Aaron Sundman

Aaron Sundman is a trailblazing RFID innovator with over 25 years in technology and business efficiency. Beginning as a software developer, his exploration of RFID technology led to significant industry advancements. At CCL eAgile, he merges technical expertise with business strategy, enhancing supply chains and inventory management. As a self-described techno-optimist he sees this technology as the way to help the entire world create a safer and more efficient pharmaceutical supply chain.

Alex Baker

Alex Baker works in Biogen’s Device Development group as a Senior Engineer II, Technical Lead based in Cambridge, MA. Alex previously worked at Veranex (formerly Ximedica), a medical device consulting company, where he was a Senior Product Development Engineer developing capital medical equipment, leading the launch of two class II medical devices, and contributing to technical deliverables for other projects. Prior to Veranex, Alex was a Senior Systems Engineer at Eli Lilly and Company, leading technical development for an electro-mechanical, mobile app, and cloud-based system. Alex has additional experience with autoinjectors, insulin pens, requirements/risk management, and Design Verification and Validation.

Alexandra Benbadis

Alexandra is a passionate human factors (HF) professional who loves everything about combination product usability. At Sanofi, she serves as the HF subject matter expert on several programs and advocates for implementing creative HF strategies, which are rooted in her strong understanding of applying HF principles to developing safe and effective combination products. Before working at Sanofi, Alexandra was a Senior Human Factors Specialist at Emergo by UL, where she was responsible for planning, managing, and conducting usability tests throughout the product development process. She has both a bachelor’s degree and master’s degree in human factors engineering from Tufts University.

Alicia Douglas

Alicia, a graduate of the University of Maryland, with a B.S in Bio-engineering, is a knowledgeable and passionate Human Factors leader. She has 16 years of experience in Pharmaceutical, Medical Device and Consumer Healthcare Industry. Throughout her career she has been focusing on devices and combination products within Oral Care to Oncology area. With a strong background in human factors, product development, and design controls she loves learn and present on these topics for devices and combination products.

Anthony Coston

Anthony drives the development of ASO combination devices and gene therapy delivery devices at Biogen. Anthony has over 25 years of medical device experience in the areas of product development, project management, marketing, new business development, and technology scouting.

Prior to his time with Biogen , Anthony was consulting with GSK and other Biotech companies in the Oral Solid Dosage CMC area pertaining to depression, oncology, and other therapeutic drugs. Anthony was also the Director of CMC Project Management at Alkermes.

In addition, Anthony was the Head of Medical Devices at Draper where he was responsible for New Business Development through leveraging the technical capabilities and expertise within Draper to provide technical solutions for unmet needs within the medical device and biotech communities. Anthony was responsible for obtaining a $16M neurological device development contract within the first year in this role which was the largest device contract obtained at Draper during that time.

Prior to Draper, Anthony worked for several medical device companies including Johnson and Johnson, Becton Dickinson, and Bard where he helped develop the leading fecal containment system, a portable urodynamic measurement system, a continuous glucose monitor and advanced the development of a thermal ablation technology to treat menorrhagia.

Anthony has four issued patents, several pending patents, and six publications. He has a PhD and a Master’s in Biomedical Engineering from Rutgers University and Penn State University respectively. His undergraduate degree is in Electrical Engineering from the University of Delaware, and he has an MBA from MIT.

Bernard Vrijens

Bernard Vrijens is Chief Executive Officer at Advanced Analytical Research on Drug Exposure (AARDEX Group). He is also Professor of Biostatistics at Liege University, Belgium.

Dr. Vrijens holds a PhD from the Department of Applied Mathematics and Informatics at Ghent University, Belgium.
He has pioneered a research program focused on a simple but robust taxonomy of common dosing errors, along with exploring optimal measurement-guided medication management that can drive adherence and maintain long-term persistence.
With over 100 peer-reviewed scientific papers and six patents to his name, Dr. Vrijens is also a founding member of the International Society for Medication Adherence (ESPACOMP) and an active member of several EU- and US-funded collaborative projects around the theme of adherence to medications.

