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Pre Filled Syringes and Injectable Drug Devices East Coast
April 22 - April 24, 2024
Pre Filled Syringes and Injectable Drug Devices East Coast

Conference Overview

NEW FOR 2023:

Pre-Conference Focus Day: Advances in PFS Design for Enhanced Delivery


Main Conference Afternoon Streams
DAY 1: A)
Developing devices for challenging to delivery drugs B) Sustainability initiatives in the medical device industry
DAY 2: A) Primary packaging development B) Incorporating digital technologies for connected devices

SAE Media Group's 11th Annual Pre-Filled Syringes East Coast Conference will return to Boston in April 2024 to bring you the latest advances in the combination product drug delivery space. As part of SAE’s leading Injectable Drug Delivery Series, the 2024 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 2024!

FEATURED SPEAKERS

Alex Baker

Alex Baker

Senior Engineer II, Product and Technology Development, Biogen
Alex Klara

Alex Klara

Business Development Specialist, Zeon
Alexandra Benbadis

Alexandra Benbadis

Usability Leader, Sanofi
Alicia Douglas

Alicia Douglas

Human Factors Lead, Merck
Anthony Coston

Anthony Coston

Principal Engineer, Biogen
Benjamin Whitenack

Benjamin Whitenack

Director, Quality, Combination Products, Gilead Sciences, Inc
Bernard  Vrijens

Bernard Vrijens

CEO & Scientific Lead, AARDEX Group
Carrie O'Donel

Carrie O'Donel

Principal Device Engineer, Teva Pharmaceuticals
Cedric Gysel

Cedric Gysel

Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability , Johnson & Johnson
Charlie Dean

Charlie Dean

Head of Sustainable Medical Technology, Cambridge Consultants Ltd
Courtney Evans

Courtney Evans

Principal Consultant, Suttons Creek, Inc.
David Morra

David Morra

Director, Devices and Digital Health, Merck, Sharpe, & Dohme
Divya Sharma

Divya Sharma

Senior Scientist, Pfizer Inc.
Duncan Paterson

Duncan Paterson

Senior Director, AstraZeneca
E Guan

E Guan

Head of Injection Systems, Takeda
Jamie Tsung

Jamie Tsung

Director CMC Development, Alnylam
John Schalago

John Schalago

Executive Director of Regulatory Affairs, Novartis
Kristina Li

Kristina Li

Sr. Engineer II, Technical Development, Biogen
Lawton  Laurence

Lawton Laurence

Head of Device & Combination Product Development, Apellis
Manuel Sanchez-Felix

Manuel Sanchez-Felix

VP Drug Delivery Search & Evaluation, Halozyme
Mark DeStefano

Mark DeStefano

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

Mark Hassett

Vice President of Business Development, Credence MedSystems
Mark Howansky

Mark Howansky

Vice President of Device Development and Commercialization, Viridian Therapeutics
Michael Song

Michael Song

Director, Moderna
Mike Wallenstein

Mike Wallenstein

Novartis Global Head RA Medical Devices, Combination Products & Precision Medicine, Novartis Pharma AG
Ning Yu

Ning Yu

Executive Director, Device and Combination Product Development, Astria Therapeutics
Peter Petrochenko

Peter Petrochenko

Associate Director, Regulatory Strategy, Regeneron Pharmaceuticals
PJ Kim

PJ Kim

VP Business Development, ApiJect Systems, Corp.
Ravi Kaushik

Ravi Kaushik

Vice President, Patient Integrated Care Innovation Platform, Takeda Pharmaceuticals
Ronald Forster

Ronald Forster

Head of Manufacturing Sciences and Technologies for Combination Product Operations, Amgen
Sarah Fairfield

Sarah Fairfield

Associate Director, RA Device and Combination Products Digital Device and Software, AbbVie
Serene Jabary

Serene Jabary

Scientist I, Biogen
Shruti Parikh

Shruti Parikh

Director, Product Design, Takeda Pharmaceuticals
Sonia Dragulin-Otto

Sonia Dragulin-Otto

Senior Scientist, AstraZeneca
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
Sriram Natarjaan

Sriram Natarjaan

Principal Engineer, Janssen Pharmaceuticals
Theresa Scheuble

Theresa Scheuble

Head of Design & Innovation, Johnson & Johnson
Tomohiro Suzuki

Tomohiro Suzuki

Associate General Manager, Mitsubishi Gas Chemical Company, Inc

Alex Baker

Senior Engineer II, Product and Technology Development, Biogen
Alex Baker

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

Alex Klara

Business Development Specialist, Zeon
Alex Klara

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

Alexandra Benbadis

Usability Leader, Sanofi
Alexandra Benbadis

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

 

Alicia Douglas

Human Factors Lead, Merck
Alicia Douglas

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

Anthony Coston

Principal Engineer, Biogen
Anthony Coston

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


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


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


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


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

Benjamin Whitenack

Director, Quality, Combination Products, Gilead Sciences, Inc
Benjamin Whitenack

Benjamin Whitenack currently serves as Director at Gilead Sciences, overseeing design assurance activities in the Medical Devices and Combination Product Quality Group. He has been working in quality with various medical device and combination product startups, as well as large companies, for more than 18 years with a focus on risk management and design control initiatives. Benjamin holds a bachelor's degree in biosystems engineering and a master's degree in biomedical engineering."

