2 Pharmaceutical Advisors Core staff with average 20 years industry experienceNetwork of over 100 Advisors and growingCovering every discipline for pharmaceutical development and commercializationFounded in 2001, currently more than 75 clientsSmall and mid-sized companiesEmerging pre-clinical and clinical stage companiesTop 5 pharmaceutical companiesSuppliers to the Life Sciences
3 The Issue We Address Everyone can pull in the various experts needed … ChemistryADMEToxClinicalManufacturingProcessDevelopmentFormulationMarketingProjectManagementDrug SubstanceQualityDrug SafetyEngineeringDrug ProductClinicalRegulatory
4 The Issue We Address…linking broad and deep perspective early is key toanticipating issues, accelerating progress, managing risk and…unlocking value!ChemistryADMEFormulationToxClinicalProcessDevelopmentMarketingManufacturingProjectManagementDrug SubstanceQualityDrug SafetyDrug ProductEngineeringClinicalRegulatory
5 Advisors Industry Focus PharmaceuticalsTransactionValuation andLicensingSuppliers to theLife SciencesAnimalHealthTechnology PlatformsVenture CapitalMedical DevicesBiotechnology
6 Advisors Functional Focus Integrating Research, Development Engineering and Commercialization ExpertiseClick on Any Hexagon for ExamplesPracticalQuality Systems & RegulatoryRapid,Interactive Expert PanelsPortfolio Decisions,Due Diligence& ValuationIntegratedDevelopment ViewLinkingCMC, Tox, ClinicalResolve IssuesBuild SkillsChemistry, FormulationDrug DeliverySafety & EfficacyADMEOperational Input toCapital PlansScale-up & Sourcing DecisionsIntegrated Development PlanningFrom development strategy to executionExpert PanelIntegrated project auditProject Portfolio ReviewRisk identification, decision support across the portfolio of projectsIssue ResolutionCM&C, Regulatory, Safety/Toxicology, and Clinical issue identification, clarification, and resolutionOperations and Process DiagnosticSite / Facility Development PlanningSupportingDevelopment, Operations, Strategy and Portfolio Management
7 What Do We Do Best? What + How = Delivery Assurance Expert Content EfficientProcessProfessionalManagement
8 Inverting the Consulting Model… Industry ExpertsExperiencedConsultantManagersUnique ClientSituationProven DeliveryInsight-DrivenCustomized ResourcingIntegrated, Experienced Functional PerspectiveHands-On Problem-SolversCost-effective, Flexible, Independent
9 With Experienced Advisors… Associate Director, Venture MgmtAsst Director for Technical AffairsChief Executive OfficerChief Operating OfficerDept. Head of Pharmaceutical EngineeringDirector of Fermentation and Biocatalysis DevelopmentDirector of Formulation DevelopmentDirector of Pharmaceutics R&DDirector of Quality ControlDirector of Sourcing & Planning of Chemical DevelopmentDirector, Clinical Operations, Medical AffairsDirector, Experimental PathologyDirector, Global Medical OperationsDirector, Planning and Business Support, U.S. Medical and Regulatory AffairsDirector, Production of Therapeutic and Diagnostic ProteinsExec Director of ManufacturingExecutive Vice President, Global Drug Safety, Metabolism and Safety PharmacologyGroup Director of Clinical ResearchGroup Director of Process R&DGroup Director, Preclinical Safety AssessmentManager of Organizational EffectivenessMgr, Radiopharmaceutical ManufacturingPresidentPresident of Technical OperationsSenior Director Operations Planning - Worldwide Pharmaceutical GroupSenior Director, North American Clinical AffairsSenior Manager, Clinical ResearchSenior Vice-President and Chief Scientific OfficerSenior Director of Process ChemistrySenior VP of Pharmaceutical R&DSenior VP, Global Drug DevelopmentVice President of Business DevelopmentVice President Information TechnologyVice President of Drug DevelopmentVice President of Process Development
