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Wearable Injectors and Connected Devices USA
September 9 - September 10, 2024
Wearable Injectors and Connected Devices USA

SAE Media Group’s Inaugural
Wearable Injectors and Connected Devices USA
September 9 - 10 2024 | Boston, MA
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SAE Media Group are proud to announce their 2nd Annual Wearable Injectors and Connected Devices USA Conference taking place on the 9th and 10th of September 2024.


As the need for at home self-administration and routes for delivery of time-dependent and high-volume drug delivery grows, on-body injectors and connected devices hold great opportunity. The conference will delve into on-body device design and development, latest advances in connectivity and digital integration of wearable devices, and opportunities for enhancement of user-interface through human factors case studies. The conference will also address challenges in regulations surrounding wearable injectors and connected devices.


As part of SAE Media Group’s leading Injectable series of conferences, we bring together high-level experts from big pharma and device developers to network and share knowledge to advance R&D. The two-day conference will not only bring you high-quality key insights needed to enhance your wearable devices and connected product 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 September 2024!

 

FEATURED SPEAKERS

Adrienne Fletcher

Adrienne Fletcher

Director Packaging and Device Innovation, Johnson & Johnson Innovative Medicine
Ajit D'Souza

Ajit D'Souza

Executive Director, Drug Delivery & Devices , Eli Lilly
Amardeep Hoonjan

Amardeep Hoonjan

Director Device R&D Lead, Biocompatibility Group, AbbVie
Bill Pedersen

Bill Pedersen

Strategic Product Manager - Medical, Lohmann Technologies
Clare Beddoes

Clare Beddoes

Head of Drug Delivery, Cambridge Design Partnership
Deep S Bhattacharya

Deep S Bhattacharya

Principal Scientist, Formulation and Process Development - Biotherapeutics, Pfizer
Dominick DeGrazio

Dominick DeGrazio

Early Device Project Engineering Lead, GlaxoSmithKline
E Guan

E Guan

Head of Injection Systems, Takeda
Fawziya Ali

Fawziya Ali

Senior Scientist, Pfizer Inc.
Gretchen Piwinski

Gretchen Piwinski

Sr Manager Combination Product Development, Regeneron Pharmaceuticals
Hans Jensen

Hans Jensen

Business Development Leader, Cambridge Design Partnership
Ingo Waschulewski

Ingo Waschulewski

Senior Sales Manager, Gerresheimer
Kinsuk Shah

Kinsuk Shah

Sr. AD Combination Product Steward, Boehringer Ingelheim
Leonel Vanegas

Leonel Vanegas

Formerly Director, Medical Device and Combination Product Quality, Alexion Pharmaceuticals
Leya Bergquist

Leya Bergquist

Associate Director, ClariMed
Liem Nguyen

Liem Nguyen

Associate Principle Scientist- Device Program Lead, Merck
Martin McLoughlin

Martin McLoughlin

Head of Device Development, Bristol Myers Squibb
Matt Marber

Matt Marber

Senior Usability Engineer, Novo Nordisk
Michael Song

Michael Song

Expert in aseptic filling, combination product and packaging development and commercialization,
Ning Yu

Ning Yu

Executive Director, Device and Combination Product Development, Astria Therapeutics
Paul Upham

Paul Upham

Global Head of Smart Devices, Roche-Genentech
Ravi Kaushik

Ravi Kaushik

Vice President, Patient Integrated Care Innovation Platform, Takeda Pharmaceuticals
Rebecca Engel

Rebecca Engel

Director, Regulatory CMC Strategy, Pfizer, Inc.
Renato Ravanello

Renato Ravanello

Sr. Director, Device and Packaging Development, Genentech
Sarah Fairfield

Sarah Fairfield

Associate Director, RA Device and Combination Products Digital Device and Software, AbbVie
Shruti Parikh

Shruti Parikh

Director, Product Design, Takeda Pharmaceuticals
Soumen Das

Soumen Das

Medical Device Qualification Lead & Associate Scientific Fellow, Takeda Pharmaceutical Company Limited
Theresa Scheuble

