Overarching Narrative PRBio Tech Hub's includes the full region of

EDA-TECH HUBS PHASE 2-2023

PRBio Tech Hub Phase 2: Overarching Narrative

I. Executive Summary

PRBio Tech Hub’s includes the full region of Puerto Rico (PR), an unincorporated,

commonwealth territory of the United States (US) with a population of ~3.3 million (2022)

American citizens, 98% Hispanic

. Nearly the entire region of PR is defined within the EDA’s

definition as a Metro/Micropolitan Statistical Area with a concentration of assets, capital, R&D,

labor market, and infrastructure strongly relevant to the EDA Tech Hub biotechnology key

technology focus areas. Since PR’s bioscience landscape incorporates employees from most of the

78 municipalities, the full region of PR will constitute the PRBio Tech Hub’s region for purposes

of the Tech Hub Competition.

The overall goal of the PRBio

Tech Hub (Hub) is to retain, grow, and

attract innovative companies in

biotechnology, enabling the

consortium to drive regional growth

and capacity to accelerate

development, manufacturing, and

distribution of 1

generation

pharmaceutical and medical products

and disruptive technology platforms.

The Hub will enable the established

ecosystem, including the coordination with the NSF Engine Development Award 2305699

Advancing Biopharmaceutical Technologies and Manufacturing Practices PR, to boldly leverage

the EDA’s key technology focus area (KTFAs) #7 including bio and medical technology, genomics,

and synthetic biology. The Hub will also intersect with KTFA #1 & #9 for advancements in medical

devices and wearable technology: artificial intelligence (AI), machine learning, and industrial

efficiency technologies. The Hub’s commitment to the EDA KTFAs ensures a resilient domestic

supply chain for Essential Medicines, Medical Countermeasures, and Critical Inputs capable of

meeting national security requirements for responding to threats arising from chemical, biological,

radiological, nuclear threats, and public health emergencies.

II. Vision for Regional Economic Development

The key question for the Hub’s visionary path is Why Puerto Rico? For more than six decades,

PR has been a global leader in the FDA regulated biotechnology sector, earning the reputation as

the Medicine Cabinet of the US. Beginning with the electronics and pharmaceutical industries and

then growing into medical devices, the biosciences industry reaches 75% of the FDA Class III

device manufacturers shares in 30 medical device facilities, demonstrating PR’s leadership in the

biosciences. The industry has been the anchor of PR’s economy representing 32.2% of its GDP,

33% of all manufacturing jobs, and employing over 83,500 of its total population representing

15.8% of total jobs in PR

. With a rich history of expertise and state-of-the-art infrastructure ready

to be utilized for the next generation of technology innovation, PR’s biotechnology industry offers

a solid foundation for innovation and growth. We believe that this moonshot opportunity will create

generational change for all of PR, while creating lasting benefits for the US and globally.

According to the BIO National Industry Report, PR stands out as the only US jurisdiction

specialized in four of the five bioscience sub-sectors including distribution, pharmaceuticals,

https://www.census.gov/quickfacts/PR

Biopharma industry creates 87K jobs, May 2022, https://newsismybusiness.com/biopharma-industry-pumps-3b-into-economy-creates-87k-jobs/

medical devices, and research

. White House Executive Order 13944 supports the US’s need to

have a strong Public Health Industrial Base with a resilient domestic supply chain and states that

these chains must be capable of meeting national security requirements. This proposal seeks to

further strengthen this important Order for the national security and well-being of all US citizens.

As a Designated Hub, PR will continue to make bold impacts on the EDA’s KTFAs of

biotechnology, medical technology, genomics, and synthetic biology, strengthening PR’s

pharmaceutical industry as an asset to national security. The Hub’s vision is to develop the

necessary strategies, activities, and workforce to further strengthen PR’s focus on Technology

Readiness Levels 6 & 7 (commercialization), 8 (deployment), and 9 (manufacturing) to support

PR as a global leader in the rapid development of new products to address unmet medical needs

of patients worldwide. The Hub members listed below will strengthen PR’s capacity to

manufacture, commercialize, and deploy critical technologies to support PR’s position as a global,

leading biopharmaceutical tech hub for decades to come.

