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PiVOT Introduction Deck
• Incorporated as Pi Health Inc. and registered
as a CRO with the Philippine FDA having
obtained a License to Operate in 2018 and
started operations in 2019
• 100% owned by First Philippine Holdings
• 96 employees and 4 secondees from FPH
• First Philippine Holdings is a Lopez-family owned
publicly listed conglomerate in the Philippines
with investments in power generation, real estate,
and manufacturing
• Currently expanding into fast growing consumer
businesses like education and healthcare
(through PiVOT and the Asian Eye Institute)
Who we are
FPH
Introduction
3
FPH Lopez Family Directors
Upholding high
standards of good and
responsible governance
Click the image for
more information
on FPH’s Mission,
Purpose, and
Chosen Path
Oscar M. Lopez
Federico R. Lopez
Manuel M. Lopez Roberta Lopez Feliciano
Mercedes Lopez-Vargas
Miguel L. Lopez
Mr. Frederico Lopez is the
Chairman and CEO. He has
been a Director of FPH since
February 2006 and was
elevated to CEO in 2010. He
graduated from the
University of Pennsylvania
in 1983 with a Bachelor of
Arts Degree, Double Major in
Economics and
International Relations (Cum
Laude).
4
FPH Senior Officers
Run by a well
experienced professional
management team
Click the image for
more information
on FPH’s Mission,
Purpose, and
Chosen Path
Giles B. Puno
President and Chief Operating Officer
Joaquin E. Quintos IV
Senior VP and Business Development Head
Mr. Puno came from the
Chase Manhattan Bank
after getting an MBA from
Northwestern University’s
Kellogg Graduate School.
Mr. Quintos was as the
Chairman and Country
General Manager of IBM
Philippines. He graduated
from the University of the
Philippines with a Bachelor
of Science degree in
Industrial Engineering cum
laude.
5
Mission
We commit to forging collaborative pathways
for a decarbonized and regenerative future.
Chosen Path
Lead the transition to a decarbonized
energy future
Nurture inclusive, well-tempered, and
creative spaces that elevate
surrounding communities and the
environment
Build infrastructure that creates
resilience and enhances the quality of
life in a complex, climate-changed world
The FPH Identity
Click the image for
more information
on FPH’s Mission,
Purpose, and
Chosen Path
FPH’s Definition of Regenerative
Excerpt from FPH’s Purpose
“ Businesses today must urgently become a
regenerative force that elevates everything
that they touch – customers, employees,
suppliers, contractors, the environment,
communities, and investors…
Our collective success will be measured by
how quickly we can decouple economic and
social prosperity from the destruction of our
planet’s life support systems. ”
6
Investments in healthcare and
education
First Balfour and ThermaPrime as emerging players in
construction and large-scale infrastructure
First Philec’s evolution as solutions provider for
electrical products and services
FPIP’s commitment to improve Filipinos’
standard of living
Rockwell Land’s admired models of integrated and
walkable communities
FPH Mission
Forging collaborative
pathways for a
decarbonized and
regenerative future
With consolidated assets of
NTD 250B and attributable
recurring net income of
NTD 6B in 2022 through
energy, real estate, and
construction, FPH is
strategically positioned to
work with various
stakeholders in accelerating
the transformation to a
decarbonized and
regenerative future.
First Gen and EDC’s leadership in clean, renewable,
and low-carbon energy
FPH Platforms
7
Photo from: Philstar
First Gen and Tokyo Gas partnership for
the development of the Philippines’ first
LNG terminal
Rockwell Land and Mitsui Fudosan partnership for
The Arton’s residential development
KKR’s USD192 million voluntary tender
offer for 12% of First Gen’s common
shares
First Balfour and Acciona partnership for the
landmark Cebu-Cordova Link Expressway
FPH Mission
Forging collaborative
pathways for a
decarbonized and
regenerative future
With consolidated assets of
NTD 250B and attributable
recurring net income of
NTD 6B in 2022 through
energy, real estate, and
construction, FPH is
strategically positioned to
work with various
stakeholders in accelerating
the transformation to a
decarbonized and
regenerative future.
