LinkedIn Icon
September 26-28, 2017
San Diego

Speakers

Expand/Collapse

Molly Story
Global Usability Engineering & Risk Management, MED
Sanofi

MOLLY STORY has been Senior Director, Global Usability Engineering and Risk Management at Sanofi since March 2014. She is the co-chair of AAMI’s Human Factors Engineering Committee. Molly was formerly Human Factors and Accessible Medical Technology Specialist at the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE), where she had an appointment to the Senior Biomedical Research Service. While at FDA, she authored, with Ron Kaye, the CDRH 2011 draft human factors guidance and the 2016 final guidance. Molly previously served as a human factors research and design consultant to a variety of consumer and medical device companies. Molly received a BSE from Princeton University, a MS from Stanford University, and a MS and a PhD from the School of Public Health at the University of California, Berkeley.

Day One

Wednesday September 27, 2017

14.40 | The Human Touch – Develop a Patient-Centric Injectable Device

Gopi Vudathala
Head, Quality Advocacy Liaison
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 One

Wednesday September 27, 2017

09.10 | Keynote Address: What is a Quality Device? Applying Risk-Based Design & QbD Approaches

Willow DiLuzio
Director of Formulation & Device Development
Takeda

Day Two

Thursday September 28, 2017

14.00 | Roundtable Discussion: Customization of Your Device, Is This Realistic?

09.10 | Case Study: Drivers & Challenges of Developing High Concentration Injectables

Thomas Miller
Vice President, Device Research & Innovation
Novo Nordisk

Thomas D. Miller is vice president in Novo Nordisk heading up a Novo Nordisk medical device research organisation in Seattle, USA. Building on a strong tradition for technology development within the organisation, his unit is working in multi-disciplinary teams to utilize technology to make diabetes and obesity treatment better and simpler. Thomas is pushing a user-driven approach to innovation, which involves anthropological methods and frequent testing with users. Previously in his career, Thomas initiated and managed medical device projects like FlexPro® and FlexTouch®, which are now launched worldwide with Novo Nordisk drugs, and have won prestigious design prices, including G-Mark Good Design Award, and Red Dot Bronze Medical Design Award. Thomas holds a PhD in industrial engineering, and a M.Sc. in mechanical engineering from Technical University of Denmark.

Day One

Wednesday September 27, 2017

16.20 | Next Generation Dose Delivery Devices

Paul Upham
Senior Principal
Roche/Genentech

Paul is a Senior Principal at Roche / Genentech where he leads the Smart Device Technology Center. Paul has 20 years of experience in medical device R&D, strategic marketing, product management, clinical research, and medical informatics. Prior to Roche / Genentech, Paul was with Becton Dickinson(BD), as Worldwide Director of Strategic Marketing in their Pharmaceutical Systems business. Paul and his team were responsible for all upstream and downstream marketing strategy for BD's self-injection business, including pen injectors, autoinjectors, and wearable patch injectors. Prior to that role, Paul was with WellDoc, Inc. as Director of Product Marketing, where he built and led the marketing team and was responsible for product management activities for WellDoc’s portfolio of mobile health solutions. He was also the Core Team Leader for WellDoc’s landmark BlueStar™ product, a class II medical device and the world’s first reimbursed, prescription-only software for type 2 diabetes. Paul’s prior experience includes 10 years at BD in the Diabetes Care business. Paul was responsible for the development and launch of the award-winning BD InterActiv® Diabetes Software, and was a member of the joint BD / Medtronic core team that launched ParadigmLink®, the world’s first wireless blood glucose meter. Paul holds an issued patent in medical software and numerous patent applications covering software and medical devices. He is also an author and co-author of numerous peer-reviewed articles in medical informatics and in diabetes. His education background includes undergraduate studies in cognitive science and graduate work in health informatics and finance at the University of Minnesota and New York University.