PRBio Tech Hub Consortium Members & Additional Partners

Consortium Lead – EDA Tech Hub Lead Applicant: Puerto Rico Science, Technology& Research Trust (PR Trust)

Component Project Leads

PRBio Tech Hub Governance; Access to Capital for Entrepreneurship; Advancing NextGen Workforce – PR Trust

Next-Generation Therapeutics & AI Drug Discovery – Bright Path Laboratories (BPL)

Acceleration of New Drug and Precision Medicine Laboratories – University of Puerto Rico Medical Sciences Campus

Entrepreneurship: Lab to Market – Molecular Sciences Research Center (MSRC)

Advanced Technologies Center (ATC): Pharmaceutical Manufacturing and Enabling Technologies – OcyonBio

Consortium Members

Institutions of Higher Education (all Minority Serving Institutes): University of Puerto Rico (UPR), UPR Medical Sciences

Campus, School of Pharmacy (UPR MSC SoP), UPR at Mayagüez, UPR at Aguadilla, UPR at Humacao, MSRC

Government: Puerto Rico Department of Economic Development and Commerce (DDEC)

Industry/Private Sector: OcyonBio, Dsquare Analytics, LLC, Galephar Pharmaceutical Research, Inc., CytoImmune

Therapeutics Puerto Rico, LLC, Bright Path Laboratories (BPL, venture development), PR5GZone (nonprofit), Industry

University Research Center Bioscience Cluster (INDUNIV, nonprofit)

Economic Development/Science Organizations: Invest Puerto Rico, PR Trust’s Parallel18 (venture development)

Workforce/Labor: DDEC (WIOA/Apprenticeship), PR Ready (Workforce Training Program of PR Trust), Coursera, Inc.

Committed Key Partners and Additional Partners: Pharmaceutical Industry Association, Johnson & Johnson, Bristol Myers

Squibb, Biotechnology Innovation Organization, Avara Pharmaceutical Contract Manufacturing Company, Bayer Healthcare

Pharmaceuticals LLC, North Carolina State University Biomanufacturing Training and Education Center, Lilly del Caribe,

Department of Biomedical Engineering at Georgia Tech and Emory University, Amgen Manufacturing Limited, Organon,

Sartorius, Principia, BLDM, PRO Quality Strategic, VOCES: Vaccine Coalitions, Viatris, BD Biosciences, GCM Medical

Group, SanaClis, AbbVie Biologics Ltd, 323 Family Trust, LLC.

The Hub members have developed six (6) component projects aligned with the PR Trust’s

Governance Project and supported by the overall Risk Mitigation Plan. Brief details of the Projects

and how each reinforces one another in the overall success of the Hub are listed below. The Hub

synergy briefly defines how the Projects will complementarily lead to the Hub’s global

competitiveness over the next decade. Each individual Project has detailed the constraints that its

activities and initiatives will enable the Hub to overcome (see full Component Projects).

Component Project Short Descriptions

Complementary Hub Synergy

PRBio Tech Hub Governance

Outlines the PR Trust’s comprehensive strategy for managing the

consortium, ensuring oversight, workflow management, evaluation,

reporting, communications, and sustainability, including the role of

the RIO. Aims to establish a robust framework that supports

transparent decision-making, accountability, efficient project

execution, and long-term sustainability.

Builds consensus with Hub consortium members/partners

for goal-driven strategies for Phase 2 implementation by

ensuring that the Component Projects are aligned with the

Hub’s overarching mission and vision and through the

leadership of the RIO and the overarching Risk Mitigation

Plan.

Access To Capital For Entrepreneurs

Seeks to solve PR’s biotechnology funding gap through the creation

of the PR Biotechnology Capital Network (PRBCN) through two

Industry sector attraction and retention plan for Hub to

determine the best strategy to attract, retain, and fund

https://go.bio.org/rs/490-EHZ-999/images/TEConomy_BIO_2022_Report.pdf

Component Project Short Descriptions

Complementary Hub Synergy

principal initiatives: i. PR Biotechnology Grant Fund; and ii. PR

Biotech Emerging Managers Program to overcome the challenges

of capital funding that local private equity & venture capital firms

encounter when investing in the PR bioscience entrepreneurs.

biopharma manufacturing businesses through leveraging

regional assets and synergistically support within Hub

component projects as the bridge to capital.

Advancing NextGen Workforce

The Hub’s Workforce Plan will harness collective learnings and

scale existing, proven approaches to education and workforce

development that are essential for biotechnology innovation

focusing on lifelong learning programs, STEM engagements,

apprenticeships, and programs that support the “cradle to career”

workforce pipeline development through various initiatives.

Industry sector workforce plan to guide the Hub to launch

and strengthen PR life sciences workforce by working

closely with a cross-section of life science employers,

academia, labor organizations, and workforce curriculum

leaders to understand industry workforce needs.

Entrepreneurship: Lab To Market

Complete the build-out of the MSRC’s EDA ASTRE project to

provide state-of-the art laboratories and pilot scale infrastructure for

small and large molecule development technologies, viral, DNA

and RNA derived immunotherapies, and gene and cell therapies for

future workforce development to accelerate benchtop to

commercialization.

Will complement the activities of the Hub’s component

projects and goals and strengthen MSRC’s

multidisciplinary ecosystem by educating new

biotechnology professionals and startups that will bolster

the biotechnology sector resulting in a more stable

pharmaceutical supply chain.

