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SMi is proud to announce the inaugural Prefilled Syringes San Francisco Virtual Conference taking place in September 2020.

The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion by 2025. With that in mind, this event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human factors studies and innovative design and delivery systems within the prefilled syringes industry.

As part of SMi's leading Injectable conference series, we will assess digital health and connected devices, biologics, biosimilars and biocompatibility for drug/device combination products, platform and device selection, regulatory insights and hear from the West Coast's biotech innovators.
 

This two-day agenda offers you peer-to-peer networking with Global Product Managers, Device Testing Managers, Senior Device Engineers, Heads of Device Development, Heads of Formulation and Drug Process Development, and many more.
 

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

Pre-Filled Syringes San Francisco will explore the latest industry case studies in platform approaches and connected devices. Gain insights from leading industry and regulatory experts on the pre-filled syringes environment. Hear from local biotechs of San Francisco and the West Coast to learn about new innovations in the pre-filled syringes space and engage in the key challenges and topics of the field in two interactive half-day workshops.

 

The SMi Virtual Conference Platform will deliver the following benefits:

  • Live and On Demand speaker content: Get access to the latest strategies and case studies from your market place online!
  • Network with all the event attendees: Connect, see who’s attending, chat and share contact details with all online delegates, speakers and sponsors
  • Exhibit a Virtual Booth: You can pack your customized booth full of documents, videos and even show who is manning the booth during the event and hosting meetings
  • Host & Join Meetings & Socials: Join preferred speaking sessions, host you own meetings and even a virtual Networking social, with in built Zoom functionality

 

  • 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:

3P Innovation Ltd; Alexion Pharmaceuticals; American Regent Inc; Amgen; Amgen Incorporated; Aptar Pharma; AstraZeneca; BCM Group LLC; BD / Becton, Dickinson and Company; Biogeneral Incorporated; BMS; Bristol Myers Squibb; Bristol-Meyers Squibb; Bristol-Myers Squibb; Celanese Corporation ; Celgene; Connecticut Spring & Stamping; Credence MedSystems, Inc.; Elektrofi; Eli Lilly and Company; Emd Serono; FDA; Ferring Pharmaceuticals; Flexion Therapeutics; Gerresheimer; Grifols; GSK; GSK Pharma; Harro Hofliger Verpackungsmaschinen GmbH; Imbrium Therapeutics; Janssen; Janssen Pharmaceutical Incorporated; Janssen Supply Chain, Johnson & Johnson; kaleo, Inc.; Key Tech; Kiniksa Pharmaceuticals; Lonstruff AG; MedImmune; Merck; Mitsubishi Gas Chemical Company, Inc; Mitsubishi Gas Chemical Singapore Pte Ltd; Momenta Pharmaceuticals; Nipro PharmaPackaging; NN Life Sciences; Nypro; Owen Mumford; Pfizer; Pfizer Inc; Pfizer Inc.; Pharmacircle; PHC Corporation of North America; Plastic Ingenuity Inc; Polyplastics, USA; Purdue Pharma; Regeneron Pharmaceuticals; RheoSense, Inc; Sagentia Ltd; Sanofi; Sanofi Pasteur; Sanofi Pharmaceuticals; Sanofi US; Schott AG; SCHOTT AG - Pharmaceutical; Smithers Rapra; Steri-Tek; Sumitomo Rubber; Takeda; Takeda Pharma Ceuticals International; Terumo Solutions; Teva Pharmaceuticals; Topas Advanced Polymers; Uhlmann; W.L. Gore & Associates, Inc.; West Pharmaceutical Services; zebrasci inc; Zeon Specialty Materials ; Zeon Specialty Materials Inc;
 

Conference programme

8:00 Chairs' Opening Remarks

Shannon Clark

Shannon Clark, Principal, UserWise, Inc.
View Bio

Steven Badelt

Steven Badelt, Founder and Managing Partner, Suttons Creek Inc
View Bio

8:10 Regulatory Considerations for Combination Products

  • Update on current FDA and CDER guidance for combination products
  • Review considerations for combination products
  • Drug and device requirements for innovative designs
  • Recommendations for engagement with the Agency
  • Kristina  Lauritsen

