 

 

 

 

David J. Pepperl, Ph.D. (speaker)

San Diego, CA
Apr. 26 - May 1, 2009 American Academy of Neurology Annual Meeting Wilson W. Bryan, MD
Seattle, WA
Apr. 25-29, 2009 CMC Strategy Forum Europe 2009 "CMC Perspectives on Biological Investigational Medicinal Products in Clinical Trials”

Nadine Ritter, Ph.D.(speaker)

Ruth Wolff, Ph.D. (speaker)

Lisbon, Portugal
Apr. 16, 2009 BenAstrum Selection and Validation of Test Methods for Host Cell Proteins Nadine Ritter, Ph.D.(speaker) webinar
Apr. 15, 2009 University of California, British Consulate-General, Canadian Consulate

Stem Cell Research and Regenerative Medicine

The Promise of Stem Cell Research to Enable Regenerative Medicine

Darin Weber, Ph.D. San Francisco, CA
Apr. 9, 2009 North Carolina Biotechnology Center Combination Products Meeting Angela Blackwell, MS
(panelist)
Research Triangle Park, NC
Apr. 2, 2009

Regulatory Affairs Professional Society (RAPS)

2009 RAPS Horizons Conference & Exhibition

"The Challenges of Nanotechnology:
Navigating the Field and the Regulatory Pathways"

Stuart Portnoy, MD
(speaker)
San Francisco, CA
Mar. 31, 2009 Compliance Online Preparing for FDA Inspections John R. Godshalk, MSE, MBA
(trainer)

webinar
Time: 1:00 PM EST

Mar. 12, 2009 Compliance Online Facility Design Considerations John R. Godshalk, MSE, MBA
(trainer)

webinar
Time: 1:00 PM EST

Mar. 11, 2009 BenAstrum Preparing for FDA Inspections of Biologics and Biotech Facilities John R. Godshalk, MSE, MBA
(trainer)

webinar
Time: 1:20 PM EST

Mar. 9, 2009 Compliance Online Preparing for FDA Inspections of Devices and Combination Products John R. Godshalk, MSE, MBA
(trainer)

webinar
Time: 1:00 PM EST

Mar. 5-6, 2009 International Pharmaceutical Academy FDA Pre-Approval Inspections Nanda Subbarao, Ph.D.
(speaker)
Somerset, NJ
Mar. 2-3, 2009 World Research Group Cell Based Assays in Drug Development: Hands on Instruction on How to Stay Ahead of the Curve & Maximize Assay Quality while Minimizing Costs Nadine Ritter, Ph.D.(speaker) Washington, DC
Mar. 2-3, 2009 IBC Life Sciences Process Validation for Biopharmaceuticals Ron Marchesani Carlsbad, CA
Feb. 25, 2009 BenAstrum Preparing for FDA Inspections of Biologics and Biotech Facilities John R. Godshalk, MSE, MBA
(speaker)
webinar
Feb. 18-20, 2009 Texas Scottish Rite Hospital for Children Carrell-Krusen Neuromuscular Symposium Wilson W. Bryan, MD Dallas, Texas
Feb. 9-12, 2009 University of Texas

International Conference on Drug Development

"Biomarker and Adverse Event Consortia Updates and Post Marketing Commitments"

Ron Salerno, PhD
(moderator)
Austin, TX
Feb. 3-4, 2009 DIA Regulatory and Scientific Issues that Challenge Comparability Assessment of Biopharmaceuticals John Jessop, Ph.D., MPH Arlington, VA
Jan. 29, 2009

ComplianceOnline.com

Webinar

"Off-Label Promotion of Medical Devices:   Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices"

Stuart Portnoy, MD
(speaker)
webinar
Jan. 28, 2009 Vanderbilt University "The FDA Approval Process for Medical Devices" Angela Blackwell, MS
(speaker)
Nashville, TN
Jan. 26-27, 2009 Phacilitate

Cell and Gene Therapy Forum 2009

"Designing cell and gene therapy clinical trials"

