Ajit D’Souza, is the Executive Director of Drug Delivery and Devices at Eli Lilly and Company. He partners with internal stakeholders to define and advance Lilly’s device and delivery strategy for the emerging portfolio. He is responsible for the development of internal drug delivery and device initiatives as well as co-development of external technologies via feasibility studies to address critical unmet patient needs. Prior to Eli Lilly, Ajit served as Senior Director of drug product development, manufacturing and device development as well as a CMC leader at Kiniksa Pharmaceuticals and worked at Becton Dickinson, BD, in various leadership roles on programs of strategic importance including development of technologies and products for subcutaneous, intradermal and pulmonary delivery. Ajit earned a Ph.D. in Pharmaceutical Chemistry from the University of Kansas, a Professional Certificate in Systems Engineering from MIT xPRO and an MBA.

Alan joined AbbVie as Global Head of Complex Devices and Drug Delivery Systems for RA Devices in October 2023. Prior to joining AbbVie, Alan worked at FDA/CDRH for 20 years as an expert in drug delivery devices and combination products. While at FDA, he led guidance development for infusion pumps, reliability of emergency use injectors, and essential drug delivery outputs. Alan has a master’s degree in reliability engineering and bachelor of science degree in mechanical engineering from the University of Maryland.

Alex Klara is the Business Development Specialist at Zeon Specialty Materials with responsibility of Cyclic Olefin Polymer business in Eastern North America. He has intimate knowledge of injection molding and experience in shape molding, specialty thermosets, and plastic part design. He holds a BS degree in Plastics Engineering Technology from Penn State University.

My name is Alfredo Ricci, I'm the CEO of Althena Medical by Platinum Pharma Service. I graduated in Mechanical Engineering. My previous experience includes Production Manager, Project Manager, and Designer. I have designed a number of medical devices, in the field of drug delivery, the majority of which are patented. I have also designed automatic assembly machines, tools, equipment, etc. In 2016 I founded Platinum Pharma Service in which Althena medical is a brand. Designing innovative medical devices is my passion, doing them well is my commitment.

Amardeep is a Director of Biological Research in Device R&D at AbbVie. She has over 30 years of experience research & development, specifically in preclinical model development for medical devices, biocompatibility, regenerative medicine and scientific team management. Amardeep’s expertise is in regenerative medicine devices and surgical devices for general, plastic and orthopedic surgical solutions. For the past 7 years, Amardeep created and leads the Biocompatibility Group for Allergan Aesthetics and AbbVie, covering a diverse range of therapeutic areas.
In addition to the work she does at AbbVie, Amardeep enjoys taking part in instruction for graduate level Medical Device Seminar courses in the Biomedical Engineering department at Rutgers University. Amardeep has a B.S.E. in Biomedical Engineering from Case Western University and a M.S in Biomechanics from Michigan State University.
 

Andy is a leading expert in usability and human factors for medical devices, with over 35 years of experience in industrial design and innovation. As Head of Usability at 42 Technology, he helps pharmaceutical and medical device companies develop user-centric solutions that balance technological advancement with real-world usability.

Prior to joining 42 Technology, Andy was Creative Director and Head of Strategy, Design & Usability at Cambridge Consultants, where he built and led a world-class team focused on medical device innovation. His work has spanned the development of drug delivery systems, including auto-injectors, patch pumps, and connected devices, along with surgical robotics, diagnostics, and critical care technologies.

With extensive experience conducting human factors studies across Europe, the US, and Asia, Andy challenges assumptions around connectivity in medical devices, advocating for solutions that enhance usability rather than introduce unnecessary complexity. He collaborates with leading pharmaceutical companies, device manufacturers, and start-ups to create breakthrough products that improve patient safety and adherence.
 

Bharat Arora is a seasoned Technical Quality Leader with over 18 years of experience in the medical device and life science industry. Currently a Director of Product Quality at Vertex Pharmaceuticals, Cell and Gene therapies, Bharat has a record of establishing and managing global quality management systems, collaborating in product development, launch and lifecycle management of diverse product portfolio includes Catheters, imaging system, software as medical device, injectable combination products, and mRNA vaccines.

Charlie specialises in integrating sustainable principles into novel medical device development. He has experience across a broad range of drug delivery device products, combining analytical and mechanical design engineering expertise to optimise devices for high-volume production.

Chris Muenzer is the Vice-President of Innovation and Development at Haselmeier. He leads a team of experts that creates customized drug delivery systems for pharmaceutical and biotechnology companies. He has almost 20 years of experience in the pharmaceutical and medical device industry, having worked at Novartis, Roche and the Battelle Memorial Institute. During this time, he has worked at all stages of device development from initial concept, through engineering development to clinical trials and launch. Chris holds a BSME from Carnegie Mellon University in Pittsburgh (PA, US). He is also the inventor of several patents and is a frequent contributor to industry conferences and ISO standards.