    Kristina Lauritsen, Combination Products Regulatory Advisor, FDA/CDER

    8:50 Notified Bodies and Article 117

    Session Reserved for

    Session Reserved for, , BSI Group

  • Notified bodies and drug device combinations
  • Experience with Article 117 applications
  • Documentation from the manufacturer
  • Notified body opinion report
  • 9:30 When and How to Connect: Your Device is NOT Your Digital Strategy

    Jace Blackburn

    Jace Blackburn, Smart Device Engineer, Genentech
    View Bio

  • Understanding the value of connected devices for patients, HCPs, and the business
  • Key considerations for selecting (or building) an appropriate connected device platform
  • Incorporating a platform connected device into digital solutions that patients will actually use
  • 10:10 Morning Break and Virtual Exhibit Hall Open

    10:25 Connected Devices and their Potential to Deliver User Benefits

    Katie Atkinson

    Katie Atkinson, Manager, Human Factors Engineering, Bigfoot Biomedical

  • What are connected systems of devices and why would a sponsor elect to develop a connected system
  • Potential benefits of connected devices and the trade-offs
  • Usability considerations of connected devices
     
  • 11:05 Developing Custom Syringes for Highly Viscous Formulations

    Walter Goodwin

    Walter Goodwin, Device Engineer, Gilead Sciences

  • Gilead and West are developing a custom cyclic olefin polymer (COP) syringe to enable delivery of viscous formulations through subcutaneous injection needles
  • Due to the high injection forces required, syringe stresses and failure modes had to be well understood to inform design improvements
  • The final syringe design can withstand forces in excess of 500N, while remaining ISO 11040-6 compliant to facilitate fill/finish activities
     
  • 11:45 Technical Overview of COP for Prefilled Syringes

    Larry Atupem

    Larry Atupem, Sr Business Development Specialist, Zeon Specialty Materials
    View Bio

  • Key properties of COP
  • Case Study (New): 
  • Protein Adsorption of Abatacept – COP vs Glass
  • Immunogenicity test of the aggregates
  • Case Study: Protein Adsorption of Humira, Embrel, Remicade – COP vs Glass
  • Case Study: Protein Adsorption with/without Polysorbate (Surfactant) – COP vs Glass
  • Leachable data on COP syringes
     
  • 12:25 Networking Break

    12:55 Elastomeric components: Supporting next generation drug delivery systems

    Douglas Cusato

    Douglas Cusato, Director of Business Development, Sumitomo Rubber
    View Bio

  • How can innovation in elastomeric components support PFS & next generation drug delivery systems?
  • How can a suppliers manufacturing network support PFS & next generation drug delivery systems?
  • What can we learn from other industries and apply it to future innovations and support drug delivery innovations?
     
  • 13:35 Your Drug or Mine? Managing Differentiation Hazards with Injectable Devices

  • Translating user and use characteristics environments into design considerations
  • Design elements for packaging and device differentiability
  • Strategies for conducting usability evaluations for product differentiation
  • Product differentiation case studies

     

  • Natalie Abts

    Natalie Abts, Head of Human Factors Engineering, Genentech
    View Bio

    Shannon Clark

    Shannon Clark, Principal, UserWise, Inc.
    View Bio

    Aly McDonald

    Aly McDonald, Human Factors Engineer, Genentech

    14:35 Latest Date of OXYCAPT Multilayer Plastic Vial & Syringe

    Hiroki  Hasegawa

    Hiroki Hasegawa, Researcher, Mitsubishi Gas Chemical Company, Inc
    View Bio

  • Comparison among OXYCAPT, COP and Glass
  • Oxygen & Ultraviolet Barrier
  • Oxidation and Aggregation Studies of Antibody
  • Development of Staked Needle Syringe
  • 15:15 Chairs’ Closing Remarks and Close of Day One

