Home

If you have registered for this conference, please click this link to login and join. Your login details should have been sent to you by portal@smi-online.co.uk

Post event on demand access to recorded presentations will be available to all attendees 5 working days from the end date of the event.

overview

For the latest COVID-19 Travel restrictions and recommendations please click here

 The SMi Group is proud to announce the 2nd annual
Pre-Filled Syringes San Francisco Conference
13th - 14th September, 2021 | Virtual Conference | All Timings are PDT
--------------------------------------------------------------------------------------------------

As part of SMi’s leading Injectables series, this year’s event will address the key drivers of the pre-filled syringes and combination products industry to give a comprehensive insight into the latest device innovations, regulatory updates and future insights for the coming year. With the global market for prefilled syringes estimated to exceed $9.7bn by 2025, the field is evolving at an exponential rate with connectivity and digital health strategies for devices and studies at the forefront. Furthermore, this event will delve into the key takeaways following the global pandemic and discover how this will be used to enhance future drug delivery device development.

This comprehensive overview will explore the changing global market and latest innovations in device design and development for injectable drug delivery. Case studies from leading industry and regulatory experts will explore platform approaches for combination products, enhanced device design and usability considerations, change management and compatibility for novel drug products.

 

The two-day agenda offers you peer-to-peer networking with 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 2021.
 

  • Engage in case studies from big pharma leading experts on smart devices and connected delivery to aid the user experience 
  • Explore evolving device design and innovations for high volume and high viscous delivery 
  • Delve into regulatory updates on device development and human factors with insights from industry and regulatory bodies 
  • Uncover how industry is incorporating risk management and controls into early stages for a holistic development process

 

  • Drug-delivery developers 
  • Medical Device Engineers 
  • Primary Packaging material designers 
  • Secondary packagers 
  • Smart device developers 
  • Training device developers 
  • Device-safety solution providers 
  • Drug developers

Previous attendees include:
 

AbbVie; Afaxys Pharma LLC; Alexion Pharmaceuticals; Allergan; Alnylam Pharmaceuticals; Amgen; Amgen Inc; Amgen Inc.; AnaptysBio Pharmaceuticals; AstraZeneca; bausch health; BCM Group LLC; BD; Bigfoot Biomedical; Biogen; Biogen Idec; Biomarin Pharmaceutical; BioMarin Pharmaceutical, Inc. ; Biomarin Pharmaceuticals; BioQ Pharma Inc; Boston Analytical Inc; Bristol Myers Squibb; Bristol-Myers Squibb Co; BSI; BSI Group; Cadila Healthcare Limited; Cadila Healthcare Ltd; Camurus; Camurus AB; Credence MedSystems, Inc.; Credence Systems Corporation; Eli Lilly and Company; FDA/CDER; Genentech; Genentech, Inc; Genentech, Inc.; Genetech; Genetech Inc; Gilead Sciences; Gilead Sciences, Inc; Heron Therapeutics; Ionis Pharmaceuticals; Janssen; Janssen Pharmaceuticals; Janssen R&D; Jazz Pharmaceuticals; Jazz Pharmaceuticals Inc; Kaleidoscope Innovation; MedImmune; Merck; Merck & Co; Minapharm Pharmaceuticals; Mitsubishi Gas Chemical Company, Inc; Mitsubishi Gas Chemical Singapore Pte Ltd; PATH; Pfizer; Pfizer Inc; Pfizer, Inc.; PHC Corporation; PHC Corporation of North America; Regeneron; Roche; Safety Assessment/Merck & Co., Inc; Sanofi Pasteur; Si02 Materials Science; Spark Therapeutics; Steris Corp; STERIS Corporation; Sumitomo Rubber; Sun Pharma; Suttons Creek Inc; Suttons Creek, Inc; Suttons Creek, Inc.; Takeda; Takeda Pharmaceutical Company Limited; TEST; The Searle Company Limited; UserWise, Inc.; W.L. Gore & Associates, Inc.; Xeris Pharmaceuticals; Zeon Specialty Materials ; Zeon Specialty Materials Inc; Zydus Cadila;

Conference programme

Pacific Daylight Time (PDT)