 

Bernard Vrijens

CEO & Scientific Lead, AARDEX Group
Bernard  Vrijens

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

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


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

 

Carrie O'Donel

Principal Device Engineer, Teva Pharmaceuticals
Carrie O'Donel

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

Cedric Gysel

Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability , Johnson & Johnson
Cedric Gysel

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

Charlie Dean

Head of Sustainable Medical Technology, Cambridge Consultants Ltd
Charlie Dean

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

Courtney Evans

Principal Consultant, Suttons Creek, Inc.
Courtney Evans

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

David Morra

Director, Devices and Digital Health, Merck, Sharpe, & Dohme
David Morra

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


 

Divya Sharma

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

Duncan Paterson

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.

E Guan

Head of Injection Systems, Takeda
E Guan

Jamie Tsung

Director CMC Development, Alnylam
Jamie Tsung

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

 

John Schalago

Executive Director of Regulatory Affairs, Novartis
John Schalago

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

Kristina Li

Sr. Engineer II, Technical Development, Biogen
Kristina Li

Lawton Laurence

Head of Device & Combination Product Development, Apellis
Lawton  Laurence

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

 

 

Manuel Sanchez-Felix

VP Drug Delivery Search & Evaluation, Halozyme
Manuel Sanchez-Felix

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

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

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

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

 

Mark DeStefano

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

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

Mark Hassett

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.

Mark Howansky

Vice President of Device Development and Commercialization, Viridian Therapeutics
Mark Howansky

Michael Song

Director, Moderna
Michael Song

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.
 

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.
 

Peter Petrochenko

Associate Director, Regulatory Strategy, Regeneron Pharmaceuticals
Peter Petrochenko

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

PJ Kim

VP Business Development, ApiJect Systems, Corp.
PJ Kim

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

Ravi Kaushik

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.

 

Ronald Forster

Head of Manufacturing Sciences and Technologies for Combination Product Operations, Amgen
Ronald Forster

Sarah Fairfield

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

Serene Jabary

Scientist I, Biogen
Serene Jabary

Shruti Parikh

Director, Product Design, Takeda Pharmaceuticals
Shruti Parikh


 

Sonia Dragulin-Otto

Senior Scientist, AstraZeneca
Sonia Dragulin-Otto

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

Soroosh Bagheriasl

Senior Account Manager, BioPhorum
Soroosh Bagheriasl

Soumen Das

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

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

Speaker to be confirmed

, Amgen
Speaker to be confirmed

Speaker to be confirmed

, UserWise
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Speaker to be confirmed

, BioPhorum
Speaker to be confirmed

Sriman Banerjee

Head of Packaging Development & CDE, Takeda Pharmaceuticals
Sriman Banerjee

Sriram Natarjaan

Principal Engineer, Janssen Pharmaceuticals
Sriram Natarjaan

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.
 

Tomohiro Suzuki

Associate General Manager, Mitsubishi Gas Chemical Company, Inc
Tomohiro Suzuki

Mr. Hiroki Hasegawa is a researcher of Advanced Business Development Division.
 

He gained a Diploma in Science in 2013 and a Master Degree of Science in 2015 from Osaka University.


Since April 2015 he has been working for Mitsubishi Gas Chemical Company, Inc. and in charge of macromolecular science, especially in composition development of thermosetting resin.
 

Since 2018 he has joined a development team of multilayer plastic vial & syringe for biologics.
 

 Why attend:

  • 3 full days of networking opportunities
  • 40+ presentations with 75% of speakers from the top 20 big pharma companies
  • The agenda has been curated by an advisory board of big pharma and biotech opinion leaders providing expertise focused on device development, regulatory affairs and quality
  • Access a focus day and 4 dedicated streams addressing the hottest topics in the industry
     

What you will gain:

  • Collaborate with pharma, biotech and device developers across 3 full days on the latest trends, advancements and challenges within the pre-filled syringe and injectable device market
  • Hear about new technological advances for challenging to delivery drugs such as large volume, highly viscous and lyophilised formulations with case studies on wearable injectors and more
  • Understand the latest regulatory requirements from experts surrounding combination products and engage in opportunities for collaboration and needs for advancing innovation in the field with an advisory board fireside chat
  • Gain insight into how big pharma is incorporating sustainable approaches into drug device design and lifecycle management
  • Delve into the growing potential of digital health to improve patient experience and treatment, and the challenges facing its implementation
  • Examine how container and packaging development can support the ever-evolving innovations drug development, including case studies on CCIT in deep-cold storage and formulator perspectives

 

 

Who should attend:

Directors, Heads of Departments and Managers for the following areas:

Device Development
Device Engineering
Combination Product Development
Drug Delivery Devices
Primary Packaging Development
Digital Health
Sustainability and Circular Economy
Large Volume Drug Delivery
Novel Drug Product Formulation
Regulatory Affairs

This year's agenda has been validated by our 2024 advisory board:

  • John Schalago, Executive Director, Senior Global Program Director, Novartis
  • Khaudeja Bano, Vice President, Combination Product Quality, Amgen
  • James P. Wabby, Global Head, Regulatory Affairs - Emerging Device Technologies and Combination Products, AbbVie
  • Mark DeStefano, Director, Combination Products and Devices R&D, Teva
  • Michael Song, Director, Drug Product Development, Moderna

sponsors

Conference agenda

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8:00

Registration & Coffee

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8:50

Chair's Opening Remarks

John Schalago, Executive Director of Regulatory Affairs, Novartis

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9:00

Opportunities for advancing your injectable device portfolio

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

  • Review of the current PFS and injectables landscape and emerging technologies
  • Recent developments in drug delivery platforms and device design or enhanced drug delivery
  • Opportunities for development processes to become more streamlined
     
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    9:30

    Collaboration for a Strategic Combination Product Development: A Case Study

    Nicholas Mandala

    Nicholas Mandala, VP Medical Devices & Combination Products, Pfizer

  • Insights into developing a combination product portfolio using advanced technologies
  • Considerations for a collaborative development process across teams
  • Meeting essential performance requirements: challenges to define and identify essential performance requirement (EPR) during the development of a combination product
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    10:00

    Session reserved for lead sponsor

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    10:30

    Morning Break

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    11:00

    Strategic Combination Product Test Method Development and Validation

  • Applying statistical techniques to Method Validation of PFS following ISO11040
  • A paradigm shift integrating a Device vs Drug Quality Risk Management Process in Combination Products
  • Successful implementation of Data Science in lifecycle approach of Combination Products
     
  • clock

    11:30

    Session reserved for sponsor

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    12:00

    Panel Discussion: Ways to streamline development, accelerate product to customer

  • Promotion of collaboration between internal stakeholders
  • Learnings from COVID and recent programs to apply for fast to clinic and future success
  • How can we better leverage platforms for enhanced development
  • Reviewing current barriers and potential opportunities to overcome
     
  • Michael Song

    Michael Song, Director, Moderna

    E Guan

    E Guan, Head of Injection Systems, Takeda

    Dany Doucet

    Dany Doucet, Director Early Engagement and Deviceability, GSK

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

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

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    12:30

    Networking Lunch

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    12:30

    Reserved sponsor session

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    13:30

    Building an Ecosystem for Development and Supply of Combination Products

    Mark Howansky

    Mark Howansky, Vice President of Device Development and Commercialization, Viridian Therapeutics

  • Exploring key regulatory and QMS requirements for a robust and successful combination product portfolio
  • Key considerations for dealing with functional “Upgrades”
  • Exploring supply chain considerations and potential implications on product development
  • Implementing a design control framework
  • Case study on use of device platforms

     

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    14:00

    Session reserved for sponsor

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    14:30

    Maximising Patient Centricity in PFS Design

    Shruti Parikh, Director, Product Design, Takeda Pharmaceuticals

  • Critical considerations for Patient Preference Study (PPS) creation
  • Executing human factors and usability studies to understand patient needs and preference and successfully implementing this in PFS design
  • Strategies and factors to consider for balancing requirements (e.g. technical, commercial, user needs)
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    15:00

    Afternoon Break

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    15:30

    Optimising Lyophilized Drug Delivery

    Dany Doucet

    Dany Doucet, Director Early Engagement and Deviceability, GSK

  • Case study on reconstitution device development
  • Reflecting on major challenges faced during development with perspectives on future improvements
  • Impact of fill/finish on patient usability
  • Opportunities and approaches for enhancing patient usability
     
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    16:00

    Navigating the Complexities of Combination Product Risk: A System-Level Approach

    Benjamin Whitenack, Director, Quality, Combination Products, Gilead Sciences, Inc

  • Integrating ICH Q9(R1) and ISO 14971 risk analyses
  • Evaluating combination product residual risks
  • Enhancing traceability
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    16:30

    Chair’s Closing Remarks and Close of Focus Day

    John Schalago, Executive Director of Regulatory Affairs, Novartis

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    8:00

    Registration & Coffee

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    8:50

    Chair's Opening Remarks

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

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    9:00

    Disruptive Medicine Innovation – Next Generation of Combination Products

    Sarah Fairfield

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

  • Analyze latest regulatory expectations and challenges
  • Understand potential future innovation platforms
  • Acknowledge potential and future Global Convergence/Harmonization initiatives for combination products
     
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    9:30

    Advisory Board Fireside Chat: Encouraging Innovation and Addressing Potential Barriers and Pitfalls