Theresa Scheuble

Head of Design & Innovation, Johnson & Johnson

Adrienne Fletcher

Director Packaging and Device Innovation, Johnson & Johnson Innovative Medicine
Adrienne Fletcher

Ajit D'Souza

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

Ajit D’Souza, is the Executive Director of Drug Delivery and Devices at Eli Lilly and Company. He partners with internal stakeholders to define and advance Lilly’s device and delivery strategy for the emerging portfolio. He is responsible for the development of internal drug delivery and device initiatives as well as co-development of external technologies via feasibility studies to address critical unmet patient needs. Prior to Eli Lilly, Ajit served as Senior Director of drug product development, manufacturing and device development as well as a CMC leader at Kiniksa Pharmaceuticals and worked at Becton Dickinson, BD, in various leadership roles on programs of strategic importance including development of technologies and products for subcutaneous, intradermal and pulmonary delivery. Ajit earned a Ph.D. in Pharmaceutical Chemistry from the University of Kansas, a Professional Certificate in Systems Engineering from MIT xPRO and an MBA.

Amardeep Hoonjan

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

Amardeep is a Director of Biological Research in Device R&D at AbbVie. She has over 30 years of experience research & development, specifically in preclinical model development for medical devices, biocompatibility, regenerative medicine and scientific team management. Amardeep’s expertise is in regenerative medicine devices and surgical devices for general, plastic and orthopedic surgical solutions. For the past 7 years, Amardeep created and leads the Biocompatibility Group for Allergan Aesthetics and AbbVie, covering a diverse range of therapeutic areas.
In addition to the work she does at AbbVie, Amardeep enjoys taking part in instruction for graduate level Medical Device Seminar courses in the Biomedical Engineering department at Rutgers University. Amardeep has a B.S.E. in Biomedical Engineering from Case Western University and a M.S in Biomechanics from Michigan State University.
 

Bill Pedersen

Strategic Product Manager - Medical, Lohmann Technologies
Bill Pedersen

Bill was born and raised in NE Ohio. He earned his B.S. of Financial Accounting from The University of Akron. After a few years he was ready for new challenge. He was presented with a career move to a business development role within the Planned Innovation Group. There was no turning back. This served as the catalyst to various commercial positions with increased responsibilities at MACtac -a Lintec Company, Avery Dennison, and Avient (formerly PolyOne) and Tietex International. His experience has been in pressure sensitive adhesive manufacturing and converting for the automotive, graphics, hygiene, industrial and medical markets. Bill joined Lohmann in 2018 and led the Americas region sales and marketing activities for a little more than 5 years. More recently, he has moved into a new role collaborating with Global Marketing and focusing on the business’s overall strategy and the development of market platforms.

Clare Beddoes

Head of Drug Delivery, Cambridge Design Partnership
Clare Beddoes

Clare leads the drug delivery sector at Cambridge Design Partnership. Her background is in researching and analysing the drug delivery industry via unmet needs exploration, technology scouting, due diligence and market strategy. Working with a broad spectrum of clients from early-stage start-ups to big, Clare is passionate about ensuring all those involved in drug delivery at CDP draw on experiences of all key stakeholders - particularly the user - in the design and development process, both to validate and advance applications of existing products or drive innovation and adoption of new concepts.

Deep S Bhattacharya

Principal Scientist, Formulation and Process Development - Biotherapeutics, Pfizer
Deep S Bhattacharya

Deep is an ambitious results-oriented CMC drug product pharmaceutical professional, currently working as Principal Scientist Formulation and Process Development at Pfizer. He has 6+ experience in formulation/biopharmaceutical sciences (mAbs, fusion proteins, recombinant proteins, mRNA modalities), and product development, resulting in multiple regulatory submissions (IND and BLAs) and cross-functional collaborations across the organization.