8:00 Chairman's Opening Remarks

Shannon Clark

Shannon Clark, CEO, UserWise, Inc.
View Bio

Paul Upham

Paul Upham, Head, Smart Device, Roche / Genentech
View Bio

8:10 An update on combination product and injection device regulatory guidance

Alan M Stevens

Alan M Stevens, Assistant Director, Injection Devices, Division of Drug Delivery, General Hospital, and Human Factors, U.S. Food and Drug Administration
View Bio

  • A review of current guidance for pre-filled syringes and what is new from the past year
  • How has COVID-19 impacted regulatory submissions and processes?
  • An update on expectations for regulatory submissions – common pitfalls and how to ensure you are meeting requirements
  • A future outlook of changes to regulatory requirements and guidance in the coming years
  • 8:45 Postmarket Safety Reporting: The current regulatory environment with a global impact

    Khaudeja Bano

    Khaudeja Bano, Executive Medical Director, Combination Product Safety Head, Amgen
    View Bio

  • What is the latest news on postmarket safety reporting?
  • An update on FDA’s recent perspective
  • Understanding the finalized FDA guidance
  • 9:20 Morning Break

    9:50 Considerations for risk-based sampling during development, stability, and release

    Scott  Surrette

    Scott Surrette, Manager, Regeneron Pharmaceuticals, Inc.
    View Bio

  • How a risk based approach can be applied in various situations including Design Verification, stability testing, and release both pre- and post- PPQ
  • Why relaxing requirements post PPQ is acceptable
  • Why departure from lot size based standards is acceptable
  • Separating investigations of non-conforming samples from disposition decision
  • 10:25 Developing on-body delivery devices with the user in mind

    Nicholas Mandala

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

  • An outlook on the need for large volume injectors and high viscosity drug products
  • Delivery device technologies for sustained delivery
  • An outlook of evolving delivery devices for novel drug products
  • 11:00 Networking Break

    12:00 Regulatory standards and guidance for combination product Instructions for Use (IFUs)

    Shannon Clark

    Shannon Clark, CEO, UserWise, Inc.
    View Bio

  • Types of User Documentation
  • Regulatory Requirements for Instructions for Use
  • Special Considerations: accommodating colorblindness, folding, font size
  • Case Study: People with Parkinson’s User Manual Comprehension Research
  • 12:35 Panel Discussion: Considerations for the ‘out of box experience’

  • What are industry leaders doing to embed IFU best practices within their business processes and quality systems?
  • Current guidance and regulations around IFUs for combination products and pre-filled syringes
  • IFUs need to be developed earlier than historically needed due to human factors - how are organizations addressing this?
  • What sort of FDA request is your company receiving around out of box experience and timing of when that needs to finalized in relation to phase I, II and III clinical trials?
  • Shannon Clark

    Shannon Clark, CEO, UserWise, Inc.
    View Bio

    Rachel Poker

    Rachel Poker, Associated Director, Human Factors, AstraZeneca
    View Bio

    Alasdair Young

    Alasdair Young, Senior Director - Device Engineering, Coherus Biosciences
    View Bio

    Denise Forkey

    Denise Forkey, Human Factors Manager, UserWise, Inc.
    View Bio

    13:10 Afternoon Tea

    13:50 Technical update of ZEONEX® and ZEONOR®: Cyclo Olefin Polymer (COP) for Pre-Filled syringes, a glass alternative

    Larry Atupem

    Larry Atupem, Strategic Business Development Manager, Zeon Specialty Materials
    View Bio

  • Key properties of COP
  • Low temp stability of nucleic acid solution in COP container
  • Protein Adsorption of Abatacept, Humira, Embrel Remicade – COP vs glass
  • Leachable data

     

  • 14:20 System Engineering Approach for Combination Product Design Controls

    James Robert Wise

    James Robert Wise, Associate Senior Consultant Engineer, Eli Lilly and Company
    View Bio

  • Establishing a formal structure for eliciting stakeholder/user needs for system requirements 
  • Working with cross-functional teams to identify problem and all needs to be able to create an optimum solution 
  • Case Study: taking a needs-based approach to resolve conflicts and manage tradeoffs 
  • Managing stakeholders to consider ramifications throughout the development lifecycle when overcoming challenges
     
