PTEK U Seminar Archive

For information about any of our past PTEK U seminars, or to get in touch with a speaker, contact Kimberly Scholz at (858) 805-6383 ext. 284 or kscholz@pharmatek.com.

Date: March 8, 2016

Topic: Supporting Accelerated Approval Pathways with Continued Process Development

Speaker: Julia O’Neill, Senior Statistician & Principal, Tunnell Consulting

About the Speaker:
Julia O’Neill is a statistician (MS, University of Wisconsin) and chemical engineer (BS, University of Maine) with over 30 years of experience in the vaccines, biologics, pharmaceutical, chemical, and paper industries. She provides strategic guidance and statistical services to organizations ranging from start-up biotech to multinational pharmaceutical manufacturers.  Her technical expertise applies to research and development, manufacturing, corporate and direct customer support functions. Prior to joining Tunnell, Julia was Director, Engineering, Global Technical Operations at Merck and Co. where she was responsible for development and deployment of process robustness strategy for manufacturing of all human health products.  Previously she served as Senior Scientific Fellow – Statistics in Regulatory & Analytical Sciences at Merck. She led the design and implementation of Continued Process Verification for Merck’s vaccines and biologics for all global manufacturing sites.  Julia is an expert in resolving challenging problems using statistical, engineering and Six Sigma methods.

Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: August 7, 2015

Topic: Extrusion-Enabled Pharmaceutical Processes

Speaker: Andrei Winkler, Global Business Development Manager, Thermo Fisher Scientific

About the Speaker:
With an education in Chemical Engineering and an MBA, Andrei has worked much of his career in the specialty chemicals industry in sales and new business development roles for Cytec Industries in Europe, Asia and North America.  Andrei has spent 5 years developing the North American business of a Dutch contract research organization serving the pharmaceutical industry with focus on high-throughput experimentation in the solid state chemistry space.  Andrei has spent the last 4 years as Commercial Leader of the Material Characterization business unit of Thermo Scientific. Since Jan 2015, Andrei is fully dedicated to business development and sales activities dedicated to the pharmaceutical, drug delivery and medical device segments.

Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: May 15, 2015

Topic: Are You Ready to Validate Your Process?

Speaker: Steve Pondell, Principal at Integrated BioTech Solutions

About the Speaker:
Steve Pondell is a Principal at Integrated BioTech Solutions. He is a CMC expert in the manufacturing, compliance and regulatory aspects of product development from clinical manufacturing, through global regulatory approvals and into commercial production. As an expert consultant, Steve has served a variety of small to medium sized pharma and biotech companies with projects that include GMP Gap Analyses, Phase I product development programs, cGMP compliance and supplier audits, and business development activities for a global logistics provider. He has experience at working with small biotech companies as well as multi-national pharmaceutical companies. He has served as a contract manufacturer and as a virtual manufacturing outsourcing manager. His particular specialty is assisting companies work across the sponsor/contract manufacturing relationship, creating high performing partnerships on a global basis.

Location: Pharmatek

For a PDF version of this presentation Click Here.

To download a recording of the presentation Click Here.
*We were having some minor technical difficulties with sound at the very beginning of the presentation, we apologize for the inconvenience.


Date: April 16, 2015

Topic: Key Considerations for Companies Outsourcing their Clinical Packaging and Distribution Needs

Speaker: Mark E. Paiz, Founder & President of Sherpa Clinical Packaging

Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: August 28, 2014

Topic: Precision Medicine:  A Medical Miracle or An Ethical Nightmare?

Speaker: Linda Strause, Ph.D., Principal at Strategic Clinical Consultants

Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: June 20, 2014

Topic: Discovery Translation & the Valley of Death:  A Personal Perspective

Speaker: Professor Maree T. Smith, Centre for Integrated Preclinical Drug Development (CIPDD)/ TetraQ, the University of Queensland Brisbane, QLD, Australia

Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: January 23, 2014
Topic: So you think you’re ready for an IND?- Strategic Design & Formulation Considerations for GLP Toxicology Studies
Speaker: Grace Furman, CEO/President at Paracelsus, Inc. & Meredith Perry, Scientist at Pharmatek
Location: BIOCOM Boardroom

For a PDF version of this presentation Click Here.

Date: October 23, 2013
Topic: Contemporary Lyophilization Science, Technology and Regulations
Speaker: Ed Trappler, President & Founder of Lyophilization Technology, Inc.
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: June 4, 2013
Topic: Scale-Up, Modeling and QbD in Spray Drying Processes
Speaker: Filipe Gaspar, Ph.D., Dir. of Drug Product Technology, Particle Design Business Unit at Hovione
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: May 21, 2013

Topic: Transitioning to Development: The importance of the Solid-Form

Speaker: Prof. Chris Frampton, CSO of SAFC-Pharmorphix

Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: June 24, 2012
Topic: Environmental, Health & Safety Auditing of Highly-Potent Facilities
Speaker: Dean Calhoun, CIH & President of Affygility Solutions
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: May 17, 2012
Topic: Leveraging Off-Target Effects Through Compound Re-Optimization
Speaker: Dr. Eric Jamois, V.P. of US Operation at Prestwick Chemical, Inc.
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: March 22, 2012
Topic: Dynamic Dissolution Testing Using TIM-1
Speaker: Dr. John E. Sagartz, President & CEO of Seventh Wave Labs
Location: WilmerHale Venture Group Office in Waltham, MA

For a PDF version of this presentation Click Here.

