acibiosimilars2011

Register Now • 888-224-2480 • AmericanConference.com/FOB

“One of the best CLEs I’ve been to in 10 years”Maryann Wiskerchen, Counsel, Eli Lilly & Co.

Come to the definitive forum where all the key players in the biosimilar market – decision-makers at branded and generic pharmaceutical and biotech companies, policy experts from major industry associations, the scientists and economists who are helping to shape the pathway, and leading regulatory and patent lawyers – unite to provide you with the tools necessary to position yourself strategically in anticipation of generic biologic entry including:

• UnderstandingtheFDA’scurrentpositionontheimplementationofabiosimilarpathway and strategically positioning your company to protect or increase market share

• Determiningwhatlevelofclinicaldatabiosimilarapplicantsmustprovidetoprove safety and efficacy

• Evaluatingtheimpactthatthe12-yearexclusivityperiodwillhaveoncompetition andresearchanddevelopment

• Assessingthefinancialviabilityofbiosimilarsinlightofpotentialregulatoryhurdles and forecasting potential profit margins

• Developingproactivestrategiesandplansinpreparationfortheeventualityofbiosimilar patent disputes

Pre-conference science primer on Biologics Science 101: Understanding and Deconstructing the Complicated Scientific Principles Behind Biosimilars

Post-conference master class, an In-Depth Breakdown of the Biosimilar Framework in the EU

American Conference Institute’s 2nd Annual Conference on

BiosimilarsThe Definitive Forum on the Legal, Regulatory, and Commercial Realities of Generic Biologics

June 7-8, 2011 • The Millennium UN Plaza • New York, NY

FromtheCreatorofMaximizing Pharmaceutical Patent LifeCycles, Biotech Patents and Paragraph IV Disputes

Earn

CLE Credits

Benefit from an exceptional faculty of industry experts including:AbbottBiotherapeuticsCorporationBarnettInstituteofChemicaland BiologicalAnalysisBayer Healthcare PharmaceuticalsBiogen IdecBiotechnology Industry Organization (BIO)BiovailLaboratoriesInternationalSRLBristol-MyersSquibbDr.Reddy’sLaboratoriesDukeUniversity,TheFuquaSchool of BusinessEliLillyandCompanyEmergentBioSolutionsGenzymeCorporationGlobalHealthyLivingFoundationMerck BioVenturesNovoNordiskInc.PfizerPhRMASandozSTCBiologicsTevaNorthAmericaAndmanymore…

Distinguished Co-Chairs:

Amy E. HamiltonVice-President – DeputyGeneralPatentCounsel EliLillyandCompany(Indianapolis,IN)

Donald R. WarePartner,FoleyHoagLLP(Boston,MA)

LeAD SponSoR:

CoCkTAIL ReCepTIon SponSoReD By: SponSoR:

SuppoRTInG SponSoRS:

Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/FOB

TheBiologicsPriceCompetition&InnovationAct(BPCIA)waspassedinMarchof2010andmadethelong-anticipatedpathwayto generic biologic products a reality at long last. However,

despitethepassageofthishistoriclegislation,theFDAhasyettoimplement regulations to guide branded and generic companies in structuringabiologicsregime.AtACI’ssecond-annualBiosimilarsconference,thekeyfigureswhoareshapingtheevolvingbiosimilarlandscape—leading policy makers, in-house representatives frombranded and generic biotechnology and pharmaceutical companies, and top-tier litigators and patent prosecutors—will convene toformulate solutions to the challenging questions left standing inthewakeofthehistoricBPCIAlegislation:

• Meetingtheheightenedstandardofinterchangeabilityandprovingordisprovingsimilarity

• Delineatingthescopeoftheexclusivityprovisionandanalyzingthepotentialimpactofthestatutory12-yearperiodonresearch,innovationandconsumeraccesstodrugs

• Analyzingthecomplexpatentresolutionmechanismsoutlinedinthestatuteandproactivelypreparingfortheintricate exchange process

• Ascertainingthevolumeandlevelofsafetydatathatwillberequiredtoprovepatientsafetyandefficacytofacilitateapproval

• Determiningthefinancialviabilityofbiosimilarsandexploringalternativepathwaystoapprovalincludingbiobetters

The major players are preparing for the inevitable—the litigation and the attacks on biosimilar IP that are sure to come

Withanestimated$100billioninpotentialbiologicssalesatstakeannuallyandawaveofpatentexpirationsstartingin2014,therewill

beahard-foughtbattletoprotectandincreasemarketshare.Whetheryou are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaderswhowillbe thefirst to traverse thepathway.Devise an immediate action plan for your biosimilar prosecutionand litigation strategies in light of the barriers to entry, research anddevelopmentcosts,andregulatoryhurdles,whicharebalancedagainstanenormouspotentialforincreasedprofitmargins.

