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Asthma                                                       Gain valuable insights into new
                                                             groundbreaking advances within the
                                                             respiratory drug development market



& COPD
                                                   TM
                                                             June 24-26, 2009
                                                             Philadelphia, PA




                                                                                                    See
                                                                                               inside for the
                                                                                             All-Access
                                                                                           Pass discount!



                                                                        Learn from Leading
                                                                        Innovators Including:
                                                                        Heribert Staudinger, PhD, Vice President,
                                                                        Clinical Development, Schering Plough
                                                                        Nestor A. Molfino, MD, Vice President, Clinical
                                                                        Development, Respiratory Diseases, Allergy and
Learn Best Practice Strategies On How To:                               Inflammation, MedImmune
                                                                        Theodore F. Reiss, MD, Vice President of Clinical
•   Assess the need for innovative drug development pipelines in the    Research, Merck Research Laboratories
    respiratory market                                                  Adam Wanner, MD, Professor, Principal
                                                                        Investigator, University of Miami Miller School
•   Uncover modern techniques for formulating a respiratory drug        of Medicine
    development pipeline                                                Shahin Sanjar, PhD, Head, Pipeline Sourcing,
                                                                        Nycomed US Inc.
•   Discover if we need new bronchodilators and anti-inflammatory
                                                                        Mark Parry-Billings, PhD, Chief Executive
    drugs for the treatment of Asthma and COPD                          Officer, Topigen Pharmaceuticals
•   Develop and enhance product design for addressing patient           Chris O’Brien, PhD, Vice President, Respiratory &
    adherence and compliance                                            Inflammation Therapeutic Area, AstraZeneca
                                                                        Kevin B. Bacon, PhD, President, Founder and
•   Discover effective strategies for improving the management of       Chief Scientific Officer, Axikin Pharmaceuticals
    patient care in Asthma                                              Colin Scott, MD, Global Brand Medical Director,
                                                                        Novartis
                                                                        Michael A. McAlexander, PhD, Senior Research
                                                                        Fellow, CEDD, GlaxoSmithKline
Media Partners:
                                                                        Lawrence de Garavilla, PhD, Research Fellow,
                                                                        Drug Discovery , Inflammation and Pulmonary
                                                                        Diseases Team, Johnson and Johnson
                                                                        Jonathan E. Phillips, Ph.D, Principal Scientist,
                                                                        Respiratory and Inflammation, Schering-Plough
                                                                        Research Institute
                                                                        Navin L. Rao, PhD, Senior Scientist, Drug
www.iqpc.com/us/asthma                                                  Discovery, Inflammation, Johnson & Johnson
Asthma                                         Gain valuable insights into new groundbreaking advances
                                                    within the respiratory drug development market


     & COPD
                                            TM

                                                     June 24-26, 2009 | Philadelphia, PA



                                                                                                   Who Will you Meet at the
                                                                                                   Conference?
                                                                                                   Directors, Heads, Scientists, Chemists,
                                                                                                   Research Leaders/Fellows/Advisors, &
                                                                                                   Managers working in the pharmaceutical or
        Dear Colleagues,                                                                           biotech industries within:
                                                                                                   •   Respiratory Therapeutics
        Respiratory diseases including Asth                                                        •   Research & Development
                                            ma are becoming more common,
        children, therefore the demand for                                      especially in      •   Inflammation
                                             continued development in respirato
        discovery and development arena                                           ry drug          •   Clinical Development
                                           has grown significantly in recent year
       commercial drug development mar                                            s. The           •   Regulatory Affairs
                                            ket in this area continues to grow                         Pulmonology
       corticosteroid/long-acting bronchod                                      with inhaled       •

                                            ilator combinations set to be the lead                 •   Drug Discovery
       value in 2014, and an estimated 300                                          ing class by
                                               million people in the world will be                 •   Respiratory Illness
       from Asthma, with COPD on the                                               suffering
                                         rise.                                                     •   Drug Delivery
                                                                                                   •   Project Management
      This year’s timely conference will cove                                                      •   Allergy Therapeutics
                                               r over 16 in-depth sessions and case
      examples including:                                                             study        •   Preclinical Development
        • Novel Tech
                                                                                                   •   Portfolio/Lifecycle Management
                      niques for Formulating a Respirato
                                                          ry Drug Development Pipeline
        • Differences
                       in the Development of Small vs. Larg
                                                              e Molecules
        • Evolving Clin
                        ical Endpoints in the Developmen                                           A special thank you to our
                                                           t of Inhaled Corticosteroids
       • Clinical Out
                      comes of PD4 Inhibitors: Valuable
                                                           Lessons Learned
                                                                                                   advisory board
       • Improving
                     the Management of Patient Care                                                Kevin B. Bacon, PhD, President, Founder and
                                                        in Asthma                                  Chief Scientific Officer, Axikin
       • Developing
                      Product Design for Addressing Patie
                                                            nt Adherence and Compliance            Pharmaceuticals
                                                                                                   Heribert Staudinger, PhD, Vice President,
     And much more including 4+ hou                                                                Clinical Development, Schering Plough
                                        rs of scheduled networking, insightfu
     panel discussions and a series of inte                                  l interactive
                                           ractive workshops.                                      Shahin Sanjar, PhD, Head, Pipeline Sourcing,
                                                                                                   Nycomed US Inc.
      Engage in dynamic conversation with                                                          Mark Parry-Billings, PhD, Chief Executive
                                             your industry peers at our multiple                   Officer, Topigen Pharmaceuticals
      sessions and work closely with man                                          networking
                                          y respiratory drug discovery and deve                    Ewan Walters, PhD, Medical Director, Teva UK
     industry leaders including AstraZen                                         lopment
                                         eca, Merck, Johnson & Johnson, Med                        Dzelal Serdarevic, PhD, Director, A&R
     Schering Plough, Nycomed, GlaxoSm                                          Immune,
                                           ithKline, Novartis and many more,                       Therapeutic Area, Clinical R&D, Pfizer
     series of medical device designers,                                       including a
                                         delivery experts and academic part                        Reza Farienfar, Director, Business
     sure to register yourself and a team                                   icipants. Be           Development, Cardinal Health
                                          of key people for this important even
                                                                                  t today!         Gerhard Scheuch, PhD, Chief Executive
    We look forward to seeing you in                                                               Officer, Activaero GmbH
                                     Philadelphia in June!