FPH Partnerships
8
Energy
Leading the transition
to a decarbonized
energy future
First Gen and EDC’s clean energy portfolio
Natural Gas
2,017 MW
Clean, flexible, reliable,
efficient, and less carbon
emissions
Geothermal
1,179 MW
Predictable, baseload,
indigenous, and
renewable
Hydro
134 MW
Renewable, indigenous,
and carbon-free
Solar and Wind
162 MW
Renewable, indigenous,
and carbon-free
First Philec’s transformer solutions
* Installed
capacity
 Distribution transformers
 Substation solutions
 Distribution line hardware
 Power equipment
 Technical services
 Digital services
9
Property
Nurturing inclusive,
well-tempered, and
creative spaces that
elevate surrounding
communities and the
environment
FPIP’s manufacturing community
Rockwell Land’s signature developments
Rockwell Center
Rockwell Land’s flagship development which
started with the transformation of an unused
thermal power plant into a thriving, self-
sustained community that seamlessly blends
residences, work spaces, and lifestyle hubs
Aruga Resort and Residences
Rockwell Land’s first premiere residential-resort
development in Cebu along a 200 meter stretch
of white beach and with a mesmerizing view of
the Hilutungan Channel and Magellan Bay
Rockwell South at Carmelray
Rockwell Land’s biggest horizontal
development—a 60-hectare master-planned
property in Laguna integrating nature into
every aspect of the community such as roads
and walkways shaded by trees, a waterway, and
pocket parks & trails
Best in-class
infrastructure &
utilities
FPIP’s first-rate road network,
power supply, industrial
water, wastewater facilities,
and telecommunications
allow operational efficiency
and resilience.
Industry-leading park
management
FPIP continues to set the bar for
park management—covering
construction, maintenance,
security, government liaison,
and environmental compliance—
allowing locators to focus on
growing their business.
Strategic location
FPIP is located near Dyson’s
Calamba site and has access to
the country’s capital, major
trade gateways, thriving
communities as well as a pool of
high-quality manpower.
Backed by industry
leaders
FPIP is a joint venture between
Japanese conglomerate
Sumitomo Corporation and
local conglomerate First
Philippine Holdings (FPH).
10
Construction
Building infrastructure
that creates resilience
and enhances the quality
of life in a complex,
climate-changed world
Complex, high-value, critical infrastructure
Design and construction of an
8.2km expressway that will feature
the main twin cable-stayed bridge
EPC contractor for the civil works
and electrical network of SEA’s
largest wind farm
Design and construction of a 7.3-
km long and 3.1-m diameter
aqueduct
Civil and architectural design &
construction of a 5.7 km elevated
line, including guide ways and
railway stations
EPC for the 43-km transmission
line connecting the Burgos Wind
Farm and substations
Construction of 111 million liters of
water reservoir with three equal
chambers
11
FPH Group CSR
Powered by Good
Mangrove
Reforestation
In First Gen’s Clean
Energy Complex
Pantabangan
Biodiversity Study
OML Center
Climate Change Resiliency
KEITECH
Technical-vocational
educational institution in
Kananga, Leyte
Verde Island
Passage
Conservation and
Scientific Workshop
BINHI
Forest restoration,
threatened native
tree species
propagation, and
biodiversity
protection
Ang Misyon
Nurture talented,
less-privileged
youth through the
transformative
power of orchestral
music
ALERT Building
Advance Local Emergency
Response Team in Batangas City
Create for the Climate
Campaign
Learning session on climate change for businesses
Uplift the lives
unelectrified rural
communities through
innovative and
sustainable renewable
energy (RE) systems
Sikat
Photo from PNA
Photo from:
Batangas City
LGU
FPH has long promoted
socially responsible and
environmentally conscious
actions and decisions as an
integral part of doing
business.
