BUSINESS DEVELOPMENT

Abeer Ayub
CONTENTS
S No TITLE
1 WHAT IS BUSINESS DEVELOPMENT?
2 PRODUCT PIPELINE
3 PORTFOLIO EXTENSION
4 LINE EXTENSION
5 TECHNOLOGY TRANSFER
6 NEW PRODUCT DEVELOPMENT
7 IDEA GENERATION
8 DEVELOPMENT
9 COMMERCIALIZATION
WHAT IS BUSINESS DEVELOPMENT?
 Business Development in Pharmaceutical provides an end-
to-end service to the organization optimizing performance
and efficiency, and ensuring comprehensive completion of
work. It does this by collaborating with all the various
departments involved in the accomplishment of that task.
Significant Tasks:
 Development of Product Pipeline

 Portfolio Extension

 Line Extension

 Technology Transfer

 In-licensing

 Outsourcing
The product pipeline comprises of the
products the company plans on launching in
the future.
 PORTFOLIO EXTENSION
 Portfolio Extension means introducing a totally
different set of products specific to a particular
area such as biotechnology portfolio, infant
nutrition portfolio, nutraceuticals products etc.
 LINE EXTENSION
 Line extension means working on the already
existing range of products and introducing newer
combinations. E.g. Tramal & Tramal Plus
 TECHNOLOGY TRANSFER

 Technology transfer is
the complete process
of transferring skills,
machines, knowledge
of manufacturing to
customers.
NEW PRODUCT DEVELOPMENT

In Searle, Pharmaceutical Business

Development is majorly divided in 3 phases:
 Idea Generation
 Development
 Commercialization
 IDEA COMMERCIALIZ
DEVELOPMENT
GENERATION A-TION

GPS Source Identification MRP Documentation

Sampling
Commercial Go-
NPPF
ahead
Formulation
Market Brief Artwork
Trial Batches

Technical feasibility Brand name

Stability Testing

Financial Feasibility Registration Forecast

 PHASE 1:IDEA
IDEA GENERATION
GENERATION
 Overview
 PHASE 1- IDEA GENERATION
 GPS form comprises of  A feasibility report is the
information of the result of a detailed
product globally & its examination of a
availability in Pakistan. proposed idea. Here, we
 New Product Proposal look into 3 prime
Form (NPPF) contains feasibilities:
the Marketing,
 Technical Feasibility
Regulatory, Medical and  Financial Feasibility
R&D/QC essential  Market Feasibility
information regarding
the product.

GPS & NPPF Feasibility

 ASSESSING FEASIBILITY
 Is the raw material  Will the capital invested
accessible? into the idea generate
 Is the manufacturing facility sufficient revenue for
accommodating? business?
 If a separate room is  If it is a me-too drug, is it
required, is it available? cost-effective and still
 If the manufacturing facility generating revenue?
is not available, can the
product be outsourced (toll)?
 Should the product be
imported?

TECHNICAL FINANCIAL
 Market Feasibility

AMarket Brief is prepared on the product

of interest assessing its feasibility and
demand in the Market.
DEVELOPMENT
 PHASE 2: DEVELOPMENT
 The first step is identifying the source for raw
material and packaging material. A sample is
made, followed by a trial batch, which is
manufactured by the R&D department and
Stability testing begins. Side by side, the
Regulatory Registration is submitted for product
Approval. The rest of the phase involves follow-up
with all the collaborating departments.
 IN-HOUSE  FINISH IMPORT
MANUFACTURE: PRODUCT:
The product is manufactured in the
A finished product is imported
Company’s own facility. from an international vendor.

 TOLL PLANT/ PARTNER:

 DISTRIBUTOR:
This is basically outsourcing and it is
A product is taken from a
done in 2 ways: private distributor
 Own material- both raw material and
packaging material but labor partner
 Both labor and material provided by
partner (outsourced/toll), marketing
expertise by the in source company

BUSINESS MODELS FOR SOURCE IDENTIFICATION

 Obtaining raw
materials to  A sample of packaging
manufacture the and raw material is
product, or a vendor obtained from the
willing to import the vendor.
product, or an outside
manufacturer ready to
manufacture the
product locally.

SAMPLE
SOURCING
 A formulation is made by the R&D and sent to
BD for approval
 If approved, trial batches are made
 The trial batches are sent for stability testing
 Follow-up of Regulatory Registration
COMMERCIALIZATION
PHASE 3: COMMERCIALIZATION
 The NPSF or the New
 MRP documentation is
filed stating the final
price of the product.
MRP DOCUMENTATION
Product Specification
Form containing all the
specifications of the
dosage form including
the colour, dimension
etc are compiled and
approved by all the
relevant departments
NPSF
 A Brand name is  Artworks are finalized
assigned to the in the form of print-
product. proofs and approved
simultaneously.

BRAND NAME ARTWORKS & DESIGN

FORECAST & GO-AHEAD
 Based on the sales forecast generated by the
marketing team, the bulk quantity of raw
material is ordered by the Supply Chain and
handed over to the Production department for
commercial production of the product.
 Go-ahead is given to the Production

department for Commercial Large-scale

Manufacture of the product.
 PRODUCTIVE TASKS
•GPS Forms
•NPSF
•IMS
•Feasibility Report
•Market Brief
•Peptide Drug Bank
•Artwork Review
•Online Research