    Best Regards,
                                                                                                   Sponsorship and Exhibition
                                                                                                   Opportunities
                                                                       teractive
                                                        P . - Highly in
                                                                                                   Sponsorships and exhibits are excellent
                                                         .S                                        opportunities for your company to showcase its
                                                                        e
                                                        and informativ                             products and services to high-level, targeted
                                                        post-confe  rence                          decision-makers attending the Asthma & COPD
                                                                        e page 5                   Summit. IQPC and Pharma IQ help companies like
    Simon Curtis
                                                         workshops! Se                             yours achieve important sales, marketing and
                                                                                                   branding objectives by setting aside a limited
                                                         for details.
    Conference Director
                                                                                                   number of event sponsorships and exhibit spaces –
    www.iqpc.com/us/asthma                                                                         all of which are tailored to assist your organization
                                                                                                   in creating a platform to maximize your exposure at
                                                                                                   the event.

                                                                                                   For more information on sponsoring or exhibiting at
                                                                                                   the Asthma & COPD Summit please contact Mario
                                                                                                   Matulich at (212) 885-2719 or
                                                                                                   sponsorship@iqpc.com.
2      1-800-882-8684 • www.iqpc.com/us/asthma
Main Conference Day One
    Wednesday, June 24, 2009




    8:00   Registration and Coffee                                                     1:30   Panel Discussion: Improving Endpoints in COPD
                                                                                              Drug Development
    8:50   Welcome Address and Chairman’s Opening Remarks                                     • Discussing the pros and cons of improved X-Ray analysis
                                                                                              • Evaluating high resolution CT scans
    9:00   Opening Keynote Presentation: Novel Techniques for                                 • Identifying newer endpoints for evaluation

           Formulating a Respiratory Drug Development Pipeline                                Kevin B. Bacon, PhD, President, Founder and Chief Scientific Officer,
           • Accelerating the drug development pipeline                                       Axikin Pharmaceuticals
           • Identifying a set of promising candidate projects addressing gaps in             Heribert Staudinger, PhD, Vice President, Clinical Development,
             several stages of the drug development pipeline from fundamental                 Schering Plough
             research to product                                                              Fred Bode, PhD, Director, Respiratory Sciences, Sepracor*
           • Evaluating strategies for generating large numbers of molecular                  Shahin Sanjar, PhD, Senior Director, Respiratory Sciences, Nycomed
             targets for drugs as well as novel molecules to attack new and existing
             drug targets                                                              2:15   Evolving Clinical Endpoints in the Development of
           • Generating the interest and funding that will move a compound along              Inhaled Corticosteroids
             the path to eventual therapeutic approval                                        • Discussing development of inhaled corticosteroid/long-acting beta-
           Theodore F. Reiss, MD, Vice President of Clinical Research, Merck                    agonist combinations
           Research Laboratories                                                              • Overviewing clinical endpoints

                                                                                              • Addressing and understanding beta-agonist safety issues/patient

    9:45   Panel Discussion: Understanding and Assessing the                                    monitoring
           Need for New Drug Development Pipelines in the                                     • Examining endpoint case study examples

           Respiratory Market                                                                 • Discussing the development of NMEs in asthma and COPD

           • Examining pipeline pitfalls from the past: What to be aware of?                  • Discovering if we need new bronchodilators and anti-inflammatory

           • Overviewing new respiratory therapeutic approaches: Strategies for                 drugs for the treatment of asthma and COPD
             predicting clinical success or failure                                           Heribert Staudinger, MD, Vice President, Clinical Development,
           • Investigating compounds which may help improve control of asthma                 Allergy, Respiratory and Immunology,, Schering Plough
             exacerbations while reducing the need for steroids and rescue
             medication                                                                3:00   Networking Break
           • Evaluating the need to find novel anti-inflammatory drugs to treat

             COPD to reduce exacerbations, disease progression and mortality           3:30   The Promise of PDE4 Inhibitors as Novel Anti-
           • Discussing and predicting the future direction of the respiratory drug           Inflammatory Agents in COPD: Valuable Lessons
             discovery and development market                                                 Learnt From Clinical Studies
           Nestor A. Molfino, MD, Vice President, Clinical Development,                       • Discussing what we can learn from animal models of COPD
           Respiratory Diseases, Allergy and Inflammation, MedImmune                          • Identifying what we have learnt from clinical studies with PDE4
           Mark Parry-Billings, PhD, Chief Executive Officer, Topigen                           inhibitors
           Adam Wanner, MD, Professor, Principal Investigator, University of                  • Choosing appropriate endpoints to reflect the drug mode of action

           Miami Miller School of Medicine                                                    • Treating systemic or lung disease

                                                                                              • Examining the place of anti-inflammatory therapy in COPD

    10:30 Networking Break                                                                    Shahin Sanjar, PhD, Head, Pipeline Sourcing, Nycomed US Inc.

    11:00 Differences in the Development of Small vs. Large                            4:15   Application of Antisense Oligonucleotides in
           Molecules                                                                          Asthma and COPD (Case Study)
           • Summarizing the main differences between small molecules and large               • Examining oligonucleotide therapeutics in respiratory disease
             molecules                                                                        • Displaying rationale for using a multi-target approach in asthma
           • Reviewing of preclinical approaches                                                and COPD
           • Understanding of main differences in clinical development programs               • Designing and pre-clinical screening of effective drug candidates

           • Exploring if combination of large and small molecules is feasible                • Discussing clinical positioning and findings

           • Comprehending the major bottlenecks in overall development                       Mark Parry-Billings, PhD, Chief Executive Officer, Topigen
           Nestor A. Molfino, MD, Vice President, Clinical Development,
           Respiratory Diseases, Allergy and Inflammation, MedImmune                   5:00   COPD: New Lessons from Alpha-1 Antitrypsin
                                                                                              Deficiency (Case Study)
    11:45 Assessment of Safety in Novel Respiratory Delivery                                  • Appreciating the global COPD problem and the lack of disease-
           Systems: Lessons from the Exubera Development                                        modifying drug therapy for COPD
           Program                                                                            • Understanding that alpha-1 antitrypsin deficiency, a rare genetic