Chris Muenzer is the Vice-President of Innovation and Development at Haselmeier. He leads a team of experts that creates customized drug delivery systems for pharmaceutical and biotechnology companies. He has almost 20 years of experience in the pharmaceutical and medical device industry, having worked at Novartis, Roche and the Battelle Memorial Institute. During this time, he has worked at all stages of device development from initial concept, through engineering development to clinical trials and launch. Chris holds a BSME from Carnegie Mellon University in Pittsburgh (PA, US). He is also the inventor of several patents and is a frequent contributor to industry conferences and ISO standards.

Christian Liebl is Director of Business Development at Schreiner MediPharm, where he leads strategic initiatives to bring smart, functional labeling solutions for the pharmaceutical and healthcare industries to the market. His focus lies in helping pharma companies meet regulatory demands while optimizing usability, digital integration, and overall safety. The solutions he helps bring to market don’t just improve compliance and patient outcomes — they also drive measurable efficiency gains and boost the bottom line.

With over a decade of experience bridging technical innovation and market needs, Christian has played a key role in advancing packaging solutions for prefilled syringes, injectables, and drug-device combination products. His work includes RFID-enabled labels, tamper-evident systems, and user-centered design innovations that enhance both process efficiency and end-user experience. As a named inventor on multiple patents, Christian combines hands-on innovation with a strategic business lens.

Christian also serves on the Executive Board of Rx-360, a global consortium dedicated to securing the pharmaceutical supply chain and protecting patient safety. His work contributes to advancing global standards in packaging security and ensuring the safe delivery of critical therapies to patients worldwide.
 

Chuck Ventura is the CEO and Founder of Ventura Solutions, a leading consulting, engineering, staffing, and training firm specializing in combination products. For nearly a decade, Ventura Solutions has served as a trusted partner to medical device, pharmaceutical and biotech companies, providing deep expertise in regulatory strategy, quality systems, design control, risk management, human factors, and more.

With close to 20 years of experience, Chuck has dedicated his career to advancing the development of combination products and medical devices. Prior to founding Ventura Solutions, he co-founded Hemotek Medical, where he served as CEO and led the development of a novel, life-saving needle for hemodialysis. Under his leadership, the product earned FDA Breakthrough Device Designation, IDE approval, global patents, and progressed through clinical trials to a successful commercial exit.

Earlier in his career, Chuck held leadership roles at Baxter, Hospira, and Pfizer, where he served as R&D Engineering Manager for Combination Products. He played a pivotal role in implementing the FDA’s 21 CFR Part 4 regulation, developing and executing some of the first combination product Design History Files (DHFs) and risk management files, which passed FDA audits with zero observations.

Chuck holds a BS in Biomedical and Electrical Engineering from the University of Illinois at Chicago and an MS in Mechanical and Aerospace Engineering from the Illinois Institute of Technology. His entrepreneurial vision and practical expertise make him a trusted leader in bringing combination products from concept to commercialization.
 

Chuck Ventura is the CEO and Founder of Ventura Solutions, a leading consulting, engineering, staffing, and training firm specializing in combination products. For nearly a decade, Ventura Solutions has served as a trusted partner to medical device, pharmaceutical and biotech companies, providing deep expertise in regulatory strategy, quality systems, design control, risk management, human factors, and more.

With close to 20 years of experience, Chuck has dedicated his career to advancing the development of combination products and medical devices. Prior to founding Ventura Solutions, he co-founded Hemotek Medical, where he served as CEO and led the development of a novel, life-saving needle for hemodialysis. Under his leadership, the product earned FDA Breakthrough Device Designation, IDE approval, global patents, and progressed through clinical trials to a successful commercial exit.

Earlier in his career, Chuck held leadership roles at Baxter, Hospira, and Pfizer, where he served as R&D Engineering Manager for Combination Products. He played a pivotal role in implementing the FDA’s 21 CFR Part 4 regulation, developing and executing some of the first combination product Design History Files (DHFs) and risk management files, which passed FDA audits with zero observations.

Chuck holds a BS in Biomedical and Electrical Engineering from the University of Illinois at Chicago and an MS in Mechanical and Aerospace Engineering from the Illinois Institute of Technology. His entrepreneurial vision and practical expertise make him a trusted leader in bringing combination products from concept to commercialization.

Conor O'Neill is an accomplished leader in the field of pharmaceutical packaging and device design, currently serving as the Head of Packaging Development & Design at GlaxoSmithKline (GSK). With nearly 22 years of experience at GSK, Conor has held various roles across Research & Development (R&D) and Global Supply Chain (GSC), giving him a comprehensive understanding of the development and manufacturing processes for new pharmaceutical products.

He has a profound expertise in packaging and device requirements for oral, inhaled, intranasal, and parenteral routes of administration. He has been instrumental in establishing and leading new teams within GSK, including the creation of R&D's Inclusive Design team, which focuses on translating patient engagement into actionable insights for the development of patient and carer-focused medicines, packaging, devices, and related services.

As a passionate advocate for sustainability, Conor has played a pivotal role in GSK's Pack of the Future project, which aims to revolutionize packaging and device technologies with a focus on sustainability and user experience. He has been a driving force behind the integration of Ecodesign principles into GSK's procedural framework, co-authoring the new GSK Ecodesign Written Standard and updating key documentation to reflect these principles.

