www.informa-ls.com/inhalation                                                                   A breath of fresh air: New...
Aspiration for respiration
                                    Pre-conference workshop – Monday 27 September 2010
        ...
Optimise the success of your inhalation drug development programmes
        •  Case study examples of bioequivalence evalu...
Inhalation Drug Development                                                                                               ...
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Inhalation Drug Development: Emerging Trends and Markets 28 - 29 September 2010, Ambassadors Bloomsbury

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One of Murgitroyd\'s distinguished attorneys will be giving a workshop at this event.

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Transcript of "Inhalation Drug Development: Emerging Trends and Markets 28 - 29 September 2010, Ambassadors Bloomsbury"

  1. 1. www.informa-ls.com/inhalation A breath of fresh air: New trends and solutions for your Inhalation Drug inhalation drug development programmes Development: Featuring Inhalation Specialists from the USA • Robert Baughman, Vice President - Experimental Pharmacology, Emerging Trends Mannkind, USA • John Patton, President and CEO, Dance Pharmaceuticals, USA • Sarvajna Dwivedi, Executive Vice President, R&D and Co-Founder, Pearl Therapeutics, USA and Markets • Robert Sievers, Professor, Department of Chemistry and Biochemistry and Centre for Pharmaceutical Biotechnology, University of Colorado, USA Exploring the future of inhalation drug delivery and showcasing European Industry Leaders • Frank Chambers, Senior Scientist Inhalation advances in inhalation drug formulation and development R&T, AstraZeneca, UK 28 – 29 September 2010 • Ambassadors Bloomsbury Hotel • London • UK • Peter Barnes, Head of Respiratory Medicine, Imperial College London, UK Benefits of Attending in 2010: • Jussi Haikarainen, Development Manager Inhalation Technology, Orion, Finland • Gain a comprehensive understanding of regulatory requirements for • Michael Goller, Associate Director inhalation drug development in Europe and USA Respiratory R&D, Teva Pharmachemie, The • Explore novel developments in inhalation drug development, including Netherlands • Birte Jensen, Principle Scientist, Respiratory inhaled insulin, inhaled vaccines and new targets for COPD Drug Delivery, Boehringer Ingelheim • Learn techniques to be more efficient in measuring particle size Pharma, Germany distribution, including an overview of the AIM concept • Anders Fuglsang, Clinical and Regulatory • Discover applications and limitations of methods in improving Strategy Manager, Aeropharm GmbH, bioequivalence and bioavailability of inhaled drugs Germany • Frank Thielmann, Senior Fellow, Novartis • Assess the impact of particle morphology on aerosol performance Horsham Research Centre, UK • Understand the influence of formulation and excipients on product • Andrew Brown, Head of Manufacturing, stability and performance Oriel Therapeutics, UK Monday 27 September 2010: Pre-conference workshop • Norbert Rasenack, Fellow, Pharmaceutical Development, Novartis Pharma AG, CRUCIAL PRE-CONFERENCE INTRODUCTION TO THOSE NEW TO THE Switzerland INHALATION INDUSTRY • Peter Daley-Yates, Director Clinical Inhalation Drug Delivery Device Technology Masterclass: Pharmacology, GlaxoSmithKline, UK A comprehensive guide to successfully developing inhalation products • Claus-Michael Lehr, Helmholtz Institute of Led by: Ola Nerbrink, Independent Consultant, Respiron Consulting, Sweden and Pharmaceutical Research, Saarland David Howlett, Owner, Pharma Delivery Solutions Ltd, UK University, Saarbrücken, Germany Tuesday 29 June 2010: Meet and greet breakfast seminar • Francesca Buttini, Post-doc Research Fellow, FREE Department of Pharmacy, University of Maximise your networking time while ‘ensuring collaborations Parma, Italy Breakfast enhance rather than stifle exploitation of new technology’ Seminar Media partner Led by: Craig Thomson, Attorney, Murgitroyd & Company, UK Tuesday 29 June 2010: Evening seminar Establishing equivalence in line-extension and generic inhalation drug development Led by: Anders Fuglsang, Clinical and Regulatory Strategy Manager, Aeropharm GmbH, Germany To Register Please Tel: +44 (0) 20 7017 7481 Fax: +44 (0) 20 7017 7823 Email: registrations@informa-ls.com Please Quote CQ5122