           • Understanding the issues of assessing respiratory safety in systemic               disease with a well characterized pathogenesis, has the same
             therapies delivered through the lung                                               pulmonary phenotype as common COPD and therefore can serve as
           • Discussing the non-traditional methodologies and endpoints used in                 an experiment of nature to study the pathogenesis of common COPD
             the respiratory safety assessment of Exubera                                     • Appreciating the fact that the concept of protease-antiprotease

           • Understanding the value of functional endpoint standardization                     imbalance, thought to be shared by alpha-1 antitrypsin deficiency
           • Understanding the potential for systemic therapies delivered by                    and common COPD, has not resulted in effective drugs for COPD
             inhalation to interact with other environmental respiratory exposures            • Becoming familiar with protein misfolding, aggregation and

             or therapies                                                                       disposal, a new link between alpha-1 antitrypsin deficiency and
           • Discussing the guidance for development of inhalable insulins that has             common COPD
             been adopted by the US FDA                                                       • Understanding that pharmacologically targeting protein misfolding

           John Teeter, MD, Senior Director, Development Lead,                                  and trafficking could lead to the development of novel drugs for
           Respiratory/Diabetes Emerging Markets, Pfizer Inc.                                   both alpha-1 antitrypsin deficiency and common COPD
                                                                                              Adam Wanner, MD, Professor, Principal Investigator, University of
    12:30 Networking Lunch                                                                    Miami Miller School of Medicine

                                                                                       5:45   End of Day One

3   1-800-882-8684 • www.iqpc.com/us/asthma
Main Conference Day Two
    Thursday, June 25, 2009




    8:00   Registration and Coffee                                                       • Discussing recent insights into the molecular biology and
                                                                                           function of the airway nociceptor and its links to cough,
    8:50   Welcome Address and Chairman’s Opening                                          dyspnea and other respiratory symptoms
           Remarks                                                                       • Examining tetrodotoxin-resistant sodium channels and transient

                                                                                           receptor potential channels as emerging therapeutic targets for
    9:00   Improving the Management of Patient Care in                                     chronic respiratory diseases
           Asthma                                                                        • Identifying translational aspects of targeting ion channels for

           • Improving communication and understanding between patients                    COPD symptom relief
             and physicians                                                              M. Allen McAlexander, PhD, Investigator, Respiratory CEDD,
           • Examining patient suggestions for improvements                              GlaxoSmithKline
           • Improving education around the illness and treatment

           • Discussing the benefits of more than one pharmacological             2:15   Formulation, Generation and Delivery of
             approach                                                                    Respiratory Therapeutic Aerosols to Rodents
           Colin Scott, MD, Global Brand Medical Director, Novartis                      • Discussing the use of animal disease models as a tool for
                                                                                           assessing efficacy of inhaled pre-clinical drug candidates
    9:45   Anti-C5 (Eculizumab) Treatment as Novel Therapy                               • Overview of instrumentation necessary to deliver dry powder

           for Asthma (Case study)                                                         aerosols to rodents and estimated the dose delivered to the
           • Displaying a proof of concept trial investigating the effect of C5            lungs
                                                                                         • Identifying ideal properties of inhaled respiratory drugs
             inhibition on development of allergen-induced airway
                                                                                         • Displaying case study examples of using this model with clinical
             responses in asthmatic subjects
           • Discussing the treating Mild allergic asthmatics whom                         standard inhaled steroids
             developed both early (EAR) and late asthmatic responses (LAR)               Jonathan E. Phillips, Ph.D, Principal Scientist, Respiratory Drug
             after allergen challenge                                                    Discovery, Schering-Plough Research Institute
           • Understanding the primary endpoint which was the effect of

             C5 inhibition on the development of LAR                              3:00   Networking Break
           • Discussing the development of eculizumab as a novel treatment

             for severe persistent asthma                                         3:30   Leukocyte Proteases in Airways Diseases (Case
           Yi Wang, PhD, Head, Preclinical Sciences, Alexion                             Study)
           Pharmaceuticals Inc.                                                          • Protease-protease inhibitor imbalance contributes to airways
                                                                                           diseases such as asthma and COPD
    10:30 Networking Break                                                               • Neutrophil derived Cathepsin G and mast cell derived chymase

                                                                                           and tryptase may be key enzymes contributing to these
    11:00 Using Patents Strategically In Respiratory Product                               diseases
           Lifecycle Management                                                          • Small molecule inhibitors of these enzymes have anti-

           • Learning how innovators and generics are using patents to                     inflammatory properties and are effective in preclinical models
             manage lifecycles                                                             of airways diseases
           • Discussing patents on combination drugs in the current                      Lawrence de Garavilla, Ph.D., Research Fellow, Inflammation
             environment                                                                 and Pulmonary Diseases Team, Drug Discovery, Johnson &
           • Using novel delivery systems—both pharmaceutical and                        Johnson Pharmaceutical Research and Development, L.L.C.
             devices—as a basis for patent protection
           • Getting competitive intelligence, patent strategy, and product       4:15   Leukotriene A4 Hydrolase Inhibitors and Airway
             strategy to work together                                                   Inflammation (Case Study)
           Bruce D. Sunstein, Co-founder, Partner, Bromberg &                            • Overview of leukotriene A4 hydrolase biology
           Sunstein LLP                                                                  • Efficacy of leukotriene A4 hydrolase inhibitors in preclinical
                                                                                           airway inflammation models
    11:45 Novel Inhaled Drug Delivery Technology                                         • Understanding the role of leukotrienes in chronic airway models