Next-Generation Therapeutics & AI Drug Discovery

Advances beyond drug manufacturing to drug development and the

go-to-market leader for biotechnology through an enabling tech-to-

chemistry capability (STT

) that allows therapeutics produced

through AI drug-discovery, repurposed, or reformulated drugs to be

synthesized using computer-aided synthesis, optimization, and

analysis to produce APIs.

Enables the Hub shared, tech-to-chemistry capabilities

produced through AI drug-discovery and acts as a conduit

to additional assets that include workforce talent, industrial

space, intellectual property, and access to capital

investments in AI drug discovery across the Hub.

Acceleration Of New Drug And Precision Medicine Laboratories

To catalyze the development and scale-up of new drugs and PMs

with the use of advanced manufacturing and enabling technologies,

provided by state-of-the-art equipment and instrumentation to

support existing infrastructure to close technology gaps to produce

innovative biopharma products and drive Enabling Technologies.

Identify Hub desired academic curriculum advancement

needs within pharmaceutical degree programs to support

regulatory professional development to strengthen the

knowledge transfer to the biopharmaceutical and medical

device ecosystem.

Advanced Technologies Center (ATC): Pharmaceutical Manufacturing & Enabling Technologies

Empower disadvantaged and limited educational backgrounds

through hands-on job training experience as support mechanism for

emerging biotech startups by providing critical, shared equipment,

facilities, resources, and expertise to enhance manufacturing

capabilities within the PR pharmaceutical sector to advance gene

and cell therapy, viral vectors, biologics, and small molecules.

Provide the Hub with shared facilities and equipment for

the development and utilization of advanced

pharmaceutical manufacturing technologies and provide

non-traditional students with hands-on job training

enabling them to qualify for high-demand jobs in emerging

technologies, addressing gaps in workforce readiness.

Puerto Rico provides a unique investment and policy commitment to the EDA’s funding for

the overall Hub’s sustainability for the 10-year expectation and beyond. While the PR Government

is supporting the Hub’s application through various commitments from DDEC and to specific

component projects, PR’s Act 60 and 73 are part of the economic incentive laws designed to attract

investment and promote various sectors, including research and development (R&D). Act 60 offers

tax credits to businesses that engage in eligible R&D activities in PR. The goal is to promote

innovation, technological advancement, and the development of a knowledge-based economy,

making PR a competitive jurisdiction for investment in these industries. Key benefits under Act

60 for R&D include a tax credit of up to 50% for investments in R&D activities, an additional 25%

tax credit for payments made to the PR Trust, and favorable tax rates on income generated from

intellectual property developed through R&D activities. These tax credit incentives, coupled with

the Hub’s commitments (See Section V.) act as a viable source of long-term, sustainable funding

for the Hub.

In the Hub’s Governance Project, the consortium has focused on the deliverables necessary for

Phase 2 implementation, ensuring PR’s biotechnology industry moves towards achieving its net-

zero goals and contributing to a greener, more sustainable future. PR’s industry also maintains the

highest EPA environmental standards, protecting water resources; minimizing air emissions; and

preventing land contamination including solvent elimination from chemical processing and

efficient use of water and energy, in coordination with government and regulatory agencies. The

quality of the products, protection of the environment, and preservation of life are intrinsic

elements of PR’s bioscience industry and are at the forefront of the Hub’s activities and outcomes.

The Hub will utilize the Climate and Economic Justice Screen Tool (CEJST) when accounting

for environmental and climate-related impacts and risk as activities are implemented throughout

Phase 2 and beyond. The PRBio Tech Hub and its biosciences industry is dedicated to improving

the nation’s health, food supply, and the environment through responsible biotechnological or

chemical applications meeting the highest regulatory standards. Since these products are sensitive

to environmental conditions such as temperature, humidity, and other conditions and contaminants,

redundant and resiliency protocols are established to maintain the business continuity during

atmospheric events that can cause power outages. The Hub will utilize the PR Trust’s disaster

preparedness plans including the Emergency Management Plan and Cyber Security Policy &

Framework of IT (see Overarching Risk Mitigation Plan) to account for weather and climate

related risks and security protections.

The Hub’s region is comprised of ~3.3 million American citizens of which, 98% are Hispanic.

The region’s communities and groups are inclusive to the definition of a SEDI (Socially and

Economically Disadvantaged Individuals) and comply with the characteristics of SEDI-owned

businesses within a Community Development Financial Institution Investment Area and

Opportunity Zone. The Hub initiatives were developed with equity in their approach to benefit the

underserved populations and communities of PR from high school and undergraduate level on-

the-job training; to apprenticeships, mentorship, and scholarship opportunities; to graduate and

post-graduate level advanced degree programs; to engaging and collaborating with STEM

underserved, minority serving institutions (MSI); to providing access to capital to Opportunity

Zone entrepreneurs. Each component project’s KPIs include measurements related to serving the

full population of the Hub and the economic growth associated with these initiatives.

