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

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

Aaron Sundman

Aaron Sundman

Innovator in RFID Technology, Business Leader, CCL eAgile
Alex Baker

Alex Baker

Senior Engineer II, Product and Technology Development, Biogen
Alexandra Benbadis

Alexandra Benbadis

Usability Leader, Sanofi
Alicia Douglas

Alicia Douglas

Human Factors Lead, Merck
Anthony Coston

Anthony Coston

Principal Engineer, Biogen
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.
Dany Doucet

Dany Doucet

Director Early Engagement and Deviceability, GSK
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
Erik Smeels

Erik Smeels

Senior Manager Packaging Engineering, Amgen
Gang Peng

Gang Peng

Biomedical Engineer, FDA
Hiroki Hasegawa

Hiroki Hasegawa

Assistant Research Manager, Mitsubishi Gas Chemical Company, Inc.
Jamie Tsung

Jamie Tsung

Director CMC Development, Alnylam
John Merhige

John Merhige

CEO, Credence MedSystems, Inc.
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
Leya Bergquist

Leya Bergquist

Associate Director of Human Factors, UserWise, a ClariMed Company
Madeline Mannion

Madeline Mannion

Associate Director, Systems Engineering, Amgen
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
Matthew Hancock

Matthew Hancock

Principal, Veryst Engineering, LLC
Michael Song

Michael Song

Director, Moderna
Nicholas Mandala

Nicholas Mandala

VP Medical Devices & Combination Products, Pfizer
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
Sean Teller

Sean Teller

Principal, Veryst Engineering, LLC
Serene Jabary

Serene Jabary

Scientist I, Biogen
Shai Assia

Shai Assia

Head of Medical Devices Development, Clexio Biosciences
Sonia Dragulin-Otto

Sonia Dragulin-Otto

Senior Scientist, AstraZeneca
Soroosh Bagheriasl

Soroosh Bagheriasl

Senior Account Manager, BioPhorum
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
Terry O'Hagan

Terry O'Hagan

General Manager, Haselmeier (medmix US)
Theresa Scheuble

Theresa Scheuble

Head of Design & Innovation, Johnson & Johnson
Tim Quigg

Tim Quigg

Development Director, Crux Product Design Ltd

Aaron Sundman

Innovator in RFID Technology, Business Leader, CCL eAgile
Aaron Sundman

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

Alex Baker

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.

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.

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.
 

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 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

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

Erik Smeels

Senior Manager Packaging Engineering, Amgen
Erik Smeels

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

 

Gang Peng

Biomedical Engineer, FDA
Gang Peng

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

Hiroki Hasegawa

Assistant Research Manager, Mitsubishi Gas Chemical Company, Inc.
Hiroki Hasegawa

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

Jamie Tsung

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 Merhige

CEO, Credence MedSystems, Inc.
John Merhige

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

John Schalago

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

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

Lawton Laurence

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.

 

 

Leya Bergquist

Associate Director of Human Factors, UserWise, a ClariMed Company
Leya Bergquist

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


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

Madeline Mannion

Associate Director, Systems Engineering, Amgen
Madeline Mannion

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

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

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

 

Manuel Sanchez-Felix

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

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

Matthew Hancock

Principal, Veryst Engineering, LLC
Matthew Hancock

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

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

Michael Song

Director, Moderna
Michael Song

Michael leads Device and Packaging plus Shipping Validation at Moderna overseeing both development and on-market activities. Prior, he has held positions as Director of Sterile Packaging at GSK and Associate Director at Takeda. Through his career, also formed and led the Device Functionality, Safety and Digital Connectivity group at AstraZeneca as well as Device, Package, and Process Engineering group at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Nicholas Mandala

VP Medical Devices & Combination Products, Pfizer
Nicholas Mandala

Nick has spent more than 20 years in cross functional roles in the device and combination products industry including systems development, clinical manufacturing, manufacturing and process engineering, validation, and combination products quality assurance. He joined Pfizer in 2017 and currently leads the team responsible for lifecycle management of drug delivery devices, implantables, SaMDs, connected devices, and IVDs. His organization’s responsibilities include device strategy, design and development of medical devices and combination products, post market surveillance, and post market innovation and sustainability. He holds a B.S. in mechanical engineering from Cornell University.