• Incorporated as Pi Health Inc. and registered
as a CRO with the Philippine FDA having
obtained a License to Operate in 2018 and
started operations in 2019
• 100% owned by First Philippine Holdings
• 96 employees and 4 secondees from FPH
• First Philippine Holdings is a Lopez-family owned
publicly listed conglomerate in the Philippines
with investments in power generation, real estate,
and manufacturing
• Currently expanding into fast growing consumer
businesses like education and healthcare
(through PiVOT and the Asian Eye Institute)
Who we are
PiVOT
Introduction
Incorporated as Pi (Philippine Impact) Health Inc. and
registered as a CRO with the Philippine FDA in 2018
PiVOT
Introduction
Regulatory Requirements
 SEC Incorporation
 BIR Registration
 FDA License to Operate
 Good Clinical Practice
Trainings
REGULATORY CLIMATE
New Clinical Trial Regulation
and 60-Day FDA Approval
Updated Pharmacovigilance
Regulation by 2020
Mandatory Phase IV Trials for
selected drugs and devices
HEALTHCARE SECTOR
Mainly out of pocket
healthcare system
NTD 640 Billion in 2022
growing 13% CAGR
1.3M births and 10M Filipinos
above 60 in 2022
CLINICAL TRIALS
Strong Experience in Oncology,
Vaccines, & Infectious Diseases
Large treatment naïve-
population pool
English Speaking Healthcare
Professionals
Source: PSA, Population Commission, PH FDA
The Philippine clinical research landscape was ripe
for the entrant of a strong local player
PiVOT
Introduction
• Level 3 DOH accredited hospital in Sto. Tomas,
Batangas with catchment area stretching as far as
Mindoro and Quezon Province
• Currently with 5 active studies in ophthalmology,
oncology, and nephrology
• Newly established medical school to inline with
hospital’s research driven strategic direction
• Clinical trial site specializing in ophthalmology with
11 branches in the Philippines
• Conducted over 100 medical drug and device
studies since 2002 with 20 different sponsors
• Currently with 25 active studies in retina, glaucoma,
cataract, and refractive
• Inspected by the US FDA in 2015 with no major
findings
PiVOT is aggressively building relationships with sites across the country
PiVOT
Partners
…and working with over 116 KOLs and PIs in major hospitals nationwide.
PiVOT
Partners
Makati Medical Center
The Medical City
Asian Hospital and Medical Center
St. Luke’s Medical Center
Bonifacio Global City
PiVOT is already utilizing 23 of the better 46 sites nationwide
with a greater push to develop sites outside of Metro Manila (NCR).
PiVOT
Partners
https://ethics.healthresearch.ph/index.php/level-3-accredited-recs
7/46
Clinical Trial Sites are
in Luzon outside NCR
4/46
are in Davao
6/46
are in the Visayas
29/46
Clinical Trial Sites are
in Metro Manila
Over 400 clinical trials in the Philippines since 2015
Trials in the
Philippines
Source: Philippine Health Research Registry 2015-2020
42
13
14
16
16
19
19
21
25
56
57
62
72
0 15 30 45 60 75
Others
Nephrology
Opthalmology
Cardiology
Neurology
Endocrinology
Rheumatology
Dermatology
Immunology
Vaccine
Pulmonology
Infectious Diseases
Oncology
PiVOT employs a lean, efficient, and experienced team
Organizational
Structure
President
Clinical Trial Management Finance & Accounting
Business Development
& Sales
Pharmacovigilance
Clinical Research
Associates
Quality Assurance
Regulatory
Executive Secretary
Human Resources & Admin
General Manager
Clinical Trial Support Service
HTA/HEOR
Medical Writing
Trainings
Data Management
PiVOT employs a lean, efficient, and experienced team
Organizational
Structure
Rodmar C. Pulido, General Manager
• 23 years experience in the clinical research industry
• President, Philippine Clinical Research Professionals, Inc.