  • How can industry keep up with emerging innovations in drug products such as cell and gene therapy
  • As we look to advance technology, how can we ensure stakeholder buy-in and truly aid the patient experience
  • Exchanging regulatory submission challenges and experiences
  • Assessing solutions for the future: considering sustainability and connected health
     
  • Mark DeStefano, Director, Combination Products and Device R&D, Teva Pharmaceuticals

    Michael Song

    Michael Song, Director, Moderna

    John Schalago, Executive Director of Regulatory Affairs, Novartis

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    10:00

    Session reserved for gold sponsor CCL

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    10:30

    Morning Break

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    11:00

    Leveraging Bridging Principles for Innovative and Biosimilar/Gx Device Development: A Risk-Based Approach

    Carrie O'Donel, Principal Device Engineer, Teva Pharmaceuticals

  • Discussion of current guidance’s for Bridging and Comparative Use Human Factors Studies for commercialization of injection devices,
  • Comparison of requirements for US versus EU relative to device bridging
  • Effectively conducting a Threshold Analysis to define differences, using bridging data to justify a “minor” versus “other” difference, and defining Negative Transfer
     
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    11:30

    Improving integration of sustainable design principles into combination product development

    Charlie Dean, Head of Sustainable Medical Technology, Cambridge Consultants Ltd

  • Using a conceptual body-worn injector to demonstrate a methodical and systematic approach to sustainable device development
  • Developing a roadmap for sustainable innovation
  • Deploying life cycle assessment to guide design for reduced environmental impact
  • Considerations for use of renewable materials
     
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    12:00

    Understanding pre-filled syringe human factors validation study results

    Alexandra Benbadis, Usability Leader, Sanofi

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    12:30

    Transforming Drug Delivery: Every Dose Delivered Better

    PJ Kim, VP Business Development, ApiJect Systems, Corp.

  • Discuss essential medicines market dynamics, drug shortages, and fill finish capacity
  • Explore the challenges and solutions related to accessibility, transportability, and sustainability in the pharmaceutical industry.
  • Examine the impact of healthcare provider (HCP) burnout rates on patient care, as well as the potential role of community health workers in addressing these challenges.
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    13:00

    Practical and Patient Considerations for Large Volume and Highly Viscous Drug Delivery

    Anthony Coston, Principal Engineer, Biogen

  • Injection tolerability – effects of device technical attributes
  • Studies on user preferences and ensuring injection duration keeps pain low and facilitate safe use
  • Impact of drug formulation on robustness
  • Regulatory hurdles to overcome
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    13:30

    Networking Lunch

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    14:30

    Chair's Opening Remarks

    Manuel Sanchez-Felix, VP Drug Delivery Search & Evaluation, Halozyme

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    14:40

    Facilitating Rapid High Volume Subcutaneous (SC) Drug Delivery

    Manuel Sanchez-Felix, VP Drug Delivery Search & Evaluation, Halozyme

  • Case study on ENHANZE™: technology breaking through subcutaneous volume limitations to facilitate rapid high-dose, high-volume subcutaneous drug delivery
  • Converting long IV infusions to short SC injections
  • Enabling large volumes to be given SC at a single site
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    15:10

    Solutions for Emerging Challenges in Injectable Drug Delivery

    Mark Hassett, Vice President of Business Development, Credence MedSystems

  • Delivery of medications is moving from formal healthcare settings to the home
  • Injection volume ranges are broadening and viscosities are increasing
  • Solutions and suspensions risk needle clogging
  • Solutions are requiring reconstitution at the time of use
  • What solutions are available to address these challenges?
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    15:40

    Progressing Next Generation On-body/Wearable Device Development

    Peter Petrochenko, Associate Director, Regulatory Strategy, Regeneron Pharmaceuticals

  • Market overview of on body delivery devices
  • Development of long-acting injections for wearable devices to allow for at home-delivery  
  • Maximising wearables potential through connectivity to allow for granular control of flow rate to improve patient comfort  
     
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    16:10

    Afternoon Break

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    17:10

    Session reserved for Veryst Engineering, LLC

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    17:40

    Design Considerations for Wearable Injectors

    Sriram Natarjaan

    Sriram Natarjaan, Principal Engineer, Janssen Pharmaceuticals

  • Applicable Standards and Regulations
  • Design Considerations
  • Studies on user preferences
     
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    17:40

    Chair's Closing Remarks and Closing of Day One

    Manuel Sanchez-Felix, VP Drug Delivery Search & Evaluation, Halozyme

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    14:30

    Chair's Opening Remarks

    Ronald Forster

    Ronald Forster, Head of Manufacturing Sciences and Technologies for Combination Product Operations, Amgen

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    14:40

    Sustainability opportunities in PFS

    Sriman Banerjee

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

  • Insight into recycling drug delivery devices after use and developing take-back schemes
  • Outlining strategies for product returns and building the environmental infrastructure
  • Waste reduction initiatives during manufacturing with consideration of plastic injection moulding
  • Opportunities for industry collaboration on recycling initiatives, optimization of processes and for promotion of sustainable material use
     
