program - d2cax41o7ahm5l.cloudfront.net€¦ · quintiles, inc. usa raymond huml vice precident...

conferenceseries.com Asian Biosimilars 2017conferenceseries.com

http://biosimilars-biologics.pharmaceuticalconferences.com/asiapacific/

Conference Secretariat2360 Corporate Circle, Suite 400 Henderson

NV 89074-7722, USAConference Series

Direct: (702) 508-5200 Ext: 8083Tel: +1 (800) 216 6499

Email: [email protected]

Program

August 10-12, 2017 Beijing, China

8th Asian Biologics and Biosimilars CongressExpert Speakers. Evidence based. Health Care Professionals.

Seating is LimitedRegister Today!

Dear Colleagues, Scientists and Friends,

The Organizing Committee is delighted to invite you to attend the 8th Asian Biosimilars Congress, one of its remarkable pharmaceutical conferences, to be held during August 10-12, 2017 in Beijing, China. The Asian Biosimilars Congress 2017 brings together scientists, researchers, industry and CRO representatives from around the world.

As of December 2016 there were 23 biosimilars marketed in the EU and 4 biosimilars licensed in the USA. As such, the biosimilars market is expected to experience an exponential growth over the coming few years. Many new biologics are making their entry in the pharma market and experiencing a notable rise in their usage compared with the conventional medications.

The 8th Asian Biosimilars Congress will present multiple aspects of biosimilars from the passage of biosimilars through a decade in Asia to the latest developments in the field of biologics and biosimilars. The whole range of portfolio selection, development, regulatory requirements and marketing will be presented.

You can join your peers from around the world focused on learning about biologics and biosimilars-related advances, which is your single best opportunity to reach the largest assembly of participants from the Biosimilars community, conduct demonstrations, distribute information, meet with professionals, make a splash with new research, and receive name recognition at this 3-day event.

The congress will provide enough space for discussion, meetings and workshops in order to allow a close contact between speakers and visitors.

We are looking forward to see you in Beijing, China

Raymond Huml, MS, DVM, RAC, QuintilesIMSOxana Iliach, PhD, QuintilesIMS

Charu Manaktala, MD, QuintilesIMS

Welcome Message

Dear Industry Colleagues, Scientists and Friends,

As a member of the Organizing Committee I am delighted to invite you to attend the 8th Asian Biologics and Biosimilars Congress to be held from August 10-12, 2017 in Beijing, China. The Asian Biosimilars Congress 2017 brings together biopharmaceutical industry colleagues, scientists, researchers, regulatory, and clinical experts from around the globe to bring to you the cutting edge information for the development of biosimilars.

The 8th Asian Biologics and Biosimilars Congress is designed to bring forth the most up to date information for the development of biosimilars. Key aspects will include regulatory, CMC, clinical and marketing considerations, as they relate to what it will take to bring these lifesaving/life altering products to the highly regulated Western Markets.

Please join your peers from around the world for this wonderful opportunity to reach the largest assembly of participants from the Biologics/Biosimilars community, meet with thought leadership experts, share your new research, and show off your cutting edge technology at this 3-day event.

I look forward to seeing you in Beijing, China at the 8th Asian Biologics and Biosimilars Congress.

Kamali ChanceMPH, PhD, RAC

Vice President Head, Global Biosimilars Regulatory Strategy

Biosimilars Center of Excellence QuintilesIMS

Welcome Message



Confreence Highlights•LatestBiosimilarsinAsianScenario•Biosimilars-Hatch-WaxmanAct&BPCIAct•ChallengesinDevelopingBiosimilars•BiosimilarsResearchPipeline•CurrentDevelopmentsinTheFieldofBiosimilars•PharmacovigilanceofBiosimilars•EmergingTrendsinBiosimilars•BiosimilarsMarket-Challenges&Prospects•CostAnalysisofBiosimilars•GlobalizationofBiosimilars•BiosimilarsAnalyticalStrategies•EmergingBiosimilarsinTherapeutics•ClinicalStudiesonBiosimilars•BCS&IVIVCBasedBiowaivers•EntrepreneursInvestmentMeet

** Speaker Slots are Available **



Organizing Committee Members

Oxana IliachSr. Director

Quintiles IMSCanada

Kamali ChanceVice PresidentQuintiles, Inc.

