December 4–6, 2017
Boston, US

Speakers

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Sabrina Restrepo
Director – Sterile & Validation Center of Excellence
Merck

Sabrina's responsibilities at Merck have included technical operations support in several areas such as deployment of single-use systems in vaccine manufacturing, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, cell culture media and drug substance manufacturing. Sabrina started her career as biochemical engineer, holding positions such as Senior Scientist, Team leader at various companies including Allergan and Irvine Scientific.

Day Two

Tuesday, December 5 2017

13.00 | Mapping Validation Considerations from Process Development to Product Launch and Beyond

Philip Duncanson
Director of Quality Assurance & Microbiology
AstraZeneca

Day One

Monday, December 4 2017

11.30 | New or Old Facility, Understanding, Assessing and Controlling Aseptic Manufacturing Risks

Claus Weisemann
Vice President, Quality Affairs
Luitpold Pharmaceuticals

Day One

Monday, December 4 2017

09.40 | How to Make Product Good with Aging Facilities and Equipment

Mark Yang
Director of Fill-Finish
Sanofi Genzyme

Dr. Yang is a Director in Global Pharmaceutic Development Biologics in Sanofi, where he leads a team responsible for formulation and lyo process development, process scale up, and technology transfers to commercial manufacturing/CMO. Prior to Genzyme, Dr. Yang was Associate Director at Acceleron Pharma, where he built the formulation lab/team and oversaw CTM manufacturing in US and EU. Dr. Yang also worked for many years in drug delivery and protein formulation in Baxter and Altus. He is the recipient of VP Award from Genzyme, Outstanding Technology Achievement Award for High Centration mAb Formulation from Baxter, and Fellows Award for Research Excellence from NIH. Besides numerous patents, he published over two dozen peer-reviewed research papers.

Day Two

Tuesday, December 5 2017

09.10 | Case Study: Develop a Robust Formulation and Fill Finish Process to Ensure a Smooth Scale Up and Tech Transfer for Drug Product Manufacturing

Greg Corcoran
General Manager/ Site Head
AntriaBio, Inc.

Mr. Corcoran joined AntriaBio's Colorado Operation in December 2016 as General Manager/Site Head. He brings over 30 years of both hands-on and leadership experience in aseptic manufacturing, Quality Assurance, Project and Process Engineering, Controls and instrumentation and Process Development at Abbott Labs, Amgen and an independent consultancy. Mr. Corcoran retired from Amgen in 2015 after 18 years serving in various high impact positions in Engineering, Operations, Quality Assurance, Contract Manufacturing and Process Development. His responsibilities included both large molecule manufacturing and aseptic fill/finish operations. In the 1990s Mr. Corcoran managed aseptic filling maintenance, lyophilization and labelling/packaging, including FDA 483 remediation at Abbott Labs. Prior to that he worked as a process engineer and process controls engineer in antibiotic drug substance, diagnostics, nutritionals, granulation, tableting and extended release oral solid dosage in Abbott locations in the US, Puerto Rico and Italy. Mr. Corcoran earned his Bachelor of Chemical Engineering from the Georgia Institute of Technology and his Masters of Management from the Kellogg School of Management at Northwestern University.

Day One

Monday, December 4 2017

09.10 | Keynote Address: Why Would a Startup Self-Perform Phase 1 Aseptic Processing? Case Studies

Melissa Stefko
Senior Director of QA
Wells Pharmacy Network, LLC

Melissa Stefko is an experienced Pharmaceutical and Biotechnology professional with a background in Quality Assurance and Quality Control in aseptic sterile processing.  Prior to joining Wells Pharmacy Network, Ms. Stefko served as Head of Quality with a start-up 503B Outsourcing Pharmacy and gained a strong CGMP understanding through previous positions within pharmaceutical manufacturers.  Ms. Stefko is an active member of the American Society for Quality as a Certified Quality Auditor and is a member of Institute of Environmental Sciences and Technology, American Society for Microbiology, Parenteral Drug Association, and IACP.  Ms. Stefko holds a Masters in Business Administration, a Masters of Science in Biotechnology, and Regulatory Affairs Certificate.

Day Two

Tuesday, December 5 2017

10.45 | Compounding Pharmacy Transition (503a to 503b) – From Small Batch to Commercial Sterile Manufacturing

Joshua Hellwig
Lyophilization Manager
Sanofi Pasteur

Josh Hellwig is the Lyophilization Manager in the Vaccine Industrial Affairs group of Sanofi Pasteur where he supports lyophilizer-related projects.  He was previously with Emergent BioSolutions in a variety of engineering roles.  He has over 9 years of experience designing, installing, commissioning, operating and repairing equipment in an aseptic environment.  Josh holds a Bachelor of Science in Electrical Engineering from the United States Naval Academy and a Master of Mechanical Engineering from Johns Hopkins University

Day Two

Tuesday, December 5 2017

09.40 | GMP Compliance for Aging Equipment

Evgenyi Shalaev
Research Investigator
Allergan

Evgenyi Shalaev, Ph.D., AAPS Fellow, is a director in Pharmaceutical Development, Allergan plc, Irvine, California, USA, and an adjunct professor in the Department of Pharmaceutics, University of Minnesota.  Dr. Shalaev held the Royal Society Fellowship in Pafra Biopreservation and the University of Cambridge, UK, post-doctoral research appointments at the University of Wisconsin-Madison and Cornell University, and worked at the Institute of Carbon (Russia), Institute of Molecular Biology (Russia), and Pfizer Inc. (USA), before taking his present position. His responsibilities in Allergan are focused on biological drug products covering both controlled release dosage forms and conventional formulations such as solutions and freeze-dried powders.  Dr Shalaev’s research interests include amorphous and other disordered solids; phase transitions in aqueous systems during freezing and drying; chemical and physical stability of small molecules and biologicals; development and scale-up of freeze-drying processes. He has published over ninety peer-reviewed papers, book chapters, and patent applications.

