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June 28-30, 2016

Palm Springs, California

Speakers

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Hanspeter Heiniger
Head of External Quality Combination Products
Roche

Day One

Wednesday June 29th 2016

09:30 | Linking Device Design Best Practices & Design Controls

Joely Gardner
Chief User Researcher
Human Factors Research

Dr. Joely Gardner is a highly experienced human factors and usability testing expert who specializes in medical devices, software, and web-based applications. She has done usability testing and voice of customer research projects for companies such as Bespak Injectables in the UK, Mitchell Medical, ThermoFisher, Quest Diagnostics Clinical Trials Division, and Cardinal Health. She also works with technology companies like Sony to bring the voice of the customer into early-stage product development efforts. In addition to her consulting practice, Dr. Gardner currently chairs the Education Committee of SDRAN (San Diego Regulatory Affairs Network) and is a part-time faculty member at California State University at Fullerton in a graduate-level Certificate Program for Customer Experience and User-Centered Design.

Day Two

Thursday June 30th 2016

12:00 | Panel Discussion: Human Factors Engineering & the Device Development Process

11:00 | Improving Patient Experience & Safety in Injectable Devices

Scott Arra
Device Technology Lead, Respiratory, Injectables,
and Topical Delivery Systems, North America, GSK

Workshop 1

Tuesday June 28th 2016

09:00 | Strategic Device Development Programs & the Seamless Transition of Drug Delivery Systems into Commercialization

Day Two

Thursday June 30th 2016

09:00 | Roundtable Discussion

Margot Thomas
New Product Development Manager
Fareva

Day One

Wednesday June 29th 2016

12:10 | Overcoming Challenges in the Manufacturing of Pre-Filled Syringes

Shem Fischer
Medical Manager, Contract Manufacturing
Oratech

Day One

Wednesday June 29th 2016

10:30 | Outsourcing for the Development & Manufacturing of PFS

Kerstin Walke
Head Global Pharmaceutical Development
Boehringer Ingelheim

Ed Israelski
Director Human Factors
AbbVie

Day Two

Thursday June 30th 2016

12:00 | Panel Discussion: Human Factors Engineering & the Device Development Process

11:30 | Human Factors Engineering Challenges in Injectable Devices

Edwin Harmon
Director of Manufacturing Operations
Genzyme

Day One

Wednesday June 29th 2016

10:00 | Successful, Cost-Effective & Efficient Industrialization & Scaling Up of Medical Device Manufacturing Pipelines

Diane Paskiet
Faculty Member PQRI Extractables and Leachables
West Pharmaceutical Services

Ms. Paskiet has over twenty years of experience in polymer analysis relating to  product failures, deformulation and migration studies.   She has served as a project advisor in support of qualification studies associated with container closure systems for regulatory filings.  Her current responsibilities include coordination of study plans and assessments  for technical support and R&D.  Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories.  
She is  a co-recipient of  the  United States Pharmacopeia (USP)  award for Innovative Response to a Public Health Challenge and currently leading revision of USP Elastomers chapter.  She is  also Chair of the PQRI Parenteral and Ophthalmic Drug Product (PODP) Leachables and Extractables Working Group and a faculty member of the PDA Training Institute as well as  author/co-author of  papers on the subject of pharmaceutical packaging

Day One

Wednesday June 29th 2016

16:10 | Panel Discussion: Analyzing Extractables & Leachables & Device Design

14:20 | The Product Quality Research Institute (PQRI) Approach to Leachables and Extractables: Application of Thresholds and Best Practices to Prefilled Syringe Systems

Day Two

Thursday June 30th 2016

14:30 | Panel Discussion: Addressing Regulation, CMC & Device Development

Mike Ronk
Principal Scientist
Amgen

Mike Ronk is a Principal Scientist at Amgen with nearly twenty years of experience in the biotechnology/pharmaceutical industry. Mike has an analytical chemistry background and his current responsibilities encompass a variety of activities within the Amgen’s extractables and leachables group.  