USA

Raymond HumlVice PrecidentQuintiles IMS

USA

Hossein PakdamanShahid Beheshti University

of Medical SciencesTehran, Iran

Candida FratazziPresident

BBCR ConsultingUSA

Charu ManaktalaSenior Medical Director

Quintiles IMSIndia

Lutz HilbrichHead of Biosimilars

Platform in China Shanghai, China

Asif MahmoodDisease Area Cluster

Lead for Biosimilars PfizerUSA

Osama O. IbrahimConsultant Biotechnology/

Food SafetyBioinnovation, USA

Suzette DiMascioCEO & President

CSI Specialty GroupUSA

Jianguo YangPresident / CEO Abpro

China DivisionUSA

T. Santha RajuSr. Director & Head

MedImmuneUSA



Top Participating Organisations

August 10-12, 2017 Beijing, China

8th Asian Biologics and Biosimilars Congress



KeynoteForumsTitle:FDA/EMACurrentThinkingonTotalityofEvidenceforDevelopmentofBiosimilarsKamaliChance,VicePresident,Head,GlobalBiosimilarsRegulatoryStrategy,BiosimilarsCenterofExcellence,Quintiles,Inc.,USATitle:Biosimilars:AcceleratingEarlyClinicalDevelopmentRaymondHuml,VicePrecident,QuintilesIMS,USATitle:StrategyfortheGlobalDevelopmentofBiosimilars:puttingit’salltogetherOxanaIliach,Sr.Director,QuintilesIMS,CanadaTitle:StrategicPartnershipforChinaBiologicsJianguoYang,President/CEO,AbproChinaDivision,USATitle:ClinicalDevelopmentofBiosimilarsforWesternMarkets:PlanningforSuccessCharuManaktala,SeniorMedicalDirector,QuintilesIMS,IndiaTitle:BiosimilarsintreatmentofmultiplesclerosisinIranHosseinPakdaman,PresidentofIranianNeurologicalAssociation,Iran

SpecialSessionsTitle:Biosimilars:ChallengesinSafetyandRiskManagementAsifMahmood,DiseaseAreaClusterleadforBiosimilars,Pfizer,USA

ScientificSessionsTitle:UpdateonbiosimilarslitigationintheU.S.:Whatifyoudon’twanttodance?GeorgeC.Yu,J.D.,M.S.,SchiffHardinLLP,USATitle:ChallengesinAssessingTherapeuticEquivalenceofNano-SimilarsBeatFlühmann,DirectorViforPharmaLtd,SwitzerlandTitle:BiosimilarGlobalization-Asilverlininginuntestedwaters!BiosimilarsinChina:balanceofrisksandopportunities.CandidaFratazziMD,President,BBCRConsulting,USATitle:TheroleofregulatorypoliciesinrelationtothelocalbiosimilarsproductionGustavoH.Marin,PhD,UNLP-CONICET,ArgentinaTitle:PracticalConsiderationsinClinicalStrategytoSupporttheDevelopmentofBiologicsDeviceCombinationProductsZhaoyangLi,Director,Sanofi,USATitle:ExpressionofwithShigaliketoxin(SLT)fusedtovascularendothelialgrowthfactor(VEGF)inEcolifortargetingangiogenesisOsamaO.IbrahimPh.D.,ConsultantBiotechnology,BioInnovationLLC,USATitle:MedicinesdistributionsandfinancingalternativesAbdeenMOmer,PhD,Khartoum,SudanTitle:SomeConsiderationsaboutBiosimlarSafetySamerM.Al-Hulu,PhD,Al-QasimGreenUniversity,IraqTitle:ThestudyofAntimicrobialandanti-Alzheimer'seffectsofturmericextractbasedonamyloidnano-bio-fibrilsformationinhibitionmethodAmirArasteh,AssistantProfessorofBiochemistry,Departmentofbiology,RashtBranch,IslamicAzadUniversity,Rasht,IranTitle:EvaluationTheCytotoxicityOfAnOscillatoriaSp.ExtractOnBreastCancerCellLine(Mcf-7)AndAssessmentOfNoxaGeneExpressionAliSalehzadeh,DepartmentofBiology,RashtBranch,IslamicAzadUniversity,Rasht,IranTitle:SignificanceofstabilityandtemperatureexcursionstudiesforBiologisticsRajivDua,SiteATSHead,SunPharmaceuticalsLtd,IndiaTitle:GlobalStatusofBiosimilars&ProspectsinAsiaMdAbuZaforSadek,InstituteofBusinessAdministration,UniversityofDhaka,BangladeshTitle:Bioassay-DirectedIsolationOfHypotensiveAlkaloidsFromHolarrenaPubescensAftabKhalid,H.E.J.ResearchInstituteofChemistry,UniversityofKarachi,PakistanTitle:HeterogeneityofMonoclonalAntibodyandChallengesinDevelopingBiosimilarofitSunitMaity,PhD,Zumutor,India