Currently PR’s biopharmaceutical sector is essential for biopharmaceutical manufacturing,

distribution, and development, and contributes 35% to PR's GDP, accounts for 45% of

manufacturing jobs, and employs over 88,000 people throughout the region. The Hub is laser

focused on the pace of change and the scale of labor market fluctuations affecting the US and the

global pharmaceutical industry. The Hub’s Projects will provide significant advancements in the

biopharmaceutical industry workforce pipeline as a global leader in advanced drug discovery and

development using emerging technologies such as generative AI, expanding production

capabilities, increasing investments, and creating new high-salary job opportunities impacting

PR’s GDP at a greater scale. While each Project has specific SMART goals and KPIs related to

the timeline of their respective activities (see Section IX), the Hub’s overarching outcomes expect

to impact PR on a larger socio-economic scale. With the Hub prioritizing closing PR’s gap in

biopharmaceutical access to capital, the project expects to impact over 10,000 individuals from the

sector, directly and indirectly, while serving entrepreneurs and R&D focused organizations. While

access to capital will provide a financial launching pad for entrepreneurs, this capital allows

companies to open and expand resulting in job creation, R&D opportunities, and indirectly fueling

the market with higher salary opportunities. During the EDA’s expected 10-year time period, the

Hub is expected to attract over 100 companies through the enrollment in the Access to Capital

Project initiatives with over $100M of raised capital, expecting to create 250+ direct jobs and ~75

new investors in PR.

The Hub has been extremely conscience of the need to make an impact starting on Day 1 to

ensure the resources necessary for biopharma companies in PR to advance globally are readily

available. With this in mind, the Hub concentrated its construction project within the Molecular

Sciences Research Center (MSRC) to complement the current EDA funded Advancing Science

and Technology Research and Entrepreneurship (ASTRE) project (EDA #01-79-14873) to

incubate and develop both new and established companies that can translate scientific discoveries

into commercial and intellectual property that can bolster PR’s economy. In addition, the Hub plans

to upskill ~2,000 PR residents through online short-form credentials provided by Coursera, Inc.

By engaging Coursera on Day 1, the Project will develop a pipeline of workers to support the Hub

activities immediately. For those completing online courses through a massive online open course

provider, 87% reported a general or tangible career benefit, ensuring increased wage growth

opportunities throughout the Hub.

III. Need for HUB

Puerto Rico’s ecosystem has been nurtured by expertise that has emanated from major

pharmaceutical companies such as Eli Lilly, Bristol Myers Squibb, Amgen, Johnson & Johnson,

and others. These companies provide many of the services needed to start a new manufacturing

operation or validate processes and complement the services offered by contract manufacturing

organizations and facilitate the implementation of a new manufacturing process. The Hub provides

a unique opportunity for new pharmaceutical companies to grow the region’s ecosystem with over

60 years of pharmaceutical manufacturing experience. With the designation of Puerto Rico’s R&D

tax credits, multiple drug development companies have begun operating within PR to expand the

ecosystem from advanced manufacturing to pharmaceutical drug development. However, these

new drug products must be approved by FDA and other regulatory agencies before they can be

available globally. Ensuring that all avenues of both advanced manufacturing and drug

development are readily available and supported by available talent, is vital to these company’s

success and PR knows that no single company or organization can ensure all elements of the

biopharmaceutical ecosystem alone. The Hub has built a growing consortium with the input and

activities of industry, private, public, academia, nonprofit, and government entities to ensure full,

wrap-around services from workforce development and on-the-job training, to regulatory and start-

up support services, to academia curriculum expansions and short-form credentialing, to access to

capital and R&D tax credits, to governance and management oversight to ensure a sustainable

ecosystem over the next 10-years.

Puerto Rico has experienced lessons learned through the cyclical closure of multiple

manufacturing plants, the Hub has used these lessons to build its goals and outcomes for the

advancement of biopharmaceutical industry, both large and small, to prevent their closure and

migration from the region. This Hub’s ecosystem will provide the foundation through matched

consortium commitments and long-term sustainability plans to ensure the longevity of the Hub as

a globally competitive powerhouse to retain, grow, and attract innovative companies in

biotechnology. The Hub has already seen a successful impact in companies such as Galephar,

Dsquare, and OcyonBio (Consortium Members), among others, as new, small pharmaceutical

companies located in the region providing new jobs opportunities.