Day One

Wednesday June 29th 2016

15:20 | Assessing the Risk of Interaction Between Extractables & Leachables (E&L) & Therapeutic Proteins

Nan Lin
Manager Drug Product Technology
Regeneron

Day One

Wednesday June 29th 2016

12:20 | Integrated Approach to Filling Technology Selection Needs & Challenges for a Pipeline of Antibody Drug Candidates from Monoclonal Antibodies to Oncolytics Utilizing Containers Ranging from PFS to Custom Containers

Day Two

Thursday June 30th 2016

09:00 | Roundtable Discussion

Ross Allen
Associate Senior Consultant Engineer
Eli Lilly and Company

Day One

Wednesday June 29th 2016

11:40 | Understanding the Design Robustness of a Prefillable Syringe System

Stephen Brych
Principal Scientist
Amgen

Stephen has worked at Amgen since 2004 focusing on drug product development for multiple protein modalities such as peptibodies and mAbs. His research interests include protein symmetry, protein stability, protein evolution and most recently investigating particulation/aggregation formation mechanisms under various stress conditions.  

Day One

Wednesday June 29th 2016

13:50 | Effect of PFS Siliconization on Particulation & Other Product Quality Attributes of Bioformulations

Doug Kiehl
Team Leader - Spectroscopy, Raw Materials and Extractables & Leachables
Eli Lilly and Company

Day One

Wednesday June 29th 2016

16:10 | Panel Discussion: Analyzing Extractables & Leachables & Device Design

15:40 | A Visualization Approach to Characterizing Complex Mixtures of Extractables/Leachables (E&L) & Other Pharmaceutically Relevant Compounds using High Resolution LC-MS with 2-D and 3-D Mass Mapping

Gopi Vudathala
Head, Regulatory Affairs CMC & Compliance
GSK Vaccines

Dr. Vudathala holds the role of Head of Global Regulatory Affairs CMC & Compliance at GSK Vaccines (former Novartis Vaccines), where he provides regulatory CMC & Compliance strategy and support for the global approval and commercialization of Vaccines to prevent various diseases. He has previously held positions at XCell Pharma Consulting, Sanofi and P&G Pharmaceuticals as well as Health Canada. He has considerable experience in the regulatory aspects for small molecules, biologics, drug-device combinations and vaccines.  He gained his bachelor’s degree in Pharmacy from Bangalore University in 1982 and his PhD in Pharmaceutics and Drug Design from the University of Alberta in 1990.

Day Two

Thursday June 30th 2016

14:30 | Panel Discussion: Addressing Regulation, CMC & Device Development

14:00 | Building Design History Files for Injectable Devices to Safeguard Compliance in Global Regions

Jonathan Amaya Hodges
Manager, Device Systems Quality
Biogen

Jonathan has over 10 years of experience in medical device and combination product development and quality assurance. At Biogen he is a senior member of the quality organization responsible for overseeing the development of medical devices and combination products, particularly drug-delivery systems, for managing quality relationships with suppliers, and for implementing and maintaining related quality systems. Prior to Biogen, he has worked in drug-delivery combination product development, quality assurance for parenteral solutions, as well as quality assurance for medical device/in-vitro diagnostics. Jonathan has a bachelor’s degree in Chemical Engineering from Northwestern University and holds ASQ certifications for Quality Engineer and Manager of Quality/Organizational Excellence.

Day One

Wednesday June 29th 2016

17:00 | Chair’s Closing Remarks

08:50 | Chair’s Opening Remarks

Day Two

Thursday June 30th 2016

15:30 | Chair’s Closing Remarks

14:30 | Panel Discussion: Addressing Regulation, CMC & Device Development

09:00 | Roundtable Discussion

08:50 | Chair’s Opening Remarks

Srini Sridharan
Director, Innovation & Drug Delivery
Bristol-Myers Squibb

Day Two

Thursday June 30th 2016

12:00 | Panel Discussion: Human Factors Engineering & the Device Development Process

John Smith
Director, Global Regulatory Affairs
Allergan

Day One

Wednesday June 29th 2016

09:00 | Unpicking Global Regulatory Guidelines for Combination Product