Andra Miller, Ph.D.
(session chair)
Washington, DC
Jan. 19-20, 2009 BIO BIO Asia Partnering Conference 2009 T.W. Tanaka Tokyo, Japan
Jan. 12-14, 2009 CASSS WCBP 2009 Ron Marchesani San Francisco, CA
Dec. 10, 2008 Colorado State University

Regional Training Center for Product Translation

“From PIND to Licensure”

Julia Barrett, M.D., MPH
(speaker)
Fort Collins, CO
Dec. 8-9, 2008 IBC Life Sciences Biopharmaceuticals Manufacturing and Development Summit Lourdes Bermejo, MS Durham, NC
Nov. 26, 2008 BenAstrum "Preparing for FDA Inspections of Biologics and Biotech Facilities" John R. Godshalk, MSE, MBA
(speaker)
Webinar
Nov. 25-26, 2008 Informa Life Sciences

17th annual Medical Device Regulations

“An Introduction to FDA Regulations for Medical Devices”. 

Miriam Provost, PhD Amsterdam, The Netherlands
Nov. 20, 2008 National Academy of Sciences Translation of Stem Cells into Clinical Stem Cell Therapeutics
Public Symposium
Darin Weber, Ph.D.
(speaker)
Washington, DC
Nov. 18-21, 2008 ASTM November Meeting week Division IV Tissue Engineered Medical Products Angela Blackwell, MS Miami Beach, FL
Nov. 17-18, 2008 IBC 6th Annual Global Follow-On Biologics Jim Kenimer, PhD Bethesda, MD
Nov. 10-12, 2008 IBC

12th Annual Well-Characterized Biologicals

"Overview of CMC Strategy Forum on Glycosylation of Biotechnology Products"

Nadine Ritter, Ph.D.(speaker) Reston, VA
Nov. 10-11, 2008 American College of Toxicology

From Bench to Bedside: The absolute Essentials of Vaccine Development (course)

Adjuvants in Vaccine Development: Regulatory Considerations (session)

Steve Kunder, Ph.D. (speaker) Tucson, AZ
Nov 10-11, 2008 PDA (Parenteral Drug Association)

Development and Regulation of Clinical Trial supplies

Eugene Johnston, CQE, CQA (speaker) Boston, MA
Nov 9-12, 2008 ACT (American College of Toxicology)

29th Annual Meeting

Introduction of Biologics (Hartsough)  

John Jessop, Ph.D., MPH
Melanie Hartsough, Ph.D. (speaker)
David J. Pepperl, Ph.D.

Tuscon, AZ
Nov. 5, 2008 UMBC Biotech Forum 2008 From Bench to Business: Biotech Career Opportunities Nadine Ritter, Ph.D.(speaker) Baltimore, MD
Nov. 4, 2008 BenAstrum “Quality Management Systems: Key Elements & Regulatory Expectations” Eugene Johnston, CQE, CQA (speaker) Webinar
Oct. 28, 2008 BenAstrum Regulatory Expectations for Biologics Facilities: an ex-FDA Inspector's Outlook"
John R. Godshalk, MSE, MBA
(speaker)
Webinar
Oct 22-23, 2008 IIR Stability Testing for Biotechnology Products

Nadine Ritter, Ph.D.(speaker)

London, UK
Oct. 15-17, 2008 Bio-Japan Bio-Japan

Jim Kenimer, PhD T.W. Tanaka
Shin-ichi Kamachi, PhD
Masamichi Gotoh

Yokohama, Japan
Oct. 14, 2008 BenAstrum “Recent Developments in the WHO/ASEAN Stability Guidance”
Nanda Subbaro, Ph.D.
(speaker)
Webinar
Oct 12-17, 2008 Transcatheter Cardiovascular Therapeutics TCT 2008 Susan Bowley, PhD Washington, DC
Oct 9-10, 2008 International Pharmaceutical Academy

Effective Response to Process Deviations and Failures

"Conducting Failure Investigations"

Eugene Johnston, CQE, CQA (speaker)

Toronto, Canada

Oct 4-7, 2008 AABB
(American Association of Blood Banks)

Annual Meeting and TXPO

"Benchside to Bedside: Translation of CT Products into Clinic" - Weber

 

Ellen M. Areman, MS, SBB
(session chair)

Darin Weber, Ph.D.
(speaker

 

