Transcript US Biotechnology: Overview of Regulatory Issues and

US Pharmaceutical/Medical
Device Regulatory and Product
Development Overview
Tom Gardner
Product Development
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Pharmaceuticals
Medical Devices
Bio-Technology
Equipment
Support Products
Who Am I:
 20+ years in pharmaceutical industry
 Quality Analyst, Manufacturing
Management, R&D Product Development,
Clinical Supplies, Senior Scientist and
Product and Process Development
Coordinator
 Involved in 7 approved FDA product/device
filings and over 50 product development
projects
Overview of Typical Pharmaceutical Product
Development
IP
Marketing
Research
PreClinical
Work
Cost:1
F
I
L
I
N
G
Preclinical to Phase II - Approximately 1-7 million
Marketing Plan
Product
Launch
A
P
P
R
O
V
A
L
Clinical
Studies
Phase III - 2 - 8 million
V
A
L
I
D
A
T
I
O
N
Registration
Validation
Validation Batches - Product Costs
and Labor X 3 to 5 batches
Commercial
Production
Total Costs = 10-25 million USD
Production Start Up Costs based on Contract or Facility
Total Time = 4.5 - 7.5 years
Time:2,3
Preclinical to Completed Clinicals - 3-5 years
FDA Approval - 13.5 months 3
Validation and Production Launch - 6-18 months
1
In 2000 Dollars - Estimates by the National Cancer Institute for all new pharmaceutical. Estimate does not consider R&D costs that are not associated with the development of the drug in question. Most drug companies use a system of cost estimates that
includes the valuation of money if it had been invested andthe cost of drug development not approved by the FDA. Most studies conclude that the rate of commercialization success to be 1:5000. How Much does it cost to develop a new drug - James Love Consumer Project on
Technology http://www.cptech.org April 2, 2000
2 Drug Approval Overregulation, MR Ward - CATO Regulation - http://www.cato.org/pubs/regulation/reg15n4e.htm
3 New York Times - November 8 1995
4
Welcome to the Jungle
Pre Clinical
Work
Stable
Clinical
Trials
Filing
GO
Registration
Validation
Approval
FAIL
Unstable
Proof of
Concept
FAIL
Effective
Effective
Ineffective
GO
FAIL
Ineffective
Safe
Max.
Energy
Batch
Phase
II
FAIL
Effective
Ineffective
GO
Inferior
FAIL
Toxic
GO
Definition
Micro
FAIL
FAIL
Grows Bugs
Passes ID
& Description
GO
Chemistry
FAIL
Degradants
& Impurities
Ineffective
Effective
Failure is Unlikely
Nominal
Batch
Clinical Report
Reformulation
Egg
START OVER
Sell
Product
GO
FAIL
GO
Launch
Quarantine
Product
FDA STUDIES
& Aseptic
Phase
III
Death of
Product
Antimicrobial
Fill Sales &
Warehouse Pipeline
GO
RESET ALL PARAMETERS
FAIL
Toxicology
Launch
Ad Campaign
FAIL
Efficacy
GO
GO
GO
Animal
Commercial
Production
Scale Up
Production
Min.
Energy
Batch
Phase
I
Stability
Pre Approval
Inspection
Phase
IV
Formula Improvement
Geriatric or Pediatric
Validation Report
Stability Testing
Drug Interaction
5
Define LT & Side Effects
Is it worth the trouble?