  2. 2. Aspiration for respiration Pre-conference workshop – Monday 27 September 2010 Inhalation Drug Delivery Device Technology Masterclass: A comprehensive guide to successfully developing inhalation products Led by: Ola Nerbrink, Independent Consultant, Respiron Consulting, Sweden and David Howlett, Owner, Pharma Delivery Solutions Ltd, UK Registration is at 12.30 for a 13.00 start. The workshop will finish no later than 20.00. Refreshments, an evening meal and workshop material will be provided. This interactive workshop is a must attend for those new to the area of inhalation • Patient suitability and capabilities drug development, providing a solid foundation and introduction to the 2-day • Design control, verification, validation and risk management in inhalation conference. Through means of case studies and group discussions, participants device development will gain a thorough understanding of dry powder inhalers, pressurised inhalers • Regulatory expectations for inhalation devices and liquid systems, including a brief history on inhalation drug delivery, technology options, formulation approaches, considerations for choosing the right With our new workshop format starting at 1pm, participants will benefit technology and considerations for developing a commercial product. from: • The same content, knowledge and discussions of a full-day workshop Topics to explore will include: • Less time out of the office - arrive on the morning of the workshop • Device/formulation considerations including the suitability of approaches for • Saving on accommodation costs - no need to book an extra night different drug characteristics and environments • FREE networking dinner to consolidate your knowledge and contacts Meet and greet breakfast seminar – Tuesday 28 September 2010 Ensuring collaborations enhance rather than stifle exploitation of new technology Led by: Craig Thomson, Attorney, Murgitroyd & Company, UK UK 08.00 for 08.15 start. The seminar will finish no later than 09.00 Ensuring collaborations enhance rather than stifle exploitation of new This seminar will provide pertinent advice to management and technical technology professionals alike, to ensure that your IP is adequately protected, company secrets are not jeopardised and a smooth and successful collaboration achieved. Changing pressures on the drug delivery industry sector mean that we are seeing more collaborations, as well as new types of collaborations, particularly relevant to Topics to explore will include: those involved in inhalation drug-device collaborations. With these changes come • Problems associated with not addressing ownership of IP early in a collaboration new challenges for agreeing ownership and exploitation of new technologies. If • How the law can help to avoid these problems these new challenges are not met, disputes between collaborators may inhibit the • Is there any reason to share IP? exploitation of new technologies. • Inhalation-specific case studies 12.10 Global outlook for inhalation drug development Day One: Tuesday 28 September 2010 • Opportunities and limitations of the Chinese and Indian markets – Market potential 08.45 Registration – Direction for devices in developing countries • Obtaining marketing authorisation outside of the USA and EU 09.15 Opening remarks from the Chair Sarvajna Dwivedi, Executive Vice President, R&D and Co-Founder, Pearl Anders Fuglsang, Clinical and Regulatory Strategy Manager, Aeropharm Therapeutics, USA GmbH, Germany 12.45 SPOTLIGHT SESSION Regulatory Feedback on Inhalation Drug Development Raise your corporate profile by sponsoring or exhibiting at the 2nd Annual Inhalation Drug Development conference. For details on speaking in this 09.20 Heterogeneous regulations: Challenge and opportunity session or other sponsorship