Michael Song leads the Device Functionality, Safety and Digital Connectivity group at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality; primary container science and technology; biocompatibility; container closure integrity testing; and digital connectivity. Prior to his current role, Michael was head of Device and Package Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Tina Rees is the Associate Director of Human Factors at Ferring Pharmaceuticals, where she is responsible for the development and implementation of Human Factors and Usability Engineering processes into the overall product development process. Prior to her move to Ferring, she was a Principal Research Scientist in Human Factors at Eli Lilly, focusing on human factors usability within the diabetes division. She has conducted many formative and summative usability studies and has participated in a number of submissions to regulatory authorities resulting in clearance of medical devices and approval of combination products. She received her Ph.D. in Biomedical Research from the Mayo Clinic in Rochester, MN. She is a strong proponent of human centered design processes and incorporating human factors early into the device development process.

Dr. Forster is the Executive Director, Device Final Drug Product Technology department at Amgen Inc. Responsible for all Container Closure Systems, their integration into combination products, devices and drug substance systems. His team has developed and published numerous standards for Biological Packaging systems, lead multi-company teams to establish guidance’s in Biological Packaging development, and serves on numerous customer advisory boards for packaging suppliers.

He is also a Board of Director memebnr as well as head of the Technical Advisory Committee for the Suzhou Industrial Park Biologics and Pharmaceutical Packaging institute (Upon accreditation this facility will become the Chinese National Biological Packaging Testing Laboratories)

Prior to joining Amgen, Ron was with Merck Inc. where he was Senior Principle Engineer leading a group that implement Quality by Design for primary packaging systems from early clinical development through commercial supply chain systems. He was a key leader in advancing the Merck Commercialization process and served as a global manufacturing lead on a key product franchise board.

During his tenure at Merck, he also served as an Adjunct Professor at Rutgers University in Biomedical Engineering and Ceramic Engineering.

Ron has an Interdisciplinary Ph.D. from Rutgers University in Chemical Engineering, Ceramic Engineering, and Mechanics and Materials Science.
 

Kesley Gallagher is the Director of External Engagement, Combination Products, at Amgen in Thousand Oaks, CA. She has worked in the pharmaceutical and medical device arenas for over 20 years in both Quality Assurance and Regulatory Affairs. Her prior responsibilities include Medical Device Regulation (MDR) implementation for both CE marked devices and products that will require notified body opinion. She led teams for the global submissions and approvals for the Repatha Pushtronex and managed the regulatory aspects of the Neulasta OnPro; these are Amgen’s first on-body injectors. Prior to joining Amgen, Kesley was an RA Manager at Abbott Medical Optics, specializing in new product development for eye care products and ophthalmologic surgical femtosecond lasers. Kesley has an MS in Regulatory Science from the University of Southern California and an BA in Biology/Chemistry from Bowdoin College. When off duty, Kesley is a seasoned expert in fly fishing, and currently holds 10 IGFA world records and won grand champion in the Ladies Tarpon Fly Tournament last spring.

Douglas Cusato is the Director of the Medical Rubber Business for Sumitomo Rubber, North America . In this role, he is responsible for all aspects of the regional business including Strategy, R&D, Operations and Sales. Douglas has been active in the parenteral packaging industry since 2006 and has served in various technical leadership roles with focus on technology and platform development. He has chaired multiple industry tasks forces and participates in numerous groups as a subject matter expert in elastomeric components for parenteral packaging applications. Doug holds a bachelor’s degree in Chemistry from Rutgers University.

Dr. Lin Li is a Senior Consultant Engineer currently working at the Delivery Devices and Connected Solutions team in Eli Lilly and Company. He has gotten his Bachelor’s degree from McMaster University (Canada) and his Ph.D from University of Tennessee in the field of Materials Science and Engineering. He joined Lilly in 2015 and has been part of Lilly’s research on the effort of developing innovative pharmaceutical packaging and devices ever since.

Diane Doughty is a senior scientist in the Drug Delivery & Device Development group at MedImmune (A Member of the AstraZeneca Group). Her focus is developing combination products for the delivery of peptides and monoclonal antibodies using prefilled syringes, autoinjectors, and pen injectors. Diane has a Ph.D. in Pharmaceutical Sciences from the University of Maryland where she investigated usability of orally inhaled and nasal drug products and the effects of patient-variability on product critical quality attributes.

Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

Michael Song leads the Device Functionality, Safety and Digital Connectivity group at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality; primary container science and technology; biocompatibility; container closure integrity testing; and digital connectivity. Prior to his current role, Michael was head of Device and Package Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Shannon E. 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 at 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 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.
 