Get the complete picture: The science, the law, the regulations and the international framework

Comeawaywithaclearunderstandingofthescientificaspectsofbiosimilars at our pre-conference primer on Biologics Science 101: Understanding and Deconstructing the Complicated Scientific Principles Behind Biosimilars. At this in-depth session, leadingscientists and academics will translate the technical and scientific complexities behind generic biologics into usable data to factor and incorporateintoyourbusinessplan.

Finally, complement your whole conference experience with ourMaster Class which will provide an In-Depth Breakdown of the Biosimilar Framework in the EU at which leading practitioners on the ground will dig into the regulatory and commercial specifics of the already-launchedEUbiosimilarframework.Diveintothenitty-grittydetailsaboutlaunchingbiosimilarsintheEUaswellasbestpracticestoimplementbasedonthesuccessofgenericlaunchesthere.

With all that is at stake, do not miss this opportunity to remain at the forefront of this pivotal growth opportunity into the long-awaitedbiosimilarmarket.Registertodaybycalling888-224-2480, fax your form to 877-927-1563, or online at www.AmericanConference.com/FOB.

C o n t i n u i n g L e g a L e d u C a t i o n C r e d i t s

Accreditation will be sought in those jurisdictions requested by theregistrantswhichhavecontinuingeducationrequirements.ThiscourseisidentifiedasnontransitionalforthepurposesofCLEaccreditation.

ACI certifies that the activityhasbeenapproved forCLEcreditby theNewYorkStateContinuingLegalEducationBoardintheamountof16.5hours.Anadditional3.5credithourswillapplytoparticipationineachworkshop.

ACIcertifiesthatthisactivityhasbeenapprovedforCLEcreditbytheStateBarofCaliforniaintheamountof14.0hours.Anadditional3.5credithourswillapplytoparticipationineachworkshop.

Youarerequiredtobringyourstatebarnumbertocompletetheappropriatestateformsduringtheconference.CLEcreditsareprocessedin4-8weeksafteraconferenceisheld.

ACIhasadedicatedteamwhichprocessesrequestsforstateapproval.PleasenotethateventaccreditationvariesbystateandACIwillmakeeveryefforttoprocessyourrequest.

QuestionsaboutCLEcreditsforyourstate?VisitouronlineCLEHelpCenterat www.americanconference.com/CLE

CLE Credits

attend the one event where the industry leaders driving the business of biosimilars unite to set the standards which will shape an evolving legal and regulatory landscape

Media partners: CanBiotechR&D Outsourcing

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Competitive Intelligence

Foley Hoagisa225-attorneyfirmwithofficesinBoston,WalthamandWashingtonDC.Weassistclientsindiverseindustriessuchas life sciences, healthcare, technology, energy, and professional servicesingainingacompetitiveadvantagebyprovidingstrategiclegaladvicetailoredtotheirgoalsateverystageofgrowth.OurWashington, DC office serves as a bridge to the internationalmarketplace, with highly respected practices in both International Arbitration and Litigation and Corporate Social Responsibility.www.foleyhoag.com


Pre-Conference Primer: Monday, June 6, 20112:00 pm – 5:00 pm (1:30 pm Registration)

A Biologics Science 101: Understanding and

Deconstructing the Complex Scientific Principles Behind Biosimilars

Graham Jones, Ph.D., D.Sc.ProfessorandChairBarnettInstituteofChemicalandBiologicalAnalysisNortheasternUniversity(Boston,MA)

Denise M. Kettelberger, Ph.D., J.D.SpecialCounselFaegre&BensonLLP(Minneapolis,MN)

Gillian R. Woollett, M.A., D.Phil.ChiefScientistEngel&Novitt,LLP(Washington,DC)