 

Ning Yu

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

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

Prior to joining Amgen, Ron was with Merck Inc. where he was Senior Principal Engineer leading a group that implement Quality by Design for primary packaging systems from early clinical development through commercial supply chain systems. He was a key leader in advancing the Merck Commercialization process and served as a global manufacturing lead on a key product franchise board.

During his tenure at Merck, he also served as an Adjunct Professor at Rutgers University in Biomedical Engineering and Ceramic Engineering.

Ron has an Interdisciplinary Ph.D. from Rutgers University in Chemical Engineering, Ceramic Engineering, and Mechanics and Materials Science.

Sarah Fairfield

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

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

Sean Teller

Principal, Veryst Engineering, LLC
Sean Teller

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

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

Serene Jabary

Scientist I, Biogen
Serene Jabary

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

Shai Assia

Head of Medical Devices Development, Clexio Biosciences
Shai Assia

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

Sonia Dragulin-Otto

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

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

Soumen Das

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.

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

Terry O'Hagan

General Manager, Haselmeier (medmix US)
Terry O'Hagan

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

Theresa Scheuble

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.
 

Tim Quigg

Development Director, Crux Product Design Ltd
Tim Quigg

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

 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

clock

8:00

Registration & Coffee

clock

9:00

Chair's Opening Remarks

John Schalago, Executive Director of Regulatory Affairs, Novartis

clock

9:10

Collaboration for a Strategic Combination Product Development: A Case Study

Nicholas Mandala, VP Medical Devices & Combination Products, Pfizer

clock

9:50

Building an Ecosystem for Development and Supply of Combination Products

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

clock

10:30

Morning Break

clock

11:00

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, Director, Moderna

    E Guan, Head of Injection Systems, Takeda

    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

    clock

    11:40

    Understanding pre-filled syringe human factors validation study results

    Alexandra Benbadis, Usability Leader, Sanofi

    clock

    12:20

    Networking Lunch

    clock

    13:20

    Optimising Lyophilized Drug Delivery

    Dany Doucet, Director Early Engagement and Deviceability, GSK

    clock

    14:00

    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
     
  • clock

    14:40

    Afternoon Break

    clock

    15:10

    Primary perspective - Effective device lifecycle management strategies: from early R&D to commercial launch

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

    clock

    15:10

    Commercial perspective - Effective device lifecycle management strategies: from early R&D to commercial launch

    Terry O'Hagan, General Manager, Haselmeier (medmix US)

    clock

    15:10

    Primary perspective - Successfully integrating combination product development with wider drug product development

    Michael Song, Director, Moderna

    clock

    15:10

    Commerical perspective - Successfully integrating combination product development with wider drug product development

    John Merhige, CEO, Credence MedSystems, Inc.

    clock

    15:10

    Primary perspective - Designing the next generation of combination products: meeting needs of emerging drug products via material choices and more

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

    clock

    15:10

    Commercial perspective - Designing the next generation of combination products: meeting needs of emerging drug products via material choices and more

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

    clock

    16:40

    Chair’s Closing Remarks and Close of Focus Day

    John Schalago, Executive Director of Regulatory Affairs, Novartis

    clock

    7:30

    Registration & Coffee

    clock

    8:20

    Chair's Opening Remarks

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

    clock

    8:30

    Disruptive Medicine Innovation – Next Generation of Combination Products

    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
     
  • clock

    9:00

    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, Director, Moderna

    John Schalago, Executive Director of Regulatory Affairs, Novartis

    clock

    9:30

    The Game Changer

    Aaron Sundman, Innovator in RFID Technology, Business Leader, CCL eAgile

  • Authentication: One tap by the end-user generates a cryptographic digital signature and verifies the authenticity of the medication.
  • Safety Check: The same simple tap will verify if a drug is recalled or expired and can create direct access to the pharmaceutical company.
  • Guidance: Users learn proper drug administration through intuitive interfaces.
  • Impact: This solution disrupts the status quo, creating an asymmetric advantage against counterfeit drug distributors. It empowers users with knowledge and confidence.
  • Join us for a live demo as we unveil the future of pharmaceuticals—one tap at a time.
  •  

