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Sept 5 – 7 | San Diego

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Speakers

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James Wabby
Executive Director - Regulatory Affairs, Devices & Combination Products
Allergan

Day One

Thursday September 6, 2018

18:00 | Chair's Closing Remarks

09:10 | Opening Address: How Safe Are My Devices? Regulatory Compliance for Different Types of Injectables

09:00 | Chair’s Opening Remarks

Day Two

Friday September 7, 2018

15:30 | Chair's Closing Remarks

09:00 | Chair’s Opening Remarks

Jennifer Hefele Wald
Director Global Regulatory Affairs Combination Products
Pfizer

Jennifer has assumed the role of Director of Combination Products, Differentiated Drug Delivery Regulatory Affairs at Pfizer since Jan 2018. She’s however been working actively in this space since 2014, and prior to that she’s the Manager of Global Regulatory Affairs at Hospira. Jennifer obtained a PhD in Biochemistry from University of Illinois at Urbana-Champaign in 1990.

Day One

Thursday September 6, 2018

09:40 | Combination Products Regulatory Expectations from the Agencies

Amy Wang
Director Drug Delivery & Device Development
Alexion Pharma

Amy Wang is Director, Drug Delivery and Device Development, at Alexion Pharmaceuticals.  Prior to join Alexion, she worked at Amgen and Biogen with extensive experience in commercialization of combination products from product design/ development to post market surveillance on parenteral drug delivery systems. She held her PhD in Materials Science and Engineering from the University of Michigan.

Day One

Thursday September 6, 2018

17:00 | Less is More – Delivering a High Volume, Highly Viscosity Drug with Precise Dosage

Stephen Gilmore
Engineering Director
Crux Product Design Ltd.

Engineering Director at Crux Product Design Ltd. with a proven history and a wealth of experience within the consultancy environment. Particular interest medical device design, and at the forefront of cutting edge technology when it comes to evidence based design, the digital twin and how In-Silico simulation methods can be applied to de-risk and accelerate design innovation across the industry. Proven track record in delivering complex programmes for a range of clients, across various business sectors, with an array of highly successful products brought to market. Expertise in the development of engineering solutions for medical, defence, consumer goods, heavy industry, technology and industrial clients.

Day One

Thursday September 6, 2018

16:30 | Device Development Using In-Silico Techniques within an FDA Framework

Chris Stevenson
Director of Product Quality Management
Shire

Chris Stevenson is currently the Director of Product Quality Management at Shire where he leads the quality assurance activities for medical devices and combination products manufactured in North and South America.  In his 20 year career with Baxter/Baxalta/Shire, Chris has held various technical and leadership positions in medical device and biologic product development, analytical development, validation, and quality systems.  He is a subject matter expert on Risk Management, Design Control, Quality by Design, and Combination Products.  He holds a Bachelor of Science degree in Biology from the University of Michigan.

Day Two

Friday September 7, 2018

10:10 | Stay Connected via Connected Device – The Next Big Thing in Injectables

Tracy VonBriesen
Director, Human Factors, Combination Products
Fresenius Kabi

Tracy VonBriesen RN, MS, is the Director of Human Factors at Fresenius Kabi focusing on new product development of combination drug-device products. Tracy has lead teams to provide clinical and human factors support during development activities required for product life cycle management of serialized and non-serialized infusion devices and combination products. Tracy is a nurse with twenty years of experience and holds a master’s degree in Patient Safety Leadership from the University of Illinois School of Medicine.  Prior to her corporate nursing career, Tracy’s clinical background includes a variety of hospital based assignments including neonatal intensive care, and liver transplant.

Day Two

Friday September 7, 2018

11:10 | Panel Discussion: Enhancing Combination Product Usability Testing

E Guan
Director, R&D, Platform Device Development
MedImmune

Day One

Thursday September 6, 2018

15:15 | Panel Discussion: Applying Human Factors Engineering to Platform Drug Delivery Devices - Pitfalls and Lessons Learned

Day Two

Friday September 7, 2018

09:10 | The Injectable Journey: From PFS to Wearable – Developing a Patient-Centric Device

Sara Waxberg McNew
Director, Human Factors & Industrial Design, Delivery Device R&D
Eli Lilly & Company