Conor's dedication to sustainability extends beyond GSK, as he actively participates in industry collaborative groups such as the Sustainable Markets Initiative (SMI), CiPPPA (Circularity in Pharmaceutical Primary Packaging Accelerator) and Pharma Manufacturers Forum (PMF) . He has also co-led a workstream in the sustainability sub-group with the Subcutaneous Consortium.
 

Dan Davenport is an Associate Director on GSK’s Early Engagement and Deviceability team where he engages with key project stakeholders to define device development strategy and conduct technical feasibility for early phase assets. He has a M.S. in mechanical engineering with 15 years’ experience in both pharmaceutical and medical device companies. Prior to joining GSK, Dan’s background includes design and development of drug delivery devices, spinal implant and instrumentation systems, diagnostic devices, dialysis equipment, high-speed automation, and sterile connectors.

Dany Doucet is Director of the Early Engagement and Deviceability group in GSK’s Packaging, Device and Design Solution department. He leads a team of engineers and scientists supporting deviceability efforts to improve probability of technical success of development programs through early evaluation and design of suitable molecules, formulations, primary packaging and devices for complex drug device combination products. He has over 20 years of experience working across all stages of the product and process development lifecycle, from the discovery interface through concept design and selection, registrational submission and commercial supply.

Dany Doucet is Director of the Early Engagement and Deviceability group in GSK’s Packaging, Device and Design Solution department. He leads a team of engineers and scientists supporting deviceability efforts to improve probability of technical success of development programs through early evaluation and design of suitable molecules, formulations, primary packaging and devices for complex drug device combination products. He has over 20 years of experience working across all stages of the product and process development lifecycle, from the discovery interface through concept design and selection, registrational submission and commercial supply.

David Vazquez is the Senior Director of External Supply Digital & Device Technical Operations at Pfizer Inc. With a background in medical device and combination product development, David has led various projects and teams at Pfizer since 2020. He currently leads a team responsible for new-product introduction and post-market lifecycle support for Medical Devices and Combination products, including IVD and SaMD products.
Before joining Pfizer, David held several key Quality Engineering and Quality Management positions at Becton Dickinson and Co., where he was responsible for establishing and executing supplier quality and quality engineering strategies across the enterprise. He also led the integration of CareFusion and CR Bard in areas of process validation and supplier quality. Prior to Becton Dickinson, David spent several years at Roche Molecular Systems, supporting QC and Design Assurance for PCR-based Diagnostic Assays.
 

David Vazquez is the Senior Director of External Supply Digital & Device Technical Operations at Pfizer Inc. With a background in medical device and combination product development, David has led various projects and teams at Pfizer since 2020. He currently leads a team responsible for new-product introduction and post-market lifecycle support for Medical Devices and Combination products, including IVD and SaMD products.
Before joining Pfizer, David held several key Quality Engineering and Quality Management positions at Becton Dickinson and Co., where he was responsible for establishing and executing supplier quality and quality engineering strategies across the enterprise. He also led the integration of CareFusion and CR Bard in areas of process validation and supplier quality. Prior to Becton Dickinson, David spent several years at Roche Molecular Systems, supporting QC and Design Assurance for PCR-based Diagnostic Assays.

Duncan Paterson has over twenty years of technical leadership experience in the development of inhalation and parenteral devices for pharmaceutical combination products. Currently a Senior Director with AstraZeneca, and previously with Novartis and Nektar Therapeutics, Duncan has led device development project teams in all stages of the product lifecycle as well as numerous technology and process improvement initiatives. Duncan holds bachelor’s and master’s degrees in engineering as well as an MBA and is a professional engineer with the UK Institution of Engineering and Technology (CEng). He is based in the US in the San Francisco Bay Area.

E is a passionate leader in building device development capabilities and improving combination product development processes. He is savvy in delivery device technology assessment, combination product development, manufacture process development, commercial scale-up and life cycle management. E currently holds the position of Head of Injection Systems at Takeda. Previously he was Director of device development with AstraZeneca. He built a very strong device team and managed multiple combination product programs in the therapeutic areas of respiratory, inflammation, autoimmune, cardiovascular, renal and metabolic diseases. Prior to AstraZeneca, he was device lead with Janssen Pharmaceuticals and Becton Dickinson, where he led and launched/relaunched a few injection device or combination product programs.
E obtained his Bachelor and PhD degrees in mechanical engineering and a master’s degree in polymer physics.
 

Fletcher Dix is a Sr. Engineer at Regeneron Pharmaceuticals specializing in the evaluation of primary container components. He’s worked at Regeneron for 4 years studying generalized and specialized primary container components for new programs, including those within new modality landscapes. His work aims to bridge the gap between research and development of emerging technologies while ensuring practicality of fill-finish.

Fran has over 5 years of experience in drug delivery device design from concept generation to design verification testing and manufacturing scale-up, with a focus on injection devices. She has led multiple drug delivery projects, from design of novel electromechanical injectors through to due diligence on On-Body Delivery systems. Fran forms part of Cambridge Design Partnership’s core sustainability group, where she is responsible for identifying opportunities for sustainable innovation within the drug delivery sector. She has a master's degree in Mechanical and Bio-Engineering from the University of Cambridge.