Montreal, Canada
Sept. 30, 2008 Benastrum                    The Significance of Quality Systems Eugene Johnston, CQE, CQA (speaker) Webinar
Sept 28-Oct 4, 2008   ISO TC 106 Dental Devices Annual Meeting Angela Blackwell, MS Göteborg, Sweden
Sept. 28-Oct. 1, 2008 Cambridge Healthtech Institute Biomarker Discovery Summit 2008 Discovery Summit 2008
Ron Salerno, PhD Philadelphia, PA
Sept. 24, 2008 Georgia Bio 2008 Georgia Life Sciences Summit Eugene Johnston, CQE, CQA
Jim Kenimer, PhD
Atlanta, GA
Sept. 22-24, 2008 International Society for Cell Therapy (ISCT)

8th Annual Somatic Cell Therapy Symposium

"IND Overview"

"Problems in Product Development for Cell-Based Therapies"

Panelist for "Product Nomenclature" Session
Darin Weber, Ph.D.
(speaker)
Bethesda, MD
Sept. 14-17, 2008 Regulatory Affairs Professional Society (RAPS)

Annual Conference & Exhibition

"Follow-on Biologics, (Biosimilars)” (Subbarao)

 

Speakers
Nanda Subbaro, Ph.D.


Lorianne Baranauskas
John Jessop, PhD
Reggie Neal
Kelly Reich, MS
Michael Trapani, MS, MBA
Holli Vaughan, MS, RAC
Keith Wells, Ph.D.

Boston, MA
Sept. 8-12, 2008 PDA/FDA 2008 PDA/FDA Joint Regulatory Conference Nadine Ritter, Ph.D. Washington, DC
Aug. 21, 2008 BenAstrum

"Immunogenicity Assays and the Current Regulatory Guidelines"

Nanda Subbaro, Ph.D. (speaker) Live Web Seminar & Group Discussion
Aug. 14, 2008 Cambridge Healthtech Institute Clinical Risk Management and Safety for Vaccines Julia Barrett, M.D., MPH
(speaker)
Cambridge, MA
July 24-25, 2008 CASSS CMC Strategy Forum Nadine Ritter, Ph.D. Bethesda, MD
June 25-26, 2008 IIR Stability Testing for Biotechnology Products

Nadine Ritter, Ph.D.(speaker)

London, UK
June 22-26, 2008 Drug Information Association 44th Annual Meeting Annie Zurbay, RN, MSN, ND
Ron Salerno, Ph.D.
Boston, MA
June 19, 2008 ComplianceOnline Implementing a GCP Vendor Qualification Program: Ensuring your vendors are in compliance with FDA requirements Carl Anderson
(speaker)
online (10 am PDT)
June 18, 2008 ASME (American Society of Mechanical Engineers) 3rd Frontiers in Biomedical Devices Conference and Exhibition Susan Bowley, Ph.D. Irvine, CA
June 17-20, 2008 BIO (Biotechnology Industry Organization) BIO 2008 (Booth #1939) Jim Kenimer
Ron Marchesani
Ron Salerno
Gil Salud
San Diego, CA
June 16-19, 2008 Seton Hall Law School

Health Care Compliance Certification Program

"Advertising & Promotion of Medical Devices"

Stuart Portnoy, MD
(speaker)
Newark, NJ
June 12-13, 2008 Center for Business Intelligence (CBI) 3rd Annual Stability Programs: Impurity Control, Global Compliance, Program Design and Stability Data Management for the Bio/Pharmaceutical Industry

“Develop Complex Stability Programs for Biologics”

David Lin, Ph.D.
(speaker)
Philadelphia, PA
June 11-12, 2008 Orange County Regulatory Affairs 11th Annual FDA/OCRA Educational Conference Ruth Wager, Ph.D. Irvine, CA
June 8-11, 2008 Preclinical Training Institute

Study Directing: Principles and Practices

"Your "other boss": How an FDA reviewer reads your reports"

