Presentations
“What Will Biosimilars Look Like in 5 Years?”, DIA Biosimilars Virtual Conference, Oct 6, 2020.
Biosimilars 2020 & Beyond, Interphex Live, Interphex Conference (Virtual), August 13, 2020.
Disruption & Innovation in Cell and Gene Therapy, Panel Moderator, BioNJ Manufacturing Briefing, NJ Institute of Technology, Sept 20, 2019
Biosimilars 5.0, Interphex Live, Interphex Conference, NY, NY. April 3, 2019
“Top Bioprocessing Trends for the Next Five Years”, AGC Global Consultants Summit, Seattle, WA, Sept 11-13, 2018.
"Biosimiliars 4.0", Interphex Conference, Interphex Live Series, New York, NY, April 17, 2018.
“A New Fusion Protein Therapeutic for Enzymatic Targeting”, Protein Engineering Summit (PEGS), Boston, MA, May 2, 2017.
“A Biosimilars Snapshot - Current Issues & Challenges", ISPE Delaware Valley Chapter, April 20, 2017.
"The Technical Aspects of Auditing", PDA Metro Symposium on Auditing, Somerset, NJ, March 28, 2017.
"Biosimilars 3.0", Interphex Conference, Interphex Live Series, New York, NY, March 22, 2017.
"A New Fab-Fusion Protein Therapeutic: Design, Production & Purification", Bioprocess Theatre, Bioprocess International Conference, Boston, MA, Oct 4, 2016.
"The Road to the Biologic IND", Interphex, April 21, 2015, New York, NY.
"Implementation and Use of Single-Use Products - A CMO Perspective", BIO 2014, IBC Bioprocess Theatre, San Diego, CA.
"A New Biobetter: Development and Manufacturing, A Collaboration Case Study", IBC Biopharmaceutical Development & Production Week, Mar 24, 2014. See pre-conference podcast and "Future of Biopharma" blogspot.
"Developing and Manufacturing Biosimilars and Biobetters", similar series of presentations at PDA Metro Chapter, Bridgewater, NJ, Jan 2014; Bioprocess Theatre at BIO2013, Chicago, Apr 2013; Sino-American Pharmaceutical Association, Chicago, Apr 2013; Biopharma Research Council, Philadelphia, Apr 2013; Tech Council of Maryland, Rockville, MD, Dec 2012; and BioNJ Bio-Manufacturing Summit, East Brunswick, NJ, Nov 2012.
"The Road to Biologic IND", on-going series of presentations in New York (Interphex, April 2015), San Diego (Janssen Labs, Nov 2013 and Nov 2012), Princeton (BioNJ, Apr 2012), Philadelphia (Science Center, Mar 2012), Hershey (Medical Center, Jan 2012), San Jose, CA (San Jose Bio Center, Jan 2012 & Apr 2011), Cambridge (Mass BIO, Oct 2011).
"Single-Use Technologies in Biopharmaceutical Manufacturing", World Orphan Drug Congress, Washington, DC, Apr 2013.
"Upstream & Downstream Challenges of Clinical Production of a Human IgM Antibody Therapeutic", Tech Council of Maryland, Rockville, MD, Feb 2013.
"Development & Manufacturing of Biopharmaceuticals", ISPE NJ Professional Development Day, Dec 2012 and World Orphan Drug Congress, Washington DC, Apr 2013 (Keynote speaker).
"Single-Use vs. Stainless Steel Bioreactor Production of a Complex Glycoprotein: A Case Study", Bioproduction 2012, Berlin, Germany, Oct 2012, and Cell Culture Congress 2012, Nov 2012.
"Purification Challenges with Fusion Proteins", ACS Biannual Recovery Conference, Stowe, VT, Aug 2012 and Biotech 2012, Philadelphia, Oct 2012.
"Upstream and Downstream Challenges of Clinical Production of a Human IgM Antibody Therapeutic", Bioprocess International Conference, Nov 2011, Long Beach, CA, and DE Chema IgM Workshop, Nov 2011, Frankfurt, Germany.
"Bioprocessing Challenges of Fusion Proteins", European Society of Animal Cell Culture Technology (ESACT), 05/15/11, Vienna, Austria.
"Downstream Challenges of Mabs and Fusion Proteins - Platforming and Its Limits", Downstream Technology Forum, keynote address, 09/29/11, Rockville, MD.
"From Vial Thaw to IND in 6 Months - A Case Study from Client & CMO Perspectives", Biopharm Production Week, 03/15/11, Bellevue, WA.