SpeakerSlotsAvailableNOTE:Programissubjecttochangewithfinalallotmentofthespeakerslots

Tentative Program



Previous Speakers

Patrick LucyPfenex Inc. , USA

Milind AntaniNishith Desai

Associates, India

Gregory J GloverPharmaceutical Law

Group PC, USA

Mark A. EmalfarbDyadic

International, Inc. USA

Alex BrillMatrix Global Advisors , USA

William A. SarrailleSidley Austin LLP

USA

Christopher J LeintzPfizer, Inc, USA

Vivek Kumar MoryaInha University,

Republic of Korea. South Korea

Jill A. MyersMomenta

Pharmaceuticals, USA

Timothy J SheaSterne, Kessler, Goldstein & Fox

P.L.L.C , USA

Subir RoyDGM- Marketing & Medical

at Zydus Cadila, India

Abdel Halim HarrathKing Saud University

Saudi Arabia

Jenny ChenWolf, Greenfield &

Sacks, P.C , USA

Denise M KettelbergerSunstein Kann Murphy & Timbers LLP, USA

Sunit MaityTheramyt Novobiologics

Pvt. Ltd., India

Neil SchauerAvaxia Biologics

USA



Previous Speakers

Sarfaraz K. NiaziTheraProteins, USA

James Harris IIIHealthcare

Economics LLC, USA

Abe HershkovitzHershkovitz &

Associates, PLLC, USA

Andreu SoldevilaCEO LeanBioPro

Spain

Angela FurlanettoDimock Stratton LLP

Canada

Lisa MuellerMichael Best &

Friedrich LLP, USA

Nigel J RulewskiQuintiles, Inc., USA

Tom CarverWragge Lawrence Graham & Co, UK

Ronald A RaderBiotechnology

Information Institute, USA

Raj DavePillsbury Winthrop Shaw

Pittman, LLP, USA

András GuttmanUniversity of

Pannonia,Hungary SCIEX, USA

Christoph VolpersSenior Patent Consultant

at Michalski & Hüttermann, Germany

Raymond A HumlQuintiles, Inc., USA

Kerisha A. BowenDentons US LLC, USA

Sumant ChaubeyBills Biotech, India

Wolfgang A. RehmannTaylor Wessing

Germany



Previous Speakers

Marcus MreyenProtagen Protein Services

GmbH, Germany

Alan L. EpsteinUSC Keck School of

Medicine, USA

Adetunji OlawaleOsun State Polytechnic

Nigeria

Samantha LittleCovance Laboratories

Ltd, UK

Min ZhangFujifilm Diosynth Biotechnologies

USA

Upendra NagaichAmity Institute of Pharmacy, India

Afshin SafaviBioAgilytix, USA

Kamali ChanceQuintiles Inc., USA

Fiona M GreerSGS Life Sciences

Switzerland

Gene M. Ransom, IIIUniversity of Maryland and

University of Baltimore School of Law, USA

Mariana BabayevaTouro College Of Pharmacy

USA

Mario DiPaolaBlue Stream Laboratories,

Inc., USA

Volker SchellenbergerAmunix Operating Inc.

