Pacific-Link Consulting

Capability Presentation
http://www.pacificlinkconsulting.com

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)

 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)

Consultant

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

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
6

Pacific-Link Key Partners

Sirius Regulatory Consulting Drug and Biotechnology Development EU Representative Biotechnology GMP Manufacturing

AccuReg Inc.
PEC and Omnicia Duck Flats Pharma, Inc. The Sage Group

GCP Auditing and Compliance eCTD Software and Filing Services Phase I/II Specialty CRO 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

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

10

EXPERIENCES

11

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

12

Example: Current Clinical Trials

Extensive Experience in Clinical Trial Management Current Clinical Trials Under Management
Momotaro Gene (MTG-REIC-PC001), Green Cross (MG110201), 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

PROJECT EXAMPLES

14

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

Important

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

16

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

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

20

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

22

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

23

Comprehensive Service
HIGH LEVEL EXPERIENCE RELATIONSH
IP WITH

HANDS-ON

FDA/EMEA

COMPREHENSIVE DEVELOPMENT PLAN / STRATEGY

English/ Japanes e Capabilit y
Low Overhea d
24

PROGRAM SUPPORT

Thank you !
Contact Richard Lowenthal richard@pacificlinkconsulting.com Sarina Tanimoto sarina@pacificlinkconsulting.com

25