Understanding the minutiae and complicated science ofbiosimilars is paramount in formulating a biosimilar business strategy.Unlikesmallmoleculedrugs,thecomplexnatureofbiologics (most are produced in living organisms) makes itdifficult to produce a highly similar copy of a reference biological product.Innovatorproductshavealreadydemonstratedthatevenminorchangesinbiologicmanufacturingprocessescanresultinmajorchangesinefficacyorimmunogenicity.Inthisin-depthandinteractiveprimer,scientistsonthefrontlinesofresearchanddevelopmentandthought-leaderswhoareguidingclientsandtheFDAontherelevantscientificconsiderationswill maximize your understanding of the science, putting you in the best position to assess actual costs of biosimilar research and development and to integrate this assessmentinto appropriate life cycle management considerations for allbiologics.Throughagreaterunderstandingof regulatoryoptions, the session will also allow better evaluation of thevalue of intellectual property in terms of both regulatoryexclusivityandpatents.

• FDAimplementationofapathwayforbiosimilarsandinterchangeable biosimilars

• Challengeswithspecificproductmanufacturingprocesses• Switchingstudies-Clinicaltrialdesignand

immunogenicity concerns • Understandingstructure/functionrelationships• Biosimilarmonoclonalantibodies-technicalchallenges

inprocessdevelopment• Referenceproductselection-keydifferentiatingprinciples

for similarity and comparability• RelationshipsbetweenPHSActlicensedproducts,and

biologicdrugsapprovedunderFD&CAct–futurechanges• WhytheHatchWaxmansmallmoleculemodelwillwork

forbiologicsandwhyitwon’t

day 1: tuesday, June 7, 2011

7:30 Registration and Continental Breakfast

8:15 Co-Chairs Opening Remarks

Amy E. HamiltonVice-President-DeputyGeneralPatentCounselEliLillyandCompany(Indianapolis,IN)

Donald R. WarePartnerFoleyHoagLLP(Boston,MA)

8:30 Update on Current FDA Position and Initiatives Regarding Biosimilars• Oneyearpost-approvalfortheabbreviatedbiosimilar

pathway:Wherearewenow?• Forecastingthefutureofbiosimilars:whataretheexpected

timelinesforimplementation?• Uncoveringspecificissuesandchallengespresentedbykey

stakeholdersattheNovember2010FDAhearingsbased on published comments

9:00 Predicting, Preparing and Positioning for the FDA’s Implementation of the Biosimilar Pathway

James BauersmithSeniorCounsel,LegalAffairsTevaNorthAmerica(NorthWales,PA)

Kay HolcombeSeniorHealthPolicyAdvisorGenzymeCorporation(Washington,DC)

David E. KornSeniorAssistantGeneralCounselPhRMA(Washington,DC)

Gregory J. Glover, M.D., J.D. PrincipalPharmaceuticalLawGroupPC(Washington,DC)

Inthissession,leadingexpertswillprovideinsightanddiscussstrategies for implementing a biosimilar pathway in accordance withFDAguidance.Topicstobediscussedinclude:

• Surveyingthebattlefield:howarethekeyplayersliningup?• Whatshouldyoubedoingnowtomakesureyouarebest

situatedtomeetpotentialdeadlines?• ActionplansforkeyprovisionsoftheBiologicsPrice

CompetitionandInnovationActof2009:- Biosimilarity- Interchangeability - Clinicaldatarequirements- Patent resolution mechanisms- Naming considerations-Exclusivity(data,marketandpediatric)

• Understandingthelegislativeintentbehindthestatute toprepareforanychallengestoFDA’srulemaking

• Exploringpotentialpracticalchallengestobiosimilars under healthcare reform

“Excellent program – informative and thought-provoking”MarkBowditch,PatentAttorney,SandozInc.

“I thought all the speakers did an excellent job in terms of content and delivery”

GregoryYork,Associate,Pearne&GordonLLP


9:45 Scrutinizing the Costs and Complexities Behind Biosimilar Research and Development

Steve Auten Vice-President,Legal-IntellectualPropertySandoz(Princeton,NJ)

Elizabeth HollowayBusinessAnalystBiogen Idec (New York, NY)

Chris SlavinskyAssistantGeneralCounsel,EstablishedProducts BusinessUnitPfizer,Inc.(NewYork,NY)

• Whatdoesthecurrentbiologicmarketlooklike?• Identifying“blockbuster”biologics• Whatwillthecommercialimpactofgenericsbe?

