PFS and Injectable Drug Devices East Coast

Shirish Ingawale is a Director of Device & Combination Product Development at Takeda. With over 20 years of diverse experience in medical devices, drug delivery technologies, and combination products, Shirish is acclaimed for his strategic vision, innovative approach, and steadfast commitment to transforming patients’ lives. He blends a robust background in R&D with a strategic perspective shaped by roles in academia and leadership positions in the medical device, biotechnology, and pharmaceutical sectors. At Takeda, Shirish spearheads strategic and collaborative innovations, motivating cross-functional teams to set new industry benchmarks in device and combination product development. Before joining Takeda, Shirish spent a decade at Amgen, where he led multidisciplinary teams and managed the lifecycle of drug delivery devices and breakthrough combination products. He played a vital role in the successful development and commercialization of drug delivery technologies, including reconstitution kits, pre-filled syringes, autoinjectors, and on-body delivery systems, along with establishing device platforms. Previously, Shirish contributed to advancement in the medical device industry and academia, with a focus on implantable devices. Shirish earned a Bachelor’s degree in Instrumentation Engineering from the University of Mumbai, India, and a Master’s and PhD in Biomedical Engineering from Wright State University, Ohio, USA.

Mr. O’Hagan joined the Stevanato Group as Vice President of Business Development of Drug Delivery Systems in January 2025. Prior to joining the Stevanato Group, he was General Manager of Haselmeier, the US entity of the Haselmeier Group based in Stuttgart, Germany (now a medmix company) where he was instrumental in establishing the US entity and growing the America region. Mr. O’Hagan has spent the last 21 years focused on the development and manufacturing of medical devices. He previously worked at Radius Product Development (now a Jabil Company) as the Global director of Business Development, and as Sr. Director of Business Development at Flextronics Medical. Mr. O’Hagan earned a Bachelor of Science in Plastics Engineering from the University of Lowell and a Master of Business Administration from Worcester Polytechnic Institute.

Tamara Hodge has more than 25 years of experience in biotherapeutic drug product development and is a Senior Principal Scientist and Group Leader in Pharmaceutical Research and Development at Pfizer, Inc. She leads formulation, process, and delivery efforts for biologics from early development through commercialization and manages a multidisciplinary team of scientists across career stages. Tamara holds a B.S. in Chemical Engineering from Northwestern University.

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).

Sriram Natarajan Ph.D., is a Sr. Manager at Johnson & Johnson Innovative Medicine. He leads E2E Quality/Compliance and Risk Management for the Combination Product, Device & Emerging Technology portfolio with NPD and LCM projects, working collaboratively with key business partners across multiple departments and sites. Prior to this, he worked in Medical Devices and Diagnostics areas. Sriram holds a Ph.D. in Chemical Engineering from the University of Utah, with a focus on materials, devices, biomolecular interactions and computational modeling.. He was the recipient of an NSF Graduate Fellowship Award and has 16 patents granted and filed.

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.

Shruti Parikh is the Packaging Design Lead, Takeda Pharmaceuticals based out of Massachusetts, USA, where she is leading and building Industrial Design, Sustainable Design and Patient-Centric Design capabilities across the company.
As the design lead in packaging development Shruti and her team works towards the remit to integrate design across the company’s consumer, medical device, and pharmaceuticals sectors. In addition to helping improve the lives of the patients using Takeda products every day, the Design team is also focused on improving the environmental impact by reducing the carbon footprint of Takeda packaging.

Specifically, Shruti is passionate about challenging people and organizations to think differently. She loves to dig into global macro trends and translate its potential to redesign products and systems. Impatient for action, she wants to help build an inclusive future that allows us all to thrive socially, ecologically and economically. She is an advocate for a circular economy and is constantly looking to connect with individuals who believe they too can make a positive impact in the world.

Shruti Mistry has worked at the FDA for 10 years and currently serves as the Assistant Director of the Injection Devices Team in FDA's Center for Devices and Radiological Health (CDRH). She earned her B.S. and M.S. in Biomedical Engineering from the Georgia Institute of Technology and Johns Hopkins University, respectively.

Roy has over 14 years of device design and development experience, including leading design control and risk management activities for implantable devices and combination products for plastic and reconstructive surgery and cell therapies as well as drug delivery devices and combination products for biologics. Roy is currently an Associate Director, Device Development at Viridian Therapeutics leading device design and development activities for the VRDN-006 program. Roy has an M.S. in Biomedical Engineering from Columbia University and a B.S. in Biomedical Engineering from the University of Rochester.