opportunities at this conference please contact: • The European guidance in practice Ben Edwards, Tel: +44 (0)207 017 4447, Email: ben.edwards@informa.com • What is expected from FDA? • Proof of dose-response: How and why? 13.15 Lunch Anders Fuglsang, Clinical and Regulatory Strategy Manager, Aeropharm GmbH, Germany 14.15 Trends in DPI device development • Role of devices in respiratory therapy Novel Developments in Inhalation Drug Development • Pathways for device development • Patient feedback features on devices 09.55 Case study: Systemic delivery of drugs by inhalation: Mannkind's • Review of the new ISO 20072 standard on aerosol drug delivery device experience with inhaled insulin design verification, and the impact on industry • AFREZZA, a novel insulin: Clinical data demonstrate the benefits of • Implementation of electronics in devices pulmonary drug delivery using a unique formulation/device combination • Reusable devices – is it a viable option? • Advantages of MannKind's Technosphere Technology and application to Jussi Haikarainen, Development Manager Inhalation Technology, Orion, other therapeutic areas Finland Robert Baughman, Vice President - Experimental Pharmacology, Mannkind Corporation, USA 14.50 Trends in propellant-based Metered-Dose Inhaler (pMDI) development and use 10.30 Case study: Inhalable dry powder aerosols of measles and HPV vaccines, • The ongoing phase-out of CFCs and TB antibiotics – History and remaining challenges • Current status of pre-clinical and Phase I clinical trials of dry powder • Opportunities to improve patient benefits measles vaccine – Novel therapies • Feasibility of using these viruses and compounds via inhalation – Patient compliance Robert Sievers, Professor, Department of Chemistry and Biochemistry and – Environmental concerns Centre for Pharmaceutical Biotechnology, University of Colorado, USA John Pritchard, Strategic Technology Director, AstraZeneca, UK 11.05 Morning coffee and networking 15.25 Afternoon tea and networking 11.35 New targets and treatments for COPD Improving Bioequivalence and Bioavailability of Inhaled Drugs • Why new treatments are needed? • How will they be found? 15.55 Case study: Evaluating bioequivalence of locally acting orally inhaled • How will they be tested? drugs Peter Barnes, Head of Respiratory Medicine, Imperial College London, UK • Overview of methodology available for assessing bioequivalence of inhaled drugs Due to unforeseen circumstances, the programme may change and Informa reserves the right to alter the venue and/or speakers © Copyright Informa BV, 2010 To Register Please Tel: +44 (0) 20 7017 7481 Fax: +44 (0) 20 7017 7823 Book online: www.informa-ls.com/inhalation Email: registrations@informa-ls.com Please Quote CQ5122
  3. 3. Optimise the success of your inhalation drug development programmes • Case study examples of bioequivalence evaluation 17.05 What happens after landings?: Modulating absorption and clearance • Comparisons of in vitro, pharmacokinetic, pharmacodynamic and efficacy processes in the lung by inhalation nanomedicines endpoints • How do drugs and particles get across the air-blood barrier – insights from • Utility and limitations of pharmacokinetic methods new in vitro models Peter Daley-Yates, Director Clinical Pharmacology, GlaxoSmithKline, UK • Can mucociliary and macrophage clearance be avoided? • Cellular targeting and delivery of inhaled nanomedicines - new 16.30 Bioavailability of inhaled drugs perspectives to treat lung cancer • Correlation between particle size and in vivo behaviour Claus-Michael Lehr, Professor and Head of Department Drug Delivery, • Relieving the burden of doing large clinical trials – how well does Helmholtz Institute of Pharmaceutical Research, Saarland University, laboratory data translate to the patient? Saarbrücken, Germany • Relevance of systemic bioavailability for local therapy • Exploring bioavailability of inhaled medicines to disease lesions 17.40 Closing remarks from the Chair John Patton, President and CEO, Dance Pharmaceuticals, USA 17.45 End of day one Evening seminar – Tuesday 28 September 2010 Establishing