Strategy

Strategic View of the Life Sciences Knowledge Economy.

Overview
Life Science is defined as the study of Living Things. In Puerto Rico Life Sciences or Bioscience industries are referred as those industries that deals with the development, manufacturing and commercialization of Pharmaceutical, biotechnological and Medical Device goods & services, the Health Care services and allied industries. These are the leading industry sectors in the new century, promising significant human Health benefits and economic growth. With an effective Life Sciences Value Chain in place, countries are able to make significant contributions to the longevity and quality of life of their citizen, recent evidence suggests that it also provides a multiplier effect to the economy. The strengthening of local capacities along the Life Sciences Value Chain further enhances the domestic economy. Presently the Life science Industry is the major contributor to the GDP in Puerto Rico. It represents more than 32 % of our GDP and 66% of our exports. We are also the 5thmanufacturer of drug products and 3rd in Biotechnology in the world and the 7th exporter of medical device products. With a solid resident knowledge base expertise in the life science industry, our strength is in the manufacturing with very small penetration and investment in the development and commercialization, making the Life Sciences value chain incomplete and inefficient. With global competition, other nations have also identified Life Sciences as a priority development sector making imperative that Puerto Rico make leap change to attract more innovation through the development of an entrepreneurial research-business community.

During 2004 more than 200 experts from Industry, Academia and Government representing a substantial and complex value chain in the Life Sciences sector worked together to develop the Life Sciences Road Map for Puerto Rico. The Road Map provides a set of strategic priorities, that if implemented, we could get ahead of the race in the Life Sciences. . The value chain begins in the universities and research labs, moves through the manufacturing process to the distributors, continues to the pharmacies/pharmacists, the hospitals/medical professionals, and the private insurance/public insurance and finally ends when the consumer has received and benefited from the Life Sciences product or service.

Statement
The Road map Advisory board has established this Life Sciences Working Group to engage in dialogue and work collaboratively to discuss policy ideas and share expertise. The Life Sciences Working Group will focus in the implementation of the Road map and strive to enhance the flow of information regarding life sciences issues among all sectors in the society and partners in other regions, thereby strengthening the Life Sciences Value Chain. In this process, this coalition of Life Sciences clusters (Pharma, Biotech, Medical device and health care) will engage relevant agencies on the following six goals:

  • Drive the Implementation of the Life science Road Map in synergy with the C&IT Road map
  • Support the creation of a Social Pact and Public Policy that enable a positive environment for the growth of the S&T enterprise and quality of life through the Alliance for PR organizations.
  • Promotion of the development of entrepreneurial innovative Life Sciences goods and services
  • Enhancement of physical and human science and technology infrastructure
  • Improvement of patients’ access to Life Sciences goods and services
  • Promotion of good clinical practices in the development and use of Life Science related goods, services, information, and technologies

STRATEGIC PROJECTS:

1) Road map strategies

  1. Development of an Innovation Zone, PR Virtual and Physical that incorporate the following elements:
  2. National Technology Transfer Center (Life Sciences, C&IT, electronics, nanotechnology)
  3. Technology driven Incubators / commercialization center

iii. Innovative / creative funding management center

  1. Clinical trials and research Center
  2. Technology driven applied research center ( include existing initiatives like Biotechnology Pilot plant, Molecular science complex, CAPTech, Comprehensive Cancer Center, Pharmaceutical Engineering Research & Training Center, Nano materials characterization center, Biomedical Materials Research Center and others )
  3. Global Certification Center for manufacturing design and operations in the regulated Industry”

vii. Digital portal for education, research, technology and skills (who’s who, data, metrics )

viii. Future Workforce Learning resource center

  1. Puerto Rico science & technology Global Network ( Global Who’s Who registry / community )
  2. Marketing and Branding Puerto Rico as the “ Biopharm Sciences Leaders of the world “

2) Bio-defense / Home Land Security Strategic Elements:

The Science Park strategy is focus in leveraging Home land Security Funding that presently amounts to $10.2 Billions and expect approvals of an additional $40 billion by 2006. The proposal is divided in independent but inter-related elements that will be dedicated to support the Federal Agencies Science laboratories, pharmaceutical, biotechnology, biomedical, health care and C&IT needs of bio-defense readiness

The key areas to be developed are related to Scientific Laboratories, Clinical Research, Technology Transfer Center, Bio – Contract manufacturing, NASA Shared Service Center, Academic Centers and related Infrastructure. It will serve as a Depot for the storage and quick deployment of critical vaccines and drugs in the event of bio-terrorism. It can also manufacture under contract Vaccines, drugs and antidotes to the federal government and other nations.