    clock

    10:00

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

    Carrie O'Donel, Principal Device Engineer, Teva Pharmaceuticals

    clock

    10:30

    Morning Break

    clock

    11:00

    Improving integration of sustainable design principles into combination product development

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

    clock

    11:30

    Navigating the Anatomical Maze: Utilizing In-Silico Modelling for Targeted Deposition Analysis

    Shai Assia, Head of Medical Devices Development, Clexio Biosciences

    clock

    12:00

    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 advantages of having a prefilled single-dose delivery solution in the global health market
  • clock

    12:30

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

    Anthony Coston, Principal Engineer, Biogen

    clock

    13:00

    Moving the Needle: Creating Measurable and Meaningful Impact in Device Design & Development

    Tim Quigg, Development Director, Crux Product Design Ltd

  • Introducing state-of-the-art tools which expedite device development and demonstrate measurable improvement on device reliability; reducing defective parts per million units (DPMU).
  • Real-world case studies: successful integration of evidence-led initiatives within primary container, device development, human factors and clinical trial applications.
  • Platform & Combination Product Insights: multi-modal approaches to de-risk development, inform use specifications and optimise device designs.
     
  • clock

    13:30

    Networking Lunch

    clock

    14:30

    Chair's Opening Remarks

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

    clock

    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
  • clock

    15:10

    Solutions for Emerging Challenges to 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?
  • clock

    15:40

    Afternoon Break

    clock

    16:10

    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  
     
  • clock

    16:40

    Multiphysics Simulation and Testing in Combination Product Design & Verification: Reducing Patient Risk

    Matthew Hancock, Principal, Veryst Engineering, LLC

    Sean Teller, Principal, Veryst Engineering, LLC

    clock

    17:10

    Enabling successful drug delivery through on body devices and advanced technologies

  • Key hurdles in delivering larger volumes and novel drug products and potential ways to address them
  • Ensuring stakeholder buy-in for the evolving injectables landscape
  • Outlook on expectations from industry and vendors for the future of injectable drug delivery
     
  • Peter Petrochenko, Associate Director, Regulatory Strategy, Regeneron Pharmaceuticals

    Matthew Hancock, Principal, Veryst Engineering, LLC

    Sean Teller, Principal, Veryst Engineering, LLC

    Mark Hassett, Vice President of Business Development, Credence MedSystems

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

    clock

    17:40

    Chair's Closing Remarks and Closing of Day One

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

    clock

    14:30

    Chair's Opening Remarks

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

    clock

    14:40

    Sustainability opportunities in PFS

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

    clock

    15:10

    Tackling Eco-Design for Sustainability

    Erik Smeels, Senior Manager Packaging Engineering, Amgen

  • Changing global regulatory landscape & customer expectations
  • Strategies for taking an eco-design approach and embedding sustainability into the medical device product life cycle
  • Successfully implementing life cycle assessment data into device & packaging design
  • Case study
     
  • clock

    15:40

    Afternoon Break

    clock

    16:10

    Panel Discussion: Making a Move Towards Sustainable Packaging

  • 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
  • clock

    16:40

    Enabling industry consensus and action for sustainable autoinjectors: A BioPhorum case study

    Madeline Mannion, Associate Director, Systems Engineering, Amgen

    clock

    17:10

    Chair's Closing Remarks and Close of Day One

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

    clock

    17:45

    End of Day One Networking Reception

    clock

    8:15

    Registration & Coffee

    clock

    8:50

    Chair's Opening Remarks

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

    clock

    9:00

    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
  • clock

    9:30

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

    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

    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
  • clock

    10:30

    Morning Break

    clock

    11:00

    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 , Senior Account Manager, BioPhorum

    Divya Sharma, Senior Scientist, Pfizer Inc.