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    15:10

    Session reserved for Sponsor

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    15:40

    Tackling Eco-Design for Sustainability

    Speaker to be confirmed

    Speaker to be confirmed , , Amgen

  • Strategies for taking an eco-design approach and embedding sustainability into the medical device product life cycle
  • Successfully implementing lifecycle assessment driven problem solving and utilising life cycle assessment data for a more sustainable future
  • Case study on Amgen’s approach
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    16:10

    Afternoon Break

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    16:40

    Making a Move Towards Sustainable Packaging

    Cedric Gysel, Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability , Johnson & Johnson

  • Potential alternative materials that are recyclable and sourcing the right materials
  • Balancing cost, biocompatibility and sustainability when selecting materials
  • Reviewing secondary packaging and opportunities for reducing non-recyclable plastics
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    17:10

    Session reserved for Sponsor

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    17:40

    Sustainable drug delivery devices: A life cycle approach to embedding circularity and decarbonization across the value chain

    Speaker to be confirmed

    Speaker to be confirmed, , BioPhorum

  • Operating context for environmental sustainability in the healthcare sector
  • What this means for the biopharmaceutical industry and where the opportunities lie
  • Designing circular drug delivery devices -challenges and opportunities
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    18:10

    Chair's Closing Remarks and Close of Day One

    Ronald Forster

    Ronald Forster, Executive Director, Amgen

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    8:15

    Registration & Coffee

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    8:50

    Chair's Opening Remarks

    Lawton Laurence, Head of Device & Combination Product Development, Apellis

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    9:00

    Navigating 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

  • Important regulatory developments in US and EU over the past year
  • Recent challenges that have arisen in US and EU and how these can be overcome
  • Assessing the impact of new EU MDR regulation
  • Case study Notified Body Opinion under the EU MDR for a Prefilled Syringe
     
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    9:30

    Bridging the Gap: Strategic Integration for Formulation and Drug Device Development

    Serene Jabary

    Serene Jabary, Scientist I, Biogen

  •  In the realm of pharmaceutical research and development, the convergence of formulation and drug device development is imperative for creating innovative and efficacious medical solutions
  • Traditional approaches often compartmentalize formulation and device development, leading to inefficiencies and delays
  • This presentation advocates for an integrated approach that strategically amalgamates formulation parameters with device intricacies
  • The utilization of data analytics and internal knowledge to build robust platforms and enhance the synergy between formulation scientists and device engineers
     
  • clock

    10:00

    Reserved gold sponsor session

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    10:30

    Morning Break

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    11:00

    Producing Devices for the Future of Injectable Drugs

    Divya Sharma, Senior Scientist, Pfizer Inc.

  • Key packaging considerations for emerging drugs such as mRNA/LNP and more
  • Satisfying needs of protein-based drug products and what is required for progression in drug product field for successful delivery
  • Delving into NextGen container closure systems and key challenges with stability and efficacy of biologics
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    11:30

    Reserved gold sponsor session

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    12:00

    Panel Discussion: Navigating the Maze: Biocompatibility Challenges and Compliance with the FDA and MDR Regulations

  • Biocompatibility Testing Across the Product Lifecycle
  • Risk Assessment Strategies and Requirements
  • Device Categorization for Cumulative Use
  • GSPR and EU MDR
  • Soumen Das, Medical Device Qualification Lead & Associate Scientific Fellow, Takeda Pharmaceutical Company Limited

    Soroosh Bagheriasl

    Soroosh Bagheriasl , Senior Account Manager, BioPhorum

    Divya Sharma, Senior Scientist, Pfizer Inc.

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    12:30

    Session Reserved for Gold Sponsor

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    13:00

    Harmonizing Innovation: Influencing Development by Integrating Device and Drug Requirements for Combo Product Functionality and Use

    Alicia Douglas, Human Factors Lead, Merck

  • The user of the combination product is the key to bringing Drug and Device together
  • How early collaboration with formulation/Human Factors/device can avoid costly late stage changes
  • How Device and Formulation partners can influence each other for development
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    13:30

    Networking Lunch

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    14:30

    Chair's Opening Remarks

    Duncan Paterson, Senior Director, AstraZeneca

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    14:40

    Characterization of Pre-fi lled Syringe Container Closure Integrity in Deep-Cold Storage Conditions

  • CCI of pre-filled syringes is challenged at deep cold storage conditions due to plunger stopper shrinkage and material property changes
  • Theoretical modelling, in-situ imaging and empirical testing were combined to characterize pre-filled syringe CCI at deep cold storage conditions
  • The critical influence of the glass transition temperature plunger stopper elastomer is explored and discussed
  • Duncan Paterson, Senior Director, AstraZeneca

    Sonia Dragulin-Otto, Senior Scientist, AstraZeneca

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    15:10

    Container Closure Integrity of OXYCAPT Vial at Deep Cold Storage

    Tomohiro Suzuki, Associate General Manager, Mitsubishi Gas Chemical Company, Inc

  • Overview of OXYCAPT Vial
  • Oxygen & Carbon Dioxide Barrier
  • Break Resistance at -80 & -180?
  • CCIT at -80?
  • Comparison of CCIT among OXYCAPT, Glass and COP
     