Dominick DeGrazio

Early Device Project Engineering Lead, GlaxoSmithKline
Dominick DeGrazio

Dominick DeGrazio is an Early Device Project Engineering Lead in the Early Engagement and Deviceability Group at GSK. In this role, he focuses on the technical feasibility of early-stage assets intended for combination product development. With 12 years of industry experience, Dominick has held roles at PTC Therapeutics, Janssen R&D, Oncobiologics, and West Pharmaceutical Services. His expertise spans end-to-end drug product development and has partaken in the commercial launch of multiple gene therapy and biologic products including Upstaza, Darzalex Faspro, and Tremfya. Dominick graduated from Franklin and Marshall College in 2012 with a B.A. in Biochemistry & Molecular Biology and Neuroscience.

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.

Fawziya Ali

Senior Scientist, Pfizer Inc.
Fawziya Ali

Fawziya Ali is a Senior Scientist at Pfizer working in the Pharmaceutical Research and Development Group. She has 10 years of experience leading formulation, process and device development of early and late-stage biologics, including mRNA-based vaccines, in novel container closure systems. Fawziya holds a BS in Chemical and Biological Engineering from MIT and an MS in Pharmaceutical Sciences from Northeastern University. She is based in the US in Andover.
 

Gretchen Piwinski

Sr Manager Combination Product Development, Regeneron Pharmaceuticals
Gretchen Piwinski

Gretchen Piwinski is a Senior Manager of Combination Product Development at Regeneron Pharmaceuticals Inc. She leads a team responsible for providing test engineering and laboratory support to the development of drug delivery systems for Regeneron’s products. Gretchen has been at Regeneron for six years and spent 12 years prior working on implantable medical devices. She holds a Bachelor of Science degree and a Master of Engineering degree, both in Chemical Engineering.

Hans Jensen

Business Development Leader, Cambridge Design Partnership
Hans Jensen

Hans is leading the business development efforts for the Drug Delivery sector at Cambridge Design Partnership. He is an experienced industry expert within drug delivery devices and has a broad understanding and hands on experience from early conceptual work to implementing high volume manufacturing lines. Working with major Biopharma customers he has worked with most parenteral delivery systems such as pen injectors, infusion pumps, OBDS devices - including managing a successfully launched FDA cleared connected Auto Injector system.
Hans holds a Bachelor’s degree in Electronics Engineering as well as an executive MBA from Henley Management College.

Ingo Waschulewski

Senior Sales Manager, Gerresheimer
Ingo Waschulewski

With over 25 years of experience in the healthcare industry, I am a result-driven, commercial professional with comprehensive international expertise in business development, sales, customer training, and marketing for medical device, in-vitro diagnostic, and pharma markets. I hold a PhD in Humanbiology, an MS in Nutritional Biochemistry, and several certifications in quality management and sales techniques.
Currently, I work as an International Business Development & Sales Manager at Gerresheimer, a leading global partner for the pharma and healthcare industry. I am responsible for sales of drug delivery devices to pharma and biotech companies, international partnership strategies and new business development, project management, e-health and digital device applications.
 

Jamie Tsung

Head of DP Formulation, CMC, 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.

Karen Lowitz

Associate Director, Regulatory CMC Devices & Combination Product, Biogen
Karen Lowitz

My career began in New Jersey at Merck as a research biologist. After eight years, I changed direction and moved into Regulatory Affairs. In 2009, I relocated to beautiful Colorado. Most of my professional time was with Terumo BCT supporting blood collection and cell processing devices, and I had the opportunity to travel to Japan, Northern Ireland, Vietnam, and India. Last year, I joined Biogen to work on a clinical phase therapy to be presented in multiple drug/device combinations for commercialization. Regulation of combination products is ever evolving, which is why it is exciting to work in this space.