Dr. Forster is the Executive Director, Device Final Drug Product Technology department at Amgen Inc. Responsible for all Container Closure Systems, their integration into combination products, devices and drug substance systems. His team has developed and published numerous standards for Biological Packaging systems, lead multi-company teams to establish guidance’s in Biological Packaging development, and serves on numerous customer advisory boards for packaging suppliers.

He is also a Board of Director memebnr as well as head of the Technical Advisory Committee for the Suzhou Industrial Park Biologics and Pharmaceutical Packaging institute (Upon accreditation this facility will become the Chinese National Biological Packaging Testing Laboratories)

Prior to joining Amgen, Ron was with Merck Inc. where he was Senior Principle Engineer leading a group that implement Quality by Design for primary packaging systems from early clinical development through commercial supply chain systems. He was a key leader in advancing the Merck Commercialization process and served as a global manufacturing lead on a key product franchise board.

During his tenure at Merck, he also served as an Adjunct Professor at Rutgers University in Biomedical Engineering and Ceramic Engineering.

Ron has an Interdisciplinary Ph.D. from Rutgers University in Chemical Engineering, Ceramic Engineering, and Mechanics and Materials Science.
 

Kesley Gallagher is the Director of External Engagement, Combination Products, at Amgen in Thousand Oaks, CA. She has worked in the pharmaceutical and medical device arenas for over 20 years in both Quality Assurance and Regulatory Affairs. Her prior responsibilities include Medical Device Regulation (MDR) implementation for both CE marked devices and products that will require notified body opinion. She led teams for the global submissions and approvals for the Repatha Pushtronex and managed the regulatory aspects of the Neulasta OnPro; these are Amgen’s first on-body injectors. Prior to joining Amgen, Kesley was an RA Manager at Abbott Medical Optics, specializing in new product development for eye care products and ophthalmologic surgical femtosecond lasers. Kesley has an MS in Regulatory Science from the University of Southern California and an BA in Biology/Chemistry from Bowdoin College. When off duty, Kesley is a seasoned expert in fly fishing, and currently holds 10 IGFA world records and won grand champion in the Ladies Tarpon Fly Tournament last spring.

Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

Delma L. Broussard, MD is a Director, Global Clinical Safety & Pharmacovigilance Physician at CSL Behring. Dr. Broussard received her Bachelor’s and Medical Degrees from Harvard University, and completed Pediatric residency and Gastroenterology training at the Children’s Hospital of Philadelphia.

Her Industry career has spanned 20 years in Risk management of drugs/biologics and medical devices either in PV directly, or as part of Regulatory Affairs or Medical Affairs/Clinical development positions. She currently has a strategic role at CSL Behring, under the Chief Safety Officer, focusing on Clinical safety of combination products and medical devices. Earlier in her career, she held senior roles at major pharmaceutical companies, including Merck & JNJ.
Delma is a board-certified pediatric gastroenterologist, formerly Associate Professor at University of Pennsylvania School of Medicine, with publications in peer-reviewed journals.
 

Michael Song leads the Device Functionality, Safety and Digital Connectivity group at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality; primary container science and technology; biocompatibility; container closure integrity testing; and digital connectivity. Prior to his current role, Michael was head of Device and Package Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Tina Rees is the Associate Director of Human Factors at Ferring Pharmaceuticals, where she is responsible for the development and implementation of Human Factors and Usability Engineering processes into the overall product development process. Prior to her move to Ferring, she was a Principal Research Scientist in Human Factors at Eli Lilly, focusing on human factors usability within the diabetes division. She has conducted many formative and summative usability studies and has participated in a number of submissions to regulatory authorities resulting in clearance of medical devices and approval of combination products. She received her Ph.D. in Biomedical Research from the Mayo Clinic in Rochester, MN. She is a strong proponent of human centered design processes and incorporating human factors early into the device development process.

Michael Song leads the Device Functionality, Safety and Digital Connectivity group at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality; primary container science and technology; biocompatibility; container closure integrity testing; and digital connectivity. Prior to his current role, Michael was head of Device and Package Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Tina Rees is the Associate Director of Human Factors at Ferring Pharmaceuticals, where she is responsible for the development and implementation of Human Factors and Usability Engineering processes into the overall product development process. Prior to her move to Ferring, she was a Principal Research Scientist in Human Factors at Eli Lilly, focusing on human factors usability within the diabetes division. She has conducted many formative and summative usability studies and has participated in a number of submissions to regulatory authorities resulting in clearance of medical devices and approval of combination products. She received her Ph.D. in Biomedical Research from the Mayo Clinic in Rochester, MN. She is a strong proponent of human centered design processes and incorporating human factors early into the device development process.

