Home
Pre-Filled Syringes and Injectable Drug Devices East Coast
April 28 - April 30, 2025
Pre-Filled Syringes and Injectable Drug Devices East Coast

 NEW FOR 2025: FREE TO ATTEND FOR PHARMA AND BIOTECH*

SAE Media Group's 12th Annual Pre-Filled Syringes East Coast Conference will return to Boston in April 2025 to bring you the latest advances in the combination product drug delivery space.

As part of SAE’s leading Injectable Drug Delivery Series, the 2025 conference will be bigger and better than ever, bringing you 3 days of expertise, comprising of a pre-conference focus day exploring the advances in PFS design for enhanced drug delivery proceeded by a two-day main conference with morning keynote plenaries and parallel afternoon topic streams addressing the industry’s hottest topics through case studies and industry insights.

This event will not only bring you key insights needed to expand and enhance your injectable device portfolio but will also give you the opportunity to network with key players throughout the industry. We hope to welcome you to this must attend event in April 2025!

FEATURED SPEAKERS

Aditya Nair

Aditya Nair

Packaging Engineer, Pfizer
Ajit D'Souza

Ajit D'Souza

Executive Director, Drug Delivery and Devices, Eli Lilly
Alfredo Ricci

Alfredo Ricci

CEO, Althena Medical
Alie Jahangir

Alie Jahangir

Head of Quality, Device and Combination Products, Biogen
Amardeep Hoonjan

Amardeep Hoonjan

Director Device R&D Lead, Biocompatibility Group, AbbVie
Bharat Arora

Bharat Arora

Director, Global Combination Products Quality, Moderna
Conor O'Neill

Conor O'Neill

Head of Packaging Development and Design, GSK
Daniel Davenport

Daniel Davenport

Associate Director Early Engagement and Deviceability, GSK
Dany Doucet

Dany Doucet

Director Early Engagement and Deviceability, GSK
David Vazquez

David Vazquez

Head SaMD Legal Manufacturing, Pfizer
Duncan Paterson

Duncan Paterson

Senior Director, AstraZeneca
Ellie Younger

Ellie Younger

Associate Principal Engineer, AstraZeneca
Fletcher Dix

Fletcher Dix

Sr. Process Characterization and Technology Engineer, Regeneron Pharmaceuticals
Gretchen Piwinski

Gretchen Piwinski

Sr Manager Combination Product Development, Regeneron
Guangli Hu

Guangli Hu

Director, Merck & Co., Inc.
James P. Wabby

James P. Wabby

Global Head, Regulatory Affairs - Emerging Device Technologies and Combination Products, AbbVie
Jayne Gavrity

Jayne Gavrity

Senior Device Engineer, AstraZeneca
Joanita Akole Lamien

Joanita Akole Lamien

Sr. Human Factors Engineer, Regeneron Pharmaceuticals
Joyce Zhao

Joyce Zhao

Director, Combination Product Development, Takeda Pharmaceuticals
Kinsuk Shah

Kinsuk Shah

Sr. AD Combination Product Steward, Boehringer Ingelheim
Lisa Ray

Lisa Ray

Executive Director Program Management – Delivery, Device & Connected Solutions, Eli Lilly
Mark DeStefano

Mark DeStefano

Director, Combination Products and Device R&D, Teva Pharmaceuticals
Mark Hassett

Mark Hassett

Vice President of Business Development, Credence MedSystems
Martin McLoughlin

Martin McLoughlin

Head of Device Development, Bristol Myers Squibb
Matt Marber

Matt Marber

Senior Usability Engineer, Novo Nordisk
Megan Heft

Megan Heft

Director, Device Development, AstraZeneca
Mike Wallenstein

Mike Wallenstein

Novartis Global Head RA Medical Devices, Combination Products & Precision Medicine, Novartis Pharma AG
Natalie Berry

Natalie Berry

Combination Product Development Engineer, Pfizer
Nicholas Mandala

Nicholas Mandala

VP Medical Device & Combination Product Technology, Pfizer
Ning Yu

Ning Yu

Executive Director, Device and Combination Product Development, Astria Therapeutics
Ram Halthore

Ram Halthore

Director of Engineering, Merck
Ravi Kaushik

Ravi Kaushik

Vice President, Patient Integrated Care Innovation Platform, Takeda Pharmaceuticals
Sarah Fairfield

Sarah Fairfield

Associate Director, RA Device and Combination Products Digital Device and Software, AbbVie
Soumen Das

Soumen Das

Medical Device Qualification Lead & Associate Scientific Fellow, Takeda Pharmaceutical Company Limited
Sriman Banerjee

Sriman Banerjee

Head of Packaging Development & CDE, Takeda Pharmaceuticals
Subhi Saadeh

Subhi Saadeh

Senior Manager, Combination Products QA, Gilead
Sujit Basu

Sujit Basu

Vice President & Head, Pharmaceutical Development, Ionis
Theresa Scheuble

Theresa Scheuble

Head of Design & Innovation, Johnson & Johnson

Aditya Nair

Packaging Engineer, Pfizer
Aditya Nair

Aditya Nair is a Packaging Engineer graduate from Michigan State University – School of Packaging and has devoted his career to container closure systems and sterile packaging for pharmaceutical drug products and medical devices. He is currently working as a Packaging Engineer in the Drug Product Design and Development group within the Pharmaceutical R&D organization in Pfizer. In his current role, he has been actively involved in development of parenteral packaging systems such as vials and prefilled syringes for biologics, system qualification / validation and various sustainability initiatives.

Ajit D'Souza

Executive Director, Drug Delivery and Devices, Eli Lilly
Ajit D'Souza

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.

Alfredo Ricci

CEO, Althena Medical
Alfredo Ricci

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.

Alie Jahangir

Head of Quality, Device and Combination Products, Biogen
Alie Jahangir

Dr. Jahangir serves as the Global Head of Quality for Device and Combination Products at Biogen, spearheading the quality engineering team dedicated to advancing drug delivery devices and other emerging technologies for neurodegenerative diseases. Renowned for his expertise, he has uniquely integrated medical devices, pharmaceuticals, and digital health, striving to transform quality systems from compliance-focused to proactive business enablers addressing patients' unmet needs. As a Key Opinion Leader, Dr. X has chaired sessions and spoken at numerous industry conferences, influencing discussions on QMS design, Design Control process, Digital Therapeutics and Wearables devices. He holds a Doctorate in Biomedical Engineering and completed a Post-Doctoral Fellowship at Harvard School of Public Health.