10 Who’ve Run Companies… AAI, Inc. American Cyanamid/Lederle Labs American Home ProductAmylin PharmaceuticalsApplied Immune ServicesArthur D. LittleAstra PharmaceuticalsAventisAxxima Pharmaceuticals AGBaxter Healthcare Corp.Benzon PharmaceuticalsBioReliance CorporationBMSBoehringer IngelheimBoots PharmaceuticalsBristol-Myers SquibbBSCI, Inc.Cambrian AssociatesCambrexCancer Research CenterCardinal HealthCentocorCiba-Geigy CorporationCorixaCoulter PharmaceuticalDentsplyDiscovery PartnersEli Lilly & CompanyEnvironmental Toxicological, Int’lUS FDA Center CBER & CDERFEI TechnologiesFisonsFluor DanielGenentechGenovoGSKGX BioSystemsHoechst Marion RousselHybridonICI PharmaceuticalsIMBICImmunexImmunogeneticsImmunomedicsIMRE CorporationIsolation TechnologiesJ&JKnoll Pharmaceuticals, NottinghamMatthew Hall EngineeringMerckMerck, Sharpe & DohmeMettler ToledoMicroProbe CorporationMillenniumMonsantoNapp Researche CentreNational Cancer InstituteNeoseNorcliff-ThayerNovartisOrtho BiotechPA Consulting GroupPfizerPharmaciaResponse BiomedicalRichardson-VicksSalmedixSchering CorporationSchering-PloughSearleSepracor Inc.Sigma-Aldrich CorporationSmithKline BeechamSUGENTektagenThe Life Sciences GroupUpjohn Ltd.US Environmental Protection AgencyWyeth-Ayerst
12 Our Strengths to Help You HOW we support our clientsSpeed & flexibilityContent expertise & general management perspectiveBusiness decisions & technical expertiseUse our approach to solve problems and address issuesThe RIGHT expertise based on client needsWe efficiently identify and involve what’s neededWe effectively deploy and integrate the RIGHT resourcesInsight about implications on other functions and processesMultiple perspectives within a specialty where needed
13 Some Relevant Case Studies Support of Critical Manufacturing Issues for a Complex BiologicHigh Powered Expert Panel on a Deal- Breaker IssuePackage/ Shipping Validation to Launch Key Products
14 Support Critical Manufacturing Issues for a Complex Biologic Recent Case Study (1)Support Critical Manufacturing Issues for a Complex BiologicThe IssueOur client is a small molecule drug discovery and development company that acquired a commercially launched biologic pharmaceutical. Process variability in the fermentation of the drug was creating N-terminal variants, preventing the product from being manufactured reliably.What We DidAssembled a cross-functional team of Bio-Analytical, Fermentation, and Bio-Manufacturing experts. We supported the client through the investigation, experimentation, and implementation phases of the project by:Assessing the process and existing data for root cause of process variabilitySelecting and directing the outsourced supplier to identify weaknesses of the existing process and analytical methods supporting the processIdentifying the most likely sources of variabilityEstablishing vendors for new analytical methods and fermentation developmentDesigning and executing an experimental protocol to definitively assign root causeDesigning cost-effective scale-up plans to manufacture the revised process at scaleProviding the client with:The root cause of variability in the face of a complex web of confounding factorsA cost-effective solution to product variability, avoiding product withdrawalProtected a key source of revenue during a critical phase of growth for a young and growing Bio-Pharmaceutical Client
15 The TeamJohn Apathy, Trained in Biochemistry and Immunology. 20 years experience developing strategies and leading pharmaceutical product development teams within a major pharmaceutical company and as senior managing consultant with a major pharmaceutical consultancy.David Dodds, PhD, Former Director of Fermentation and Bio-catalysis Development with BMSKent Iverson, formerly with Immunex and Coulter Pharmaceuticals, has led the Process Development and Materials Management departments of all products from pre-clinical development through commercialization.John McEntire, PhD Former Corporate Vice President of BioReliance, with expertise in biopharmaceutical development analytical and formulation.Tim Noonan, PhD. Trained as a medicinal chemist, and a former VP of manufacturing, Tim has broad manufacturing, operations and quality systems experience, was instrumental in the formation of a successful contract oligonucleotide manufacturing firm. Dr. Noonan also worked as a consultant to venture capital firms performing technology due diligence.
