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1、PDAConnecting People,Science and Regulation,PDA and the Global Pharmaceutical Market,Presented at the 2011 Parenteral Drug Industry Congress,Beijing,ChinaSeptember 2011,PDA and the Global Pharmaceutical Market,About PDAThe Global Pharmaceutical MarketSummary,4,Agenda,About PDAWho are we?Our Vision,M
2、ission&FocusOur ActivitiesMember Core CompetenciesMember Benefits,5,We are:,A community of 9,500 individual member scientists and professionals in 70 countries representing large and small pharmaceutical and biopharmaceutical companies,regulatory agencies,suppliers and academia.,6,Our Vision,To be t
3、he foremost global provider of science,technology,and regulatory information and education for the pharmaceutical and biopharmaceutical community.,7,Our Mission,To develop scientifically sound,practical technical information and resources to advance science and regulation for the pharmaceutical and
4、biopharmaceutical industry through the expertise of our global membership.,8,Strategic Focus,9,Our Activities(Volunteers),Over 1,000 PDA volunteers worldwide actively carry out its mission.PDA is an influential voice and a leading technical organization in the field of pharmaceutical science and tec
5、hnology.Through the development of Technical Reports and responses to regulatory initiatives,PDA and its members influence the future course of pharmaceutical/biopharmaceutical products technology.,9,10,In the areas of Science andTechnology,PDA influences industrydirectionDevelops positions on curre
6、nt and proposed applications of technologyRooted in scienceConsensus drivenRepresent industry best practicesIdentifies and monitors new technologies,Our Activities(SciTech),11,Supports the application of technology and compliance requirements through membership participationScience Advisory Board(SA
7、B)Biotechnology Advisory Board(BioAB)Regulatory Affairs and Quality Advisory Board(RAQAB)Interest Groups(IGs)Task Forces(TFs),Our Activities(SciTech)Cont.,12,PDA Interest Groups are aligned to Advisory Boards,12,13,Our Activities(TRs),Technical ReportsMeant as recommendation,and guidance,but are non
8、-prescriptiveHowever:Most read and used documents by regulators and industryTRs have influenced regulatory Guidances,e.g.FDAs 2004 Aseptic Guideline,ISO 13408-2 and PIC/S Aseptic Guide.,New Technical Reports(2010 and 2011 Year to Date),TR 47-Preparation of Virus Spikes Used for Virus Clearance Studi
9、esTR 48-Moist Heat Sterilizer Systems:Design,Commissioning,Operation,Qualification and MaintenanceTR 49-Points to Consider for Biotechnology Cleaning ValidationTR 50-Alternative Methods for Mycoplasma TestingTR 51-Biological Indicators for Gas and Vapor-Phase Decontamination Processes:Specification,
10、Manufacture,Control and UseTR 52-Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain TR 53 Guidance for Industry:Stability Testing to Support Distribution of New Drug Products,15,Our Activities(Regulations),Monitor Global Regulatory ActivityPrimary Focus:U.S.and European Reg
11、ulatory AgenciesIncludes ICH,PIC/S,USP,EP and WHODeveloping interest in Asia and IndiaInfluence Global Regulatory PolicyInteractions with global regulatory authoritiesCo-sponsor meetings with Regulators(FDA,EMA,PIC/S,ICH)Comments on proposed regulations and guidancePromote science-based regulations,
12、Our Activities(PCMOSM),16,ScopeUtilizing PDAs membership expertise to drive:the establishment of“best practice”documentstraining events and coursesto aid the pharmaceutical manufacturers to implement ICH Q8,Q9 and Q10 IMP and commercial productsSee our project dossier on the PDA website(www.pda.org/
13、pcmo)for more information,17,Our Activities(PCMOSM),ObjectivesEnable an innovative environment for continual improvement of products and systemsPut science into practiceEnable increase of process robustness and knowledgeFoster relief from regulatory prescriptions,PCMO Projects,Life cycleIMP manufact
14、ure and distributionImplementation of QbD in ManufacturingTechnology TransferSupply Chain/Good Distribution PracticesQuality SystemsCapturing knowledge management during commercial manufacturingManagement of Suppliers and ContractorsEstablishing a Pharmaceutical Quality SystemConcepts for training,A
15、dditional PCMO Projects,ProcessFrom Process Validation to Process VerificationConcepts for Cleaning ValidationHow to improve robustness of a manufacturing processUtilization of statistical methods for production and business processesCorrective and preventive actionsRisk ManagementRisk Based Manufac
16、turingSterile APIsRisk-Based scheduling of audits,20,Our Activities(Conferences),World-class events Designed to Educate Promote interactionAdvance member interestsGlobal venuesScience and Regulatory focus,21,Our Activities(TRI),State-of-the-art training facilityLearning in a risk free environment,PD
17、A Training&Research Institute,22,The TRI Curriculum,ValidationLyophilizationPre-filled SyringesSterilization TechnologyCold ChainVisual Inspection,Aseptic ProcessingBiotechnologyEnvironmental MonitoringFiltrationMicrobiologyQuality/Regulatory Affairs,Includes courses in:,23,PDAs State of the Art Tra
18、ining Facility and Remote Courses Bring Consistency Worldwide,PDA has provided Inspectorate Training to a number of countriesThe most recent are:RussiaKazakhstanEMA and many of the EU Inspectorate-Italy,UK,Ireland,Sweden,etc.US FDATraining has been conducted in Russian and Chinese languages,Our Acti