A seasoned leader with over 25 years of experience in medical device development, including the past decade dedicated to combination product development. Successfully led teams in developing prefilled syringes, integrating platform auto-injectors, and collaborating with third-party CDMO partners for prefilled syringe fill/finish processes. Expertise includes combination product quality and regulatory strategies, seamlessly integrating these into global drug development teams. Driven by a strong focus on identifying and addressing unmet user needs to maximize value in combination products.

With over twenty years' experience in medical device leadership, engineering, and management consultancy, Philip has led the development of an extensive range of medical technologies, with a particular focus on drug delivery.

Ning Yu is Vice President of Device and Combination Product Development at BioCryst Pharmaceuticals, overseeing the full device lifecycle from R&D to manufacturing at CDMOs. With about 20 years’ experience in medical devices and combination products, Ning has worked at Astria, Biogen, BD, and Zimmer-Biomet. Ning’s expertise includes pen injectors, prefilled syringes, auto-injectors, on-body and implanted drug delivery devices, connected devices, and smart packaging. Ning holds a PhD in Mechanical Engineering from the University of Illinois and an MBA from BU.

Dr. Swinney leads drug delivery innovation & new product planning for Gilead Sciences. She has more than 22 years of experience in strategy and product development for medical devices, pharmaceuticals, and combination products, with previous tenure at Eli Lilly, Becton Dickinson, and Johnson & Johnson. The recipient of many industry awards for excellence in innovation and product development, and an inventor on more than 80 patents, she holds a Ph.D in polymers from MIT and a B.S. in chemistry from the University of Massachusetts.

Merin Kalapurackal is an Engineer within the Device Development, Human Factors Engineering team at Bristol Myers Squibb, where she has worked on several combination product programs, employing several different types of delivery technologies. Prior to her time at BMS, Merin spent 3 years with Vantage MedTech contributing to the development of many device programs and managing relationships with clients and partners. She has enjoyed working across a range of different device technologies and the entire product lifecycle. Merin has a BS in Biomedical Engineering from The College of New Jersey and is currently pursuing an MS in BME from Johns Hopkins University.

Meredith Bernstein is Instron’s Biomedical Product Manager, driving innovation in mechanical testing for pharmaceutical and medical device companies. Through her past experience working with Instron's customers in the drug delivery device space, she developed a deep understanding of critical industry standards, common testing challenges, and customer needs though hands on testing and support of complex customer projects in a highly regulated environment. Now, she uses this experience, technical expertise, and close customer relationships to ensure that Instron’s products continue to meet the needs of an ever-evolving industry.

Highly experienced plastics engineer and manufacturing executive with over three decades of leadership across product development, injection moulding, tooling, and integrated manufacturing solutions. Blending deep technical fluency with strong commercial execution. Oversees regional and global sales strategy, customer partnerships, and growth initiatives across MGS’s integrated manufacturing offerings.

Daniel Schwartz is the Director of Sales at Schreiner MediPharm, where he leads high-performance commercial teams in delivering value-based, solution-oriented labeling and packaging for the premium pharmaceutical sector. With a career defined by transitioning organizations from transactional sales to mission-critical partnerships, he focuses on integrating technical innovations—such as RFID connectivity, digital security features, and production efficiency enhancements—into functional solutions that improve drug protection and supply chain transparency. He also holds an MBA in Corporate Finance, which helps him ground these high-tech innovations in the real-world financial goals and long-term stability of his partners.

Tim Miller is the Director of Device & Combination Product Development in Pfizer’s Global Hospital & Biosimilars organization.  He has 30+ years’ experience in product development, leading the development of syringe and primary container components, packaging, medical devices, and combination products.  Prior to his 8 years with Pfizer, he worked 20 years at West Pharmaceutical Services as well as time with Johnson & Johnson and SiO2 Medical Products. 