          • Evaluating the effectiveness of Inhalation of bronchodilators                • Displaying mechanisms of action of leukotriene A4 hydrolase

            and glucocorticosteroids                                                       inhibitors
          • Minimizing local (oropharyngeal) and systemic side-effects of                Navin L. Rao, PhD, Senior Scientist, Drug Discovery,
            drugs                                                                        Inflammation, Johnson & Johnson
          • Uncovering simple to use, portable, durable, unobtrusive and

            cost effective medical device aspects                                 5:00   Functional Endpoints In Asthma
          • Examining the pros and cons of the pressurized metered-dose                  • Discussing lung function use as a primary endpoint in asthma
            inhaler (pMDI) - The most widely used delivery system                          clinical trials
          • Discussing the increased-use of DPIs (Dry-powder Inhalers) to                • Discussing relationships between, traditional and patient-

            deliver asthma medications                                                     centered endpoints during treatment with different classes of
          Speakers are to be announced. Please check the website                           medication
                                                                                         • Examining severe asthma indicated by poor lung function,
          for speaker updates.
                                                                                           frequent symptoms or reliever use, night waking and
    12:30 Networking Lunch                                                                 exacerbations
                                                                                         • Understanding the relationship between end-points and

    1:30   Novel Ion Channel Drug Development Strategies                                   medication class
           for the Treatment of COPD Symptoms                                            • Identifying novel functional endpoints in Asthma with case

           •   Displaying the use of RNA interference for in vivo pre-clinical             study examples
               validation of ion channel targets in non-mouse species                    Chris O’Brien, PhD, Vice President, Respiratory & Inflammation
           •   Understanding automated patch-clamp and baculovirus-based                 Therapeutic Area, AstraZeneca
               vectors for transient transfection as enabling technologies for
               ion channel drug discovery                                         5:45   End Of Conference & Chairman’s Closing Remarks


4    1-800-882-8684 • www.iqpc.com/us/asthma
Post-Conference Workshops
    Friday, June 26, 2009




         9:00 am – 12:00 pm (Registration at 8:30 am) Coffee will be served            12.30 pm – 3.00 pm (Registration at 12:00 pm) Lunch included
     A   The Effective Use of Biomarkers in
         Respiratory Drug Discovery
                                                                              B        Asthma and Allergy issues: Addressing
                                                                                       Approaches to Allergic Disorders
         Studying clinical effects of new therapies on patients through               Currently within the respiratory arena, there have been modern
         electronic monitoring of lung function (FEV1) as well as                     misconceptions why asthma–related drug development
         advanced lung function and exercise and challenge test has                   programs have not been pursued commercially in the form of
         become possible. As a result of this., respiratory drug                      tackling other similar allergy-therapeutic disorders. Given that,
         development companies are employing human whole blood                        there are many similarities between both asthma-based drug
         flow cytometry and non-invasive sampling to assess                           therapeutics and many allergy-based drug development
         pharmacodynamic effects of new therapies in phase I/II clinicial             programs. This workshop will uncover and overview some of the
         studies. Surrogate biomarkers in COPD may be assessed in                     novel approaches to these new drug development pipelines
         blood, exhaled breath, induced sputum, bronchial mucosal                     focused on allergy therapeutics, and identify some of the most
         biopsy, bronchoalveolar lavage (BAL), and through advanced                   commercially viable pipelines currently in development.
         radiographic imaging.
                                                                                      What will be covered:
         What will be covered:                                                        • Displaying novel approaches for identifying genes responsible

         • Making a suited claim to the FDA for therapeutic purposes                    for allergic disorders
         • Identifying and understanding new biotechnology agents and                 • Discussing standardized immuno-therapeutic approaches for

           biomarkers for asthma                                                        allergies
         • Studying clinical effects of new therapies on patients through             • Evaluating unorthodox testing methods:

           electronic monitoring of lung function (FEV1)                                1. Vega (electro-diagnostic) testing
         • Employing human whole blood flow cytometry and non-                          2. Cytotoxic testing (quot;Bryan's testquot;) and the Alcat test
           invasive sampling to assess pharmacodynamic effects of new                   3. Iridology
           therapies in phase I/II clinical studies                                     4. Kinesiology
         • Relying on a collaboration between academics in clinical                     5. IgG food antibody testing and other techniques
           research, the pharmaceutical industry and regulatory                       • Developments in allergy elimination techniques - allergen

           authorities                                                                  immunotherapy
                                                                                      • Uncovering the link between allergic disorders and asthma

         Workshop Leaders:                                                              approaches
         Yi Wang, PhD, Head, Preclinical Sciences, Alexion
         Pharmaceuticals                                                              Please check the website for up-to-date details about
         Marianne Mann, MD, Clinical & Regulatory Drug Development                    the workshop.
         Consultant
         Please check the website for up-to-date details about
         the workshop.




    About the Media Partners
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                      other offerings from PharmiWeb solutions, please visit www.pharmiwebsolutions.com.

                      Piribo is a UK-based independent online store supplying business information on the pharmaceutical and biotechnology industries.
                      The website now carries nearly 10,000 English language titles including, market reports, studies and books and is the UK's largest
                      online biopharma information store. www.piribo.com

                      Report Buyer is the intelligent way to buy market research online. Browse and choose from a current and comprehensive range of
                      specialised intelligence from leading publishers covering most industry and market sectors. Trusted by information professionals
                      across the world, Report Buyer’s mission is to help you find the right business intelligence. www.reportbuyer.com




5   1-800-882-8684 • www.iqpc.com/us/asthma
Asthma                                                                                                    Gain valuable insights into new
                                                                                                              groundbreaking advances within the
                                                                                                              respiratory drug development market



    & COPD
                                                                                        TM
                                                                                                          June 24-26, 2009
                                                                                                          Philadelphia, PA




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    Registration Information
    Qualified Pharmaceutical and Biotech Organizations:
        PRICING                   Register by April 3, 2009         Register by April 17, 2009      Register by May 1, 2009       Register by May 29, 2009             Standard Price

        Conference Only              $1,199 (save $400)                 $1,299 (save $300)            $1,399 (save $200)             $1,499 (save $100)                     $1,599

        All-Access Pass              $1,999 (save $698)                 $2,099 (save $598)            $2,199 (save $498)             $2,299 (save $398)              $2,399 (save $298)

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    Others:
        PRICING                             Register by May 1, 2009                                Register by May 29, 2009                                  Standard Price