    Shannon Clark

    Shannon Clark, Principal, UserWise, Inc.
    View Bio

    Steven Badelt

    Steven Badelt, Founder and Managing Partner, Suttons Creek Inc
    View Bio

    8:00 Chairs' Opening Remarks

    Shannon Clark

    Shannon Clark, Principal, UserWise, Inc.
    View Bio

    Steven Badelt

    Steven Badelt, Founder and Managing Partner, Suttons Creek Inc
    View Bio

    8:10 Qualification and validation of VH2O2 industrial low temperature terminal sterilizer process and equipment - Case study on process control and monitoring

    Juha Mattila

    Juha Mattila, Director, Sterilisation Technologies, STERIS Corporation
    View Bio

  • Brief introduction to VH2O2 sterilization process, technology and applications
  • Discuss validation and meeting ISO14937 standard requirements - and looking at the scenario of future VH2O2 specific standards
  • Present the essential process variables forVH2O2 sterilization
  • Case study on testing and comparing performance of various hydrogen peroxide concentration measurement methods – and proposing an applicable approach
     
  • 8:50 Human Factors Validation Study Guidelines for Medical Devices

    Shannon Clark

    Shannon Clark, Principal, UserWise, Inc.
    View Bio

  • An overview of the FDA human factors guidance and the 21 CFR 820.30(g) 
  • Ensuring comprehensive risk analysis to minimize/eliminate of use errors
  • What does the FDA mean by “Task Acceptance Criteria”?
  • The Perception, Cognition, Action (PCA) analysis framework
  • Considering all components of the user interface including packaging, labelling, instructions, displays and controls
  • Understanding what validation study requirements are expected of manufacturers
  • 9:30 Post-Market safety reporting (PMSR) for combination products – Implementation

    Khaudeja Bano

    Khaudeja Bano, Senior. Medical Director, Abbott Laboratories
    View Bio

  • Summary of implemented updates to the guidance for industry
  • Strategies in implementation of PMSR and its application to drugs and devices
  • Industry response and developments - what have we seen in industry already and what is still needed? 
  • Case study: implementation of PMSR for a combination product
  • 10:10 Morning Break and Virtual Exhibit Hall Open

    10:25 Combination product drug delivery

    James Leamon

    James Leamon, Director of Biologics Device Development, Jazz Pharmaceuticals

  • Meeting the needs of oncology and respiratory disease patients
  • Intravenous to subcutaneous delivery
  • The future of combination products
  • 11:05 Challenges and Considerations in the Manufacture of Large Volume Containers

    Jason E. Fernandez

    Jason E. Fernandez, Senior Scientist, Biogen
    View Bio

  • An outlook of industry demand for large volume injectors for drug delivery 
  • Bolus injector primary container manufacturing challenges
  • Key considerations for process implementation and fill/finish
  • Case study: Large Volume Primary Container Development
  • 11:45 The Clinical Development of the Voretigene Neparvovec, a gene therapy for RPE65 associated Inherited Retinal disease and the routes of ocular administration, past and future

    Daniel  Chung

    Daniel Chung, Global Medical Strategy Lead-Ophthalmology, Spark Therapeutics
    View Bio

  • Clinical development of Voretigene Neparvovec
  • Current routes of gene therapy delivery
  • Challenges and barriers to PFS 

     

  • 12:25 Networking Break

    12:55 Biocompatibility assessments for PFS: Global regulatory considerations

    Christine Lynn Lanning

    Christine Lynn Lanning, Distinguished Scientist, Device Area Leader, Safety Assessment/Merck & Co., Inc
    View Bio

  • Regulatory landscape for biocompatibility: US, EU-MDR, and recent changes in ISO 10993-1:2019
  • Biocompatibility Risk Assessment: triggers, challenges and leveraging supplier data versus testing
  • Case Studies: syringe, safety devices, and needles
  • Regulatory submissions: presenting Biocompatibility assessments in a global dossier
  • 13:35 High viscosity parenterals – syringeability and injectability issues

    Reza Fassihi

    Reza Fassihi, Professor of Biopharmaceutics and Industrial Pharmacy, Temple University
    View Bio