Bob brings more than 30 years of experience in custom plastics and strategic growth to his role as Senior Vice President of Global Sales and Marketing. Since joining the organization in 2004, he has been a driving force behind MGS’ commercial transformation, helping expand the company’s global footprint and strengthen its position as a leading contract development and manufacturing organization (CDMO) serving the Pharma, Diagnostics and MedTech markets. Throughout his tenure, Bob has led cross-functional teams in shaping a forward-looking commercial strategy focused on improving health outcomes while accelerating innovation. His ability to align global teams, build high-performing partnerships and anticipate market needs has helped MGS deliver measurable value to healthcare innovators worldwide, accelerating the path from idea to market with precision, speed and purpose. With decades of specialized experience in pharmaceutical and auto-injector manufacturing, Bob brings critical insights to developing next-generation, scalable drug delivery solutions like A.i.r. that reach patients faster. A strategic thinker and collaborative advisor, Bob is known for cultivating long-term relationships and leading with a sharp focus on innovation, execution and outcomes. He continues to guide MGS’ commercial growth with a clear mission: to deliver impactful, patient-centric solutions that improve lives around the world.

Jeffrey Dirk Lovelace is Director of New Product Development at CCL Healthcare, where he leads innovation in labeling systems for pharmaceutical drug delivery devices including pre-filled syringes and auto-injectors. With more than 25 years of experience in materials science and pressure-sensitive technologies, his work focuses on integrating smart packaging technologies such as RFID, temperature indicators, and anti-counterfeiting features into functional labels that support drug stability, patient safety, and regulatory compliance. He collaborates with global pharmaceutical manufacturers to translate advanced materials and smart labeling technologies into scalable commercial solutions.

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.

Karla Sanchez leads biomedical engineering and CNS‑technology development at CDP, specialising in drug‑delivery systems for the brain and other hard‑to‑reach targets. With more than 15 years of experience in medical‑device development, she integrates complex physiology, fluid dynamics and engineering constraints into feasible development pathways, helping teams navigate uncertainty and translate scientific complexity into practical solutions.

Her expertise spans CNS drug delivery, physiological fluid mechanics and the systems‑level integration required to develop technologies for challenging biological environments. She holds a PhD from Imperial College London focused on cerebrovascular flow and cerebrospinal‑fluid movement, and has collaborated with clinicians and academics to build physiological models across the brain, kidneys and lungs.

Karla is an honorary researcher at Imperial College London, where she continues to support CNS research that informs next‑generation CNS therapeutics and advanced drug‑delivery technologies.

John is currently supporting CGT Combination Product RA for AskBio.  John previously was the head of new products and LCM for CP and devices regulatory @ Novartis and Head of CP, Devices, & Digital @ Sanofi. 

John holds a master of science in Biomedical Engineering from NJIT and MS in RAQA from Temple.

Development Director at Crux with over 13 years of device development experience. Tim has worked across a wealth of medical device & combination product platforms including 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.

David DeSalvo is Vice President of Combination Product Development at Kindeva, overseeing drug delivery device/drug combination product development. David DeSalvo is an award-winning innovator and executive leader with a proven track record in driving growth through technology and business strategy leadership. With over 25 years of experience, David has led the development and market launch of more than 50 delivery device/drug combination products for leading pharma and biotech companies. He has also negotiated and closed dozens of licensing, development, and manufacturing deals driving substantial enterprise value.

Prior roles include Senior Director at Emergent BioSolutions, founder and CEO of Nuance Designs, Senior Director at SHL Medical and New Product Development Manager at Becton Dickinson (BD).

David holds an MBA from Marist College and a Master’s and Bachelor’s in Mechanical Engineering from Rensselaer Polytechnic Institute.

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.

Andy Pidgeon is the Director of Medical Technology & Usability 42 Technology and an advocate for the design of medical devices that work in the real world. With over 40 years in industrial design and innovation, he helps pharmaceutical and device companies create products that balance technological ambition with practical usability.

Andy began his career as an industrial designer, spending 20 years working across consumer goods, electronics, telecommunications, and medical and scientific equipment. It was during this time that he developed his focus on usability and the importance of designing around real user needs rather than assumptions.

He later joined Cambridge Consultants, where he became Creative Director and Head of Strategy, Design and Usability, building and leading a team focused on medical device innovation. His work has covered a wide range of technologies, including drug delivery systems such as auto injectors and patch pumps, connected devices, surgical robotics, diagnostics and critical care.