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    15:40

    Formulator's perspective: Considerations of primary container closure selection

    Jamie Tsung, Director CMC Development, Alnylam

  • Selection criteria of containers from a formulation perspective
  • Evaluating container option to satisfy needs of protein-based drug products and what is required for progression in drug product field for successful delivery
  • Case study example of wrong container selection, consequences and learnings
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    16:10

    Afternoon Break

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    16:40

    Device Biocompatibility strategy and challenges

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

  • Defining biocompatibility, key deliverables, and submission to health authorities
  • Strategically generating a toxicology risk assessment by unitizing a risk-based approach
  • Recent experiences with the global regulatory agencies

     

  • clock

    17:10

    ZEONEX® and ZEONOR ® Cyclo Olefin Polymer (COP) for Pre Filled syringes

    Alex Klara, Business Development Specialist, Zeon

  • Who is Zeon? What are ZEONEX® and ZEONOR ® Cyclo Olefin Polymers ?
  • What are the key benefits of ZEONEX® in Medical Device Applications?
  • Study on delamination with glass syringe vs COP syringe.
  • Study of nucleic acid adsorption in COP tube vs PP tube
  • Study on Protein adsorption/ aggregation/ Immunogenicity
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    17:40

    Chair's Closing Remarks and Closing of Day Two

    Duncan Paterson, Senior Director, AstraZeneca

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    14:30

    Chair's Opening Remarks

    David Morra, Director, Devices and Digital Health, Merck, Sharpe, & Dohme

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    14:40

    The True Value of Connectivity: Opportunities and Challenges to be Overcome

    David Morra, Director, Devices and Digital Health, Merck, Sharpe, & Dohme

  • Striking a balance between a user-friendly device and a valuable asset
  • Achieving adequate benefits to the patient to offset problems with upgrades
  • Using connectivity broadly vs specific patient populations
  • Current barriers to advancing connectivity and potential ways to overcome this
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    15:10

    Unlocking the Potential: Harnessing Digital Technologies to Ensure Accurate Dosing History Data

    Bernard Vrijens, CEO & Scientific Lead, AARDEX Group

  • Introduction to digital technologies' role in advancing drug delivery systems
  • Discussion on challenges of traditional methods and benefits of digital integration
  • Emphasis on reliable dosing history data for optimizing treatment outcomes
  • Case studies demonstrating the value of connected drug devices
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    15:40

    Taking a 3D Approach: Drug, Device and Digital

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

  • Necessary steps to be taken to build a 3D ecosystem
  • Learnings to be taken from the established insulin pump ecosystem
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    16:10

    Afternoon Break

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    16:40

    Combination Product Aging Strategies: Key Considerations to Minimize Technical Risk and Support Program Milestones

  • Real Time vs. Accelerated Aging: how to effectively define aging strategy while reducing technical risk and meeting stakeholder needs
  • Technical Considerations: how to define requirements to test and characterize aging conditions
  • Executing the Test Plan and Planning for Failure: how to prepare samples for testing and successfully create a Plan B
     
  • Alex Baker, Senior Engineer II, Product and Technology Development, Biogen

    Kristina Li

    Kristina Li, Sr. Engineer II, Technical Development, Biogen

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    17:10

    Reserved for Suttons Creek, Inc.

    Courtney Evans, Principal Consultant, Suttons Creek, Inc.

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    17:40

    Integration of Human Factors into the Product Life Cycle of Connected Devices

    Speaker to be confirmed

    Speaker to be confirmed, , UserWise

  • What types of human factors practices are appropriate for each stage of product development?
  • Considerations for training and training decay
  • Navigating human factors as it relates to your devices in an ecosystem
  • What to expect for human factors timelines and workload
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    18:10