  • 14:55 Chairman’s Closing Remarks and Close of Day One

    8:00 Chairman's Opening Remarks

    Shannon Clark

    Shannon Clark, CEO, UserWise, Inc.
    View Bio

    Paul Upham

    Paul Upham, Head, Smart Device, Roche / Genentech
    View Bio

    8:10 Digital technology for continuous improvement of delivery devices

    James Leamon

    James Leamon, Director of Biologics Device Development, Jazz Pharmaceuticals
    View Bio

  • Software within a Delivery Device: Continuous Improvement Overview
  • Artificial Intelligence Goals 
  • Data Management: What is the value?
  • Patient Advocacy
  • 8:45 How to Use Smart Devices Intelligently to Deliver Outcomes

    Paul Upham

    Paul Upham, Head, Smart Device, Roche / Genentech
    View Bio

  • Differentiating digital strategies from business objectives 
  • Why spending the time to form a digital strategy is essential to deliver value with Smart Devices
  • How to use Smart Devices and Behavior Design to deliver on key elements of a digital strategy
  • 9:20 Morning Break

    9:55 Application of Modelling & Simulation (M&S) in Drug Delivery Devices

    Alie Jahangir

    Alie Jahangir, Senior Principle Engineer, Janssen Pharmaceuticals
    View Bio

  • Basics of M&S and its ability to address the needs for faster development and validations processes at lower cost.
  • Comparative case study to illustrate a validation process using traditional vs. advanced predictive modelling tools 
  • FDA position on accepting computational modelling studies in medical device submissions
  • Discussions of current limitations
  • 10:30 Panel Discussion: Insights into connected device experiences: What can industry do to improve?

  • Transitioning from the value proposition of connectivity to real-work experiences and generated evidence
  • An introduction into experiences with connected devices both in development and on the market
  • Assessing practical applications of technologies for connected delivery devices
  • What works, what doesn’t and how can companies look to improve connected devices?
  • How can we look to use this technology to improve or accelerate our clinical trials?
  • Paul Upham

    Paul Upham, Head, Smart Device, Roche / Genentech
    View Bio

    George Cusatis

    George Cusatis, Director, Merck
    View Bio

    Scott Mullen

    Scott Mullen, Senior Director, Connected Healthcare, Ascendis Pharma
    View Bio

    Alie Jahangir

    Alie Jahangir, Senior Principle Engineer, Janssen Pharmaceuticals
    View Bio

    11:05 Networking Break

    12:00 Drug Product Strategies to Enable Accelerated Clinical Development Timelines

    Mehak Mehta

    Mehak Mehta, Scientist II, Protein Drug Product Development, Biogen
    View Bio

  • Approaches to fast scale-up & tech-transfer to CMO’s
  • Flexibility and collaborative relationship with CMO’s is critical
  • Importance of timely decision making and timely input from right stakeholders
  • 12:35 Importance of understanding injection device needs in rare disease patients: a holistic approach for early-stage research

    Sindhuja Kuchibhatla

    Sindhuja Kuchibhatla, Device Development Engineer, Regeneron Pharmaceuticals
    View Bio

  • Specific challenges for rare disease patients
  • Approaches to prioritize the patient experience over the solution
  • Early findings from qualitative user research
  • Value of patient needs research at the early stage of device development
  • 13:10 Afternoon Break

    13:40 Sterile Diluent DP or not DP

    Maria Linzmayer

    Maria Linzmayer, Director, Global Pharmaceutical Operations, Quality, Merck & Co. Inc.
    View Bio

  • Drug delivery
  • Combination product device development
  • Platform strategy, NBOps
  • IFU: comparability
  • 14:15 Design for Manufacturability and Next Generation Drug Delivery Devices Innovation

  • Recent innovations in drug delivery systems would challenge the current state of the art of the readily available manufacturing technologies.
  • Therefore, it becomes more and more important that next-generation drug delivery devices development would take into consideration of design for manufacturability (DfM) assessment in the early innovation phases.
  • This talk will emphasize the advantages and challenges of design for manufacturability assessment in the drug delivery device innovation and the concurrent engineering approach to accelerate the innovation and development process.
  • Moreover, some of the recent manufacturing technologies and developments that have not been applied in the medical and combination products industries will be discussed.
  • Murat Gunay