Now at 42 Technology, Andy collaborates with pharmaceutical companies, device manufacturers and startups to develop user centred solutions that improve patient safety and adherence. Having conducted human factors research across Europe, the US and Asia, he is known for challenging the assumption that more technology always leads to better outcomes, advocating instead for simpler, more effective solutions that deliver genuine value.

Veda received her B.S. in Clinical Laboratory Science from Indiana State University and M.B.A. from Indiana Wesleyan University. She has 25+ years of experience in biopharmaceutical Contract Development and Manufacturing.

Prior to her current role she was with Catalent Pharma Solutions for 8 years serving as the Vice President, Quality, for biologics and cell & gene therapies, and VP, Global Regulatory Affairs & Compliance overseeing the corporate quality functions and regulatory affairs support for Catalent’s broad product portfolio.

In her current role as Chief Quality and Regulatory Officer at Stevanato Group she oversees the quality management system and regulatory support services for drug containment, drug devices and IVD solutions, and the engineering business unit.

Amy Wise is an Associate Director, Regulatory Affairs Emerging Technologies, Combination Products and Devices at AbbVie. Amy has been in the pharmaceutical industry for 25 years with 15 years in regulatory affairs, 5 years in quality and 5 years in pharmaceutical sciences. She has successfully provided the device regulatory strategy and led the preparation of new marketing applications/post-approval variations for drug/device combination products in the US, EU and global markets. Amy earned her B.S. in chemistry from St. Mary’s College (Notre Dame, IN) and MBA from Lake Forest Graduate School of Management (Lake Forest, IL).

As Director of Business Development at MGS, Frank Engel Rasmussen drive commercial collaboration and partnerships with leading Pharma, Diagnostics, and MedTech companies to deliver robust injectable drug delivery devices, combination products and other medical devices from concept to commercialization. Drawing on over two decades of experience from various leadership positions across the value chain in the medical device industry, Frank Engel Rasmussen bridges R&D, quality, tooling, automation, and manufacturing to help customers design, develop and scale reliable products that meet stringent performance and patient-safety requirements.Based at MGS’ Design and Development site in Denmark, Frank Engel Rasmussen  collaborates with global teams to drive a patient-centric design and development process that mitigates risks, accelerates timelines, and ensures production readiness. Frank Engel Rasmussen holds a PhD and a Master of Science in Engineering in Microand Nanotechnology, with a focus on electrochemistry, materials science, advanced surface technology and semiconductor physics.

Duncan Paterson has over twenty years of technical leadership experience in the development of inhalation and parenteral devices for pharmaceutical combination products and is currently a Senior Director with AstraZeneca. Duncan leads early and late-stage device development and CMC project teams as well as a range of strategic technology initiatives.  In recent years, Duncan has taken on increasing internal and external sustainability related responsibilities including co-leading the sustainability sub-team within the Subcutaneous Consortium.

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.

Brittany Conrad earned a Bachelor of Social Work from the University of Toledo in 2012 and held several patient-facing roles, gaining experience in medical and user-centric support. In 2020, she completed a Master of Science in Human Factors with a Systems Engineering concentration from Embry-Riddle Aeronautical University. Since launching her Human Factors career, Brittany has contributed to developing Class II and III medical devices and defining crew interface requirements for NASA’s Artemis program. She is currently a Senior Human Factors Engineer at Pfizer, where she provides human factors support to prefilled syringe (PFS) delivery system programs.

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.

Bart Burgess is the Senior Vice President, Innovation and Product Strategy at SHL Medical, where he leads the newly established function responsible for advancing the company’s early-stage innovation through cross-functional collaboration between technical and commercial teams. In this role, he oversees scientific research, innovation initiatives, and product portfolio strategy to strengthen SHL Medical’s innovation pipeline, enhance customer-centric development, and support the company’s continued leadership in drug delivery devices. Bart has over 20 years of experience in the primary packaging and drug delivery space, often working at the intersection of technical and business roles. Prior to this position, he served as Global Head of Portfolio Strategy and Customer Solutions at SHL Medical.

Ashish Pokharel is a Senior Device Engineer at AstraZeneca and a key member of the computational modeling team within AstraZeneca’s Device Development group. He specializes in mathematical models and physics-based digital twins to predict performance, guide design choices, and accelerate verification and validation. His work spans autoinjectors and nasal delivery systems, integrating simulation with bench testing to deliver reliable, patient centric drug delivery solutions. He collaborates closely with cross functional partners to de risk programs and enable data driven decisions from concept through verification. Ashish holds an M.S. in Mechanical Engineering from The University of Texas at Arlington.