Day One

Thursday September 6, 2018

15:15 | Panel Discussion: Applying Human Factors Engineering to Platform Drug Delivery Devices - Pitfalls and Lessons Learned

Hung-Hsiang Chen
Strategic Design Director, DDCS User Centered Design
Eli Lilly & Company

Day Two

Friday September 7, 2018

09:40 | Innovating in the Connect Care space through Design

Jessica Gwinnup
Director - Mechanical Engineering, Delivery, Device & Connected Solutions
Eli Lilly & Company

Jessica Gwinnup is currently Director of Mechanical Engineering in the Delivery, Device & Connected Solutions organization for Eli Lilly and Company where she leads the mechanical design and testing of products across the commercialization portfolio. Since joining Lilly in 2008, Jessica has held various technical and leadership positions in device development, primarily focused on the application of design control requirements for combination products and medical devices. She received a Bachelor of Science degree, magna cum laude, in Mechanical Engineering with a Minor in Biomedical Engineering from Michigan State University.

Day Two

Friday September 7, 2018

11:50 | The Art of Engineering – Developing a Patient Friendly Autoinjector

Alasdair Young
Associate Director - Device Engineering
Coherus BioSciences

Alasdair is the Associate Director of Device Engineering at Coherus BioSciences where he leads combination product design and development activities in support of the portfolio. Alasdair has over a decade of experience in medical devices and combination products arena fulfilling of roles from pre-clinical product design through commercialization to commercial product support. Prior to Coherus, Alasdair worked for Roche/Genentech, DCA Design International, and Pfizer device design and development projects. His education background includes undergraduate engineering studies at the University of Glasgow and graduate studies at the University of Cambridge.

Day One

Thursday September 6, 2018

14:45 | A Different Perspective – Biosimilars Combination Product Development Considerations and Challenges?

Raihan Hossain
Associate Director CH I&D Medical Device Quality
Bayer

Day One

Thursday September 6, 2018

15:15 | Panel Discussion: Applying Human Factors Engineering to Platform Drug Delivery Devices - Pitfalls and Lessons Learned

Day Two

Friday September 7, 2018

12:20 | The Challenges with Device Providers – Platform Solutions vs. Customization

Robert Sean Harper
Sr. Manager Human Factors & Usability
Regeneron

Regeneron R&D                                                                         Sr. Manager, Human Factors and Usability Engineering, Combination Product Development.

  • Combination Products development and usability testing Manager for devices
  • PFS, PFSS, Auto injectors
Alcon R&D Staff, Human Factors, Engineering Fellow
  • SME for Vit/Cataract Human Factors and Usability
  • Design testing for Constellation and Centurion Product lines
  The Boeing Company, Johnson Space Center Principal Human Factors Design Engineer  
  • Usability and Testing Manager for Space Station Science
Twenty years of HF experience in developmental product evolution and Cognitive science. Lead a team of HF usability experts with NASA to obtain first time success in Design and Usability testing studies for Space Station Crew Members.

Day Two

Friday September 7, 2018

11:10 | Panel Discussion: Enhancing Combination Product Usability Testing

Gay Steinbrick
Lead Medical Device & Combination Products, Global Safety
Merck

Dr Steinbrick started her Pharma career as Assistant Professor of Clinical Pharmacy at Rutgers University.   Gay has more than 25 years of professional experience and held various leadership and management positions Schering-Plough including Head of Global Drug Information Services, Director Clinical Quality and Director Chief Medical Office.  Since joining Merck & Co she has been involved in clinical risk management and for the past 3 years as Director Medical Devices and Combination Products, Clinical Safety and Risk Management.    Gay holds a Doctorate in Pharmacy and completed a post-doctoral residency at the Hospital of the University of Pennsylvania.

Day One

Thursday September 6, 2018

11:30 | How to Anticipate the 2020 Deadline – EU Medical Device Directive

Katie Hansbro
CEO
Design Science Consulting Inc.

