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Pharmaceutical Medical Devices

Injectable Drug Delivery

21-22 Mar 2017

GBP EUR USD
Standard 1399 1959 2182
Early 1199 1679 1870
Excluding VAT @ 20.00%

Book by 10 Feb to get the early booking price shown above.

Venue: Le Meridien Piccadilly Hotel, London

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Course Overview

The pharmaceutical industry and its main markets continue to change. Geopolitical changes influence healthcare industry funding models, demographic changes (in developed countries) increase the demand for healthcare and technology advancement opens up new opportunities. In drug delivery we have witnessed a very significant transition. For many years oral tablets held the leading market positions. For example, at one time oral H2 receptor blockers were the blockbusters. These were replaced by proton pump inhibitors and then cholesterol lowering drugs as the world’s biggest sellers. Today, depending upon which list you look at, around 9 of the world’s 12best-selling drugs require a drug delivery device, as they are biologics for parental delivery or drugs for treatment of asthma, requiring an inhaler.

Injection devices to deliver the latest generation of drugs are evolving. First generation devices were typically mechanical and functioned only to get the drug into the body. Increasingly, in next generation parenteral devices, the drug delivery device is recognised as the interface between the drug and the patient. It can offer many features and functions which improve usability, safety, efficacy and compliance, plus many other functions beyond such as connectivity and diagnostics.

This conference looks at the latest trends, technologies and applications.

 

Also of interest

Please note we are also running our annual Pre-Filled Syringe on the 20 March 2017 and should you wish to attend both the Pre-Filled Syringe and the Injectable Drug Delivery events please enter code PFSIDD when booking on-line to receive a £200/€200 discount.

 

Exhibitors:

Mikron logo

 

Clamason logo

 

Upg logo

 

3PInnovation logo

 

Harro Hofliger logo

 

Exhibition opportunities are available. Please contact Customer Services on +44 (0)20 7749 4730
or contact us through our contact form.

Benefits in attending

  • Hear the latest trends in injectable drug delivery
  • Know what’s in development for large volume and patch pump technology
  • Keep abreast of market opportunities
  • Understand the latest technologies using parenteral methods
  • Clarify the importance of human factor studies and compliance monitoring
  • Comply with the latest regulatory guidance and standards
  • Meet other medical device and pharmaceutical professionals in the parenteral market

Who should attend

This conference will be of particular interest to:
Scientists and management in medical devices, pharmaceutical and biotechnology companies working in parenteral delivery. Personnel responsible for device programmes, product development, regulatory affairs and product lifecycle management will find this event beneficial. Previous delegates include: Directors, Senior Executives in R&D, Head of Device Departments, Combination Products Specialists, Drug Delivery Managers, Business Development Executives, Product Development Managers and those in Project Co-ordination and Marketing roles.

Programme - Day one

Chairman’s welcome and introduction

Dr Greg Berman, Head of Medical, Kinneir Dufort, UK

Trends in Injection Devices – where is the market going?

  • Will the rise of connectivity and ‘green issues’ drive a new wave of reusable devices?
  • Will alternative actuator technologies supersede the classic coil spring?
  • Is ‘patient on-boarding’ opening a new communication channel for pharma?
  • Or will we keep doing the same thing…

Nic Bowman, Senior Director, Head of Devices Centre of Excellence, Pfizer, UK

Impact of drug delivery device technologies on user experience

  • Perspective on drug delivery device technology has dramatically shifted
  • G-CSF administration exemplifies the opportunity to significantly advance user experience through drug delivery device technology

Scott Gibson, Advance Device Technologies Group, Amgen, USA

Discussion followed by refreshments

Drug-device combinations – is the message getting across? – a reflection on industry (and regulator) response to these product types

  • Evolution during the last five to ten years
  • The fundaments: competence, organisation, characterisation, design control, risk management, human factors
  • Integration of drug and device: combination product mind set, device initiation, clinical studies, stability, control strategy
  • Outcomes: submission, inspection, approvals, warning letters, post-market

Mark Chipperfield, Company Director and Principal Consultant, Corvus Device, UK

The value of cyclic olefins in designing drug containers for use within auto injectors

Advantages for primary drug containers:

  • COP and shatter resistance
  • Container Closure Integrity (CCI)
  • Stiction
  • Glide force and friction
  • Device flexibility
  • Mathematical modelling

Advantages for auto injectors:

  • User-centric design
  • Modular design
  • Inserted needle depth
  • Delivered volume
  • Delivery time

Clinical trials are currently being planned using this technology, and will be reported later this year

Matthew Young, CEO, Oval Medical Technologies, UK

Discussion followed by Lunch

Advances in hospital-based medication delivery
Healthcare industry requirements for improved parenteral administration of medications continue to grow. In acute care settings medication delivery is becoming increasingly integrated with hospital IT systems that are designed to better manage the flow of medication throughout the hospital. This presentation will highlight the latest technologies enabling this integration, including:

