Your partner for successful biopharmaceutical development and approval

Dr. Gabriele Dallmann Dr. Diane Seimetz+ 25yearsofexperienceinregulatoryaffairsanddrug development

+ Ex-regulatorPaul-Ehrlich-InstitutandEMA Committees

+ HeadedapprovalofantibodyproductsatthePaul- Ehrlich-Institut

+ Co-rapporteurforseveralbiopharmaceuticals

+ Founder of the European Centre for Regulatory Affairs,www.eucraf.eu

+ 16yearsofmanagerial,regulatory&drug development experience

+ FormerExecutiveVicePresident&CSOofFresenius Biotech

+ HeadedRegulatoryAffairs,MedicalAffairs, Preclinical&ClinicalDevelopmentandProgram Management

+ Successfullydevelopedthefirsttrifunctional antibodycatumaxomab

01

About the Founders Experienced experts with unique agency and industry backgrounds

We,Dr. Gabriele Dallmann andDr. Diane Seimetz, providein a unique way the agency AND industry perspective tothedevelopmentandregulatoryprojectsofourcustomers. Weknowbiopharmaceuticalsinallitsfacets,weunderstandtheauthorities in Europe, theU.S. and theBRIC countries.We are well aware of the interests of industrial partnersand investors. We always strive for valid and pragmaticsolutions, from product idea to life cycle management. Withourexperienceandaneyefortheessentialswedevelopthestrategicdevelopmentandregulatoryplansthatfitbestforourcustomers.

InScientificAdviceproceduresweensurethatourcustomersasktherightquestionsandprovideconvincingpositionstotheagencies.Weprepare thecompany’s team forprofessionalpresentationanddiscussionswiththeregulators.

With our international biopharmaceutical experience, weidentify opportunities and risks within licensing deals andacquisitions.

With our network of renowned experts, we can answeralmost any question professionally. This enables ourcustomerstousetheirresourceswiselyandtoeffectivelyreachtheirtargets.

We,Dr.GabrieleDallmannandDr.DianeSeimetzworkedtogetherforthefirsttimein1999.

At this time, Gabrielewas in charge of antibodies, sera,vaccinesandbloodproductsatthePaul-Ehrlich-Institut,theGermanFederalAgencyforVaccinesandBiomedicines.Shewas also represented in key regulatory Committees at EUlevel.

Dianewasresponsibleforpoly-andmonoclonalantibodiesandcell-basedtherapeuticsatFresenius.

Ourinteractionembracedthelifecyclemanagementoftheexistingbiologicsportfolioand thedevelopmentoffirst-in-classantibodyproducts.

Gabriele:„IlikedverymuchtheprofessionalismofDianeandher team to present their unique and demanding projects to the agency. The team was well positioned and theirdocuments including scientific rationale were convincinglyprepared.We achieved amutual understanding of quality,safetyandefficacyrequirements.“

Diane: „The engaging and clear style of Gabriele und heragency team essentially contributed to our understandingof the regulatory expectations. This allowed us to preparein a focusedway. Iwas impressed byGabriele’s pragmaticapproach to identify solutions with the applicants. I hadtheimpressionthatthefocuswason’approval‘ratherthan’rejection‘.“

We have experienced that the understanding of drug projects fromanagencyANDindustryperspectivecombinedwithaneyefortheessentialsisakeyingredientforsuccess.

Our customers can significantlybenefit fromourparticularexperience.Thisexperienceisthefoundationofourmission:Together for your success.

Our company name, Biopharma Excellence, stands for ourcommitmenttoexcellence.

0302

Biopharma Excellence in BriefOur history: Agency and Industry

We provide targeted solutions for the development andapproval of your products and support your company and peopletoexcel.Thisisourcommitmenttoexcellence.

Strategy and Integrated Development Planning

Preparing the regulatory and development plan according to yourneedswillensuretimelyandcosteffectivecompletionofyourprojects.

Strategic planning and bridging of the various disciplinesinvolved is essential for successful product development.One key element is an integrated development plan whichincludespharmaceuticalmanufactureandcontrol,non-clinicalandclinicalaspectsaswellastheintendedkeyclaimsoftheproduct. Regulatory and development strategies go hand inhand,aseverystepinthedevelopmentchainneedstobeinlinewithregulatoryrequirementstoensureapprovability.