• Former Country Manager, EPS International Philippines Branch
• Former Regional Business Development Manager, EPS International
• Established Clinical Research Center in Makati Medical Center
PiVOT employs a lean, efficient, and experienced team
Organizational
Structure
Charles Anthony P. Suarez, RPh, Pharmacovigilance and Regulatory Lead
• Registered pharmacist with over 15 years experience in Pharma Industry
• Experiences include Hospital Clinical Pharmacy, Clinical Research, Regulatory Affairs, and
Pharmacovigilance including Risk Management Plans
• Postgraduate units in International Health from the University of the Philippines focused on
Health Systems Management
• Previous employers include Boehringer-Ingelheim, Novartis Healthcare, Cognizant, Quintiles
(IQVIA), ClinTec, EPS International, and Innovative Trials UK
PiVOT employs a lean, efficient, and experienced team
Organizational
Structure
Lizbeth G. Salonga, RMT, Clinical Operations Manager
• 18 years experience in the pharmaceutical clinical research industry with focus on project
management, clinical monitoring, site management, real world evidence, Philippine National
Formulary, and HEOR studies
• Postgraduate units in Public Health from the University of the Philippines
• Experience in Cutaneous Diseases (Lupus), Endocrinology, Infectious Diseases, Neurology,
Oncology, and Vaccines
• Previous employers include Pfizer, Quintiles (IQVIA), IndiPharm, and Innovative Trials UK
Despite only 3 years of operation, PiVOT is beaming with activity
Company
Track Record
Besides the individual staff experience, the company as a whole has…
• 14 clinical trials, of which are 9 vaccine related, with over 40,000 patients recruited
• A pipeline of oncology, cardio, and antibiotic trials
• Live pharmacovigilance services with local clients
• Ongoing regulatory support for local and international clients
• Experience working with foreign pharmaceuticals, regional CROs, and global NGOs
• Passed 4 inspections of PH FDA, 2 foreign FDA inspections, and 3 client audits
• Presence in international conferences
Typical Clinical Trial Registration Workflow
Clinical Trial
Registration
Institutional Review Board
Ethics Committee
Approval in
45 to 180 Days
Customs
Release of IP
Study Initiation
Estimate SIV
Study Approval and
Import License
in 60 Days
Parallel
Submission
Site Contract
for Review
Clinical Trial
Submission
Dossier
Drug and Device Trial Management
Services
• Management of Phase I to IV trials on proof of concept or small scale trials on
drugs, biologics, and devices
• Designed for publication to peer-reviewed journals or to support the decision to
pursue large scale FDA registration trials
• Compliance with applicable requirements such as Data Privacy Laws, Good
Clinical Practice, and applicable regulatory requirements and guidelines
• Services include protocol development, regulatory affairs services, monitoring,
data management and analysis, and report writing
Post Marketing Surveillance (PMS) and Real World Evidence (RWE)
Services
• Combined experience in monitoring and processing more than 20,000 subjects
for PMS
• Compliance with applicable requirements such as Data Privacy Laws, Good
Clinical Practice, and applicable regulatory requirements and guidelines
• Services include protocol development, monitoring, data management and
analysis, and report writing
Pharmacovigilance
Services
• End-to-end 24 hour monitoring and aggregate regulatory reporting service
• Complemented by a EMA and US FDA compliant software
• Highly experienced staff in adverse event (drug, device, cosmetic) case intake, triage,
case processing, CIOMS form generation, regulatory reporting, and submission
• Available for Medicinal Products and Medical Devices (including technical complaints)
• Pharmacovigilance Training (for internal employees and affiliates)
• Audit & Inspection Preparation and Readiness Program (including System and SOP
audit)
Medical Writing and Health Economics and Outcomes Research
Services
Medical Writing
• Accomplishing Company and Drug-focused Risk Management Plans
• Study reports required by regulatory authorities
Health Economics and Outcomes Research (HEOR)
• Evidence identification and KOL validation through HCP/Hospital Survey
• Economic Evaluation including model adaptation, analysis and/or reporting
• Dossier development, including HTA Report for Philippine National Formulary
• Submission and hospital formulary inclusion
Investigator-Initiated Research (including registries)
Services
• We help the Filipino researcher write grants and manage the research to reach
deliverables set by the grant agencies
• Our team of experienced individuals can advise researchers on grant application,
research contract negotiations, intellectual property protection and management,
technology transfer, and commercialization
• Journal writing and publication can also be outsourced to PiVOT
Other Unique and Specialized Services
Services
Bioavailability (BA) and Bioequivalence (BE) Studies
• GLP Certified BA/BE Partner in Malaysia
• Inspected by the US FDA and the French Regulatory Authority (ANSM)
Experienced staff capable in conducting the following trainings and audits:
• Good Clinical Practice (GCP)
• Good Manufacturing Practice (GMP)
• Good Pharmacovigilance Practice (GPVP)
Contact Person:
Joseph Cheng
jocheng@pivot-cro.com
+63 2 8370 5942
+63 917 527 5639
www.pivot-cro.com
Office Address:
6th Floor, Tower 3
Rockwell Business Center
Ortigas Avenue, Pasig City
Metro Manila, Philippines
We hope to hear from you soon
Contact Us
Thank you

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PiVOT Introduction Deck

  • 2. • Incorporated as Pi Health Inc. and registered as a CRO with the Philippine FDA having obtained a License to Operate in 2018 and started operations in 2019 • 100% owned by First Philippine Holdings • 96 employees and 4 secondees from FPH • First Philippine Holdings is a Lopez-family owned publicly listed conglomerate in the Philippines with investments in power generation, real estate, and manufacturing • Currently expanding into fast growing consumer businesses like education and healthcare (through PiVOT and the Asian Eye Institute) Who we are FPH Introduction
  • 3. 3 FPH Lopez Family Directors Upholding high standards of good and responsible governance Click the image for more information on FPH’s Mission, Purpose, and Chosen Path Oscar M. Lopez Federico R. Lopez Manuel M. Lopez Roberta Lopez Feliciano Mercedes Lopez-Vargas Miguel L. Lopez Mr. Frederico Lopez is the Chairman and CEO. He has been a Director of FPH since February 2006 and was elevated to CEO in 2010. He graduated from the University of Pennsylvania in 1983 with a Bachelor of Arts Degree, Double Major in Economics and International Relations (Cum Laude).