Andrew Moore is global director of product management for drug delivery devices and system integration at Gerresheimer. He is passionate about enabling patient-administered drug delivery and collaborating across the value chain to make innovative solutions more accessible. In his current role, he focuses this passion on driving end-to-end solutions for combination products. Before joining Gerresheimer, Andrew managed device development and product management teams at SHL Medical and led product management for wearable injectors at West Pharmaceutical Services.

Alison received her PhD in Chemistry from UC Berkeley and did Post-Doctoral work at MIT in the Research Laboratory of Electronics. She has 20+ years of experience in Medical Devices for Cell and Gene Therapy applications. Prior to her current role she was with Curate Biosciences (GPB Scientific) for 10+ years, serving as the VP R&D Engineering and Intellectual Property. In her current role as Chief Science Officer at Zeon Specialty Materials she supports sales of their Cyclic Olefin Polymer into Life Sciences fields.

Alison Phillips, PhD, is a Technical and Scientific Expert at Datwyler, specializing in parenteral packaging solutions. She partners with the Sales Team to provide expert project support and technical guidance to global clients. Prior to joining Datwyler in 2024, Dr. Phillips spent a decade in the specialty chemical industry, holding various technical and customer-facing leadership roles. She earned her PhD in Chemistry from the University of Maryland, College Park.

Alicia Douglas is a graduate of the University of Maryland, with a B.S in Bio-engineering. She is a Human Factors Leader in the Device Development & Technology group at Merck. She has 20 years of experience in the 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, she is passionate about integrating human factors into the development process to enhance safety, usability and user experience.
Throughout her career she has led cross-functional teams in the development of various products that prioritize patient-centric design. Alicia believes in the critical importance of understanding user needs and behaviors driving her commitment to develop solution that improve health outcomes.
In addition to Alicia’s technical expertise, she is dedicated to fostering a culture of learning and collaboration. She actively educates partners on the significance of human factors, ensuring user – centric development is at the forefront of product development strategies.

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 also designed automatic assembly machines, tools, equipment, etc. In 2016 I founded Platinum Pharma Service whose Althena medical is a brand. Designing innovative medical device is my passion, doing them well is my commitment.

Alex is a highly strategic Biomedical Engineer with 13 years of MedTech industry experience, specializing in solving complex R&D challenges and ensuring strict Quality Assurance and Compliance. Alex transforms product development through rigorous statistical analysis and process optimization, consistently delivering substantial quality enhancements and guaranteeing minimal Post Market Surveillance complaints. As the lead Quality Engineer for numerous global commercial product launches, he has successfully operated in diverse environments, from large corporations to small startups, and across multiple domestic and international locations, including Japan. 

Alex Fong MBA is an experienced senior manager in the Insight, Analytics and Strategy fields. He has applied these skills in a broad range of Industries including the FMCG/CPG, tourism, investment banking, telecoms, and management consulting sectors. For the last 9 years, Alex has been leading the market research drive at Owen Mumford, with an ever-increasing focus on sustainability.

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.

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.

Liat Shochat is Vice-President of Combination Product Development and has over 20 years of experience in design and development management of combination products and medical devices. Her expertise includes strategic and technical development, lifecycle management, and global launch of single-use disposable electromechanical drug-delivery platforms, drug-device combination products, and medical devices — including leadership of the development, lifecycle management, and customer programs for the SmartDose® wearable delivery system for home use, deployed with pharma companies. Throughout her career, Ms Shochat has held management roles in R&D, engineering, project management, regulatory, human factors, and clinical trials.

Krishna Patel has over 20 years of experience in Quality Assurance and Quality Engineering for combination product and medical device industry. She had lead quality activities to enable product development for new combination products, medical devices, and supported regulatory filings and inspections. Currently, Krishna leads CMC Quality team for clinical manufacturing at Immunovant including QA responsibilities for drug substance, drug product, autoinjector, and clinical complaints. 

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.

Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional.

Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, AbbVie Inc and Amgen. Her career includes global medical / clinical
and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.

She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).