16 Recent Case Study (2)High Powered Expert Panel on a Deal- Breaker IssueThe IssueOur client identified a degredant as a known mutagen. The client needed to understand the implications for development and the value of the compound for a partner meeting. They also needed the right regulatory strategy, as well as an understanding of the trade-offs between salt forms to pursue appropriate development programs.What We DidIn less than 2 weeks assembled a team that addressed their issues2 Gentox experts that wrote the ICH guidelines1 Gentox expert that convinced the FDA to act favorably with a similar situationCMC expertise with polymorph expertisePharmacologyTox expertise in early and late development strategiesProviding the client with:Answers to the right questions to show their partner that they had control and a planAwareness of questions they had not consideredUnderstanding of what was NOT an issueInsight into the right development strategies to manage riskConfidence that they had explored all the alternativesOne place to go for follow-up and coachingNo one got on a plane, stayed overnight, or was wined and dinedNo one had to assemble and assimilate the input
17 The TeamJane S. Allen, Ph.D., D.A.B.T., former Director of Toxicology, GSK, RTP with expertise in genetic toxicology. Member of US PhRMA committee that established the ICH genetic toxicology guidelines.Michael Berman, PhD, is a former biotech CEO with broad experience in pre-clinical development for Phase I studies with a focus on biologicals and peptides as well as small molecules. Dr. Berman has taken a number of novel biologicals into Phase I.Robert L. Brent, MD, Ph.D. Distinguished Professor of Pediatrics, Radiology and Pathology and Louis and Bess Stein Professor of Pediatrics, Jefferson Medical College, Philadelphia. Former advisor to Aventis for ARAVATM, with expertise in clinical medicine related to genetic toxicology.Charles E. Piper, PhD, former Executive Director, Clinical Research Strategic Partnering, Clinical Development, and former Executive Director, Product Safety Assessment, Preclinical Development, Searle. Member of US PhRMA committee that established the ICH genetic toxicology guidelines.Thomas Crawford, PhD, former Group Director of Process R&D with Pfizer where he was responsible for the development of chemical technology and the manufacture of supplies for drug candidates from nomination to transfer to Pfizer's Global Manufacturing Group.William D. Kerns DVM, MS, DACVP former Executive Vice President, Global Drug Safety, Metabolism and Safety Pharmacology, Eisai and SmithKlineBeecham.Guy Paulus, PhD. Served most recently as Senior Vice President Drug Safety Evaluation Pfizer Central Research Groton U.S.Robert Ronfeld, Ph.D. who led Pfizer’s Clinical Pharmacokinetics and Pharmacodynamics group with particular expertise in Drug Metabolism and Development Strategy.Richard S. Woodward, Ph.D. Biotechnology and pharmaceutical executive with multidisciplinary international experience. Formerly with Pharmacia, Ajinomoto USA, Inc. and Quality Biotech, Inc.Tim Noonan, PhD. Trained as a medicinal chemist, and a former VP of manufacturing, Tim has broad manufacturing, operations and quality systems experience, was instrumental in the formation of a successful contract oligonucleotide manufacturing firm. Dr. Noonan also worked as a consultant to venture capital firms performing technology due diligence.
18 Complex Package/ Shipping Validation to Launch Key Products Recent Case Studies (3)Complex Package/ Shipping Validation to Launch Key ProductsThe IssueOur client is extending its growth strategy requiring an enhanced capability in packaging / package design, logistics, shipping validation, quality, and management of vendors beyond current resources and internal capabilities.What We DidAssembled a cross-functional team of Logistics, Quality, Packaging and Manufacturing / Operations experts. We are supporting the client through the investigation, planning & experimentation, and implementation phases of the project by helping to determine:when and how to utilize engineering resources from package design and testing firms vs. independent engineering resources,the cumulative effect of expected Time /Temp excursions in the context of stability / shelf life and possible variations in packaging and logisticswhere to utilize off-the-shelf secondary packaging solutionswhere custom packaging solution are appropriate, trading off cost of manufacture and design with logistics and other costs.efficiencies anywhere in the distribution chain, based on decisions in packaging or other areaswith complex, issues such as this, any key activities or decisions not assigned or staged.Providing the client with:Roadmap for the packaging, shipping and shipping validation project, maintaining the timelineKey program managementEnabling progress in a critical area without the need to scale-up resources
19 The TeamJohn Apathy, Trained in Biochemistry and Immunology. 20 years experience developing strategies and leading pharmaceutical product development teams within a major pharmaceutical company and as senior managing consultant with a major pharmaceutical consultancy.William Gierke, former manager of Package Development with Eli Lilly and a member of the Drug & Pharmaceutical Packaging CommitteeKent Iverson, former Vice President of Manufacturing & Process Development at Corixa, Coulter and Immunex. Kent has broad operational expertise and has implemented practical solutions to complex controlled temperature shipping issues for injectables and has developed successful supply plans for numerous 2-8C products.John Pock, former head of Performance Engineering & Worldwide Quality as well as manager of International Distribution at Eli Lilly.
