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Prefilled Syringes San Francisco
September 19 - September 20, 2022
Prefilled Syringes San Francisco

SAE Media Group’s 3rd Annual Conference
Pre-Filled Syringes San Francisco
September 19 - 20, 2022 | San Francisco, CA, USA
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The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, and large-volume drug products.

This year’s conference will bring together big pharma, biotech and device developer leaders from the San Francisco and Southern California region to assess the latest developments in new technologies for next generation injectable drug delivery to aid your drug pipeline.

Industry case studies will delve into the growing use of computational simulation approaches forming the digital revolution of device design and the latest advances in digital combination product development will be explored through the lens of lifecycle management and user-centric combination products. Furthermore, leading experts from big pharmwill be presenting case studies on recent advances in platform approaches in drug delivery devices and smart devices, while a panel discussion will explore the emerging opportunities of platforms for injectable devices. With recent developments in industry regulations and guidance, the 2022 agenda will give an international insight into the global regulatory environment and leading FDA representatives will address the key standards to be aware of in injectable device development. 

 

As part of SAE's leading injectable drug delivery series, don't miss this unmissable opportunity to network with the pharma, biotech and device developer community of San Francisco and Southern California; the two-day agenda offers you peer-to-peer networking with Directors of Drug Delivery, Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more.

We look forward to welcoming you to the conference in September 2022.

FEATURED SPEAKERS

Abhi Raj

Abhi Raj

Senior Director, Device Development, R&D, AstraZeneca
Ajay A Deshmukh

Ajay A Deshmukh

Principal Engineer, Genentech
Alan M Stevens

Alan M Stevens

Assistant Director, Injections Devices Team, U.S. Food and Drug Administration
Denise Forkey

Denise Forkey

Director, Human Factors, UserWise, Inc.
James Leamon

James Leamon

Director of Biologics Device Development, Jazz Pharmaceuticals
Jamie Tsung

Jamie Tsung

Head of DP formulation, Alnylam Pharmaceuticals, Inc
Michael Song

Michael Song

Associate Director, Takeda
Miles Buroker

Miles Buroker

Human Factors Engineer, UserWise
Nicholas Mandala

Nicholas Mandala

Senior Director, Medical Device and Combination Product Technology, Pfizer
Peter Dorski

Peter Dorski

Associate Director, CMC Regulatory Affairs, Janssen, Pharmaceutical Companies of Johnson and Johnson
Peter Harley

Peter Harley

Head of Technology, Crux Product Design
Renato Ravanello

Renato Ravanello

Sr. Director, Device and Packaging Development, Genentech
Scott Nunn

Scott Nunn

Director, Device Development, Gilead Sciences
Shannon Clark

Shannon Clark

CEO, UserWise, Inc.
Simone Marquardt

Simone Marquardt

Key Account Manager Silicone Europe, Raumedic AG

Abhi Raj

Senior Director, Device Development, R&D, AstraZeneca
Abhi Raj

Abhi Raj is a Senior Director in the device development group at AstraZeneca and is based out of the US West Coast office in South San Francisco. Abhi has 15+ years of combination product and medical device development experience and has worked at medical device and pharmaceutical companies. He has multiple granted patents in the field and is passionate about device technology development. He has successfully launched pen needles, pre-filled syringes, and auto-injectors over his career. Some of his current focus areas include smart/digital devices as well as large volume delivery technologies.

Ajay A Deshmukh

Principal Engineer, Genentech
Ajay A Deshmukh

Ajay A. Deshmukh is a Principal Engineer in the Device & Packaging Development Department of Genentech, a member of the Roche group. At Genentech, Ajay has spent 12 years developing subcutaneous injection devices such as prefilled syringes, needle-safety devices, autoinjectors, and on-body delivery devices. He has been involved in all stages from concept development through authoring sections of regulatory filing documents.
Prior to this role, Ajay had worked for 8 years designing in vitro medical devices. Ajay holds a Ph.D. from the University of California, Berkeley and a B.S. from Columbia University, both in mechanical engineering.

Alan M Stevens

Assistant Director, Injections Devices Team, U.S. Food and Drug Administration
Alan M Stevens

CAPT Alan Stevens is the acting division director for the Division of Drug Delivery and General Hospital Devices and Human Factors, which includes the Injection Devices Team, Infusion Devices Team, General Hospital Devices Team, and the Human Factors and Reliability Engineering Team. This division regulates the product lifecycle of its devices, including premarket submission review and postmarket safety and compliance. The division also provides human factors expertise and consulting across FDA.
Prior to becoming a manager in CDRH, CAPT Stevens spent 10 years as an engineering reviewer in the Office of Device Evaluation and three years as a compliance officer in CDRH’s Office of Compliance. CAPT Stevens received his undergraduate mechanical engineering degree and masters degree in reliability engineering from the University of Maryland.