  • 4. 4 FPH Senior Officers Run by a well experienced professional management team Click the image for more information on FPH’s Mission, Purpose, and Chosen Path Giles B. Puno President and Chief Operating Officer Joaquin E. Quintos IV Senior VP and Business Development Head Mr. Puno came from the Chase Manhattan Bank after getting an MBA from Northwestern University’s Kellogg Graduate School. Mr. Quintos was as the Chairman and Country General Manager of IBM Philippines. He graduated from the University of the Philippines with a Bachelor of Science degree in Industrial Engineering cum laude.
  • 5. 5 Mission We commit to forging collaborative pathways for a decarbonized and regenerative future. Chosen Path Lead the transition to a decarbonized energy future Nurture inclusive, well-tempered, and creative spaces that elevate surrounding communities and the environment Build infrastructure that creates resilience and enhances the quality of life in a complex, climate-changed world The FPH Identity Click the image for more information on FPH’s Mission, Purpose, and Chosen Path FPH’s Definition of Regenerative Excerpt from FPH’s Purpose “ Businesses today must urgently become a regenerative force that elevates everything that they touch – customers, employees, suppliers, contractors, the environment, communities, and investors… Our collective success will be measured by how quickly we can decouple economic and social prosperity from the destruction of our planet’s life support systems. ”
  • 6. 6 Investments in healthcare and education First Balfour and ThermaPrime as emerging players in construction and large-scale infrastructure First Philec’s evolution as solutions provider for electrical products and services FPIP’s commitment to improve Filipinos’ standard of living Rockwell Land’s admired models of integrated and walkable communities FPH Mission Forging collaborative pathways for a decarbonized and regenerative future With consolidated assets of NTD 250B and attributable recurring net income of NTD 6B in 2022 through energy, real estate, and construction, FPH is strategically positioned to work with various stakeholders in accelerating the transformation to a decarbonized and regenerative future. First Gen and EDC’s leadership in clean, renewable, and low-carbon energy FPH Platforms
  • 7. 7 Photo from: Philstar First Gen and Tokyo Gas partnership for the development of the Philippines’ first LNG terminal Rockwell Land and Mitsui Fudosan partnership for The Arton’s residential development KKR’s USD192 million voluntary tender offer for 12% of First Gen’s common shares First Balfour and Acciona partnership for the landmark Cebu-Cordova Link Expressway FPH Mission Forging collaborative pathways for a decarbonized and regenerative future With consolidated assets of NTD 250B and attributable recurring net income of NTD 6B in 2022 through energy, real estate, and construction, FPH is strategically positioned to work with various stakeholders in accelerating the transformation to a decarbonized and regenerative future. FPH Partnerships
  • 8. 8 Energy Leading the transition to a decarbonized energy future First Gen and EDC’s clean energy portfolio Natural Gas 2,017 MW Clean, flexible, reliable, efficient, and less carbon emissions Geothermal 1,179 MW Predictable, baseload, indigenous, and renewable Hydro 134 MW Renewable, indigenous, and carbon-free Solar and Wind 162 MW Renewable, indigenous, and carbon-free First Philec’s transformer solutions * Installed capacity  Distribution transformers  Substation solutions  Distribution line hardware  Power equipment  Technical services  Digital services
  • 9. 9 Property Nurturing inclusive, well-tempered, and creative spaces that elevate surrounding communities and the environment FPIP’s manufacturing community Rockwell Land’s signature developments Rockwell Center Rockwell Land’s flagship development which started with the transformation of an unused thermal power plant into a thriving, self- sustained community that seamlessly blends residences, work spaces, and lifestyle hubs Aruga Resort and Residences Rockwell Land’s first premiere residential-resort development in Cebu along a 200 meter stretch of white beach and with a mesmerizing view of the Hilutungan Channel and Magellan Bay Rockwell South at Carmelray Rockwell Land’s biggest horizontal development—a 60-hectare master-planned property in Laguna integrating nature into every aspect of the community such as roads and walkways shaded by trees, a waterway, and pocket parks & trails Best in-class infrastructure & utilities FPIP’s first-rate road network, power supply, industrial water, wastewater facilities, and telecommunications allow operational efficiency and resilience. Industry-leading park management FPIP continues to set the bar for park management—covering construction, maintenance, security, government liaison, and environmental compliance— allowing locators to focus on growing their business. Strategic location FPIP is located near Dyson’s Calamba site and has access to the country’s capital, major trade gateways, thriving communities as well as a pool of high-quality manpower. Backed by industry leaders FPIP is a joint venture between Japanese conglomerate Sumitomo Corporation and local conglomerate First Philippine Holdings (FPH).