Apart from the integrated support, we can help you alongon individual elements of your regulatory or development pathway.Weprovidegapanalysisofyourdevelopmentplansanddossiers.Wemake recommendationshow todealwiththesegaps.

Chemistry, Manufacturing and Control (CMC) Development

Proper technical development is one of the pillars of biopharmaceutical drug development. Your processes,methods,controlsandreleasemethodsmustbeestablishedandworkingtoreliablymeetspecifications.

Our services which are typically required during thedevelopmentofbiopharmaceuticalsinclude:

+ Developmentplansforbiopharmaceuticals,including recombinant proteins and cell-based products

+ Product comparability or similarity strategy

+ Immunogenicity risk assessment

+ Biopharmaceuticalproductqualitycontrol& characterisation

+ Validationofanalytical&bioanalyticalmethods

+ Datarequirementsduringearlydevelopmentfor successfulclinicaltrialapplications

Consulting Services

DEVElOPMENT AUTHORIzATION lIFECYClE

+ StrategyandIntegratedDevelopmentPlanning

+ CMCDevelopment

+ Non-ClinicalandClinicalDevelopment

+ ScientificAdviceandliaisonwithRegulatoryAuthorities

+ SupportforSuccessfulSubmissions

+ DueDiligence&Partnering

+ Rescue Projects

05

Nonclinical and Clinical Development

The safety of human subjects and patients is key. Diligentnonclinicaltestingandsoundclinicaltrialdesignwillkeepthepatientsafeandgeneratesoliddata.

Withinournetworkwecandesignyournon-clinicalprogramfrom feasibility studies, receptorbinding, xenograft studiesallthewaytotoxicitystudiesinrodentsornon-rodents.Wewill also attend to individual elements of your programorreviewyourexistingprogramanddocumentation.

We provide strategic clinical development advice to ensure that regulatory expectations aremet.We can assist in theinterpretationofyourclinicaldataandtheircommunicationtoregulatoryagencies.

Advisoryboardswithkeyclinicalopinionleaderareessentialto properly prepare the clinical development program and protocols.Earlyinvolvementofkeyopinionleaderandtheirsupport is crucial for successfulmarket launch.Wehave along standing experience in the set-up and management of advisoryboardsthatwearepleasedtoshare.

Scientific Advice and Liaison with Regulatory Authorities

To prepare for ameetingwith authorities, a briefing bookwith the questions and company’s position needs to bepreparedintime-oftenacriticalphaseforthedevelopmentteam.Togetthebestpossiblefeedbackfromtheauthorities,wehelptodefinethescientificadvicestrategy,toidentifythequestionsofinterestandthecompany’sposition.

Dr.GabrieleDallmannhadbeenamemberoftheScientificAdviceWorking Party of the EMA and has held numerousscientific advice meetings at the German Authority (Paul-Ehrlich-Institut)onbiopharmaceuticals.

Dr.DianeSeimetzlooksbackonalargenumberofmeetingswithEMA,nationalEuropeanagencies,FDA,HealthCanada,and TGA aswell as other jurisdictions. She has dealt withthese regulators during (parallel) scientific advice, pre-submission,submission,inspections,andpost-authorizationphasesofherprojects.

Due Diligence & Partnering

licensing of new biopharmaceutical candidates requirescarefulassessmentoftheirpotential,IPaswellasscientific,developmentandregulatory issues.Wesupportourclientsin assessing business opportunities for biopharmaceuticalproducts,either intheareaofacquisitionsandmergers, inthelicensingofnewproductsorininvestmentdecisions.Weidentifythepotentialofabiopharmaceuticaloraportfolio,keyissuesandrisksfromadrugdevelopment,regulatoryandscientificpointofview.Ourresultswill support theclient’sdecision-makingandnegotiationprocesses.

Fromournetworkwecanrecruitatailormadeduediligenceteamforyourspecificneeds.

