November 16th - 17th 2011, Boston, USA

Organised By

Examining latest scientific research, manufacturing and commercial opportunities

To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/ddsamericas

Anand Subramony, Principal Fellow & Head Novel Delivery Technologies & Therapeutics, Novartis

Avinash G. Thombre, Research Fellow, Pfizer

Bernhardt L. Trout, Director, Novartis-MIT Center for Continuous Manufacturing

Danchen Gao, Director of Intellectual Property Strategy, Abbott

Joseph Wong, Principal Scientist, Baxter

Kathleen L. Hefferon, Professor, University of Toronto

Lee Shorter, Director R&D Open Innovation, GlaxoSmithKline

Niren Murthy, Associate Professor, Georgia Institute of Technology

Oliver Steinbach, Senior Director, Head Bio-Molecular Engineering, Philips Corporate Technologies

Otilia Koo, Senior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb

Peter Hoffmann, VP New Technology Development, Genzyme

Riccardo Panicucci, Head of Chemical & Pharmaceutical Profiling, Novartis

Saileta Prabhu, Scientist, Genetech

Z. Jane Li, Senior. Research Fellow, Boehringer-Ingelheim

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Drug Delivery Systems Americas 2011

Driving the Industry Forward | www.futurepharmaus.com

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Conference IntroductionDrug Delivery Systems Americas

November 16th - 17th 2011, Boston, USA

Dear Colleague,

Worth$93.60bnin20091,drugdeliverytechnologyandsystemsisone

ofthefastestgrowingmarketsinthepharmaceuticalandbiotechnology

sectorswithalmost50%oftherevenuegeneratedfromNorthAmerica2.

Thissectorisexpectedtomaintaindoubledigitgrowthinthecomingyears

whichwilldependonnewandinnovativedevelopmentsindrugdelivery

technologythatofferimprovedclinicaladvantages,patientcomfort,

convenienceandcompliance.

DrugDeliverySystemsAmericas2011-buildingonthesuccessofour

previoussixdrugdeliveryconferenceswillbringtogetherindustryexperts

fromaroundtheworldtodiscussthecrucialissuesandcurrenttrends

indrugdeliverysystems.Thistwodayeventwillfocusonvariousdrug

formulations,deliveryoflipids,proteinsandpeptidesadditionallyexploring

drugdeliverycommercialaspects,partneringandout-sourcing,key

regulatoryandlegalissues.

Attendance at this conference will enable you to:

•Overcomechallengesandopportunitiesinthedeliveryofsmallmolecules

•Gaininsightaboutproteinandpeptidedrugdeliverystrategiesforproduct

lifecyclemanagement

•Exploreinnovationsingenericdevelopmentofdrugdeliverysystems

•Discussaboutenhancingthebioavailabilityofpoorlysolubledrugs

•Learnimpactonproductlifecycles:controlled-releasetechnologies

•Evaluateniosomesaseffectivetransdermaldrugdeliverysystems

•Discoveradvancesinoraltransmucosaldrugdelivery

•Stayaheadbylearninglatestonbiologicsdeliverysystems

•Identifydifferentstrategiesinmanagingadrugdeliveryalliance

•ExaminePTD–DRBDsiRNADelivery

•Obtainlatestinformationonultrasonicdrugdelivery

•Createpatientcentereddrugdeliveryproduct

•Findoutinformationonregulationsandcurrentpracticesnasaldrugproducts

•ReviewadvancedtechnologicalandregulatorydevelopmentsonQbD/PAT

inPharmaceuticaldevelopment

•Preventaggregationinmanufacturingandformulationofproteinand

peptidetherapeutics

•Obtainthelatestmarketanalysis,andmeetmanufacturersshowcasing

theirleadingproducts

Ilookforwardtomeetingyouattheconference

Bestregards

Sonia Tomar Conference Producer

Poster PresentationAt a busy conference it is hard to make sure everyone who shares your interests knows what you are doing. Maximise your time at Visiongain’s Biosimilars and Follow-On Biologics Americas meeting by sharing your results in a poster presentation. With a plethora of key decision makers, take advantage of this senior networking opportunity.

Please send your 200 word abstract, in English, to: info@visiongainglobal.com for approval. The deadline for submissions is Friday, November 4th, 2011. Please include contact details for the corresponding author(s).

Academic institutions will not be charged a fee if booked as full-price delegates. Posters submitted by pharmaceutical and biotechnology firms will be charged a fee of £199 (USD $319*).

Posters submitted by service providers / vendors are welcome and will be subject to evaluation. Upon approval a fee of £500 (USD $801*) will apply. Two delegates from your organisation must be booked at full price to present a poster.