Ed Israelski is a consultant and the recently retired director of Human Factors at AbbVie, a biopharmaceutical company. He joined the company in 2001, where he led a cross-company team to imbed best-practice human factors engineering HFE design methods into all of AbbVie’s products, to ensure safety and usability. He did this through hands-on design and evaluation of key new products, managing a group of HF professionals; training and mentoring internal resources, writing corporate policy and guidelines and facilitating the use of outside professional HFE resources.

He is the co-convener for IEC and ISO Ergonomic and Usability Engineering groups in developing international Human Factors/Usability medical devices standards. Ed is also past co-chair of the AAMI Human Factors Engineering committee, which develops HF standards for medical devices. He is a certified human factors professional CHFP. He has authored fourteen book chapters and numerous articles in the area of human factors. Ed holds thirty patents. He is a fellow of the Human Factors and Ergonomics Society and a member of the National Academy of Sciences Board on Human-System Integration. He is on the editorial board for the journal Human Factors and serves as a regular reviewer for several other scientific journals.

He has worked as a systems engineer, product manager, market researcher, industrial/organizational psychologist as well as a human factors engineer at various companies including Lucent Technologies - Bell Labs, formerly AT&T, Ameritech/SBC and Human Factors International, Ed is an adjunct instructor at Northwestern University. He received a B.S. in electrical engineering from NJIT, an M.S. in operations research from Columbia University and a Ph.D. in industrial and engineering psychology from Stevens Institute of Technology.
 

Rita Lin joined the U.S. Food and Drug Administration in 2017 as a Human Factors Reviewer in the Center for Devices and Radiological Health (CDRH).
At the FDA, her human factors reviews have focused on general hospital devices such as infusion pumps and pre-filled syringes, respiratory and anesthesia care, and digital health apps. She has been involved in providing edits to numerous standards, FDA guidance development, and teaching at external speaking events with HFES and AAMI, amongst others.
Rita previously worked in the orthopedic devices industry with experience in quality assurance (QA) and research & development (R&D). Her responsibilities included leading major design change projects, conducting empathic interviews, performing verification and validation testing and risk management, and implementing manufacturing process changes in Puerto Rico.
Rita earned her B.S. and M.S. in biomedical engineering and global health from Duke University.
 

Séverine DUBAND has joined Nemera in 2018 as Global Category Manager of the parenteral segment. She is responsible for developing the parenteral products, including the passive safety systems Safe’n’Sound®, the innovative autoinjector Safelia®, as well as several other projects.
Graduated from EM Lyon Business School in 2004, Séverine worked 10 years for FMCG in the chemical industry as International Category Manager, supervising strategic planning, NPD launches, project management and brand communication.

Tina Rees is the Associate Director of Human Factors at Ferring Pharmaceuticals, where she is responsible for the development and implementation of Human Factors and Usability Engineering processes into the overall product development process. Prior to her move to Ferring, she was a Principal Research Scientist in Human Factors at Eli Lilly, focusing on human factors usability within the diabetes division. She has conducted many formative and summative usability studies and has participated in a number of submissions to regulatory authorities resulting in clearance of medical devices and approval of combination products. She received her Ph.D. in Biomedical Research from the Mayo Clinic in Rochester, MN. She is a strong proponent of human centered design processes and incorporating human factors early into the device development process.

Valerie Fenster has thirty plus years’ experience developing intuitively optimized interfaces for critical business applications. She is a persuasive advocate for best practices in human factors engineering and user interaction and is dedicated to developing powerful and user-centered design for combination products, digital health devices and interactive voice response systems.
Valerie is the Director of Insights & Human Factors at Kaleidoscope Innovation in Cincinnati, where she and her team ensure users remain the top consideration in device design solutions. Prior to Kaleidoscope, Valerie founded Amgen’s human factors engineering group and successfully guided many combination products and wearable devices through the HFE process. At Abbot, formerly St. Jude Medical, she helped design and develop their remote care connectivity system for patients with pacemakers or defibrillators.
Valerie currently holds a Master of Science in Human-Computer Interaction from DePaul University in Chicago, Illinois, as well as Bachelor of Arts degrees in both Psychology and Humanities. She is an active member of HFES and AAMI.
 

Ed Israelski is a consultant and the recently retired director of Human Factors at AbbVie, a biopharmaceutical company. He joined the company in 2001, where he led a cross-company team to imbed best-practice human factors engineering HFE design methods into all of AbbVie’s products, to ensure safety and usability. He did this through hands-on design and evaluation of key new products, managing a group of HF professionals; training and mentoring internal resources, writing corporate policy and guidelines and facilitating the use of outside professional HFE resources.