Dr. Vrijens is a highly-accomplished public speaker, having presented lectures at over 200 industry events and scientific conferences around the world over the past 20 years. Public speaking experience includes the NIH Adherence Network Distinguished Speaker Webinar Series, CDER Drug Packaging Summit at the FDA, European Society of Cardiology Congress, American Society on Pharmacometrics, WHO Global Forum on Innovation for Aging Populations, among many others.

Carrie O'Donel

Ms. O’Donel began her career in industry over a decade ago. Holding degrees in Physics and Mechanical Engineering, she began her career in Forensic Engineering, providing scientific investigations in the areas of Injury Biomechanics, Material Failure, Medical Device Failure, and Amusement Park Ride Design and Operation, to name a few. During her time at Teva Pharmaceuticals, she has worked as both a Quality Engineer and Device Engineer, on programs at every stage of the design process – from Discovery to Commercial and Life-Cycle Management. Her current focus is new and evolving technologies within the Injectable Drug-Delivery System space.

Cedric Gysel

Cedric Gysel is a Healthcare Solutions Manager for Johnson & Johnson Design, driving human-centered solutions for patients and customers and leading key innovation projects for device & packaging sustainability as we all product end of life programs across the pharmaceutical and medical device sectors of Johnson & Johnson. He has more than 15 years of experience with the development and design of devices and combination products. He holds a bachelor’s in pharmaceutical technology from the University of Basel and a master’s in medical device technology from the University of Applied Science.

Charlie Dean

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.

Courtney Evans

Courtney Evans has over 8 years of experience in medical device and drug delivery development and regulation, including over 4 years at the FDA as a Reviewer and Team Leader of injection device combination products. They bring a passion and natural proclivity for complex combination product regulatory strategy, as evidenced by their contributions to policy development of connected “smart” drug delivery devices, on-body delivery systems, emergency-use injectors, and implantable infusion pumps.
Courtney’s passion for combination product development is bolstered by their prior experience as a test/quality engineer, supporting medical device programs and process improvement initiatives. Their collaboration with the global regulatory community extends to speaking engagements at various international conferences.
 

Dany Doucet

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 Morra

David comes with over a decade of experience developing complex combination products and home use digital solutions within large, medium, and start-up organizations. David has led R&D, Regulatory, and Quality organizations through development, clinical testing, FDA approval and clearance, and ultimately commercialization of these solutions in a variety of disease states and risk profiles.

Divya Sharma

• Divya Sharma is a Sterile and Specialty Product Development Scientist with expertise in formulation development and bioanalytical characterization of advance drug delivery systems.
• She graduated with a doctoral degree in Pharmaceutical Sciences from North Dakota State University where she worked on basal insulin delivery using stimuli sensitive polymer, and silencing RNA based gene therapy for treatment of insulin resistance.
• She currently works as a Senior Scientist in the Drug Product Design and Development Department at Pfizer in Andover, MA.
• Her major projects include mRNA-based vaccine therapeutics and investigating novel container closure systems for various applications.
   

Duncan Paterson

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 Guan

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.
 

Erik Smeels

Erik is a passionate and creative professional with over 25 years of experience working in the pharma & FMCG industry. Erik graduated from Delft University of Technology in the Netherlands with a Master of Science degree in Industrial Design Engineering and a specialization in Product Design. As a leader he enjoys navigating through the complexities of developing packaging solutions with a strong emphasis on patient needs, manufacturability, and sustainability. His experience reaches from food packaging and regulatory compliance to medical device development and complete primary and secondary packaging configurations.

Gang Peng

I graduated from Rice University in 2017, obtaining degrees in biomedical and chemical engineering and economics. It was soon after that I started working at FDA as a researcher, assessing the guidelines of ISO 10993-12. Continuing my work at FDA for 6 years, I stepped into numerous roles such as biocompatibility/engineering subject matter expert, combination product reviewer, lead reviewer, team lead, etc. From this experience, I was selected to give feedback to industry as well as provide mentorship and present trainings internally. Today, I am passionate about continuing the learning and communication between FDA and industry.