    Murat Gunay, Sr. Consultant Engineer – Mechanical Engineering, Eli Lilly and Company
    View Bio

    Ho-Seon Jin

    Ho-Seon Jin, Engineering Advisor, Delivery, Device and Connected Solutions, Eli Lilly and Company
    View Bio

    14:50 Chairman’s Closing Remarks and Close of Day Two

    Shannon Clark

    Shannon Clark, CEO, UserWise, Inc.
    View Bio

    Paul Upham

    Paul Upham, Head, Smart Device, Roche / Genentech
    View Bio

    +

    FEATURED SPEAKERS

    Alan M Stevens

    Alan M Stevens

    Assistant Director, Injection Devices, Division of Drug Delivery, General Hospital, and Human Factors, U.S. Food and Drug Administration
    Alasdair Young

    Alasdair Young

    Senior Director - Device Engineering, Coherus Biosciences
    Alie Jahangir

    Alie Jahangir

    Senior Principle Engineer, Janssen Pharmaceuticals
    George Cusatis

    George Cusatis

    Director, Merck
    Ho-Seon Jin

    Ho-Seon Jin

    Engineering Advisor, Delivery, Device and Connected Solutions, Eli Lilly and Company
    Jace Blackburn

    Jace Blackburn

    Smart Device Engineer, Genentech
    James Leamon

    James Leamon

    Director of Biologics Device Development, Jazz Pharmaceuticals
    James Robert Wise

    James Robert Wise

    Associate Senior Consultant Engineer, Eli Lilly and Company
    Khaudeja Bano

    Khaudeja Bano

    Executive Medical Director, Combination Product Safety Head, Amgen
    Larry Atupem

    Larry Atupem

    Strategic Business Development Manager, Zeon Specialty Materials
    Maria Linzmayer

    Maria Linzmayer

    Director, Global Pharmaceutical Operations, Quality, Merck & Co. Inc.
    Mehak Mehta

    Mehak Mehta

    Scientist II, Protein Drug Product Development, Biogen
    Murat Gunay

    Murat Gunay

    Sr. Consultant Engineer – Mechanical Engineering, Eli Lilly and Company
    Nicholas Mandala

    Nicholas Mandala

    Senior Director, Medical Device and Combination Product Technology, Pfizer
    Paul Upham

    Paul Upham

    Head, Smart Device, Roche / Genentech
    Rachel Poker

    Rachel Poker

    Associated Director, Human Factors, AstraZeneca
    Scott  Surrette

    Scott Surrette

    Manager, Regeneron Pharmaceuticals, Inc.
    Scott Mullen

    Scott Mullen

    Senior Director, Connected Healthcare, Ascendis Pharma
    Shannon Clark

    Shannon Clark

    CEO, UserWise, Inc.
    Sindhuja Kuchibhatla

    Sindhuja Kuchibhatla

    Device Development Engineer, Regeneron Pharmaceuticals
    Young Chun

    Young Chun

    Associate Director Lead, Human Factors & User Research, Takeda Pharmaceutical Company Limited

    Alan M Stevens

    Assistant Director, Injection Devices, Division of Drug Delivery, General Hospital, and Human Factors, 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.

    Alasdair Young

    Senior Director - Device Engineering, Coherus Biosciences
    Alasdair Young

    Alasdair is a Senior Director at Coherus BioSciences where he leads the Device Engineering group. Alasdair has worked in medical devices and combination products for over ten years with experience throughout the development and commercialization process.

    Prior to working at Coherus BioSciences, Alasdair held engineering positions at Roche / Genentech, DCA Design, and Pfizer.

    Alasdair is a graduate of Cambridge University with an MPhil in Manufacturing Management. Alasdair also holds a BEng from Glasgow University.
     

    Alie Jahangir

    Senior Principle Engineer, Janssen Pharmaceuticals
    Alie Jahangir

    Dr Jahangir is a Sr. Principle Engineer at Janssen Pharmaceutical, with a proven record of accomplishments in the area of Device Quality Engineering for company’s diverse combination products as well as other Advanced Emerging Technologies. His key areas of expertise and interest are at the intersection of quality system optimization, device platform harmonization and of course utilizing advance innovative tools to enhance overall quality system performances. Prior to Janssen, Alie has led a successful R&D career, managing, developing and commercializing advanced polymeric technologies in consumer, medical devices, and pharma sector. Dr. Jahangir is also an adjunct professor at the department of Bioengineering at Temple University. He holds a Doctorate Degree in Polymer & Biomedical Engineering from University of Toronto and Dalhousie University and completed a Post-Doctoral Fellowship at Harvard School of Public Health.

