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

Registration closes at midnight Thursday September 10th

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
    View Bio

    8:50 Notified Bodies and Article 117

    Jonathan Sutch

    Jonathan Sutch, Medicinal Specialist, BSI Group
    View Bio

  • 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

    10:30 Connected Devices and their Potential to Deliver User Benefits

    Katie Atkinson

    Katie Atkinson, Manager, Human Factors Engineering, Bigfoot Biomedical
    View Bio

  • 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
     
  • 11:10 Developing Custom Syringes for Highly Viscous Formulations

  • Gilead and SiO2 Materials Science are developing a custom cyclic olefin polymer (COP) syringe with a proprietary barrier and lubrication system 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 without major impact to fill/finish activities

     

  • Walter Goodwin

    Walter Goodwin, Device Engineer, Gilead Sciences
    View Bio

    Kushal Varma

    Kushal Varma, Vice President, Si02 materials science
    View Bio

    Joseph Rogers

    Joseph Rogers, Senior Director of Product Development, Si02 Materials Science
    View Bio

    11:50 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
     
  • 12:30 Networking Break

    13:15 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?
     
  • 13:55 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
    View Bio

    Valerie Fenster

    Valerie Fenster, Director of Insights & Human Factor , Kaleidoscope Innovation
    View Bio

    14:55 Latest Data of OXYCAPT Multilayer Plastic Vial & Syringe

    Hiroki  Hasegawa

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

    15:35 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”?
  • 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, Executive Medical Director, Combination Product Safety Head, Amgen
    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

    10:30 Combination product drug delivery

    James Leamon

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

  • Meeting the needs of oncology and respiratory disease patients
  • Intravenous to subcutaneous delivery
  • The future of combination products
  • 11:10 Challenges and Considerations in the Manufacture of Large Volume Containers

    Mehak Mehta

    Mehak Mehta, Scientist II, Parenteral Drug Product Development, 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
  • 11:50 ‘Device innovation’ for unmet injectable needs

    Mark Hassett

    Mark Hassett, Vice President of Business Development, Credence MedSystems, Inc.
    View Bio

  • Innovation without change
  • Device innovation vs. Implementation challenges
  • Device innovation for specific therapeutic markets
  • 12:30 Networking Break

    13:15 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 

     

  • 13:55 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
  • 14:35 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
    Denise Forkey

    Denise Forkey

    Senior Human Factors Engineer, UserWise, Inc.
    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
    James Leamon

    James Leamon

    Director of Biologics Device Development, Jazz Pharmaceuticals
    Jonathan Sutch

    Jonathan Sutch

    Medicinal Specialist, BSI Group
    Joseph Rogers

    Joseph Rogers

    Senior Director of Product Development, Si02 Materials Science
    Juha Mattila

    Juha Mattila

    Director, Sterilisation Technologies, STERIS Corporation
    Katie Atkinson

    Katie Atkinson

    Manager, Human Factors Engineering, Bigfoot Biomedical
    Khaudeja Bano

    Khaudeja Bano

    Executive Medical Director, Combination Product Safety Head, Amgen
    Kristina  Lauritsen

    Kristina Lauritsen

    Combination Products Regulatory Advisor, FDA/CDER
    Kushal Varma

    Kushal Varma

    Vice President, Si02 materials science
    Mark Hassett

    Mark Hassett

    Vice President of Business Development, Credence MedSystems, Inc.
    Mehak Mehta

    Mehak Mehta

    Scientist II, Parenteral Drug Product Development, Biogen
    Miles Buroker

    Miles Buroker

    Human Factors Engineer, UserWise, Inc.
    Natalie Abts

    Natalie Abts

    Head of Human Factors Engineering, Genentech
    Shannon Clark

    Shannon Clark

    Principal, UserWise, Inc.
    Steven Badelt

    Steven Badelt

    Founder and Managing Partner, Suttons Creek Inc
    Theresa Jeary

    Theresa Jeary

    Technical Specialist & Scheme Manager, BSI
    Walter Goodwin

    Walter Goodwin

    Device Engineer, Gilead Sciences

    Aly McDonald

    Human Factors Engineer, Genentech
    Aly McDonald

    Aly is a Human Factors Engineer at Genentech, where she acts as the primary HF representative on 3 project teams, including a digital health program, a novel drug-device platform, and a late stage drug-device combination product. She has experience conducting human factors activities from early-stage research through design validation. Prior to joining the Human Factors team, Aly held various roles within Pharma Technical Operations at Genentech.