IV. Nexus

How does the Hub fulfil this moonshot opportunity? Puerto Rico has committed to

transforming the region into a bio-manufacturing and product development hub where ideas can

flourish, and bioscience products can efficiently reach customers while creating a more resilient

supply chain to enable national security. This transformation is strongly supported by initiatives

driven by the PR Department of Economic Development and Commerce (DDEC, Consortium

Member), who in May of 2022 unveiled the strategic framework of sustainable economic

development or PR’s Comprehensive Economic Development Strategy, the PRoposito. The

strategy supports the Hub’s initiative to transform PR’s pharmaceutical manufacturing sites with

smaller, more flexible, cost-effective operations. The Hub’s directed activities within its

committed academic institutions will have students and researchers readily available to help

transform these manufacturing sites through modern manufacturing approaches. The nexus of the

Hub members is united in its collaboration with emerging, local pharmaceutical companies to

incorporate advanced pharmaceutical manufacturing and drug development based on industry-led

guidance and training within the Hub’s universities and workforce development plans. These

approaches have been presented to and accepted by the local pharmaceutical industry through

INDUNIV (Consortium Member) and PIA (Partner). The Hub already has real-time examples that

indicate a future PR-based pharmaceutical industry is a possibility through emerging companies

such as MBQ Pharma, a local company that licensed its intellectual property from UPR

(Component Lead), currently developing two drug candidates for the effective removal of pre-

existing metastases to lead to the removal of solid tumor cancer. However, companies still require

substantial financial, talent, and programmatic support, all represented in the Phase 2 Hub

activities to meet the overall Hub goal to retain, grow, and attract innovative companies in

biotechnology, enabling the consortium to drive regional growth and capacity to accelerate

development, manufacturing, and distribution of 1

generation products and disruptive technology

platforms. In addition, the Hub provides a governance structure and overall risk mitigation plan

aligned with the industry’s highest national and economic security at the forefront.

V. Partnership Commitments

The role of the private sector in PR’s bioscience industry plays a crucial role in its

development. PR currently hosts 12 of the world’s top 20 pharmaceutical companies including

Amgen, AbbVie, Bristol Myers Squibb, Sartorius, Boston Scientific, among others. According to

the Bureau of Labor Statistics, PR led US exports of pharmaceutical and medicine manufacturing

in 2020, accounting for 19.3% of total US exports. Therefore, the PR biopharmaceutical, medical

device, and supporting technology manufacturing sectors are a cornerstone of the US bioscience

industry and the Hub. The biotech industry encompasses a wide range of activities, and the Hub

has aligned multiple private sector entities to contribute to the Hub as Project Leads and members,

through investments, job creation, and as R&D sites to contribute to PR’s overall economic growth

while establishing PR as a global leader in biopharma advancement. The industry’s growth, driven

by private sector innovation, contributes to economic diversification making PR less reliant on

traditional industries and creating a knowledge-based economy. A full list of the Hub’s

commitments is listed below.

Commitment

Entity Type

Entity Name

Associated Component Project(s)

Value

Delivery

Cash Match

Government

DDEC

Advancing NextGen Workforce

$1,000,000

12/31/2027

Cash, In-Kind

Industry

Dsquare

Advancing NextGen Workforce

$680,000

12/31/2028

Cash Match

Industry

323 Family Trust

Next-Gen Therapeutics & AI Drug

$254,087

12/31/2028

Cash, In-Kind

Industry

OcyonBio

Advanced Technology Center (ATC)

$1,900,000

03/31/2028

Cash, In-Kind

Higher Ed

UPR MSC SoP

Acceleration of New Drug & PM Lab

$728,905

08/31/2029

Cash Match

EDO

PR Trust

PRBio Tech Hub Governance

$626,968.15

08/31/2029

Cash Match

EDO

PR Trust

Access to Capital for Entrepreneurs

$870,000

08/31/2029

Cash Match

Higher Ed

MSRC

Entrepreneurship: Lab to Market

$750,000

08/31/2029

Cash Match

Industry

BPL

Advanced Technology Center (ATC)

$90,000

12/31/2025

In-Kind, Policy

Higher Ed

UPR MSC SoP

Advancing NextGen Workforce

$310K/$1.5M

12/31/2028

In-Kind Match

Higher Ed

UPR – Mayaguez

Advanced Technology Center (ATC)

$360,000

12/31/2028

In-Kind Match

Industry

INDUNIV

Advancing NextGen Workforce,

Acceleration of New Drug & PM Lab

$640,500

08/31/2029

In-Kind Match

Industry

INDUNIV

Advancing NextGen Workforce

Invaluable

08/31/2029

In-Kind Match

Industry

BPL

Next-Gen Therapeutics & AI Drug

$572,160

08/31/2025

In-Kind Invest

Industry

BPL

Advanced Technology Center (ATC)

$2,910,000

12/31/2025

Investment

Industry

BPL

Advancing NextGen Workforce

$500,000

10/15/2025

Policy Match

Government

DDEC

All Component Projects

$4,500,000

12/31/2027

In-Kind, Invest

Workforce

Coursera, Inc.