Day Two

Thursday September 28, 2017

13.30 | Digital & Connected Platforms – Roche/Genentech Case Study

Vijay Damodaran
Advisor/Director, Quality, Medical Devices & Combination Products
Eli Lilly & Company

Vijay Damodaran is currently Advisor/Director - Quality, Medical Devices & Combination Products at Eli Lilly & Company.  He has over 15 years of experience in quality assurance, quality control, regulatory compliance, technical services, process engineering and manufacturing in medical devices, combination products and pharmaceuticals.  In his current role, he is responsible for providing overall direction and leadership for device quality systems and ensuring compliance with global medical device and combination product regulations.  In addition, he is the Management Representative for Lilly Devices network and acts as a liaison with Notified Bodies and is responsible for maintenance of multi-site ISO 13485 certification and CE Marking for medical devices.  Vijay received his Master of Science in Microbial (Biochemical) Engineering from University of Minnesota, Minneapolis/St. Paul.

Day One

Wednesday September 27, 2017

09.40 | Combination Products Part 4 Compliance & Implementation at Multi-Site Networks Including CMOs

Chin-Wei Soo
Senior Regulatory Program Director
Genentech

Day One

Wednesday September 27, 2017

10.10 | Post-Market Surveillance Requirements – How to Implement?

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

Wednesday September 27, 2017

14.10 | Success Story of Developing a Patient-Centric Device

Shawn Olsson
Commercial Lead, US Opioid & Syringe Technology Portfolio
Pfizer

Shawn Olsson is seasoned pharma leader in the injectable and prefilled syringe industry.  Shawn is responsible for a $0.5B US prefilled syringe business which includes 6 on market prefilled syringes and 30 distinct molecules.  Prior to his commercial responsibility for Pfizer Injectables US Prefilled Syringe and Opioid portfolio, Shawn was the Director of On Market Strategy for Pfizer’s Global Injectable business and was the Director of On Market Strategy for Hospira’s $3B Global Generic Business Units.

Day Two

Thursday September 28, 2017

11.10 | Master Mind: The Winning Team – Bridging the Gap between Technical, Strategy & Commercial Elements for a Quality Injectable Device

Steve Bowman
Device Program Lead
Shire

Dr. Steve Bowman joined Shire in 2015 as the Leader of the newly-formed Device Center of Excellence, in recognition of the increasing importance of devices and combination products to Shire’s continued growth.  He’s now the Device Program Lead for two high-value rare disease products (Natpar/Natpara and Gattex/Revestive), responsible for all new global device development activities.  Prior to joining Shire Steve was the Sr. Director of Sports Medicine R&D for Smith & Nephew, responsible for all global development of surgical implants and instruments for arthroscopic knee, shoulder and hip repair.   He started his career at Johnson & Johnson, with multiple roles of increasing responsibility in R&D, Biologics Manufacturing, Project Management and Alliance Management.  Steve earned a BS in Mechanical Engineering from Columbia University, and a PhD in Medical Engineering and Medical Physics from the Harvard - MIT Program of Health Sciences and Technology.

Day One

Wednesday September 27, 2017

12.40 | Lifecycle Management of Your PFS & Injectable

Bobbijo Redler
Associate Principal Scientist
Merck

Day Two

Thursday September 28, 2017

10.40 | Should We Switch? Syringe Material & E&L Considerations

Xu Song
Principal Engineer, Manufacturing Science and Technology
Bristol-Myers Squibb

Xu Song, Principal Packaging Engineer, Manufacturing Science and Technology, Bristol-Myers Squibb. Xu is currently the technical expert responsible for primary packaging components utilized in commercial BMS biologic drug products. Xu jointed BMS in 2013, initially in R&D, responsible for primary packaging components for new drug product development. Prior to BMS, Xu worked at BD Pharmaceutical Systems and Johnson & Johnson Vision Care Inc.   Xu Song received his Master’s Degree in Engineering from University of Massachusetts Lowell and Bachelor’s Degree in Chemistry from Nankai University in Tianjin China.