    Gang Peng, Biomedical Engineer, FDA

    clock

    11:50

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

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

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

    clock

    12:20

    Networking Lunch

    clock

    13:20

    Chair's Opening Remarks

    Duncan Paterson, Senior Director, AstraZeneca

    clock

    13:30

    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

    clock

    14:00

    Container Closure Integrity of OXYCAPT Vial at Deep Cold Storage

    Hiroki Hasegawa, Assistant Research 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
     
  • clock

    14:30

    Afternoon Break

    clock

    15:00

    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

    15:30

    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
  • clock

    16:00

    Chair's Closing Remarks and Closing of Day Two

    Duncan Paterson, Senior Director, AstraZeneca

    clock

    13:20

    Chair's Opening Remarks

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

    clock

    13:30

    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
  • clock

    14:00

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

    Bernard Vrijens, CEO & Scientific Lead, AARDEX Group

    clock

    14:30

    Afternoon Break

    clock

    15:00

    Connected Health Opportunities & Complexities for Injection Devices

    Courtney Evans, Principal Consultant, Suttons Creek, Inc.

  • An overview of the current landscape of digital drug delivery systems (smart injectors) from the industry lens. What technology advancements and need opportunities are driving innovation?
  • Development of internal process flow/framework/policy regarding connected drug delivery product concepts for US market: focusing on the when, the who (internal stakeholders), and the what (FDA and non-FDA requirements).
  • Interpreting and applying the current guidance/policy/precedence: digital health guidance, PDURS guidelines, Human Factors, cybersecurity etc. to combination product regulatory actions (e.g. clinical study applications, CDER/CBER-led applications, potential one-way/cross-labeled accessories)
  • Best practices to successfully navigate the development and U.S. regulatory process (when classification of connected software device is not clear), take advantage of opportunities for FDA collaboration, and prepare for the post-market (long-term considerations at the pre-market stage).
  • Common pitfalls gathered from past FDA experience reviewing connected drug delivery systems (including mobile apps).

     

  • clock

    15:30

    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
  • clock

    16:00

    Addressing critical human factors considerations through the connected product life cycle, from early-stage development to post-market monitoring

  • Selecting appropriate human factors methods for each stage
  • Navigating FDA pre-submission and review processes
  • Setting realistic timelines and resources allocations for human factors activities
  •  

    Leya Bergquist, Associate Director of Human Factors, UserWise, a ClariMed Company

    clock

    16:30

    Chair's Closing Remarks and Close of Day Two

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


    Innovator in RFID Technology, Business Leader
    CCL eAgile
    Senior Engineer II, Product and Technology Development
    Biogen
    Usability Leader
    Sanofi
    Human Factors Lead
    Merck
    Principal Engineer
    Biogen
    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 Early Engagement and Deviceability
    GSK
    Director, Devices and Digital Health
    Merck, Sharpe, & Dohme
    Senior Scientist
    Pfizer Inc.
    Senior Director
    AstraZeneca
    Head of Injection Systems
    Takeda
    Senior Manager Packaging Engineering
    Amgen
    Biomedical Engineer
    FDA
    Assistant Research Manager
    Mitsubishi Gas Chemical Company, Inc.
    Director CMC Development
    Alnylam
    CEO
    Credence MedSystems, Inc.
    Executive Director of Regulatory Affairs
    Novartis
    Sr. Engineer II, Technical Development
    Biogen
    Head of Device & Combination Product Development
    Apellis
    Associate Director of Human Factors
    UserWise, a ClariMed Company
    Associate Director, Systems Engineering
    Amgen
    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
    Principal
    Veryst Engineering, LLC
    Director
    Moderna
    VP Medical Devices & Combination Products
    Pfizer
    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
    Principal
    Veryst Engineering, LLC
    Scientist I
    Biogen
    Head of Medical Devices Development
    Clexio Biosciences
    Senior Scientist
    AstraZeneca
    Senior Account Manager
    BioPhorum
    Medical Device Qualification Lead & Associate Scientific Fellow
    Takeda Pharmaceutical Company Limited
    Head of Packaging Development & CDE
    Takeda Pharmaceuticals
    General Manager
    Haselmeier (medmix US)
    Head of Design & Innovation
    Johnson & Johnson
    Development Director
    Crux Product Design Ltd