Amardeep Hoonjan

Director Device R&D Lead, Biocompatibility Group, AbbVie
Amardeep Hoonjan

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.
 

Bharat Arora

Director, Global Combination Products Quality, Moderna
Bharat Arora

Bharat Arora is a seasoned Technical Quality Leader with over 17 years of experience enhancing patient outcomes through strategic quality engineering in combination products and medical devices. Currently a Director at Moderna, Bharat has a record of establishing global quality systems, driving design controls, risk management, and post-market surveillance. Known for his adaptive leadership, he excels in regulatory compliance, product lifecycle management, and cross-functional collaboration, underscoring his dedication to quality excellence in healthcare.

 

Confirmed Senior Representative

, AbbVie
Confirmed Senior Representative

Confirmed Senior Representative

, BioPhorum
Confirmed Senior Representative

Confirmed Senior Representative

, Biophorum
Confirmed Senior Representative

Conor O'Neill

Head of Packaging Development and Design, GSK
Conor O'Neill

Craig Voellmicke

Director of Sales, Suttons Creek, Inc.
Craig Voellmicke

Daniel Davenport

Associate Director Early Engagement and Deviceability, GSK
Daniel Davenport

Dany Doucet

Director Early Engagement and Deviceability, GSK
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 Vazquez

Head SaMD Legal Manufacturing, Pfizer
David Vazquez

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

Senior Director, AstraZeneca
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.

Ellie Younger

Associate Principal Engineer, AstraZeneca
Ellie Younger

Fletcher Dix

Sr. Process Characterization and Technology Engineer, Regeneron Pharmaceuticals
Fletcher Dix

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.

Gretchen Piwinski

Sr Manager Combination Product Development, Regeneron
Gretchen Piwinski

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 Hu

Director, Merck & Co., Inc.
Guangli Hu

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.

James P. Wabby

Global Head, Regulatory Affairs - Emerging Device Technologies and Combination Products, AbbVie
James P. Wabby

Jayne Gavrity

Senior Device Engineer, AstraZeneca
Jayne Gavrity

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.

Joanita Akole Lamien

Sr. Human Factors Engineer, Regeneron Pharmaceuticals
Joanita Akole Lamien

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.
 

Joyce Zhao

Director, Combination Product Development, Takeda Pharmaceuticals
Joyce Zhao

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.
 

Kinsuk Shah

Sr. AD Combination Product Steward, Boehringer Ingelheim
Kinsuk Shah

Lisa Ray

Executive Director Program Management – Delivery, Device & Connected Solutions, Eli Lilly
Lisa Ray

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

Director, Combination Products and Device R&D, Teva Pharmaceuticals
Mark DeStefano

Mark Hassett

Vice President of Business Development, Credence MedSystems
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.

Martin McLoughlin

Head of Device Development, Bristol Myers Squibb
Martin McLoughlin

Martin has 25 years of experience in device and combination product development and commercialization in the pharmaceutical industry. He has worked across a range of therapeutic areas, treatment modalities and routes of administration including infusion, inhalation and injection.
He has led the development of several commercially launched devices and combination
products including needle safety devices, mechanical and electronic auto-injectors. He has had end-to-end responsibility from concept to launch including the development of advanced manufacturing processes and automation. He is currently Head of Device Development at Bristol-Myers Squibb, New Brunswick. He holds a BS in Materials Science and Engineering and a PhD in Materials Science from the University of Bath, UK and is the first named inventor on 40 issued patents in the field of drug delivery and devices.
 

Matt Marber

Senior Usability Engineer, Novo Nordisk
Matt Marber

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.

Megan Heft

Director, Device Development, AstraZeneca
Megan Heft

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.

Mike Wallenstein

Novartis Global Head RA Medical Devices, Combination Products & Precision Medicine, Novartis Pharma AG
Mike Wallenstein

Mike holds the position as Global Head Regulator Devices & Combination Products at Novartis Pharma AG since August 2022.

Prior to this role, Mike had the position of Executive Director QA role and was overseeing all activities related to the EU MDR implementation for Medical Devices & Combination Products.


Mike joined Novartis in 2010 as Global Auditor in Group Compliance and Audit. He has over 25 years of experience in QA, R&D, and Manufacturing within the Medical Devices & Pharmaceutical Industry.


Mike is member of several US and EU Expert Committees and Interest Groups on Combination Products and lecturer at the Universities of Bern/CH and Baltimore/US.
 

Natalie Berry

Combination Product Development Engineer, Pfizer
Natalie Berry

Natalie Berry has been a combination product development engineer within Pfizer’s drug product design and development group for the last four years, supporting the development of various prefilled syringe programs. She has previous experience at Cook Medical as a medical device engineer on the post-market side, supporting design control activities and post market design changes for mainly class II devices. Natalie graduated from Purdue University with a bachelor’s in Biomedical Engineering and has her Six Sigma yellow belt.

Nicholas Mandala

VP Medical Device & Combination Product Technology, Pfizer
Nicholas Mandala

Ning Yu

Executive Director, Device and Combination Product Development, Astria Therapeutics
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.

Ram Halthore

Director of Engineering, Merck
Ram Halthore

Ravi Kaushik

Vice President, Patient Integrated Care Innovation Platform, Takeda Pharmaceuticals
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.

