Strategic decision making in pharmacological companies. Techno managerial aspects in pharmacological companies. Regulations of biotechnological products

1. Strategic decision making; techno-
management aspects; returns on
investment and regulation of
biotechnology based products and
industry
Presented by
Akem Lazare

2. Introduction
• Definition of biotechnology: is the study of biology and
technology i.e exploitation of biological agent on any
component of biology to generate useful products and
services
• It combines other disciplines like Microbiology, Chemistry,
Biochemistry, Genetics, Molecular Biology, Immunology, and
Engineering.
• Its scope can be divided into the following; Medical
biotechnology, Agriculture (both Plant and Animal)
biotechnology, Environmental biotechnology and Industrial
Biotechnology
• All these broad areas involves effective management,
strategic decision making, planning and regulations of
products and industry

3. Strategic decision making in biotechnological
companies
• Definition: It is a process of understanding the interaction
of decisions and their impact upon the organization to gain
an advantage either to remain competitive or survive.
• Decision making is a core function of any drug production
firm as drug production involves a lengthy and expensive
process a timely valid decisions are empirical.
• Every phase of drug production has specific financing
obligation with Phase III being the most expensive and most
drugs candidate have fail in this phase without reaching the
market.
• But with a sound strategic decision such drugs destine to fail
can be stop and prevent the company from losing money

4. Characteristic of a good decision making
• Decisions should be made in a coordinated sequence.
• Decision-making should be viewed as a dynamic process
that changes over time.
• The size of the Company determines how much of the
preparatory work for decision-making can be done in-house
and how much needs to be outsourced.
• despite the need to make optimal decisions while managing
drug pipelines, human judgment rather than any formal
analytical method is used in pharmaceutical companies

5. The need for decisions
• Generally, product development can be organized into two
categories:
• the decisions made within a single developmental project and
• those decisions made in establishing an organizational context
and in planning its projects.
• Both are influenced by
- Access to infos about the science
- Manufacturing issues
- Marketing and financial aspects
- the firm’s internal clinical capabilities
- the ability to internalize critical external knowledge
- selecting prime targets for drug discovery
- focusing limited resources to enhance speed
- breaking down barriers between research and manufacturing

6. Return on investment (ROI)
• They are sets of calculations used by pharmaceutical and
biotechnology companies in evaluating product returns,
guiding decisions on further product development or
terminating programs prior to company losses.
• It evaluate the estimated profit and compares it to cost of
product.
• When combined when with SWOT analysis,
•
• ROI can provide invaluable and comparable insight into the
value of potential projects and products.

7. Biotechnology management
• Definition: Is a systematic way of planning, organizing,
controlling and administering the application of scientific and
engineering principles to process the materials by biological
agents to provide goods and service.
• Good managt in biotechnology is needed to drive national
devt and growth.
• However lack of understanding and adequate support from
the govert poses a challenge
• Legal and ethical issues
• Lack of awareness of biotech from the public

8. The significance and impact of
biotechnology management on the human
• Better quality of food products
• Environmental and economic benefit
• Diagnostics and therapeutics merit
• Vaccine production
• Increase in animal biotechnology
• Agricultural production application

9. Regulation of biotechnological products and
industry
• Biotech techniques make many products, including medical,
agricultural, industrial, consumer and research products.
• In the realm of agriculture, biotech techniques can help in
producing new varieties of plants, animals, and microbes or new
substances derived from these sources.
• Examples of products range from insect-protected and/or
herbicide-resistant crops, to apples that do not readily brown
when sliced, to algae modified to produce biofuels or plastic, to
human and animal vaccines and pharmaceuticals
• Three federal agencies are primarily responsible for
regulating biotechnology products

10. Environmental Protection Agency(EPA)
• The mission of the EPA is protection of human health and the
environment.
• EPA regulates the sale, distribution, use and testing of pesticides
in order to protect health and the environment, regardless of how
the pesticide was made or its mode of action.
• Contaminated lands and toxic sites are cleaned up by potentially
responsible parties and revitalized; and
• Chemicals in the marketplace are reviewed for safety.
• EPA is also responsible for determining the amount of bio
pesticide residues that can safely be in food

11. Food and Drug Administration(FDA)
• is responsible for protecting the public health by ensuring the
safety, efficacy, and security of human and veterinary drugs,
biological products, and medical devices;
• has responsibility for regulating the manufacturing, marketing,
and distribution of tobacco products to protect the public health
and to reduce tobacco use by minors.
• is responsible for advancing the public health by helping to speed
innovations that make medical products more effective, safer, and
more affordable

12. U.S. Department of Agriculture
• The mission of USDA and Animal and Plant Health
Inspection Service (APHIS) is to protect agriculture from
pests and diseases.
• In that role it regulates biotech products that could pose
a risk to plant health.
• USDA also has regulatory oversight over products of
biotech that are included in veterinary biologics, and
ensures that veterinary biologics are pure, safe, potent
and effective.

13. Laws that EPA, FDA, and USDA use to
regulate biotechnology products
• Plant Protection Act (PPA) administered by USDA
• Animal Health Protection Act administered by USDA
• Federal Food, Drug, and Cosmetic Act (FD&C Act)
administered by FDA
• Public Health Service Act (PHS Act) administered by FDA
• Federal Food, Drug and Cosmetic Act (FD&C Act), Section
408 administered by EPA
• Endangered Species Act (ESA administered by EPA and FDA