Invited Speaker:
Current Trends in General Toxicology and Food Safety, International Congress, June 2017, Havana, Cuba
ICHM3 and the Timing of Toxicology Studies, ACT, November 2016, Baltimore, MD
Forum for Students and Early Career Professionals, ACT, November 2016, Baltimore, MD
New Pathways to Support Drug Development (expert panelist), RAPS 2015 Annual Conference, October 2015, Baltimore, MD
New Pathways to Support Drug Development (expert panelist), RAPS 2015 Annual Conference, October 2015, Baltimore, MD
BiTE Blincyto: Regulatory and Nonclinical Challenges of a Breakthrough Therapy, Charles River 21st Annual Biotechnology-Derived Therapeutics: Perspectives on Nonclinical Development Symposium, September 2015, San Diego, CA
Regulatory History, Challenges and Progress in Developing Biologics, Huntingdon Life Sciences Biologics Symposium, February 2015, Bridgewater, NJ
Overview of Current Labeling Rule under the Physician’s Labeling Rule, ACT, November 2013, San Antonio, Tx
Safety Testing & Considerations for Biologics/Biosimilars, USC, July 2012, Los Angeles, CA
Regulatory Strategy for Emerging Markets, ACDRS – San Francisco University, February 2012, San Francisco, CA
Regulatory Challenges for Drugs Intended to treat Age-Related Neurodegenerative Diseases, USC Moving Targets Symposium, October 2011, Los Angeles, CA
Methods in Toxicology, USC, January 2011, Los Angeles, CA
Gaining Critical Efficiencies in Biotech Drug Development by Applying Global Regulatory Strategy: Leveraging Markets as part of a Global Strategy for Developing Biologics; Drug Information Association Annual Meeting, June 2010, Washington, DC
Progress in the understanding of the impact of glycosylation on quality, safety and Efficacy during the development of monoclonal antibody products; 2nd European Congress of Immunology, September 20009, Berlin, Germany
Regulatory and Clinical Review of the Enbrel PSO Application Status; Drug Information Association, June 2009, San Diego, CA
Preclinical Drug Development Strategies for Large Molecules; American Course on Drug Development and Regulatory Sciences (ACDRS), February 2009, San Francisco, CA
Comparability Challenges: Regulatory and Scientific Issues in the Assessment of
Biopharmaceuticals; DIA sponsored event, February 2009, Arlington, VA.
ICH M3 (R2) Non-Clinical Safety Studies for the Conduct of Human Clinical Trials And Marketing Authorization for Pharmaceuticals; BioSafe General Membership Meeting, October 2008, Boston, MA
Toxicology Study Strategies for Biopharmaceuticals in Comparison to Small Molecules;15th North American Regional ISSX Meeting, October 2008, San Diego, CA
Preclinical Drug Development Strategies for Large Molecules; American Course on Drug Development and Regulatory Sciences (ACDRS), September 2008, San Francisco, CA
Phase 1 Clinical Trials Science and Regulatory Framework; What are the questions that
TNG1412 raised? CMR Conference, April 16, 2007, Surrey, UK
Preclinical Safety Assessment of Biologics and Traditional Pharmaceuticals in the Current Regulatory Environment; St. John’s University, April 2007, Queens, NY
Carcinogenicity Assessments of Biopharmaceuticals; Toxicology Winter Forum, February 2007 at Washington, DC
Preclinical Safety Testing of Biotechnology Products vs Traditional Pharmaceuticals; California State University Channel Islands, April 2006, Camarillo, CA
Regulatory Implications of TeGenero; St. John’s University, October 2006, New York, NY
Safety Assessment of Biotechnology Products – Modified Proteins; NYMC – Chemical Safety Assessment: Contributions of Toxicological Pathology and Mechanistic Investigations, October 2005 at Valhalla, NY
Safety Assessment of Biotechnology Products – Modified Proteins;NYMC – Chemical Safety Assessment: Contributions of Toxicological Pathology and Mechanistic Investigations, October 24, 2004 at Valhalla, NY
Safety Assessment of Biotechnology Products – Modified Proteins;NYMC – Chemical Safety Assessment: Contributions of Toxicological Pathology and Mechanistic Investigations, September 23, 2003 at Valhalla, NY
Pre-clinical Safety Testing of Biotechnology Products vs. Traditional Pharmaceuticals; Wilkes University, November 8, 2002 at Scranton, Pennsylvania.
Safety Assessment of Biotechnology Products – Modified Proteins 10th Annual Course on Safety Assessment of Medical Products;NYMC – Advanced Course, September, 2002 at Hyeres, France.
Strategic Toxicology Evaluation of Bio-Pharmaceuticals – Past, Present, and Future; Japanese Society of Toxicology, 29th Annual Meeting, June 18-20, 2002 at Nagoya, Japan.
In Vitro Screening: Predicting Toxicology in Early Drug Development, Information Technology Pharma Workshop (IBC) June 21-23, 2000 at Philadelphia, PA.
Pre-clinical Safety Testing of Drugs Produced by Biotechnology (ACT) November 7, 1999.
Pre-clinical Safety Testing of Drugs Produced by Biotechnology vs. Small Molecules (ICSD) September 21, 1999.
Pre-clinical Safety Testing of Drugs Provided by Biotechnology, Biotech Workshop (BIRA) June 7, 1999.
Pre-clinical Safety Testing of Drugs Produced by Biotechnology vs. Small Molecules (ICSD) University of Kansas, April 9, 1999 at, Lawrence, KS.
Pharmacokinetics and Toxicology of Pegylated Proteins, Biotech Conference (SBI) Tahoe, NV June 1, 1998.