Please note that all posters will be displayed at the discretion of Visiongain Ltd and are subject to approval. Due to limited space, please register your interest early.

Who should attend this conference?VPs, Directors, Heads, Managers of:• Pharmaceutical Development• Drug Delivery• Delivery Device Development• Product Development• Analytical Chemistry• Pre-formulation• Project Management• Technology Development• Drug Delivery Partnering• Out-sourcing• In-Licensing• Technology Assessment• Lifecycle management• Strategic Planning and Development• Formulation/Stability• Business Development• Licensing• Commercial Development• Patents• Lifecycle Management• Strategic Planning and Development• Financial Analyst• Pharmaceutical and Analytical R&D• Testing• New Product Planning• New Technology Evaluation• Marketing• Brand Management• Product Management• Sales• Regulatory AffairsOthers: • Intellectual Property Attorneys• Venture Capitalists• Medical Device Companies• Analysts/Investment Banks• CROs• Contract Sales Organisations• Universities and Government Research• Testing and Manufacturing Equipment • Packaging Companies

1visiongain’sDrugDeliverytechnologies:Commercialprospects2010-20252MarketsandMarkets:Top10DrugDeliveryTechnologiesMarkettobeUS$156Billionby2015

*USDpriceisestimateonly

Day 1Drug Delivery Systems Americas

Wednesday November 16th 2011

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 The magic bullets of the shots heard round the world targeted macromolecule delivery

•Obtainoverviewoftheoptiontodeliverbiologicstotarget •Stimulateuseadvanceddrugdeliveryformulationfortargeting •Enablemacromoleculestargetingtotreat •Identifystateofthearttargetingdeliveryoptions

Peter Hoffmann VPNewTechnologyDevelopmentGenzyme Pharmaceuticals

10:20 Emerging drug delivery technologies towards patient centric therapy

•Deliveryofhighvolumebiologics/antibodies: •Patchpumpsdevicesasanemergingalternativetosubcutaneous

injectionsforthedeliveryofbiologics •Useofmechanicalandelectromechanicalsystems •Creatingpatientcentricdrugdeliverytoolsviauserstudies •Microneedlesandthetrandermalinterface •Programmabledrugdeliverymethods

Anand Subramony PrincipalFellowandHeadNovartis

11:00 Morning refreshments

11:20 Overcome challenges and opportunities in the delivery of small molecules

•Fundamentalsofdeliveryofsmallmolecules •Controlledreleaseindeliveryofproteinsandnucleicacids •Analysingintestinalsolubilityandpermeabilityandparticlesizeto

overcomeratelimitedabsorption

Z. Jane Li SeniorResearchFellowBoehringer-Ingelheim

12:00 Development and administration of intravenous nanosuspension

•Therehasbeengrowinginterestinnanoparticlesasanapproachtoformulatepoorlysolubledrugs

•Thispresentationprovidesaninsightintovariouschallengesassociatedwithdevelopingandadministratingintravenousnanosuspensionincluding:

•Aformulationapproachofstabilizingnanosuspension •Particlesizeandnanosuspensionsterilityconsiderations •Pre-clinicaldispositionofananosuspensionfollowingIVadministration •Infusionratesfornanosuspension

Joseph Wong PrincipalScientistBaxter

12:40 Networking lunch

13:40 Life cycle management through drug delivery technologies

•Challengesandopportunitiesinlifecyclemanagement •Productenhancementusingdrugdelivery •Platformcontrolledreleasetechnologies •Casestudiesandlessonslearned

Avinash G. Thombre ResearchFellowPfizer

14:20 Life-cycle management: development and manufacturing process considerations for fixed-dose combination drug products

•Materialpowderandmechanicalpropertiesconsiderationsthatimpacttheprocessibilityandquantityoffixed-dosecombinationproducts

•Technologiestomonitorprocessandproductquality,aswellastomanagerisks

•Controlsystemsthatcanimprovescale-upandmanufacturing

Otilia Koo SeniorResearchInvestigator,DrugProductScience&TechnologyBristol-Myers Squibb

15:00 Afternoon Refreshments

15:20 The mucosal response to plant-derived biopharmaceuticals

•Biopharmaceuticalscanbeproducedquicklyandinexpensivelyinplants

•Consumptionofvaccinesproteinsviaedibleplanttissueshasbeendemonstratedtoeffectivelyelicitamucosalimmuneresponse