 

Sarah Fairfield

Associate Director, RA Device and Combination Products Digital Device and Software, AbbVie
Sarah Fairfield

Soumen Das

Medical Device Qualification Lead & Associate Scientific Fellow, Takeda Pharmaceutical Company Limited
Soumen Das

Sriman Banerjee

Head of Packaging Development & CDE, Takeda Pharmaceuticals
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

Subhi Saadeh

Senior Manager, Combination Products QA, Gilead
Subhi Saadeh

Sujit Basu

Vice President & Head, Pharmaceutical Development, Ionis
Sujit Basu

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

Head of Design & Innovation, Johnson & Johnson
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.
 

sponsors

Conference agenda

clock

8:00

Registration & Coffee

clock

8:50

Chair's Opening Remarks

Alie Jahangir, Head of Quality, Device and Combination Products, Biogen

clock

9:00

Streamlining Collaboration in Drug/Device Combination Product Development

Ajit D'Souza, Executive Director, Drug Delivery and Devices, Eli Lilly

  • Exploring bespoke vs. platform approaches: designing devices for specific drugs or using adaptable platform devices for broader applications
  • Key considerations and strategies for a successful transition from IV to subcutaneous administration
  • Enhancing cross-functional communication to improve collaboration between drug and device R&D teams, ensuring alignment and streamlining device development
  • clock

    9:30

    New Frontier in Combination Products: Implantable Devices for Neurodegenerative Disease

    Alie Jahangir, Head of Quality, Device and Combination Products, Biogen

  • Optimization of localized drug delivery
  • Biocompatible, miniaturized single entity combination products capable of sustained and controlled drug release
  • These novel class of combination products offer synergistic effects, improving the efficacy of treatments for conditions such as Alzheimer Disease, Parkinson Disease and glioblastoma
  • These combination products have the potential to reduce systemic side effects and improve patient compliance and offer a great opportunity in management of clinical unmet needs in neurodegenerative diseases
  • clock

    10:00

    Session Reserved for Lead Sponsor

    clock

    10:30

    Morning Networking Break

    clock

    11:00

    From Concept to Lifecycle in Combination Product Development: Synergies Between Drug Product and Device Development

    Bharat Arora, Director, Global Combination Products Quality, Moderna

  • Establishing awareness of drug product and device development
  • Navigating challenges at Clinical and Lifecycle product stages
  • Structural approach to drive collaboration from the beginning
  • Identify the collaboration areas and integration plans
  • Understand “Fit for Purpose” development process
     
  • clock

    11:30

    Session Reserved for Cambridge Design Partnerships

    clock

    12:00

    Manufacturing and Scale Up Challenges for Injectable Drug Delivery Systems

    Ram Halthore

    Ram Halthore, Director of Engineering, Merck

  • Utilising platform technologies to enable increased manufacturing efficiencies.
  • Building a bridge between design and manufacturing, Voice of manufacturing during the development of injectable drug delivery systems
  • Effective supplier qualifications for device development to enable scalability
  • clock

    12:30

    Navigating Essential Drug Delivery Outputs (EDDO) in Combination Product Development

    Confirmed Senior Representative

    Confirmed Senior Representative, , AbbVie

  • Examining the Clarity and Direction in EDDO Guidance and Industry Response
  • Addressing regulatory challenges related to EDDO integration
  • clock

    13:00

    Networking Lunch

    clock

    14:00

    Combination Product Risk Management: Understanding and Drug vs Device Methodologies

    Ning Yu, Executive Director, Device and Combination Product Development, Astria Therapeutics

  • Integrating distinct drug and device risk management methodologies to ensure regulatory compliance and patient safety
  • Practical tools and strategies for cross-functional collaboration to manage risks throughout the product lifecycle
  • clock

    14:30

    Session Reserved for Sponsor

    clock

    15:00

    Successful Human Factors Integration During Device Development: Best Techniques to Integreate Human Factors Early on in Device Design Process and to Successfully Implement Recommendations from Human Factors Findings in Device Design

    Joanita Akole Lamien, Sr. Human Factors Engineer, Regeneron Pharmaceuticals

  • Best approaches to successfully integrate Human Factors early on in device development process
  • Contributing effectively to device iterative design through human factors/usability studies
  • Identify key steps to successfully implement recommendations from Human factors formative studies in device development
  • clock

    15:30

    Afternoon Networking Break

    clock

    16:00

    Producing New Technologies for the Future: Getting Ahead of the Curve and Gaining Stakeholder Buy In

    Mark DeStefano

    Mark DeStefano, Director, Combination Products and Device R&D, Teva Pharmaceuticals

  • Anticipating future needs and strategies to stay ahead of technology demands in injectable drug devices
  • Building consensus with best practices for gaining stakeholder alignment and fostering collaboration to support innovation
  • clock

    16:00

    Utilizing In Silico Technologies in Development Programs: Integration, Uses and More

    Joyce Zhao, Director, Combination Product Development, Takeda Pharmaceuticals

  • Exploring how in Silico technology can streamline product design, development, lifecycle management, testing, and optimization processes for injectable devices
  • Discussion of practical In Silico technology use cases for accelerating development timelines and improving product efficacy
  • clock

    16:00

    Effectively Taking a Platform Approach: Implications, Technicalities and Regulations

    David Vazquez , Head SaMD Legal Manufacturing, Pfizer

  • Benefits and challenges of leveraging platform technologies for multiple drug-device combinations and when it this approach appropriate
  • Addressing compliance and design considerations when implementing a platform strategy
  • clock

    17:30

    Chair’s Closing Remarks and End of Focus Day

    Alie Jahangir, Head of Quality, Device and Combination Products, Biogen

    clock

    7:30

    Registration & Coffee

    clock

    8:20

    Chair's Opening Remarks

    Nicholas Mandala

    Nicholas Mandala, VP Medical Device & Combination Product Technology, Pfizer

    clock

    8:30

    Power of AI for Accelerating Combination Product Development from a Submission and Clinical Standpoint

    Nicholas Mandala

    Nicholas Mandala, VP Medical Device & Combination Product Technology, Pfizer

  • Leveraging AI in design controls and GMP operations
  • Future opportunities for utilising AI and computer simulation, starting from modelling device performance to bioavailability and extension into running full in silico trials

     

  • clock

    9:00

    Considerations for Phase-Appropriate Drug-Device Combination (DDC) Product Development

    Daniel Davenport

    Daniel Davenport, Associate Director Early Engagement and Deviceability, GSK

  • Introduction to approaches and key factors affecting development strategy
  • When is the best time to introduce a device into clinical studies?
  • Strategies and examples of bridging to a DDC product
  • Stakeholders alignment across the organization

     

  • clock

    9:30

    Introductory Short Presentation: An Update: The Evolving Drug Delivery Device Landscape