Gretchen Piwinski is a Senior Manager of Combination Product Development at Regeneron Pharmaceuticals Inc. She leads a team responsible for providing test engineering and laboratory support to the development of drug delivery systems for Regeneron’s products. Gretchen has been at Regeneron for six years and spent 12 years prior working on implantable medical devices. She holds a Bachelor of Science degree and a Master of Engineering degree, both in Chemical Engineering.

Guangli is an accomplished scientific leader with more than a decade of experience in medical devices and biopharmaceuticals. He earned his Ph.D. in Mechanical Engineering from Johns Hopkins University and champions multidisciplinary research to enhance the robustness and innovation of combination products. Currently, he leads the Combination Product Characterization team at Merck Device Development & Technology. Guangli holds 35 US patents and has published 19 peer-reviewed articles. As a recognized expert and inclusive mentor, he fosters a culture of technical excellence and collaboration within his organization and across the broader technical community.

Dr. Jamie Tsung received her Ph.D. in pharmaceutical sciences from the University of Connecticut. Currently, she is an Associate Director at Alnylam Pharmaceuticals. Prior to Alnylam, she worked for Momenta, Shire, Baxter, and UCB. Her biopharmaceutical experience spans preclinical to marketed products, integrating formulation, characterization, processing technology, regulatory, and quality control providing a valuable perspective and creative approach to product development.

Dr. Jamie Tsung received her Ph.D. in pharmaceutical sciences from the University of Connecticut. Currently, she is an Associate Director at Alnylam Pharmaceuticals. Prior to Alnylam, she worked for Momenta, Shire, Baxter, and UCB. Her biopharmaceutical experience spans preclinical to marketed products, integrating formulation, characterization, processing technology, regulatory, and quality control providing a valuable perspective and creative approach to product development.

As a biomedical engineer specializing in biomechanics and device development, Jayne Gavrity, has cultivated a diverse professional background starting in an orthopedic focus and transitioning to combination products with AstraZeneca. Jayne has an in-depth knowledge of testing and functionality evaluation of devices, and currently acts as technical lead to AZ device development teams focused on parenteral delivery systems.

Jerzy Wojcik is Vice President of Quality and Regulatory Affairs Services at EdgeOne Medical Inc., and has over 25 years of industry experience in quality and regulatory affairs at Baxter Healthcare, Avery Dennison Medical (Vancive Medical), Deloitte, Abbott Laboratories and Baxter (Takeda) BioLife Plasma Services. His expertise includes identification and execution of regulatory activities across all stages of product development and lifecycle management necessary to support Class I, II and III (in both US and EU) medical device, device-biological and device-drug combination products, including wearable sensors and mobile medical applications. Jerzy also has expertise in US distribution and dispensing regulation compliance and US regulatory surveillance for drug, biologics and devices. In addition to medical product regulatory responsibilities, Jerzy also helped develop and implement quality systems and various process quality compliance initiatives.
Mr. Wojcik has a Bachelor of Science in Biology, Medical Technology and Cytotechnology from Augustana College, IL, and was an Adjunct Professor in the School of Law at Northwestern University, IL. He is a member of Regulatory Affairs Professional Society (RAPS) and volunteers with Chicago Innovation Mentors (CIM). Jerzy speaks Polish and Spanish.
 

With 18 years of extensive experience in the pharmaceutical and medical device industries, Dr. Jia Huang serves as an Associate Director at Merck & Co., a global leader in delivering innovative medical solutions to improve patient health worldwide.
Dr. Huang specializes in developing and implementing global regulatory strategies for digital health technologies used in clinical investigations, including Software as a Medical Device, software in medical devices, artificial intelligence, and machine learning applications. Passionate about advancing regulatory science, she actively collaborates with cross-functional teams and external partners to address emerging challenges and achieve shared goals in the ever-evolving healthcare landscape.
 

Joanita Lamien is a Senior Human Factors Engineer at Regeneron, bringing over seven years of extensive experience in the field. Her expertise lies in designing medical and surgical devices, as well as combination products, ensuring they are both safe and effective for use.

Joanita holds a Bachelor's degree in Biomedical Engineering and a Master's degree in Industrial and Human Factors Engineering from Wright State University in Dayton, OH. Her academic background has provided her with a solid foundation in both the technical and human-centric aspects of engineering.

Outside of her professional life, Joanita enjoys reading, traveling, and spending quality time with her family and friends.
 

John A. Merhige is Chief Commercial Officer at Credence MedSystems, leading the Company's commercial activities and external collaborations. Previously, John was Vice President, Market Development at Sanofi BioSurgery. He came to Sanofi upon its acquisition of Pluromed in 2012, which John joined in its early stages and where he was a member of the executive management team. He led the commercial activities at Pluromed, which developed and commercialized highly innovative rapid transition polymers for use in cardiovascular and other surgical procedures.

Prior to Pluromed, John founded Prelude Devices to target early stage medical device technologies for development and commercialization, and previously he gained general management and leadership experience at Ford Motor Company and Avery Dennison.

