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SMi's 5th Annual Pre-Filled Syringes East Coast 2018 Conference and Exhibition returns to Boston on the 11th and 12th of April 2018. Developing on its annual success, this fifth event in the series will give a unique insight the areas of regulation, manufacturing, emerging trends and innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their devices.

This year’s agenda will feature:

  • Guidance on the regulations for device development
  • Human Factors considerations and end-user feedback
  • Highlight common pitfalls of good manufacturing practice and seek to solve these
  • Address the emerging challenges that biologic drugs present to pre-filled syringes
  • Showcase hot topics of combination products, including wearable devices, auto-injectors and patient-centric design
  • Interactive panel discussions led by industry experts

Developing on our annual success, this must-attend conference will gather an international audience to discuss and accelerate pre-filled syringe development in all the related sub-fields. Some notable areas of increased attention have been the broader trends for combination products and biologics in the pharmaceutical industry, as well as the move towards digital health and improving patient adherence due to increased self-administration figures. As well as these areas of lucrative opportunity, there are still a number of ongoing challenges that the key-thought leaders are battling to overcome. these include the challenges of chemical compatibility, user safety, high-volume and highly viscous formulation, and non-compliance.

  • Analyse key market trends
  • Explore safety assessments, human factors considerations and compliance issues
  • Consider innovative solutions for combination products
  • Overcome the challenges presented by the increased trends towards biologics
  • Navigate the latest regulations from officially bodies

Executives, Directors, VPs, Heads, Principals, Managers, Scientists, Researchers of:

  • Pre-filled Syringes
  • Autoinjectors
  • Device Engineering
  • Human Factors
  • CMC
  • Injectables
  • Sterile Manufacturing
  • Packaging
  • Regulatory Affair 

Previous attendees include:

Actavis; Ajinomoto Althea, Inc.; Allergan; Amgen; Aptar Pharma; AstraZeneca; Biogen; BMS; Cambridge Consultants Ltd; Catalent Pharma Solutions; Datwyler Schweiz AG; DuPont; Eli Lilly & Company; Epione BioPharmaceuticals; FDA; FDAPharma Consulting; Gateway Analytical; Genentech; Genentech Inc; Genzyme ; GSK; Heritage Pharmaceuticals ; Icon Bioscience; Insulet Corporation; Janssen R&D LLC; Janssen, Pharmaceutical Companies of Johnson and Johnson; Kappa Pharmaceuticals Limited; KBI Biopharma; KBI Biopharma, Inc.; Lupin Pharmaceuticals; Medicines Company; Medimmune; Merck & Co., Inc.; Merck, Sharp & Dohme Corp.; Merz; MITSUBISHI GAS CHEMICAL COMPANY, INC; Momenta Pharmaceuticals Inc; Nemera; Nipro; Nipro PharmaPackaging; Novavax; Novavax, Inc.; Novo Nordisk; Noxilizer Inc; Noxilizer, Inc.; Oncobiologics Inc.; Otsuka US; Overlook Industries, Inc.; Owen Mumford; Pfizer; Pfizer CentreOne; Pfizer Pharmaceuticals; Pharmascience Incorporated; Protein Sciences Corporation; Sanofi Pasteur; Sanofi S A; Schreiner MediPharm; Semigator GmbH; Sio2 Medical Products; Smithers Rapra; Team Consulting; Teleflex; Terumo Americas Holding, Inc; Terumo Medical Corporation; The Langford Research Institute; Valeant Pharmaceuticals; W.L. Gore & Associates, Inc.; West Pharmaceutical Services Inc; West Pharmaceutical Services, Inc.; West-Ward Pharmaceuticals; WL Gore & Associates Inc; Zeon Chemicals L.P.; Zoetis;
 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dhairya Mehta

Dhairya Mehta, Associate Director of Device and Combination Products, Shire

Stephen Barat

Stephen Barat, Head of Pre-Clinical and Early Clinical Development, Scynexis

9:10 Session Reserved for FDA

9:50 Syringe filling of high-concentration monocolonal antibody formulation: Challenges and solutions

Kashappa-Goud Desai

Kashappa-Goud Desai, Associate Fellow, GSK

  • There has been a steady increase in the number of high-concentration mAb formulations in ready-to-use pre-filled syringes for subcutaneous administration
  • Challenges of successful syringe filling of high-concentration mAb formulations by an automated filling machine
  • Outlining challenges associated with syringe filling of high-concentration formulations
  • This presentation summarizes the key challenges and mitigation strategies
  • 10:30 Morning Coffee Sponsored by Zeon