Melanie Hartsough, Ph.D.
(speaker)
South Lake Tahoe, CA
June 5-6, 2008 FDLI Introduction to Biotechnology Law
and Regulation
John R. Godshalk, MSE, MBA
(speaker)
Washington, DC
May 19– 21, 2008 IBC Life Sciences TIDES 2008: Oligonucleotide and Peptide Technology and Product Development Conference Proven Strategies for Successful Drug and Diagnostic Development

David Lin, Ph.D. Las Vegas, NV
May 18 – 21, 2008 Society for Clinical Trials 29th Annual Meeting Wilson W. Bryan, MD St. Louis, MO
May 17-20, 2008 ISCT ISCT 14th Annual Meeting

speakers

Ellen M. Areman, MS, SBB
David J. Pepperl, Ph.D.
Darin Weber, Ph.D.

Miami, FL
May 8-10, 2008 UCSC Extension in Silicon Valley

Special Regulatory Programs - click below to sign up for either course presented by BCG at UCSC

"FDA Regulation of Biotechnology and Biologics Products: From IND to BLA"

"Medical Devices and the FDA: An Insider's Perspective"

 

Jim Kenimer,Ph.D.
Ron Marchesani
Janice Wilson, Ph.D.

Carl Anderson
Susan Bowley, Ph.D.
Stuart Portnoy, M.D.

University of California Extension, Santa Cruz
May 6-9, 2008 ASTM International

Committee Week

Division IV Tissue Engineered Medical Products

Medical and Surgical Materials and Devices

Angela Blackwell, MS


Susan M. Bowley, Ph.D.

Denver, CO
May 6, 2008 FDA & Industry Conference Creating New Knowledge, FDA & Industry in dialogue Michael Trapani, MS, MBA Philadelphia, PA
April 29-May 2, 2008 Institute of Validation Technology (IVT)

Lab Compliance

“Stability Testing Fundamentals and Considerations in the Current Regulatory Environment”

David Lin, Ph.D.
(speaker)
Baltimore, MD
April 29, 2008 ComplianceOnline GLP Compliance Audits: What to look out for at a New Nonclinical CRO David Pepperl, Ph.D.
(speaker)
on-line seminar
April 28 - May 2, 2008 Cambridge Healthtech Institute

4th Annual PEGS (Protein Engineering Summit)

"Implementation of a flexible cGMP complaint Stability Program for Phase I, II and III Studies"

Nanda Subbarao, Ph.D.
(speaker)
Boston, MA
April 24-25, 2008 International Pharmaceutical Academy, Canada Developing an Effective
Complaint Handling and Recalls Program
Janice Wilson, Ph.D.
(speaker)
Toronto, Canada
April 20-25, 2008 Society of Quality Assurance (SQA) 24th SQA Annual Meeting and Training

Carl Anderson
(speaker)
Michael Trapani, MS, MBA (speaker)

Memphis, TN
April 17, 2008 North Carolina Biotechnology Center's Bioprocessing and Process Development Group

BioProcessing & Process Development Intellectual Exchange Group

"Immune Response to Protein Therapeutics"

Nanda Subbaro, Ph.D.
(speaker)
Research Triangle Park, NC
April 14-18, 2008 PDA

2008 Annual Meeting

"Critical Issues in the Vaccine Industry: A Review of Recent FDA Warning Letters" (Wilson)

Nadine Ritter, Ph.D.

Janice Wilson, Ph.D.
(speaker)

Colorado Springs, CO
April 12 – 19, 2008
American Academy of Neurology 60th Annual Meeting Wilson W. Bryan, MD Chicago, IL
April 7-9, 2008 CASSS European CMC Strategy Forum Nadine Ritter, Ph.D. Paris France
April 3-5, 2008 AADR American Associate for Dental Research Annual Meeting Angela Blackwell, MS Dallas, TX
April 3, 2008 ComplianceOnline FDA Expectations for Cell, Tissue and Gene Therapy Products David J. Pepperl, Ph.D.
(speaker)
on-line seminar
March 28-29, 2008 AABB
(American Association of Blood Banks)

Spring Conference 2008

Regulatory Considerations of Using Stem Cells for Cardiac Applications

Ellen M. Areman, MS, SBB
(speaker)
Orlando, FL
March 26-28, 2008 Reed Life Sciences