  • Assessing delivery considerations of highly viscous polymeric fluids
  • Challenges of parenteral delivery of complex formulations with diverse viscosities
  • The inter-relationship between needle size, syringe volume, viscosity and injectability of polymeric solutions
  • Study findings and how can this be applied for improved delivery of concentrated biologics
  • 14:15 Chairs’ Closing Remarks and Close of Day Two

    Shannon Clark

    Shannon Clark, Principal, UserWise, Inc.
    View Bio

    Steven Badelt

    Steven Badelt, Founder and Managing Partner, Suttons Creek Inc
    View Bio

    +

    FEATURED SPEAKERS

    Aly McDonald

    Aly McDonald

    Human Factors Engineer, Genentech
    Christine Lynn Lanning

    Christine Lynn Lanning

    Distinguished Scientist, Device Area Leader, Safety Assessment/Merck & Co., Inc
    Daniel  Chung

    Daniel Chung

    Global Medical Strategy Lead-Ophthalmology, Spark Therapeutics
    Douglas Cusato

    Douglas Cusato

    Director of Business Development, Sumitomo Rubber
    Hiroki  Hasegawa

    Hiroki Hasegawa

    Researcher, Mitsubishi Gas Chemical Company, Inc
    Jace Blackburn

    Jace Blackburn

    Smart Device Engineer, Genentech
    Juha Mattila

    Juha Mattila

    Director, Sterilisation Technologies, STERIS Corporation
    Khaudeja Bano

    Khaudeja Bano

    Senior. Medical Director, Abbott Laboratories
    Kristina  Lauritsen

    Kristina Lauritsen

    Combination Products Regulatory Advisor, FDA/CDER
    Michael Koby

    Michael Koby

    Senior. Principle Scientist, Pfizer, Inc.
    Natalie Abts

    Natalie Abts

    Head of Human Factors Engineering, Genentech
    Reza Fassihi

    Reza Fassihi

    Professor of Biopharmaceutics and Industrial Pharmacy, Temple University
    Shannon Clark

    Shannon Clark

    Principal, UserWise, Inc.
    Steven Badelt

    Steven Badelt

    Founder and Managing Partner, Suttons Creek Inc
    Walter Goodwin

    Walter Goodwin

    Device Engineer, Gilead Sciences

    Aly McDonald

    Human Factors Engineer, Genentech
    Aly McDonald

    Christine Lynn Lanning

    Distinguished Scientist, Device Area Leader, Safety Assessment/Merck & Co., Inc
    Christine Lynn Lanning

    Dr. Christine Lynn Lanning is a Distinguished Scientist in Safety Assessment at Merck. In this role, she provides oversight of the biocompatibility of medical devices and medical device combination products. She has a PhD from Duke University in Pharmacology/Toxicology and is Six Sigma Green and Black Belt Certified. She has been at Merck over 20 years in drug and device development in varying roles as a Study Director, toxicologist, compound leader, regulatory liaison, the Head of the Toxicological Sciences group and as the lead of the MRL Quality Management System. She has authored over 200 scientific reports and over 50 regulatory submissions.

    Daniel Chung

    Global Medical Strategy Lead-Ophthalmology, Spark Therapeutics
    Daniel  Chung

    Dr. Chung is the Medical Strategy Lead- Ophthalmology for Spark Therapeutics and the company’s inherited retinal disease and ophthalmology expert and resource. He also served as Spark’s Medical Affair Ophthalmic Lead and the Clinical Development Ophthalmic Lead. Prior to joining Spark Therapeutics, he was a senior investigator at the FM Kirby Center for Molecular Ophthalmology at the Scheie Eye Institute at the Perelman School of Medicine of the University of Pennsylvania, working in retinal gene therapy and transfer. Concurrently, he served as the scientific advisor on the RPE65 gene therapy study team at the Children’s Hospital of Philadelphia (CHOP). He was the PI and first author for the RPE65 natural history study and the Multi-luminance Mobility Test (MLMT) validation study. Dr. Chung earned his medical degree from the New York Institute of Technology College of Osteopathic Medicine and completed his residency in Akron, Ohio. He then completed fellowships in pediatric ophthalmology and ocular genetics research at the Cole Eye Institute at the Cleveland Clinic, with additional training in retinal gene therapy at the National Eye Institute/NIH in Bethesda, MD. As the medical strategy lead for ophthalmology, he works in the areas of medical affairs, clinical development and operations, pre-clinical studies, patient advocacy, commercial and marketing and business development.

