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PTEK U Archive
For information about any of our past PTEK U seminars, or to get in touch with a speaker, contact Cecily Connor at (858) 805-6383 or cconnor@pharmatek.com.
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Date: December 15, 2011
Topic: A 33,000 Foot Overview of Drug Development
Speaker: Luana Pesco Koplowitz, MD, PhD, FCP, FFPM, President & Chief Medical Officer, DUCK FLATS Pharma, LLC
Location: WilmerHale Venture Group Office in Waltham, MA
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Date: December 8, 2011
Topic: Spray-Dried Dispersion Formulations in Suspensions and Solid Dosage Forms Speaker: Dr. Corey Bloom, Director of Formulation Science, Bend Research, Inc.
Location: Pharmatek Laboratories, Inc.
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Date: November 17 , 2011
Topic: Dynamic Dissolution Testing Using TIM-1
Speaker: Dr. John E. Sagartz, President and CEO, Seventh Wave Labs
Location: Pharmatek Laboratories, Inc.
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Date: August 2, 2011
Topic: Streamlining the Clinical Trial Materials Supply Chain
Speaker: Maureen Spataro, Founder and President, Spataro & Associates, Inc.
Location: Pharmatek Laboratories, Inc.
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Date: July 14, 2011
Topic: Orally Disintegrating Tablet and Film Technologies
Speaker: Carly Aubrey, Drug Delivery/Pharmaceuticals Research Manager, Technology Catalysts International
Location: Pharmatek Laboratories, Inc.
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Date: April 26, 2011
Topic: Evaluating Greening, Sustainability & Cost Savings for Biopharma Labs
Speaker: John A. MacKay, PhD, Senior Director, Waters Corporation
Location: Pharmatek Laboratories, Inc.
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Date: February 15, 2011
Topic: 30 Years of HAPI/Cytotoxic Manufacture Experience
Speaker: Dr. Eric De Vos, Senior R&D Manager, OmniChem
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Date: January 13, 2011
Topic: Potholes and Craters
Speaker: James Bruno, Owner, Chemical and Pharmaceutical Solutions
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Date: November 10, 2010
Topic: Tools for Improving the Quality and Robustness of Process Development
Speaker: Dagmar Meissner, Owner, BioProcess Solutions
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Date: October 12, 2010
Topic: A 33,000 Foot Overview of Drug Development: From Out of the Research Laboratories to NDA Filing
Speaker: Luana Pesco Koplowitz, MD, PhD, FCP, FFPM, President, Chief Medical & Scientific Officer, DUCK FLATS Pharma, LLC
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Date: June 2, 2010 August 12, 2010
Topic: Regulatory Safety Considerations for Clinical Dosage Formulations: Efficient strategies to manage and qualify impurities, degradents, residual solvents, extractables and leachables
Speaker: Shayne Cox Gad, Ph.D., D.A.B.T., ATS, Principal, Gad Consulting Services
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Date: April 15, 2010
Topic: Regulatory Intelligence: What is it and how can it accelerate your company's drug development?
Speaker: Sybille L. Sauter, Senior Regulatory Scientist, Ph.D., R.A.C. (US & EU), Cato Research Ltd.
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Date: March 18, 2010
Topic: An Overview of Filmcoating Strategies and Technology
Speaker: Heather Young, Area Technical Manager, Colorcon, Inc.
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Date: October 6, 2009
Topic: The Mechanistic Basis and Clinical Relevance of Pharmacokinetic Drug-Drug Interactions
Speaker: Thomas N. Thompson, Ph.D., President and Principal Consultant, R&D Services LLC
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Date: July 30, 2009
Topic: Amorphous Solid Dispersions
Speaker: Leah Appel, Ph.D., Managing Partner, Green Ridge Consulting
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Date: June 25, 2009
Topic: How to Design Studies and Analyze Data from Clinical Trials
Speaker: Todd Gross, Ph.D., Vice President, Statistics and SAS Programming, ClinOps LLC
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Date: January 22, 2009
Topic: Considerations of Oral Bioavailability in Drug Development
Speaker: Thomas N. Thompson, Ph.D., President and Principal Consultant, R&D Services LLC
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Date: November 13, 2008
Topic: Case Study - The Development of AAV-Neurturin as a Novel Neurorestorative Therapy for Advanced Parkinson's Disease: From Concept to Clinical Trials and Beyond
Speaker: Raymond T. Bartus, Ph.D., Exec. Vice President and Chief Scientific Officer, Ceregene, Inc.
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Date: October 1, 2008
Topic: Regulatory Requirements & Strategies for a Successful IND
Speaker: Patricia D. Williams, Ph.D., Chief Operating Officer, Summit Drug Development
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Date: September 23, 2008
Topic: Similarities and differences between the CMC information required for the EU IMPD CTA and the US IND
Speaker: Randal R. Lane MBA, R.A.C., Sr. Director Pharmaceutical Development & Asst. Managing Director, Cato Research San Diego
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Date: April 17th, 2008
Topic: Genotoxicity Testing for Pharmaceuticals – Current and Emerging Practices
Speaker: Grace M. Furman, Ph.D., D.A.B.T., CEO and President, Paracelsus, Inc.
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Date: March 6th, 2008
Topic: Occupational Health and Environmental Issues in Drug Development
Speaker: Allan W. Ader, Ph.D., D.A.B.T. , Vice President and Principal Toxicologist, SafeBridge Consultants, Inc.
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Date: February 12th, 2008
Topic: Nonclinical Drug Safety Requirements to Open an IND/FIM Trial
Speaker: Shayne Cox Gad, Ph.D., D.A.B.T., ATS, Principal, Gad Consulting Services
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Date: December 6th, 2007
Topic: Selecting and Managing a CRO
Speaker: Robert Ternansky, Ph.D., former Senior VP of Chemistry at Attenuon, LLC
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