Hiroki Hasegawa

Mr. Hiroki Hasegawa is a researcher of Advanced Business Development Division.
He gained a Diploma in Science in 2013 and a Master Degree of Science in 2015 from Osaka University.
Since April 2015 he has been working for Mitsubishi Gas Chemical Company, Inc. and in charge of macromolecular science,
especially in composition development of thermosetting resin.
Since 2018 he has joined a development team of multilayer plastic vial & syringe for biologics.
 

Jamie Tsung

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.

John Merhige

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.

John Schalago

John is Regulatory/Quality/Clinical professional with over 30 years of experience in research & development, quality assurance/control, clinical affairs, regulatory affairs and executive management. John has extensive experience with global health authorities as well as with CDRH, CBER, and CDER managing submission strategies, HA interactions and submissions. John has a diverse background which includes expertise in combination products, software-controlled medical device submissions including, sensors (implantable, minimally invasive and in-vitro diagnostics, and software as a medical device, including, mobile applications and web-based clinical decision software.

Kristina Li

Kristina is a device development engineer at Biogen, developing combination products with on-body delivery systems, autoinjectors and pre-filled syringe systems. She has over ten years of experience designing and developing combination products and medical devices, including new product development and life-cycle management for post commercial launch devices.

Lawton Laurence

Mr. Laurence is Head of Combination Product Development for Apellis Pharmaceuticals, a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. Known as a results-oriented entrepreneur, with a demonstrated track record of success, Mr. Laurence provides leadership in strategic planning and execution for local and systemic drug delivery. Notably, Apellis recently achieved the first in industry approval for a 20ml On-Body Injector. Prior to joining Apellis, he held roles in Research and Technology Development at West Pharmaceutical Services and co-founded an orthopedic medical device company.

Leya Bergquist

Leya Bergquist, Associate Director of Human Factors Engineering at UserWise, a ClariMed Company, is a dedicated leader with over 20 years of experience in the medical device industry. Her broad range of expertise includes product development, preclinical studies, human factors, clinical studies, technology transfer, risk assessment, product verification, design controls, cross-functional collaboration, project and budget planning, mentoring, and team building. For the past 8 years, Leya has focused on integrating human factors throughout the product life cycle, ensuring that devices and therapies are optimized for patient usability and safety.

As a key member of ClariMed, a best-in-class consultancy specializing in integrating human factors engineering and user experience design into medical device product development, Leya is well-versed in identifying and applying the appropriate human factors practices at each stage of product development. She regularly works with human factors submission strategies and compliance documentation for FDA Human Factors Guidance and international standards related to usability engineering (e.g., IEC 62366-1, IEC 60601-1-6, and ISO 14971) for both home and hospital use products.
 

Madeline Mannion

As an Associate Director within the Combination Product Operations function at Amgen, Madeline manages the Systems Engineering team at the Cambridge, MA facility. Her team is responsible for combination product development, early engagement programs, and technology feasibility initiatives.

Madeline has been with Amgen since 2021. Previously, she worked for over 15 years at Medtronic as a leader developing catheter-based delivery systems for transcatheter heart valves, leadless pacemakers, neuromodulation leads & endovascular grafts.

Madeline holds a BS in Biomedical Engineering from the University of Connecticut and an MS in Engineering Management from Northeastern University.

Manuel Sanchez-Felix

Dr. Manuel Sanchez-Felix is the VP of the Drug Delivery Search & Evaluation Group at Halozyme. He is a scientific leader with over 20 years of experience in drug discovery and development where he co-invented products and contributed to the successful development and launch of various patient centric pharmaceutical products.