    Denise Forkey

    Senior Human Factors Engineer, UserWise, Inc.
    Denise Forkey

    Douglas Cusato

    Director of Business Development, Sumitomo Rubber
    Douglas Cusato

    Douglas Cusato is the Director of the Medical Rubber Business for Sumitomo Rubber, North America . In this role, he is responsible for all aspects of the regional business including Strategy, R&D, Operations and Sales. Douglas has been active in the parenteral packaging industry since 2006 and has served in various technical leadership roles with focus on technology and platform development. He has chaired multiple industry tasks forces and participates in numerous groups as a subject matter expert in elastomeric components for parenteral packaging applications. Doug holds a bachelor’s degree in Chemistry from Rutgers University.

    Hiroki Hasegawa

    Researcher, Mitsubishi Gas Chemical Company, Inc
    Hiroki  Hasegawa

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

    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

    Jason E. Fernandez

    Senior Scientist, Biogen
    Jason E. Fernandez

    Jason Fernandez is a Senior Scientist in the Protein Pharmaceutical Development group at Biogen. He is responsible for the formulation, manufacturing process development, tech transfer and container development of liquid parenteral dosage forms. Jason has over 18 years of experience focused on therapeutic protein drug product development over multiple companies.

    Juha Mattila

    Director, Sterilisation Technologies, STERIS Corporation
    Juha Mattila

    Juha Mattila is Director, Sterilization Technologies, responsible for STERIS Finn-Aqua product portfolio, including steam and VHP sterilization and biodecontamination technologies and WFI distillation and pure steam generation systems. He has Bachelor of Science with Honors in HVAC and process engineering, and Master of Engineering in Business Informatics. He joined STERIS in 2000 and has 20 years of experience with pharmaceutical and research technologies, including R&D, engineering and product management and total of technology and engineering experience exceeding 25 years. He is a member of PDA, ISPE and Finnish Biosafety Network and subject matter relative international standard work groups, representing Finland.

    Katie Atkinson

    Manager, Human Factors Engineering, Bigfoot Biomedical
    Katie Atkinson

    Khaudeja Bano

    Senior. Medical Director, Abbott Laboratories
    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).
     

    Kristina Lauritsen

    Combination Products Regulatory Advisor, FDA/CDER
    Kristina  Lauritsen

    Larry Atupem

    Sr Business Development Specialist, Zeon Specialty Materials
    Larry Atupem

    Larry Atupem is the Sr. Business development specialist 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.

    Michael Koby

    Senior. Principle Scientist, Pfizer, Inc.
    Michael Koby

    Michael joined Pfizer in 2013 and currently leads a group of Packaging SME’s within the BioTherapeutics Formulation and Process Development group that is part of Pfizer’s Pharmaceutical Sciences R&D organization. Michael is a Sr. Principle Scientist at Pfizer’s new research and development facility in St. Louis and supports numerous R&D and commercial manufacturing sites around the world. His areas of expertise include package integrity, component and container closure system development, qualification and testing, as well as design and design verification of combination products.
    Michael has a Bachelor of Science degree from the Ohio State University and over 30 years of experience with the pharmaceutical industry. Prior to joining Pfizer, Michael held roles in Quality Control, Quality Assurance and Technical Services supporting both development and commercial manufacturing in small startups as well as large pharmaceutical and Biotech manufacturing companies.
     