  • Prefilled syringes that streamline drug delivery at the bedside
  • Smart infusion pumps that help clinicians achieve correct dosing of drugs
  • Pharmacy management systems and automated pharmacy dispensing cabinets that enable hospitals and clinicians to electronically track and record medication delivery

Vince Sullivan, PhD, Director, MPS Catheter Applied R&D, BD Technologies, USA

Partnering with biosimilar and generic companies for injection devices

  • Device requirements, self-injection needs
  • FDA biosimilar guidance and examples
  • “Me-too” or “device-better”?
  • Requirements from the device company
  • Examples from DALI’s SAN product line and E3D’s Flexi-Q autoinjector product line

David Daily, CEO & Co Founder, DALI Medical Devices, Israel

Discussion followed by refreshments

Anticipating unmet medical needs for self-injection

Speaker (invited)

Transforming the patient experience with a computer-controlled needle-free device
Delivering high viscosity, high concentration biologics is a challenge for the biopharma industry. Injections are slow and painful, and patients don’t like using needles. Drug adherence is a well-known problem costing billions of dollars per year. The Portal device offers a transformed patient experience that is needle-free and computer-assisted. The injection is fast, imperceptible and the device is easy to use. Connectivity tools augment the delivery and provide patient support, motivation and education while giving unprecedented insights on patient behaviour. We will present our recent progress including patient tolerability and preference data.

Patrick Anquetil, CEO & Co-Founder, Portal Instruments, USA

Discussion followed by close of day one

Networking drinks reception

Programme - Day two

Review of day one

Dr Greg Berman, Head of Medical, Kinneir Dufort, UK

Injectable drug delivery – future needs
Josie Wright, Principal Engineer, Device Development, Astra Zeneca, UK (invited)

New wearable injectors and higher force auto injectors

  • Pharma interest and positioning of higher volume injectors
  • YpsoMate drive systems and their characteristics
  • YpsoDose wearable injector device characteristics and pharma/patient needs

Ian Thompson, Vice President Business Development, Ypsomed Delivery Systems, Switzerland

Discussion followed by refreshments

Pen Injectors – 25 Years later – how will they change going forward?

  • Are pen injectors still attractive, relevant and important? Why?
  • Will pen injectors be soon replaced (e.g. electronic injectors, bolus injectors, going back to syringes, Auto injectors)?
    • from a business perspective – it differs heavily from region to region;
    • from a technological perspective – how can specific features maybe for niche indications/user fields);
    • from a patient perspective – why patients would still prefer or at least accept a pen injector over other user-optimized devices/solutions

Paul Jansen, PE, aVP Medical Device Development, Sanofi, USA

Innovative technologies in the manufacturing process of glass pre-filled syringes

  • Introduction of a laser-assisted glass cutting technology
  • Resulting in reduced glass particle count, mechanically stronger and more dimensionally stable finger flanges
  • Features and benefits of an innovative X-ray inspection unit
  • Addressing increasing regulatory requirements for CCI and for drug delivery systems safety

Philippe Lauwers, Business Unit Director PFS, Nipro PharmaPackaging, Belgium

Discussion followed by Lunch

High viscosity, high volume (HVHV) overcoming challenges in delivery

*Market projections and trends over the next ten years in large volume injections

Uri Baruch, Head of Drug Delivery, Cambridge Design Partnership, UK

Drug/device combination product lifecycle management regulatory considerations

  • Overview of global regulatory expectations
  • Strategies for overcoming common registration and post-approval challenges
  • Building a sustainable regulatory dossier

Suzette Roan, Associate Director, Regulatory Affairs CMC Combination Products, Biogen, USA

*Human factors in injection design to meet patient needs

Ian Culverhouse, Head of Usability, Kinneir Dufort, UK

Discussion and Chairman’s closing remarks

Close of forum and refreshments

Presenters

Paul Jansen

Global Head Medical Devices Development

Sanofi-Aventis

Paul Jansen, Global Head of Medical Devices Development for Sanofi-Aventis, is an engineer with more than twenty years of experience in medical devices. He completed his engineering degree in mechanical engineering and graduate studies in biomedical engineering.

Mr Jansen has extensive experience in the design, development, manufacturing and lifecycle management of medical devices, and has successfully launched several devices. In addition, he has expertise in the design and development of injection molding systems and electronic components.

Mr Jansen is an active member of the International Standards Organisation and is currently a convenor with Technical Committee 84, which is responsible for automated functions for injection systems.

Mr Jansen lives with his wife in Frankfurt, Germany.

