Page 1

Pacific-Link Consulting Capability Presentation


Company Overview  Founded in 2007  Founder Richard E. Lowenthal MS, MSEL Sarina Tanimoto, MD, PhD

 Office San Diego, CA Tokyo, Japan London, UK (Partner, Sirius Consulting)

 US Employees: 16 employees 2

Services  Comprehensive Therapeutic Product Development Consulting (US/EU/Japan)  Regulatory Affairs and Quality Assurance  Auditing and Quality Management  Clinical and Pharmaceutical Development  Biostatistics  Medical / Technical Writing  Electronic eCTD (IND/NDA/MAA)  Licensing  Due Diligence (Pharmaceutical,VC) 3


 Richard 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 4

Consultant  Sarina Tanimoto, MD MBA  Main Past Positions    

MD, MPH, MBA, PhD Nippon Roche (Clinical Development) AnGes MG (Clinical and Business Development) Founder PLC in the US and Japan

 Expertise and Experiences  Clinical Development and Safety Monitoring for Drug and Biologics  Japan MHLW Orphan Drug Designations  PMDA Negotiations and Meetings  Business Development in Japan and US 5

Pacific-Link Biologics Experts  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 6

Pacific-Link Key Partners 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 7

Key Areas of Expertise  Strategic Development for Biologics and Pharmaceutical Products  Regulatory Interactions and Strategy for US, Japan and EU (Global Development)  Project Management  Clinical Development and Site Management  Business Development and Value Maximization Strategies  Support of Due Diligence Reviews for Companies and Venture Capital Groups 8

Experience  Support Multiple High Tech Companies  Jennerex – Oncolytic Viruses  Green Cross – Advanced Biologic Peptide  Momotaro Gene – Viral Vaccine Therapy  REGiMMUNE – Immune Regulatory Tehrapy Other biologics utilizing cell based production (NGM, Coheris, Polaris, I2O, iGM, )

 Multiple Other Past and Present Clients


Biosimilar Expertise  Extensive expertise with the development of advanced Biologic based products: Complex proteins Cell based therapies and production processes Viral therapies and production processes

 Regulatory experience with advanced biologics in both CDER and CBER




Example: Momotaro-Gene Inc.  Full Project Management Responsibilities  Manufacturing Support in Liverpool England and Baylor University  Managed GLP Toxicology Studies at MPI Research  Worked with Okayama University on Preclinical Program  Prepare and conduct Phase I trial

 FDA Interactions and Consultation  Pre-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 31  Conducting Phase I Clinical Trials in 2 indications


Example: Current Clinical Trials  Extensive Experience in Clinical Trial Management  Current 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 13



Support for Innovators  Overall Project Management  Development 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 assessment

 Obtain advice from agencies regarding studies and quality required →Avoid unnecessary work and focus on necessary studies to achieve key company milestones

 Manage clinical trial Consult with Agencies in VERY early stage 15

Support for BioPharmaceutical Companies  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 Agencies


Support 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 17

Quality Auditing and Management  Direct Auditing Expertise for both Manufacturing and Clinical Sites Richard Lowenthal formerly member of the FDA GMP Committee during CFR 211 Rewrite of Regulations. Expertise in GCPs and Clinical Audits Partner Companies and Experts Available to further Support Client Needs

 Routinely Audit Biotech and Drug Facilities  Routinely Audit Clinical Sites and Central Labs 18

Support for Generic Business  Experience with Multiple ANDA Filings and OGD procedures  Structured Templates that Meet OGD Requirements  Relationships 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 19

Support for US Operations  PLC routinely supports foreign companies subcontracting in the United States (US) Direct supervision of contract facilities GMP Production, GLP Nonclinical Studies Manage CROs for Clinical Trials

 PLC can subcontract to consolidate contracting and management of US Contractors


Safety Management  Medical Monitoring Capability Clinical Site Management of Medical Issues Collection of Safety Data Central Medical Monitor Interpretation of Events

 Regulatory Reporting  SAEs  Annual Report 21

Support for Overseas companies  Overall Project Management  Development 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 assessment

 Product Development Support  Select manufacturing sites and support technology transfers  Build relationships with subcontractors  Conduct pre-qualification audits  Evaluated product development plans and data  Help managed US subcontract facilities


Support for Japanese Market  Overall Project Management  Development Plans and Regulatory Support  Orphan Drug Designation  Asian bridging trials  PMDA 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 assessment

 Clinical Development Support  Select clinical sites and prepare & conduct clinical trial  Build relationship with KOLs and investigators  Create protocol  Identify CRO and CRO management  DSMB management  Report writing


Comprehensive Service

English/Ja panese Capability

Low Overhead 24

Thank you ! Contact Richard Lowenthal Sarina Tanimoto


Biotechnology Consulting  

Biotechnology consulting refers to the practice of organization involved in Pacificlinkconsulting services contact: San Diego, CA 92127 Phon...