USA

Gordon T. BolgerNucro-Technics

Canada

Andy UpsallBioOutsource, UK

Francesco MarchesiRegina Elena National Cancer Institute, Italy



Previous Speakers

Candida FratazziBBCR Consulting, USA

Krishna MenonCellceutix

Corporation, USA

Daniel GalbraithBioOutsource Ltd, UK

Siddhartha RoyCSIR - Indian Institute of Chemical Biology, India

Noelle SunstromNeuclone PTY LTD

Australia

Dipti GulatiPJI Biotech, USA

Alexander PittersKaiser Optical Systems

France

Laszlo EndrenyiUniversity of Toronto

Canada

Christina VesselyBiologics Consulting, USA

Ruideger JanwoskyCinfa Biotech GmbH

Germany

Christelle DagoneauCatalent Biologics

USA

Aparna KasinathSyngene International

India



Why to Attend???JoinyourpeersaroundtheworldfocusedonlearningaboutBiologicsandBiosimilarsrelatedadvances,whichisyoursinglebestopportunitytoreachthelargestassemblageofparticipantsfromtheBiosimilarscommunity,conductdemonstrations,distributeinformation,meetwithcurrentandpotentialprofessionals,makeasplashwithanewresearchworks,andreceivenamerecognitionatthis3-dayevent.World-renownedspeakers,themost recent research, advances, and thenewestupdates inBiologicsandBiosimilarsarehallmarksof thisconference.

AtAsianBiosimilars2017meetyourtargetaudiencesfromaroundtheworldfocusedonlearningaboutbiologicsandbiosimilars.Thisconferencewouldbeyoursinglebestopportunitytoreachthe largestassemblageofparticipantsfromthebiologicsandbiosimilarscommunity.

Abstract Information: Oral / Poster Presentation GuidelinesOralPresentationsaregenerallysplitintoTWOcategories,asfollows:

1.PlenaryLectures• EachPlenarylectureis25minutesinlengthandcomprisesonepresentation.Werecommendyouplantopresentforapproximately20minuteswith5minutesforquestions/discussion.

• WherePlenaryLectures arepresentedasdebates, eachof two speakers shouldplan topresent for20minutes,allowingfiveminutesforclosingquestionsandconclusions.WerecommendthatinvitedspeakerscommunicateinadvanceoftheModeratorsothatpresentationsmaybecoordinated.

2.OralSessions• EachOral Session is 60minutes in length and comprises two presentations, of 30minutes each. Werecommendthatyouplantopresentforapproximately15minutes,allowingtimeforquestions/discussionattheendofthepresentation.

Pleaseprepareyoupresentationin16:9format(screenareinformat16:9).WerecommendyoutosaveyourPowerPointpresentationusingPPT(X)formatinsteadofPPS.

Atechnicianisavailableineverysessionroomtoprovideassistancewhenneeded.Duetotheonlinepresentationsystem,allspeakersarekindlyrequestedtouseprovidedPConsite.Pleasebepresentinthesessionroom15minutespriorthestartofyoursessionandfollowtheinstructionsfromtheChairsand/ortechnician.Duringyour presentation a remote controlwill be available for controlling your presentation. Please observe thetimeallottedtoyouasyouwillnotbepermittedtospeakfor longertime.AttheendoftheCongress,allpresentationswillbedeletedfromthepresentationsystemandcomputerson-site.

SpeakerPreviewRoom

AllspeakersareaskedtouploadtheirpresentationattheSpeakerPreviewRoom(locatedintheRegistrationarea)atleastonehourbeforethebeginningofthesessionorthedaybeforeincaseofamorningsession.



Poster GuidelinesTheposterexhibitionwillbeanintegralpartofMedPharmaCongress.

Theposterexhibitionwillbelocatedontheexhibitionareaofthecongresscentre.Theareawillbeclearlysignpostedfromtheregistrationarea.

