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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
Capital Sourcing
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
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/FOB
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
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/FOB
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
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/FOB
day 2: Wednesday, June 8, 2011
7:45 Registration and Continental Breakfast
8:15 Co-Chairs Opening Remarks
Amy E. HamiltonVice-President-DeputyGeneralPatentCounselEliLillyandCompany(Indianapolis,IN)
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
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/FOB
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
Amy E. HamiltonVice-President-DeputyGeneralPatentCounselEliLillyandCompany(Indianapolis,IN)
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
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/FOB
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