PharmaMedDevice Conference

"Combination Products -- Regulatory: Applications & Documentation"

Stuart Portnoy, MD
(speaker)
Philadelphia, PA
March 26-28, 2008 Regulatory Affairs Professional Society (RAPS) 2008 Horizons Conference Ron Marchesani
(speaker)
Janice Wilson, Ph.D.
San Francisco, CA
March 18-19, 2008 British Columbia Institute of Technology (BCIT) Design and Implementation of Effective Stability Studies for Biotechnology Products Nadine Ritter, Ph.D.
(course director)
Vancouver, BC, Canada
March 16-20, 2008 Society of Toxicology SOT Annual Meeting and Tox Expo John Jessop, Ph.D., MPH Seattle, WA
March 13, 2008 ComplianceOnline Utilizing ICH Guidelines for GCP Regulatory Compliance Carl Anderson
(speaker)
on-line seminar
March 10-11, 2008 IBC Life Sciences Training Academy Process Validation for Biologicals Conference Ron Marchesani San Diego, CA
March 6-7, 2008 ASENT (American Society of Experimental NeuroTherapeutics) Annual Meeting Wilson W. Bryan, MD
(course co-director)
Washington, DC
March 2-4, 2008 The Barnett Institute Biogenerics 2008 Nanda Subbaro, Ph.D. Boston, MA
February 25-29, 2008 Seton Hall Law School

Health Care Compliance Certification Program

"Advertising & Promotion of Medical Devices"

Stuart Portnoy, MD
(speaker)
Newark, NJ
February 21-22, 2008 Texas Scottish Rite Hospital for Children 30th Annual Carrell-Krusen Neuromuscular Symposium Wilson W. Bryan, M.D. Dallas, TX
February 12-15, 2008 R&D Directions 5th Annual Drug Development Summit 2008 David T. Lin, Ph.D.
(speaker)
Amelia Island, FL
February 11-13, 2008 Pharmaceutical Education and Research Institute (PERI), Inc. Effective Planning & Management of Clinical Trials Wilson W. Bryan, M.D.
(course co-director)
Arlington, VA
February 9-10, 2008 ISCTR (International Society for Cardiovascular Translational Research)

Annual Meeting

"Regulatory Considerations for Cell Manufacturing and Cell Delivery"

Darin Weber, Ph.D.
(speaker)
San Diego, CA
February 9-10, 2008 DIA (Drug Information Association) 21st Annual DIA Conference for Electronic Document Management: Managing Documents and Records Dan Offringa
Kelly Reich, MS
Holli Vaughan, MS, RAC
Philadelphia, PA
January 28-30, 2008 Phacilitate Phacilitate Cell & Gene Therapy Forum 2008 Andra Miller, Ph.D.
Maritza C. McIntyte, Ph.D.
Darin Weber, Ph.D.
Washington DC
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
(speaker)
Toronto, Canada
January 27-30, 2008 CASSS

CMC Strategy Forum

12th Annual Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products

Nadine Ritter, Ph.D.
(speaker)
Keith Wells, Ph.D.
Ruth Wolff, Ph.D.
Washington, DC
January 27-30, 2008 CASSS

CMC Strategy Forum

Extractables and Leachables: Challenges and Strategies in Biopharmaceutical Development

Keith Wells, Ph.D.
Ruth Wolff, Ph.D.
Washington, DC
January 27-30, 2008 CASSS

CMC Strategy Forum

Current Practices for Assessing the Comparability and Stability of Gene Therapy Products