TechnicalInstructions:•PostersmustbepreparedinPortraitstyle.•PleaseDONOTpreparealandscapeposter•Thedimensionsshouldbe100cmhighby70cmwide•Postersshouldbeattachedtotheboardswithstickers,whichyouwillbesuppliedtotheorganizers.•PostersessionschedulePosterswillbedisplayedandpresentedinsession.

Pleaseplantobeatyourposterandavailabletoanswerquestionsfromdelegatesatthetimeofyourassignedpostersession.PosterswillbedisplayedaccordingtothePOSTERnumbersgivenbytheorganizersandwillbegroupedbysubtopic.

Young Researchers ForumTheYoungResearchersForumoffersyoungresearchersthepossibilitytomeetanddiscussresearchtopicsandmethodologies,shareanddevelopideas,learnfromeachotherandgainknowledgefromseniorresearchers.

YoungResearcher Sessions are organized at theMedPharmaCongress, toprovide auniqueplatform forYoung Researchers/Investigators for presenting latest research projects with an in-depth analysis. YoungInvestigators(e.g.Post-Graduatestudents,Post-doctoralfellows,Trainees,Juniorfaculty)arethefocusofthisevent.Participantsshouldbebelowtheageof33years.AllsubmissionsmustbeinEnglish.

Theprizewinningpaperswillbeconsideredforpublicationintheinternationaljournalsoncethepaperissubjectedtostandardreviewprocedures.

Forfurtherinformationpleasecontact:[email protected]



Registration InformationHowToRegister

Website:http://biosimilars-biologics.pharmaceuticalconferences.com/asiapacific//registration.php

Registration Fees• Earlyregistrationfee:$799

• (SAVE$100.00—DEADLINE:May25,2017)

• Regularregistrationfee:$899

• SAVE$100.00—February28,2017throughJune27,2017)

• Lateregistrationfee:$999

• GroupDiscount:Registerthreeormoreattendeesandreceive$50.00offperperson

• StudentRegistration:$249

• YoungResearchersForumFee:399$

Cancellation PolicyCancellationsmustbereceivedinwriting60dayspriortothemeetingandaresubjecttoa$100processingfee.RefundswillnotbegrantedafterApril03,2017,norwilltheybegivenforno-shows.Pleaseemailcancellationstobiosimilarsasia@pharmaceuticalconferences.org

AccommodationsDoubleTreebyHiltonBeijing168GuangAnMenWaiAvenueXiChengDistrict,Beijing100055China

Tomakereservationsandensurethatyouwillhaveahotelroomatthesamelocationastheconference,pleasechooseyourpackageandregisterathttp://biosimilars-biologics.pharmaceuticalconferences.com/asiapacific//registration.php

PaymentsWeacceptVisa,MasterCard,AmericanExpressandchecks.Ifpayingbycreditcard,pleaseutilizeouronlineregistrationsitelocatedathttp://biosimilars-biologics.pharmaceuticalconferences.com/asiapacific//registration.phpIfyouwishtopaybycheck,pleasecontactbiosimilarsasia@pharmaceuticalconferences.orgFormoreinformation:Questions?Contact1(800)2166499orinquiries:[email protected]://biosimilars-biologics.pharmaceuticalconferences.com/asiapacific//

Stay Connected Before, During and After the Event!



Day1:August10,2017OpeningCeremony

ConferenceSouvenirLaunchNewPerspectivefrontiersintheareaofBiologicsandBiosimilarsKeynoteForum(&ExhibitionsFullday)(PaneldiscussionsandReviews)CoffeeBreak:Networking&RefreshmentsGroupPhoto

SpeakerForumSessionsChair’sIntroductionTrack1:LatestBiosimilarsinAsianScenarioTrack2:Biosimilars-Hatch-WaxmanAct&BPCIActTrack3:ChallengesinDevelopingBiosimilarsTrack4:BiosimilarsResearchPipelineTrack5:CurrentDevelopmentsinTheFieldofBiosimilarsPaneldiscussionsandReviews