Advancing NextGen Workforce

$300,000

12/31/2027

In-Kind Match

EDO

Invest PR

PRBio Tech Hub Governance

$100,000

08/31/2029

In-Kind Match

Nonprofit

PR5GZone

PRBio Tech Hub Governance

$250,000

08/31/2029

VI. Sustainability

PR’s existing assets are included as part of the Hub’s plan towards ensuring sustainability for

both its Component Projects and the Overarching 10-year EDA timeframe. Existing assets include

but are not limited to expertise in advanced manufacturing, partnerships in PR’s universities and

industry, research and laboratory facilities, talent in pharmaceutical science and engineering to

advance manufacturing, biopharmaceutical incubators, initiatives to enhance workforce

development, and efforts and implementation of advanced concepts such as Industry 4.0, 5G, and

IoT. Furthermore, the Hub has aligned its goals and outcomes with the PR Trust’s awarded NSF

Engine Development Award (2305699 Advancing Biopharmaceutical Technologies and

Manufacturing Practices PR) and through its EDA funded Forward Center for incubation and

acceleration capabilities for up to 60 technology-driven start-ups and early-stage companies. The

Hub will continue to leverage the PR Trust’s Technology Transfer Office (TTO) which enables

academic inventors in disclosing new discoveries by providing best-in-class technology transfer

support for PR’s scientists and researchers.

The Hub’s ecosystem has shown its ability to continue and transform within the

biopharmaceutical sector including developing the first Industrial Biotechnology program in PR,

proving the ability to transform from small molecule tablet-based manufacturing to successfully

implementing biologic products in collaboration with Amgen, AbbVie, and Eli Lilly. These assets

have opened the door to biotechnology job development for many large pharma and small start-

ups companies providing top industry positions throughout PR. The Hub’s assets also include the

MSRC (Component Lead), funded by both EDA and NIH awards, a Ph.D. in Pharmaceutical

Sciences at the UPR MSC (Component Lead), and the collaboration of the Engineering Research

for Cell Manufacturing Technologies through the NSF Center for Structured Organic Particulate

System. The ecosystem’s sustainability is further strengthened with the mission to drive

entrepreneurship, beginning with the development of companies such as PACIV providing

computer validation services and PharmaBioServ serving multiple world-wide locations. The

ecosystem has developed logistics companies, providing indirect job opportunities, and is adapting

to contract manufacturing to focus large pharmaceutical companies on developing new products

while contracting their manufacturing with in-region companies such as ThermoFisher, Avara,

among others. Finally, the UPR-Mayagüez (Consortium Member) was recently awarded an NSF

Phase 1 EPIIC grant, ensuring best practice models and training to enhance partnership capacity-

building providing a foundation for the management of the Hub’s ecosystem. Under the EDA

Phase 2 funding, the Hub’s ability for self-sustainability increases greatly with its consortium

commitments (see Section V.). In addition, many Hub Projects are self-sustained by PY 3-5 due to

generated revenue, PR’s R&D Act 60/73 tax credits, and access to capital initiatives.

VII. Labor Union Engagement

The Hub’s Entrepreneurship: Lab To Market Project includes the MSRC construction to

complete the previously EDA-grant funded Advancing Science and Technology Research and

Entrepreneurship (ASTRE) Center. The MSRC will pursue project labor agreements (PLAs) with

bid awarded contracting entities in PR. This construction will require soliciting electricians,

plumbers, engineers, and a host of specialized trade workers. The MSRC will pursue contracts

with PLA to ensure economic benefits of this construction are equitable and local residents are

closest to their impact. And although the MSRC doesn’t have a community benefits agreement in

place, all wages for this effort will be at or above the minimum wage and comply with all

construction wages under the PLA. In addition, the Hub’s workforce plan includes supporting

existing, registered apprenticeship programs which support good quality jobs. Lastly, the Hub will

incorporate promising practices such as the AFL-CIO Technology Center which has partnered

with Microsoft to support the voice of Labor in AI development.

VIII. Equity

The Hub’s distributed manufacturing concept allows for diverse distribution of jobs, equitable

economic, and inclusive workforce development, while raising the existing footprint of the

industry in PR. Included Letters of Commitment demonstrate the Hub’s commitment to ensuring

the representation of underserved communities, businesses, and the PR workforce as they serve

the full region of PR including underserved, rural, and socioeconomically disadvantaged

populations. In addition, the PR Trust’s TTO manages a portfolio of 96 technologies from its

partner universities and diversity in inventorship is exceptional, as 42% of the inventors (76 of 179

total) are female compared to the US average of 13% female inventor-patentees. The Hub’s

workforce development commitments will also ensure that Hub benefits are equability shared

across PR since its bioscience landscape encompasses nearly a third of PR’s cities, incorporating

employees from nearly all 78 municipalities. Expanding the technology and innovation beyond

advanced manufacturing to drug discovery will only further expand the Hub’s reach, positively

impacting economic development across a historically disadvantaged region. The Hub’s focus to

expand the pharmaceutical landscape positions the Hub’s academic institutions and workforce

labor organizations to expand industry-specific course certifications and degree programs,

providing direct benefits to Minority/Hispanic Serving institutes, workplaces, and communities.

