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Product
Development Planning
Product
Planning is critical to any organization, and a well-conceived and
comprehensive Product Development Plan (PDP) can provide a detailed
assessment of your product and the most effective pathway to market
or licensure.
The
PDP is:
- 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 and 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 PDP?
- 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
Typical
PDP Content:
To be developed with client on case-be-case basis
| Background
and Product Assessment |
| |
Clinical
Indication and Need |
| |
Product
History and Mechanism of Action |
| |
Regulatory
Assessment |
| |
Overall
Development Strategy |
| Manufacturing
Development Plan |
| |
Drug
Substance and Drug Product Manufacturing |
| |
Process
Development and Optimization Needs |
| |
Analytical
Testing Evaluation |
| |
In-house
vs. Contract Manufacturing Considerations |
| Preclinical
Development Plan |
| |
Summary
of Completed Studies |
| |
Proof
of Concept Studies |
| |
Proposed
Nonclinical Plan |
| |
|
Pharmacology
and Pharmacokinetic Studies |
| |
|
Toxicology
(safety) Program |
| |
Potential
Nonclinical Vendors |
| Clinical
Development Plan |
| |
Overview
of Clinical Plan |
| |
Phase
1 Protocol Synopsis |
| |
Potential
CROs |
| Regulatory
Development |
| |
Regulatory
Expectations and Strategy |
| |
Pre-IND
Requirements |
| |
Phase
1 IND Requirements/Submission Plan |
| Project
Management |
| |
Project
Management Requirements |
| |
Program
Team Development Plan |
| Budget |
| |
Cost
estimates for all Tasks |
| Timelines |
| |
Timelines
for both overall and individual development programs |
Other
Strategic Planning Services:
BCG
can tailor a PDP to suit your needs regardless of the scope (i.e.,
when a full PDP Plan is not needed). Examples include:
- Preclinical
Development Strategies
- Strategies
for Alternative Indications
- Chemistry
& Manufacturing Strategies
- Focused
Regulatory Plans
Outsourcing
and Project Management Support
In support of your overall program development, BCG can also help
to identify and manage qualified manufacturing, nonclinical and
clinical vendors suitable for any biologic project. Once your plan
is underway, we can assist with:
- Vendor
identification and qualification
- Design
of manufacturing and nonclinical safety programs
- Placing
and managing both manufacturing, and nonclinical development projects
- Program
oversight and appointment of a program manager
- Budget
and Timeline Tracking
BCG's
Product Experience Encompasses
- Vaccines
- Therapeutic
Proteins
- Monoclonal
Antibodies
- Cell
and Tissue Therapies
- Combination
Device and Biologic Products
- Blood
Products
- Cytokines/Interferons
- Bacterial
and Viral Therapies
- Peptides
and Small Molecules
PDP
Costs :
Typically $25,000-40,000 depending on complexity of product and
regulatory pathway. Can be priced on a fixed-fee or time-and-materials
basis.
PRODUCT
DEVELOPMENT PLANNING
A PDP is a "living document" that can evolve with the
life of your product. A well-designed plan can streamline your development
program and dramatically decrease overall cost and turnaround times.
Give BCG a call today to find out how our regulatory and product
development experts can put you on the path to success!
Page
Updated:
September 28, 2006
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