equivalence in line-extension and generic inhalation drug development Led by: Anders Fuglsang, Clinical and Regulatory Strategy Manager, Aeropharm GmbH, Germany Discussion Panel will include John Patton, President and CEO, Dance Pharmaceuticals, USA 18.00 for 18.15 start. The seminar will finish no later than 21.30. This seminar will include documentation and evening meal. Establishing equivalence in line-extension and generic inhalation drug By means of presentation and group discussions, participants will: development • Gain practical advice to design efficient studies for the demonstration of Do you have problems understanding what is comparable and understanding the equivalence degree of sameness? This participative evening seminar will cover: ways to measure • Understand the scientific bottlenecks in inhalation drug development equivalence, including in vitro, pharmacokinetic and pharmacodynamic equivalence; • Learn to navigate the murky waters of regulatory requirements for inhalation how to prove your product is the same in terms of quality and efficacy; and the drug development parameters required to prove comparability to regulatory authorities. Formulation Considerations and Drug Stability Day Two: Wednesday 29 September 2010 13.30 Influence of particle morphology on aerosol performance 09.00 Opening remarks from the Chair • Micronisation and particle engineering: Opportunities, pros and cons Frank Thielmann, Senior Fellow, Novartis Horsham Research Centre, UK • Effect of manufacturing technique on particle morphology and drug product performance Advances in Analytical and Characterisation Techniques • Opportunities of a seamless drug substance-drug product interface • Influence of morphology factors, e.g. surface characteristics, particle 9.10 Advances in physico-chemical characterisation techniques charge, shape, on aerosol performance • Requirements with respect to physico-chemical parameters • Impact of particle characteristics on aerosol efficacy • Methods for determining glass transition, amorphous content and Norbert Rasenack, Fellow, Pharmaceutical Development, Novartis Pharma crystalline structure AG, Switzerland • Electrical properties and triboelectrification • Active centres and energy distribution - new methods for characterisation 14.05 Novel developments and applications in formulation preparation techniques Frank Thielmann, Senior Fellow, Novartis Horsham Research Centre, UK • High shear versus low shear blending of dry powders – Challenges of combining high lung deposition with low dose variability 9.45 Measuring particle size distribution: Can we reduce the analytical – Importance of ensuring a robust final manufacturing process burden? Michael Goller, Associate Director Respiratory R&D, Teva Pharmachemie, • How the AIM concept is being used for rapid screening of formulations The Netherlands • Overview of the 2-stage impactor – benefits and challenges • Accuracy in predicting functionality 14.40 Afternoon tea and networking Frank Chambers, Senior Scientist Inhalation R&T, AstraZeneca, UK 15.10 Optimising dry powder inhaler performance through formulation 10.20 Morning coffee and networking • Current challenges in dry powder formulations • Impact of excipients on product performance 10.50 Characterisation by dissolution testing • Interactions between the device and the formulation • Is dissolution testing feasible for inhalation products? • Manufacturing considerations • Challenges/benefits of dissolution testing for inhalables Andrew Brown, Head of Manufacturing, Oriel Therapeutics, UK • Comparison of different dissolution test methods Birte Jensen, Principle Scientist, Respiratory Drug Delivery, Boehringer 15.45 Managing excipients in inhalation drug development: DPI options Ingelheim Pharma, Germany • Requirements for excipients and regulatory aspects (liquid/powder) • Excipient surface characteristics on DPI performance: How to manipulate this 11.25 Advances in analytical techniques for drug substance/drug product • Influence of excipients on performance and stability characterisation Francesca Buttini, Post-doc Research