1. PHARMACEUTICAL BIOTECHNOLOGY:
UNIVERSITY OF JORDAN
Lecture 2:
PHARMACEUTICAL BIOTECHNOLOGY:
The art of the future
Dr.YUSUF AL-HIARI
2017

2. Introduction
The biotechnology industry emerged in the 1970s, based largely on a new recombinant DNA (making proteins. such as human insulin and other therapies).
rDNA were published in 1973 by Stanley Cohen of Stanford University and Herbert Boyer of the University of California.
Boyer went on to co-found Genentech, which today is biotechnology's largest company by market capitalization.

3. - Biotechnology has created more than 250 approved new therapies and vaccines, including products to treat cancer, diabetes, HIV/ AIDS and autoimmune disorders (until 2010). More than 800 product till 2016.
There are more than 418-(FDA 2007) biotech drug products and vaccines currently in clinical trials targeting more than 200 diseases, including various cancers, Alzheimer’s disease, heart disease, diabetes, multiple sclerosis, AIDS and arthritis.
- 2015: almost 50%FDA approved products are originating from Biotechnology origin.

4. Some Facts About Biotechnology
- Biotechnology has introduced new uprising in scientific and industrial application word wild.
The biotech industry is regulated by the U.S. Food and Drug Administration (FDA), the Environmental Protection Agency (EPA) and the Department of Agriculture (USDA).
Europe counterparts: EMEA
Market capitalization, the total value of publicly traded biotech companies (U.S.) at market prices, was $360 billion as of late April 2008 (based on stocks tracked by BioWorld).
2016: market capitalization is more that $ 800 billion.

5. Biotechnology is one of the most research-intensive industries in the world. U.S. publicly traded biotech companies spent $27.1 billion on research and development in 2006.*
There were 180,000 employed in U.S. biotech companies in 2006.* The top five biotech companies invested an average of $170,000 per employee in R&D in 2007.
In 1982, recombinant human insulin became the first biotech therapy to earn FDA approval. The product was developed by Genentech and Eli Lilly and Co.
>2000, Corporate partnering has been critical to biotech success. According to BioWorld, in 2007 biotechnology companies struck 417 new partnerships with pharmaceutical companies and 473 deals with fellow biotech companies. The industry also saw 126 mergers and acquisitions.

6. Word wide:
- 1992, < 100 products - clinical use or human trials
, more than 26 products were approved by FDA
2006, more than 250 approved drug (rDNA and MABs)
2006 FDA report, more than 418 drug in development for more than 100 disease (mostly monoclonal)
2016: >800 product (approved or in clinical stage, MABs)
2016: 4 antisense products are launched.
- In 1992, more than 737 biotechnology companies from 25 countries have been listed (out of these 547 in the US)
In 2000 more than 1000 biotechnology company have been listed , out of which 742 in the US
As of Dec. 31, 2006, there were more than 2000 companies wordwide, 1,452 biotechnology companies in the United States

8. Biotechnology definition:
Biotechnology in general is based on technological application that uses biological systems, living organisms, or derivatives for human purposes.
It involves many fields of basic sciences such as biology, molecular biology, agriculture, food science, and medicine. Modern use of the term refers to genetic engineering as well as cell- and tissue culture technologies in addition to many new terms and fields discovered later such as genomics, proteomics and other fields.

9. Biotechnology has applications in four major industrial areas, including
Health care (medical and pharmaceutical),
Crop production and agriculture,
Non food (industrial) uses of crops and other products (e.g. biodegradable plastics, vegetable oil, biofuels),
Environmental uses.

10. Branches of Biotechnology involves:
Medical diagnostic tests that keep the blood supply safe from HIV and detect other conditions early enough to be successfully treated. Home pregnancy tests are also biotechnology diagnostic products.
Agricultural biotechnology :increasing yields and farm income, decreasing pesticide applications and improving soil and water quality, and providing healthful foods for consumers (GMF).
Environmental biotech products make it possible to clean up hazardous waste more efficiently by harnessing pollutioneating microbes.
Industrial biotech :cleaner processes that produce less waste and use less energy and water in such industrial sectors as chemicals, pulp and paper, textiles, food, energy, and metals and minerals. For example, most laundry detergents contain biotechnology-based enzymes.

11. Pharmaceutical biotechnology:
Forensic biotechnology: DNA fingerprinting, a biotech process, has dramatically improved criminal investigation and forensic medicine. It has also led to significant advances in anthropology and wildlife management.
Pharmaceutical biotechnology:
development of vaccines, diagnosis of many diseases, in addition to the major application of synthesis of proteins and hormons such as insulin and new therapies.

12. Pharmaceutical biotechnology
The industrial use of living organisms utilizing biological technique developed for improving or developing of old or new pharmaceutical products :
1- Synthesis of proteins and hormons such as insulin, human growth hormone, clotting factors for hemophiliacs, fertility drugs, erythropoietin and other drugs (Biopharmaceuticals).
2- Development of vaccines,
3- Diagnosis of many diseases,
1- Development of tailor-made drugs:Monoclonal antibodies and antisense technology.
Targeted diseases: hepatitis B, hepatitis C, cancers, arthritis, haemophilia, bone fractures, multiple sclerosis, and cardiovascular disorders.

13. = As of 2015, about 670 public companies and over 200 thousand employees in these regions generate some 133 billion U.S. dollars of biotech revenue.
= Globally, around 170 billion U.S. dollars were spent on biopharmaceuticals in This figure is expected to exceed 220 billion U.S. dollars by 2017.
2016, more than 3000 companies worldwide which deals with production of pharmaceuticals: (BIO-RAD)
1- rDNA products
2- Monoclonal Abs
3-Antisense products
4- Diagnostics: Kits, DNA probes
5- RNAi research

15. THANK YOU

16. 1998 BIOTECHNOLOGY INDUSTRY STATISTICS
($ In Billions)
1998
1997
Percent Growth
Number of Companies
1,283
1,274 1%
Number of Employees
153,000
140,000 9%
R&D Expenses
$9.9
$8.5
16%
Product Sales
$13.4
$11.5
17%
Revenues
$18.6
$16.1
Market Capitalization
$97
$93 4%
Net Loss
$5.1
$5.4 5%
Biotechnology
Industry
Statistics

17. 1997 PRODUCT SALES BY MARKET SEGMENT Percentage Increase over 1996
(Average Company)
Avg Sales/Company
Percentage Increase over 1996
Diagnostic
$21,605,000 9%
Therapeutic
$29,882,000
20%
Agricultural Biotech
$56,198,000
30%
Supplier
$31,679,000
15%
Chemical, Environmental & Services
$178,430,000
23%

18. Patents · FY 1997 Biotechnology Patent Application Submissions 10,500
8,860
· FY 1995 Biotechnology Patent Application Submissions
15,652
· FY 1994 Biotechnology Patent Application Submissions
13,600
· Average pendency time for a biotechnology patent (FY 1997)
27.1 months
· Average pendency time for a biotechnology patent (FY 1996)
26.2 months
· Average pendency time for a biotechnology patent (FY 1995)
21.6 months
· Average pendency time for a biotechnology patent (FY 1994)
20.8 months
Patents