    Gold Sponsor

    Sponsors

    Exhibitors

    Official Media Partner

    30 seconds with James Wabby from Abbvie

    Download

    5 minutes with Alicia Douglas, Human Factors Lead at Merck

    Download

    5 minutes with Alexandra Benbadis, Usability Leader at Sanofi

    Download

    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



    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.


    Crux

    Gold Sponsor
    https://www.cruxproductdesign.com/

    Crux was founded to address challenging technical briefs and deliver compelling solutions for the drug delivery and medical device sectors. Based in Bristol, United Kingdom, our technical team champion evidence-based problem solving, coupling world-class equipment, software and facilities with a scientific approach to maximise success. Be it discovering unmet user needs, developing novel products or deploying new technologies, our team are dedicated to solving our client’s biggest problems..


    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


    BBS Automation Chicago,

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

    BBS Chicago is a long-standing institution, with more than 50 years of experience in automation technology. The U.S. division joins BBS Group in 2014. It is close to one of the USA’s thriving cultural, trade and technology centers

    For years, the Great Lakes area hosted the world’s largest concentration of production for oil, coal, steel, automobiles, synthetic rubber, agricultural machinery, and heavy transport equipment. Over time, the region has evolved from a purely industrial area to a high-tech territory. Today, the region is one of the world’s leaders in advanced manufacturing and research & development, with significant innovations in production processes in various industrial sectors.

    BBS Automation opened the new American factory in 2016, in the Chicago suburb of Bartlett.



    BioPhorum

    Exhibitors
    https://www.biophorum.com/

    The biopharmaceutical industry’s most trusted collaborative environment for change.

    BioPhorum is where the global biopharmaceutical and device industries can collaborate and accelerate progress – for the benefit of all.

    BioPhorum consists of 12 Phorums directing more than 100 workstreams – industry-changing initiatives contributed to by thousands of subject matter experts.

    Our focus is to enable member companies to drive tangible value and impact. We work with our members to ensure that their participation in the collaboration delivers adoptable outputs which are aligned with strategic objectives – improving performance at company and industry levels.



    Gerresheimer

    Exhibitors
    http://www.gerresheimer.com

    Gerresheimer is the innovative system and solution provider and global partner for the pharma and biotech industry. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health and cosmetics industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, ampoules, tablet containers, dropper bottles, other bottles and more. Gerresheimer ensures the safe delivery and administration of drugs to the patient. With 36 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for the regional markets. With over 11,000 employees, the company generated revenues of around €1.82bn in 2022. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).


    Instron

    Exhibitors
    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.



    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.



    Noxilizer

    Exhibitors
    https://noxilizer.com/

    Noxilizer is the expert in the application of the NO2 process within the supply chain. Noxilizer sells sterilization equipment to pharmaceutical, biotech, and medical device manufacturers and also offers contract sterilization services.



    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.


    Drug Delivery Leader

    Official Media Partner
    https://www.drugdeliveryleader.com/

    Drug Delivery Leader focuses on the people, technologies, and processes responsible for optimizing the therapeutic delivery of pharmaceutical compounds. The community highlights best practices and advancements throughout the development process with respect to drug delivery, from drug formulation to the design/development and, ultimately, procurement of drug delivery solutions. Scientific and engineering professionals will gain insights into addressing the biggest challenges related to drug delivery – via injectable, oral solid dose, inhalation, infusion, transdermal, and ocular routes of administration.


    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 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


    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.

    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.