Andra Miller, Ph.D.
Maritza C. McIntyte, Ph.D.
Nadine Ritter, Ph.D.
(co-leader)
Darin Weber, Ph.D.
Washington, DC
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.
(speaker)
San Diego, CA
January 17 - 18, 2008 IBC China US FDA Biological Approval Process Lei Zhang, MD, Ph.D.
(speaker)
Taipei, Taiwan
January 14 - 16, 2008 ALS Association ALSA Research Workshop Wilson W. Bryan, M.D.
(speaker)
Tampa, FL
January 14 - 15, 2008 IBC China US FDA Biological Approval Process Lei Zhang, MD, Ph.D.
(speaker)
Seoul, South Korea
December 20, 2007 Pennsylvania BIO & Nanotechnology Institute & Ben Franklin Technology Partners Overcoming Barriers Faced When Bringing a Bio-Nanotechnology Product to Market
Stuart Portnoy, MD
Philadelphia, PA
December 13 - 14, 2007 IBC China US FDA Biological Approval Process Lei Zhang, MD, Ph.D.
(speaker)
Beijing, China
December 7 - 11, 2007 American Society of Hematology 49th Annual Meeting and Exposition Liana Harvath, Ph.D. Atlanta, GA
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.
(speaker)
San Diego, CA
November 12-14, 2007 ACT (American College of Toxicology) Annual Meeting

Melanie Hartsough, Ph.D.
John Jessop, Ph.D., MPH
David J. Pepperl, Ph.D.

Charlotte, NC
November 12-13, 2007 Pharma Conference Current GMP Concepts: Focus on Biologics Eugene Johnston, CQE, CQA San Antonio, TX
November 8-9, 2007 FDA-HHS-NIAID workshop Anthrax Vaccines- Bridging Correlates of Protection in Animals and Immunogenicity in Humans Ann Sutton Gaithersburg, MD
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
(speaker)
Munich, Germany
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
(speaker)

Carl Anderson
(speaker)

Bethesda, MD
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
(moderator)
Anaheim, CA
October 8 - 9, 2007 BioNJ and Pennsylvania Bio Biotech 2007 Joe Clancy - BCG Board of Directors
Michael Trapani, MS, MBA
Keith Wells, Ph.D.
Philadelphia, PA
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.
(speaker)
Taipei, Taiwan
October 2 - 3, 2007 IVT Lab Week

Capturing the Science of Stability Testing

"Out-of -Specification Investigations for Stability Samples"

Nanda Subbaro, Ph.D.
(speaker)
San Diego, CA
September 26, - 28, 2007 ISCT

Somatic Cell Therapy Symposium

“Use of Devices in Cell Therapy Manufacturing”

Ellen M. Areman, MS, SBB
(session moderator)
Liana Harvath, Ph.D.
(session moderator)

Bethesda, MD
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.

 


John Jessop, Ph.D., MPH
Ron Marchesani
Reggie Neal
Kelly Reich, MS
Holli Vaughan, MS, RAC
Keith Wells, Ph.D.

Boston, MA
September 17 - 21, 2007 University of Wisconsin-Madison 10th Annual Land O'Lakes Conference on Drug Metabolism/Applied Pharmacokinetics Melanie Hartsough, Ph.D.
(speaker)
Merrimac, WI
September 10 - 12, 2007

AAPS (Amercian Association of Pharmaceutical Scientists)

AAPS Workshop on Stability: Developing a Stability Program for the Global Market

Stability Challenges of OTCs, Nutraceuticals and Combination Products

Nanda Subbaro, Ph.D.
(moderator)
North Bethesda, MD
August 21 - 24, 2007 Cambridge Healthtech Institute

Target Immunotherapeutics and Vaccine Summit

"Selecting a Study Population"

Stephen Litwin, MD
(speaker)
Cambridge, MA
June 27 - 28, 2007 Pharmaceutical Training Institute

“Design and Implement Effective Stability Programmes for Biotechnology Products”

Nadine Ritter, Ph.D.
(speaker)
London, England
June 19 - 20, 2007 IVT Method Validation Conference "Test Method Qualification or Test Method Validation: What is the Difference?" Nadine Ritter, Ph.D.
(speaker)
Brussels, Belgium
June 18 - 20, 2007 BIO VentureForum East 2007 Wilson W. Bryan, M.D.
(speaker)
Montreal, Canada
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.
(speaker)
Atlanta, GA
June 17 - 23, 2007   Options for Control of Influenza VI Mike Williams Toronto, Canada
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.
(speaker)
Seattle, WA
May 30 - Jun 3, 2007 ASGT (American Society of Gene Therapy) 10th Annual Meeting Maritza C. McIntyre, Ph.D.
(speaker)

