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Pharmaceutical Medical Devices

Injectable Drug Delivery

22-23 Mar 2018

GBP EUR USD
Standard 1499 2099 2339
Early 1299 1819 2027
Excluding VAT @ 20.00%

Book by 22 Dec to get the early booking price shown above.

Venue: Le Meridien Piccadilly Hotel, London

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Bespoke training

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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 12 best-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.

Previous exhibitors:

Mikron logo

 

Clamason logo

 

Upg logo

 

3PInnovation logo

 

Harro Hofliger logo

 

Owen Mumford 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

Gregory Berman

Gregory Berman is an Independent Consultant and Director of Cantab Innovations Ltd. Previously he was 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.

Ian Thompson

Ian has been Vice President Business Development, Delivery Systems with Ypsomed AG since 1995. He has had 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.

Arnaud Guillet

Arnaud is currently business development associate at BIOCORP, in charge of finding partnerships and license opportunities for BIOCORP’s range of connected devices. Previously, he worked for a healthcare consulting firm with a strong focus on connected health strategies for pharma and insurance companies. Other past experiences in the pharmaceutical industry (Sanofi) and the insurance industry (AXA). Graduated from HEC Paris, a major European business school. For 20 years, BIOCORP has been designing, developing and manufacturing medical devices for the pharmaceutical industry, enhancing drug reconstitution, safety, packaging and delivery.

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