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        All-Access Pass                        $2,899 (save $798)                                     $3,199 (save $498)                                  $3,499 (save $198)

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    * CT residents or people employed in the state of CT must add 6% sales tax. For IQPC’s Cancellation, Postponement and Substitution Policy, please visit
                                                                                www.iqpc.com/cancellation
    TEAM DISCOUNTS
    or information on team discounts, please contact IQPC Customer Service at Note: Conference venue to be confirmed shortly. Please check www.iqpc.com/us/asthma for updated
    1-800-882-8684. Only one discount may be applied per registrant.            information.
    Special Discounts Available: A limited number of discounts are available   Special Dietary Needs: If you have a dietary restriction, please contact Customer Service at 1-800-882-
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6        1-800-882-8684 • www.iqpc.com/us/asthma

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Asthma & COPD

  • 1. Register by April 3rd and SAVE up to $698 Asthma Gain valuable insights into new groundbreaking advances within the respiratory drug development market & COPD TM June 24-26, 2009 Philadelphia, PA See inside for the All-Access Pass discount! Learn from Leading Innovators Including: Heribert Staudinger, PhD, Vice President, Clinical Development, Schering Plough Nestor A. Molfino, MD, Vice President, Clinical Development, Respiratory Diseases, Allergy and Learn Best Practice Strategies On How To: Inflammation, MedImmune Theodore F. Reiss, MD, Vice President of Clinical • Assess the need for innovative drug development pipelines in the Research, Merck Research Laboratories respiratory market Adam Wanner, MD, Professor, Principal Investigator, University of Miami Miller School • Uncover modern techniques for formulating a respiratory drug of Medicine development pipeline Shahin Sanjar, PhD, Head, Pipeline Sourcing, Nycomed US Inc. • Discover if we need new bronchodilators and anti-inflammatory Mark Parry-Billings, PhD, Chief Executive drugs for the treatment of Asthma and COPD Officer, Topigen Pharmaceuticals • Develop and enhance product design for addressing patient Chris O’Brien, PhD, Vice President, Respiratory & adherence and compliance Inflammation Therapeutic Area, AstraZeneca Kevin B. Bacon, PhD, President, Founder and • Discover effective strategies for improving the management of Chief Scientific Officer, Axikin Pharmaceuticals patient care in Asthma Colin Scott, MD, Global Brand Medical Director, Novartis Michael A. McAlexander, PhD, Senior Research Fellow, CEDD, GlaxoSmithKline Media Partners: Lawrence de Garavilla, PhD, Research Fellow, Drug Discovery , Inflammation and Pulmonary Diseases Team, Johnson and Johnson Jonathan E. Phillips, Ph.D, Principal Scientist, Respiratory and Inflammation, Schering-Plough Research Institute Navin L. Rao, PhD, Senior Scientist, Drug www.iqpc.com/us/asthma Discovery, Inflammation, Johnson & Johnson
  • 2. Asthma Gain valuable insights into new groundbreaking advances within the respiratory drug development market & COPD TM June 24-26, 2009 | Philadelphia, PA Who Will you Meet at the Conference? Directors, Heads, Scientists, Chemists, Research Leaders/Fellows/Advisors, & Managers working in the pharmaceutical or Dear Colleagues, biotech industries within: • Respiratory Therapeutics Respiratory diseases including Asth • Research & Development ma are becoming more common, children, therefore the demand for especially in • Inflammation continued development in respirato discovery and development arena ry drug • Clinical Development has grown significantly in recent year commercial drug development mar s. The • Regulatory Affairs ket in this area continues to grow Pulmonology corticosteroid/long-acting bronchod with inhaled • ilator combinations set to be the lead • Drug Discovery value in 2014, and an estimated 300 ing class by million people in the world will be • Respiratory Illness from Asthma, with COPD on the suffering rise. • Drug Delivery • Project Management This year’s timely conference will cove • Allergy Therapeutics r over 16 in-depth sessions and case examples including: study • Preclinical Development • Novel Tech • Portfolio/Lifecycle Management niques for Formulating a Respirato ry Drug Development Pipeline • Differences in the Development of Small vs. Larg e Molecules • Evolving Clin ical Endpoints in the Developmen A special thank you to our t of Inhaled Corticosteroids • Clinical Out comes of PD4 Inhibitors: Valuable Lessons Learned advisory board • Improving the Management of Patient Care Kevin B. Bacon, PhD, President, Founder and in Asthma Chief Scientific Officer, Axikin • Developing Product Design for Addressing Patie nt Adherence and Compliance Pharmaceuticals Heribert Staudinger, PhD, Vice President, And much more including 4+ hou Clinical Development, Schering Plough rs of scheduled networking, insightfu panel discussions and a series of inte l interactive ractive workshops. Shahin Sanjar, PhD, Head, Pipeline Sourcing, Nycomed US Inc. Engage in dynamic conversation with Mark Parry-Billings, PhD, Chief Executive your industry peers at our multiple Officer, Topigen Pharmaceuticals sessions and work closely with man networking y respiratory drug discovery and deve Ewan Walters, PhD, Medical Director, Teva UK industry leaders including AstraZen lopment eca, Merck, Johnson & Johnson, Med Dzelal Serdarevic, PhD, Director, A&R Schering Plough, Nycomed, GlaxoSm Immune, ithKline, Novartis and many more, Therapeutic Area, Clinical R&D, Pfizer series of medical device designers, including a delivery experts and academic part Reza Farienfar, Director, Business sure to register yourself and a team icipants. Be Development, Cardinal Health of key people for this important even t today! Gerhard Scheuch, PhD, Chief Executive We look forward to seeing you in Officer, Activaero GmbH Philadelphia in June! Best Regards, Sponsorship and Exhibition Opportunities teractive P . - Highly in Sponsorships and exhibits are excellent .S opportunities for your company to showcase its e and informativ products and services to high-level, targeted post-confe rence decision-makers attending the Asthma & COPD e page 5 Summit. IQPC and Pharma IQ help companies like Simon Curtis workshops! Se yours achieve important sales, marketing and branding objectives by setting aside a limited for details. Conference Director number of event sponsorships and exhibit spaces – www.iqpc.com/us/asthma all of which are tailored to assist your organization in creating a platform to maximize your exposure at the event. For more information on sponsoring or exhibiting at the Asthma & COPD Summit please contact Mario Matulich at (212) 885-2719 or sponsorship@iqpc.com. 2 1-800-882-8684 • www.iqpc.com/us/asthma