    Denise Forkey

    Human Factors Manager, UserWise, Inc.
    Denise Forkey

    Denise has over 25 years of experience in medical device and combination product testing with experience in human factors engineering, pre-clinical testing, R&D and quality engineering. The last 5 years Denise has directed her efforts to Human Factors and Usability Engineering of complex medical devices, combination products, and consumer based medical products. She joined UserWise in early 2016 and leads human factors engineering projects for injectables through robotic surgery systems. She partners with UserWise clients on human factors strategy for FDA and international human factors submissions as well as any and all aspects of the usability engineering process. Denise has experience developing use-related risk analyses; preparing documentation for and executing formative and summative usability evaluations and human factors validation testing; authoring Human Factors Engineering Submission Reports for FDA; and providing human factors engineering training sessions. She also assists UserWise clients with gap analyses and compliance documentation for IEC 62366:2007, IEC 62366-1:2015, IEC 60601-1-6, and FDA Human Factors Guidance Documents.

    George Cusatis

    Director, Merck
    George Cusatis

    George Cusatis is Director of Merck’s Device & Digital Health team, part of Global Regulatory Affairs & clinical Safety based in Upper Gwynedd, PA. In this role, he supports the Medical Device and Combination Product (MDCP) and digital health solutions business across Merck. George provides guidance and support for more than 40 products, including auto injectors, prefilled syringes, digital health software, and contraceptives.
    George has extensive experience with the Product Development Lifecycle, including product safety, regulatory submissions, quality assurance, and clinical affairs. Prior to joining Merck, he worked at Sanofi in Swiftwater, PA, as a Pharmacovigilance Scientist for postmarket and clinical vaccine and drug products, and as a Research Associate focused on clinical pharmaceutical and vaccine applications and discovery. George also has extensive experience as a research scientist, managing research and clinical teams at Johns Hopkins University and SUNY Upstate Medical University.
    George received a M.S. in Regulatory Affairs / Quality Assurance from Temple University in Philadelphia, a M.S. in Bioengineering from Syracuse University in New York, and a B.S. in Biology from Wilkes University in Wilkes Barre, PA. He is a member of RAPS to which he holds the RAC certification, ASQ, and DIA professional societies and holds ISO certifications in Quality Management Systems Requirements (ISO 9001), Information Security Management (ISO 27001), Service Management Systems (ISO 20000), and Medical Devices Quality Management Systems (ISO 13485). He is also an author on 14 peer-reviewed publications.
     

    Ho-Seon Jin

    Engineering Advisor, Delivery, Device and Connected Solutions, Eli Lilly and Company
    Ho-Seon Jin

    Ho-Seon Jin is currently engineering advisor at Delivery Device, and Connected Solutions, R&D organization of Eli Lilly and Company, leading molding innovation for early innovation projects and commercial development. He had extensive injection molding process development experiences in the medical device industries. He had been prolific innovator and creative problem solver who consistently resolves complex issues to decrease cost and increase revenue. He always had explored emerging and disruptive technologies, applying them in new ways, and bringing real world solutions to future project.
    Ho-Seon Jin holds Bachelor of Engineering in Materials Engineering, and Doctor of Engineering degree in plastics engineering
     

    Jace Blackburn

    Smart Device Engineer, Genentech
    Jace Blackburn

    Jace Blackburn is a Smart Device Engineer at Genentech where he oversees development of Connected Device Platforms to improve the patient experience and enable new digital strategies for the business. He holds a degree in Chemical and Biological Engineering from the University of Colorado Boulder and is currently pursuing a Masters in Bioinformatics from Johns Hopkins. He holds multiple certifications in Product Management and brings expertise on the development of software as a medical devices, connected devices, and digital combination products.

    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.
     