Day One

Monday, December 4 2017

12.00 | Terminal Sterilization of Lyophilies: Impact of Ionizing Radiation on Product Stability

Nithin Raghunathan
Research Scientist
Purdue University

Nithin Raghunathan received his Ph.D in electrical engineering from Purdue University, West Lafayette, IN, USA, in 2014. His dissertation focused on the development on micro-machined g-switches for impact applications typically in the ranges of 100 – 60,000 g’s. He worked as Post-Doctoral Research associate from 2014 to 2015 and was involved in the development of wireless radiation sensors for dosimetry applications. He is currently a Staff Scientist at the Birck Nanotechnology Center at Purdue University. His current research focus is in the development of sensors for pharmaceutical lyophilisation and aseptic processing.  His other interests include novel MEMS inertial devices, development of new microfabrication techniques, wireless and flexible sensors and Internet of things (IOT) and also sensors for industrial and harsh environments.

Day One

Monday, December 4 2017

14.30 | Advanced Aseptic Process Monitoring

Tony Van Hoose
CEO
Global Aseptic Process Solutions, LLC

Tony has been involved in the pharmaceutical industry for over 35 years as a Quality Assurance/Quality Control professional both for operating companies and as a consultant.  Tony holds a B.S. degree in Microbiology from Auburn University.  He has been a presenter at numerous IVT, ISPE, PDA and ASM conferences and has been an invited presenter for the FDA Aseptic Process Inspector Training classes. Currently Tony is the President/CEO of Global Aseptic Process Solutions, LLC.  Global Aseptic Process Solutions or GAPS, LLC provides general quality system and technical support for aseptic product manufacturing companies specializing in modernization and renovation of aseptic manufacturing facilities and processes assisting client in the transition from conventional filling technologies to state of the art aseptic manufacturing processes and systems utilizing RABS and isolator technologies to improve the sterility assurance of final products.  Tony is an expert in sterilization, visual inspection, container closure integrity testing and aseptic manufacturing processes.

Day One

Monday, December 4 2017

13.45 | Roundtable Discussion – Defining Aseptic Processing and Sterilization Standards, and Translating into Actions with Your Partners

Paul Gold
Principal
Pamigo Aseptic

Paul Gold is owner and principal consultant at Pamigo Aseptic.   He was previously Director, Global Aseptic Technology at Pfizer, Inc from which he retired after a career spanning nearly 40 years.  He has extensive experience in both hands-on execution and team leadership in aseptic processing operations.  His expertise in design and execution of aseptic drug product processes and equipment enabled him to lead and implement many different types of commercial and clinical projects on 3 continents.  In addition, Paul has executed multiple significant successful projects in the field of process containment for extreme high-potency materials.

Day Two

Tuesday, December 5 2017

11.15 | Master Mind: How to Work with Your Internal and External Partners to Enhance AP & Sterility Quality?

Nan Yung Lin
Independent Expert

Nan Yung is a pharma expert and has had leadership roles for leading a team of device, drug product, and biologic/ device combination product development programs from concept through commercialization. He was Manager, Drug Product Technology at Regeneron and Consultant Engineer at Eli Lilly. Nan Yung is a seasoned professional in Verification and Validation (V&V), Medical Devices, Change Control, Failure Mode and Effects Analysis (FMEA), Aseptic Processing, and Biotechnology. Strong product management professional with a Bachelors from Rutgers University and a MBA from Butler University.

Day One

Monday, December 4 2017

15.00 | Challenges and Opportunities in Filling Highly Viscous Biologics with New Pump and Closure Processing Technologies

Dominic DeGrazio
Associate Scientist- Large Molecule Drug Product Development
Janssen

Upon graduating from Franklin and Marshall College in 2012 with a degree in biochemistry and neuroscience, Dominick began working in the analytical laboratory at West Pharmaceutical Services performing extractable and leachable testing on parenteral packaging systems. He then transitioned to a role in Global R&D where he implemented the strategy for assessing the compatibility of primary packaging components with biologic drug products. In 2014, Dominick joined the analytical development group of Oncobiologics, a small biosimilar start-up. While at Oncobiologics, he developed and validated multiple assays for several biosimilar candidates currently within clinical trials. About two years ago, Dominick shifted into his current role within the drug product development group for large molecules at Janssen R&D.

Day Two

Tuesday, December 5 2017

13.30 | Container-Closure Integrity Testing for Parenteral Drug Products: Evolving with the Changing Regulatory Landscape