IX. Expected Outcomes

The worldwide competition in manufacturing and commercialization has been dominated by

the maturation, commoditization, and widespread application of computation in production

equipment and logistics, effectively leveling the global technological playing field. The next

generation of biotechnological competition will be dictated by inventions of new materials,

chemicals, devices, processes, and methods, among others. The Hub Component Projects have

considered bold investments to fulfil this moonshot opportunity with the fundamental R&D

required in AI, biotech, materials science, sustainability, education, and workforce development

for PR to lead globally. Upon award, the Hub will continue enhancing its leadership in

biomanufacturing, drug development, and commercialization through the joint impact its Projects’

Key Performance Indicators (KPI) per Project Year (PY) (primary KPIs represented below).

PRBio Tech Hub Component Projects: KPIs

PY1

PY2

PY3

PY4

PY5

Total

PRBio Tech Hub Governance

Number of Advisory Board meetings

Number of Steering Committee meetings

Percentage resolution of day-to-day risk & issue resolutions

70%

70%/yr

Minimum number of marketing materials for Hub use

115

Access To Capital For Entrepreneurs

Enrolled investors/entrepreneurs

10/5

15/10

20/10

65/35

Number of company/entrepreneur graduates

Total jobs created

Total Capital Raised by Investors

$500K

$1M

$2M

$5M

$8.5M

Total Capital Closings

Advancing Nextgen Workforce

Number of candidates who complete DDTC training

Number of participants enrolled/complete PR Integrated

Biomanufacturing STEM Program

25/20

80/100

Number of mentorships supported by PR Integrated

Biomanufacturing STEM Program

200

Apprenticeship: Number of participants

enrolled/completed/employed

10/8/8

40/36/36

PR Ready: Number of candidates enrolled/complete

50/25

50/45

75/70

225/165

Coursera: Number of trainings started/completed

1000/500

1000/800

1800

Entrepreneurship: Lab To Market

Number of underrepresented students served

100

500

Number of incubated companies within the space

Number of biotech/biosimilars in cGMP startups

Number of new incubation biotechnology companies

PRBio Tech Hub Component Projects: KPIs

PY1

PY2

PY3

PY4

PY5

Total

Next-Generation Therapeutics & AI Drug Discovery

Number of molecules identified/manufactured/to market

10/2/3

10/3/3

20/3/3

50/10/12

Total Capital Raised (Non-dilutive and dilutive)

$1M

$3M

$5M

$9M

$18M

Acceleration Of New Drug And Precision Medicine Laboratories

Broader Impact: Number of Publications

Infrastructure & Staffing: Jobs Created

Infrastructure & Staffing: Investment (capital/funds)

$5.8M

$0.3M

$0.4M

$0.3M

$7.1M

Project Income: New Collaborative/Partnerships

Project Income: Co-working space/contract income

(startups); onshoring D&D (scaleups)

1/0

1/1

4/2

Project Income: New grants (STTR/SBIR/CREST)

Number of patents granted/licensing agreements

1/1

2/2

5/5

Number of first-to-market products

Advanced Technologies Center: Pharmaceutical Manufacturing & Enabling Technologies

Number of drug shortage candidates selected to support

real-world process training

Number of sterile injectables capable of production

Established new startups and sponsored projects

Training certificates to participants

120

Number of scholarships awarded

These SMART PY interim goals and/or milestones will be used by the Hub to monitor the

progress of Hub activities, ultimately allowing the EDA to further monitor progress of Hub

outcomes. The goals will serve not only as the basis for determining the success of the consortium

but also as a basis for building evidence-based policies to support which strategies and approaches

work and which should be course-corrected based on the recommendations from the Hub’s

Steering, Advisory, and other overarching leadership committees. The PR Trust’s Regional

Innovation Officer (RIO) and Support Office will work with Project Leads to establish a

comprehensive framework for evaluating project outcomes, reporting progress, and maintaining

transparent communication with stakeholders. Upon Phase 2 funding, the RIO will provide a full

overview of required EDA reporting tools and ensure comprehensive tracking practices are in

place with each Lead. The evaluation plan will measure project impacts and progress towards

overall Component Project’s activities, goals, and objectives. The RIO will maintain open channels

of communication between the consortium and the EDA to proactively identify challenges and

collaborate with EDA and partners to find solutions that foster collaboration and support.