Previously he was at Novartis where he led a cross-functional group from Discovery and Development that have evaluated and implemented external Novel Delivery Technologies for many different types of modalities. He is also part of initiatives designed to promote innovation within Novartis. His previous position at Novartis involved heading a group of scientists at the interface between Research and Development, establishing physicochemical and biopharmaceutical properties, and combining this information to initiate development strategy and formulation design. Prior to joining Novartis, Manuel was at Eli Lilly & Company for 20 years.

His area of expertise includes Biopharmaceutics, drug delivery and patient-centered formulation design. Areas of drug discovery where he has developed products include CNS, infectious diseases (specifically TB), oncology, regenerative, cardiovascular and metabolic diseases.

Dr. Sanchez-Felix received his B.Sc. Honors degree and Ph.D in Chemistry from the University of Surrey, UK. He is also an Adjunct Professor in the Department of Industrial and Physical Pharmacy at Purdue University (West Lafayette, IN) and a Fellow of the Royal Society of Chemistry. Recently, he has joined the Advisory Board for the Biomedical Program at Middlesex Community College.

Mark DeStefano

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.

Mark Hassett

Mark Hassett, Vice President of Business Development, Credence MedSystems, Inc.
Mr. Hassett has 30+ years’ experience in the medical device industry. In that time, he has functioned as Global VP Sales, Marketing, and Business Development for IVAC Corporation, Block Medical, Medication Delivery Devices, Safety Syringes, Venetec Int’l, Unilife Medical, and ROVI Contract Manufacturing (EU).
His responsibilities included commercialization of infusion pumps, injectable devices (PFS), wearable devices, and autoinjectors.
He has injectable device experience in multiple markets to include, acute care, alternate site, and more specifically for Pharmaceutical and Biotech the last 20 years.
He holds a BS degree from Georgia State University in Atlanta, GA.

Mark Howansky

Mark Howansky is the Vice President of Device Development and Commercialization at Viridian Therapeutics, where he leads a team responsible for the development, launch and commercial supply of the device constituent part of combination products.
Mark is a dynamic leader with over 25 years of industry experience including serving as Director of Device Development at Bristol-Myers Squibb and Director of Engineering at Caliber Therapeutics (now Orchestra Biomed).
Mark holds a Bachelor’s degree in Engineering Sciences from Harvard University and a MBA from Stern School of Business, New York University.
 

Matthew Hancock

Dr. Matthew Hancock is a Principal at Veryst Engineering, a technical consulting firm in the Boston area. Dr. Hancock has extensive experience in fluid mechanics related to product design and performance, with core areas including microfluidics, surface tension and wetting, heat transfer, species transport, and mixing. He consults in microfluidic and fluidic devices in biopharma, biotechnology, medical devices, combination products, process technologies, and consumer products. For combination products, he and his team consult on a range of topics including autoinjector performance, syringe stopper lubrication and motion, vial fogging, lyophilization, dense suspension jamming, drug product drying, water ingress, and leakage.

Dr. Hancock has worked in academic, medical, and industrial settings, both as project lead and as a model-based engineering consultant. He earned his PhD in environmental fluid mechanics from MIT. Prior to joining Veryst, he worked with the Broad Institute, the Wyss Institute, Brigham and Women’s Hospital, Harvard Medical School, and the Department of Applied Mathematics at MIT. Dr. Hancock has coauthored dozens of peer-reviewed research articles in journals such as Nature Materials, Lab on a Chip, Small, and Biomaterials.
 

Michael Song

Michael leads Device and Packaging plus Shipping Validation at Moderna overseeing both development and on-market activities. Prior, he has held positions as Director of Sterile Packaging at GSK and Associate Director at Takeda. Through his career, also formed and led the Device Functionality, Safety and Digital Connectivity group at AstraZeneca as well as Device, Package, and Process Engineering group 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.

Nicholas Mandala

Nick has spent more than 20 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 currently leads the team responsible for lifecycle management of drug delivery devices, implantables, SaMDs, connected devices, and IVDs. His organization’s responsibilities include device strategy, design and development of medical devices and combination products, post market surveillance, and post market innovation and sustainability. He holds a B.S. in mechanical engineering from Cornell University.