- Effectonstockprices• Determiningwhichbiologicsareparticularlyvulnerable

to follow-on competition• Blurringthelinesbetweentraditionalinnovatorsandgenerics• Alternativepathsandnewalliancescreatedbya12-year

exclusivityperiod• Shiftingresourceallocationbetweeninnovationversus

de-risk portfolios• Assessingbarrierstoentryforcompetitiveproducts:

doesitmakesensetousetheabbreviatedpathway?• Realisticallyforecastingprofitabilitywhenfactoring

in regulatory hurdles and production costs • Factoringinthehighcostsofmanufacturingabiologic

product• Exploringincentivesforbothinnovatorsandfollow-on

companiestoresearchanddevelopnewtreatments

10:45 Morning Coffee Break

11:00 No Two Biologics are Alike: Defining Biosimilarity and Meeting the Heightened Standard of Interchangeability Under the Statute

Graham Jones, Ph.D., D.Sc.ProfessorandChairBarnettInstituteofChemicalandBiologicalAnalysisNortheasternUniversity(Boston,MA)

Rochelle K. Seide, Ph.D., J.D. FormerVicePresident,IntellectualPropertyBiovailLaboratoriesInternationalSRL (Barbados, West Indies)

Madison C. JellinsPartnerAlston&BirdLLP(PaloAlto,CA)

Kevin E. Noonan, Ph.D.PartnerMcDonnellBoehnenHulbert&BerghoffLLP (Chicago,IL)

• Outliningtheparametersofsimilarityinthecontext of large complex biological compounds

• Whatdoesitmeantobe“highlysimilar”?• Groundingtheregulationsgoverningbiosimilarsinscience:

Anoverviewofthemechanicsofbiosimilars

• Understandingthemajorimpactthatminorchangesinstructure,formulation,orimpuritiescanhaveonhumansubjects- Immunogenicity- Maximum concentrations- Proteinsversuspeptidesandpolypeptides

• Structuringsafetystudiesinlightofthekeydifferencesbetweenbiologicsvis-à-vistheirsmallmoleculecounterparts

• Substitutingthebiosimilaratthepharmacylevel• Distinguishingbetweeninterchangeableproductsand

second-generation products • Accountingfordriftinthemanufacturingprocessof

originalsandfollow-onproducts:batch-to-batchvariation• FactoringinDoctrineofEquivalentsconsiderationswhen

demonstrating interchangeability • ReviewingandapplyingcomparabilitystudiesbytheFDA

12:15 Networking Luncheon

1:30 Debating the Practical Implications of a 12 Year Exclusivity Period: Striking a Balance Between Innovator and Biosimilar Interests

Sandra J.P. DennisDeputyGeneralCounselforHealthcareBiotechnology Industry Organization (BIO) (Washington,DC)

Henry G. Grabowski, Ph.D.ProfessorEmeritusDukeUniversity,TheFuquaSchoolofBusiness (Durham,NC)

Donald R. WarePartnerFoleyHoagLLP(Boston,MA)

• Theevolutionofthe12-yeardataexclusivityperiod• Thedifferencebetweendataandmarketexclusivity• Whatchangesinbiologicalstructurewillallowforan

additionalexclusivityperiod?• Theimpactofa12-yeardataexclusivityperiod:whatare

the implications to both generic and branded companies ifitislowered?

• DoesdataexclusivityforbiologicsintheUShaveanymeaning that one can use to predict competition and genericentry?

2:45 Afternoon Refreshment Break

3:00 Branding and Promotional Considerations for Biosimilars

Gillian M. CannonVicePresidentforProductDevelopmentMerckBioventures(Rahway,NJ)

• Commercializationchallenges• Varyingnomenclature

- Howdistinctdoesthefollow-onproductnamehave tobefromtheoriginal?