Among the centers to be developed includes:

  • Joint Federal Agencies Forensic / Toxicology / Reference Laboratory

This laboratory will be develop envisioning the need to provide services to

all Federal enforcement agencies and police. The Center could be staffed

with top scientist from the agencies and academia. The Center is intended to be a join forces regional HUB for the FDA, USDA, CDC, DEA, EPA, FBI, CIA,

US Postal Services and HLS. It will be the 1st in PR and could service the Caribbean, Central and South America and southeastern USA.

The Center could be equipped with the latest technology in partnership with

the suppliers for these technologies and through the university component

participation more science is expected to be introduced in the process.

Facilities could be federally owned of rented from the park developers.

  • Bio-defense Vaccine and Antidote Depot

Convert the underground missiles depot into a state of the arts refrigerated

warehouse facility for the storage of vaccines, antidotes and critical drug products to

be fast deployed to the US Eastern Corridor, Central and South America. Because

the strategic location of Roosevelt Road and its airport facility, with the Air Natl.

Continue INDUNIV Strategies Guard Base component, fast deployment will be possible within a 3hrs. scenario

from the destination. This scenario fulfills the Home Land Security response time guidelines for the

deliverables.

  • Puerto Rico Technology Transfer Center ( on and off Site )

Establish a technology dual transfer center with capacity to transfer technologies to the private and academic sectors from declassified patents of the DOD and National Laboratories. The center will contain all the necessary elements to search for opportunities, market intelligence, IP protection, research and commercialization, alternate financing ( See Attachments )

  • Contract Bio Pharmaceutical Manufacturer for Government and others

( on and off site ) Establish facilities to manufacture vaccines, anti-dotes and

critical drug products under government contract and / or for Industry.

  • Life Science Regulatory Center for Excellence

With the collaboration of the FDA and EPA (US Customs, DEA, HLS to some

extent) developed a center to identify strength and weaknesses in PR regulatory

posture, developed training programs to close those loops and introduce more

science into the process design and manufacturing It will also serve as a cross

training center among the Federal Agencies which is becoming more common now.

Generate a training Center in partnership with the FDA, EPA, NIPTE, UPR,

professional organizations such as RAPS (Regulatory Affairs Professionals

Society), and ISPE ( International Society of Pharmaceutical Engineers ). This center

will bring PR competitiveness and skills to its highest level. Moreover, it will

provide best practices in manufacturing that will improve the quality and

efficiencies of products manufactured in PR among some of the benefits.

  • Clinical Research Center ( on and off Site )

This Center is intended to conduct clinical research and clinical trials in metabolic,

cardiovascular, infectious diseases and cancer. The center could be associated with

the UPR Comprehensive Cancer Center in partnership with the MD Anderson

Cancer Center in Texas. The center should establish a CRO for clinical trials to

service the pharmaceutical companies, CDC and DOD trials on non – lethal

weapons. The center needs a hospital, laboratories, BLS III / IV containment and clinics. PR has one of the

must loyal population as it relates to clinical trials retention and a captive

Hispanic genotype required by Federal programs. The center

will also promote Biomedical and medical devise research.

  • Telemedicine Resources and Call Center

With the utilization of Telemedicine and wireless network technologies, the Center can provide the Pan American Health Organization with primary and secondary virtual consultancy services to the un-privileged communities of Latin America and the Caribbean. I will also be a resource Center to Train Clinicians, Engineers, Technicians in the use and maintenance of this tools. It will be responsible for its network in order to maintain a standardized systems and processes.

The strategic accessible location, sophisticated communication network, bilingual capabilities and highly educated workforce in the health and electronic sectors makes Puerto Rico the ideal location for such Center.

