Biotechnology consulting refers to the practice of organization involved in Pacificlinkconsulting services contact: San Diego, CA 92127 Phone: 858-335-1300
2. 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
3. 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
4. Consultant
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
5. 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
6. 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
7. 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
8. 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
9. 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
9
10. 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
12. 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
13. 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
15. 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
16. 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
17. 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
18. 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
19. 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
20. 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
21. 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
22. 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
23. 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
23