“Comparison Of Cell Culture Production Of A Recombinant Protein in Stainless Steel vs. Single-Use Bioreactors”, IBC Conference on Single-Use Applications for Biopharmaceutical Manufacturing, 06/14/10, La Jolla, CA.
“Biomanufacturing at Laureate Pharma”, BioNJ Breakfast Forum on Biomanufacturing in New Jersey, 03/ 25/10, Iselin, NJ. Similar presentation made at ISPE Forum on the Future of Biopharmaceutical Contract Manufacturing, 04/08/10, Bridgewater, NJ.
“Disposable Technologies in Biopharmaceutical Manufacturing from Cell Culture to Aseptic Filling”, ISPE Annual Conference, 11/11/09, San Diego, CA.
“Development of a Novel Fusion Protein Therapeutic for Macular Degeneration”. Joint presentation with Kirk Dornbush, President of Iconic Therapeutics, Biotechnology Industry Organization Annual Meeting, Bioprocess Theatre, 05/19/10, Atlanta, GA.
“Platform Technologies to Streamline Development”, Session Chair at ISPE Annual Conference, 10/29/08, Boca Raton, FL.
“High-Throughput Methods for High-Titer Products”, ISPE Annual Conference, 10/27/08, Boca Raton, FL.
“Solutions to Fusion-Molecule Purification”, joint presentation with Thomas P. Loisel, Group Leader of Biology at Enobia Pharma, Bioprocess International Conference, 9/25/08, Anaheim, CA.
“The Pilot Plant as a Key Element for Efficient Tech Transfer”, IBC Conference on Tech Transfer of Biopharmaceuticals, 3/10-11/08, San Diego, CA.
“Enhancing Tech Transfer from Development into cGMP Manufacturing”, Waterside Conference on Scale Up and Production of Recombinant and Monoclonal Antibodies, 2/4-6/08, Miami, FL.
“Tech Transfer & Process Modernization of a Radio-therapeutic Antibody for Glioblastoma”, joint presentation with Kerry M. Barnhart, M.D., President & CSO, Bradmer Pharmaceuticals. IBC Conference on Outsourcing Manufacturing of Biopharmaceuticals, 2/27-28/07, Carlsbad, CA. Similar presentation given at the Bioprocess Zone of the Biotechnology Industry Organization annual meeting, 5/9/07, Boston, MA.
“Development of a Third-Generation Radio-therapeutic Antibody”, joint presentation with John Tedesco, VP Operations & Regulatory Affairs, IBC Conference on Antibody Development and Production, 3/1-3/06, Carlsbad, CA.
“Growth and Evolution of Early-Phase Clinical Production: Case Study of Antibody Production and Filling”, joint presentation with Thomas Lauzon, Sr. Director of Operations, ImmunoGen Corp., IBC Conference on Outsourcing Manufacturing of Biopharmaceuticals, 2/26-27/06, Carlsbad, CA.
“Case Study of the Technology Transfer of a New Radio-therapeutic Antibody between a CRO, CMO and a Sponsor”, joint presentation with John Tedesco, Sr. Director of Quality & Operations, Cytogen Corp., IBC Conference on Logistics for Biopharmaceuticals, 12/12-13/05, Reston, VA.
“Early-Stage Tech Transfer for Two Antibody Products”: Seminar on Tech Transfer, Bioprocess International Conference, 9/21-24/05, Boston, MA.
“Effective Tech Transfer between a Biopharmaceutical Company and Its CMO: Two Case Histories of Antibody Therapeutics”, joint presentation with Mark O’Mahony, Sr. Director of Manufacturing, TolerRx, Inc., IBC Conference on Logistics for Biopharmaceuticals, 12/6-7/04, San Francisco, CA.
“Biopharmaceuticals for the Non-Scientist”. Biotech 2004, Joint Annual Meeting of Biotech Council of NJ and Pennsylvania Biotech Association, 10/4-5/04, Philadelphia, PA.
“Antibodies as Biopharmaceuticals”. American Chemical Society, South Jersey Chapter, 4/20/04, Deptford, NJ.
“Developing Antibody-Based Therapeutics – Teamwork between a Biopharmaceutical Company & Its CMO” – Joint presentation with client representative, Manupharma Congress, 4/4-5/04, Boston, MA.
“Innovations in Biopharmaceutical Manufacturing to Enhance Productivity and Recoveries”. Biotechnica, 10/10- 12/03, Hanover, Germany.
“Developing your Antibody Pharmaceutical through Partnership with a cGMP Supplier”. Scientific Research Institute’s First Conference on Antibody Deal Making and Financing, 4/8-9/02; San Diego, CA.
“Practical Issues in Antibody Purification for Biopharmaceutical Manufacture”. European Conference on Antibody Production & Purification, 10/27-29/99, Paris, France.