    James Robert Wise

    Associate Senior Consultant Engineer, Eli Lilly and Company
    James Robert Wise

    James joined the Container Closure Development group at Eli Lilly in 2016 and is currently an Associate Senior Consultant Engineer in the Delivery Device and Connected Solutions Systems Engineering group. He has led container closure systems and delivery devices development for pipeline new molecule entity (NME) products, serving a dual role as tech lead and systems engineer supporting Lilly’s autoinjectors, and prefilled syringe drug delivery combination products. Previously, James worked on development projects for secondary packaging at Roche/Genentech and combination product primary packaging at Abbot Vascular. He holds a master’s degree in Business and Packaging from San Jose State University.

    Khaudeja Bano

    Executive Medical Director, Combination Product Safety Head, Amgen
    Khaudeja Bano

    Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional.

    She is an Abbott President’s award winner, avid Toastmaster and Coach. Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.

    She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).
     

    Larry Atupem

    Strategic Business Development Manager, Zeon Specialty Materials
    Larry Atupem

    Larry Atupem is the Strategic Business Development Manager at Zeon Specialty materials with responsibility for development and marketing of Cyclic Olefin Polymer business in North America. He has over decade of experience in multiple industries spanning from pharmaceutical science, thermal packaging, and thermoplastics. He holds a Bachelor of Science degree in Chemical & Biological Engineering from Tufts University along with management business coursework from Boston University.

    Maria Linzmayer

    Director, Global Pharmaceutical Operations, Quality, Merck & Co. Inc.
    Maria Linzmayer

    Maria Linzmayer is part of the Global Pharmaceutical Operations Medical Device & Combination Products (MDCP) organisation at Merck & Co. Inc. She leads the Pre-Filled Syringes Team which included the oversight for all pre-filled syringes at Merck sites and CMOs for production in the commercial space. Maria also served as the Product Steward for the development of alternative combination product images and product transfers.

    Maria started her career at Merck as a Sterile Process Technology group in Global Vaccine Technology and Engineering. Maria managed complaint investigations for Live Virus Vaccines and sterile products and multiple compliance and manufacturing initiatives to increase capacity of Merck’s vaccine portfolio.
     

    Mehak Mehta

    Scientist II, Protein Drug Product Development, Biogen
    Mehak Mehta

    Mehak Mehta is a Scientist in the Parenteral Drug Product Development group at Biogen. She is responsible for formulation, process development, tech transfer and container development of parenterals with an expertise in lyophilized drug products and solid-form characterization. Mehak received her Ph.D. in Pharmaceutics from University of Minnesota.

    Murat Gunay

    Sr. Consultant Engineer – Mechanical Engineering, Eli Lilly and Company
    Murat Gunay

    Murat Günay is currently a Senior Consultant Engineer at Delivery, Device and Connected Solutions organization of Eli Lilly and Company (a.k.a. Lilly) and responsible for ensuring the integrity of robust drug delivery devices design through providing mechanical design expertise. He previously led various medical gas delivery systems development and the drug manufacturing process development at Linde plc (formerly Praxair Inc.) Healthcare Applications Research & Development department. Moreover, as a Mechanical Design Engineer, he had carried out the design process of new transmission control products from concept phase to production launch at Sensata Technologies (formerly Texas Instruments).

    Murat Günay holds Bachelor of Science, Master of Science and Doctor of Philosophy degrees in mechanical engineering, and he is a licensed professional engineer in the USA and Canada.
     

    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.

    Paul Upham

    Head, Smart Device, Roche / Genentech
    Paul Upham

    Paul is the 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 and his team were responsible for all upstream and downstream marketing strategy for BD's self-injection business, including pen injectors, autoinjectors, and wearable patch injectors.
    Prior to that role, Paul was with WellDoc, Inc. as Director of Product Marketing, where he built and led the marketing team and was responsible for product management activities for WellDoc’s portfolio of mobile health solutions. He was also the Core Team Leader for WellDoc’s landmark BlueStar™ product, a class II medical device and the world’s first reimbursed, prescription-only software for type 2 diabetes.
    Paul’s prior experience includes 10 years at BD in the Diabetes Care business. Paul was responsible for the development and launch of the award-winning BD InterActiv® Diabetes Software, and was a member of the joint BD / Medtronic core 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 multiple patent applications covering software and medical devices. He is also an author and co-author of numerous peer-reviewed articles in medical informatics and in diabetes. His education background includes undergraduate studies in cognitive science and graduate work in health informatics and finance at the University of Minnesota and New York University.
     