    Theresa Scheuble, Head of Design & Innovation, Johnson & Johnson

    clock

    9:40

    Advisory Board Fireside Chat: Keeping Up with the Evolving Drug Delivery Landscape and Looking to the Future and Beyond

  • Exploring how patients will manage their own health by the end of 2025 and its impact on drug delivery and device design, including self-injection device demand
  • Evaluating AI’s effectiveness in healthcare and its real-world applications in drug discovery, delivery and patient care
  • Approaches for mapping device needs and patient preferences for emerging injectable therapies touching on the rise of the GLP-1 market
  • Identifying key drivers of successful partnerships in pharma, devices, and digital health, and forecasting future trends in healthcare, keeping sustainability in mind
  • Bharat Arora, Director, Global Combination Products Quality, Moderna

    Dany Doucet, Director Early Engagement and Deviceability, GSK

    Nicholas Mandala

    Nicholas Mandala, VP Medical Device & Combination Product Technology, Pfizer

  • Exploring how patients will manage their own health by the end of 2025 and its impact on drug delivery and device design, including self-injection device demand
  • Evaluating AI’s effectiveness in healthcare and its real-world applications in drug discovery, delivery and patient care
  • Approaches for mapping device needs and patient preferences for emerging injectable therapies touching on the rise of the GLP-1 market
  • Identifying key drivers of successful partnerships in pharma, devices, and digital health, and forecasting future trends in healthcare, keeping sustainability in mind
  • Subhi Saadeh

    Subhi Saadeh, Senior Manager, Combination Products QA, Gilead

    Ravi Kaushik, Vice President, Patient Integrated Care Innovation Platform, Takeda Pharmaceuticals

    Sujit Basu, Vice President & Head, Pharmaceutical Development, Ionis

    clock

    10:20

    Session Reserved for Instron

    clock

    10:50

    Morning Networking Break

    clock

    11:20

    Quality by Design: Enhancing Safety, Efficacy and Manufacturability of your Injection Device

    Subhi Saadeh

    Subhi Saadeh, Senior Manager, Combination Products QA, Gilead

  • Introduction to the quality by design framework
  • How to maximise product safety and efficacy
  • Insight into improving development efficiency and aligning design controls
  • Ensuring labelling and IFUs are patient centric
  • clock

    11:50

    Navigating the Drug Delivery Device Development Process

    Alfredo Ricci, CEO, Althena Medical

  • Why it is so important to have a customer centric approach in order to develop a new medical device
  • Which advantage in having a full turnkey service
  • Two cases study: why being fast and flexible add value to the customer
     
  • clock

    12:20

    Device Submission Acceleration Using Platform Strategy

    Lisa Ray, Executive Director Program Management – Delivery, Device & Connected Solutions, Eli Lilly

  • Share acceleration levers utilized to conduct multiple human factors studies, execute a clinical study and accelerate a device submission
  • Includes details related to leveraging an existing device platform strategy while balancing other portfolio priorities
  • Includes key learnings toward replication of this strategy across other device programs

     

  • clock

    12:50

    The Vendor Perspective: Approaching Challenges That Can Derail Combination Product Development

    Craig Voellmicke

    Craig Voellmicke, Director of Sales, Suttons Creek, Inc.

  • The Situation: Review of the common pain points experienced in Biopharma / Device Supplier partnerships and the resulting delays, setbacks and resource drains
  • Suppler-Driven Solutions: OEM and CMO strategies for stronger alignment, collaboration, and impact
  • Biopharma-Driven Solutions: Best practices for planning/ budgeting, cross-functional alignment, vendor management, regulatory strategy, QMS set up, and postmarket systems
  • clock

    13:20

    Advancing Approaches to Combination Product Test Method Development and Validation

    Gretchen Piwinski, Sr Manager Combination Product Development, Regeneron

  • Applying statistical techniques and ISO11040 standards for robust method validation in pre-filled syringes and combination products
  • Integrating a device vs. drug quality risk management process to enhance the lifecycle approach for combination products
  • Identifying critical variables, setting test limits, and establishing acceptance criteria to ensure effective test method validation
  • Leveraging data science and understanding manufacturing processes, including special considerations for destructive testing, to optimize combination product testing
  • clock

    13:50

    Networking Lunch

    clock

    14:50

    Chair's Opening Remarks

    Mark DeStefano

    Mark DeStefano, Director, Combination Products and Device R&D, Teva Pharmaceuticals

    clock

    15:00

    Innovation for Drug Delivery Devices: What’s Needed and What's Next?

    Martin McLoughlin, Head of Device Development, Bristol Myers Squibb

  • Fostering Innovation: Key steps the industry must take to drive research and development for cutting-edge drug delivery devices
  • Learning from Experience: Lessons from past device successes and challenges to inform future advancements and strengthen the case for newer developments
  • Pharma’s Perspective: what are we looking for in drug delivery devices such as autoinjectors and wearables
  • clock

    15:30

    Session Reserved for Sponsor

    clock

    16:00

    ELVIS - Evaluation of Large Volume Injection Study in Human Subjects

    Mark DeStefano

    Mark DeStefano, Director, Combination Products and Device R&D, Teva Pharmaceuticals

  • Rising drug dose volumes have led to the adoption of large volume injection devices, with several recent drug approvals including these devices
  • Understanding patient perspective of these large volume injections: A 30-subject study was conducted to assess pain levels and user preferences across different injection volumes, speeds, and device types
  • Findings highlight key considerations in indications utilizing large drug volumes. Key findings are centred around the following:
  • Where does injection pain come from and does the device type influence injection pain?
  • What are the effects of injection site location on the pain experienced during an injection?
  • What injection/device preference would user have after experiencing various injections?
  • clock

    16:30

    Afternoon Networking Break

    clock

    17:00

    Dual Sourcing Prefilled Syringe Device Development

    Natalie Berry, Combination Product Development Engineer, Pfizer

  • Approach to maintaining syringe barrel subassembly supply for high viscosity monoclonal antibodies
  • Effective device and drug product development partnership
  • Dual sourcing regulatory considerations for drug product and device stability and comparability
  • Efficient design control dual sourcing considerations
  • clock