Day Two

Thursday September 28, 2017

09.40 | Container & Closure System Integrity Testing (CCIT)

Joyce Zhao
Associate Director, Device Engineering & Development
Dr. Reddy’s Laboratories

Dr. Zhao has more than 10 years experience on medical device development including combination product device such as Autoinjector, Wearable/Patch injector, Pen Injector, Prefill Syringe (PFS), as well as needle technology, and other drug delivery devices.  Currently Dr. Zhao is an Associate Director at Dr. Reddy’s Laboratories responsible for all device development activities.  Prior to Dr. Reddy’s, Dr. Zhao has been with Becton Dickinson and Company (BD) at Franklin Lakes, NJ USA for 9 years.  Her work at BD was focused on drug delivery systems.  She was the technical lead and project leader at R&D for various device development projects and has hands on experience on device concept, design, characterization, analysis and manufacturing.  Dr. Zhao holds a Ph.D in mechanical engineering from University of Washington, Seattle, WA USA.

Day One

Wednesday September 27, 2017

12.10 | Interface from PFS to Auto-Injector

Michael Song
Snr. Manager, Drug Delivery & Device Development
MedImmune

Michael Song is Sr. Manager of Device Functionality, Safety and Digital Connectivity at MedImmune, a Member of the AstraZeneca Group. In his role he oversees device functionality test method development and testing; primary container science and technology; biocompatibility; and digital connectivity for biologics. Prior to his current role, Michael built and led the Device and Package Engineering team at Adello Biologics, a subsidiary of Amneal Pharmaceuticals, where he focused on combination product development, vial and device packaging development, and fill & finish process development. He also have held key engineering and toxicology SME positions at Stryker and Kavlico, a member of Schneider Electric. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Day Two

Thursday September 28, 2017

13.00 | The Future of Connected Injectable Device Platform

Patty Kiang
Principal
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. Dr. Kiang holds five patents in the field of polymeric surface coatings. She received a Ph.D. in Analytical Chemistry from Villanova University and holds an MBA from Pennsylvania State University.

Tim Reeves
Managing Director
Human Factors MD

Tim is the Managing Director of Human Factors MD and founded the company in early 2001. He has 20 years of commercial experience evaluating and designing usable, effective, and safe medical devices. He is a Certified Human Factors Professional, and as a member of the AAMI’s Human Factors Committee, is an contributor to HE:75. He has been an invited speaker at several professional meetings, including the AAMI/FDA sponsored Human Factors and Patient Safety for Medical Devices and the first IBC’s conference on Human Factors and Combination Products. Tim is the lead faculty for AAMI’s popular Human Factors for Medical Device Design course. Tim has a PhD in cognitive psychology and human factors from the University of Toronto.

Christina Mendat
Partner & Senior Technical Director
Human Factors MD

Christina is a Partner and the Senior Technical Director. She has conducted numerous formative and summative studies, and led clients successfully through regulatory approval process. For Human Factors MD, Christina provides technical oversight to our HF team and is an expert at translating research findings such as user needs, requirements, product strengths and weaknesses into compelling design directions and solutions. She brings over a decade of experience in human factors having spent more than 5000 hours in surgical suites, medical device usability studies, and outpatient facilities. She has presented papers to the Human Factors and Ergonomics Society and the American Psychology Society and has been providing multiple workshops and lectures on navigating the latest standard, HE75, and human factors integration in quality management systems to groups including PDA (Parenteral Drug Association), ISPE (International Society for Pharmaceutical Engineering), and ASQ (American Society for Quality). Christina has a PhD in experimental psychology and ergonomics from North Carolina State University.

Shannon Clark
Principal & CEO
UserWise, Inc.

Shannon Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants a UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors. Before founding UserWise in 2015, Shannon was a Human Factors Engineer at Intuitive Surgical and Abbott Laboratories. Shannon graduated in 2010 from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. Shannon is additionally a Certified Processional Industrial Engineer, holds two patents, and has written and published three books.