    Rachel Poker

    Associated Director, Human Factors, AstraZeneca
    Rachel Poker

    Rachel Poker is an Associate Director, Human Factors, at AstraZeneca, where she has responsibilities leading the incorporation of human factors and a patient- and user-centric mindset from early stage technology development to support for on market products for the biologics and parenteral portfolio.
    With 15 years in both device and drug-led combination products across a range of roles in R&D, her experience includes parenteral, inhalation, and ocular drug delivery devices, connected device technologies, and vascular intervention products.
    Rachel has a bachelors in Biomedical Engineering from the University of Minnesota and PMP certification from the Project Management Institute

    Scott Surrette

    Manager, Regeneron Pharmaceuticals, Inc.
    Scott  Surrette

    Scott Surrette is a Manager of Combination Product Development at Regeneron Pharmaceuticals Inc. Scott leads a team responsible for developing medical devices to support the use of Regeneron’s products for subcutaneous and intraocular injection. He has been at Regeneron for 8 years and worked in orthopedic research prior. He has a Master’s in Biomedical Engineering, Master’s of Business Administration, and Bachelor’s in Exercise Biology. Scott spends his free time with his wife, four-year-old daughter, 2-year-old son, and three dogs.

    Scott Mullen

    Senior Director, Connected Healthcare, Ascendis Pharma
    Scott Mullen

    Scott is currently the commercial lead for connected healthcare projects at Ascendis Pharma. Prior to joining Ascendis, he worked at Bayer as the brand lead for Betaseron (interferon beta-1b), where he led the U.S. launch of the BETACONNECT connected healthcare system.

    His prior work includes positions with prominent pharmaceutical companies such as Novo Nordisk, Merck and Wyeth, with past roles in drug manufacturing (solid dosage forms and sterile products), market research, medical education, field sales and brand marketing leadership.

    Scott currently lives in the Philadelphia, Pennsylvania area. He earned his BSc (Biology) and MBA (Marketing) degrees at Syracuse University.
     

    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.

    Before founding UserWise in 2014, Shannon was a Human Factors Engineer at Intuitive Surgical and Abbott Laboratories.

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

    Sindhuja Kuchibhatla

    Device Development Engineer, Regeneron Pharmaceuticals
    Sindhuja Kuchibhatla

    Sindhuja Kuchibhatla is a Device Development Engineer in the Combination Products New Technologies Management team at Regeneron. Her role involves understanding the needs of Regeneron’s pipeline and patients to develop innovative drug delivery technologies.
    After earning a Bachelor’s degree in biomedical engineering from The College of New Jersey, Sindhuja completed her Master’s in the same field at Cornell University. Prior to joining Regeneron, Sindhuja worked at West Pharmaceutical Services on their Innovation & Technology team, focusing on patient insights and digital health.
     

    Young Chun

    Associate Director Lead, Human Factors & User Research, Takeda Pharmaceutical Company Limited
    Young Chun

    Young leads human factors activities and provides technical leadership throughout product development life cycle in various platforms for delivery of Takeda’s wide portfolio of drugs.
    Before joining Takeda, Young was at Biogen where she led human factors activities for various medical devices/combination products and Software as a Medical Device project. Prior to Biogen, Young worked as a human factors researcher and investigated Musculoskeletal Disorders and mental stress in the automobile industry. Young also edited a book ‘Industrial Standardization’ published by Korea National Open University Press.

    Young obtained her doctorate degree from Texas Tech University, with specialty of Human factors.
     

    Sponsors

    Exhibitors

    Official Media Partner

    Supporting Media Partners

    VENUE

    Online Virtual Event

    Online Virtual Event , USA

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

    Preliminary Attendees 2021

    Download

    Speaker Interview with Shannon Clark, UserWise, Inc.

    Download

    Speaker Interview with Scott Surrette, Regeneron Pharmaceuticals, Inc.