Denise Forkey

Director, Human Factors, UserWise, Inc.
Denise Forkey

Denise Forkey is currently Director, Human Factors at UserWise, a consultancy that helps medical device and combination product manufacturers and start-ups to design safe and easy-to-use medical products. She leads a team of human factors consultants who fulfil any and all aspects of the usability engineering process.

Denise has experience performing use-related risk analyses, conducting usability testing, designing instructions for use and implementing the usability engineering process for home-use injection products through complex robotic surgery system. Denise regularly works on human factors submission strategy 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). She has helped numerous UserWise clients successfully navigate FDA human factors submissions, create usability documentation for CE mark, and manage notifying body and test lab audits of the usability engineering file. Denise has been working in the medical products industry for more than 25 years and has experience in medical device testing and quality systems/engineering, with her last 6 years focusing on human factors engineering processes and testing.

She holds a master’s degree in Biomedical Engineering and has severed as a board member of the national Biomedical Engineering Society and the Bio2Device group and was the founding President of the San Francisco Bay Area Chapter of the Biomedical Engineering Society.

James Leamon

Director of Biologics Device Development, Jazz Pharmaceuticals
James Leamon

Jim is a medical device and drug device combination product development leader, an engineering director, and a manufacturing manager. He is experienced in working across functions and business groups in varying organizations. Jim has successfully brought new and effective products to market throughout the world and has developed and implemented new engineering, quality control and manufacturing processes. Jim continues to lead product development, and contract engineering teams while working at Jazz Pharmaceuticals. He is highly experienced and proficient in CMC drug-device combination product leadership as well as strategic planning, design engineering, manufacturing engineering and new product and process development. Currently, he is working with Jazz manufacturing teams to expand the availability of a current small cell lung cancer drug product that is in high demand.

Jim is also a community leader in social justice and feeding the hungry. As treasurer of a non-profit organization, he has used his strategic planning and financial management skills to help people in need. This correlates well with his career drive to improve the lives of cancer patients and those with other life threatening diseases.

Jamie Tsung

Head of DP formulation, Alnylam Pharmaceuticals, Inc
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.

Michael Song

Associate Director, Takeda
Michael Song

Michael currently is Associate Director of Device Development at Takeda. Prior to his current role he was head of Combination Product Manufacturing at Heron Therapeutics where he led medical device and combination product commercial readiness. Prior to Heron, he formed and led the Device Functionality, Safety and Digital Connectivity group at AstraZeneca where his group oversaw device functionality portion of device development; primary container science and technology; biocompatibility; container closure integrity programs; and digital connectivity. Prior to AstraZeneca, he was head of Device, Package, and Process Engineering 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.

Miles Buroker

Human Factors Engineer, UserWise
Miles Buroker

Miles first joined UserWise as an intern for the summer of 2018 and came on as a full-time consultant in mid-2019. He is experienced in forming use-related risk analyses and test protocols; observing usability study sessions for formative and validation testing; preparing test reports, risk-benefit analyses and Human Factors Engineering Submission Reports for FDA; providing human factors trainings and workshops; and with establishing compliance documentation for IEC 62366:2007, IEC 62366-1:2015, and FDA Guidance Documents. His focus is predominantly on combination products. Miles brings a wide range of pertinent experience from his undergraduate career, including serving as a research assistant, developing a stress-sensing wearable device and accompanying application, and participation in design studios.

Nicholas Mandala

Senior Director, Medical Device and Combination Product Technology, 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.

Peter Dorski

Associate Director, CMC Regulatory Affairs, Janssen, Pharmaceutical Companies of Johnson and Johnson
Peter Dorski

Peter Dorski is an Associate Director, CMC Regulatory Affairs at Janssen, Pharmaceutical Companies of Johnson and Johnson. He has worked within the pharmaceutical and combination products industry for going on nine years, driving regulatory strategies based on industry best practices for global/major market product development and supporting advancement of complex, innovative delivery systems using leading-edge therapies.
Within the pharma industry, Peter works to understand and influence the continuously evolving regulatory landscape surrounding combination products to serve industry stakeholders and patients. Peter holds a BS in microbiology from The Ohio State University and a MS in Health Sciences from The George Washington University.
 

Peter Harley

Head of Technology, Crux Product Design
Peter Harley

11 years since graduating as a mechanical engineer working in simulation and analytics, in that time completed a PhD while working in automotive and moved into a leadership role through time in Dyson Research. Current aim is to drive digital methods from other sectors into the medical device world to de-risk development programs early and accelerate time to market through simulation and analytics.

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).
 

