bcg overview of services and value propositions 2010

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Overview of Services and Value Propositions 2010

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Page 1: BCG Overview Of Services And Value Propositions 2010

Overview of Servicesand Value Propositions

2010

Page 2: BCG Overview Of Services And Value Propositions 2010

Q: Besides Being Blockbuster Products,What Do These Have in Common?

$4.4B*

$3.8B*$3.6B*

Drug-elutingcoronary stent

$1.5B*

A: Before they could be sold, approval was required by the Food and Drug Administration orassociated regulatory agency outside the U.S.

* 2008 annual sales

Page 3: BCG Overview Of Services And Value Propositions 2010

Alexandria (Headquarters) Beijing Boston

Raleigh San Francisco Tokyo

• 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

Biologics Consulting Group:17+ Years of Expertise in Helping Companies

Move Technology into the Marketplace

Facilitates and accelerates product development by:

Page 4: BCG Overview Of Services And Value Propositions 2010

BCG Offers ComprehensiveRegulatory Strategic Planning

Audits and Inspections Clinical Development Pharmacology/Toxicology Process validation Product Development Program Management Regulatory Support Training programs U.S. Agent

Biologics Combination Products Devices Diagnostics Drugs

Industries Services

All Major Markets, incl: Autoimmunity/Transplantation Cancer Cardiac disease Diabetes/Metabolic disease Infectious disease Inflammatory disease Neurological disease Orthopedics

Page 5: BCG Overview Of Services And Value Propositions 2010

Regulatory Affairs ImpactKey Early Development Milestones

BasicResearch Development Preclinical

• Pre-IND Follow-up• Protocol Preparation• CMO/CRO Mgmt• Quality Systems Implementation• Method Qualification

Pre-IND meeting with FDA• Line development• CMO selection• Method development

• Gap analysis• Development plan

• Pre-IND support• Pre-clinical plan• Clinical synopsis• CRO selection

Lead ID Proof-of-concept IND

Page 6: BCG Overview Of Services And Value Propositions 2010

Preclinical

Regulatory Affairs ImpactKey Clinical Development Milestones

Clinical Development

Phase 1 Phase 2 Phase 3

FDA Filing,Approval &Launch

1st-in-human P1 P2 BLA/NDA

• IND preparation

• Clinical site selection

Initial IND submission

• Ongoing submission• IND support• Clinical trial support

End of Phase 2 meeting

Pre-BLA or -NDA meeting

Market Application submission

Safety update

Page 7: BCG Overview Of Services And Value Propositions 2010

A Poor Regulatory Strategy Has a Significant, Negative Financial Impact

▼ Clinical Hold

▼ Refusal to file

▼ Complete Response Letter

▼ Warning Letter

▼ Bridging Studies

▼ New product Designation

▼ Comparability Studies

▼ Clinical Supply Shortages

▼ Non-approval

Private company: Bridge financing may be needed Down round may occur Flat round may occur IPO/M&A unlikely

Public company: Decreased market cap Secondary offering unlikely Loss of confidence by

public markets

How big can we make our role?

CAUSE EFFECT

Page 8: BCG Overview Of Services And Value Propositions 2010

BCG Consultants PossessExtensive Regulatory Affairs Experience

Page 9: BCG Overview Of Services And Value Propositions 2010

BCG Consultants RepresentBoth FDA and Industry Experience

Page 10: BCG Overview Of Services And Value Propositions 2010

BCG: Continual Increase in Clients Served(2000-2008)

115

77

160186

218

265

312

397

439Most projects come from:• Word-of-mouth• Referrals• Repeat business

Continual growth and increased revenues for 16 straight years, despite:

• No marketing department• No sales department• No business development

department

Page 11: BCG Overview Of Services And Value Propositions 2010

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)

To sell a device, the FDA must approve a:• 510k, or • Pre-Marketing Approval (PMA)

To test a product in humans, the FDAmust allow an:

• Investigational New Drug (IND) Application

In 2009, FDA issued a guideline (Guidance Document) for Common Technical Documents (CTDs)

• CTDs are standards used by U.S., Japan,and Europe to expedite human studies

Paper SubmissionsINDs (non-CTD and CTD) 60

BLAs/NDAs/PMAs 1

Electronic SubmissionseINDs and related Amendments (non-CTD) 9

eINDs and related Amendments (CTD) 14

eBLAs/NDAs 4

FDA and other world bodies are rapidly moving towards electronic submissions –and away from paper

Page 12: BCG Overview Of Services And Value Propositions 2010

Commercial Sector:Project Examples

Client Project Summary

Top-5 Public Pharmaceutical Firm (U.S.) On-site biologics training regarding vaccine manufacturing technologies and regulatory compliance.

Top-5 Public Pharmaceutical Firm (Japan)

Due diligence for strategic partnership. Evaluated raw material control, manufacturing, in-process control, specifications and 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.

Top-5 Drug Development Contract Research Organization

Developed a strategy and plan for writing a BLA for an assay to screen injectable drugs, biologics, medical devices, and raw materials for the presence of bacterial endotoxin. Applicationreceived FDA approval. Assay currently marketed.

Large, Private Device Firm Electronic publishing of their IVIG BLA in eCTD format for submission to CBER, FDA.