John graduated from Dartmouth College earning a BA, a BE in mechanical engineering, and a Masters in Engineering Management from Dartmouth’s Thayer School of Engineering and Tuck School of Business. John is married with three children.
 

John A. Merhige is Chief Commercial Officer at Credence MedSystems, leading the Company's commercial activities and external collaborations. Previously, John was Vice President, Market Development at Sanofi. He came to Sanofi upon its acquisition of Pluromed, which John joined in its early stages and where he was a member of the executive management team leading the Company’s sales and marketing efforts. Prior to Pluromed, John founded Prelude Devices to target early-stage medical device technologies for development and commercialization.

Dr. Zhao is currently the Director of Combination product development at Takeda Pharmaceuticals. She has 20 years of experience in combination product device development, manufacturing and lifecycle management. Her expertise is focused on drug delivery injection systems such as prefilled syringe, autoinjector, large volume wearable injector, pen injectors as well as digital transformation of combination products.
Prior to Takeda, Dr. Zhao took various technical leading roles at Becton Dickinson and Company and Dr Reddy’s, focusing on medical device new product developments.
Dr. Zhao holds PhD and master degree in mechanical engineering and bachelor degree in material science and engineering.
 

Dr. Julie Li holds a Ph.D. in Polymer Science and brings extensive experience in the healthcare and chemical industries. Her expertise spans medical device biocompatibility, failure analysis, material selection and characterization, as well as new product development and manufacturing. Since 2024, Dr. Li has been with Eli Lilly, where she leads the Biocompatibility Team within Delivery Device and Connected Systems. In this role, she provides strategic guidance on material selection, and biological risk assessment to support product development, change management, and regulatory submissions in alignment with ISO 10993 and other relevant standards.

Kelsey Golk is a Biocompatibility Scientist at Pifzer and operates as the biocompatibility subject matter expert for medical devices in development and in life cycle management. She also has previous experience in particulate analysis, materials science, and engineering. She has been a member of the BioPhorum Biocompatibility Workstream since its initiation and greatly enjoys the opportunity to collaborate with industry peers in the biocompatibility space.

Kinsuk Shah is currently Sr. AD, Combination Product Steward at Boehringer Ingelheim, responsible for device lifecycle management and strategy for Cyltezo. Mr. Shah is accountable for continuing development and oversight of CP manufacturing + supply, leading an interdisciplinary team of internal SMEs (e.g., drug product, packaging, final assembly, device, quality). Prior to joining BI, Mr. Shah was Director of Device Development at Viridian Therapeutics, responsible for device strategy and development, including establishing internal and external capabilities within the device space, evaluation and selection of wearable and auto-injector devices. Mr. Shah has over 10 years of drug-device combination product experience from Janssen, West and Alexion. Prior to Viridian, Mr Shah was at Alexion, where he was responsible for Strategy and Program Management for ongoing device dependent programs. At West Mr Shah was the Business Development lead for the SmartDose and SelfDose platforms, successfully partnering with multiple pharmaceutical companies in establishing joint combination product programs for each product.

Kristin Booth is currently a Senior Biocompatibility Scientist at AbbVie. She has over a decade of experience in the medical device industry with a diverse background including product surveillance, quality assurance, preclinical research, and biocompatibility. In her current role, she supports the biocompatibility evaluation of medical devices and combination products for both clinical and commercial use, as well as providing ongoing support for marketed products through change control initiatives. She holds a B.S. degree in Animal Science from Rutgers University. Outside of work she enjoys agility training with her dog, horseback riding, and hiking.

Landon Goldfarb is the Biomedical Product & Market Manager at Instron where he works with the world's leading biomedical companies to implement, improve, expand, and automate their static mechanical testing. In his role, he works to develop testing solutions, including hardware, software, and services, based on direct customer feedback and the trends driving the industry at large. His focus has been specifically within the pharmaceutical industry, partnering with device manufacturer, pharmaceutical companies, and CDMOs to design bespoke systems to evaluate the performance of drug delivery devices ranging from vials to PFS to autoinjectors.

 

Lisa Ray is an Executive Director responsible for Program Management of Diabetes and Obesity Device projects in the Delivery, Devices and Connected Solutions (DDCS) organization at Lilly. Lisa joined Lilly in 1995 after receiving her Master of Science in Biochemistry from Purdue University and her Bachelor of Science in Chemistry from Butler University. She has a strong scientific background, deep understanding of drug/ device product development and is a six-sigma black belt who has held a variety of individual contributor and leadership roles. Currently, Lisa’s team is responsible for device development opportunities to support Lilly’s growing Diabetes and Obesity assets.
 

Mark DeStefano is the Director of New Device Technology, Combination Products and Devices R&D for Teva Pharmaceuticals focusing on strategic planning for Teva’s future combination products including new device and drug delivery technology identification and development for Teva pipeline drugs and platform combination products. He is an experienced device development professional with a demonstrated 34 yr. history of product innovation, design, development, and launch in many areas of the medical device industry from surgical devices to drug delivery devices. Mr. DeStefano has spent the last 24 years in drug delivery device development, including 13 years in the development of implantable sensors, insulin pumps and infusion sets for Type 1 Diabetes and 11 years in the development of injection devices for parenteral drugs.