Seattle, WA
May 21 - 22, 2007 IVT Method Validation Conference "Test Method Qualification or Test Method Validation: What is the Difference?" Nadine Ritter, Ph.D.
(speaker)
Boston, MA
May 15 - 16, 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.
(speaker)

Boston, MA
May 7 - 9, 2007 Pharmaceutical Education Research Institute (PERI) Effective Planning and Management of Clinical Trials Wilson W. Bryan, M.D.
(Course Co-Director )
Arlington, VA
May 6 - 9, 2007 BIO (Biotechnology Industry Organization) BIO 2007 (Booth #2281)

Jim Kenimer, Ph.D.
& Others

Boston, MA
Apr. 28 - May 5, 2007 American Academy of Neurology 59th Annual Meeting Wilson W. Bryan, M.D. Boston, MA
Apr. 23 - 27, 2007 BioProcess International European Conference "Workshop on Stability Testing For Biological Drugs" and "Workshop on Managing CMC Changes from a Regulatory Perspective" Nadine Ritter, Ph.D.
(speaker)
Paris, France
Apr. 11 - 12, 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.
(speaker)
San Diego, CA
Mar. 28 - 30, 2007 Regulatory Affairs Professional Society (RAPS) RAPS 2007 Horizons Conference & Exhibition Sarah McNulty, RAC San Francisco, CA
March 25-28, 2007 Society of Toxicology SOT Annual Meeting

John Jessop, Ph.D.
David Pepperl, Ph.D.
Tanya Kersten, Ph.D.

Charlotte, NC
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)
San Diego, CA
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)

Washington, DC
March 19-21, 2007 Institute for International Research (IIR) Formulation and Forced Degradation Strategies for Biomolecules

“Regulatory Requirements for Successful Product Development”

David T. Lin, Ph.D.
(speaker)
San Diego, CA
Mar. 14 - 17, 2007 Mayo Clinic Oncolytic Virus Conference Maritza C. McIntyte, Ph.D.
(speaker)
Carefree, AZ
Mar. 14 - 15, 2007 Pharmaceutical Training Institute

“Design and Implement Effective Stability Programmes for Biotechnology Products”

Nadine Ritter, Ph.D.
(speaker)
London, England
Mar. 8 - 10, 2007 California Separation Science Society (CASSS)

EU CMC Strategy Forum

“Life Cycle Approach to Establishing Biotechnology Product Specifications”

Nadine Ritter, Ph.D.
(speaker)
Brussels, Belgium
Mar. 8 - 10, 2007 American Society for Experimental NeuroTherapeutics (ASENT) Annual Meeting Wilson W. Bryan, M.D.
(Course Co-Director )
Washington, DC
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.
(speaker)
San Francisco, CA
Feb. 22-23, 2007   Carrell-Krusen Symposium
Wilson W. Bryan, M.D. Dallas, Texas
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.
(speaker)
Toronto, Canada
Jan. 22-24, 2007 Phacilitate Cell & Gene Therapy Forum 2007 Darin Weber, Ph.D. Baltimore, MD
Jan. 22-24, 2007 IIR 4th Annual Forced Degradation Studies David T. Lin, Ph.D.
(speaker)
Las Vegas, NV
Jan. 9-10, 2007 Cambridge Healthtech Institute PepTalk: Optimizing Protein and Antibody Therapeutics David T. Lin, Ph.D.
(speaker)
San Diego, CA
Dec. 6-7, 2006 PTI (Pharmaceutical Training Institute Stability Testing for Biotechnology Products Nadine Ritter, Ph.D.
(course instructor)
London, UK
Nov. 6-8, 2006 Williamsburg BioProcessing Foundation

WilBion Viral Vectors and Vaccines Meeting

"WilBion Viral Vectors and Vaccines Meeting"

Maritza C. McIntyte, Ph.D.
(speaker)
Southampton, Bermuda
Nov. 1-3, 2006 FDANews FDA Inspections Summit: Getting it Right the First Time, Every Time John Godshalk, MSE, MBA Rockville, MD.
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.
(speaker)
San Antonio, TX
Oct. 21-22, 2006 AABB

Annual Meeting

"Regulation of Cell Therapy Products for Cardiac Disease"

Ellen M. Areman, MS, SBB
(speaker)
Miami Beach, FL
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.
(speaker)
Boston, MA
Oct. 16-17, 2006 DIA

First International DIA Workshop on “Developing Probiotics as Foods and Drugs – Scientific and Regulatory Challenges”

Ann Sutton University of Maryland College Park Campus
Oct. 16-17, 2006 SRI Institute 6th Annual Stem Cells and Regenerative Medicine Meeting Darin Weber, Ph.D. Pittsburgh, PA
Oct. 15-18, 2006 Regulatory Affairs Professional Society (RAPS) Annual Conference & Exhibition

Jim Kenimer, Ph.D.