Katie Hansbro is the CEO at Design Science Consulting in Philadelphia, PA, where she manages all facets of human factors research including contextual inquiry and usability studies, labeling and instructional video development. Prior to joining Design Science, Katie spent 10 years at Baxter in research and development for the transfusion therapies, medication delivery, and renal therapies divisions. As a systems engineer, she worked closely with the human factors, clinical, and marketing teams to determine and validate user needs. Katie served as the Lead System Designer for a Baxter Top Project and received Baxter’s Innovation Award in 2012. Katie sits on the Human Factors Engineering and Home Care committees for AAMI and is the Vice President of Membership for the Philadelphia PDMA chapter.  She has a B.S. in Biomedical Engineering and Psychology and an M.S. in Product Design and Development from Northwestern University.

Day Two

Friday September 7, 2018

11:10 | Panel Discussion: Enhancing Combination Product Usability Testing

Kesley Gallagher
Senior Regulatory Affairs Manger
Amgen

Day One

Thursday September 6, 2018

12:00 | The New Beginning after Launch – A Device Regulatory Perspective and Journey

Allison Strochlic
Research Director, Human Factors Engineering
UL

Allison Strochlic, MS, CHFP Allison Strochlic is UL’s Human Factors Engineering Research & Design (HFR&D) team's Research Director based in Concord, Massachusetts. Allison contributes to and manages various research projects such as usability testing, contextual inquiry, and interviews. She also helps clients develop key HFE documents for their design history files, advises clients on how apply HFE during device development, and facilitates HFE-related meetings with regulators'. Allison has over a decade of experience applying HFE almost exclusively to medical devices and combination products, including various injectables such as prefilled syringes, autoinjectors, pen injectors, and patch pumps. Allison studied human factors at Tufts University and Bentley University, where she received her undergraduate and graduate degrees, respectively. She is a co-author of Usability Testing of Medical Devices (2nd edition published in 2015) and several technical articles, and is a Certified Human Factors Professional (CHFP).  

Day One

Thursday September 6, 2018

15:15 | Panel Discussion: Applying Human Factors Engineering to Platform Drug Delivery Devices - Pitfalls and Lessons Learned

Young Chun
Principal Engineer – Human Factors Lead
Shire

Dr. Young Chun is a Principal Engineer Human Factors Lead at Shire (Barrington, IL), a global biopharmaceutical company focusing on rare diseases. Dr. Chun is leading Human Factors work on multiple projects including: management of early stage user research and later-stage formative and summative validation studies, risk management, user interface requirement development and interfacing with FDA and other regulatory agencies on Human Factors topics. Prior to joining Shire, Dr. Chun was a Sr. Engineer at Biogen (Cambridge, MA) where she led Human Factors/ Usability Engineering activities for medical devices/ combination products and also compliance-related design control activities involved in the design development of drug delivery devices. Dr. Chun has also been a senior Human Factors researcher on Musculoskeletal Disorders (MSDs) in the automobile industry and edited the book ‘Industrial Standardization’ published by Korea National Open University Press. Dr. Chun received her doctorate degree in Industrial Engineering, with specialty of Ergonomics/ Human factors, at Texas Tech University in 2014 and holds M.E. and B.E. in Industrial and Informational Engineering from Hongik University in Seoul, South Korea. She is an official member of Alpha Pi Mu and Human Factors Ergonomics Society and a Six Sigma Green belt.

Day One

Thursday September 6, 2018

13:45 | Human Factors Study – How, When, What and Who?

Alie Jahangir
Sr. Manager, Quality Engineering & Design to Value
Janssen Pharmaceutical

Dr. Jahangir is a Senior Manager in Combination Product Centre of Excellence and a member of Product Quality Management team at Janssen Pharmaceutical Companies of Johnson and Johnson; Working with Janssen’s multidisciplinary global teams, his current activities are focused on development and deployment of design quality framework for emerging and legacy Drug/Biologic-Device combination products, embedding best practices to assure advance quality and efficient development as well as robust lifecycle management. Previously, Alie has led a successful R&D career managing, developing and commercializing cutting-edge polymeric technologies in consumer, medical devices and other sectors. He holds a M.A.Sc. and a Doctorate Degree in Polymer & Biomedical Engineering from University of Toronto, and completed his Post-Doctoral Fellowship at Harvard.