- Thebenefitsanddrawbacksofauniquenonproprietaryname to distinguish biosimilars from reference products

• Creatingamarketingplaninlightofbiosimilars• Meetingthechallengeofthebroadcapabilitiesrequired


day 2: Wednesday, June 8, 2011

7:45 Registration and Continental Breakfast

8:15 Co-Chairs Opening Remarks


Donald R. WarePartnerFoleyHoagLLP(Boston,MA)PreparingfortheRealityofBiosimilarPatentLitigation

8:30 An Overview of the Statutory Dispute Resolution Mechanisms: Steering Clear of Any Potential Gaps in the Litigation

Hans Sauer, Ph.D., J.D.AssociateGeneralCounselforIntellectualPropertyBiotechnologyIndustryAssociation(Washington,DC)

Jessica Wolff PartnerCooleyLLP(SanDiego,CA)

Ha Kung WongPartnerFitzpatrick,Cella,Harper&Scinto(NewYork,NY)

• ExploringthemechanismsinplaceunderTitleVII,SubtitleAoftheBPCIAct- Patent exchange- Good faith negotiations- Remediesandinjunctions- Declaratoryjudgmentactions- Damages

• ImplicationsofdroppingtheOrangeBook• AssessingthedegreetowhichtheHatch-Waxmanmodel

applies to follow-on biologics- ContrastingtheParagraphIVLitigationwithanticipated

FOBlitigation• Meetingtheburdenofprovinginfringement• Remedieswithrespecttoinfringement,includingwhen

preliminaryandpermanentinjunctionsareavailable

9:45 Morning Coffee Break

W h o Yo u W i L L M e e t:• PatentAttorneys(in-houseandlawfirm),RegulatoryCounsel,BusinessExecutives,andPolicyAnalystsfor:

- Brand name pharmaceutical companies - Biopharmaceutical companies- Generic pharmaceutical companies - Biotechnology companies

• Surveyingtheevolvingenvironment- Howaretheplayersdefiningtheirroles?- Whatproductsarebeingadopted?

• Thenecessityofeducationaboutproductdifferences toimprovepatientsafety

• Successfullong-termstrategies- Differentiationopportunities- Portfolio approach

4:00 Learning from the Global Development of Biosimilars: Enforcement and Risk Management Strategies to Protect your Biologic on the International Stage

Naomi Pearce (Invited)IPDirectorandCounselHospira,Inc.(Australia)

Adrienne M. BlanchardPartnerGowlingLafleurHendersonLLP(Ontario,Canada)

Candi Soames, Ph.D.PartnerEdwardsAngellPalmer&DodgeInnovationsLLP (London,England)

Michael J. WisePartner/Chair,ChinaIntellectualPropertyPracticePerkinsCoieLLP(LosAngeles,CA)

• SurveyingtheEuropeanpatentlandscape:Understandinghownewcaselawandevolvingruleswillaffectclaimingand litigation strategies

• Filingclaimsofsufficientscopeinlightofnewrulesondivisionalapplications

• Exploringopportunitiesforgrowthintoglobalmarkets:infringement risk assessment and claiming strategies for emergingmarketsincludingChinaandIndia

• UnderstandingSubsequentEntryBiologics(SEBs)inCanada• Accountingforgenericbiologicsbeingtreatedthesameas

generic small molecule drugs• Pricecontrolsforfollow-onbiologics• Howcost-effectivehavelaunchesofgenericbiologicsbeen

aroundtheworld?Casestudiesandcomparisonsfromactual product launches

• Towhatextentisthereapossibilityofharmonizationbetweenglobalregulationsofgenericbiologics?

• HowmighttheUSfollowestablishedlawsgoverningbiosimilarsintheEUandCanada?

5:15 Conference Adjourns to Day 2

Cocktail Reception Hosted by


12:30 Networking Luncheon

1:30 Ascertaining the Type and Volume of Clinical Data Necessary to Establish Biosimilarity

Dr. Michael Bui, DDS, MPH, JD AssociateDirector,GlobalRegulatoryStrategy,OncologyBayerHealthcarePharmaceuticals(Montville,NJ)

Seth D. GinsbergPresident GlobalHealthyLivingFoundation (UpperNyack,NewYork)

Magdalena Leszczyniecka, Ph.D., M.B.A.Co-FounderandChiefExecutiveOfficerSTCBiologics,Inc.(Cambridge,MA)

Anshuman Patwhardan, Ph.D., MBASeniorDirector,PortfolioStrategyandLicensingDr.Reddy’sLaboratories,Ltd.(Bridgewater,NJ)

Moderator:

Brian J. MalkinPartnerFrommerLawrence&HaugLLP(NewYork,NY)