  • EPA’s Caribbean Environmental Center

As proposed by Pedro Gelabert and Carl Soderberg from EPA to the PR Environmental and Energy Cluster. For a research, testing and educational center

  • NASA Shared Service Center

The NSSNC concept is to consolidate selected NASA business and

technical services currently performed at ten remote NASA Centers to one location, in order to eliminate duplication, improved quality and efficiency, and lower cost. Services include procurement transactional services, to include award administration of NASA Grants and Cooperative Agreements, Small Business Innovative Research and Small Business Technology Transfer contracts, managing a Procurement Workforce Training Program, and providing procurement electronic services; as well, the NSSC would provide IT services including IT support (e.g. web applications, local intranet, and contact center).

  • Caribbean Primate Research Center ( on and off site )

The 15 acres site located in Sabana Seca, Toa Baja, PR and 38 acres at Cayo Santiago owned by the UPR (Transferred from Navy to GSA to NIH to UPR). The AAALAC International accredited site contains more than 2000 Rhesus monkeys, including Specific Pathogen Free Colonies. This center can be turned into a National Primate research Center for the testing of non-lethal weapons and new drugs animal trials for clinical data filing with FDA. (This Center can stay at Sabana Seca as support infrastructure )

Science Park Next steps::

1- Secure Bio-defense funds through the appropriation committee of the US Congress – work with Governor, Federal Agencies, Corporate Wash. Offices and the PR Resident commissioner office and firms such as Mc Kenna Long & Aldridge.

2- Form multi-agency task force team to further develop project

3- Support agencies to expedite facilities request

4- Obtain Support from Navy to acquire facilities as for Public Interest Use (or Economic Development)

5- Align Life Sciences and C&IT roadmap strategies for the development of the PR INNOVATION physical and virtual zone.

6- Benchmark science parks elsewhere; try to attract contact organizations such as

Batelle Labs (a non-profit organization) leader in National Laboratories development and

administration in America.

That may synergize with the park development.

2) INDUNIV is a non-for-profit organization established 21 years ago to promote and catalyze effective collaboration among academia, industry and government to stimulate knowledge base capabilities. Its vision is to make PR the prefer location for new business opportunities and knowledge creation in the Life Sciences and allied Industries.

INDUNIV developed and administer the Pharmaceutical and Biotechnology clusters and Support the Health Care Council and the Medical Devise Clusters. Through the work of the clusters the Biotechnology pilot plant research and training center concept was developed, study and recommendations proposed to the government for funding. Its committees work in the development of curriculum and certification programs to prepare our workforce, the improvement of permitting process, the enhancement of our supply chain and many other tactical and strategic projects. Throughout the years INDUNIV provided more than $2.5 millions in grants, funding about 56 projects to our University researchers to work in pharmaceutical applied research.

INDUNIV is also working in the development of needed center of excellence such as the fallowing:

o MCC ( Material Characterization Center ) developed 1995 with about $7 Million funding to creat the only facility within 1,000 miles to offer highly specialized analytical services and the corresponding scientific expertise under one roof.

o CAPTech ( Center for Advance Packaging Technology ) primary objective is to establish a local facility that offer cutting edge packaging services in design, development testing, line integration, data and education in what it is a multi-billion dollars business. It also incorporates a specialty team to innovate AUTENTICATION, TRACK & TRACE Technologies that could be commercialized. This center supports our manufacturing operations that amounts to 44% of our economy.

o Regulatory Center of Excellence ( see science park above for description ) the center will also establish a center for the development of the PROCESS ANALITICAL TECHNOLOGIES that will bring the Pharmaceutical industry to a new level of technological advancement.

o Pharmaceutical Engineering Research and Training Center for the solid dose and parenterals technologies. The center is an initiative of the UPR-M Chemical Engineering Department and the Pharma Cluster to establish world class center that promoted research and development and be recognize as the education center for pharmaceutical processing.

o Clinical Research Center ( Road map objective ) in collaboration with the Health care Council and its clinical research committee is developing the framework that will enable the growth of the Clinical Testing and Research in PR.

o Technology Transfer Center (Read map objective ) In collaboration with the US Commerce department MBDA program, the West Virginia National Technology Transfer Center , the UPR, and SBDC, INDUNIV is facilitating the effort to implement the technology transfer center that will provide the elements necessary to identify technologies from the federal government that could be further developed, funded and commercialized .