Kinsuk Shah

Sr. AD Combination Product Steward, Boehringer Ingelheim
Kinsuk Shah

Kinsuk Shah is currently Sr. AD, Combination Product Steward at Boehringer Ingelheim, responsible for device lifecycle management and strategy for Cyltezo. Mr. Shah is accountable for continuing development and oversight of CP manufacturing + supply, leading an interdisciplinary team of internal SMEs (e.g., drug product, packaging, final assembly, device, quality). Prior to joining BI, Mr. Shah was Director of Device Development at Viridian Therapeutics, responsible for device strategy and development, including establishing internal and external capabilities within the device space, evaluation and selection of wearable and auto-injector devices. Mr. Shah has over 10 years of drug-device combination product experience from Janssen, West and Alexion. Prior to Viridian, Mr Shah was at Alexion, where he was responsible for Strategy and Program Management for ongoing device dependent programs. At West Mr Shah was the Business Development lead for the SmartDose and SelfDose platforms, successfully partnering with multiple pharmaceutical companies in establishing joint combination product programs for each product.

Leonel Vanegas

Formerly Director, Medical Device and Combination Product Quality, Alexion Pharmaceuticals
Leonel Vanegas

Leya Bergquist

Associate Director, ClariMed
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.
 

Liem Nguyen

Associate Principle Scientist- Device Program Lead, Merck
Liem Nguyen

Liem Nguyen is a Device Program Lead within the Device Development and Technology team at Merck, where he aids in the selection of appropriate delivery technologies for therapeutic assets and leads the development of device constituents for combination products. Prior to his time at Merck, Liem spent 7 years with BD, contributing to the development of a wearable injector device and managing relationships with pharmaceutical partners. As such, he has had the unique experience during his career of working on both sides of a cross-company combination product development program: as a device constituent partner and as a pharmaceutical partner

Ling Zheng

Director - Device Development, Alexion Pharmaceuticals Inc
Ling Zheng

Ling Zheng is a device development lead at Alexion Pharmaceuticals, AstraZeneca’s Rare Disease Unit. She is currently working on developing drug delivery devices for combination products. She has many years of experience developing electro-mechanical on-body injectors.

Martin McLoughlin

Head of Device Development, Bristol Myers Squibb
Martin McLoughlin

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

Matt Marber

Senior Usability Engineer, Novo Nordisk
Matt Marber

Matt Marber (he/him) is a Senior Usability Engineer at Novo Nordisk where he applies human factors engineering to the development of combination products. He has experience planning, managing, and conducting usability tests throughout the device development process, with most of his experience in executing successful HF validation tests. Prior to joining Novo Nordisk, he worked as a consultant at Emergo by UL and PA Consulting. He received his BS in Engineering Psychology and his MS in Human Factors, both from Tufts University.

Michael Song

Expert in aseptic filling, combination product and packaging development and commercialization,
Michael Song

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.

Paul Upham

Global Head of Smart Devices, Roche-Genentech
Paul Upham

Paul is the Global Head of Smart Devices at Roche / Genentech. Paul has 20+ years of experience in medical device R&D, strategic marketing, product management, clinical research, and medical informatics.
Prior to Roche / Genentech, Paul was with Becton Dickinson(BD), as Worldwide Director of Strategic Marketing in their Pharmaceutical Systems business.

Paul was also the head of Product at WellDoc, Inc., where he led the product management activities for WellDoc’s portfolio of mobile health solutions. He was responsible for WellDoc’s landmark BlueStar™ product, a class II medical device and the world’s first reimbursed, prescription-only software for diabetes.

Paul’s prior experience includes 10 years in BD’s Diabetes Care business. Paul was responsible for the award-winning BD InterActiv® Diabetes Software, and was a member of the BD / Medtronic team that launched ParadigmLink®, the world’s first wireless blood glucose meter.

Paul holds four issued patents in medical software and drug delivery devices and has multiple patent applications. He is also an author of numerous peer-reviewed articles in medical informatics and diabetes. His education includes undergraduate studies in cognitive science and graduate work in health informatics and finance at the University of Minnesota and New York University.

 

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.

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.