Vincent Sullivan

Dr. Vincent J. Sullivan is Director, MPS Catheter Applied R&D, for BD Technologies and previously was Senior Scientist and Chemistry/Pharmaceutics Group Leader for BD Technologies, the Corporate Technology and Innovation Center for Becton, Dickinson & Company. He is responsible for research and development on novel drug delivery systems as well as stabilization of vaccines and other biologics. His research at BD has focused on development of systems for respiratory and skin based delivery of drugs and vaccines. He received his PhD in Chemistry from Carnegie Mellon University in 1990, and has over 18 years experience in drug delivery and materials research. Dr. Sullivan holds numerous patents on delivery technologies and has published widely in the fields of medical devices, pharmaceutical formulation, and materials technology. He joined BD in 1999, and was previously employed by Ticona LLC, where he was a Medical Market Segment Leader.

Gregory Berman

Gregory Berman is Head of the Medical Group at Kinneir Dufort, an award-winning research, innovation, design and product development company, with over 30 years’ experience helping companies discover, create, develop and realise tangible new products, brands and experiences.
He helps clients in the life-science, medical and healthcare sectors to develop products in complex situations, optimise life-science R&D and exploit technology strategically. For example he:
Led the design and development of SmartJect™; an autoinjector which automatically retracts the needle and was launched by J&J in 2010 with an important next-generation drug.
Worked with Chrono Therapeutics, helping to develop their SmartStop™ based device, the world’s first programmable, wearable transdermal smoking cessation therapy.
Participated in a detailed design review of an autoinjector being developed by a leading pharmaceutical company for a new drug.
Undertook the Voice of Customer study for a leading biopharmaceutical company, as the starting point for developing high volume parenteral delivery devices for lifesaving immunotherapies.
Undertook a technology survey for a company interested in needle-free, transdermal, micro-needle, electroporation and iontophoresis drug delivery devices.
Developed the business plan and identified partners for a quoted UK drug delivery company to develop a new drug formulation technology they had in-licensed
Has worked extensively with start-up drug delivery companies to help commercialise the technology.
He has also conducted a number of due diligence and technology assessments e.g.:
On behalf of Trinity Biotech Plc. (listed on NASDAQ) undertook the due diligence on Fiomi Diagnostics. Subsequently Trinity acquired Fiomi for $13.1m, strengthening its position in the growing $900m point-of-care cardiac biomarker diagnostics market.
For a UK plc evaluated a company developing a needless injector.

For a multinational assessed a small company developing an autoinjector

For a UK drug delivery plc evaluated a privately held US formulations group

An experts report for the offering memorandum for a French company producing therapeutic proteins.

Nic Bowman

Nic Bowman is the head of the Devices Centre of Excellence (DCoE) at Pfizer Ltd, based in Cambridge in the UK. He has a BSc in Mechanical Engineering from Bath University, England (1984).

Nic worked initially in the energy sector, firstly engineering in coal mining, and then in oil exploration, reaching the role of Chief Mechanical Engineer for Sperry Sun in 1993.

Between 1993 and 2006 he worked for The Technology Partnership, Cambridge, UK, specialising in drug delivery devices. During this period Nic worked with a number of pharma and device companies, developing a range of breath actuated Metered Dose Inhalers (MDIs), MDI counters and Dry Powder Inhalers.

Between 2006 and 2008 Nic worked as Head of Medical Product Development for Sagentia, Cambridge, UK. He built up Sagentia’s pharma experience and portfolio.

Nic moved to Pfizer in 2008 and as Director of Device Design and Development with responsibility for the design and development of novel drug delivery devices for Pfizer. He was promoted to Senior Director in 2010, and to Head of DCoE in 2011.

Nic is a Fellow of the Institution of Mechanical Engineers. He is a regular conference speaker, and is named in more than 20 patents.

Ian Thompson

Ian Thompson, Vice President Business Development, Delivery Systems, has been with Ypsomed AG since 1995 in a number of roles in key account management and business development working with pharma companies to develop and bring to market innovative self-injection systems.
He studied biochemistry and biotechnology in the UK from 1979-1983 and has worked in medical device companies since moving to Switzerland in 1990.
Following the successful development and launch of a range of new pen and autoinjector custom products, Ypsomed Delivery Systems’ continues to focus on the development of next generation pen, autoinjector and bolus injector technologies.

David Daily

David Daily is CEO and co-founder of DALI Medical Devices, a R&D company focused on developing innovative drug delivery devices and, Director of R&D and BD, Injectable Drug Delivery Devices, Elcam Medical.

DALI is a R&D company focused on developing innovative drug delivery devices. The proprietary Safe Auto-Needles (SANs) product family provides improved patient compliance through hidden needle with automatic needle insertion. The unique SANs are designed and customizable for use with all types of syringes with extremely simple user-interface in a cost-effective design. A variety of autoinjectors are developed in partnership with Elcam Medical, a world-class manufacturer of precision injection-molded disposable medical devices, with production facilities in the EU, USA and Israel.