19、vities(Membership),Membership competenciesMembership benefitsNew membership category for emerging economies,24,25,Membership Core Competencies,Applied SciencesAseptic ProcessingManufacturingProcess EngineeringBiotechnologyMicrobiologyProcess Validation,25,Quality and Regulatory Regulatory Compliance
20、/GMP Supply Chain Quality Systems,26,Membership Benefits,Professional Resources&NetworkInterest GroupsTask ForcesChaptersCareer Service CenterStudent Scientific ProgramsSci-Tech Discussion Group Online Membership Directory,27,PublicationsPDA Journal of Pharmaceutical Science&Technology PDA LetterTec
21、hnical ReportsBooks and Scientific Publications,Membership Benefits(Cont.),28,PDA Journal Website,Journal HighWire website launched in 2009Easy to use and searchArchives back to 1998More features to comeNew Journal Editorial Staff on boardRenewed emphasis on core PDA member interestsBiotech,Microbio
22、logy,Aseptic Processing and Manufacturing articles desired,New Reduced Cost Membership,For emerging economies(including China)Electronic access to:PDA Journal website,current and prior yearPDA LetterPDA membership directoryNo access to:Electronic Technical ReportsPrint version of PDA LetterAnnual Co
23、st:$100.00 can upgrade to full membership for additional$149.00(total$249),30,Summary,PDA offers a unique network and platform to exchange knowledge and experiencesPDA has strong relationships with global regulators and standard setting organizations and its Technical Reports are welcomedPDA serves
24、the industry with by influencing scientific,technological®ulatory trendsPDA is the organization for parenterals,The Global Pharmaceutical Market,AgendaBusiness EnvironmentPharma Manufacturing EnvironmentRegulatory EnvironmentClosing Thoughts,32,Business Changes in Pharma,Dependence on Blockbuster
25、s Emerging Markets Loss of Patent Protection Consolidation/Mergers&Acquisitions,33,Dependence on Blockbusters,34,Diversification via Geographic ExpansionEmerging markets share of global pharma growth:,Source;IMS Health,35,Patent“Cliff”,36,Recent Pharma Mergers and Acquisitions,37,Processes have been
26、 evolving,From mortar and pestle to highly complex bioreactors.From manually intensive aseptic processes to highly automated equipment with advanced environmental controls.From test tubes to Raman spectroscopy.From Pen and Paper to Gigabytes of electronic data.,38,The Pharmaceutical Supply Chain has
27、 become more complex,Globalization of Supply Chain More off-shore sourcing and distributionIncreased percentage of“cold chain”productsIncrease in diversion,counterfeiting and“economically motivated adulteration”,39,Our concept of quality has changed,From test and release to Quality Assurance to Qual
28、ity by Design.From craftmanship to validated processes.From R&D/Manufacturing/Quality silos to Quality System Approach that reaches from beginning of new products throughout the lifecycle.,40,Our regulatory framework has also changed,30 years ago:Highly fragmented,lack of consistency,20 years ago:Be
29、ginnings of EU integration and international harmonization.TodayAdvances in International HarmonizationTomorrowGreater cooperation and exchange of information among global regulators,41,Challenges for the Pharmaceutical Industry in the 21st Century,GlobalizationRationalizationIntegrationCost Reducti
30、onSupply Chain IntegrityAll add up to increased Complexity,42,Globalization,Rationalization of Manufacturing capacity is occurring at the same time that global demand for pharmaceuticals is rising.Growth rate is most noticeable in“pharmerging”marketsChina,Brazil,Mexico,South Korea,India,Turkey and R
31、ussia vs.US/EU/JapanCost pressures are driving more manufacturing to“pharmerging”countries,43,Rationalization,Pharma manufacturing has over-capacityReduction of facilities is ongoingImpact is greatest in US and EuropeProduct rationalization is ongoing at major pharma,44,Integration,Integrating merge
32、r partnersIntegrating CROs and CMOsIntegrating SuppliersAPIsExcipientsPackaging ComponentsKey Manufacturing materials,45,Cost Reduction,Decline in top-line revenue adds pressure on Pharma companies to reduce expenses to maintain bottom line revenueRationalization of overcapacityPricing pressure on m
33、aterials and Cost of GoodsGovernment pricing pressure is increasing worldwide,46,Supply Chain Integrity,Enhancing Supplier Quality Managementsupplier selection and qualification processes,on-going monitoring and management.Increasing Supply Chain Controls for incoming materials and components,supply
34、 route security and verification,verification of incoming components and materials and authentication of supporting documentation.,47,Supply Chain Integrity,Improving Analysis and Testing Strategies and Technologies to improve the detection of adulterantsMonitoring and Responding to Signals in the M
35、arketplace and assessing the risk of the market/environment,including:economically motivated adulteration risks,as well as alert,response and communication at local and global level.,48,The challenges that we as an industry face are many.PDA as an Association faces these challenges beside you.We inv
36、ite you to become an active PDA memberWith your support and participation,we will continue Connecting People,Science and Regulation.,Closing thoughts,49,Thank you for your time and attention,50,PDA Contact Info:,PDA USA Member Relations:4350 East West Hwy.Suite 200,Bethesda,MD USAinfopda.org or 301-656-5900 PDA Europe Member Relations:Adalbertstr.9,16548 Glienicke/Berlin,Germany Tel:+49 33056 2377-0 or-10 or Fax:+49 33056 2377-77 or-15info-europepda.org Speakers Contact Information:Robert L.Dana,Senior Vice President,PDAdanapda.org,