• WhatwillFDArequireintermsofclinicaltesting?• Meetingthestandardof“noclinicallymeaningfuldifferences”• Strikingabalancebetweenrequiringlargerandmore

sophisticated trials and facilitating market entry for biogenerics

• Understandingthepatientperspectiveinthebiosimilarconversation- Biologic and biosimilar safety and efficacy- Pharmacovigilance:collecting,monitoring,researching,

assessingandevaluatingadverseevents- Costtothepatient- Therapeuticsubstitutionissues- Barriers to care

• WhatlevelofsupportwillFDArequiretogetapproval?• Extrapolatingdataobtainedinclinicaltrialsforareference

product to support biosimilar applications • Whatindicationscanyouuseforthebiosimilar?

- Head-to-head trials• Relyingondataprovidedbyex-U.S.companiesfor

comparator products • Evaluatingthepotentialforcitizens’suitsbasedonsafety

andefficacywhenevaluatingsafetyandefficacyforcomplexand multifaceted molecules

• Contrastingclinicalandanimalstudyrequirements inconnectionwitha351(k)application

2:45 Afternoon Refreshment Break

3:00 Structuring a Patent Portfolio Strategy to Protect IP in Light of FOB Legislation


Janis K. Fraser, Ph.D. PrincipalFish&Richardson(Boston,MA)

PrePariNg for The realiTY of BiosiMilars liTigaTioN

10:00 Developing Proactive Procedures and Strategies Today For the Flood of Biosimilar Litigation Tomorrow: From Early Planning through the Exchange of Patent Lists

Heather BoussiosIntellectualPropertyCounselEmergentBioSolutions(Rockville,MD)

Reza Green, Ph.D., J.D.ChiefIntellectualPropertyCounselNovoNordiskInc.(Princeton,NJ)

Barbara A. FiaccoPartnerFoleyHoagLLP(Boston,MA)

Irene E. HudsonPrincipalFish&Richardson(NewYork,NY)

• Determiningthepotentialvalueofproducts,dealsandrevenuestreamsinlightoffollow-onproducts

• Evaluatingtradesecretsprotectionversuspatentprotection• Exploringthepossibilityofauthorizedgenerics• Ascertainingwhatpatentsarerelevantandplanningtomeet

exchangerequirementsintheabsenceofanOrangeBookequivalent- Atwhatstageshouldabiosimilarchallengerbeginresearching

thepatentlandscapesurroundingaparticulardrug?- Determiningwhichpatentstostrategicallyassert- Identifying who has discretion to decide which patents

will be litigated and when• Dealingwithissuesinherentinthelistexchangeprocess

including the prosecution bar• Reassessingexistinglicensesanddecidingtheoptimal

courseofactionwithrespecttouniversitypatents• Renegotiatingcurrentlicensingagreements

- What specific clauses and terms should be included inagreementstoaccountforfollow-ons?

- Navigatingmulti-partyagreements

11:15 Developing Proactive Procedures and Strategies Today For the Flood of Biosimilar Litigation Tomorrow: From the Exchange of Patents to be Litigated to Project Launch Renee M. Kosslak, Ph.D.SeniorCounsel,PatentandTrademarkDepartmentAbbottBiotherapeuticsCorporation(RedwoodCity,CA)

Ralph J. GabricChair,PatentLitigationPracticeBrinksHoferGilson&Lione(Chicago,IL)

Michelle S. Rhyu, Ph.D.PartnerCooleyLLP(PaloAlto,CA)

• Decidingwhichpatentstolitigateinthefirstphasesversusthe second phase

• Wheretheparametersofthesafeharborliepost-Merck v. Integra and what is applicable to biosimilars

• Deciding where to litigate• Strategicdiscoveryconsiderations:whatyouneedand

howtogetitquickly• Managingthelitigationandworkingwithmultipleco-plaintiffs• Specialstrategicconsiderationsforcompaniesfollowing

both branded and follow-on paths


Raymond R. MandraChair,BiotechnologyPracticeGroupFitzpatrick,Cella,Harper&Scinto(NewYork, NY)