 

Rebecca Engel

Director, Regulatory CMC Strategy, Pfizer, Inc.
Rebecca Engel

Becky Engel is a Director of Regulatory CMC Strategy at Pfizer working in the Global Regulatory Sciences Group in Medical Devices and Combination Products. She has over 23 years of combined industry experience leading device and formulation development, technology transfer of medical devices, OTC and pharmaceutical drugs, as well as global regulatory strategy development and pre- and post-market submissions for pharmaceutical drugs, medical devices and combination products. Becky holds a BS in Physics from the University of Michigan and an MS in Biomedical Engineering from the University of Akron. She is based in the US in Kalamazoo, MI.

Renato Ravanello

Sr. Director, Device and Packaging Development, Genentech
Renato Ravanello

Renato Ravanello is responsible for Late Stage Development in the Device and Packaging team at Genentech in South San Francisco, CA. Renato leads the design of new combinations products for clinical and commercial, focusing on new technologies for sub-cutaneous and ocular drug delivery.

Renato has been developing and commercializing combination products and medical devices for over 17 years, and has extensive experience in pre-filled syringes, needle safety devices, injector pens, patch injectors, auto-injectors, ocular drug delivery, and respiratory and transdermal drug delivery devices. He holds an M.S. in Aerospace Engineering from the University of Colorado (Boulder) and a Degree in Aeronautical Engineering from the Politecnico di Milano (Italy).
 

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).

Shruti Parikh

Director, Product Design, Takeda Pharmaceuticals
Shruti Parikh

Shruti Parikh is the Packaging Design Lead, Takeda Pharmaceuticals based out of Massachusetts, USA, where she is leading and building Industrial Design, Sustainable Design and Patient-Centric Design capabilities across the company.
As the design lead in packaging development Shruti and her team works towards the remit to integrate design across the company’s consumer, medical device, and pharmaceuticals sectors. In addition to helping improve the lives of the patients using Takeda products every day, the Design team is also focused on improving the environmental impact by reducing the carbon footprint of Takeda packaging.
Specifically, Shruti is passionate about challenging people and organizations to think differently. She loves to dig into global macro trends and translate its potential to redesign products and systems. Impatient for action, she wants to help build an inclusive future that allows us all to thrive socially, ecologically and economically. She is an advocate for a circular economy and is constantly looking to connect with individuals who believe they too can make a positive impact in the world.
 

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.

Stephen Gianelis

Formerly Senior Director, Digital Health Operations, Teva Pharmaceuticals
Stephen Gianelis

Stephen Gianelis most recently served as the Senior Director of Digital Health Operations at Teva Pharmaceuticals and boasts an illustrious career spanning over two decades in the healthcare technology sector. Throughout his journey, he has amassed invaluable expertise, honed at distinguished firms such as Ximedica and Proven Process Medical Devices. His proficiency traverses a diverse spectrum, encompassing implantable drug delivery products, robotic surgical devices, injection products, wearables, and cutting-edge digital health technologies.
Stephen stands as a beacon of success, having thrived in roles ranging from engineering to senior leadership. He is currently pursuing his Master of Business Administration at Fitchburg State University and he holds a degree in Mechanical Engineering Technology from Northeastern University.
Beyond his corporate endeavors, Stephen is an entrepreneur and podcaster. He consistently melds his technical acumen with strategic foresight to drive innovation in the realm of healthcare technology.
 

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.
 

Why to attend:

  • 2 full days of networking opportunities.
  • 16+ sessions with 75% of speakers from big pharma companies
  • An agenda designed for professionals within the wearable injectors space, focused on the development, implementation and application of wearable injectors and connected devices.
  • The only conference discussing wearable injectors and connected devices together.

The experience:

  • A collaborative environment for pharma, biotech and device developers to discuss the latest trends and challenges within the wearable injectors and connected device market.
  • Learn from key industry players about new technologies, strategies and processes for the development of wearable injectors.
  • Gain insights into the regulatory processes for the approval of wearable injectors and develop a greater understanding of how-to bring devices to market.
  • Create a dialogue with industry leaders for wearable injectors, and develop a network with the key stake-holders in the market.
  • Delve into the world of digital health and connectivity for the healthcare sector, and discuss the future of connectivity for wearables.
  • Examine the importance of usability for at home injectors, and what is needed to make a device appropriate for patient administration.
     