    Miles Buroker

    Human Factors Engineer, UserWise, Inc.
    Miles Buroker

    Natalie Abts

    Head of Human Factors Engineering, Genentech
    Natalie Abts

    Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

    Reza Fassihi

    Professor of Biopharmaceutics and Industrial Pharmacy, Temple University
    Reza Fassihi

    Dr. Fassihi is a professor of biopharmaceutics and industrial pharmacy at Temple University, School of Pharmacy, where he has taught and done research in the pharmaceutical sciences since 1992. He has worked as an assistant professor at Isfahan University (1979-1982), a postdoctoral fellow at Brighton University (1983), a Senior Scientist at Welsh School of Pharmacy (1984), and Senior Lecturer at Rhodes University in South Africa (1984-1988). He was Founder and Head of School of Pharmacy, and Professor and Chair of Department, at University of the Witwatersrand in Johannesburg, South Africa (1988-1992), where he was awarded with gold medals by both the Academy of Pharmaceutical Sciences and the Society of Cosmetic Chemists. In 1991 he was a visiting professor at Cincinnati University undertaking research in advanced biopharmaceutics with Professor Wolfgang A. Ritschel and in 1992 he joined Temple University, School of Pharmacy, where he has served as professor, director of graduate programs, chair of various university committees and professional organizations. His research emphasizes on design, development, evaluation (in-vitro and in-vivo), optimization and scale-up operations of oral dosage forms, oral-soluble films, orally disintegrating tablets, capsules, tablets, enteric coated, osmotic pumps, tampered resistant systems, controlled and modified release drug delivery(CR), dispersed systems, topical products, gels, parenteral and advanced delivery systems.

    Session Reserved for

    , BSI Group
    Session Reserved for

    Shannon Clark

    Principal, 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.
     

    Steven Badelt

    Founder and Managing Partner, Suttons Creek Inc
    Steven Badelt

    Steve is a seasoned expert in combination products, engineering management, systems engineering, and business development. He has over 20 years of experience in the design and launch of combination products and medical devices, including autoinjectors, insulin pumps, implantable defibrillators, connectivity, and patient management software.
    Steve founded consulting firm Suttons Creek, Inc. in 2012, which has served as the device team for pharma on over 50 combination product programs. He is a member of the advisory board for the Los Angeles-based Greenwings, a seed-capital investment fund for technology transfer through the startup phase into the biotech/medtech market. Steve leads the Biomedical and Healthcare Working Group (BHWG) for the International Council on Systems Engineering (INCOSE) in southern California. And, he also serves as a Graduate Professor at Loyola Marymount University. Helping others to learn and grow is a core value of Steve’s, so in his “spare time,” he also advises startups and speaks nationally about combination products and connectivity.
    Steve holds a BS in Electrical Engineering from Carnegie Mellon University, an MS in Biomedical Engineering from UCLA, and a PhD in Neuroengineering from UCLA. He has been awarded multiple awards for his business plan writings (Tech Coast Angels), his research (Yahoo!, The Smithsonian), his leadership (Carnegie Mellon), and his excellence in his field (St. Jude Medical).
    Steve is a long-time member of both the International Council on System Engineering and the Institute for Electronics and Electrical Engineering (IEEE), and was honored as a Distinguished Speaker of the latter. His extensive list of previous employment includes industry leaders such as IBM, Cardiac Insight, Inc. and Bioness, as well as leading organizations in the fields of social networking, alternative energy and defense.

    Walter Goodwin

    Device Engineer, Gilead Sciences
    Walter Goodwin

    Sponsors

    Exhibitors

    Official Media Partner

    Supporting Media Partners

    Workshops

    A notified body roadmap to Article 117 and pre-filled syringes regulatory strategy
    Workshop

    A notified body roadmap to Article 117 and pre-filled syringes regulatory strategy

    Online Virtual Event
    16th September 2020
    Online Virtual Event , USA

    Human Factors and Risk Management
    Workshop

    Human Factors and Risk Management

    Online Virtual Event
    16th September 2020
    Online Virtual Event , USA

    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 list - July 2020

    Download

    Speaker interview Jace Blackburn, Genentech

    Download

    Brochure 2020

    Download

    Workshop A

    Download

    Workshop B

    Download

    Speaker Bio's

    Download

    Chair letter

    Download

    Past attendee list (PFS WC)