K. Shannon Mrksich, Ph.D. Co-Chair,BiotechnologyPracticeGroupBrinksHoferGilson&Lione(Chicago,IL)

• Updateoncurrentcaselawaffectingyourportfolio• Writtendescriptionandenablementrequirementsinlight

of Ariad and Centocor• MethodclaimsandtheviabilityofpatentinggenesafterMyriad• Assessingyourexistingportfolio• Usingyourpendingapplicationstoclaimfuturebiosimilars• Consideringobviousnesstypedoublepatentingof

copending cases• Ensuringabroadscopeofpatentprotectionwhilecrafting

claimsthatcoverproductsandprocesses• Anticipatingattackspremisedonwrittendescription

and enablement• Protectingagainstdesigns-around• Claimdraftingstrategiestoensuremaximumpatentlife

for your biologic

4:00 Alternative Routes to Market for Biosimilars: Evaluating the Benefits of Using the Abbreviated Pathway

Thomas F. Gillespie, IIIIPTransactionalCounselEmergentBioSolutions(Rockville,MD)

Michelle Lewis SeniorCounselBristol-MyersSquibb(Princeton,NJ)

Timothy J. Shea, Jr.DirectorSterne,Kessler,Goldstein&FoxP.L.L.C.(NewYork,NY)

• ComparisonofthebiosimilarpathversusBLAs(biologiclicenseapplications)or505b2applications

• Determiningwhetherresearchanddevelopmentresourcesare best spent on pursuing a biosimilar pathway based on abreakdownoftiming,costsandfreedomtovaryfromtheoriginal molecule

• Weighingthebenefitsofgoingdownatestedtrailagainstthe new opportunities inherent in the still-to-be determined biosimilar route

• WhenisaBLAmoreeconomicallyviable?• Casestudiesofmarketpenetration,costsandapproval

process for existing biologics • WhentofileaBLA• DeterminingthevolumeofclinicaldatanecessarytofileaBLA• Determiningthevalidityof“skinny”BLAsandminimum

disclosurerequirements• Evaluatingtheeffectivenessof505b2approvalthrough

a case study of Omnitrope• Thepossibilityofbiobetters:howwillqualitativesuperiority

bedeterminedforproductswiththesameindications?• Howwillsafetyandefficacyconcernsshapetheclinical

trialsrequirementsforbiobetters?

5:00 Conference Adjourns

Post-Conference Master Class: June 9, 20119 am – 12 pm (Registration 8:30 am)

B In-Depth Breakdown of the Biosimilar Framework in the EU

Maarten Meulenbelt PartnerHowreyLLP(Brussels,BE)

Carla SchoonderbeekPartnerNautaDutilhNV(Amsterdam,NE)

• DivingdownintothedraftguidelinesissuedbytheEuropeanMedicinesAgency(EMA)- Definitionofabiologicandabiosimilar- Howdoestheapprovalofabiologiccomparetoasmall

moleculedrug?- Clinicaltestingrequirementstoprovesafetyandefficacy- Exclusivityprovisions- Namingconventionsandtheadoptionofan

InternationalNonproprietaryNamingSystem• Assessingthevulnerabilityofmonoclonalantibodiesin

lightoftheestablishmentofapathwaybytheEMA- OverviewonthespecificEUguidelinesformonoclonal

antibodies- Neartermcompetitionversuslaterstagecompetition

• Studyingapprovalstodate:whathavetheactualcostsbeenandwhatareexpectedprofits?- Understandingtherationalebetweenrejectionsof

human insulin - Gaininginsightsofthecompetitivelandscapein

biosimilars:US,EUandemergingmarkets• Leveraginglicensingopportunitiesforbiosimilars

© American Conference Institute, 2011

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American Conference Institute’s 2nd Annual Conference on

BiosimilarsThe Definitive Forum on the Legal, Regulatory, and Commercial Realities of Generic Biologics

June 7-8, 2011 • The Millennium UN Plaza • New York, NY

FromtheCreatorofMaximizing Pharmaceutical Patent LifeCycles, Biotech Patents and Paragraph IV Disputes PLUS,don’tmissthein-depth

andinteractivesessionsthatwillgiveyou the expertise to truly set yourself

apartfromthecompetition:

Pre-conferenceprimer: Biologics Science 101:

Understanding and Deconstructing the Complicated Scientific Principles

Behind Biosimilars

Post-conferencemasterclass: In-Depth Breakdown of the

Biosimilar Framework in the EU

acibiosimilars2011

Documents