    11:00 COP - Technical data update

    Toshiro Katayama

    Toshiro Katayama, Product Manager, Zeon Chemicals L.P.
    View Bio

  • Key properties of COP - update
  • Case Study: Study on Protein adsorption/aggregation with actual protein drug - COP vs. glass
  • Case Study: Study on delamination with glass syringe vs. COP syringe
  • Leachable data on COP syringe with various chemicals
  • 11:40 Safety evaluation of leachables when developing a pre-filled syringe drug product

    Stephen Barat

    Stephen Barat, Head of Pre-Clinical and Early Clinical Development, Scynexis

  • Background on leachables from pre-filled syringe drug devices
  • Whys safety assessment of leachables is required
  • How leachable issues related to drug product quality can impact safety and efficacy
  • Best practice recommendations during development
  • 12:20 Networking Lunch

    13:20 Pre-filled syringe second source initiative: A dual source identification to reduce supply using Quality-by-Design (QbD) principles

    Kashappa-Goud Desai

    Kashappa-Goud Desai, Associate Fellow, GSK

    Nathan Heacock

    Nathan Heacock, Associate Scientist, GSK

    14:00 Integrating drug-device combination product development

  • Integrating the design process with methodical pharmaceutical development
  • QbD and design controls as a paradigm for aligning combination development
  • Comparison with regulatory guidance on Combination Products and the current state of development of drug device development
  • Justin Lacombe

    Justin Lacombe, Senior Manager Process Development, Teva Pharmaceuticals USA
    View Bio

    Gary Henniger

    Gary Henniger, Director Engineering, Teva Pharmaceuticals USA
    View Bio

    14:40 Afternoon Tea Sponsored by Zeon

    15:10 The best plastic syringe for biologics

    Shota Arakawa

    Shota Arakawa, Researcher , Mitsubishi Gas Chemical America Inc

  • OXYCAPT Multilayer Plastic Syringe having Glass-like Oxygen Barrier
  • Excellent Oxygen Barrier contributes to Stability of Biologics
  • Very Low Extractables contribute to Stability of Biologics
  • Good UV Barrier contributes to Stability of Biologics
  • 15:50 Debating the challenges and solutions for PFS development and the increasing trends towards biologics

  • What are the biggest challenges for biologic drug products at the interface of formulation, primary packaging and applications?
  • How should we bridge the gaps in drug-delivery innovations to address the challenges of delivering complex biologics?
  • How should we maintain patient centricity to our development processes?
  • Dhairya Mehta

    Dhairya Mehta, Associate Director of Device and Combination Products, Shire

    Steve Bowman

    Steve Bowman, Device Program Lead, Shire US Inc

    16:30 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Dhairya Mehta

    Dhairya Mehta, Associate Director of Device and Combination Products, Shire

    Stephen Barat

    Stephen Barat, Head of Pre-Clinical and Early Clinical Development, Scynexis

    9:10 Keynote Address: The critical importance of recognizing the considerations, decisions and trade-offs inherent in all combination product developeent

    Steve Bowman

    Steve Bowman, Device Program Lead, Shire US Inc

  • Your product has multiple customers beyond patients - do you know all of them? How well? Are you sure? Prove it!
  • The saying "a chain is a s strong as its weakest link" applies to combination product development too. What's yours (likely there are many)? What are you doing to address them?
  • The future of combination products is bright - but are we confident we know what it will look like?
  • 9:50 Lessons learned from Human Factor studies of pre-filled syringes

    Tieming Ruan

    Tieming Ruan, Associate Director of Device Development, Takeda

  • Formative study versus Summative study
  • Number of arms (IFU only versus IFU + QRG)
  • 10:30 Morning Coffee Sponsored by Zeon

    11:00 Session Reserved for Sponsor

    11:40 Panel Discussion: What is missing from the Human Factors studies and why is this still a prevalent issue?