Scott Nunn

Director, Device Development, Gilead Sciences
Scott Nunn

Scott Nunn is responsible for Device Engineering at Gilead Sciences in Foster City, CA. Scott is passionate about developing products to improve patient’s lives. Gilead’s combination product portfolio includes both development and commercial combination products developed to treat grievous illnesses.
Scott has been working in the pharmaceutical industry for 16 years and has experience in development of various parenteral drug delivery devices. In his free time, Scott enjoys spending time with his family, working on home renovation projects and spending time outdoors.

Session Reserved For Biophorum

, BioPhorum
Session Reserved For Biophorum

Shannon Clark

CEO, UserWise, Inc.
Shannon Clark

Shannon E. Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors.

Shannon graduated from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. Shannon is a Certified Professional Industrial Engineer, holds two patents, and has written and published three books.

Simone Marquardt

Key Account Manager Silicone Europe, Raumedic AG
Simone Marquardt

Over 28 years’ experience in technical fields in various industries and market segments.
Experienced application engineer in the field of silicone chemistry.

Simone joined RAUMEDIC in 2017 as Business development manager silicone for Europe.
Since January 2021, she has worked as a Key account manager silicone Europe to promote silicone in medical application.

The field of medical technology is an important and growing sector of industry.
Looking at trends and new market requirements where silicone could be a beneficial solution, supporting the whole development process – from the initial idea through to the end medical-technology product.
 

sponsors

Conference agenda

clock

8:00

Registration & Coffee

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9:00

Chairs' Opening Remarks

Scott Nunn, Director, Device Development, Gilead Sciences

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

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9:10

Lifecycle management for digital combination product development

Abhi Raj, Senior Director, Device Development, R&D, AstraZeneca

  • A look back on the past year and developments in connected combination products
  • Ensuring effective risk management for a successful digital combination product
  • Regulatory considerations for the implementation of digital components in device development
  • Opportunities for enhancements of current combination products through digital tools
  • clock

    9:50

    Etrolizumab Autoinjector Development - From Concept to Marketing Application

  • Development of an autoinjector combination product and overcoming unexpected challenges
  • Improving and demonstrating product robustness
  • Conducting design validation during a pandemic
  • Developing a control strategy for EPRs
  • Ajay A Deshmukh, Principal Engineer, Genentech

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    10:30

    Morning Coffee

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    11:00

    Leveraging Platforms for Combination Product Development

    Nicholas Mandala, Senior Director, Medical Device and Combination Product Technology, Pfizer

  • Risk management for combination drug delivery portfolios
  • Quality management systems and quality system development
  • Design control documentation efficiencies
  • Clinical and Human Factors considerations and case studies
  • clock

    11:40

    Flexible approaches to injectable delivery device platforms

  • Leveraging platforms to support safety and effectiveness with other active ingredients
  • Introducing modifications in a device platform to avoid challenge of a ‘one-size-fits-all’ approach
  • Planning for the future, attempting to avoid premature platform obsolescence.
  • Planning for platform extensions to improve and extend the life cycle of the platform
  • James Leamon, Director of Biologics Device Development, Jazz Pharmaceuticals

    Michael Song, Associate Director, Takeda

    Nicholas Mandala, Senior Director, Medical Device and Combination Product Technology, Pfizer

    clock

    12:20

    Networking Lunch

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    13:20

    The Do’s and Don’ts of Designing Effective Instructions for Use for Lay Users

    Miles Buroker, Human Factors Engineer, UserWise

  • Regulatory Requirements and Guidelines for Developing an IFU for Lay Users
  • Steps to Develop Effective IFUs
  • Types of User Documentation and Instructions
  • Best Practices for IFUs
  • clock

    14:00

    Deploying Digital Threads: Accelerating & Augmenting Device Development

    Peter Harley, Head of Technology, Crux Product Design

  • Digital transformation: trends and insights
  • Emerging tech: successful selection for medical devices
  • Digital threads: implementation case studies
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    14:40

    Afternoon Tea

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    15:10

    Approaches and considerations to building an efficient and de-risk combination product development program

    Michael Song, Associate Director, Takeda

  • Cross functional interconnection and ways to ensure program success
  • EU MDR GSPR and leveraging from program success
  • Understanding essential performance requirement
  • How an effective control strategy can help ensure program success
  • Design control and risk reduction activities
  • clock

    15:50

    From early to late-stage development: Transitioning from vial to pre-filled syringe

    Jamie Tsung, Head of DP formulation, Alnylam Pharmaceuticals, Inc

  • Approaches to pre-filled syringe development
  • Evaluating key CMC considerations
  • Challenges in transitioning from vial to pre-filled syringe and pathways to overcome these
  • clock

    16:30

    Chairs' Closing Remarks and Close of Day One

    Scott Nunn, Director, Device Development, Gilead Sciences

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

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairs' Opening Remarks

    Scott Nunn, Director, Device Development, Gilead Sciences

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

    clock

    9:10

    An update on combination product and injection device regulatory guidance

    Alan M Stevens, Assistant Director, Injections Devices Team, U.S. Food and Drug Administration

  • A review of current guidance for pre-filled syringes and what is new from the past year
  • Updates to regulatory guidance on bridging studies for injectable devices
  • Essential performance requirements for combination products and injectable devices
  • Post market safety reporting for combination products
  • clock

    9:50

    Findings and Implications of U.S FDA-UserWise Training Decay Research

    Shannon Clark, CEO, UserWise, Inc.