“The Design of Antibody Purification Processes for cGMP Manufacturing”. Fifth IBC Conference on Antibody Production & Downstream Processing, 3/8-10/99, San Diego, CA.
"Production of Purified Antibodies by High Performance Tangential Flow Filtration (HPTFF)". Fourth IBC Conference on Monoclonal Antibody Purification, 3/18/98, San Diego, CA. (Also served as conference chairperson).
"Ultrafiltration (HPTFF) as an Alternative to Column Chromatography for Antibody Purification” BioPharm '97, Session II: Downstream Processing, 5/5-7/97, San Francisco, CA.
"Purification of Monoclonal Antibodies from Macromolecular Components of Culture Feedstock using Ultrafiltration", Third IBC Conference on Monoclonal Antibody Purification, 3/19-20/97, San Diego, CA.
"Production & purification processes for a monoclonal antibody from initial stages through clinical trials", Second IBC Conference on Monoclonal Antibody Purification, 5/16-17/96, La Jolla, CA. (Also served as session chairperson).
"Vertical Integration in the Purification of a Monoclonal Antibody", First IBC Conference on Monoclonal Antibody Purification, 4/20-21/95, San Francisco, CA.
"Validation of Viral Removal/Inactivation in the Manufacture of Monoclonal Antibody for Human Use", First IBC Conference on Monoclonal Antibody Production, 4/20-21/95, San Francisco, CA.
"Pharmacokinetics and Tumor Localization of 99mTc-labeled Fab' Derived from Monoclonal Antibody 15A82a", Eighth International Conference on Monoclonal Antibodies for Cancer, 3/18-20/93, San Diego, CA.
"Inhibition of Mannosidase in Hybridomas Yields Monoclonal Antibodies with Greater Capacity for Carbohydrate Labeling", Oak Ridge Clinical Chemistry Conference, 4/88, Savannah, GA.“A New Fusion Protein Therapeutic for Enzymatic Targeting”, Protein Engineering Summit (PEGS), Boston, MA. May 2, 2017.“A New Fusion Protein Therapeutic for Enzymatic Targeting”, Protein Engineering Summit (PEGS), Boston, MA. May 2, 2017.“A New Fusion Protein Therapeutic for Enzymatic Targeting”, Protein Engineering Summit (PEGS), Boston, MA. May 2, 2017.
Biosimilars 2020 & Beyond, Interphex Live, Interphex Conference (Virtual), August 13, 2020.
Disruption & Innovation in Cell and Gene Therapy, Panel Moderator, BioNJ Manufacturing Briefing, NJ Institute of Technology, Sept 20, 2019
Biosimilars 5.0, Interphex Live, Interphex Conference, NY, NY. April 3, 2019
“Top Bioprocessing Trends for the Next Five Years”, AGC Global Consultants Summit, Seattle, WA, Sept 11-13, 2018.
"Biosimiliars 4.0", Interphex Conference, Interphex Live Series, New York, NY, April 17, 2018.
“A New Fusion Protein Therapeutic for Enzymatic Targeting”, Protein Engineering Summit (PEGS), Boston, MA, May 2, 2017.
“A Biosimilars Snapshot - Current Issues & Challenges", ISPE Delaware Valley Chapter, April 20, 2017.
"The Technical Aspects of Auditing", PDA Metro Symposium on Auditing, Somerset, NJ, March 28, 2017.
"Biosimilars 3.0", Interphex Conference, Interphex Live Series, New York, NY, March 22, 2017.
"A New Fab-Fusion Protein Therapeutic: Design, Production & Purification", Bioprocess Theatre, Bioprocess International Conference, Boston, MA, Oct 4, 2016.
"The Road to the Biologic IND", Interphex, April 21, 2015, New York, NY.
"Implementation and Use of Single-Use Products - A CMO Perspective", BIO 2014, IBC Bioprocess Theatre, San Diego, CA.
"A New Biobetter: Development and Manufacturing, A Collaboration Case Study", IBC Biopharmaceutical Development & Production Week, Mar 24, 2014. See pre-conference podcast and "Future of Biopharma" blogspot.
"Developing and Manufacturing Biosimilars and Biobetters", similar series of presentations at PDA Metro Chapter, Bridgewater, NJ, Jan 2014; Bioprocess Theatre at BIO2013, Chicago, Apr 2013; Sino-American Pharmaceutical Association, Chicago, Apr 2013; Biopharma Research Council, Philadelphia, Apr 2013; Tech Council of Maryland, Rockville, MD, Dec 2012; and BioNJ Bio-Manufacturing Summit, East Brunswick, NJ, Nov 2012.