•Plantshaveadvantagesasbioreactorsbecauseunlikebacterialsystems,theypossesspost-translationalmachinery,andunlikemammaliancellculturesystems,theyarefreefrominfectiouscontaminants

•Plant-derivedbiopharmaceuticalshaveenormouspotentialforassistingvaccinationprogramsindevelopingcountries,forthepreventionofglobalpandemics/bioterrorism,andforapplicationsinpersonalizedmedicine

•Anumberofplantderivedbiopharmaceuticalshavecompletedclinicaltrialsandhavenowenteredtheglobalmarketplace

Kathleen L. Hefferon ProfessorUniversity of Toronto

16:00 Addressing delivery of antibodies across the blood-brain barrier (BBB)

•Overviewofthetransportbarriersforantibodiesinthebrain

•DispositionofantibodiesintheCNS

•Leveragingreceptor-mediatedtranscytosisforCNSdelivery

Saileta Prabhu ScientistGenetech

16:40 Closing remarks from the chair

16:50 Networking Drinks Take your discussions further and build new

relationships in a relaxed and informal setting.

Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011

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Day 2Drug Delivery Systems AmericasThursday November 17th 2011

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 New materials for drug delivery and molecular imaging

•Overviewonnewmaterialsfordrugdelivery

•Autocatalyticdrugdeliveryvehincles

•Polyketals:anewbiomaterialfordrugdelivery

•OralsiRNAdeliveryvehicles

Niren Murthy AssociateProfessorGeorgia Institute of Technology

10:20 IMAG(IN)E global - release local – Image-guided ultra sound-triggered drug delivery

•Medicalimagingtechnologiesarebecominganintegralpartoftherapeuticinterventions

•Thedevelopmentofultrasoundtechniquesthatcouldnon-invasivelytriggerthedeliveryofalsoverynewdrugformatssuchasRNAitherapeuticsatatargetedlocationopensupexcitingpossibilitiesforadvancingpersonalizedmedicine

•Akeysuccessfactorfortheeffectivetranslationofnewdrugdeliveryconceptsintoclinicalpracticearepartnershipswithleadingacademic,medicalinstitutionsandindustrialpartners

•Philips’image-guidedultrasound-mediateddrugdeliveryplatformoffersresearchersauniqueapproachtoinvestigatingthedeliveryofvarioustherapeuticmoleculesandcapitalizesuponPhilips’existingexpertiseinmedicalimagingtechnologiesfordiagnosis,therapyplanningandminimally-invasivemedicalprocedures

•WeshowadvancesintemperaturesensitiveliposomeswithincorporateddrugsandMRI-imaginglabelsaswellaspressure-sensitivemicrobubbleswithspecificultrasound-imaginganddrugreleasecharacteristicsforthelocaldeliveryofsmallmolecule-andnucleic-acidbasedtherapeuticsincludingsiRNA

Oliver Steinbach SeniorDirector,HeadBio-MolecularEngineeringPhilips Corporate Technologies

11:00 Morning refreshments

11:20 Sponsor Spotlight Session

Takethisuniqueopportunitytobeapartoftheconferencetheme,network,shareideasandprovideanoverviewofyourproduct/servicestotheaudience.Formoreinformationpleasecontactdamian.gorman@visiongainglobal.com

12:00 Presentation to be announced

Riccardo Panicucci HeadofChemical&PharmaceuticalProfilingNovartis

12:40 Networking lunch

13:40 Prevent aggregation in manufacturing and formula-tion of protein and peptide therapeutics

•Techniquestopredictaggregationpropensity

•Newapproachestopreventingaggregation

•Astrategyfordevelopabilityandmanufacturabilityearlyon

•Waystodesignmoleculesforstability

Bernhardt L. Trout Director, Novartis-MIT Center for Continuous Manufacturing Professor,DepartmentofChemicalEngineering, Massachusetts Institute of Technology

14:10 Finding synergy in drug delivery through strategic outsourcing

•Thevalueofstrategicoutsourcing:decisiondrivers

•Fromtransactionaltostrategic

•Strategicoutsourcing:whatliesahead

Danchen Gao DirectorofIntellectualPropertyStrategyAbbott

15:00 Afternoon refreshments

15:20 Open Innovation in preclinical development at GSK pharmaceuticals

•Whatisopeninnovation?

•WhyisGSKusingopeninnovationwithintheplatformtechnologyandSciencegroup?

•ProcessGSKPTSisfollowingforopeninnovation

•Examplesofsuccessfulopeninnovationcollaborations

•Howwillsuccessofopeninnovationbemeasured?