20 Other Recent ProjectsRapid due diligence of compounds for critical decisionsManufacturing and Outsourcing strategy including determination of number of locations and in- source / outsource mixIntegrated early and full drug development plansQuality Systems planning and implementation for developing companycGMP Quality System Gap Analysis for an established companyProcess development to address issues on a marketed productSite Audits with regulatory and practical operations perspectiveManufacturing readiness assessmentSourcing - identification of sources and review / selectionCandidate nomination process and portfolio reviewFormulation and drug delivery choicesMarket studies by simulating a pharma development groupDeal valuation supportcGMP Supplier Management
21 Why do clients look to us? Trust and confidence that we will get it doneWe apply world-class expertise that exactly meets the needEfficiency and effectiveness of our structured approachAvoid time consuming management and coordination of challenging resources and diverse inputs to complex issuesSpeed of resultsAccountability at a single, rather than multiple pointsWe ensure a cross-functional and downstream viewFixed predictable budget vs. multiple experts with “ the meters running at different rates”Delivery Assurance
23 Practical Quality Systems & Regulatory Help What we do and how it’s different:Operations oriented Quality perspective, not just “ex-FDA…”Practical approaches to regulatory complianceHelps avoid costly reactive remedial consultantsCost-effective, proactive complianceExamples of recent projects:Establishment of appropriate cGMP systems for a research based company moving to commercial developmentGAP Analysis and Action Plans following FDA Warning LetterVendor Audits that strengthen the vendor / client relationshipCGMP Gap Analysis and Action PlanPre-Approval Inspection Readiness AssessmentReturn / Next
24 Operational Input to Capital Plans What we do and how it’s different:Application of functional operations AND engineering expertise to complement client resourcesHelps client identify operational implications and issues with a "downstream” perspectiveAvoids costly change orders and “feature creep”, and supports sound decisions, early in the processExamples of recent projects:Development of a URS ( User requirement Specification ) for $200M Small and Large Molecule development facility“Future Proofing” of current pharmaceutical process through process and equipment reviewsProcess Validation, Equipment Qualification and Operational Efficiency input to design of new vessels for aseptic processingDevelopment of downstream processing technology requirements to meet future development needs.Return / Next
25 Resolve Issues and Build Skills What we do and how it’s different:Focused and efficient application of functional expertiseIntegrated development perspectiveMulti-company perspectivesAccess to the latest thinkingIntegration of inputs without costly coordinationExamples of Recent Projects:Expert oversight of challenging outsourced cytotoxic fermentationDosage form strategy and action plan to obtain IP protectionDosage form strategy to overcome half life deficiencyMicro Lab productivity analysis and recommendations to improve efficiency and handle greater workload without adding staffOperational Cost Model for research stage company transitioning to a product stage companyInformed Tox, CMC development and risk reduction plans to accelerate progressReturn / Next
26 Rapid & Interactive Expert Panels What we do and how it’ s different:Expert teams, custom assembled to address critical issuesFocused assignments for panel members ensure efficient processIndividual and group discussions, across-functions and within functionsInteractive panel discussions via telecon with the clientReal, actionable answers, action plansCompleted in 1-3 weeksExamples of recent projects:A rapid due diligence review of targetsImplications and path forward for gen- tox issue to support out-licenseReview and selection of appropriate animal modelsGo / No-Go review of existing efficacy dataManufacturability & scalability of synthetic routesReturn / Next
27 Scale-up and Sourcing Decisions What we do and how it’s different:Capitalize on multiple advisors experience in development, sourcing, and vendor managementRapid identification of technical requirements, identification of possible vendors, screening & qualification, support development of contracting, quality agreements etc.Drug Substance/API, Intermediates, Formulation, Drug Product, Fill-FinishExamples of Recent Projects:Identified and qualified sources for hard-to-locate emulsion capability in EuropeIdentified and qualified US sources of peptide manufacture for a European companyAPI Development, Scale-Up and route filing strategyScalability / Manufacturability reviewVendor Management Strategy and Process for an emerging large BiotechIdentification and Qualification of Controlled Release Drug Product manufacturers for an established BiotechReturn / Next
28 Integrated Development View The Core of Advisors’ ApproachLeverage understanding of the interrelationship between CMC, Clinical and Safety development to create and protect valueMulti-company and cross-functional perspectivesInsight-driven anticipation of Advisors Functional Focus issues for improved risk managementAdvisors who have been accountable for all aspects of developmentApplication to specific issues and overall program managementReturn / Next
29 Portfolio Decisions, Due Diligence and Valuation What we do and how it’s different:Concurrent technical and business perspectivePortfolio management decision experience across a wide range of technologies and therapeutic areasRapid inclusion of focused subject matter expertise rather than generalist researchExamples of recent projects:Due Diligence of compounds in various therapeutic areasDue Diligence of company business modelsValuation of compounds in support of out-licensing decisionAssembly of a “ Virtual Pharmaceutical Company” team of users to help a supplier understand the value of their technologies resulting in successful new business strategyReturn / Next
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