  • An overview of Training Decay and why it matters
  • What does the FDA say about Training Decay
  • Insights and revelations from our FDA-backed training decay research study
  • How our findings affect future regulatory policy
  • clock

    10:30

    Morning Coffee

    clock

    11:00

    Silicone in medical application

    Simone Marquardt, Key Account Manager Silicone Europe, Raumedic AG

  • We would like to talk about a silicone material which we have developed which can be used in injection systems for applications which are very sensitive.
  • The trend of oral administration of medicine is increasingly being replaced by injection. In particular, we find that biopharmaceuticals and personalized medicine are growing above average. 
  • RAUMEDIC has dealt intensively with these trends in recent years and created innovations that contribute to improving a safe and easy administration of drugs. 
  • In particular in the area of syringe systems and components, we support various companies in development and manufacture. One of our innovations are our silicone syringe stoppers. These enable easier application and better dosage of the medication due to improved breakaway and gliding properties. We would like to talk about these and other innovations and introduce the new silicone stopper concept
  • clock

    11:40

    Global regulatory landscape and harmonization of combination products

    Peter Dorski, Associate Director, CMC Regulatory Affairs, Janssen, Pharmaceutical Companies of Johnson and Johnson

  • Recent updates to international regulatory requirements for injectable combination products
  • Industry challenges in the evolving regulatory landscape
  • Assessing international harmonization: guidance for industry to conform to international standards
  • What we can expect in future updates to combination product international regulatory guidance and how to prepare
  • clock

    12:20

    Networking Lunch

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    13:20

    Large volume Injectable Delivery of Biologics

    James Leamon, Director of Biologics Device Development, Jazz Pharmaceuticals

  • The growing need for large volume delivery for biologics 
  • Challenges in delivery technology for biologics and what injectable devices are currently being used?
  • Overcoming formulation challenges for biologic delivery
  • How do we need the delivery system landscape to move forward meet the needs of biologic subcutaneous delivery?
  • clock

    14:00

    Challenges and opportunities for high volume sub-cutaneous drug delivery

  • Opportunities to improve patient experience.
  • Device technology challenges.
  • Tolerability and other unknowns
  • Renato Ravanello, Sr. Director, Device and Packaging Development, Genentech

    clock

    14:40

    Afternoon Tea

    clock

    15:10

    Device Development for Long Acting Injectables

    Scott Nunn, Director, Device Development, Gilead Sciences

  • How have long-acting injectable devices evolved in recent years
  • Common pitfalls and challenges in long-acting combination product design
  • clock

    15:50

    Chairs' Closing Remarks and Close of Day Two

    Scott Nunn, Director, Device Development, Gilead Sciences

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


    Senior Director, Device Development, R&D
    AstraZeneca
    Principal Engineer
    Genentech
    Assistant Director, Injections Devices Team
    U.S. Food and Drug Administration
    Director, Human Factors
    UserWise, Inc.
    Director of Biologics Device Development
    Jazz Pharmaceuticals
    Head of DP formulation
    Alnylam Pharmaceuticals, Inc
    Associate Director
    Takeda
    Human Factors Engineer
    UserWise
    Senior Director, Medical Device and Combination Product Technology
    Pfizer
    Associate Director, CMC Regulatory Affairs
    Janssen, Pharmaceutical Companies of Johnson and Johnson
    Head of Technology
    Crux Product Design
    Sr. Director, Device and Packaging Development
    Genentech
    Director, Device Development
    Gilead Sciences
    BioPhorum
    CEO
    UserWise, Inc.
    Key Account Manager Silicone Europe
    Raumedic AG

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    Preliminary Attendees List

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    Speaker Bios

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    Workshop Agenda

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    Conference Co-Chair Letter

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    Past Attendees

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    SURVEY RESULTS INFOGRAPHIC - STATE OF THE INDUSTRY 2022

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    Past Presentation - Paul Upham, Roche

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    Past Presentation - Larry Atupem, ZEON

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    Prefilled Syringes San Francisco Brochure 2022

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    WHAT IS CPD?

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

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

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

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

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

    CPD AND PROFESSIONAL INSTITUTES

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

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

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

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

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

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

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

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

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

    GLOBAL CPD

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

    CPD Certificates

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

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    Contact SAE Media Group

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




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