Pacific-Link ConsultingPacific-Link Consulting

Capability Presentation

http://www.pacificlinkconsulting.comhttp://www.pacificlinkconsulting.com

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Company OverviewCompany OverviewFounded in 2007 Founder

Richard E. Lowenthal MS, MSELSarina Tanimoto, MD, PhD

OfficeSan Diego, CATokyo, JapanLondon, UK (Partner, Sirius Consulting)

US Employees: 16 employees

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ServiceServicessComprehensive Therapeutic Product

Development Consulting (US/EU/Japan)Regulatory Affairs and Quality AssuranceAuditing and Quality ManagementClinical and Pharmaceutical DevelopmentBiostatisticsMedical / Technical WritingElectronic eCTD (IND/NDA/MAA)LicensingDue Diligence (Pharmaceutical, VC)

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ConsultantConsultantRichard E. Lowenthal MS, MSELRichard E. Lowenthal MS, MSEL

Main Past Positions FDA New Drug Reviewer Regulatory Affairs and Global Project Leader at Janssen VP of Regulatory Affairs and Quality Assurance at

Somerset, AnGes, Maxim and Cadence Acting Sr. Vice President at Jennerex Biotherapeutics and

Auspex Member of the Board at Momotaro Gene since 2012

(responsible for all US operations)

Expertise and Experiences Regulatory Strategy, Negotiation with Agencies

(FDA/EMEA/PMDA) Biologics and Drugs: FDA, EMA and NIH/RAC Participated in the filing and approval of 18 marketed

products

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ConsultantConsultantSarina Sarina Tanimoto, MD MBATanimoto, MD MBA

Main Past PositionsMain Past Positions MD, MPH, MBA, PhDMD, MPH, MBA, PhD Nippon Roche (Clinical Development)Nippon Roche (Clinical Development) AnGes MG (Clinical and Business Development)AnGes MG (Clinical and Business Development) Founder PLC in the US and JapanFounder PLC in the US and Japan

Expertise and ExperiencesExpertise and Experiences Clinical Development and Safety Monitoring for Clinical Development and Safety Monitoring for

Drug and BiologicsDrug and Biologics Japan MHLW Orphan Drug DesignationsJapan MHLW Orphan Drug Designations PMDA Negotiations and MeetingsPMDA Negotiations and Meetings Business Development in Japan and USBusiness Development in Japan and US

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Pacific-Link Biologics Pacific-Link Biologics ExpertsExperts

Key PLC Experts on Biologics Robert Bell PhD - Biologics Manufacturing Expert

25 years Baxter and Barr; Member of USP Biologics Committee

Michael Hatfield, PhD – Biotechnology Development Selective Genetics, Onyx, Jennerex; Extensive Analytical Expertise

Joyce Reyes, MSc RAC – Biologics Quality and Reg. Invitrogen, Xoma, InterMune, Cell Genesis, Geron, Jennerex

Charles Olson, PhD – Biologics Manufacturing Expert Bayer, Onxy, Biomarin, Cell Genesis, NextBio

Joseph Crea – Quality Assurance Expert 30+ years biologic qualify experience; Janssen, Iroko

Tracy Ross-Teichart, PhD - Nonclinical

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Pacific-Link Key PartnersPacific-Link Key Partners

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Sirius Regulatory Consulting

EU Representative

Drug and Biotechnology Development

Biotechnology GMP Manufacturing

AccuReg Inc. GCP Auditing and Compliance

PEC and Omnicia eCTD Software and Filing Services

Duck Flats Pharma, Inc. Phase I/II Specialty CRO

The Sage Group High Level Business Development

Key Areas of ExpertiseKey Areas of ExpertiseStrategic Development for Biologics and

Pharmaceutical ProductsRegulatory Interactions and Strategy for

US, Japan and EU (Global Development)Project ManagementClinical Development and Site

ManagementBusiness Development and Value

Maximization StrategiesSupport of Due Diligence Reviews for

Companies and Venture Capital Groups

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ExperienceExperience

Support Multiple High Tech Companies Jennerex – Oncolytic Viruses Green Cross – Advanced Biologic Peptide Momotaro Gene – Viral Vaccine Therapy REGiMMUNE – Immune Regulatory TehrapyOther biologics utilizing cell based

production (NGM, Coheris, Polaris, I2O, iGM, )Multiple Other Past and Present Clients

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Biosimilar ExpertiseBiosimilar ExpertiseExtensive expertise with the

development of advanced Biologic based products:Complex proteinsCell based therapies and production

processesViral therapies and production processes

Regulatory experience with advanced biologics in both CDER and CBER

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EXPERIENCESEXPERIENCES

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Example: Momotaro-Gene Example: Momotaro-Gene Inc.Inc.Full Project Management Responsibilities

Manufacturing Support in Liverpool England and Baylor University

Managed GLP Toxicology Studies at MPI ResearchWorked with Okayama University on Preclinical ProgramPrepare and conduct Phase I trial