Lee Shorter DirectorR&DOpenInnovationGlaxoSmithKline

16:00 Patent and other Intellectual property rights in drug delivery

•Advancementsindrugdeliverytechnology

•Patentingthetechnologicaladvancements

•Issuesaroundmanufacturingprocesspatents

•Intellectualpropertyprotection,suchastradesecrets,copyrights,andtrademarks

16:40 Chair’s closing remarks

16:50 End of Conference

PartnersDrug Delivery Systems Americas

November 16th - 17th 2011, Boston, USA

Media Partners:

PharmiWeb.comistheleadingindustry-sponsoredportalforthepharmaceuticalsector.Supported

bymostoftheleadingpharmaceuticalcorporations,PharmiWeb.comprovidesdynamicreal-timenews,features,eventslistingsandinternationaljobstoindustryprofessionalsacrossEuropeandtheUS.For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGYEUROPEisownedbyBIOTECHNOLOGYWORLD.Itisbasedandlocated

inWarsaw,Poland.BiotechnologyWorldwasfoundedin2007toprovidetheworld’sbiotechandpharmainformationandmarkettomakeituniversallyaccessibleandusefulforscientificandbusinessprocesses.ItsfirststeptofulfillingthatmissionwasbuildingtheBIOTECHNOLOGYEUROPEplatformthatwillallowaquickspreadofinformationindifferentchannels.BIOTECHNOLOGYEUROPEofferscompaniescompletedinternetpublicrelations,publicationandmarketingsolutions.OneofthemainsgoalsofBIOTECHNOLOGYEUROPEistointegratetheBiotechandPharmaSectorinEuropetoglobalbiotechnology,pharmaceuticalandlifescienceactivities.For further information please visit www.biotechnology-europe.com

InPharmistheonlineplatformforexclusivepharmaceuticalnews,comment,contracts,services,

jobsandeventsandishometoInPharmjobs.com,PharmafileandPharmafocus.For further information please visit: www.inpharm.com

FuturePharmaceuticalshasforgedpowerfulrelationshipswithkeyindustryleaderstoprovide

aplatformforsuccessfulbrandrecognition,andforseniordecision-makerstohavethemeanstoprocureandplanimplementationstrategiesbasedonthetopicscovered.Positionedtobeanauthoritativeresourcewithintoppharmacompaniesaswellassmall,specialty,andbiotech,FuturePharmaceuticalsmagazineisgearedtocreateadeeppenetrationintoahighlytargetedandresponsiveaudience,bridgingthegapbetweentheindustries’topissuesandthesolutionstop-tiervendorscanprovide.For further information please visit: www.futurepharmaus.com

Driving the Industry Forward | www.futurepharmaus.com

Sponsorship and exhibition opportunities:

This event offers a unique opportunity to meet and do business

with some of the key players in the pharmaceutical and biotech

industries. If you have a service or product to promote, you can

do so at this event by:

• Hosting a networking drinks reception

• Taking an exhibition space at the conference

• Advertising in the delegate documentation pack

• Providing branded bags, pens, gifts, etc.

If you would like more information on the range of

sponsorship or exhibition possibilities for visiongain's

Drug Delivery Systems Americas Conference,

please contact us.

Damian Gorman, +44 (0)20 7549 9934

damian.gorman@visiongainglobal.com

About visiongain:

Visiongain is a specialist business information company focused on

providing cutting edge products and services across the Pharmaceutical/

Biotech, Telecommunications, Defence and Finance sectors, which

include reports, conferences, online daily news and offline news

analysis and bespoke consultancy. With a commitment to innovation

and excellence, visiongain offers flexible solutions to meet our clients’

business intelligence needs, providing the right information at the

right time to facilitate the commercial decision-making process. Our

pharmaceutical products include Pharma Business Daily, the leading

daily email newsletter for the pharmaceutical, biotech and healthcare

industries, and a range of independent, high-quality, in-depth reports

covering focused and topical areas of concern. Our pharmaceutical

conferences address the hottest commercial, regulatory and technical

topics and provide an ideal forum for debate and networking for

pharmaceutical professionals from around the world.

For further information, please visit: www.visiongain.com

How to bookEmail:piyush.patel@visiongain.comWeb:http://www.visiongain.com/ddsamericas

UK Office:Tel: +44(0)207549 9961Fax:+44(0)2075499932 VisiongainLtd230CityRoadLondonEC1V2QYUK

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Registration FormDrug Delivery Systems Americas

November 16th - 17th 2011, Boston, USA

www.visiongain.com/ddsamericas

Drug Delivery Systems AmericasNovember 16th - 17th 2011

Boston, USA