  • 3. Main Conference Day One Wednesday, June 24, 2009 8:00 Registration and Coffee 1:30 Panel Discussion: Improving Endpoints in COPD Drug Development 8:50 Welcome Address and Chairman’s Opening Remarks • Discussing the pros and cons of improved X-Ray analysis • Evaluating high resolution CT scans 9:00 Opening Keynote Presentation: Novel Techniques for • Identifying newer endpoints for evaluation Formulating a Respiratory Drug Development Pipeline Kevin B. Bacon, PhD, President, Founder and Chief Scientific Officer, • Accelerating the drug development pipeline Axikin Pharmaceuticals • Identifying a set of promising candidate projects addressing gaps in Heribert Staudinger, PhD, Vice President, Clinical Development, several stages of the drug development pipeline from fundamental Schering Plough research to product Fred Bode, PhD, Director, Respiratory Sciences, Sepracor* • Evaluating strategies for generating large numbers of molecular Shahin Sanjar, PhD, Senior Director, Respiratory Sciences, Nycomed targets for drugs as well as novel molecules to attack new and existing drug targets 2:15 Evolving Clinical Endpoints in the Development of • Generating the interest and funding that will move a compound along Inhaled Corticosteroids the path to eventual therapeutic approval • Discussing development of inhaled corticosteroid/long-acting beta- Theodore F. Reiss, MD, Vice President of Clinical Research, Merck agonist combinations Research Laboratories • Overviewing clinical endpoints • Addressing and understanding beta-agonist safety issues/patient 9:45 Panel Discussion: Understanding and Assessing the monitoring Need for New Drug Development Pipelines in the • Examining endpoint case study examples Respiratory Market • Discussing the development of NMEs in asthma and COPD • Examining pipeline pitfalls from the past: What to be aware of? • Discovering if we need new bronchodilators and anti-inflammatory • Overviewing new respiratory therapeutic approaches: Strategies for drugs for the treatment of asthma and COPD predicting clinical success or failure Heribert Staudinger, MD, Vice President, Clinical Development, • Investigating compounds which may help improve control of asthma Allergy, Respiratory and Immunology,, Schering Plough exacerbations while reducing the need for steroids and rescue medication 3:00 Networking Break • Evaluating the need to find novel anti-inflammatory drugs to treat COPD to reduce exacerbations, disease progression and mortality 3:30 The Promise of PDE4 Inhibitors as Novel Anti- • Discussing and predicting the future direction of the respiratory drug Inflammatory Agents in COPD: Valuable Lessons discovery and development market Learnt From Clinical Studies Nestor A. Molfino, MD, Vice President, Clinical Development, • Discussing what we can learn from animal models of COPD Respiratory Diseases, Allergy and Inflammation, MedImmune • Identifying what we have learnt from clinical studies with PDE4 Mark Parry-Billings, PhD, Chief Executive Officer, Topigen inhibitors Adam Wanner, MD, Professor, Principal Investigator, University of • Choosing appropriate endpoints to reflect the drug mode of action Miami Miller School of Medicine • Treating systemic or lung disease • Examining the place of anti-inflammatory therapy in COPD 10:30 Networking Break Shahin Sanjar, PhD, Head, Pipeline Sourcing, Nycomed US Inc. 11:00 Differences in the Development of Small vs. Large 4:15 Application of Antisense Oligonucleotides in Molecules Asthma and COPD (Case Study) • Summarizing the main differences between small molecules and large • Examining oligonucleotide therapeutics in respiratory disease molecules • Displaying rationale for using a multi-target approach in asthma • Reviewing of preclinical approaches and COPD • Understanding of main differences in clinical development programs • Designing and pre-clinical screening of effective drug candidates • Exploring if combination of large and small molecules is feasible • Discussing clinical positioning and findings • Comprehending the major bottlenecks in overall development Mark Parry-Billings, PhD, Chief Executive Officer, Topigen Nestor A. Molfino, MD, Vice President, Clinical Development, Respiratory Diseases, Allergy and Inflammation, MedImmune 5:00 COPD: New Lessons from Alpha-1 Antitrypsin Deficiency (Case Study) 11:45 Assessment of Safety in Novel Respiratory Delivery • Appreciating the global COPD problem and the lack of disease- Systems: Lessons from the Exubera Development modifying drug therapy for COPD Program • Understanding that alpha-1 antitrypsin deficiency, a rare genetic • Understanding the issues of assessing respiratory safety in systemic disease with a well characterized pathogenesis, has the same therapies delivered through the lung pulmonary phenotype as common COPD and therefore can serve as • Discussing the non-traditional methodologies and endpoints used in an experiment of nature to study the pathogenesis of common COPD the respiratory safety assessment of Exubera • Appreciating the fact that the concept of protease-antiprotease • Understanding the value of functional endpoint standardization imbalance, thought to be shared by alpha-1 antitrypsin deficiency • Understanding the potential for systemic therapies delivered by and common COPD, has not resulted in effective drugs for COPD inhalation to interact with other environmental respiratory exposures • Becoming familiar with protein misfolding, aggregation and or therapies disposal, a new link between alpha-1 antitrypsin deficiency and • Discussing the guidance for development of inhalable insulins that has common COPD been adopted by the US FDA • Understanding that pharmacologically targeting protein misfolding John Teeter, MD, Senior Director, Development Lead, and trafficking could lead to the development of novel drugs for Respiratory/Diabetes Emerging Markets, Pfizer Inc. both alpha-1 antitrypsin deficiency and common COPD Adam Wanner, MD, Professor, Principal Investigator, University of 12:30 Networking Lunch Miami Miller School of Medicine 5:45 End of Day One 3 1-800-882-8684 • www.iqpc.com/us/asthma