Day Two

Friday September 7, 2018

14:30 | A Systematic Approach to Develop a Novel E2E Stability Program for Combination Products: A Unique Product Quality Management Perspective

Scott Nunn
Manager, Device Development & Clinical Packaging Engineering
Gilead

Day Two

Friday September 7, 2018

13:55 | Master Mind: Rethink Your Device Selection and Development Program

Eugene Wu
Combination Products Manager
Novavax

Eugene Wu currently works at Novavax as Combination Products Manager to develop and commercialize novel vaccines for protection against respiratory syncytial virus and influenza.  Prior to Novavax, Eugene worked at Human Genome Sciences and GlaxoSmithKline in various roles including drug product process development and device & packaging development.  Eugene holds a Bachelor’s degree in biology from Cornell University and a Master’s degree in regulatory science from Johns Hopkins University.

Day Two

Friday September 7, 2018

15:00 | Simple as it Seems – How to Close Your Container?

Nick Zampa
Senior Engineer, Technical Development Human Factors & Risk Management
Biogen

I work as a Senior Engineer of Human Factors and Risk Management at Biogen. My current areas of focus include usability risk management, general technical device risk management, and combination product development. I am currently a Doctorate of Engineering candidate at George Washington University’s School of Engineering and Applied Science, focusing on structured expert judgment elicitation and quantitative risk management techniques. Formerly, I worked in Biologics Formulation Development, including the development of pre-filled syringes for biologics. I currently hold a Master’s of Science in Biology/Biotechnology from Tufts University.

Day One

Thursday September 6, 2018

14:15 | Human Factors within the Device Design Control Paradigm

Day Two

Friday September 7, 2018

11:10 | Panel Discussion: Enhancing Combination Product Usability Testing

Faz Chowdhury
CEO
Nemaura

Dr Faz Chowdhury is CEO at Nemaura Pharma Limited, specialising in Skin Drug Delivery and minimally invasive diagnostics. He has an MSc in Microsystems and Nanotechnology, and PhD in nanomedicine from the University of Oxford. He has authored text book chapters on nanosciences for Wiley and Elsevier, and is the holder of more than 50 patents spread over 15 patents families. He is also a board member of the UK East Midlands Medilink Organisation, and chair of the UK-KTN Drug Delivery group.

Day One

Thursday September 6, 2018

17:30 | Downsizing: Microneedle Opportunity in Injectables

Edwin Bills
Principal Consultant
ELB Consulting

During his career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions including a recent period as Corporate Director of Risk Management.   He has over 36 years’ experience in the field of quality and regulatory affairs.  Currently he consults and provides training in the area of medical device quality, regulatory and risk management. With Stan Mastrangelo, he co-authored Lifecycle Risk Management for Healthcare Products: From Research Through Disposal published by PDA. Mr. Bills was also a member of the adjunct faculty serving Virginia Tech’s graduate on-line degree program in Health Products Risk Management.  ASQ has awarded Mr. Bills with Fellow status as well as Certified Quality Engineer, Certified Quality Auditor, Certified Manager of Quality and Organizational Excellence, and he is a Regulatory Affairs Certified by the Regulatory Affairs Professionals Society. Mr. Bills serves in international standards work, currently participating in the revision of ISO 14971 risk management standard as an international member of the technical committee.   He also serves on the US national committee for the medical devices quality system standard, ISO 13485 and the AAMI technical committee developing a combination products risk management guidance.

Patty Kiang
Principal & Founder
Kiang Consultant Services

Dr. Kiang specializes in pharmaceutical packaging and delivery devices for liquid and lyophilized products, prefilled syringe systems & injection devices, and CMC filing for combination products.  She is a consultant for bio/pharm industry in the area of combination products development, quality assurance and regulatory affair.  She was Head of Device Development for Genentech, led the development of a new autopen injector for human growth hormone, and was CMC leader for prefilled syringe combination product development. Prior to joining Genentech, she held positions as Director, Injectable Drug Products delivery for Schering Plough, and Director of Technology Development for West Pharmaceutical Services. She is a member of the faculty of the PDA’s Training and Research Institute, where she teaches courses on Prefilled Syringe & injection devices and Parenteral Packaging; she also served has committee or conference chair for USP Packaging Expert Committee, PDA Sterilization of Polymeric Materials Committee and PDA Global Prefilled Syringe & Injection Device Conference. She was president of the Chinese Bioscience Association in Northern CA.

Joely Gardner
Chief User Researcher; Professor
Human Factors Research; UCSD Graduate Business School