Who should attend:

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

  • Device Development
  • Smart Devices
  • Digital Health and Connectivity
  • Connected Devices
  • Device Engineering
  • Drug Delivery
  • Formulation for Wearables
  • Combination Product Development
  • On Body Device Development
  • Large Volume Drug Delivery
  • Regulatory Affairs
  • Medical Devices

Our Wearable Injectors and Connected Devices event is the only conference that discusses both wearable injectors and connected devices in one event. Over two days, we bring together executives within the pharmaceutical industry to discuss the opportunities and challenges that face on-body devices, and to collaborate on the future of the industry. The event provides and intimate environment to speak with experts and peers to learn from each other’s experiences, and to meet with a variety of solutions providers working to supplement the industry.
 

sponsors

Conference agenda

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8:00

Registration & Coffee

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9:00

Chair's Opening Remarks

Paul Upham, Global Head of Smart Devices, Roche-Genentech

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9:10

Industry Perspective On Design Considerations For Large Volume And Highly Viscous Injection-Based Delivery Systems

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

  • The evolution of at home drug delivery devices
  • Overview of wearable injector options
  • Patient and end user considerations when developing large volume and highly viscous delivery systems.
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    9:50

    Streamlining Drug/Device Combination Product Development Collaboration

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

  • Designing a device to use with a drug versus designing a drug with a device inside? Bespoke vs platform devices.
  • Large volume/high concentration drug deliveries. Considerations when making the switch from IV to subcutaneous administration.
  • Communications between drug R&D and device R&D – how do separate teams communicate and collaborate to streamline device development.
  • How has the industry progressed in making the switch from IV to subcutaneous injections
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    10:30

    Morning Coffee

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    11:00

    Skin Contact Adhesives -Design Considerations for your Wearable Injector

    Bill Pedersen, Strategic Product Manager - Medical, Lohmann Technologies

  • Critical Factors for Design
  • Main Customer Requests
  • Common Construction of Wearables
  • Skin as a Substrate
  • Skin Approved Adhesives -Biocompatibility
     
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    11:40

    A Risk-Based Approach To Design Controls To Support Pivotal Clinical Studies In The Development Of A Novel Drug-Device Combination Product

    Karen Lowitz, Associate Director, Regulatory CMC Devices & Combination Product, Biogen

  • Device development is an iterative process in which design and requirements are refined as the product moves through design control phases. Device design and requirements continue to be confirmed when a novel device is introduced into clinical studies to support a combination drug/device therapy. 
  • Using a risk-based approach, it is possible to support clinical release of combination products using a limited set of requirements as appropriate for the clinical phase (i.e Phase 1 healthy volunteers vs. Phase 3 patient population).
  • Using a risk-based approach, it is possible to support clinical use of a novel device in a combination therapy for which design changes may be implemented prior to commercialization.
  • Using a risk-based approach to combination product device design and verification requirements allows sponsors to move into clinical studies earlier while ensuring test product safety and effectiveness.
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    12:20

    Networking Lunch

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    13:20

    The Regulatory Challenge: Strategies for Bringing Wearables To The Market

    Peter Petrochenko, Associate Director, Regulatory Strategy, Regeneron Pharmaceuticals

  • What regulatory strategies should we be employing during device development to streamline submissions?
  • Navigating uncertainties throughout the device approval process
  • Strategies for collecting data and evidence during the device development process
  • Managing conflicting requirements of global regulatory agencies and industry news for harmonisation 
  •  

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    14:00

    Creating a Desirable and Usable Product from Early Device Development

    Matt Marber, Senior Usability Engineer, Novo Nordisk

  • Making the case for a wearable injector, using patient preferences to drive innovation.
  • The importance of integrating human factors studies into early device development to reduce delays.
  • Ensuring collaboration for device development: integrating human factor concerns into early-stage development to optimise usability.
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    14:40