  • 4. Main Conference Day Two Thursday, June 25, 2009 8:00 Registration and Coffee • Discussing recent insights into the molecular biology and function of the airway nociceptor and its links to cough, 8:50 Welcome Address and Chairman’s Opening dyspnea and other respiratory symptoms Remarks • Examining tetrodotoxin-resistant sodium channels and transient receptor potential channels as emerging therapeutic targets for 9:00 Improving the Management of Patient Care in chronic respiratory diseases Asthma • Identifying translational aspects of targeting ion channels for • Improving communication and understanding between patients COPD symptom relief and physicians M. Allen McAlexander, PhD, Investigator, Respiratory CEDD, • Examining patient suggestions for improvements GlaxoSmithKline • Improving education around the illness and treatment • Discussing the benefits of more than one pharmacological 2:15 Formulation, Generation and Delivery of approach Respiratory Therapeutic Aerosols to Rodents Colin Scott, MD, Global Brand Medical Director, Novartis • Discussing the use of animal disease models as a tool for assessing efficacy of inhaled pre-clinical drug candidates 9:45 Anti-C5 (Eculizumab) Treatment as Novel Therapy • Overview of instrumentation necessary to deliver dry powder for Asthma (Case study) aerosols to rodents and estimated the dose delivered to the • Displaying a proof of concept trial investigating the effect of C5 lungs • Identifying ideal properties of inhaled respiratory drugs inhibition on development of allergen-induced airway • Displaying case study examples of using this model with clinical responses in asthmatic subjects • Discussing the treating Mild allergic asthmatics whom standard inhaled steroids developed both early (EAR) and late asthmatic responses (LAR) Jonathan E. Phillips, Ph.D, Principal Scientist, Respiratory Drug after allergen challenge Discovery, Schering-Plough Research Institute • Understanding the primary endpoint which was the effect of C5 inhibition on the development of LAR 3:00 Networking Break • Discussing the development of eculizumab as a novel treatment for severe persistent asthma 3:30 Leukocyte Proteases in Airways Diseases (Case Yi Wang, PhD, Head, Preclinical Sciences, Alexion Study) Pharmaceuticals Inc. • Protease-protease inhibitor imbalance contributes to airways diseases such as asthma and COPD 10:30 Networking Break • Neutrophil derived Cathepsin G and mast cell derived chymase and tryptase may be key enzymes contributing to these 11:00 Using Patents Strategically In Respiratory Product diseases Lifecycle Management • Small molecule inhibitors of these enzymes have anti- • Learning how innovators and generics are using patents to inflammatory properties and are effective in preclinical models manage lifecycles of airways diseases • Discussing patents on combination drugs in the current Lawrence de Garavilla, Ph.D., Research Fellow, Inflammation environment and Pulmonary Diseases Team, Drug Discovery, Johnson & • Using novel delivery systems—both pharmaceutical and Johnson Pharmaceutical Research and Development, L.L.C. devices—as a basis for patent protection • Getting competitive intelligence, patent strategy, and product 4:15 Leukotriene A4 Hydrolase Inhibitors and Airway strategy to work together Inflammation (Case Study) Bruce D. Sunstein, Co-founder, Partner, Bromberg & • Overview of leukotriene A4 hydrolase biology Sunstein LLP • Efficacy of leukotriene A4 hydrolase inhibitors in preclinical airway inflammation models 11:45 Novel Inhaled Drug Delivery Technology • Understanding the role of leukotrienes in chronic airway models • Evaluating the effectiveness of Inhalation of bronchodilators • Displaying mechanisms of action of leukotriene A4 hydrolase and glucocorticosteroids inhibitors • Minimizing local (oropharyngeal) and systemic side-effects of Navin L. Rao, PhD, Senior Scientist, Drug Discovery, drugs Inflammation, Johnson & Johnson • Uncovering simple to use, portable, durable, unobtrusive and cost effective medical device aspects 5:00 Functional Endpoints In Asthma • Examining the pros and cons of the pressurized metered-dose • Discussing lung function use as a primary endpoint in asthma inhaler (pMDI) - The most widely used delivery system clinical trials • Discussing the increased-use of DPIs (Dry-powder Inhalers) to • Discussing relationships between, traditional and patient- deliver asthma medications centered endpoints during treatment with different classes of Speakers are to be announced. Please check the website medication • Examining severe asthma indicated by poor lung function, for speaker updates. frequent symptoms or reliever use, night waking and 12:30 Networking Lunch exacerbations • Understanding the relationship between end-points and 1:30 Novel Ion Channel Drug Development Strategies medication class for the Treatment of COPD Symptoms • Identifying novel functional endpoints in Asthma with case • Displaying the use of RNA interference for in vivo pre-clinical study examples validation of ion channel targets in non-mouse species Chris O’Brien, PhD, Vice President, Respiratory & Inflammation • Understanding automated patch-clamp and baculovirus-based Therapeutic Area, AstraZeneca vectors for transient transfection as enabling technologies for ion channel drug discovery 5:45 End Of Conference & Chairman’s Closing Remarks 4 1-800-882-8684 • www.iqpc.com/us/asthma
  • 5. Post-Conference Workshops Friday, June 26, 2009 9:00 am – 12:00 pm (Registration at 8:30 am) Coffee will be served 12.30 pm – 3.00 pm (Registration at 12:00 pm) Lunch included A The Effective Use of Biomarkers in Respiratory Drug Discovery B Asthma and Allergy issues: Addressing Approaches to Allergic Disorders Studying clinical effects of new therapies on patients through Currently within the respiratory arena, there have been modern electronic monitoring of lung function (FEV1) as well as misconceptions why asthma–related drug development advanced lung function and exercise and challenge test has programs have not been pursued commercially in the form of become possible. As a result of this., respiratory drug tackling other similar allergy-therapeutic disorders. Given that, development companies are employing human whole blood there are many similarities between both asthma-based drug flow cytometry and non-invasive sampling to assess therapeutics and many allergy-based drug development pharmacodynamic effects of new therapies in phase I/II clinicial programs. This workshop will uncover and overview some of the studies. Surrogate biomarkers in COPD may be assessed in novel approaches to these new drug development pipelines blood, exhaled breath, induced sputum, bronchial mucosal focused on allergy therapeutics, and identify some of the most biopsy, bronchoalveolar lavage (BAL), and through advanced commercially