Cell & Gene Therapy Post-Approval Solutions

Covance
CovanceCovance

Cell & Gene Therapy post-approval solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.

Supported the development of
BOTH
GENE
REPLACEMENT
THERAPIES
FDA approved
CAR-T therapies and helped
advance the first 2 FDA-approved
Real-World Evidence Studies
& Post-Marketing Commitments
Long-term follow-up studies
Disease and product registries
Global presence; deep therapeutic area expertise
~25 Project Managers
Database of 200,000 physicians worldwide
Contacts with regulatory and payers in
key markets
Access to policy, fee schedule payment data
and decision makers
Patient Safety & Pharmacovigilance
1,300+ safety professionals across the U.S., Europe and Asia Pacific
200+ person team of highly experienced safety writing professionals
120+ member team of medical reviewers–case review, aggregate
review and signal management
PV SMEs available locally in each region to provide guidance in
global and local regulations
CELL & GENE THERAPY
Post-Approval Solutions
With specialized expertise, coordinated capabilities and focused
investments across preclinical, clinical and post-approval phases, we’ll help
you to reduce the time and risk in your product’s development.
Processed
in the last
5 years
From intake
and case
processing
automation
Regulatory compliance
achieved in the last 4 years
~2.5M 55% >99.5%
CASES TIME
SAVINGS
Across all product & therapeutic areas
Precision Medicine Solutions Designed Around Your Needs
Visit us at www.covance.com/CGT
Covance is a business segment of LabCorp, a leading global life sciences company, which
provides contract research services to the drug, medical device and diagnostics, crop protection
and chemical industries. COVANCE is a registered trademark and the marketing name for
Covance Inc. and its subsidiaries around the world.
www.covance.com
© Copyright 2019 Covance Inc. SSCGT004-0220
Covering a variety of
disciplines
1,500+
CALL CENTER
STAFF
Precision Medicine Solutions Designed Around Your Needs
www.covance.com/CGT
Covance is a business segment of LabCorp, a leading global life sciences company, which
provides contract research services to the drug, medical device and diagnostics, crop protection
and chemical industries. COVANCE is a registered trademark and the marketing name for
Covance Inc. and its subsidiaries around the world.
© Copyright 2019 Covance Inc. SSCGT004-0220
CELL & GENE THERAPY
Post-Approval Solutions
Patient & Field Support
Field reimbursement
Clinical education
Payer and customer relations
120+ field team members and 300+
clinical educators (U.S.)
Non-commercial pharmacy
CMC Analytical Testing
Routine global lot and release and
stability testing
Out of Scope/Out of Trend data
trending and alerts
Long-term stability testing
Manufacturing comparability
Regulatory & Strategic Product
Development Consulting
Differentiation studies
Label/indication expansion
Combination strategy
Health economics
Per year for commercial
product (all product &
therapeutic areas)
900+
RELEASE EVENTS
Supporting regulatory
consulting, submissions
management and project
management
180STAFF

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Cell & Gene Therapy Post-Approval Solutions

  • 1. Supported the development of BOTH GENE REPLACEMENT THERAPIES FDA approved CAR-T therapies and helped advance the first 2 FDA-approved Real-World Evidence Studies & Post-Marketing Commitments Long-term follow-up studies Disease and product registries Global presence; deep therapeutic area expertise ~25 Project Managers Database of 200,000 physicians worldwide Contacts with regulatory and payers in key markets Access to policy, fee schedule payment data and decision makers Patient Safety & Pharmacovigilance 1,300+ safety professionals across the U.S., Europe and Asia Pacific 200+ person team of highly experienced safety writing professionals 120+ member team of medical reviewers–case review, aggregate review and signal management PV SMEs available locally in each region to provide guidance in global and local regulations CELL & GENE THERAPY Post-Approval Solutions With specialized expertise, coordinated capabilities and focused investments across preclinical, clinical and post-approval phases, we’ll help you to reduce the time and risk in your product’s development. Processed in the last 5 years From intake and case processing automation Regulatory compliance achieved in the last 4 years ~2.5M 55% >99.5% CASES TIME SAVINGS Across all product & therapeutic areas
  • 2. Precision Medicine Solutions Designed Around Your Needs Visit us at www.covance.com/CGT Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. COVANCE is a registered trademark and the marketing name for Covance Inc. and its subsidiaries around the world. www.covance.com © Copyright 2019 Covance Inc. SSCGT004-0220 Covering a variety of disciplines 1,500+ CALL CENTER STAFF Precision Medicine Solutions Designed Around Your Needs www.covance.com/CGT Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. COVANCE is a registered trademark and the marketing name for Covance Inc. and its subsidiaries around the world. © Copyright 2019 Covance Inc. SSCGT004-0220 CELL & GENE THERAPY Post-Approval Solutions Patient & Field Support Field reimbursement Clinical education Payer and customer relations 120+ field team members and 300+ clinical educators (U.S.) Non-commercial pharmacy CMC Analytical Testing Routine global lot and release and stability testing Out of Scope/Out of Trend data trending and alerts Long-term stability testing Manufacturing comparability Regulatory & Strategic Product Development Consulting Differentiation studies Label/indication expansion Combination strategy Health economics Per year for commercial product (all product & therapeutic areas) 900+ RELEASE EVENTS Supporting regulatory consulting, submissions management and project management 180STAFF