Kevin Maloney is Sr. Director of Biologics Drug Product Development at Biogen in Cambridge, MA with responsibility for parenteral formulation development and aseptic fill-finish development. Prior to Biogen, Kevin began his biopharmaceutics career with Amgen. A guiding CMC development theme Kevin has experienced over a nearly 3-decade career is the concept of end-to-end development. A robust combination product control strategy considers interconnected parameters between drug substance, drug product, and device during the development process. Kevin earned degrees in Chemistry from Worcester Polytechnic Institute and the Oregon Graduate Institute of Science and Technology and pursued post-doctoral studies at Caltech.

I am Associate Director, GRA Device Lead – Specialty Care, Devices and Combination Products at Sanofi. In this role, I provide strategic leadership and technical expertise in global regulatory affairs for medical devices and combination products, ensuring compliance with evolving standards and driving innovation in device development.
After completing my Bachelors in Pharmacy, Mumbai, India I went on to acquire an advanced degree from the United States. Mr. Sukthankar obtained his Master’s in Drug Regulatory Affairs from the Long Island University, New York. This advanced degree equipped me with a comprehensive understanding of the U.S. healthcare and pharmaceutical regulatory landscape, including drug and device approval processes, and policy compliance under FDA and EMA frameworks. I began my career as a Regulatory Consultant at mdi Consultants Inc., where I contributed to the preparation and successful submission of several FDA 510(k) submissions for clients and conducting mock audits of the client’s manufacturing sites and their Quality Management Systems to ensure compliance with 21 CFR part 820. In 2016, I joined Fresenius Medical Care and was responsible for preparing and reviewing comprehensive 510(k) regulatory documentation packages for submission to the FDA, ensuring full compliance with applicable regulatory requirements and guidelines.
Throughout my career, I have contributed to critical projects involving regulatory strategy, device lifecycle management, and global submissions, helping organizations navigate complex regulatory landscapes. My ability to bridge technical details with regulatory requirements has made me a trusted partner in delivering safe and effective solutions to patients worldwide.
Looking ahead, I aspire to further influence the regulatory domain by shaping strategies that accelerate access to life-saving therapies and devices globally.

Katie Falcone is a seasoned professional with over a decade of experience in the pharma/biotech industry, specializing in parenteral packaging. As Director of Technical Services (TCS) for the Integrated Systems team at West Pharmaceutical Services, she leads technical collaboration by leveraging her expertise to drive customer success, enable data-driven decision making, and deliver innovative drug delivery solutions.

Junwei Li is an innovation leader with extensive experience across the pharmaceutical development spectrum in GLP-1 and anti-obesity treatment, including research, clinical, and product supply functions. With a strong foundation in global, cross-functional collaboration, Junwei has successfully led initiatives spanning drug development and device innovation. Junwei’s expertise includes advancing injectable, oral, and software-based therapeutics, with a particular focus on combination product development. Junwei has also played a key role in strategic partnerships and business development, and focusing on hunting and assessing innovative combination product collaboration opportunities.

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.

Jayne Gavrity is a biomedical engineer with 10+ years in medical devices and combination products. She began in orthopedic research and now leads AstraZeneca device teams for injectable drug delivery programs, serving as technical lead within cross functional groups. Jayne champions practical strategies to embed environmental considerations in current development processes.

Javad Eshraghi earned his PhD in Mechanical Engineering from Purdue University, specializing in experimental fluid mechanics and the use of image and signal processing for applications spanning fundamental physics to cardiovascular systems. He is a biomechanical research scientist with expertise bridging biomedical engineering, experimental fluid dynamics, and measurement science. Javad joined Eli Lilly and Company in 2023 and serves as the Device Technical Lead for multiple combination products across the development pipeline. His work focuses on advancing device performance, patient-centric design, and data-driven evaluation methods. He is also an active peer reviewer for several pharmaceutical and biomedical engineering journals.

Hannah Simmons is a pharmaceutical packaging professional with experience in glass primary packaging for pharmaceutical applications. She currently serves as Business Development Manager for Glass Prefillable Syringes at SCHOTT Pharma, bringing hands-on commercial and technical expertise in tubular pharmaceutical glass packaging formats across the North American market. She holds a Master of Science in Biological Sciences and a Graduate Certificate in Applied Statistics and Data Management from North Carolina State University. Prior to her industry career, Hannah worked in research at the Duke School of Medicine. Her combination of scientific training and industry-specific packaging experience informs her work at the intersection of drug delivery innovation and glass primary container design.