Small, Private, Infectious Disease Biotechnology Firm

Craft Product Development Plan (PDP), including: (1) scale-up and validation, and (2) qualification/validation of the test methods for product characterization, and potency evaluation.

Page 13: BCG Overview Of Services And Value Propositions 2010

Government and Public Sector:Project Examples

Client Project Summary

American Red CrossAudit blood product manufacturing facility. Assess current level of compliance with – and corrective actions regarding – applicable US regulatory requirements for licensure,

Major, World-wide Infectious Disease Foundation

Assess capabilities and needs for various clinical programs and manufacturing facilities related to producing treatments for key developing-world diseases.

State of Texas’ University ResearchSystem

Regulatory support leading to the filing of an Investigation New Drug (IND) application with the FDA for a phase 1 clinical trial of a virus-based treatment for Cystic Fibrosis.

National Institutes of Health’s Grand Program in Global Health

Pre-clinical and clinical development support for medical investigators, to get promising research to human studies.

St. Jude Children’s Research HospitalDetermine appropriate levels of quality systems for various tissue-based therapies, and whether they adhere to FDA mandates.

Pan-Provincial Vaccine Enterprise/University of British Columbia

Product development support for initiatives involving several potentially pandemic diseases.

Page 14: BCG Overview Of Services And Value Propositions 2010

Consulting Areas: AUDITS AND INSPECTIONS

• Inspection of manufacturing facilities • Audit of system/process validation studies • Evaluation of company Quality System • Evaluation of company procedures • Good Laboratory Practices (GLP) Audits • Quality Systems Audits

CLINICAL DEVELOPMENT• Assistance in responding to questions

from FDA:» Center for Biologics Evaluation and Research (CBER)» Center for Drug Evaluation and Research (CDER)» Center for Devices and Radiological Health (CDRH)

• Biostatistics • 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

PHARMACOLOGY/TOXICOLOGY• Program planning to support clinical

product development• Writing of the pharm/tox section of INDs,

BLAs, NDAs • Review and interpretation of toxicology

study data with respect to potential risk• Participation in due diligence programs for

perspective new products• GLP audits• Development of comparability protocol• Writing of product label• Recommendation/interface with toxicology

Contract Research Organizations (CROs)• Participation in FDA meetings

BCG has Extensive, Comprehensive Consulting Expertise

Page 15: BCG Overview Of Services And Value Propositions 2010

BCG has Extensive, Comprehensive Consulting Expertise

PROCESS VALIDATION• Evaluate process validation status• Identifying critical process parameters and

designing appropriate validation studies • Apply statistical methods to the evaluation

of process validation data • Assist in preparing process validation

related submissions to CBER/CDER/CDRH • Validation Master Plan• Facility Validation

o Equipment Validationo Utilities Validationo Cleaning Validation

PRODUCT DEVELOPMENT• A "roadmap" for your product's

development• A concise, product-focused, strategic

document laying out the path to market approval or licensure

• A detailed analysis of your product status and developmental requirements, including the four primary aspects of product development:

• Manufacturing

• Preclinical• Regulatory• Clinical Development• An integrated stand-alone document tying

all the four main areas of product development with budgets, tasks, and timelines through Phase 1 or beyond

Why Develop a Product Development Plan?• Planning is crucial at every stage of

development, particularly at the outset• Provides a concise detailed analysis of

your product and the roadmap to market• Clearly states developmental objectives

and crucial milestones• Presents a single (or multiple, if desired)

focused regulatory strategy for presenting your product to the FDA

• Presents strategies for dealing with potential roadblocks and hurdles in the product development process

• Lays out accurate and realistic budgets and timelines through clinical development

Page 16: BCG Overview Of Services And Value Propositions 2010

BCG has Extensive, Comprehensive Consulting Expertise

PROGRAM MANAGEMENT• Prepare Product Development Plan• Prepare Project Timeline• Provide oversight and ongoing quality

review and adjustment of project• Identify external contractors• Pre-clinical, Clinical, and CMC coordination• Central liaison with contractors and

sponsor• Monitoring of project resources, tasks

and timeline• Preparation and management of budget• Provide project updates/reports

REGULATORY SUPPORT• Pre-IND and IND support• BLA/NDA support• Device support• Electronic submissions• Request for Orphan Drug designation• Preparation of Drug Master Files

TRAINING PROGRAMS• Develop specific seminars and workshops• BCG has offered courses such as:

o "The Biologics Approval Process”o “Systems Approach to Process

Validation”o “Clinical Study Documents –

Regulatory Requirements and Review.”

U.S. AGENT• U.S. Agent for filing INDs• U.S. Agent for Foreign Establishment

Registration and Listing

Page 17: BCG Overview Of Services And Value Propositions 2010

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

Summary

Page 18: BCG Overview Of Services And Value Propositions 2010

BCG Contacts

James G. Kenimer, [email protected]

Ronald A. MarchesaniHead, West Coast [email protected]

Corporate Office1317 King StreetAlexandria, VA 22134www.bcg-usa.comP: 800-485-0106

703-739-5695

West Coast Office1840 Gateway Drive, Suite 200www.bcg-usa.comP: 650-378-1303