    17:30

    Session Reserved for Sponsor

    clock

    18:00

    Navigating the Evaluation of Dual Chamber Devices

    Jayne Gavrity, Senior Device Engineer, AstraZeneca

  • Navigating the current landscape and limitations
  • Design considerations on function and usability
  • Integration of the primary container and the delivery system
  • Manufacturing considerations
  • clock

    18:30

    Chair's Closing Remarks and Close of Day One

    Mark DeStefano

    Mark DeStefano, Director, Combination Products and Device R&D, Teva Pharmaceuticals

    clock

    14:50

    Chair's Opening Remarks

    Duncan Paterson, Senior Director, AstraZeneca

    clock

    15:00

    Adoption of Sustainability Practices within Subcutaneous Drug Delivery: Inudstry Insights

    Duncan Paterson, Senior Director, AstraZeneca

  • Overview of an industry benchmarking survey to understand industry sustainability trends
  • Insights into the current state of adoption and prioritization of sustainability practices within the industry
  • Highlighting key barriers to implementation and opportunity areas for impactful change
  • Benchmarking insights and opportunities for sustainability best practices and collaboration
  • clock

    15:30

    Solving Challenges Related to Sustainability and Other Emerging Trends in Injectable Drug Delivery

    Mark Hassett, Vice President of Business Development, Credence MedSystems

  • Sustainability: An opportunity rather than an obligation
  • Avoiding a compromise between sustainability and cost of ownership
  • Incorporating sustainability into innovative device design
  • Let’s not forget about the social side of sustainability
  • clock

    16:00

    Adopting EcoDesign for Packaging and Device Development

    Conor O'Neill

    Conor O'Neill, Head of Packaging Development and Design, GSK

  • Barriers to implementing sustainable practices in injectables devices and their associated packaging
  • The mega trends that are likely to influence future injectable devices
  • Sustainability hot spots for injectable devices and how ecodesign principles, aligned to the waste hierarchy, could be leveraged to overcome them
  • Case study on GSK’s approach: developing sustainable future facing packaging and injectable devices
  • clock

    16:30

    Afternoon Networking Break

    clock

    17:00

    Addressing Usability Considerations for Sustainable Devices

    Matt Marber, Senior Usability Engineer, Novo Nordisk

  • Transitioning from single-use injection devices to more durable, metal-based alternatives for long-term sustainability
  • Influence of user preferences on more eco-friendly solutions on device development and design choices
  • Balancing sustainability and usability - key considerations for maintaining ease of use while adopting more sustainable materials and practices in drug delivery devices
  • clock

    17:30

    Session Reserved for Sponsor

    clock

    18:00

    Determining areas for Improvement During Product Lifecyle

    Confirmed Senior Representative

    Confirmed Senior Representative, , BioPhorum

  • An updated review on environmental challenges and opportunities for the biopharmaceutical sector, from design to end-of-life management
  • Review of lifecycle assessment tools and approaches
  • Successfully implementing life cycle assessment data into device & packaging design
  • clock

    18:30

    Chair's Closing Remarks and Closing of Day One

    Duncan Paterson, Senior Director, AstraZeneca

    clock

    7:30

    Registration & Coffee

    clock

    8:20

    Chair's Opening Remarks

    Mike Wallenstein, Novartis Global Head RA Medical Devices, Combination Products & Precision Medicine, Novartis Pharma AG

    clock

    8:30

    From Drug Development to Successful Combination Product

    Sujit Basu, Vice President & Head, Pharmaceutical Development, Ionis

  • Aligning drug development with evolving therapeutic delivery needs for combination products
  • Key criteria for selecting the right partners to support
  • early-stage development through commercialization
  • Case study on the journey from concept to approval, highlighting regulatory, design, and testing insights for combination products
  • clock

    9:00

    Driving Patient Centricity in Biosimilars Development and Device Strategies

    Kinsuk Shah

    Kinsuk Shah, Sr. AD Combination Product Steward, Boehringer Ingelheim

  • Exploring the latest advancements in biosimilar development and implications for device requirements, including customisation for complex therapies
  • Case studies: challenges and experiences in biosimilar device development, regulatory hurdles and patient centric design
  • Strategies for adapting device platforms to accommodate a diverse portfolio of biosimilars, improving scalability and time to market
  • clock

    9:30

    Navigating EU and US Updates in Injection Device Regulatory Framework: Addressing Current Gaps in Knowledge

    Mike Wallenstein, Novartis Global Head RA Medical Devices, Combination Products & Precision Medicine, Novartis Pharma AG

  • Reviewing the FDA EDDO guidance and industry interpretations
  • Addressing impact on device development stages, challenges that have arisen and how these can be overcome
  • Exploring developments in Europe: EMA call for feedback on the EU MDR and IVDR
  • clock

    10:00

    Sesion Reserved for Gerresheimer

    clock

    10:30

    Morning Networking Break

    clock

    11:00

    Innovative Approaches in Biopharmaceutical Formulation and Delivery: Enhancing Safety, Performance ,and Stability

    Guangli Hu, Director, Merck & Co., Inc.

  • Robust Primary Container System Selection: Investigation of needle clogging & coring in elastomeric needle shields of pre-filled syringes using advanced imaging techniques, material characterization, and predicative modelling to inform effective mitigation strategies
  • Advanced Characterization Techniques: Utilizing imaging and analytical models, studies on plunger movement, siliconization, and protein formulation stability provide critical insights for optimizing pre-filled syringe performance and drug delivery
  • Optimizing Injectability Through Innovation: Analysis of high concentration suspensions and the factors influencing needle clogging, providing insights into formulation and device design to enhance injectability and ensure accurate drug delivery
  • clock

    11:30

    Session Reserved for Gold Sponsor

    clock

    12:00

    Helping Licence Holders, CDMOs and Suppliers Speak the Same Language: Aligning Risk Assessments for Streamlined Submissions

    Confirmed Senior Representative

    Confirmed Senior Representative, , BioPhorum

  • Licence holders, suppliers and CDMOs often have different ratings and take approaches to the same hazards when conducting risk assessments
  • This also applies to the terminology used, often referring to the same hazards in different ways, all of which can result in unnecessary over testing in mitigation, and lead to delays and further requests for clarification following submissions
  • BioPhorum’s Risk Management team is creating a library of common hazards and harms
  • This will help to streamline and harmonize ratings across sponsors, CDMOs, suppliers, helping to make submissions across the industry more consistent and with more predictable results
  • clock