He is the co-convener for IEC and ISO Ergonomic and Usability Engineering groups in developing international Human Factors/Usability medical devices standards. Ed is also past co-chair of the AAMI Human Factors Engineering committee, which develops HF standards for medical devices. He is a certified human factors professional CHFP. He has authored fourteen book chapters and numerous articles in the area of human factors. Ed holds thirty patents. He is a fellow of the Human Factors and Ergonomics Society and a member of the National Academy of Sciences Board on Human-System Integration. He is on the editorial board for the journal Human Factors and serves as a regular reviewer for several other scientific journals.

He has worked as a systems engineer, product manager, market researcher, industrial/organizational psychologist as well as a human factors engineer at various companies including Lucent Technologies - Bell Labs, formerly AT&T, Ameritech/SBC and Human Factors International, Ed is an adjunct instructor at Northwestern University. He received a B.S. in electrical engineering from NJIT, an M.S. in operations research from Columbia University and a Ph.D. in industrial and engineering psychology from Stevens Institute of Technology.
 

Diane Doughty is a senior scientist in the Drug Delivery & Device Development group at MedImmune (A Member of the AstraZeneca Group). Her focus is developing combination products for the delivery of peptides and monoclonal antibodies using prefilled syringes, autoinjectors, and pen injectors. Diane has a Ph.D. in Pharmaceutical Sciences from the University of Maryland where she investigated usability of orally inhaled and nasal drug products and the effects of patient-variability on product critical quality attributes.

Michael Song leads the Device Functionality, Safety and Digital Connectivity group at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality; primary container science and technology; biocompatibility; container closure integrity testing; and digital connectivity. Prior to his current role, Michael was head of Device and Package Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Mr. Swapnil Pansare is Scientist at Medimmune and in his current role, Mr. Pansare is responsible for Drug Product fill finish and process development for liquid and freeze-dried biologics. He is a key member of Process Engineering and Packaging team currently supporting tech transfer of commercial products to commercial site. In his previous role, Mr. Pansare was responsible for developing protein formulations suitable for combination products. He received his MS in pharmaceutical sciences from northeastern university. Mr. Pansare’s research interests include process development, scale up and tech transfer and formulation development for Drug Products (including combination products).

Toshiro Katayama is the product manager, at Zeon Specialty Materials Inc and responsible in development of Cyclic Olefin Polymer business in the USA. He has over 35 years of various commercial experience, general management, sales and market management, strategic planning, merger and acquisition and purchasing at Gets Bros. & Co Inc (Marmon Group), Union Carbide Corp and Itoh-Chu. He holds Bachelor of Science degree in Mechanical Engineering and Master of Science degree in Structural Engineering from Polytechnic Institute of Brooklyn.

Benjamin Werner obtained his Master degree in Pharmacy from the University of Munich. After his education Mr. Werner joined the group of Prof. Dr. Gerhard Winter at the Chair of Pharmaceutical Technology and Biotechnology at the University of Munich for his PhD and visited the University of Kansas for a research stay. During his studies he took part in collaborations with the industry and gained experience in the area of protein formulation, stabilization and analysis. In the last years he focused on novel primary packaging materials and other strategies to diminish protein particles in solutions which may cause immunogenicity after administration. Mr. Werner joined Boehringer Ingelheim last year as a Scientist. He is responsible for the primary packaging and process development of parenteral drugs.

Sarah Sundelacruz is a Scientist in the Protein Pharmaceutical Development group at Biogen. In her current role, her focus is on formulation development and fill-finish process development for parenteral drug products. Sarah received her B.S. in Biomedical Engineering from Johns Hopkins University and her Ph.D. in Biomedical Engineering from Tufts University.

Lori received her B.S. in Pharmacy from the University of North Carolina at Chapel Hill in 1990 and her Ph.D. in Pharmaceutical Chemistry from the University of Kansas in 1996. She is currently a Senior Principal Scientist in the Parenteral Science and Technology group at Bristol-Myers Squibb and has over 20 years of experience in the development of drug product formulations for proteins, peptides, and small molecules from early through commercial phase.

Michael Song leads the Device Functionality, Safety and Digital Connectivity group at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality; primary container science and technology; biocompatibility; container closure integrity testing; and digital connectivity. Prior to his current role, Michael was head of Device and Package Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Tina Rees is the Associate Director of Human Factors at Ferring Pharmaceuticals, where she is responsible for the development and implementation of Human Factors and Usability Engineering processes into the overall product development process. Prior to her move to Ferring, she was a Principal Research Scientist in Human Factors at Eli Lilly, focusing on human factors usability within the diabetes division. She has conducted many formative and summative usability studies and has participated in a number of submissions to regulatory authorities resulting in clearance of medical devices and approval of combination products. She received her Ph.D. in Biomedical Research from the Mayo Clinic in Rochester, MN. She is a strong proponent of human centered design processes and incorporating human factors early into the device development process.