Rescue Projects

Preventionisbetterthantreatment.ThisisourunderstandingatBiopharmaExcellence.Ourpreventionapproachcomprisesappropriateguidancetoourcustomerswhileconsideringtheirspecialneeds.However,shouldyourprojectsorprogramsinthe course of the development or approval process need a therapeuticinterventionforwhateverreason,weareatyourdisposaltoidentifysolutions.Don’thesitatetogetincontactwithus.Thesoonerthebetter.

Emergencyrequestsaretypicallyrequestede.g.for:

+ Oralexplanationatday181ofthecentralizedprocedure

+ Toturnnegativeopinionsintoapprovalorconditional approval

+ Majordeviationsintheproductionprocess

+ Troubleshootingduringdevelopment

0706

Biopharma Excellence provides targeted solutions for thedevelopment and approval of your products and supports yourcompanyandpeopletoexcel.Thisisourcommitmenttoexcellence.

Duringourprofessionalcareerwehavelearnedthattrueandsustaining success requires twoessentialelements.On theonehandyouneedpromisingproductsandsmartstrategies.On theotherhand thereare thepeoplewhoworkon theproducts, the strategies and the implementation thereof.Therefore, the teamofBiopharmaExcellence is committedtothecoachingofmanagersandemployees.

Weoffertargetedcoachingsessionsforyou,e.g.:

+ Coachingforeffectiveleadership

+ Coachingtoachieveyourfullpotential

+ Coaching for career success

+ Coachingforeffectiveteams

We can design further coaching sessions according to your specificneeds.

Biopharmaceuticalsarespecialandrequirespecialknowledge.

We provide in-house training for regulatory affairs andproduct development professionals on all aspects of biopharmaceutical drugdevelopment.Our courses provideinsights into the particulars of the development and authorisation of biopharmaceuticals including biosimilarsandadvancedtherapies.

Weareactivelyinvolvedinpre-andpost-graduateprogramssuch as EUCRAF(www.eucraf.eu).

Wedesigntrainingsessionsaccordingtoyourspecificneeds.

09

Coaching Training

Successfuldrugdevelopment&approvalisamultidisciplinary approach.

In collaboration with our international expert network weprovide unique and focussed support for all aspects related to biopharmaceuticaldrugdevelopment,i.e.fromproductideatoapprovalandbeyondwitheffectivelifecyclemanagementstrategies. The network comprises well renowned ex-regulatorsandexpertsforimmunogenicity,CMC,viralsafety,non-clinical topics and intellectual property. Together withour partners experienced in medical and CMC writing weprepare applications for clinical trials, briefing books anddossiersintheCTDformat.

Successful Drug Development & Approval is a Multidisciplinary Approach

We work with our international networkofrenownedexpertstoprovidetailormadesolutionsforourcustomers

Our Network

1110

DrugSafety

PK expert

CMCexperts

Devices

Expert Pharmalaw

Statistician

Ex- regulators

Non-clinicalexpert

Virussafety

Immuno- genicity expert

IPSpecialist

Biopharma Excellence

As well as:Henrik Hansson

Hannelore WillkommenGopalan Narayanan

Peter H. Kalinka Biosimilars and novel biopharmaceuticals

Bernd Müller-Beckmann Pre-Clinical Expert

Michael Rinck MedicalDevices,IVD

Heike Wachenhausen Pharmaceuticallaw,MedicalDeviceslaw,HealthcareCompliance,ProductPromotionlaw

Pierrette Zorzi Ex-Regulator(FrenchAgency),ATMPs,Biosimilars,CMCBiotechProducts

Wolfgang Berthold Manufactureandfacilitystrategy

Denis Bourgarel Patentlawyer(IPandFTO)

Paul Chamberlain Biopharmaceuticalproduct development &immunogenicityspecialist

Simon Day Clinical development strategyandstatistics

Mairéad Duke CMCExpert

1312

For more information, please visit our website and contact us www.biopharma-excellence.com Contactusbymail:info@biopharma-excellence.com Wearepleasedtodiscusshowwecanbestsupportyou. Visitusinperson Biopharma Excellence c/oMunichTechnologyCenter Agnes-Pockels-Bogen1 80992Munich, Germany

Sabine Kistner Phone Freiburg:+49(0)76113734420 Phone Munich:+49(0)8944235998

Biopharma Excellence02/2014