X. Expected Growth Plan

Accommodating the growth in housing demand resulting from the success of a technology

hub, while preventing displacement and ensuring access to jobs for existing low-income residents

requires a comprehensive approach that addresses supporting affordable housing development

policies, preservation and renovation of existing affordable housing, direct community

engagement, inclusive workforce development programs, and the promotion of transportation

accessibility. While the Hub cannot tackle all these areas with the EDA funding, the Hub will

actively support PR’s multifaceted approach around affordable housing development such as the

recent announcement of a FirstBank and CDBG-MIT jointly funded $30M investment for the

construction of Vista al Norte

, an affordable housing development that will benefit 102 low-

income renters who earn 60% or less of the median annual household income in the metropolitan

area of PR (Central Hub area). The Hub’s committees will also support local community

engagement efforts in the planning and decision-making processes of major economic and

workforce development projects via the PR government and/or public/private interest to prevent

displacement. The Hub’s activities are invested in academics, training, and research activities from

basic to advanced skill development to empower PR residents with the skills needed for entry to

https://newsismybusiness.com/firstbank-grants-21-5m-in-financing-for-vista-al-norte-project-in-guaynabo/

executive level biotechnology jobs creating a workforce that supports high wages to encourage

home ownership and aligns with regional rental income levels.

XI. Relevant Activities between Phase 1 & Phase 2

During Phase 1, PR Trust secured the contracted services of Accenture to provide strategic

project management for a comprehensive assessment of PR’s current biotechnology industry

through documentation review and interviews of selected stakeholders resulting in a detailed work

and resource plan to initiate Hub activity roles and responsibilities. Under Accenture, a two-day

workshop was held to inform and receive feedback and input from industry, public and private

sectors, nonprofits, government, relevant Clusters, academia, workforce industry, and others

interested in Hub participation. This ecosystem building led to meetings with government,

workforce, relevant industry operators, and academia, ultimately expanding the Hub’s consortium,

commitments, and supporting partnerships.

From the aforementioned collaborative approach, the Hub has grown and evolved from Phase

1 Designation to the Phase 2 Implementation application to ensure the catalyzation of the Hub’s

emergence over the next decade and beyond as a self-sustainable, globally competitive region. The

Hub is now positioned as an established ecosystem, including the coordination with financial and

policy commitments, collaborative partnerships, and other sources of funding, to support the

EDA’s mission to strengthen US economic and national security through EDA KTFAs 7, 9, and 1

with PR’s assets, resources, capacity, and potential to become globally competitive, within ten

years, in the biotechnology industry of the future. Over the past four months, the consortium has

executed the activities presented below to prepare for Phase 2 Implementation. The Hub and its

supporting structures under the PR Trust Governance, expects to evolve its capacity through its

members, stakeholders, advisory board, community, and industry needs and involvement to

translate innovation into equitable regional economic growth and to strengthen the overall national

security by accelerating the development, manufacturing, and distribution of new products to

address unmet medical needs of patients worldwide.

Phase 1 Goal 1 Relevant Activities from Phase 1-2: Consensus-driven Strategies for PRBio Tech Hub

- Component Projects selected through competitive abstract submissions, followed by full proposal submission.

- Secured facilitator/consultant – Accenture project management hired for Hub assessment resulting in a detailed SOW of Hub

activities through consortium agreement and a full Hub plan with roles and responsibilities.

- Cross-examined NSF Engines and existing funding sources for overlapping or duplication within Hub activities.

Phase 1 Goal 2 Relevant Activities from Phase 1-2: Industry Attraction, Retention, and Growth

- Assessment of Boston Consulting Group gaps in Hub and engagement of necessary partners for Phase 2.

- Assessed the most attractive industry sub-segments, key players, and drivers of site selection decisions and identified the

most attractive product classes that match capabilities of existing infrastructure.

Phase 1 Goal 3 Relevant Activities from Phase 1-2: Industry Future Workforce

- Post-secondary institutions aligned and defined new pathways to workforce needs.

- Planned and defined DDEC and Hub’s role in workforce development roles for the Hub.

- Defined industry needs for on-the-job training, apprenticeships, and fellowship opportunities within industry.

Phase 1 Goal 4 Relevant Activities from Phase 1-2: Regulatory Support Center

-Identified the academic curriculum and workforce training needs in regulatory professional development.

Phase 1 Goal 5 Relevant Activities from Phase 1-2: Contract Research Development and Manufacturing Organization

-Developed design estimates and budget for infrastructure and equipment for state-of-the art laboratory and pilot scale

infrastructure for small and large molecule development.

- Identified necessary initiatives for technologies, viral, DNA and RNA derived immunotherapies, and gene and cell therapies

with a parallel platform for future workforce development to complement industry capabilities.

Phase 1 Goal 6 Relevant Activities from Phase 1-2: Advanced Manufacturing and Enabling Technologies Center

-Planned a Center with platforms to deliver innovative and disruptive technologies with private industry and public university

collaboration with full workforce alignment.

XII. Statement of Consortium Member Commitment: Please see Letters of Commitment within the

submission package.

XIII. Key Partners – Letters of Commitment: Please see Letters of Commitment within the submission

package.