"The Road to Biologic IND", on-going series of presentations in New York (Interphex, April 2015), San Diego (Janssen Labs, Nov 2013 and Nov 2012), Princeton (BioNJ, Apr 2012), Philadelphia (Science Center, Mar 2012), Hershey (Medical Center, Jan 2012), San Jose, CA (San Jose Bio Center, Jan 2012 & Apr 2011), Cambridge (Mass BIO, Oct 2011).
"Single-Use Technologies in Biopharmaceutical Manufacturing", World Orphan Drug Congress, Washington, DC, Apr 2013.
"Upstream & Downstream Challenges of Clinical Production of a Human IgM Antibody Therapeutic", Tech Council of Maryland, Rockville, MD, Feb 2013.
"Development & Manufacturing of Biopharmaceuticals", ISPE NJ Professional Development Day, Dec 2012 and World Orphan Drug Congress, Washington DC, Apr 2013 (Keynote speaker).
"Single-Use vs. Stainless Steel Bioreactor Production of a Complex Glycoprotein: A Case Study", Bioproduction 2012, Berlin, Germany, Oct 2012, and Cell Culture Congress 2012, Nov 2012.
"Purification Challenges with Fusion Proteins", ACS Biannual Recovery Conference, Stowe, VT, Aug 2012 and Biotech 2012, Philadelphia, Oct 2012.
"Upstream and Downstream Challenges of Clinical Production of a Human IgM Antibody Therapeutic", Bioprocess International Conference, Nov 2011, Long Beach, CA, and DE Chema IgM Workshop, Nov 2011, Frankfurt, Germany.
"Bioprocessing Challenges of Fusion Proteins", European Society of Animal Cell Culture Technology (ESACT), 05/15/11, Vienna, Austria.
"Downstream Challenges of Mabs and Fusion Proteins - Platforming and Its Limits", Downstream Technology Forum, keynote address, 09/29/11, Rockville, MD.
"From Vial Thaw to IND in 6 Months - A Case Study from Client & CMO Perspectives", Biopharm Production Week, 03/15/11, Bellevue, WA.
“Comparison Of Cell Culture Production Of A Recombinant Protein in Stainless Steel vs. Single-Use Bioreactors”, IBC Conference on Single-Use Applications for Biopharmaceutical Manufacturing, 06/14/10, La Jolla, CA.
“Biomanufacturing at Laureate Pharma”, BioNJ Breakfast Forum on Biomanufacturing in New Jersey, 03/ 25/10, Iselin, NJ. Similar presentation made at ISPE Forum on the Future of Biopharmaceutical Contract Manufacturing, 04/08/10, Bridgewater, NJ.
“Disposable Technologies in Biopharmaceutical Manufacturing from Cell Culture to Aseptic Filling”, ISPE Annual Conference, 11/11/09, San Diego, CA.
“Development of a Novel Fusion Protein Therapeutic for Macular Degeneration”. Joint presentation with Kirk Dornbush, President of Iconic Therapeutics, Biotechnology Industry Organization Annual Meeting, Bioprocess Theatre, 05/19/10, Atlanta, GA.
“Platform Technologies to Streamline Development”, Session Chair at ISPE Annual Conference, 10/29/08, Boca Raton, FL.
“High-Throughput Methods for High-Titer Products”, ISPE Annual Conference, 10/27/08, Boca Raton, FL.
“Solutions to Fusion-Molecule Purification”, joint presentation with Thomas P. Loisel, Group Leader of Biology at Enobia Pharma, Bioprocess International Conference, 9/25/08, Anaheim, CA.
“The Pilot Plant as a Key Element for Efficient Tech Transfer”, IBC Conference on Tech Transfer of Biopharmaceuticals, 3/10-11/08, San Diego, CA.
“Enhancing Tech Transfer from Development into cGMP Manufacturing”, Waterside Conference on Scale Up and Production of Recombinant and Monoclonal Antibodies, 2/4-6/08, Miami, FL.
“Tech Transfer & Process Modernization of a Radio-therapeutic Antibody for Glioblastoma”, joint presentation with Kerry M. Barnhart, M.D., President & CSO, Bradmer Pharmaceuticals. IBC Conference on Outsourcing Manufacturing of Biopharmaceuticals, 2/27-28/07, Carlsbad, CA. Similar presentation given at the Bioprocess Zone of the Biotechnology Industry Organization annual meeting, 5/9/07, Boston, MA.
“Development of a Third-Generation Radio-therapeutic Antibody”, joint presentation with John Tedesco, VP Operations & Regulatory Affairs, IBC Conference on Antibody Development and Production, 3/1-3/06, Carlsbad, CA.