    Afternoon Tea

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    15:10

    Review of Formulation Strategy, Based on The Commercial Product

    Jamie Tsung, Head of DP Formulation, CMC, Alnylam

  • Formulation considerations when developing drug delivery devices
  • CMC challenges when developing the wearable products
  • In use stability strategies for wearable injectors
     
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    15:50

    Chair’s Closing Remarks and Close of Day One

    Paul Upham, Global Head of Smart Devices, Roche-Genentech

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    8:30

    Registration & Coffee

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    9:00

    Chair's Opening Remarks

    Paul Upham, Global Head of Smart Devices, Roche-Genentech

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    9:10

    Connectivity, Usability and Necessity: Creating A Balance

    Paul Upham, Global Head of Smart Devices, Roche-Genentech

  • When should we involve software in a device, and when should we not? Considering factors such as treatment regularity, sensors, adherence.
  • In challenging to deliver drugs, how can connectivity improve adherence and reduce risk of at home treatment?
  • Software and app development as a part of the device development process – when should it be integrated and how?
  • How do we manage the risk of software being outdated when the device hits the market?
     
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    9:50

    SaMD and Digital Health – From Concept to Market

    Stephen Gianelis, Formerly Senior Director, Digital Health Operations, Teva Pharmaceuticals

  • What are the unique challenges with bringing SaMD and digital health products to market? 
  • How do we integrate new digital technologies with healthcare systems appropriately?
  • Clinical trials or studies for digital products – best practices.
  • Ensuring patient usability and training when designing digital products for at home use.
     
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    10:30

    Morning Coffee

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    11:00

    On-Body Injectors: Opportunities and Challenges

    Ling Zheng, Director - Device Development, Alexion Pharmaceuticals Inc

  • Why is there a need for on body injectors?
  • Why are there such a limited number of on body injectors on the market?
  • The challenges: from design and manufacturing to final approval. 
  • Post-market supply – managing commercial supply of components, and potential need for a design change.
     
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    11:40

    Building the Business Case for Wearable Injectors

    Liem Nguyen, Associate Principle Scientist- Device Program Lead, Merck

  • What are your considerations for your company when you identify a wearable injector.
  • Strategies for identifying how compatible your drug product and device are.
  • Building partnerships between device manufacturers and pharmaceutical companies.
     
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    12:20

    Networking Lunch

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    13:20

    Innovation for Wearable Drug Delivery Devices: What Next?

    Martin McLoughlin, Head of Device Development, Bristol Myers Squibb

  • What steps does the industry need to make to foster innovation in drug delivery research and development.
  • What lessons can we learn from past devices to strengthen the case for newer developments?
  • The pharmaceutical perspective – what are we looking for in a wearable device?
  • clock

    14:00

    CLOSING PANEL - Hitting the Sweet Spot: What Trade-Offs Need To Be Made For Wearable Injectors?

  • Materials – how can we balance costs and scalability with performance?
  • Adherence matters: acknowledging training factors in order to increase usability across the patient population.
  • Streamlining approval processes while maintaining accurate and relevant evidence collection. Can we see harmonisation develop internationally?
  • Where is connectivity useful and where is it creating more problems than it solves? How do we decide the line between smart and overly complicated?
     
  • Paul Upham, Global Head of Smart Devices, Roche-Genentech

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

    Martin McLoughlin, Head of Device Development, Bristol Myers Squibb

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    14:40

    Afternoon Tea

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    15:10

    Formulation Approaches to Understanding High Concentration, High Volume Drug Development

    Deep S Bhattacharya, Principal Scientist, Formulation and Process Development - Biotherapeutics, Pfizer

  • Current paradigms around these products in the subcutaneous spaces.
  • Drug product development from a more biophysical lens.
  • Challenges and opportunities around higher concentration subcutaneous injection and formulation focus areas.
     