    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

    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.

    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

    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. 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.

    Jonathan Sutch

    Medicinal Specialist, BSI Group
    Jonathan Sutch

    Dr Jonathan Sutch is a senior medicinal specialist at the Notified Body BSI Group, working with medical devices containing medicinal substances and drug/device combinations. Jon trained as a Pharmacist at the London School of Pharmacy prior to completing a PhD in Pharmaceutical Sciences at Nottingham University, UK. He has 15 years of experience in the pharmaceutical industry as a formulation scientist and manager before moving to BSI 3 years ago.

    Joseph Rogers

    Senior Director of Product Development, Si02 Materials Science
    Joseph Rogers

    Mr. Rogers joined to SiO2 Material Science prior to its founding in 2011. He is currently the Senior Director of Product Development, responsible for directing development activities and applications support for parenteral products. In this role he coordinates internal and external resources. He is responsible for working with customers to identify requirements and develop products using SiO2 Medical Products innovative technologies to solve unique challenges.

    Before joining SiO2 Materials Science, Mr. Rogers held similar positions at and CV Holdings, Elan Pharmaceuticals and i-STAT Corporation and led global development teams to develop medical and pharmaceutical products.

    Mr. Rogers has a Mechanical Engineering degree from Lafayette College. He has several patents for innovative product designs.
     

    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

    Katie Atkinson lives to improve the lives of patients and providers through intuitive and value add products. Katie currently works as the manager of Human Factors Engineering at Bigfoot Biomedical. She has over a decade of experience working on the design and development of medical devices and combination products across a variety of therapeutic areas and use environments. Throughout her career, Katie has worked to foster an integrated and cross-functional understanding of advantages usability engineering brings to the wider product development context.

    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).
     

    Kristina Lauritsen

    Combination Products Regulatory Advisor, FDA/CDER
    Kristina  Lauritsen

    Kristina Lauritsen, PhD serves as a Combination Product Policy Advisor within the Center for Drug Evaluation and Research (CDER) at the FDA. In this role, she is responsible for engaging in development of CDER's policies related to combination product review and regulation, including activities such as guidance development, facilitating coordination with the FDA's Office of Combination Products, CBER and CDRH, and representing CDER in cross-center combination product working groups. Kristina originally joined FDA in 2003 as a device reviewer in CDRH. She later joined the Office of Combination Products and spent several years there prior to joining CDER in 2014. She holds a B.S. in Biology from Shippensburg University, and a Ph.D. in tumor biology from Georgetown University.

    Kushal Varma

    Vice President, Si02 materials science
    Kushal Varma

    As Vice President of Program Management, Kushal Varma heads the program management team at SiO2. He is responsible for planning, execution and commercialization of all SiO2’s programs/projects. Mr. Varma has more than 10 years of experience in product development and product launch in pharma medical devices. He has led and managed global cross-functional teams to execute complex medical device and drug-device combination product development projects through to launch. Mr. Varma received his master’s degree in biomedical engineering from Drexel University.

    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.

    Mark Hassett

    Vice President of Business Development, Credence MedSystems, Inc.
    Mark Hassett

    Mark Hassett, Vice President of Business Development, Credence MedSystems, Inc.
    Mr. Hassett has 30+ years’ experience in the medical device industry. In that time, he has functioned as Global VP Sales, Marketing, and Business Development for IVAC Corporation, Medication Delivery Devices, Safety Syringes Inc., ROVI Contract Manufacturing and other innovative delivery system companies. His responsibilities included commercialization of infusion pumps, injectable devices with prefilled syringes, wearable devices, and autoinjectors. He has injectable device experience in multiple markets including acute and home care as well as 15 years of experience specifically in Pharmaceutical and Biotech space. He holds a BS degree from Georgia State University in Atlanta, GA.
     

    Mehak Mehta

    Scientist II, Parenteral 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.