“Growth and Evolution of Early-Phase Clinical Production: Case Study of Antibody Production and Filling”, joint presentation with Thomas Lauzon, Sr. Director of Operations, ImmunoGen Corp., IBC Conference on Outsourcing Manufacturing of Biopharmaceuticals, 2/26-27/06, Carlsbad, CA.
“Case Study of the Technology Transfer of a New Radio-therapeutic Antibody between a CRO, CMO and a Sponsor”, joint presentation with John Tedesco, Sr. Director of Quality & Operations, Cytogen Corp., IBC Conference on Logistics for Biopharmaceuticals, 12/12-13/05, Reston, VA.
“Early-Stage Tech Transfer for Two Antibody Products”: Seminar on Tech Transfer, Bioprocess International Conference, 9/21-24/05, Boston, MA.
“Effective Tech Transfer between a Biopharmaceutical Company and Its CMO: Two Case Histories of Antibody Therapeutics”, joint presentation with Mark O’Mahony, Sr. Director of Manufacturing, TolerRx, Inc., IBC Conference on Logistics for Biopharmaceuticals, 12/6-7/04, San Francisco, CA.
“Biopharmaceuticals for the Non-Scientist”. Biotech 2004, Joint Annual Meeting of Biotech Council of NJ and Pennsylvania Biotech Association, 10/4-5/04, Philadelphia, PA.
“Antibodies as Biopharmaceuticals”. American Chemical Society, South Jersey Chapter, 4/20/04, Deptford, NJ.
“Developing Antibody-Based Therapeutics – Teamwork between a Biopharmaceutical Company & Its CMO” – Joint presentation with client representative, Manupharma Congress, 4/4-5/04, Boston, MA.
“Innovations in Biopharmaceutical Manufacturing to Enhance Productivity and Recoveries”. Biotechnica, 10/10- 12/03, Hanover, Germany.
“Developing your Antibody Pharmaceutical through Partnership with a cGMP Supplier”. Scientific Research Institute’s First Conference on Antibody Deal Making and Financing, 4/8-9/02; San Diego, CA.
“Practical Issues in Antibody Purification for Biopharmaceutical Manufacture”. European Conference on Antibody Production & Purification, 10/27-29/99, Paris, France.
“The Design of Antibody Purification Processes for cGMP Manufacturing”. Fifth IBC Conference on Antibody Production & Downstream Processing, 3/8-10/99, San Diego, CA.
"Production of Purified Antibodies by High Performance Tangential Flow Filtration (HPTFF)". Fourth IBC Conference on Monoclonal Antibody Purification, 3/18/98, San Diego, CA. (Also served as conference chairperson).
"Ultrafiltration (HPTFF) as an Alternative to Column Chromatography for Antibody Purification” BioPharm '97, Session II: Downstream Processing, 5/5-7/97, San Francisco, CA.
"Purification of Monoclonal Antibodies from Macromolecular Components of Culture Feedstock using Ultrafiltration", Third IBC Conference on Monoclonal Antibody Purification, 3/19-20/97, San Diego, CA.
"Production & purification processes for a monoclonal antibody from initial stages through clinical trials", Second IBC Conference on Monoclonal Antibody Purification, 5/16-17/96, La Jolla, CA. (Also served as session chairperson).
"Vertical Integration in the Purification of a Monoclonal Antibody", First IBC Conference on Monoclonal Antibody Purification, 4/20-21/95, San Francisco, CA.
"Validation of Viral Removal/Inactivation in the Manufacture of Monoclonal Antibody for Human Use", First IBC Conference on Monoclonal Antibody Production, 4/20-21/95, San Francisco, CA.
"Pharmacokinetics and Tumor Localization of 99mTc-labeled Fab' Derived from Monoclonal Antibody 15A82a", Eighth International Conference on Monoclonal Antibodies for Cancer, 3/18-20/93, San Diego, CA.
"Inhibition of Mannosidase in Hybridomas Yields Monoclonal Antibodies with Greater Capacity for Carbohydrate Labeling", Oak Ridge Clinical Chemistry Conference, 4/88, Savannah, GA.“A New Fusion Protein Therapeutic for Enzymatic Targeting”, Protein Engineering Summit (PEGS), Boston, MA. May 2, 2017.“A New Fusion Protein Therapeutic for Enzymatic Targeting”, Protein Engineering Summit (PEGS), Boston, MA. May 2, 2017.“A New Fusion Protein Therapeutic for Enzymatic Targeting”, Protein Engineering Summit (PEGS), Boston, MA. May 2, 2017.