  • 10. 10 Construction Building infrastructure that creates resilience and enhances the quality of life in a complex, climate-changed world Complex, high-value, critical infrastructure Design and construction of an 8.2km expressway that will feature the main twin cable-stayed bridge EPC contractor for the civil works and electrical network of SEA’s largest wind farm Design and construction of a 7.3- km long and 3.1-m diameter aqueduct Civil and architectural design & construction of a 5.7 km elevated line, including guide ways and railway stations EPC for the 43-km transmission line connecting the Burgos Wind Farm and substations Construction of 111 million liters of water reservoir with three equal chambers
  • 11. 11 FPH Group CSR Powered by Good Mangrove Reforestation In First Gen’s Clean Energy Complex Pantabangan Biodiversity Study OML Center Climate Change Resiliency KEITECH Technical-vocational educational institution in Kananga, Leyte Verde Island Passage Conservation and Scientific Workshop BINHI Forest restoration, threatened native tree species propagation, and biodiversity protection Ang Misyon Nurture talented, less-privileged youth through the transformative power of orchestral music ALERT Building Advance Local Emergency Response Team in Batangas City Create for the Climate Campaign Learning session on climate change for businesses Uplift the lives unelectrified rural communities through innovative and sustainable renewable energy (RE) systems Sikat Photo from PNA Photo from: Batangas City LGU FPH has long promoted socially responsible and environmentally conscious actions and decisions as an integral part of doing business.
  • 12. • Incorporated as Pi Health Inc. and registered as a CRO with the Philippine FDA having obtained a License to Operate in 2018 and started operations in 2019 • 100% owned by First Philippine Holdings • 96 employees and 4 secondees from FPH • First Philippine Holdings is a Lopez-family owned publicly listed conglomerate in the Philippines with investments in power generation, real estate, and manufacturing • Currently expanding into fast growing consumer businesses like education and healthcare (through PiVOT and the Asian Eye Institute) Who we are PiVOT Introduction
  • 13. Incorporated as Pi (Philippine Impact) Health Inc. and registered as a CRO with the Philippine FDA in 2018 PiVOT Introduction Regulatory Requirements  SEC Incorporation  BIR Registration  FDA License to Operate  Good Clinical Practice Trainings
  • 14. REGULATORY CLIMATE New Clinical Trial Regulation and 60-Day FDA Approval Updated Pharmacovigilance Regulation by 2020 Mandatory Phase IV Trials for selected drugs and devices HEALTHCARE SECTOR Mainly out of pocket healthcare system NTD 640 Billion in 2022 growing 13% CAGR 1.3M births and 10M Filipinos above 60 in 2022 CLINICAL TRIALS Strong Experience in Oncology, Vaccines, & Infectious Diseases Large treatment naïve- population pool English Speaking Healthcare Professionals Source: PSA, Population Commission, PH FDA The Philippine clinical research landscape was ripe for the entrant of a strong local player PiVOT Introduction
  • 15. • Level 3 DOH accredited hospital in Sto. Tomas, Batangas with catchment area stretching as far as Mindoro and Quezon Province • Currently with 5 active studies in ophthalmology, oncology, and nephrology • Newly established medical school to inline with hospital’s research driven strategic direction • Clinical trial site specializing in ophthalmology with 11 branches in the Philippines • Conducted over 100 medical drug and device studies since 2002 with 20 different sponsors • Currently with 25 active studies in retina, glaucoma, cataract, and refractive • Inspected by the US FDA in 2015 with no major findings PiVOT is aggressively building relationships with sites across the country PiVOT Partners
  • 16. …and working with over 116 KOLs and PIs in major hospitals nationwide. PiVOT Partners Makati Medical Center The Medical City Asian Hospital and Medical Center St. Luke’s Medical Center Bonifacio Global City