Ning Yu

Ning Yu is an Executive Director, Device and Combination product development at Astria Therapeutics, responsible for the entire Device Lifecycle from early stages of research and development to late and commercial product development and manufacturing at Contract Development and Manufacturing Organizations (CDMOs). Ning has 18 plus years of experience with medical devices and combination products, and worked in companies like Biogen, BD, Zimmer-Biomet. Ning has extensive experience with Pen injector, PFS, Auto-Injectors, On Body Injector, implanted drug delivery device, connected device and smart packaging. Ning holds a PhD in Mechanical Engineering from the University of Illinois and MBA from BU.
 

Peter Petrochenko

Peter Petrochenko, PhD, is an Associate Director, CMC and Combination Product Regulatory Affairs at Regeneron Pharmaceuticals. Dr. Petrochenko is responsible for combination product development from early clinical use through post-marketing. Dr. Petrochenko spent almost a decade at the US FDA in at both CDER and CDRH as an NSF Scholar-in-residence and a Senior Staff Fellow, authored several FDA guidance documents. His work at the FDA has been recognized with the FDA Outstanding Intercenter Scientific Collaboration Award. Dr. Petrochenko graduated with a BS with Distinction and a PhD in Biomedical Engineering from UNC-Chapel Hill and received several scholarships and NSF funds.

PJ Kim

PJ Kim’s 19+ years in regulated pharmaceuticals, healthcare, and clinical trials includes responsibilities in quality, sales, program management, key account management, and corporate strategy. At ApiJect, Mr. Kim is responsible for developing strategic plans for new and existing key accounts in drug delivery design, development, and manufacturing utilizing ApiJect’s technology.
Previously, Mr. Kim served as an Executive Director in Syngene International’s NA CDMO business, developing new integrated drug development programs. Earlier posts included Pharmaceutics International’s Head of Commercial and Corporate Development, and Account Manager with Johnson Matthey, identifying API portfolio business opportunities and negotiating contracts. At Advanced Bioscience Laboratories, he was directly responsible for new growth, capturing and developing key large pharma and R&D programs. As Head of Quality and Regulatory at Cleveland Clinic’s Taussig Cancer Institute, he managed a team of monitors and auditors ensuring compliance the NCI regulations on IND studies. His career began at Ben Venue Laboratories starting as a bench chemist, moving to quality assurance, and eventually landing in account management focusing on servicing BVL’s sterile injectable clients. Mr. Kim earned his MBA from Baldwin-Wallace College and a Bachelor’s in Biology with a Chemistry minor at Case Western Reserve.
 

Ravi Kaushik

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.

Ronald Forster

Dr. Forster is the Executive Director, Head of Combination product Operations Manufacturing Sciences and Technologies, Amgen Inc. Responsible for Process Engineering and Technology transfers, all physical methods, Container Science and Engineering, Secondary Packaging, cold chain thermally engineered solutions and site-based process development for combination products/final products. Prior to this role, Ron held many diverse leadership roles.

Prior to joining Amgen, Ron was with Merck Inc. where he was Senior Principal 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.

Sarah Fairfield

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).

Sean Teller

Dr. Sean Teller is a Principal Engineer at Veryst Engineering, a technical consulting firm in the Boston area. Dr. Teller has extensive experience in testing and modeling the mechanical behavior of materials to help clients improve product performance, understand failure modes, and manufacture robust, high-performing devices. He consults in medical devices and technology, combination products, consumer products, automotive, and consumer electronics industries, and applies his knowledge of polymer material behavior and failure to help clients solve their R&D and design problems.