Dr McLoughlin is currently Vice President, Devices and Delivery Technologies at Apogee Therapeutics. He has 25 years experience in combination product development and has previously held leadership positions at UCB and Bristol Myers Squibb. He has developed devices and combination products across several therapeutic areas and routes of administration including inhalation, subcutaneous injection and IV infusion. He holds BS and PhD degrees in materials science and engineering and is named as an inventor on more than 40 patents in the field of devices and drug delivery covering mechanical and electromechanical autoinjectors, prefilled syringes, IV infusion and connected health technologies.

Mr. Masashi Miura is a researcher of Hiratsuka Research Laboratory.
He gained a Diploma in Science in 2020 and a Master Degree of Science in 2022 from Osaka University.
In University, he majored in applied chemistry and studied crystalline porous materials.
Since April 2022 he has been working for Mitsubishi Gas Chemical Company, Inc.
Since May 2022 he has joined a development team of multilayer plastic vial & syringe for biologics.
 

Matt Marber (he/him) is a Senior Usability Engineer at Novo Nordisk where he applies human factors engineering to the development of combination products. He has experience planning, managing, and conducting usability tests throughout the device development process, with most of his experience in executing successful HF validation tests. Prior to joining Novo Nordisk, he worked as a consultant at Emergo by UL and PA Consulting. He received his BS in Engineering Psychology and his MS in Human Factors, both from Tufts University.

Professional Qualifications:

• • 3+ years at the FDA as a member of the infusion devices team including developing and setting review practices for life-critical drug delivery systems and electroporation systems
• • (previous) Member of AAMI ID and IP infusion pump committees
• • 2+ years at Medtronic developing and maintaining electrocautery platforms
• Academic Qualifications
• • Bachelors of Science in Biomedical Engineering, Boston University School of Engineering
• • Masters of Science and Doctor of Philosophy in Materials Science and Engineering, University of Maryland College Park
• • Author of 11 peer-reviewed publications, 17 conference presentations, and 3 patents (to date)

Training / Quality Systems / Specialties:

• • AAMI Medical Device Quality Systems (ISO 13845 and 21 CFR 820)
• • Drug delivery systems requiring high reliability
• • Electroporation systems
• • Implantable and external infusion systems
• • Multidisciplinary Systems engineering
• • Complex system verification and validation, including vulnerable populations (e.g. pediatrics, sensitive populations, etc.)
• • Risk management/ISO 14971/FMEA particularly for devices which lack established standards or performance controls
• • Total Product Lifecycle Management
• • 21 CFR 4
• • Design for Manufacturability and Reliability
• • Process Qualification and Process Validation
   

Megan Heft is Director of Device Development at AstraZeneca, where she leads device teams in development of parenteral combination products for assets ranging from early to late stage. Megan has over fourteen years of industry experience, with prior roles as device team lead in Combination Products R&D at Teva Pharmaceuticals and technical lead in Primary Container R&D at West Pharmaceutical Services. Megan holds a Master of Engineering in Biomedical Engineering from Cornell University and a Bachelor of Science in Biomedical Engineering from Bucknell University.

Moritz is Product Manager at Gerresheimer, focusing on innovative products in the large volume / on body drug delivery space. His expertise spans from his past as a research fellow at Harvard, to commercialization of the technology developed at university within a startup, to his current work in drug delivery devices.

In his role as Product Manager at Gerresheimer, Moritz focuses on the development of innovative drug delivery devices. His expertise spans from a research fellowship at Harvard, to commercialization of technology developed at university within a startup, to his current role at Gerresheimer in Switzerland.

Naveed Currently works as a Scientist at the Pharmaceutical R&D department of Pfizer Inc. He supports process development and progression of projects ranging from Phase-I to Phase-III, focusing primarily on Vaccines and Protein based modalities. Naveed has special interest in process improvement in the biologics manufacturing, such as filtration, fill-finish, packaging, and design control aspects for combination products. Apart from the Pharmaceutical Industry, Naveed has a strong background in Technical Sales and Healthcare industry. On the academic front, Naveed obtained his MSc. degree from University of Western Ontario Canada with a focus on Biophysical Analysis and Structural Characterization of Macromolecules.

Nick has spent 25 years in cross functional roles in the device and combination products industry including systems development, clinical manufacturing, manufacturing and process engineering, validation, and combination products quality assurance. He joined Pfizer in 2017 and leads the team responsible for external supply technical operations from API through finished product as well as the lifecycle management of drug delivery devices, implantables, SaMDs, connected devices, and diagnostics. His organization’s responsibilities include external partner due diligence; device strategy; design and development for devices, combination products, and diagnostics; post market surveillance; post market innovation; and sustainability. He holds a B.S. in mechanical engineering from Cornell University.

Nolan Dow has been a combination product development engineer within Pfizer’s drug product design and development group for the last three and half years, supporting the pre-market development of various prefilled syringe programs. He has previous experience at Waters Corporation as a design quality engineer supporting development of analytical laboratory instruments. Nolan graduated from Clemson University with a master’s in biomedical engineering and a bachelor’s in bioengineering.