    Chair's Closing Remarks and Close of Day Two

    David Morra, Director, Devices and Digital Health, Merck, Sharpe, & Dohme


    Senior Engineer II, Product and Technology Development
    Biogen
    Business Development Specialist
    Zeon
    Usability Leader
    Sanofi
    Human Factors Lead
    Merck
    Principal Engineer
    Biogen
    Director, Quality, Combination Products
    Gilead Sciences, Inc
    CEO & Scientific Lead
    AARDEX Group
    Principal Device Engineer
    Teva Pharmaceuticals
    Manager, Sustainable Innovation & Circular Economy Solutions at the Office of Sustainability
    Johnson & Johnson
    Head of Sustainable Medical Technology
    Cambridge Consultants Ltd
    Principal Consultant
    Suttons Creek, Inc.
    Director, Devices and Digital Health
    Merck, Sharpe, & Dohme
    Senior Scientist
    Pfizer Inc.
    Senior Director
    AstraZeneca
    Head of Injection Systems
    Takeda
    Director CMC Development
    Alnylam
    Executive Director of Regulatory Affairs
    Novartis
    Sr. Engineer II, Technical Development
    Biogen
    Head of Device & Combination Product Development
    Apellis
    VP Drug Delivery Search & Evaluation
    Halozyme
    Director, Combination Products and Device R&D
    Teva Pharmaceuticals
    Vice President of Business Development
    Credence MedSystems
    Vice President of Device Development and Commercialization
    Viridian Therapeutics
    Director
    Moderna
    Novartis Global Head RA Medical Devices, Combination Products & Precision Medicine
    Novartis Pharma AG
    Executive Director, Device and Combination Product Development
    Astria Therapeutics
    Associate Director, Regulatory Strategy
    Regeneron Pharmaceuticals
    VP Business Development
    ApiJect Systems, Corp.
    Vice President, Patient Integrated Care Innovation Platform
    Takeda Pharmaceuticals
    Head of Manufacturing Sciences and Technologies for Combination Product Operations
    Amgen
    Associate Director, RA Device and Combination Products Digital Device and Software
    AbbVie
    Scientist I
    Biogen
    Director, Product Design
    Takeda Pharmaceuticals
    Senior Scientist
    AstraZeneca
    Senior Account Manager
    BioPhorum
    Medical Device Qualification Lead & Associate Scientific Fellow
    Takeda Pharmaceutical Company Limited
    UserWise
    BioPhorum
    Head of Packaging Development & CDE
    Takeda Pharmaceuticals
    Principal Engineer
    Janssen Pharmaceuticals
    Head of Design & Innovation
    Johnson & Johnson
    Associate General Manager
    Mitsubishi Gas Chemical Company, Inc

    Gold Sponsor

    Sponsors

    Exhibitors

    Official Media Partner

    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

    2024 Sponsorship Prospectus

    Download

    Past Presentation: James Leamon, EdgeOne Medical

    Download

    Past Presentation: Deep Bhattacharya, Pfizer

    Download

    Past Presentation: Christian Liebl, Schreiner MediPharm

    Download

    Letter from the Advisory Board

    Download

    2023 Attendee List

    Download

    Sponsors and Exhibitors


    ApiJect™

    Gold Sponsor
    https://info.apiject.com/industry-events

    ApiJect™ is a global medical technology company creating the future of pharmaceutical injections.

    Our mission is to provide products with superior convenience, quality, and safety of prefilled syringes at the manufacturing scale and cost-efficiency of multi-dose formats – regardless of manufacturing volume. 

    Our Platform brings together two globally trusted manufacturing technologies: Blow-Fill-Seal (BFS) aseptic filling and high-precision plastic injection molding. Our supply chain is simple and compact, using widely available raw materials, ensuring reliability and resilience.  

    The promise of our platform can be seen in our first device, a single-dose prefilled injector is designed to enhance commercial markets and global healthcare accessibility, enabling a wider range of healthcare professionals to administer necessary medications and vaccines to patients.



    Cambridge Consultants

    Gold Sponsor
    https://www.cambridgeconsultants.com/home

    Cambridge Consultants develops breakthrough products, services and intellectual property, and provides business consultancy in technology-critical issues for clients worldwide. For more than 60 years, the company has been helping its clients turn business opportunities into commercial successes, whether they are launching first-to-market products, entering new markets or expanding existing markets through the introduction of new technologies. With a team of more than 800 team members, including engineers, scientists, mathematicians and designers, in offices in Cambridge (UK), Boston (USA), Tokyo (Japan) and Singapore, Cambridge Consultants offers solutions across a diverse range of industries including medical technology, industrial and consumer products, digital health, energy and wireless communications.



    CCL Healthcare

    Gold Sponsor
    https://cclhealthcare.com/

    CCL Healthcare excels in pharmaceutical labeling for injectables for vials, syringes, prefilled syringes, and autoinjectors. Our expertise covers labels, cartons, patient instructions, and smart labeling solutions, enhancing patient experience and adherence. With our high-speed RFID packaging line management, we enable encoding with speeds of 700 injectable items per minute, ensuring peak performance for hard-to-tag items through custom RFID product design. Contact us to discuss how we can enhance your injectable solutions with smart labels and packaging.

    Sponsors


    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.


    Suttons Creek

    Sponsors
    https://suttonscreek.com/

    Suttons Creek is pharma’s device team. Any company adopting combination product technology needs an experienced combination products team working alongside their drug team, including specialists in areas like quality, regulatory, vendor selection and management, systems engineering, risk management, clinical development, and commercialization. Suttons Creek has over 650 years of combined experience and 120+ combination product projects under its belt, with a talent pool of subject matter experts that specialize in all aspects of combination product development from strategic planning through device development to launch and postmarket activities. We can be any or all things combination product to a client, consulting hour by hour or engaging in strategic partnerships to achieve milestones, lift roadblocks, fill knowledge gaps, and drive program success.