Fellow, Department of Pharmacy, • Application of QbD in inhalation drug development University of Parma, Italy • Laser diffraction for micronised drug substance • Dynamic particle engineering for lactose carriers 16.20 Combination inhaled products: Key challenges for product development Rachel Brody, Principal Scientist, Pfizer, UK • Benefits of combination products • Considerations for different inhalation device platforms 12.00 SPOTLIGHT SESSION • Novel approaches to combination product development Raise your corporate profile by sponsoring or exhibiting at the 2nd Annual Nayna Govind, Team Manager, AstraZeneca, UK Inhalation Drug Development conference. For details on speaking in this session or other sponsorship opportunities at this conference please contact: 16.55 Discussion of issues arising from the conference and closing remarks from Ben Edwards, Tel: +44 (0)207 017 4447, Email: ben.edwards@informa.com the Chair 12.30 Lunch 17.30 End of day two PROMOTIONAL OPPORTUNITIES Raise your corporate profile by sponsoring or exhibiting at the 3rd Annual Genotoxic Impurities conference. For details on promotional opportunities at this conference please contact: Sukhvir Hayre, Tel: +44 (0)207 017 7131, Email: sukhvir.hayre@informa.com To Register Please Tel: +44 (0) 20 7017 7481 Fax: +44 (0) 20 7017 7823 Book online: www.informa-ls.com/inhalation Email: registrations@informa-ls.com Please Quote CQ5122
  4. 4. Inhalation Drug Development Conference Code: CQ5122C 28 – 29 September 2010, Ambassadors Bloomsbury, London, UK Pre-Conf Workshop Code: CQ5122X www.informa-ls.com/inhalation Evening seminar code: CQ5122Y 5 Easy ways to Register LS/MB/BE/AAJ/CC/DH +44 (0)20 7017 7481 The Bookings Department Informa UK Ltd +44 (0)20 7017 7823 PO Box 406 registrations@informa-ls.com Byfleet KT14 6WL www.informa-ls.com/inhalation Group Bookings: To take advantage of group bookings please contact Simon Lau on +44 (0) 207 017 7165 or email simon.lau@informa.com Are we mailing you correctly? To update your contact details on Your VIP number is on the address label. If there is no label, please quote our database please email integrity@informa.com Tel: +44 (0) 207 017 7077 or Fax +44 (0) 207 017 7828 Event selection Code Date Book before Friday Save Book between 9th July Save Book after Friday Save 9th July 2010 2010 and 3rd Sept 2010 3rd Sept 2010 Full Pass: Conference + pre-conf CQ5122CXY 27-29 Sept £2497+ VAT@17.5% ????? £2597+ VAT@17.5% ????? £2697+ VAT@17.5% ????? workshop + evening seminar 2010 = £2933.98 = £3051.48 = £3168.98 3 Day Pass: Conference CQ5122CX 27-29 Sept £2098 + VAT@17.5% ????? £2198+ VAT@17.5% ????? £2298+ VAT@17.5% + pre-conf workshop 2010 = £2465.15 = £2582.65 = £2700.15 2 Day Pass: Conference CQ5122CY 28-29 Sept £1898 + VAT@17.5% ????? £1998+ VAT@17.5% ????? £2098+ VAT@17.5% + evening seminar 2010 = £2230.15 = £2347.65 = £2465.15 Conference only CQ5122C 28-29 Sept £1399 + VAT@17.5% ????? £1499+ VAT@17.5% ????? £1599+ VAT@17.5% 2010 = £1643.83 = £1761.33 = £1878.83 Please tick if you will be attending the FREE breakfast seminar on Tuesday 28 Sept DELEGATE DETAILS – Please photocopy form for multiple bookings! 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Alternatively, if you would like to book your FEE: This includes all technical sessions, lunch and documentation. provided by you, will be held on a database and may be shared with other CANCELLATIONS: Cancellations received in writing before and on Monday companies in the Informa Group in the UK and internationally. If you do not accommodation by phone, you can call Daniel Spinner on 020 7292 2335 (if 13 September 2010 will be subject to a service charge of £99. The full wish your details to be available to other companies in the Informa Group outside UK +44 20 7292 2335), quoting Special Reference Code M9YPW, who conference fees remain payable after Monday 13 September 2010. please contact the Database Manager at the above address, Tel +44 (0)20 will be happy to help you with your hotel booking and provide assistance Substitutions are welcome at any time. 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