ICHM3 and the Timing of Toxicology Studies, ACT, November 2016, Baltimore, MD
Forum for Students and Early Career Professionals, ACT, November 2016, Baltimore, MD
New Pathways to Support Drug Development (expert panelist), RAPS 2015 Annual Conference, October 2015, Baltimore, MD
New Pathways to Support Drug Development (expert panelist), RAPS 2015 Annual Conference, October 2015, Baltimore, MD
BiTE Blincyto: Regulatory and Nonclinical Challenges of a Breakthrough Therapy, Charles River 21st Annual Biotechnology-Derived Therapeutics: Perspectives on Nonclinical Development Symposium, September 2015, San Diego, CA
Regulatory History, Challenges and Progress in Developing Biologics, Huntingdon Life Sciences Biologics Symposium, February 2015, Bridgewater, NJ
Overview of Current Labeling Rule under the Physician’s Labeling Rule, ACT, November 2013, San Antonio, Tx
Safety Testing & Considerations for Biologics/Biosimilars, USC, July 2012, Los Angeles, CA
Regulatory Strategy for Emerging Markets, ACDRS – San Francisco University, February 2012, San Francisco, CA
Regulatory Challenges for Drugs Intended to treat Age-Related Neurodegenerative Diseases, USC Moving Targets Symposium, October 2011, Los Angeles, CA
Methods in Toxicology, USC, January 2011, Los Angeles, CA
Gaining Critical Efficiencies in Biotech Drug Development by Applying Global Regulatory Strategy: Leveraging Markets as part of a Global Strategy for Developing Biologics; Drug Information Association Annual Meeting, June 2010, Washington, DC
Progress in the understanding of the impact of glycosylation on quality, safety and Efficacy during the development of monoclonal antibody products; 2nd European Congress of Immunology, September 20009, Berlin, Germany
Regulatory and Clinical Review of the Enbrel PSO Application Status; Drug Information Association, June 2009, San Diego, CA
Preclinical Drug Development Strategies for Large Molecules; American Course on Drug Development and Regulatory Sciences (ACDRS), February 2009, San Francisco, CA
Comparability Challenges: Regulatory and Scientific Issues in the Assessment of
Biopharmaceuticals; DIA sponsored event, February 2009, Arlington, VA.
ICH M3 (R2) Non-Clinical Safety Studies for the Conduct of Human Clinical Trials And Marketing Authorization for Pharmaceuticals; BioSafe General Membership Meeting, October 2008, Boston, MA
Toxicology Study Strategies for Biopharmaceuticals in Comparison to Small Molecules;15th North American Regional ISSX Meeting, October 2008, San Diego, CA
Preclinical Drug Development Strategies for Large Molecules; American Course on Drug Development and Regulatory Sciences (ACDRS), September 2008, San Francisco, CA
Phase 1 Clinical Trials Science and Regulatory Framework; What are the questions that
TNG1412 raised? CMR Conference, April 16, 2007, Surrey, UK
Preclinical Safety Assessment of Biologics and Traditional Pharmaceuticals in the Current Regulatory Environment; St. John’s University, April 2007, Queens, NY
Carcinogenicity Assessments of Biopharmaceuticals; Toxicology Winter Forum, February 2007 at Washington, DC
Preclinical Safety Testing of Biotechnology Products vs Traditional Pharmaceuticals; California State University Channel Islands, April 2006, Camarillo, CA
Regulatory Implications of TeGenero; St. John’s University, October 2006, New York, NY
Safety Assessment of Biotechnology Products – Modified Proteins; NYMC – Chemical Safety Assessment: Contributions of Toxicological Pathology and Mechanistic Investigations, October 2005 at Valhalla, NY
Safety Assessment of Biotechnology Products – Modified Proteins;NYMC – Chemical Safety Assessment: Contributions of Toxicological Pathology and Mechanistic Investigations, October 24, 2004 at Valhalla, NY
Safety Assessment of Biotechnology Products – Modified Proteins;NYMC – Chemical Safety Assessment: Contributions of Toxicological Pathology and Mechanistic Investigations, September 23, 2003 at Valhalla, NY
Pre-clinical Safety Testing of Biotechnology Products vs. Traditional Pharmaceuticals; Wilkes University, November 8, 2002 at Scranton, Pennsylvania.
Safety Assessment of Biotechnology Products – Modified Proteins 10th Annual Course on Safety Assessment of Medical Products;NYMC – Advanced Course, September, 2002 at Hyeres, France.
Strategic Toxicology Evaluation of Bio-Pharmaceuticals – Past, Present, and Future; Japanese Society of Toxicology, 29th Annual Meeting, June 18-20, 2002 at Nagoya, Japan.
In Vitro Screening: Predicting Toxicology in Early Drug Development, Information Technology Pharma Workshop (IBC) June 21-23, 2000 at Philadelphia, PA.
Pre-clinical Safety Testing of Drugs Produced by Biotechnology (ACT) November 7, 1999.
Pre-clinical Safety Testing of Drugs Produced by Biotechnology vs. Small Molecules (ICSD) September 21, 1999.
Pre-clinical Safety Testing of Drugs Provided by Biotechnology, Biotech Workshop (BIRA) June 7, 1999.
Pre-clinical Safety Testing of Drugs Produced by Biotechnology vs. Small Molecules (ICSD) University of Kansas, April 9, 1999 at, Lawrence, KS.
Pharmacokinetics and Toxicology of Pegylated Proteins, Biotech Conference (SBI) Tahoe, NV June 1, 1998.