    Veryst

    Sponsors
    https://www.veryst.com/

    Veryst Engineering, LLC provides premium engineering consulting services at the interface of technology and manufacturing. We aim to be the best in the world for multiphysics simulation, materials science, failure analysis, and material modeling and testing, often applied to nonlinear, coupled problems, so that our clients can deliver the best products to their customers. We help clients around the world optimize product design, improve manufacturing processes, and diagnose product problems. Our methods are based on technical fundamentals – employing grounded knowledge of mechanics, physics, chemistry, material science, electricity and magnetism, and manufacturing to produce practical, useful results. Our consultants' backgrounds encompass industrial experience, research, teaching for some of the world’s best engineering schools, and publishing.

    At Veryst, we work to understand your needs, uses, purposes, and goals before proposing a solution or embarking on a program. We won’t just answer your questions—we help you solve your problems.



    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


    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).



    Noble

    Exhibitors
    https://www.gonoble.com/

    Noble and Metaphase an Aptar pharma company, provide expertise and the “voice of the patient” in product design, user-experience research, human factors, along with tailored training & on-boarding solutions to help our clients Ideate, Validate, and Educate throughout the product development process. In addition, Noble manufactures and commercializes training devices. These devices mimic the exact feel, force, and function of drug delivery devices such as autoinjectors, prefilled syringes, onbody, nasal and pulmonary devices in order to increase patient adherence and confidence and decrease usage errors. Noble was founded in 1994 and is based in Orlando, Florida. For more information, visit www.gonoble.com.



    Owen Mumford

    Exhibitors
    http://www.owenmumford.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.

    For more information please visit https://www.ompharmaservices.com/



    Raumedic

    Exhibitors
    http://www.raumedic.com

    RAUMEDIC serves Pharma / Biopharma / Cell and Gene Therapy - with first class tubing for fluid transfer and fluid handling applications.

    Benefit from Raumedic's 70+ years of experience as a single source tubing supplier - with an in-house materials department, in-house product development and tried and trusted manufacturing expertise at five different production sites in three countries.

    With Raumedic as your supplier, you can count on:

    Standards compliance and validation

    Biocompatibility

    Low extractable values

    Increased flow rates / Cell Growth yield

    Discover innovative tubing from Raumedic - In stock and ready to ship!

    • Standards compliance and validation

    • Biocompatibility

    • Low extractable values

    • Increased flow rates / Cell Growth yield

    • Platinum cured Silicone Tubing

    • Platinum cured Braided Silicone Tubing (high pressure)

    • Thermoplastic Elastomer Tubing (TPE)

    • Tubing sets - bespoke customer design



    Schott

    Exhibitors
    https://www.schott.com/en-us/markets/health/pharma

    SCHOTT is a global manufacturer of high-tech materials for specialty glass. With more than 130 years of experience, and represented in 34 countries, the company is a highly skilled partner for high-tech industries: Healthcare, Home Appliances & Living, Consumer Electronics, Semiconductors & Datacom, Optics, Industry & Energy, Automotive, Astronomy, and Aerospace. In the fiscal year 2020, its 16,500 employees generated sales of 2.24 billion euros. SCHOTT is one of the world’s leading experts for parenteral packaging and supplies the pharma industry with more than 12 billion syringes, vials, ampoules, and cartridges of tubing glass and polymer per year.


    Media Partners


    On Drug Delivery

    Official Media Partner
    http://www.ondrugdelivery.com/subscribe

    ONdrugDelivery provides 30,000 readers throughout global pharma/biopharma, with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: www.ondrugdelivery.com/subscribe.


    Pharma network magazine

    Official Media Partner
    https://www.pharmanetwork.digital

    PHARMAnetwork is a company specialized in publishing for the pharmaceutical industry. PHARMAnetwork has developed publications for CMO, CDMO and professionals working in the life sciences. PHARMAnetwork designs specialized studies for pharmaceutical companies, contract service providers and investment firms. PHARMAnetwork magazine covers, every aspect of pharmaceutical value chain, the change and developments in the intersection between pharmaceutical industry and outsourcing industry. We perform interviews and write articles whose thematic strategies, organizations, mergers and acquisitions, regulatory, innovation in the pharmaceutical development and contract manufacturing. https://www.pharmanetwork.digital


    The Medicine Maker

    Official Media Partner
    https://themedicinemaker.com/?utm_source=media_partner_24&utm_medium=event&utm_campaign=sae_media_logo

    The Medicine Maker is a print and digital publication as well as a weekly newsletter. At The Medicine Maker, we bring people into the limelight, showcasing the industry’s success stories and examining its biggest points of contention. Engaging content covers the entire spectrum of drug development, keeping all medicine makers up to date with the most pressing topics, trends and technologies driving the pharma industry forward. Register for your FREE print or digital magazine or subscribe to our newsletter here! https://themedicinemaker.com/?utm_source=media_partner_24&utm_medium=event&utm_campaign=sae_media_logo


    pharmaphorum

    Official Media Partner
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    Pharma Journalist

    Official Media Partner
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.

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    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.
     

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    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

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    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
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