Speakers

Ellen M. Areman, MS, SBB
Bette A. Goldman, RN, MPH
Stephen Litwin, MD
Maritza C. McIntyte, Ph.D.

Attendees
John Jessop, MPH, Ph.D.
Tanya Kersten, Ph.D.
Dan Offringa
Kelly Reich
Holli Vaughan, MS, RAC
Mike Williams

Baltimore, MD
Sept. 25-27, 2006 ISCT/FDA

Somatic Cell Therapy Symposium

Moderating session on Release Testing of Cell Therapy Products

Ellen M. Areman, MS, SBB
Stephen Litwin, MD

Bethesda, MD
July 20-21, 2006 CaSSS

WCBP CMC Strategy Forum

"Changing Paradigms in Process Validation"

Nadine Ritter, Ph.D.
(speaker)
NIH campus
Bethesda, MD
June 29 - July 1, 2006 International Society for Stem Cell Research (ISSCR) 4th Annual Meeting Jim Kenimer, Ph.D.
Ellen Areman, MS, SBB
Darin Weber, Ph.D.
Toronto, Ontario
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.
(course instructor)
Boston, MA
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.
(speaker)
San Diego, CA
June 19-21, 2006 American Association of Pharmaceutical Scientists' (AAPS)

2006 National Biotechnology Conference

"Regulatory Issues in Developing New Vaccines"

Peter Patriarca, M.D.
(speaker)
Boston, MA
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.
(workshop facilitator)
Reston, VA
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.
(speaker)
Philadelphia, PA
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.
(speaker)
Princeton, NJ
May 31 - June 4 ASGT (American Society of Gene Therapy) 9th Annual Meeting Jim Kenimer, Ph.D.
& Others
Baltimore, MD
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.
(course instructor)
Seattle, WA
May 16-18, 2006 IVT (Institute for Validation Technology)

Annual Method Validation Conference

"What is Test Method Qualification"

Nadine Ritter, Ph.D.
(speaker)
Dublin, Ireland
May 10-11, 2006 PTI (Pharmaceutical Training Institute Stability Testing for Biotechnology Products Nadine Ritter, Ph.D.
(course instructor)
London, UK
May 4-7, 2006 ISCT (International Society for Cellular Therapy)

12th Annual Meeting

Cellular Therapy for Cardiac Applications

Ellen Areman, MS, SBB Berlin Germany
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.
(speaker)
UMBC Colesville Campus
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.
(speaker)
Carlsbad, CA
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.
(course instructor)
Philadelphia, PA
Apr. 9 - 12, 2006 BIO (Biotechnology Industry Organization) BIO 2006

Jim Kenimer, Ph.D.
& Others

Chicago, IL
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.
(speaker)


Ruth Wolff, Ph.D.

(speaker)

Barbara G. Matthews, MD, MPH
(BCG Affiliate, speaker)
Bethesda, MD
Mar. 21, 2006 Carilion Biotech Association   John Jessop, MPH, Ph.D.
(speaker)
Roanoke, VA
Mar. 8-9, 2006 PTI (Pharmaceutical Training Institute Stability Testing for Biotechnology Products Nadine Ritter, Ph.D.
(course instructor)
London, UK
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.
(speaker)
San Francisco, CA
Jan. 30 - Feb. 1, 2006 Phacilitate Phacilitate Vaccine Forum Jim Kenimer, Ph.D.
Peter Patriarca, M.D.
Mike Williams
Baltimore, MD
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.
(speaker)
San Francisco, CA
Page Updated: June 19, 2009


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