Opportunities And Challenges of investing in biotechnology in Arab World
Abdulmohsen H. AL Rohaimi, DDS, APC, MSc, Ph.D Director of Research and Publication March 3rd - 5th, 2008 Amman, Jordan Kempinski Hotel
Human Health Biotechnology Services Agriculture and Environment Animal Health Biodiagnostics
Biotechnology Altered the Thinking
Biologics, based on vaccines (horse serum)
Control process not product
Biopharmaceuticals are `safer'
Finding the clinical application
Proving effectiveness is hard
Exception, early biotech products
Replacement manufacturing: HGH, r-insulin, EPO ect.
Over 320 biotech drugs and vaccines approved -70% approved in last six years. Over 800 million people have used biotech drugs. Hundreds of medical diagnostic tests. Technology advances continue -370 products in the clinic.
Biotechnology is becoming a considerable force in economic development and social progress in Islamic countries the Arabian markets for the information is the most attractive market for foreign investments.
The Current Efforts From The Arabian Governments
Studies showed that: the Arabic governments started building the technological infrastructure which appropriate to carry on the technology. Allow for foreigner investor with PLUS VISION , in an attempt to help them to transport the technology. Encouraging the Arabic privet sector to boost the investment opportunities. the Arab world planed policy that starts from the taking the advantages of Arabian markets requirements with the focus on the Arabic local talents, the Arabic governments goes through the reforms in economical structures , the ways of privatization and encouraging the private sector to get through the developmental and advanced technology field. Moreover, the investments rules in the Arabic world allow the dispensation of taxes for the investors, apply the appropriate finance rules and protect the intellectual property.
WTO for the Arab world
Balancing Access and Benefit Sharing Legal Protection of Innovations From Bioprospecting
DIMENSIOMN OF CHALLANGES
Need for the investments in Research
The need is defines in terms of : Its consequences for the community. Size of the problem overall. Size of the problem in various segments of the population. and/or significant changes or trends in incidence or prevalence.
Need for the investments in Research
Genetic disorders in the Arab world are a legitimate threat. It is a problem in the region due to the high prevalence of the disorders compared with the rest of the world.
Genomics: Changing the field
Revising our view of diseases Molecular basis rather than symptoms Individual medicines Target clinical trials more economic Surrogate markers better understood Block busters will be harder to find
CHALLENGES IN RESEARCH
TRANSLATIONAL RESEARCH POSTMARKETING SURVEILANCE CLINICAL IMPLICATION ROLE OF HEALTH PROFESSIONAL LIABILITY ISSUES
SFDA Prof. Industry
Regulatory Issues: Biological Molecules
Approval of facility, commercial use Manufacturing methods Scale-up, need clinical equivalence, stability Purity, repeating units (peptides, DNA, RNA) Biological Generics
Regulatory Issue: BioGenerics FDA framework for scientific evaluation of safety and efficacy of biogenerics EMEA has framework for "biosimilar" Less data than required of innovator Assess similarity or "sameness" therapeutic proteins and peptides Physiochemical characteristics Animal and human clinical studies
Bioethics: Genetic Information
Is genetic information the same or different than other medical information? Blood type Cholesterol type Challenges to professionals/clinicians Confidentiality Informed consent Challenges to society Policies and laws regarding access Fair uses of genetic health risk information
Lack of successful model in arab world Raw material (API) No supportive research lab : E.g virology Cost and duration ---revenue Lack of regulatory frame work Lack of clinical institute GCP APPROVED
Understanding the challenges and opportunity context
Politics, Funding, - Research Interagency support, Competing organizations, Competing interests, Social and economic conditions, And history (of the program, agency, and past collaborations).
The Arabic world considered to be a productive market. The amount of investments at the field of information technology (IT) is billions of dollars in United States of America, Europe and Asia. The total percentage of these investments in the Arab world is only 3% which is a weak amount if we compare it with the total investments. The Arab world turned to be a good environment for the foreign investments.
Start with simple programs rests on the range of acceptance of these programs in the Arabic world, followed by a full transport of technology so it can transfer the technological development in Arab world
The investment should be corporate (conjuncted) by Arab and other investor, specially with the return of Arabian money to its origin unless the investor companies give the positive image on the Arabic world.
Economics Presence of national healthcare system Few national disease registry Funding
No coherent legal and ethics frame work No established for complicated decision making limited national compliance and capacity in biotechnology and genetic epidemiology
Establish related laws and regulations. Establish new technology and/or transfer technology Model organization
Very low standardization and quility Competition vs. collaboration
The information nowadays is available to anyone