    12:30

    Hidden but Vital: The Importance of Biocompatibility for Patient Safety

    Amardeep Hoonjan, Director Device R&D Lead, Biocompatibility Group, AbbVie

  • What is biocompatibility and why is it important for combination product safety
  • The evolution of biocompatibility standards
  • Where should biocompatibility be considered in combination product development
  • Impact of biocompatibility on final product
  • clock

    13:00

    Networking Lunch

    clock

    14:00

    Chair's Opening Remarks

    Soumen Das

    Soumen Das, Medical Device Qualification Lead & Associate Scientific Fellow, Takeda Pharmaceutical Company Limited

    clock

    14:10

    Developing a comprehensive primary container strategy for new modality programs

    Fletcher Dix, Sr. Process Characterization and Technology Engineer, Regeneron Pharmaceuticals

  • Assessing growth of new modalities (such as siRNA or AAV) and implications for primary containers including the need for deep cold storage
  • Delving into the use and role of polymers in development
  • Best practices for ensuring regulations are successfully met to ensure a safe end product
  • Considering fill-finish and transportation in earlier stages of development while aligning with the CMO processes
  • clock

    14:40

    Session Reserved for Mitsubishi Gas Chemical

    clock

    15:10

    Afternoon Networking Break

    clock

    15:10

    Exploring the Non-linear Friction Effects in a Pre-filled Syringe System

    Aditya Nair, Packaging Engineer, Pfizer

  • The interface between the syringe and stopper is most crucial for functional performance of the prefilled syringe system and the value in gaining a deeper understanding of this system will be presented
  • A prefilled syringe system features a tribological contact mechanism between the glass wall and stopper that results in friction and deformation which ultimately govern the functional aspects such as break loose and extrusion forces
  • The various nonlinear friction effects in a syringe stopper interface such as stick-slip, presliding, stiction are discussed
  • Existing models relevant to nonlinear friction effects are introduced with a demonstration on how these models may be implemented for the syringe seal. Understanding of these
  • models can prove to be a crucial step towards modelling of the dynamic forces in a PFS which can further aid in predicting functionality and saving experimental resources
  • clock

    16:10

    Collaboration with Commercial Suppliers: Relations and Lifecyle Management

    Ellie Younger

    Ellie Younger, Associate Principal Engineer, AstraZeneca

  • Best practices for setting up an effective quality agreement
  • Implications on validation and verification
  • Dealing with changes from suppliers
  • clock

    16:40

    Session Reserved for Zeon

    clock

    17:10

    Navigating Recent Updates and Preparing for Future Standards in Biocompatibility

    Soumen Das

    Soumen Das, Medical Device Qualification Lead & Associate Scientific Fellow, Takeda Pharmaceutical Company Limited

  • Recent updates and regulatory expectations for biocompatibility testing in injectable drug devices
  • Recent experiences and lessons learned from implementing biocompatibility assessments under evolving guidelines
  • Forecasting the new biocompatibility standards for 2025: anticipated changes and their implications for device design and compliance
  • clock

    17:40

    Chair’s Closing Remarks and Close of Day Two

    Soumen Das

    Soumen Das, Medical Device Qualification Lead & Associate Scientific Fellow, Takeda Pharmaceutical Company Limited

    clock

    14:00

    Chair's Opening Remarks

    Sujit Basu, Vice President & Head, Pharmaceutical Development, Ionis

    clock

    14:10

    Opening Panel Discussion: Connectivity, Usability and Necessity: Creating A Balance

  • When should we involve software in a device, and when should we not? Considering use settings and factors such as treatment regularity, sensors and adherence
  • How do we make these technologies impactful in clinical trials and financially viable for post market real world evidence studies
  • Software and app development as a part of the device development process – when should it be integrated and how?
  • How do we manage the risk of software being outdated when the device hits the market?
  • Ravi Kaushik, Vice President, Patient Integrated Care Innovation Platform, Takeda Pharmaceuticals

    Martin McLoughlin, Head of Device Development, Bristol Myers Squibb

    Sarah Fairfield

    Sarah Fairfield, Associate Director, RA Device and Combination Products Digital Device and Software, AbbVie

    Sriman Banerjee, Head of Packaging Development & CDE, Takeda Pharmaceuticals

    clock

    14:40

    Reserved Sponsor Session

    clock

    15:10

    Considerations for Early Technology Evaluation for Injection Devices

    Megan Heft, Director, Device Development, AstraZeneca

  • Patient-centric evaluation: incorporating early human factors evaluations to inform use case boundaries
  • Technical approaches to maximize characterization when drug product is scarce or unknown
  • Balancing use, technical, and manufacturing trade-offs in technology selection
  • clock

    15:40

    Afternoon Networking Break

    clock

    16:10

    Best Strategies for Ensuring your Connected Ecosystem is Secure

    Sarah Fairfield

    Sarah Fairfield, Associate Director, RA Device and Combination Products Digital Device and Software, AbbVie

  • Reviewing guidance and insight into FDA expectations
  • Exploring requirements for manufacturers of cyber devices and related systems
  • Assessing data implications on patient safety
  • Maximising adoption of new technologies by designing devices for the long term as well as adaptive cybersecurity and safe patient access
  • clock

    16:40

    Reserved Sponsor Session

    clock

    17:10

    Digital Health Evolution: Trends in Connected Medical Devices

    Sriman Banerjee, Head of Packaging Development & CDE, Takeda Pharmaceuticals

  • Exploring the latest advancements in connected drug delivery devices, including real-time monitoring and data integration
  • Examining how connected devices are enhancing patient adherence, experience, and outcomes but also enhancing clinical trials
  • Understanding the evolving requirements for digital health technologies, focusing on compliance and data security
  • Future outlook on the integration of AI, machine learning, and IoT to drive the next generation of connected injectable devices
  • clock