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    15:50

    Chair’s Closing Remarks and Close of Day Two

    Paul Upham, Global Head of Smart Devices, Roche-Genentech


    Director Packaging and Device Innovation
    Johnson & Johnson Innovative Medicine
    Executive Director, Drug Delivery & Devices
    Eli Lilly
    Director Device R&D Lead, Biocompatibility Group
    AbbVie
    Strategic Product Manager - Medical
    Lohmann Technologies
    Head of Drug Delivery
    Cambridge Design Partnership
    Principal Scientist, Formulation and Process Development - Biotherapeutics
    Pfizer
    Early Device Project Engineering Lead
    GlaxoSmithKline
    Head of Injection Systems
    Takeda
    Senior Scientist
    Pfizer Inc.
    Sr Manager Combination Product Development
    Regeneron Pharmaceuticals
    Business Development Leader
    Cambridge Design Partnership
    Senior Sales Manager
    Gerresheimer
    Head of DP Formulation, CMC
    Alnylam
    Associate Director, Regulatory CMC Devices & Combination Product
    Biogen
    Sr. AD Combination Product Steward
    Boehringer Ingelheim
    Formerly Director, Medical Device and Combination Product Quality
    Alexion Pharmaceuticals
    Associate Director
    ClariMed
    Associate Principle Scientist- Device Program Lead
    Merck
    Director - Device Development
    Alexion Pharmaceuticals Inc
    Head of Device Development
    Bristol Myers Squibb
    Senior Usability Engineer
    Novo Nordisk
    Expert in aseptic filling, combination product and packaging development and commercialization
    Executive Director, Device and Combination Product Development
    Astria Therapeutics
    Global Head of Smart Devices
    Roche-Genentech
    Associate Director, Regulatory Strategy
    Regeneron Pharmaceuticals
    Vice President, Patient Integrated Care Innovation Platform
    Takeda Pharmaceuticals
    Director, Regulatory CMC Strategy
    Pfizer, Inc.
    Sr. Director, Device and Packaging Development
    Genentech
    Associate Director, RA Device and Combination Products Digital Device and Software
    AbbVie
    Director, Product Design
    Takeda Pharmaceuticals
    Medical Device Qualification Lead & Associate Scientific Fellow
    Takeda Pharmaceutical Company Limited
    Formerly Senior Director, Digital Health Operations
    Teva Pharmaceuticals
    Head of Design & Innovation
    Johnson & Johnson

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    September 11 - September 12, 2024
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    Past Presentation: Alexandra Benbadis, Usability Leader, Sanofi

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    Sponsors and Exhibitors


    Lohmann

    Gold Sponsor
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    Lohmann is a privately held company headquartered in Neuwied Germany. We are a pressure sensitive adhesive manufacturer and converter, specializing in component parts for wearable, ostomy, diagnostic and other medical related applications. With both US and EU manufacturing sites, we are a leading provider of adhesive and value chain solutions for the Medical Device Industry. We engineer our adhesives and technologies into usable forms that enhance our customer’s product performance, production efficiency and sustainability.


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    Gerresheimer

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    http://www.gerresheimer.com

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



    TxSphere

    Exhibitors
    http://www.tx2sphere.com

    TxSphere was founded as a spin-off of Intuvie LLC to focus exclusively on drug delivery devices for drug-device combination products. This new company builds on our experience with infusion pumps, connectivity, and a custom drug delivery device for a pharmaceutical combination product. Our first product is the Horizon, a unique semi-reusable micro wearable injector platform. The Horizon system is a pod-sized device that is capable of larger infusion volumes up to 20 mL or more. The latest version, the Horizon III, is reusable and rechargeable. The disposable component includes a micro cannula insertion system and can be pre-filled with medication. For more information, please see www.tx2sphere.com.


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    On Drug Delivery

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    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

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    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.


    Pharma Journalist

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


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    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


    The Medicine Maker

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    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

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    WHAT IS CPD?

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

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

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

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

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

    CPD AND PROFESSIONAL INSTITUTES

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

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

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

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

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

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

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

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

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

    GLOBAL CPD

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

    CPD Certificates

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

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