Paul is the Sales Director for CCL Healthcare in the Western US. Paul has worked in Healthcare labeling for 20 years and in the label industry for over 30. Paul works with large biotech companies and has managed many biological packaging programs in secondary packaging and labeling including vial, PFS, Combination products and RFID. Paul has worked in RFID labeling at CCL since 2003 and has also worked in printed integrated circuit (IC) electronics representing Thinfilm Electronics.

Ravi joined Takeda in 2021 as the VP, Global Program Leader, PDT Integrated Care Solutions where he has formed a GPT to drive patient centered integrated care solutions with devices/digital innovations to help drive better patient outcomes while growing the PDT business (initially focusing on IG home infusion therapy).
Ravi was most recently the CEO for TransAsia Biomedical Ltd. (a large IVD company) where he led & drove the Strategy, Product Development & Launch Execution, Leadership Team Management, Business development & growth with P&L Responsibility (~ $120MM).
Earlier, Mr. Kaushik was with Medtronic as the Group Marketing Director, APAC & Country Director, India for the Diabetes business (insulin pump & CGM). He drove strategic growth for the ~$100 MM business and led innovative patient centric business models to improve solutions and services for Diabetes patients (value-based healthcare) across the APAC region.
Prior to that, Mr. Kaushik was at Baxter International (Baxalta-Shire) as Director for Strategy & Healthcare Innovation function for the Emerging Asia/India markets. He provided strategic leadership, identifying, and executing key market and patient centric innovation programs while aligning these initiatives with the global company strategic plan. He also led the commercial (P&L) of the $70MM Baxalta India when it was spun off from Baxter in 2015.
Earlier, Mr. Kaushik was at GE Healthcare as the Director of Global Upstream Marketing (Maternal Infant Care), Emerging Markets leading multiple teams of product managers for disruptive medical device product innovation, driving market creation with organic growth across Asia & Africa.
Prior to that Mr. Kaushik was with GE LED Lighting as a Global Product Marketing Manager, in Cleveland, USA leading several new product innovations in LED lighting for retail display.

Overall, Ravi has 25+ years of global leadership experience in strategic product and business model innovation in various roles/industries ranging from Healthcare (MedTech & Pharma), LED Lighting, & Industrial companies globally. Ravi has proven himself as a disruptive innovator, strategic thinker, inclusive and execution driven leader in business analytics, strategic planning, global marketing, new product & business model innovation.

Over the past decade, Ravi has been recognized globally as India’s Top 20 Healthcare CEOs (Transasia) in 2020, Global transformative leader award (Medtronic) in 2018, Emerging Market Growth Leader award (Medtronic) in 2018, Healthcare Innovation speaker at World Federation of Hemophilia Congress (2016), Global CEO Award for “Imagining the possibilities” Business Model Innovation at Baxalta (Shire) (2015), CEO Award for Patient Centricity (GE Healthcare, India) in 2012

Mr. Kaushik holds an MBA from the prestigious Kellogg School of Management (Northwestern University) in Chicago. Mr. Kaushik also has graduate degrees of Masters in Mechanical Engineering from the University of Wyoming and Bachelors’ in Mechanical Engineering from MS University, Baroda, India.

Sarah Fairfield currently works as an Associate Director, Regulatory Affairs at AbbVie in Combination Products and Digital Devices. She began her career in the medical device industry as a Process Engineer and moved into Regulatory Affairs just over 16 years ago. Her experience includes global regulatory strategy development for medical devices and digital health technologies, pre- and post-market submissions for stand-alone devices and combination products, and regulatory compliance. She holds a Bachelor of Science degree in Biomedical Engineering from Purdue University, an MBA in Health Sector Management from Boston University, and US Regulatory Affairs Credential (RAC).

Soumen Das is an experienced professional in the field of product development within the medical device industry, with a track record spanning over nine years. For the past five years, Soumen has dedicated his efforts to ensuring the biocompatibility of medical devices for the FDA, EU, and PMDA regulatory submissions. His expertise ranges from in-vitro diagnostics to implantable medical devices. His Ph.D. and postdoctoral work focused on material and nanoparticle compatibility with biology, including systemic and organ toxicity. His extensive research has resulted in over fifty peer-reviewed international journal publications showcasing his commitment to advancing the field. He holds eight patents alongside his publications, demonstrating his innovative and creative problem-solving abilities. Recognized for his achievements, Soumen has been honored with several prestigious awards, including the Young Investigator Award 2016 and the 2014 at Gordon Conference in Radiation Chemistry. Additionally, he received the University of Central Florida Innovator Award in 2014.