FDA Interactions and ConsultationPre-PreIND Consultation Jan 2009 (design of Dev. Plan)PreIND Meeting Nov 2009 (adjust Dev. Plan and IND)Multiple informal discussions and consultations

NIH RAC Filed Jan 2010 : Public Meeting March 2010 : RAC Approval March 2010

IND Filed March 1 2010 : Approved March 31Conducting Phase I Clinical Trials in 2 indications

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Example: Current Clinical Example: Current Clinical TrialsTrials

Extensive Experience in Clinical Trial ManagementCurrent Clinical Trials Under Management

Momotaro Gene (MTG-REIC-PC001), Green Cross (MG1102-01), REGiMMUNE (RGI-2001-02) and others

Preparation Write protocol: Develop Protocol with KOLs and Pis, Negotiate

Protocol with FDA, Obtain Scientific and IRB Approvals at Sites Select sites: Evaluate Site qualifications, build relationship with

investigators Create documents: IRB related, CRF Manage IRB Submissions and Approvals Site initiation Manage trial conduct directly through contract CRA and Data

Management Evaluate & negotiate proposals from CRO: Develop Trial

Management Plan, Budget, Responsibilities and Compliance requirements.

Management Train site coordinator, monitor and pharmacy Track enrollment DSMB: chose members, organize charter and hold meetings Manage conduct of CRO

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PROJECT EXAMPLESPROJECT EXAMPLES

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Support for Innovators Support for Innovators Overall Project ManagementDevelopment Plans and Regulatory Support

What quality and studies are required for IND and MA

Pharm studies, Preclinical studies (incl. Tox) and Clinical studies, what , where and when?

Risk assessmentObtain advice from agencies regarding

studies and quality required→Avoid unnecessary work and focus on necessary

studies to achieve key company milestones

Manage clinical trial

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Consult with Agencies in VERY early stage

Support for BioPharmaceutical Support for BioPharmaceutical CompaniesCompanies

Senior Level Strategic Advice and Review of Submissions.

Long Term Regulatory Liaison Support/Emergency Support

Support Compliance and Production Processes

Prepare Clinical/Regulatory Documents IND/BLA/NDA documents Protocols, IB, SSP

Communication with Agencies16

Support for VCSupport for VC Due Diligence

Review Product Technical Details Product Risk Assessment (Probability of

Success from a Technical Perspective) Review Regulatory Pathway for FDA, EMA

and PMDA Review of Development Plan and Cost

Estimates Provide Strategic Advice to Venture Start-

up Companies

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Quality Auditing and Quality Auditing and ManagementManagementDirect Auditing Expertise for both

Manufacturing and Clinical SitesRichard Lowenthal formerly member of

the FDA GMP Committee during CFR 211 Rewrite of Regulations.

Expertise in GCPs and Clinical AuditsPartner Companies and Experts Available

to further Support Client NeedsRoutinely Audit Biotech and Drug

FacilitiesRoutinely Audit Clinical Sites and

Central Labs18

Support for Generic Support for Generic BusinessBusinessExperience with Multiple ANDA

Filings and OGD proceduresStructured Templates that Meet

OGD RequirementsRelationships with OGD Staff

Capability to resolve potential issues prior to submission

Able to negotiate critical points during review

Full Filing Capability Including Electronic eCTD Capability

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Support for US OperationsSupport for US OperationsPLC routinely supports foreign

companies subcontracting in the United States (US)Direct supervision of contract facilitiesGMP Production, GLP Nonclinical

StudiesManage CROs for Clinical Trials

PLC can subcontract to consolidate contracting and management of US Contractors

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Safety ManagementSafety ManagementMedical Monitoring Capability

Clinical Site Management of Medical Issues

Collection of Safety DataCentral Medical Monitor

Interpretation of Events

Regulatory Reporting SAEs Annual Report

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Support for Overseas Support for Overseas companiescompaniesOverall Project ManagementDevelopment Plans and Regulatory

Support IND – NDA/BLA – Launch Define what quality and studies are required each stage

Pharm studies, Preclinical studies (incl. Tox) and Clinical studies, what , where and when?

Risk assessmentProduct Development Support

Select manufacturing sites and support technology transfers

Build relationships with subcontractorsConduct pre-qualification auditsEvaluated product development plans and dataHelp managed US subcontract facilities

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Support for Japanese Support for Japanese MarketMarketOverall Project ManagementDevelopment Plans and Regulatory

Support Orphan Drug DesignationAsian bridging trialsPMDA consultation for development IND – NDA/BLA – Launch Define what quality and studies are required each stage

Pharm studies, Preclinical studies (incl. Tox) and Clinical studies

Risk assessmentClinical Development Support

Select clinical sites and prepare & conduct clinical trialBuild relationship with KOLs and investigatorsCreate protocol Identify CRO and CRO managementDSMB managementReport writing

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Comprehensive ServiceComprehensive Service

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Low Overhe

ad

English/Japanes

e Capabili

ty

Thank you !Thank you !

Contact

Richard Lowenthal richard@pacificlinkconsulting.com

Sarina Tanimoto sarina@pacificlinkconsulting.com

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