LunchBreakYoungResearchForum(PaneldiscussionsandReviews)CoffeeBreak:Networking&RefreshmentsB2BMeetingsCertificatesFelicitationbytheorganizingCommittee

Day3:August12,2017Introduction

KeynoteForum(&ExhibitionsFullday)(PaneldiscussionsandReviews)CoffeeBreak:Networking&Refreshments

SpeakerForumSessionsChair’sIntroductionTrack11:BiosimilarsAnalyticalStrategiesTrack12:EmergingBiosimilarsinTherapeuticsTrack13:ClinicalStudiesonBiosimilarsTrack14:BCS&IVIVCBasedBiowaiversTrack15:EntrepreneursInvestmentMeetPaneldiscussionsandReviewsYoungResearchForum(PaneldiscussionsandReviews)

LunchbreakSpeakerSessions(Cont…)PosterSessionsEvaluationbytheCommitteeRefreshmentsAwardCeremonyFelicitationofthebestposterawards

ClosingCeremony

Day2:August11,2017Introduction

KeynoteForum(&ExhibitionsFullday)(PaneldiscussionsandReviews)CoffeeBreak:Networking&Refreshments

SpeakerForumSessionsChair’sIntroductionTrack6:PharmacovigilanceofBiosimilarsTrack7:EmergingTrendsinBiosimilarsTrack8:BiosimilarsMarket-Challenges&ProspectsTrack9:CostAnalysisofBiosimilarsTrack10:GlobalizationofBiosimilarsPaneldiscussionsandReviews

LunchBreakYoungResearchForum(PaneldiscussionsandReviews)CoffeeBreak:Networking&RefreshmentsB2BMeetingsCertificatesFelicitationbytheorganizingCommittee

Program



Glimpses of Biosimilars 2016



Media Partners @ Asian Biosimilars 2017



Plan your Trip to Beijing7 UNESCO World Heritage Sites

Forbidden City Grand Canal

Great Wall Ming Tombs

Summer Palace Temple of Heaven

Zhoukoudian Forbidden City

Contact Detailshttp://biosimilars-biologics.pharmaceuticalconferences.com/asiapacific

Submit your abstract online at: http://biosimilars-biologics.pharmaceuticalconferences.com/asiapacific/abstract-submis-

sion.phpRegister online:

http://biosimilars-biologics.pharmaceuticalconferences.com/asiapacific/registration.php

About BeijingBeijing (formerly Romanized as Peking) is the capital of the People’s Republic of China and the world’s third most populous city proper. It is also one of the world’s most populous capital cities. Beijing is the second largest Chinese city by urban population after Shanghai and is the nation’s political, cultural, and educational center. It is home to the headquarters of most of China’s largest state-owned companies, and is a major hub for the national highway, expressway, railway, and high-speed rail networks. The Beijing Capi-tal International Airport is the second busiest in the world by passenger traffic. The city’s subway network is among the longest and busiest in the world. The city is renowned for its opulent palaces, temples, parks, gardens, tombs, walls and gates, and its art treasures and universities have made it a center of culture and art in China.

Beijing has seven UNESCO World Heritage Sites – the Forbidden City, Temple of Heaven, Summer Pal-ace, Ming Tombs, Zhoukoudian, as well as parts of the Great Wall and the Grand Canal. Beijing hosted the 2008 Summer Olympics and was chosen to host the 2022 Winter Olympics, which will make it the first city to ever host both events.

Beijing’s primary airport is the Beijing Capital International Airport (IATA: PEK) about 20 kilometers (12 mi) northeast of the city center. The airport is the second busiest airport in the world after Hartsfield-Jackson Atlanta International Airport. After renovations for the 2008 Olympics, the airport now boasts three terminals, with Terminal 3 being one of the largest in the world. Most domestic and nearly all inter-national flights arrive at and depart from Capital Airport. It is the main hub for Air China and a hub for China Southern and Hainan Airlines. The airport links Beijing with almost every other Chinese city with regular air passenger service.

program - d2cax41o7ahm5l.cloudfront.net€¦ · quintiles, inc. usa raymond huml vice precident...

Documents