viable pipelines currently in development. radiographic imaging. What will be covered: What will be covered: • Displaying novel approaches for identifying genes responsible • Making a suited claim to the FDA for therapeutic purposes for allergic disorders • Identifying and understanding new biotechnology agents and • Discussing standardized immuno-therapeutic approaches for biomarkers for asthma allergies • Studying clinical effects of new therapies on patients through • Evaluating unorthodox testing methods: electronic monitoring of lung function (FEV1) 1. Vega (electro-diagnostic) testing • Employing human whole blood flow cytometry and non- 2. Cytotoxic testing (quot;Bryan's testquot;) and the Alcat test invasive sampling to assess pharmacodynamic effects of new 3. Iridology therapies in phase I/II clinical studies 4. Kinesiology • Relying on a collaboration between academics in clinical 5. IgG food antibody testing and other techniques research, the pharmaceutical industry and regulatory • Developments in allergy elimination techniques - allergen authorities immunotherapy • Uncovering the link between allergic disorders and asthma Workshop Leaders: approaches Yi Wang, PhD, Head, Preclinical Sciences, Alexion Pharmaceuticals Please check the website for up-to-date details about Marianne Mann, MD, Clinical & Regulatory Drug Development the workshop. Consultant Please check the website for up-to-date details about the workshop. About the Media Partners A major STM publisher, Bentham Science answers the information needs for the pharmaceutical, Bio-medical and medical research community. Leading journals include Current Pharmaceutical Design (Impact Factor 4.8) and Current Medicinal Chemistry (Impact Factor 4.9) FREE online journals & information: www.bentham.org Since 1999, PharmiWeb.com has been bringing the latest news and developments in the pharmaceutical industry to a global audience, now reaching close to a quarter of a million professionals. Sponsored by many of the world’s leading pharmaceutical corporations, PharmiWeb.com is widely regarded as the leading pharma portal. To find out more about PharmiwWeb.com, and the other offerings from PharmiWeb solutions, please visit www.pharmiwebsolutions.com. Piribo is a UK-based independent online store supplying business information on the pharmaceutical and biotechnology industries. The website now carries nearly 10,000 English language titles including, market reports, studies and books and is the UK's largest online biopharma information store. www.piribo.com Report Buyer is the intelligent way to buy market research online. Browse and choose from a current and comprehensive range of specialised intelligence from leading publishers covering most industry and market sectors. Trusted by information professionals across the world, Report Buyer’s mission is to help you find the right business intelligence. www.reportbuyer.com 5 1-800-882-8684 • www.iqpc.com/us/asthma
  • 6. Asthma Gain valuable insights into new groundbreaking advances within the respiratory drug development market & COPD TM June 24-26, 2009 Philadelphia, PA REGISTRATION CARD (Email this form to info@iqpc.com or fax to 646-378-6025) YES! Please register me for ❑ Conference Only ❑ All-Access Pass ❑ Workshops Name ____________________________________________________________ Job Title _________________________________________________ Organization______________________________________________________ Approving Manager________________________________________ Address _____________________________________________ City________________________________________State__________Zip__________ Phone_____________________________________________E-mail____________________________________________________________________ ❑ Please keep me informed via email about this and other related events. ❑ Check enclosed for $_________ (Payable to IQPC) ❑ Charge my ❑ Amex ❑ Visa ❑Mastercard ❑ Diners Club Card #_______________________________Exp. Date___/___ ❑ I cannot attend, but please keep me informed of all future events. Registration Information Qualified Pharmaceutical and Biotech Organizations: PRICING Register by April 3, 2009 Register by April 17, 2009 Register by May 1, 2009 Register by May 29, 2009 Standard Price Conference Only $1,199 (save $400) $1,299 (save $300) $1,399 (save $200) $1,499 (save $100) $1,599 All-Access Pass $1,999 (save $698) $2,099 (save $598) $2,199 (save $498) $2,299 (save $398) $2,399 (save $298) Workshops $549 each $549 each $549 each $549 each $549 each Others: PRICING Register by May 1, 2009 Register by May 29, 2009 Standard Price Conference Only $1,999 (save $600) $2,299 (save $300) $2,599 All-Access Pass $2,899 (save $798) $3,199 (save $498) $3,499 (save $198) Workshops $549 each $549 each $549 each See website at www.iqpc.com/us/asthma for an explanation of a Qualified Pharmaceutical and Biotech Organizations. Please note multiple discounts cannot be combined. Reference: Please include the name of the attendee(s) and the event number: 17336.001 A $99 processing charge will be assessed to all registrations not Payment Policy: Payment is due in full at the time of registration and includes lunches, refreshment accompanied by credit card payment at the time of registration. and detailed conference materials. Your registration will not be confirmed until payment is received and may be subject to cancellation. MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC * CT residents or people employed in the state of CT must add 6% sales tax. For IQPC’s Cancellation, Postponement and Substitution Policy, please visit www.iqpc.com/cancellation TEAM DISCOUNTS or information on team discounts, please contact IQPC Customer Service at Note: Conference venue to be confirmed shortly. Please check www.iqpc.com/us/asthma for updated 1-800-882-8684. Only one discount may be applied per registrant. information. Special Discounts Available: A limited number of discounts are available Special Dietary Needs: If you have a dietary restriction, please contact Customer Service at 1-800-882- for the non-profit sector, government organizations and academia. For more 8684 to discuss your specific needs. information, please contact customer service at 1-800-882-8684. ©2009 IQPC. All Rights Reserved. The format, design, content and arrangement of this brochure Details for making payment via EFT or wire transfer: constitute a trademark of IQPC. Unauthorized reproduction will be actionable under the Lanham Act JPMorgan Chase - Penton Learning Systems LLC dba IQPC: 957-097239 and common law principles. ABA/Routing #: 021000021 6 1-800-882-8684 • www.iqpc.com/us/asthma