    17:40

    Chair's Closing Remarks and Closing of Day Two

    Sujit Basu, Vice President & Head, Pharmaceutical Development, Ionis


    Packaging Engineer
    Pfizer
    Executive Director, Drug Delivery and Devices
    Eli Lilly
    CEO
    Althena Medical
    Head of Quality, Device and Combination Products
    Biogen
    Director Device R&D Lead, Biocompatibility Group
    AbbVie
    Director, Global Combination Products Quality
    Moderna
    BioPhorum
    Biophorum
    Head of Packaging Development and Design
    GSK
    Director of Sales
    Suttons Creek, Inc.
    Associate Director Early Engagement and Deviceability
    GSK
    Director Early Engagement and Deviceability
    GSK
    Head SaMD Legal Manufacturing
    Pfizer
    Senior Director
    AstraZeneca
    Associate Principal Engineer
    AstraZeneca
    Sr. Process Characterization and Technology Engineer
    Regeneron Pharmaceuticals
    Sr Manager Combination Product Development
    Regeneron
    Director
    Merck & Co., Inc.
    Global Head, Regulatory Affairs - Emerging Device Technologies and Combination Products
    AbbVie
    Senior Device Engineer
    AstraZeneca
    Sr. Human Factors Engineer
    Regeneron Pharmaceuticals
    Director, Combination Product Development
    Takeda Pharmaceuticals
    Sr. AD Combination Product Steward
    Boehringer Ingelheim
    Executive Director Program Management – Delivery, Device & Connected Solutions
    Eli Lilly
    Director, Combination Products and Device R&D
    Teva Pharmaceuticals
    Vice President of Business Development
    Credence MedSystems
    Head of Device Development
    Bristol Myers Squibb
    Senior Usability Engineer
    Novo Nordisk
    Director, Device Development
    AstraZeneca
    Novartis Global Head RA Medical Devices, Combination Products & Precision Medicine
    Novartis Pharma AG
    Combination Product Development Engineer
    Pfizer
    VP Medical Device & Combination Product Technology
    Pfizer
    Executive Director, Device and Combination Product Development
    Astria Therapeutics
    Director of Engineering
    Merck
    Vice President, Patient Integrated Care Innovation Platform
    Takeda Pharmaceuticals
    Associate Director, RA Device and Combination Products Digital Device and Software
    AbbVie
    Medical Device Qualification Lead & Associate Scientific Fellow
    Takeda Pharmaceutical Company Limited
    Head of Packaging Development & CDE
    Takeda Pharmaceuticals
    Senior Manager, Combination Products QA
    Gilead
    Vice President & Head, Pharmaceutical Development
    Ionis
    Head of Design & Innovation
    Johnson & Johnson

    Gold Sponsor

    Sponsors

    Exhibitors

    VENUE

    Sheraton Boston Hotel

    39 Dalton Street, Boston, MA, USA

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Past Attendee List

    Download

    Sponsorship Prospectus

    Download

    Sponsors and Exhibitors


    Althena Medical

    Gold Sponsor
    http://www.althenamedica.it/

    Althena Medical is an Italian company specialized in the development and production of medical devices in the pharmaceutical field (pre-fillable syringes, oral liquid dispensers, droppers, etc.). In our catalogue we currently have COP pre-fillable syringes in several volumes. We also offer filling service and turn-key products.

    We work for small, medium and big brands for which we have designed, created and produced patented products.

    We differ from our competitors because we are flexible, reliable and we develop medical devices on demand very quickly.

    100% Made in Italy!



    Gerresheimer

    Gold Sponsor
    http://www.gerresheimer.com

    Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical primary packaging, drug delivery systems and digital solutions. Gerresheimer ensures that medicines reach patients safely and can be administered reliably. With around 12,000 employees and 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for the regional markets with a focus on the pharma industry.



    Instron

    Gold Sponsor
    https://www.instron.com/en-gb/

    Instron® brings a wealth of knowledge to the biomedical industry, serving as a strategic partner to companies of all sizes. Our equipment and services are primed to help you investigate new technologies and ensure product quality, all while maintaining the highest levels of data integrity and security. Instron has been embedded in the biomedical industry for more than 75 years, and the technological, regulatory, and manufacturing challenges facing our customers have driven us to develop products and services to address their needs. These developments include specialized fixturing, compliant software, and automation capabilities. Our most valuable asset is our extensive customer network, which represents a wide range of medical device and pharmaceutical manufacturers, CDMOs, universities, test houses, and startups.



    Suttons Creek

    Gold Sponsor
    http://www.suttonscreek.com


    Sponsors


    Cambridge Design Partnership

    Sponsors
    https://www.cambridge-design.com/

    Cambridge Design Partnership is an end-to-end innovation partner. We build breakthrough products and services – from insight to ideas, prototypes to production. Our Drug Delivery sector focus on injection systems including auto injectors, pen injectors, wearable (OBDS) devices and infusion pumps, as well as Digital Health applications including connected drug delivery devices, diagnostics/biomarker devices, app development and cloud services.


    Credence MedSystems

    Sponsors
    http://www.credencemed.com

    Credence MedSystems is an innovator in injectable drug delivery devices. Credence’s philosophy of Innovation Without Change results in products that impress and protect end-users while preserving pharma’s existing processes, sourcing strategies and preferred primary package components. The Companion® family of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in Staked and Luer needle formats. The Dual Chamber platform offers single-step mixing and injection for drugs requiring reconstitution at the time of delivery. Additional products such as metered dose devices, multi-length staked needles and other novel devices address the needs of specific therapeutic markets.


    Haselmeier

    Sponsors
    https://haselmeier.com/en/

    o Haselmeier, the drug delivery device business of medmix, designs, develops and manufactures advanced drug delivery systems such as pen injection systems and autoinjectors. Patient comfort and customers’ needs are always at the heart of the company’s practices. With its broad portfolio of technologies and services, Haselmeier delivers user-friendly injection systems that enable patients to self-administer their medication reliably and accurately. Haselmeier is known for its excellent and long-standing track record in providing these innovative drug delivery devices based on its proprietary IP business model. The company collaborates closely with its customers in the pharmaceutical and biopharmaceutical industries. Medmix, with its precision injection molding capabilities and expertise in liquid micro-dosing plus financial strength and global footprint, helps Haselmeier accelerate innovation in healthcare. With more than 100 years of expertise in the development and manufacture of drug delivery devices, our global footprint, nearly 250 distinguished and motivated experts, more than 200 patents granted, and numerous patents pending, Haselmeier remains committed to developing innovative solutions that support our customers and help improve the health of millions of people worldwide.



