Meenal Maurya- D-14

Akshita Sharma- E-06

Saasha Jethwani- E-17
Shirin Sharma- E-36

Managing the risk aspects of the

product development process at
the Upjohn Company
Lea Prevel Katsanis
Concordia University, Montreal, Canada, and
Dennis Pitta
University of Baltimore, Baltimore, Maryland, USA
Introduction
• W.E. Upjohn, a physician practicing in Kalamazoo,
Michigan in late 1800s

• Some of the local population discouraged meat eating

• As a remedy iron pills were started

 The Upjohn “Iron” Pills

The Kalamazoo Office

Introduction
 Pill Rolling operation given to one of his brothers

 Spawned a no. of competitors

 Some pills in the market were rock solid

 Upjohn Company pills demonstrated purity and quality

 The Regulatory Environment

 For some industries devotion to product quality is

enough

 In pharmaceutical industries, government regulation is

intense

 Everyday FDA seizes food and drugs deemed harmful or

defective

The BOD Meeting

 The Regulatory Environment

 The cost of defective food and drugs are enormous

 To protect the general public, FDA created tough guidelines

and procedures for companies to enter US market

 Each set requires detailed set of results

 In a production process, the further along a mistake occurs,

the higher the cost

 Bost and other managers decided to hedge their bets as

much as possible
 The Regulatory Environment
 Even if the drug passed successful, FDA could withdraw
it

 Upjohn Successfully introduced two generations of ant

diabetes agents from Germany’s Hoechst
Pharmaceutical

 Pharmacia and Upjohn

RECENT CHANGES (1970-1990)
 Internal group- industry developments & internal policies-
changes in the role of NPD & marketing
 NPD’s ROLE , Task 1- Pass the product through FDA
regulations- efficacy & safety
1) Discovery- involves finding targets for the drug and
optimizing its composition for the best effects
2) Clinical Trials- Involve 4 phases- tests on animal subjects
to gauge safety and toxicity (rats & rabbits)
3) Other mammals
4) Human volunteers
5) Post introduction surveillance
Task 2- Determining the drug’s
indications and contraindications

 If, for example, long-term use of a drug can damage a

person’s liver, underlying liver disease is a contraindication
and those with the condition should use the drug.
CHANGES IN THE FUNCTION OF MARKETING
Before After
Initial adoption to Keeping the drug on
recover product the market
development costs, throughout its
funds for next cycle lifecycle,
Limited patent
protection
Consequently, the marketing team must focus on both early and
long-term sales.
CONTD…

• The Upjohn Company has always been sensitive to promoting its

products in the most careful way.

 FDA regulations

 pharmaceuticals are highly complex products used in an

equally complex environment

 For example, a tranquilizer called Maolate. (malt in beer)

 Upjohn pulled the product to avoid further deaths, even

though a warning would have protected it from lawsuits.
 Risk management in the pharmaceutical
industry

 Risk management is the process of minimizing a drug’s risk during the

product’s life cycle – Risk assessment and risk minimization

Mechanisms

• Extensive sales force training

• FDA approved package insert- advisory tool for physicians and is

the legal protection for the manufacturer

• Extensive post introduction surveillance – Worldwide and timely

 Three common elements to aid in risk
management:

traditional education- information

booklets, letters to doctors, and letters
to patients.
reminder programs- informed consent
agreement documents
controlled access- limits the distribution
of the drug to certain types of patients.
Four basic questions that were the foundation
of a pharmaceutical risk management effort:

Frank Paine introduced below basic questions for

pharmaceutical risk management effort:

1. Who should not use the drug?

2. How is the drug used?
3. What things do patients need to avoid when taking the
drug?
4. To what extent are there issues of informed consent?
Design of a risk management effort

1. When to start the effort

 As early as possible

 Real data usually come much later

 Hence risk assessment should be an ongoing process

 Begin as early in the discovery phase as possible

Cont…

Phase 1 : Risk identification

Phase 2 : Devise testing protocol
Phase 3 : Respond to the risk
Composition of the risk management
team

 Team membership can be broad or smaller

 Should include vital experts

a. safety and risk management

b. regulatory affairs

c. medical affairs and medical communication

d. marketing and sales

e. legal department
RISK MANAGEMENT TEAM
ORGANISATION
 KEY ASPECTS
• Clearly defined roles and responsibilities
• Leader (Reward power)
• Key decisions of the product
• Reward system
• Regulatory affairs office
 TEAM AT UPJOHN
 Cross-functional team
 Led by marketing
 Team divided into 2 parts
Cont…
 PRE-RELAESE PHASE
• Product developers
• Research
• Internal processes
• Shape the product
• Safety and efficacy
 POST-RELEASE PHASE
• Product commercializes
• Fine tune promotions
• Marketing plan
• Responds to issues (not necessarily related to safety)
EXTENDED CHALLENGES
 External factors-
• Physicians giving wrong prescription
• Given to contraindicated patients
• Wrong dosage
• Example- Cleocin (anti-staphylococcus antibiotics)
Standard dose- 150mg four times a day
Prescribing 450mg four times a day
• Lower than effective dose
 FDA & POST APPROVAL STEPS
• Pairing of RM team with company’s FDA representation team
• Choice of members simplified
• More effective as representatives
 CONTD…

 POST- APPROVAL
• Rigorous surveillance system
• Take immediate action
• Benefit to other product’s launch
• Helps ward off FDA intervention

 IMPLICATIONS
• One of the earliest company to address risk management
issue
• Pharmacia & Upjohn merged with Pfizer
Pfizer’s REM
 Risk evaluation and mitigation strategy, includes
• A medication guide
• A patient package insert
• Communication plan- information to health care
providers
• Elements to ensure safe use of product:-
1. Training/certification for health care professionals
2. Dispensing medicine in certain settings
3. Registration of each patient using medication

• An implementation system