1. Overview of Services
and Value Propositions
2010

2. Q: Besides Being Blockbuster Products,
What Do These Have in Common?
$4.4B* $1.5B*
Drug-eluting
coronary stent
$3.8B*
$3.6B*
A: Before they could be sold, approval was required
by the Food and Drug Administration or
associated regulatory agency outside the U.S.
* 2008 annual sales

3. Biologics Consulting Group:
17+ Years of Expertise in Helping Companies
Move Technology into the Marketplace
Facilitates and accelerates product development by:
• Deep understanding of FDA regulations
• Identification, design, and review of the key steps required for testing in man
• Anticipation of land-mines in the road to commercialization
• Practical advice and solutions tailored to a company’s product development plans
Alexandria (Headquarters) Beijing Boston
Raleigh San Francisco Tokyo

4. BCG Offers Comprehensive
Regulatory Strategic Planning
Industries Services
 Biologics  Audits and Inspections
 Combination Products  Clinical Development
 Devices  Pharmacology/Toxicology
 Diagnostics  Process validation
 Drugs  Product Development
 Program Management
 Regulatory Support
All Major Markets, incl:  Training programs
 Autoimmunity/Transplantation  U.S. Agent
 Cancer
 Cardiac disease
 Diabetes/Metabolic disease
 Infectious disease
 Inflammatory disease
 Neurological disease
 Orthopedics

5. Regulatory Affairs Impact
Key Early Development Milestones
Lead ID Proof-of-concept IND
Basic
Research Development Preclinical
• Pre-IND support
• Line development • Pre-clinical plan Pre-IND meeting with FDA
• CMO selection • Clinical synopsis
• Method development • CRO selection
• Gap analysis
• Development plan • Pre-IND Follow-up
• Protocol Preparation
• CMO/CRO Mgmt
• Quality Systems Implementation
• Method Qualification

6. Regulatory Affairs Impact
Key Clinical Development Milestones
1st-in-human P1 P2 BLA/NDA
Clinical Development FDA Filing,
Preclinical Approval &
Phase 1 Phase 2 Phase 3 Launch
Initial IND End of Phase 2 Market Safety
submission meeting Application update
submission
• IND preparation • Ongoing submission
• Clinical site selection • IND support
• Clinical trial support Pre-BLA or -NDA meeting

7. How big can we make our role?
A Poor Regulatory Strategy Has a
Significant, Negative Financial Impact
CAUSE EFFECT
▼ Clinical Hold Private company:
▼ Refusal to file  Bridge financing may be needed
▼ Complete Response Letter
 Down round may occur
 Flat round may occur
▼ Warning Letter
 IPO/M&A unlikely
▼ Bridging Studies
▼ New product Designation Public company:
 Decreased market cap
▼ Comparability Studies
 Secondary offering unlikely
▼ Clinical Supply Shortages
 Loss of confidence by
▼ Non-approval public markets

8. BCG Consultants Possess
Extensive Regulatory Affairs Experience

9. BCG Consultants Represent
Both FDA and Industry Experience

10. BCG: Continual Increase in Clients Served
(2000-2008)
Most projects come from: 439
• Word-of-mouth 397
• Referrals
• Repeat business
312
265
Continual growth and increased 218
revenues for 16 straight years, 186
despite: 160
• No marketing department 115
• No sales department 77
• No business development
department

11. BCG Has Extensive, Successful
Submission Experience (2002-2007)
 To sell a drug , the FDA must approve a:
• Biologics License Application (BLA), or
• New Drug Application (NDA) Paper Submissions
 To sell a device, the FDA must approve a: INDs (non-CTD and CTD) 60
• 510k, or BLAs/NDAs/PMAs 1
• Pre-Marketing Approval (PMA)
To test a product in humans, the FDA Electronic Submissions
must allow an: eINDs and related Amendments (non-CTD) 9
• Investigational New Drug (IND) Application
eINDs and related Amendments (CTD) 14
 In 2009, FDA issued a guideline eBLAs/NDAs 4
(Guidance Document) for Common
Technical Documents (CTDs)
• CTDs are standards used by U.S., Japan,
and Europe to expedite human studies
 FDA and other world bodies are rapidly moving towards electronic submissions –
and away from paper

12. Commercial Sector:
Project Examples
Client Project Summary
On-site biologics training regarding vaccine manufacturing
Top-5 Public Pharmaceutical Firm (U.S.)
technologies and regulatory compliance.
Due diligence for strategic partnership. Evaluated raw material
control, manufacturing, in-process control, specifications and
Top-5 Public Pharmaceutical Firm (Japan)
analytical methods, cell bank status, and development and
commercialization strategy. Alliance executed.
Top-5 Public Biotechnology Firm Review and gap analysis of commercial stability programs.
Top-5 Public Biotechnology Firm Process Validation Master Plan for pandemic flu.
Developed a strategy and plan for writing a BLA for an assay to
Top-5 Drug Development Contract screen injectable drugs, biologics, medical devices, and raw
Research Organization materials for the presence of bacterial endotoxin. Application
received FDA approval. Assay currently marketed.
Electronic publishing of their IVIG BLA in eCTD format for
Large, Private Device Firm
submission to CBER, FDA.
Craft Product Development Plan (PDP), including: (1) scale-up
Small, Private, Infectious Disease
and validation, and (2) qualification/validation of the test
Biotechnology Firm
methods for product characterization, and potency evaluation.