Sriman Banerjee has over 15 years experience in the field of Plastics & Packaging having worked with Reliance Industries , Marico & Johnson & Johnson. Currently he is working as Head of Packaging Development and Commercial Device Engineering at Takeda and prior to this he was Head of Packaging Development - Respiratory category at Glaxo Smithkline - Consumer Healthcare & co-based out of Switzerland & USA. Sriman is a Mechanical Engineer with a Masters in Packaging from Indian Institute of Packaging and a Post Graduate in Plastic Technology from Indian Plastic Institute. He has also a Masters in Financial Management from Mumbai University. He is a Certified Packaging Professional from IOPP, USA. He is also a Fellow of Indian Plastic Institute. Sriman has presented papers on Plastics technology & Packaging technology in National & International conferences organized by PackExpo, Pharmapack, American Packaging, International Corrugated Conference, PACE, Indian Plastics Institute, AIPMA, Indian Institute of Packaging, India Packaging Show, etc... He has published papers and written articles in South Asia Packaging, IPI Journal, Packaging India, ET Polymers. Etc… He is instrumental in developing many new technologies & applications like PP thermoforming, PP – ISBM, Random co-polymers, Ter-polymers, Spouted pouches, Frenel’s Lens cartons, Unidose packs, etc..… Under his leadership, GSK has been awarded several IndiaStar, Asia Star, Ameristar, WorldStar over the last 6 years & PlastIndia Sustainability award for Excellence in packaging

Steve is a seasoned expert in combination products, engineering management, systems engineering, and business development. With over 30 years of experience, he has been instrumental in the design and launch of various medical devices, including auto injectors, insulin pumps, inhalers, connectivity solutions, and patient management software. In 2012, Steve founded Suttons Creek, the managed services firm that has successfully operated as the device team for hundreds of pharmaceutical programs. He now serves as the executive vice-president of this growing entity, which has expanded services in toxicology, supply chain management, and clinical trials.
Steve has successfully built, led, and sold two companies, and currently holds several board positions and actively engages in mentorship for entrepreneurs and investors. Committed to leadership and education, Steve has served as a Graduate Professor at Loyola Marymount University, where he shared his extensive knowledge and experience with the next generation of engineers and business leaders. In his spare time, he is honing a newer skill set, managing 30 varietals of fruit and three rare breeds of sheep on the family’s 56-acre vineyard property.
 

Subhi Saadeh is a Quality Professional and host of Let’s Combinate, a YouTube channel & Podcast focused on the intersection of drugs and devices. With a background leading quality, manufacturing, and R&D initiatives, he has supported the development and launch of hardware, disposable devices, and combination products across vaccines, generics, and biologics.

He currently serves as Associate Director of MDPC QA at Gilead Sciences. His previous roles include positions at Pfizer and Baxter, where he led cross-functional efforts for complex combination product platforms. Subhi also chairs the International Working Group for the Combination Products Coalition (CPC), where he manages an international regulatory intelligence database and leads global harmonization initiatives. He is a member of ASTM Committee E55 and has served on AAMI's Combination Products Committee.
 

Dr. Basu is currently the Head of Pharmaceutical Development at Ionis. Dr. Basu’s prior experiences include serving as Vice President, Pharmaceutical Sciences, and Pharmaceutical Development at Takeda/Shire where he led the Device and Combination Products Center of Excellence that was responsible for development and commercialization of delivery devices and combination products, digital health, and diagnostic solutions, as well as Vice President at Dicerna Pharmaceuticals (now part of Novo Nordisk). Dr. Basu studied Pharmaceutical Technology and Engineering (BS & MS) in Kolkata, India (Jadavpur University), Pharmaceutical Sciences (PhD) in Los Angeles (USC) and Certificate in Management in Cambridge, MA (Harvard).

Theresa Scheuble is Head of Design & Innovation for Johnson & Johnson. She is an expert on combination product requirements and considerations supporting all segments of Johnson & Johnson.
Prior to her current role, Theresa was Head of the Combination Product Drug Delivery Systems Development for the East Coast team in Janssen, a Johnson & Johnson Company. While at Janssen, Theresa was responsible for Combination Product Device development and led cross-sector initiatives. Theresa has been with Johnson & Johnson for greater than 25 years, working in all Segments of Johnson & Johnson with 18 years specifically in the Medical Device Segment. She was the project lead and technical lead for greater than 20 portfolio enhancing products by Johnson & Johnson companies. She also has experience in the Automotive and Aerospace industries.
 

• ­ Extensive experience in high-tech production machinery, robotics & automation, laser material processing in automotive, life sciences and consumer industries.
• ­ General Manager at PIA Automation US Inc.
• ­ Previous roles include: Chief Business Officer at BBS Automation, President North America at Zeltwanger; Managing Director for Mühlbauer AG in Malaysia; Business Unit Leader Robotics at Yaskawa Europe (Motoman Robotics) and Business Developer / Segment Manager at Trumpf Laser.
• ­ Master degree in Mechanical Engineering / Automation as well as MBA.

Tim Quigg is development director at Crux Product Design, with more than 10 years experience leading medical device development programmes for top pharmaceutical companies.

Tim Quigg is development director at Crux Product Design, with more than 10 years experience leading medical device development programmes for top pharmaceutical companies.

Yvette Appleby, RAC, CSM, CAPM, CSPO, is a seasoned professional with a robust background in regulatory affairs and project management focused on software as a medical device. She holds a master’s degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University. Currently, she serves as a Senior Manager at Pfizer, where she manages the assessment process for all medical software designed, developed, or promoted by or on behalf of Pfizer. In her role, Yvette also supports business strategy and solution delivery initiatives. Yvette is also a certified Scrum Master and Product Owner.