    Mitsubishi Gas Chemical

    Sponsors
    https://www.mgc.co.jp/eng/products/abd/oxycapt.html

    Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen, ultra violet and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.


    ZEON

    Sponsors
    https://www.zeon.eu/

    o ZEON’s Zeonex® and Zeonor® cyclo olefin polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns. Please visit our booth and discover why COP is an excellent choice for drug storage and pre filled syringes.


    Exhibitors


    BBS Automation Chicago,

    Exhibitors
    https://www.bbsautomation.com/company/locations/chicago

    Since 1965, BBS Automation has specialized in assembly systems for the medtech, consumer, mobility, and new energy sectors of the future. After BBS Automation’s acquisition in 2023 by the Dürr Group, the Production Automation business now consists of the combined forces of BBS Automation, teamtechnik, Kahle and HEKUMA. In its production sites around the world, BBS Automation and sister companies develop custom automation solutions for complete production processes that set standards in terms of efficiency, safety, reliability and innovation. We are able to do so thanks to our comprehensive service portfolio of platforms and processes, and also our expertise in feeding technology, palletizing systems and software.



    Fischer Söehne AG

    Exhibitors
    http://www.fischersoehne.ch/de



    KORU

    Exhibitors
    https://www.korumedical.com/

    KORU is, first and foremost, a patient-centric organization that will go the extra mile for our customers, providers, and partners who depend on our devices. We are a world-class manufacturer of subcutaneous infusion devices that deliver life-saving immunoglobulin therapies to patients with chronic illnesses such as Primary Immunodeficiencies (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).



    Kymanox

    Exhibitors
    https://www.kymanox.com/

    Kymanox® is your life science solutions partner with a diverse team of experts who know how to connect the dots and make sure you have the right end-to-end solutions for your modern medicine development & commercialization challenges.

    We are experts in providing our clients in the combination products, biologics, pharmaceutical, and medical device industries with support from early development to post-market. We help bring products from bench to patient.



    Lyophilization Technology

    Exhibitors
    https://lyotechnology.com/

    Lyophilization Technology, Inc. (LTI) is a Contract Development & Manufacturing Organization (CDMO) focused on all aspects of lyophilization for preparation of health care products.

    Clients leverage our abilities for bringing new products to the clinic and implementing improvements for current products. LTI is recognized as an industry leader with unparalleled capabilities in product development, process engineering, clinical manufacturing, and technical support.

    To the benefit of our clients, LTI has provided Development and Clinical Trial Material Manufacturing services to more than 500 biotechnology and pharmaceutical organizations spanning virtual companies to large multi-national corporations for over 25 years. Our proven track record of performance comes from successfully developing formulations, manufacturing processes, and prepared material for clinical trials for over 900 diverse products.

    A talented and dedicated staff, skilled with over 300 years of combined experience, enjoys the reputation of providing innovative solutions, achieving desired results, and exceeding client expectations.

    Gain the benefits of our experience and capabilities for creating solutions for the unique needs of your lyophilized product.



    Owen Mumford

    Exhibitors
    http://www.ompharmaservices.com

    Owen Mumford Pharmaceutical Services is a specialist in the design, development and manufacture of injectable drug delivery systems for the pharmaceutical, biotech & generics industries. These include single dose and multidose reusable and disposable auto-injectors, pens and syringes for subcutaneous and intramuscular administration. Our innovative products are designed to meet both the need of our pharmaceutical partners and their patients by facilitating ease of use and improving safety and patient compliance. Our devices are also designed with aim of reducing complexity and risk for the pharmaceutical & biotech industry in the development of their combination products.


    RheoSense

    Exhibitors
    http://www.rheosense.com

    RheoSense is a biotechnology firm headquartered in San Ramon, Calif. The company specializes in creating industry leading viscometers using their groundbreaking VROC® (Viscometer-Rheometer-On-a-Chip) technology. This technology, originally released in 2009, was the first new method of measuring viscosity in over 45 years. The methodology, now called rectangular slit viscometry, is documented in the US Pharmacopeia chapter 914 and makes measuring the viscosity of fluids exponentially simpler and more accurate. RheoSense’s patented rectangular slit viscometers use VROC® chips equipped with sensors to measure the viscosity of samples as they flow through the chip.



    Terumo

    Exhibitors
    https://www.terumopharmaceuticalsolutions.com/en-EMEA

    As Part of Terumo Medical Care Solutions, the Pharmaceutical Solutions Division develops patient-oriented parenteral delivery solutions for therapeutic performance and safety.

    Globally trusted for quality and precision, we offer pharmaceutical and medical device manufacturers around the world comprehensive product design and development services.

    We have decades of experience collaborating with pharmaceutical companies from the earliest phases of drug development to product commercialization to optimize critical aspects of parenteral drug delivery.

    Innovation and creativity are central to our value proposition. Our expert teams lead the industry in developing and manufacturing advanced, high-performing infusion and injection technologies, including CDMO services for all parenteral applications.

    We listen. We question. We deliver.


    SAVE TO


    Outlook Calendar  OUTLOOK CALENDAR
    Google Calendar  GOOGLE CALENDAR
    ICal Calendar  ICAL CALENDAR
    Yahoo! Calendar  YAHOO! CALENDAR

    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199
    USA

    Sheraton Boston Hotel

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download

    Title


    Description

    Download

    Title


    Description


    Download


    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    Group Booking

    Please complete the below form and a member of SAE Media Group’s booking team will be in contact within 24 hours

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.

    Thank you for visiting our event

    If you would like to receive further information about our events, please fill out the information below.

    By ticking above you are consenting to receive information by email from SAE Media Group.
    Full details of our privacy policy can be found here https://www.smgconferences.com/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data.privacy@smgconferences.com.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smgconferences.com/opt-out

    Fill in your details to download the brochure

    By submitting this form you agree to our privacy policy and consent to receiving communications, you may opt out at any time.