13. Government and Public Sector:
Project Examples
Client Project Summary
Audit blood product manufacturing facility.
American Red Cross Assess current level of compliance with – and corrective actions
regarding – applicable US regulatory requirements for licensure,
Assess capabilities and needs for various clinical programs and
Major, World-wide Infectious Disease
manufacturing facilities related to producing treatments for key
Foundation
developing-world diseases.
Regulatory support leading to the filing of an Investigation New
State of Texas’ University Research
Drug (IND) application with the FDA for a phase 1 clinical trial of
System
a virus-based treatment for Cystic Fibrosis.
National Institutes of Health’s Grand Pre-clinical and clinical development support for medical
Program in Global Health investigators, to get promising research to human studies.
Determine appropriate levels of quality systems for various
St. Jude Children’s Research Hospital tissue-based therapies, and whether they adhere to FDA
mandates.
Pan-Provincial Vaccine Product development support for initiatives involving several
Enterprise/University of British Columbia potentially pandemic diseases.

14. BCG has Extensive, Comprehensive
Consulting Expertise
Consulting Areas:
 AUDITS AND INSPECTIONS  PHARMACOLOGY/TOXICOLOGY
• Inspection of manufacturing facilities • Program planning to support clinical
• Audit of system/process validation studies product development
• Evaluation of company Quality System • Writing of the pharm/tox section of INDs,
BLAs, NDAs
• Evaluation of company procedures
• Review and interpretation of toxicology
• Good Laboratory Practices (GLP) Audits study data with respect to potential risk
• Quality Systems Audits • Participation in due diligence programs for
perspective new products
 CLINICAL DEVELOPMENT • GLP audits
• Assistance in responding to questions • Development of comparability protocol
from FDA: • Writing of product label
» Center for Biologics Evaluation and Research (CBER)
» Center for Drug Evaluation and Research (CDER)
• Recommendation/interface with toxicology
» Center for Devices and Radiological Health (CDRH) Contract Research Organizations (CROs)
• Biostatistics • Participation in FDA meetings
• Case Report Form (CRF) design
• Clinical Development Plan
• Clinical Development Support
• Investigator’s Brochure (IB) preparation
• Medical writing, grant preparation
• Phase I/II study design
• Protocol design and preparation
• Phase I study site selection

15. BCG has Extensive, Comprehensive
Consulting Expertise
 PROCESS VALIDATION • Preclinical
• Evaluate process validation status • Regulatory
• Identifying critical process parameters and • Clinical Development
designing appropriate validation studies • An integrated stand-alone document tying
• Apply statistical methods to the evaluation all the four main areas of product
of process validation data development with budgets, tasks, and
timelines through Phase 1 or beyond
• Assist in preparing process validation
related submissions to CBER/CDER/CDRH
Why Develop a Product Development Plan?
• Validation Master Plan
• Planning is crucial at every stage of
• Facility Validation
development, particularly at the outset
o Equipment Validation
• Provides a concise detailed analysis of
o Utilities Validation your product and the roadmap to market
o Cleaning Validation
• Clearly states developmental objectives
and crucial milestones
 PRODUCT DEVELOPMENT • Presents a single (or multiple, if desired)
• A "roadmap" for your product's focused regulatory strategy for presenting
development your product to the FDA
• A concise, product-focused, strategic • Presents strategies for dealing with
document laying out the path to market potential roadblocks and hurdles in the
approval or licensure product development process
• A detailed analysis of your product status • Lays out accurate and realistic budgets and
and developmental requirements, including timelines through clinical development
the four primary aspects of product
development:
• Manufacturing

16. BCG has Extensive, Comprehensive
Consulting Expertise
 PROGRAM MANAGEMENT  TRAINING PROGRAMS
• Prepare Product Development Plan
• Develop specific seminars and workshops
• Prepare Project Timeline
• BCG has offered courses such as:
• Provide oversight and ongoing quality
o "The Biologics Approval Process”
review and adjustment of project
o “Systems Approach to Process
• Identify external contractors
Validation”
• Pre-clinical, Clinical, and CMC coordination
o “Clinical Study Documents –
• Central liaison with contractors and Regulatory Requirements and
sponsor Review.”
• Monitoring of project resources, tasks
and timeline
 U.S. AGENT
• Preparation and management of budget
• U.S. Agent for filing INDs
• Provide project updates/reports
• U.S. Agent for Foreign Establishment
Registration and Listing
 REGULATORY SUPPORT
• Pre-IND and IND support
• BLA/NDA support
• Device support
• Electronic submissions
• Request for Orphan Drug designation
• Preparation of Drug Master Files

17. Summary
 Highly experienced experts from bench to market/patient
 FDA/Industry experience provides best of both perspectives
 Expertise covering a wide range all aspects of numerous major
markets, including:
– Biologics
– Pharmaceuticals
– Medical devices
– Combination products

18. BCG Contacts
James G. Kenimer, PhD Ronald A. Marchesani
CEO Head, West Coast Operations
jkenimer@bcg-usa.com rmarchesani@bcg-usa.com
Corporate Office West Coast Office
1317 King Street 1840 Gateway Drive,
Alexandria, VA 22134 Suite 200
www.bcg-usa.com www.bcg-usa.com
P: 800-485-0106 P: 650-378-1303
703-739-5695