    Miles Buroker

    Human Factors Engineer, UserWise, Inc.
    Miles Buroker

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

    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.

    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.

    Theresa Jeary

    Technical Specialist & Scheme Manager, BSI
    Theresa Jeary

    Theresa Jeary has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle. She holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and is eligible to be a Pharmaceutical Qualified Person.

    Additionally, Theresa has over 12 years Notified Body experience, at BSI as a technical expert and LRQA as the Head of Notified Body. Before re-joining BSI as a technical specialist in the Medicinal and Biologics team, Theresa worked as a consultant to the Medtech sector.
     

    Valerie Fenster

    Director of Insights & Human Factor , Kaleidoscope Innovation
    Valerie Fenster

    Valerie Fenster has thirty plus years’ experience developing intuitively optimized interfaces for critical business applications. She is a persuasive advocate for best practices in human factors engineering and user interaction and is dedicated to developing powerful and user-centered design for combination products, digital health devices and interactive voice response systems.
    Valerie is the Director of Insights & Human Factors at Kaleidoscope Innovation in Cincinnati, where she and her team ensure users remain the top consideration in device design solutions. Prior to Kaleidoscope, Valerie founded Amgen’s human factors engineering group and successfully guided many combination products and wearable devices through the HFE process. At Abbot, formerly St. Jude Medical, she helped design and develop their remote care connectivity system for patients with pacemakers or defibrillators.
    Valerie currently holds a Master of Science in Human-Computer Interaction from DePaul University in Chicago, Illinois, as well as Bachelor of Arts degrees in both Psychology and Humanities. She is an active member of HFES and AAMI.
     

    Walter Goodwin

    Device Engineer, Gilead Sciences
    Walter Goodwin

    Walter is a Device Engineer at Gilead Sciences. In this role, he is responsible for leading a custom injection device project, as well as supporting primary container development and stability testing. He holds a Bachelor of Engineering degree in Mechanical Engineering from Stevens Institute of Technology and a Master of Science degree in Mechanical Engineering from Stanford University.

    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 - Updated September 2020

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    Video Interview with Co-Chairs

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    Video interview with Jim Leamon

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    Speaker interview Jace Blackburn, Genentech

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    Brochure 2020

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    Workshop A

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    Workshop B

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    Speaker Bio's

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    Chair letter

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    Past attendee list (PFS WC)

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    Full programme 2020

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    Short programme 2020

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    Past presentation - Valerie Fenster, Kaleidoscope innovation

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    Past presentation - ZEON

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    Past presentation - Sumitomo Rubber Industries

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    Past presentation - Tina Rees,Ferring Pharmaceuticals

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    Past presentation - Shannon Clark, UserWise

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    Past presentation - Severine Duband, NEMERA

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    Past presentation - Mitsubishi Gas Chemical

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    Past presentation - Natalie Abts, Genentech

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    Past presentation - Lori Burton, Bristol-Myers Squibb

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    Past presentation - FDA

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    Past presentation - Ed Israelski, HFE

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    Past presentation - Dr.Benjamin Werner, Boehringer ingelheim

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    Past presentation - Diane Doughty, AstraZeneca

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    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.


    SIO2 Materials Science

    Sponsors
    https://www.sio2ms.com/

    SiO2’s patented materials science is a combination of an engineered polymer container with a nano-layer of pure glass coating on the inside. Essentially combining the best of both glass and plastic without the drawbacks of either, but with the benefits of both. The technology is ideally suited for the biological drugs, mRNA Vaccines, Viral Vectors, and Cell & Gene Therapies. Essential characteristics of SiO2’s patented materials coating include thermal stability and integrity, chemical stability, a gas barrier, mechanical durability, no breakage, and precision molding. For the last 100 years, the pharmaceutical industry has had to choose glass or plastic and had to sacrifice attributes of one or the other. The SiO2 primary packaging platform for pharmaceutical drugs and vaccines is the only way to realize the possibility to have the best attributes of both glass and plastic.


    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.

    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.


    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


    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.


    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!


    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


    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


    World Pharma News

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


    SAVE TO


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    Online Virtual Event

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    Online Virtual Event

    HOTEL BOOKING FORM

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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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