Date: February 7, 2012
Topic: FDA Latest Trends
Speaker: Virginia L. Corbin, Manager of Corporate Alliance Marketing at Waters Corporation
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: December 15, 2011
Topic: A 33,000 Foot Overview of Drug Development
Speaker: Luana Pesco Koplowitz, MD, Ph.D., FCP, FFPM, President & Chief Medical Officer of DUCK FLATS Pharma, LLC
Location: WilmerHale Venture Group Office in Waltham, MA

For a PDF version of this presentation Click Here.

Date: December 8, 2011
Topic: Spray-Dried Dispersion Formulations in Suspensions & Solid Dosage Forms
Speaker: Dr. Corey Bloom, Director of Formulation Science at Bend Research, Inc.
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: November 17, 2011

Topic: Dynamic Dissolution Testing Using TIM-1

Speaker: Dr. John E. Sagartz, President & CEO of Seventh Wave Labs

Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: August 2, 2011

Topic: Streamlining the Clinical Trial Materials Supply Chain

Speaker: Maureen Spataro, Founder & President of Spataro & Associates, Inc.

Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: July 14,  2011
Topic: Orally Disintegrating Tablet & Film Technologies
Speaker: Carly Aubrey, Drug Delivery/Pharmaceuticals Research Manager at Technology Catalysts International
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: April 26, 2011

Topic: Evaluating Greening, Sustainability & Cost Savings for Biopharma Labs

Speaker: John A. MacKay, Ph.D., Sr. Director at Waters Corporation

Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: February 15,  2011
Topic: 30 Years of HAPI/Cytotoxic Manufacture Experience
Speaker: Dr. Eric De Vos, Senior R&D Manager at OmniChem
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: January 13, 2011

Topic: Potholes & Craters

Speaker: James Bruno, Owner of Chemical & Pharmaceutical Sciences

Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: November 10,  2010
Topic: Tools for Improving the Quality & Robustness of Process Development
Speaker: Dagmar Meissner, Owner of BioProcess Solutions
Location: Pharmatek

For a PDF version of this presentation Click Here.

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 Kopowitz, MD, Ph.D., FCP, FFPM, President and Chief Medical & Scientific Officer at DUCK FLATS Pharma, LLC

Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: August 12, 2010

Topic: Regulatory Safety Considerations for Clinical Dosage Formulations

Speaker: Shayne Gad, Ph.D., D.A.B.T., ATS, Principal at Gad Consulting Services

Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: October 6,  2009
Topic: The Mechanistic Basis & Clinical Relevance of Pharmacokinetic Drug-Drug Interactions
Speaker: Thomas N. Thompson, Ph.D., President & Principal Consultant at R&D Services, LLC
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: July 30, 2009
Topic: Amorphous Solid Dispersions
Speaker: Leah Appel, Ph.D., Managing Partner at Green Ridge Consulting
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: June 25, 2009
Topic: How to Design Studies & Analyze Data from Clinical Trials
Speaker: Todd Gross, Ph.D., V.P. of Statistics and SAS Programming at ClinOps, LLC
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: January 22, 2009
Topic: Considerations of Oral Bioavailability in Drug Development
Speaker: Thomas N. Thompson, Ph.D., President & Principal at R&D Services, LLC.
Location: Pharmatek

For a PDF version of this presentation Click Here.

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 & Beyond

Speaker: Raymond T. Bartus, Ph.D., Exec. V.P. & Chief Scientific Officer at Ceregene, Inc.

Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: October 1, 2008
Topic: Regulatory Requirements & Strategies for a Successful IND
Speaker: Patricia D. Williams, Ph.D., Chief Operating Officer at Summit Drug Development
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: September 23, 2008
Topic: Similarities & Differences between the CMC Information Required for the EU IMPD CTA & the US IND
Speaker: Randal R. Lane, MBA, R.A.C., Sr. Dir. Pharmaceutical Development & Asst. Managing Director at Cato Research San Diego
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: April 17, 2008
Topic: Genotoxicity Testing for Pharmaceuticals- Current & Emerging Practices
Speaker: Grace M. Furman, Ph.D., D.A.B.T., CEO & President at Paracelsus, Inc.
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: March 6, 2008
Topic: Occupational Health & Environmental Issues in Drug Development
Speaker: Allan W. Ader, Ph.D., D.A.B.T., V.P. & Principal Toxicologist at SafeBridge Consultants, Inc.
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: February 12, 2008
Topic: Nonclinical Drug Safety Requirements to Open an IND/FIM Trial
Speaker: Shayne Gad, Ph.D., D.A.B.T., ATS, Principal at Gad Consulting Services
Location: Pharmatek

For a PDF version of this presentation Click Here.

Date: December 6, 2007
Topic: Selecting and Managing a CRO
Speaker: Robert Ternansky, Ph.D., Former Sr. V.P. of Chemistry at Attenuon, LLC
Location: Pharmatek

For a PDF version of this presentation Click Here.

 

 

 

 

 

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