    Download

    Speaker Interview with Paul Upham, Roche / Genentech

    Download

    Speaker Interview - Alie Jahangir, Senior Principle Engineer, Janssen Pharmaceuticals

    Download

    Speaker Interview - Jace Blackburn, Smart Device Engineer, Genentech

    Download

    Chair Letter 2021

    Download

    Workshop B (Short Programme)

    Download

    Workshop B (Full Programme)

    Download

    Workshop A (Short Programme)

    Download

    Workshop A (Full Programme)

    Download

    Past Attendees 2021

    Download

    Speaker Bios 2021

    Download

    Short programme 2021

    Download

    Full programme 2021

    Download

    Brochure 2021

    Download

    Past presentation with Christine Lynn Lanning, Merck & Co., Inc

    Download

    Past presentation with Jim Leamon, Jazz Pharmaceuticals

    Download

    Past presentation with Shannon Clark, UserWise, Inc.

    Download

    Past Presentation with Walter Goodwin, Gilead Sciences

    Download

    Past Presentation with Jace Blackburn, Genentech

    Download

    Past Presentation with Jonathon Sutch, BSi

    Download

    Sponsors


    ZEON

    Sponsors
    http://www.zeonex.com

    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.

    Exhibitors


    Almac Group

    Exhibitors
    http://www.almacgroup.com

    Almac is an established contract development and manufacturing organization that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. From our Audubon, PA facilities, Almac provides innovative commercial packaging solutions built upon quality & flexibility to support all your packing needs, from niche/orphan drug launches to high volume products. Our specialized packaging solutions for all biopharmaceutical dosage forms (vials, ampoules, pre-filled syringes, auto-injector pens) includes:
    • - Pack design and prototype generation
    • - Labeling, assembly and secondary packaging
    • - Complex kit assembly
    • - Temperature sensitive storage
    • - Serialization
    Our wide range of services and flexibility to handle projects of any size, makes us your preferred US packaging partner.


    Boston Analytical

    Exhibitors
    http://www.bostonanalytical.com

    Boston Analytical is a cGMP compliant, FDA/DEA registered, ISO/IEC-17025:2005 certified analytical laboratory located in Salem, NH. Boston Analytical provides testing services to Pharmaceutical and Medical Device companies worldwide including Analytical Testing and Method Development, Microbiological Testing and Environmental Monitoring Services, Biologics, Stability Testing & ICH-compliant Storage, and Extractables & Leachables Studies.

    Media Partners


    ONdrugDelivery Magazine

    Official Media Partner
    http://ondrugdelivery.com

    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.


    American Pharmaceutical Review

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

    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


    Medical Design Briefs

    Official Media Partner
    http://WWW.TECHBRIEFS.COM/SUBSCRIBE/MDB/SMIEAST21

    Medical Design Briefs (MDB) is the only publication for the medical OEM market dedicated to medical product design engineers and managers. We offer timely, accurate, quality content and editorial, and we report on engineering-related topics that are at the core of the latest medical technologies. From materials to manufacturing, we dive into the technical side of bringing medical devices to market. From biosensors to cybersecurity, we keep our fingers on the pulse of the hottest trends and topics that may augment or disrupt medical technology.

    Media Partners


    Pharmaceutical Outsourcing

    Supporting Media Partners
    http://www.pharmoutsourcing.com

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


    Pharmiweb

    Supporting Media Partners
    http://www.pharmiweb.com

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    Pharmaceutical Technology

    Supporting Media Partners
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    Pharmalicensing

    Supporting Media Partners
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Technology Networks

    Supporting Media Partners
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Farmavita

    Supporting Media Partners
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    World Pharma Today

    Supporting Media Partners
    http://www.worldpharmatoday.com



    Mednous

    Supporting Media Partners
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Pharma Journalist

    Supporting Media Partners
    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.


    Biocompare

    Supporting Media Partners
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    World Pharma News

    Supporting Media Partners
    http://www.worldpharmanews.com/



    Drug Discovery Today

    Supporting Media Partners
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    Pharmacircle

    Supporting Media Partners
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….

    SAVE TO


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

    Online Virtual Event

    Online Virtual Event
    USA

    Online Virtual Event

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    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, SMI 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@smi-online.co.uk

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




    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 SMi.
    Full details of our privacy policy can be found here https://www.smi-online.co.uk/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data@smi-online.co.uk.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smi-online.co.uk/opt-out