  • Are we misunderstanding patient compliance?
  • Real world case-studies and considering end-user group needs - are we using the bigger picture?
  • How is IoT assisting in Human Factors studies and is this actually a hinderance to device interaction?
  • Gary  Mills

    Gary Mills , Associate Director, Drug Product Development , TESARO

    Stephen Barat

    Stephen Barat, Head of Pre-Clinical and Early Clinical Development, Scynexis

    Molly Story

    Molly Story, Head, Global Usability Engineering and Risk Management, Sanofi Pharmaceuticals
    View Bio

    12:20 Networking Lunch

    13:20 Session Reserved for Nemera

    Adrien Tisserand

    Adrien Tisserand, Category Manager - Parenteral, Nemera

    14:00 The Challenges of Platformization

    Molly Story

    Molly Story, Head, Global Usability Engineering and Risk Management, Sanofi Pharmaceuticals
    View Bio

  • From a human factors perspective, what would it take to create a device that is a true platform which can be utilized for multiple molecules and a variety of user groups?
  • What effects might the choice of molecule have on design of the device?
  • What effects might the choice of molecule have on the user's interactions with the device?
  • For which users should the device be designed?
  • 14:40 PFS tech transfer of in-line products not originally developed as combination prodcuts

    Maria Linzmayer

    Maria Linzmayer, Associate Director, Drug Delivery Devices, Merck

  • Defining Design User Requirements
  • Dealing with suppliers providing device constituent components
  • Systems engineering needs
  • Retrospective design documentation
  • 15:20 Afternoon Tea Sponsored by Zeon

    15:50 Future of digitially connected device and changing paradigm in diseease management

    Michael Song

    Michael Song, Sr. Manager, Drug Delivery and Device Development, MedImmune Inc
    View Bio

  • Digitalization: Benefits of electronic-enabled drug delivery devices in patient disease management beyond adherence
  • Tackling hurdles of connectivity for combination products: cost, technology, regulatory and time-to-market considerations
  • Evaluating add-on platforms as a step towards integrated device ecosystem
  • Exploring opportunities for pharma, patient and HCP engagement through connected drug delivery devices
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    Sponsors and Exhibitors

    Workshops

    Design Considerations for the World Outside the Clinic
    Workshop

    Design Considerations for the World Outside the Clinic

    Sheraton Boston Hotel
    10th April 2018
    Boston, USA

    Human Factors for Connected Drug Delivery Systems
    Workshop

    Human Factors for Connected Drug Delivery Systems

    Sheraton Boston Hotel
    10th April 2018
    Boston, USA

    VENUE

    Sheraton Boston Hotel

    39 Dalton Street, Boston, MA, USA

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    HOTEL BOOKING FORM

    Sponsors and Exhibitors


    Mitsubishi Gas Chemical

    Sponsors and Exhibitors
    http://www.mgc.co.jp/

    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 and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.


    Nemera

    Sponsors and Exhibitors
    http://www.nemera.net

    NEMERA is a world leader in the design, development and manufacturing of drug delivery solutions for pharmaceutical, biotechnology and generics industries. Nemera’s expertise covers several modes of delivery: Parenteral, Nasal, Buccal, Auricular, Ophthalmic, Pulmonary, Dermal and Transdermal. Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing, through customized solutions. Nemera developed: Safe’n’Sound®, a fully passive safety device for prefilled syringes to avoid accidental needle-sticks. Safelia®, a new generation of 2-steps auto-injector for fluid and viscous formulations.


    NN Precision Engineered Products

    Sponsors and Exhibitors
    http://www.pep-corp.com

    NN, Inc Precision Engineered Products Group is an engineered solutions company, focusing on medical and drug delivery devices. We provide components, complex assemblies and clean room packaging, specializing in metal stamping, injection molding and ISO Class VIII clean room assembly. Learn more at www.pep-corp.com.


    SCHOTT North America, Inc. – Pharmaceutical Packaging

    Sponsors and Exhibitors
    http://www.us.schott.com/pharma

    SCHOTT is a world leading supplier of parenteral packaging servicing the pharmaceutical, biotech, biopharmaceutical, diagnostic, analytical, dental & ophthalmic markets. Products include glass and polymer prefillable syringes (bulk and sterile), cartridges, ampoules, vials, and innovative coated containers. Ready-to-use solutions are available to meet existing and new fill & finish equipment.


    Terumo Pharmaceutical Solutions

    Sponsors and Exhibitors
    http://www.terumo-ps.com/

    Terumo Pharmaceutical Solutions offers the pharmaceutical and biotechnology industry unique solutions in medical technology. In addition to offering our valued products, our specialized team also provides customized and dedicated solutions designed to meet your specific requirements.


    ZEON

    Sponsors and Exhibitors
    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.

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    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199
    USA

    Sheraton Boston Hotel

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    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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