    Download

    Full programme 2020

    Download

    Short programme 2020

    Download

    Past presentation - Valerie Fenster, Kaleidoscope innovation

    Download

    Past presentation - ZEON

    Download

    Past presentation - Sumitomo Rubber Industries

    Download

    Past presentation - Tina Rees,Ferring Pharmaceuticals

    Download

    Past presentation - Shannon Clark, UserWise

    Download

    Past presentation - Severine Duband, NEMERA

    Download

    Past presentation - Mitsubishi Gas Chemical

    Download

    Past presentation - Natalie Abts, Genentech

    Download

    Past presentation - Lori Burton, Bristol-Myers Squibb

    Download

    Past presentation - FDA

    Download

    Past presentation - Ed Israelski, HFE

    Download

    Past presentation - Dr.Benjamin Werner, Boehringer ingelheim

    Download

    Past presentation - Diane Doughty, AstraZeneca

    Download

    Past presentation - Delma L. Broussard, CSL Behring

    Download

    Sponsors


    Mitsubishi Gas Chemical

    Sponsors
    https://www.mgc.co.jp/eng/products/abd/oxycapt.html

    Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen, ultra violet and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.


    STERIS

    Sponsors
    http://www.sterislifesciences.com

    STERIS Life Sciences is your trusted partner in contamination control. For over 100 years, STERIS has been a global leader and expert in the industries of sterilization, cleaning and infection control.

    Today, we continue to build on this heritage by providing the products and resources you need throughout every step of your process. From innovation to results, our comprehensive portfolio of products and services is designed to meet your needs.

    With offices located worldwide and technicians in over 100 countries, you can count on us to be where you are when you need us, every step of the way. Trust STERIS Life Sciences to help you create a healthier and safer world.



    Sumitomo Rubber Industries

    Sponsors
    http://hybrid.srigroup.co.jp/en/products/cleanrubber/

    Since our founding in 1909 as the first modern rubber factory in Japan, we at Sumitomo Rubber Industries have strived to produce advanced, environmentally friendly products based on the latest innovations in rubber technology. Within the medical rubber group, we are focused on providing the highest quality products, and ultimately dedicated to improving the lives of people around the world. Utilizing the latest in material and process innovations and our global manufacturing footprint, our team members work diligently to ensure we deliver consistent high performing products and provide strong assurance of supply.


    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


    Credence MedSystems

    Exhibitors
    http://www.credencemed.com

    Credence MedSystems is an innovator in injectable drug delivery devices. Credence’s philosophy of Innovation Without Change results in products that impress and protect end-users while preserving pharma’s existing processes, sourcing strategies and preferred primary package components. The Companion® family of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in Staked and Luer needle formats. The Dual Chamber platform offers single-step mixing and injection for drugs requiring reconstitution at the time of delivery. Additional products such as metered dose devices, multi-length staked needles and other novel devices address the needs of specific therapeutic markets.


    PHC Corporation

    Exhibitors
    http://www.phchd.com/global/

    PHC Corporation of North America is a subsidiary of PHC Holdings Corporation, Tokyo, Japan, a global leader in Medical Devices, Healthcare IT and Life Sciences. With drug delivery devices, ultra-low temperature freezers, biomedical refrigerators and incubators, PHC offers technologies and solutions for pharmaceutical, life science and biotechnology applications across industries.


    Plastic Ingenuity

    Exhibitors
    http://www.plasticingenuity.com

    Plastic Ingenuity is a custom thermoformer that provides packaging for the drug delivery and pharmaceutical markets. We specialize in creating secondary packaging for pharmaceutical combination products and automation trays that integrate into high volume assembly equipment for our drug delivery partners. These parts run flawlessly on highly complex automated equipment.

    Media Partners


    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


    Pharma Journalist

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

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


    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.


    Medical Design Briefs

    Official Media Partner
    http://WWW.TECHBRIEFS.COM/SUBSCRIBE/MDB/PMEAST20

    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


    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.


    pharmaphorum

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

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


    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


    World Pharma News

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



    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.

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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, 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

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    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
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