Dr. Teller’s consulting focuses on polymer material testing, material modeling for finite element (FE) simulations, FE simulations, and failure analysis. He has extensive experience in advanced FE modeling, and often solves problems involving sealing and leakage, ageing and degradation of materials, design verification studies of engineered systems, verification and validation studies, and manufacturing and assembly of medical devices and combination products. He uses his background and education in materials science and mechanical engineering to design testing, modeling, and characterization plans to solve client problems, and has experience in developing new experimental methods, designing and building test fixtures and machines, and using FE analysis to inform design and failure analysis. Dr. Teller earned his Ph.D. in Solid Mechanics from Brown University, where he worked on a project to characterize the high-frequency mechanical behavior of soft tissues for tissue engineering applications.
 

Serene Jabary

Serene Jabary is a drug product development scientist with a background in supporting end-to-end drug development activities with expertise in Closed System Transfer Devices (CSTD’s). She thrives on the challenge of developing novel platforms, designing non-platform studies, and exploring ways to optimize current processes to enhance capabilities. Fostering synergy across departments and organizations by considering the needs of all stakeholders involved. Serene is also the co-chair of the IQ working group ‘Use of CSTD’s & Biologics on the NIOSH list’.

Shai Assia

Shai is a Product Development leader with more than 15 years of experience in a wide range of responsibilities and organizations. Shai leads the Medical Device Design, Development and Manufacturing for novel Combination Products and Drug-Delivery Platforms. Prior to Clexio Biosciences, Shai was the Head of Medical Devices at MobileODT, developing Optical Detection Technologies for early-stage cancer detection through enhanced visual assessment.
Shai holds a BSc in Bio-Medical Engineering from Tel Aviv University as well as a MSc in Mechanical Engineering and MBA from the Massachusetts Institute of Technology (MIT), where he received the Leaders for Global Operations Fellowship.
 

Sonia Dragulin-Otto

Sonia is a Senior Scientist in Biopharmaceutical Development at AstraZeneca working in the Formulation Sciences group. Having started her career in analytical sciences, she has been responsible for many aspects formulation development for monoclonal antibody, RNA and adenovirus-based combination products including regulatory filings, primary container characterization, compatibility and stability. During her time as formulation lead across multiple molecule teams, the characterization of deep-cold storage of drug substance and drug product, and the effects of freeze-thaw cycles have been specific areas of focus for Sonia. She is based in Maryland, US.

Soroosh Bagheriasl

Soroosh Joined MediPhorum by BioPhorum in 2022 as Senior Account Manager within MediPhorum. With a PhD in Biomaterials Science, Soroosh has over 10 years’ experience in the Medical Device industry, possessing a great deal of technical, commercial, and regulatory knowledge ascertained through time spent as a Principal Consultant and Commercial Manager.
Account managing both young start-ups and established, large blue-chip organisations within the MedTech industry has provided Soroosh with a thorough insight and understanding of the challenges such organisations face and how by working collaboratively across MediPhorum can bring accelerated progress for the benefit of all.
 

Soumen Das

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

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

Terry O'Hagan

Terry O’Hagan is the General Manager of the US entity of Haselmeier, a medmix brand, based in Stuttgart, Germany. He is responsible for the commercial development of the North and South American markets and joined Haselmeier in 2013. Mr. O’Hagan has spent the last 21 years focused on the development and manufacturing of medical devices and has worked at Radius Product Development and Flextronics Medical in addition to Haselmeier. He holds a Bachelor of Science in Plastics Engineering from the University of Lowell and a Master of Business Administration from Worcester Polytechnic Institute.

Theresa Scheuble

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.
 

Tim Quigg

Development Director at Crux with over 12 years of device development experience. Tim has worked across a wealth of medical device & combination product platforms including asthma inhalers, pre-filled syringes, pen/autoinjectors, on-body/large volume and connected devices. With a focus on evidence-led device development, he champions early-stage feasibility assessment through data-driven design and quantitative evaluation. This work includes computational simulation and modelling and early-adoption of enabling technologies. Today, Tim leads both off-the-shelf platform selection and novel device development programmes, acting as a trusted advisor and technical reviewer to support the wider Crux team.