Before co-founding DALI in 2003, Daily worked as the Product Development Manager at a subsidiary of Élan Pharmaceuticals, where he was responsible for leading the development of a variety of disposable automatic injection and micro-infusion systems from initial prototypes until registration.

Daily is named inventor on many international patents and patent applications. He is an author of various publications and gave presentations in professional conferences in the parenteral drug delivery arena.

He received a M.Sc. degree in Biomedical Engineering and a B.Sc. degree in Mechanical Engineering from the Technion (Israel Institute of Technology, Haifa), and a Master’s degree in Business Administration (MBA) from the Hebrew University of Jerusalem (honors).

Mark Chipperfield

Mark Chipperfield is Head of Device Development, EU Biologics, at F. Hoffmann-La Roche. He spent 20 years working within large Pharma (GSK, Sanofi-aventis, Novartis and F. Hoffmann-La Roche) in the field of drug delivery devices and special purpose packaging.
He obtained his Bachelor degree in Mechanical Engineering from South Bank in London, UK and later his Master of Science in Engineering Management from Loughborough, UK. Through his career to date he has been heavily involved in development of medical devices for combination products in several forms: solutions / suspension inhalers, multi-dose disposable and reusable dry powder inhalers, convenience kits, pen injectors, auto-injectors, dispensers and special purpose applicators.
He has performed numerous due diligence and technical evaluations of novel delivery technologies developed products through the full design control phases to market and maintained marketed products.
He has experienced many of the challenges associated with delivery device development and device product maintenance within large pharmaceutical companies and implemented Medical Device development guidance, quality systems and business processes. During 2013 Mark co-authored the PDA publication on ‘Combination Products: Implementation of cGMP requirements’.

Matthew Young

After more than ten years’ experience in developing injection devices with a leading medical product development consultancy, Matthew Young founded Oval Medical Technologies in 2009 to develop a novel parenteral drug delivery technology.

His work has encompassed industrial design, engineering, human interface design, manufacture, quality systems, regulatory compliance, material selection, technical due diligence and project management.

Matthew has spoken on autoinjector development at key industry conferences, and attended review meetings with the FDA in Washington and the ISO committee developing new standards in this area.

Patrick Anquetil

Dr. Patrick Anquetil is Portal Instrument’s Chief Executive Officer. He brings more than 18 years of experience in nanotechnology, including extensive knowledge in the areas of cleantech, material science, and instrumentation.
From 2009 to 2012, he was co-founder and director of strategic and process planning for SynapDx Corporation, where he had responsibility for development of the company’s business and operational plans as well as securing $9 million in Series A funding. He began his career as a science and nanotechnology equity research analyst at Susquehanna International Group, authoring and marketing nanotechnology industry and equity research reports to hedge funds and portfolio managers. He holds a doctorate in bio-instrumentation from MIT, an MBA from Harvard University, and a master’s degree from the ETH in Zurich and the University of Tokyo. His work has appeared in numerous peer-reviewed publications as well as mainstream media, including MIT Technology Review, Wired Magazine, PBS, and CNBC among others.

Josie Wright

Josie Wright is Principal Scientist (Device Development), AstraZeneca

Uri Baruch

Uri Baruch is Head of Drug Delivery, Cambridge Design Partnership

Ian Culverhouse

Ian Culverhouse is Head of Usability, at Kinneir Dufort.

Philippe Lauwers

Philippe Lauwers is Business Unit Director Pre-Filled Syringes at Nipro PharmaPackaging (NPP); a division of Nipro Corporation.

NPP is a global, vertically integrated primary packaging manufacturer with a broad product portfolio and knowledge, giving unparalleled industry know-how and expertise.

Mr. Lauwers graduated in Biotechnology from the University in Ghent, Belgium and worked as a scientific researcher at the Catholic University of Leuven.

Upon obtaining an additional degree in Biomedical Engineering at the Catholic University of Leuven he moved from an academic to an industrial environment.

He has been active in the Medical and Pharma packaging sector for the last 10 years in various roles.

He joined Nipro PharmaPackaging in January 2016 and is involved in technical and scientific discussions with customers, as well as in scientific marketing and business development activities.

Suzette Roan

Suzette Roan joined Biogen in 2014 and is currently Associate Director in Regulatory CMC – Device Regulatory, where she leads the combination product regulatory team responsible the development and commercial combination product portfolio. Prior to Biogen, Suzette was with Pfizer for 19 years, with roles in Analytical Development, Outsourcing and Regulatory CMC. She has experience with pulmonary inhaler, prefilled syringe, autoinjector and on body delivery systems.

Suzette holds a BS in Chemistry from the University of Connecticut, a MS in Management from Albertus Magnus College and a JD from the University of Connecticut School of Law. She is an active member of ISO/TC 84 working groups, PDA and is currently chair of the Combination Products Coalition Marketing Submissions working group.

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