  • 17. PiVOT is already utilizing 23 of the better 46 sites nationwide with a greater push to develop sites outside of Metro Manila (NCR). PiVOT Partners https://ethics.healthresearch.ph/index.php/level-3-accredited-recs 7/46 Clinical Trial Sites are in Luzon outside NCR 4/46 are in Davao 6/46 are in the Visayas 29/46 Clinical Trial Sites are in Metro Manila
  • 18. Over 400 clinical trials in the Philippines since 2015 Trials in the Philippines Source: Philippine Health Research Registry 2015-2020 42 13 14 16 16 19 19 21 25 56 57 62 72 0 15 30 45 60 75 Others Nephrology Opthalmology Cardiology Neurology Endocrinology Rheumatology Dermatology Immunology Vaccine Pulmonology Infectious Diseases Oncology
  • 19. PiVOT employs a lean, efficient, and experienced team Organizational Structure President Clinical Trial Management Finance & Accounting Business Development & Sales Pharmacovigilance Clinical Research Associates Quality Assurance Regulatory Executive Secretary Human Resources & Admin General Manager Clinical Trial Support Service HTA/HEOR Medical Writing Trainings Data Management
  • 20. PiVOT employs a lean, efficient, and experienced team Organizational Structure Rodmar C. Pulido, General Manager • 23 years experience in the clinical research industry • President, Philippine Clinical Research Professionals, Inc. • Former Country Manager, EPS International Philippines Branch • Former Regional Business Development Manager, EPS International • Established Clinical Research Center in Makati Medical Center
  • 21. PiVOT employs a lean, efficient, and experienced team Organizational Structure Charles Anthony P. Suarez, RPh, Pharmacovigilance and Regulatory Lead • Registered pharmacist with over 15 years experience in Pharma Industry • Experiences include Hospital Clinical Pharmacy, Clinical Research, Regulatory Affairs, and Pharmacovigilance including Risk Management Plans • Postgraduate units in International Health from the University of the Philippines focused on Health Systems Management • Previous employers include Boehringer-Ingelheim, Novartis Healthcare, Cognizant, Quintiles (IQVIA), ClinTec, EPS International, and Innovative Trials UK
  • 22. PiVOT employs a lean, efficient, and experienced team Organizational Structure Lizbeth G. Salonga, RMT, Clinical Operations Manager • 18 years experience in the pharmaceutical clinical research industry with focus on project management, clinical monitoring, site management, real world evidence, Philippine National Formulary, and HEOR studies • Postgraduate units in Public Health from the University of the Philippines • Experience in Cutaneous Diseases (Lupus), Endocrinology, Infectious Diseases, Neurology, Oncology, and Vaccines • Previous employers include Pfizer, Quintiles (IQVIA), IndiPharm, and Innovative Trials UK
  • 23. Despite only 3 years of operation, PiVOT is beaming with activity Company Track Record Besides the individual staff experience, the company as a whole has… • 14 clinical trials, of which are 9 vaccine related, with over 40,000 patients recruited • A pipeline of oncology, cardio, and antibiotic trials • Live pharmacovigilance services with local clients • Ongoing regulatory support for local and international clients • Experience working with foreign pharmaceuticals, regional CROs, and global NGOs • Passed 4 inspections of PH FDA, 2 foreign FDA inspections, and 3 client audits • Presence in international conferences
  • 24. Typical Clinical Trial Registration Workflow Clinical Trial Registration Institutional Review Board Ethics Committee Approval in 45 to 180 Days Customs Release of IP Study Initiation Estimate SIV Study Approval and Import License in 60 Days Parallel Submission Site Contract for Review Clinical Trial Submission Dossier
  • 25. Drug and Device Trial Management Services • Management of Phase I to IV trials on proof of concept or small scale trials on drugs, biologics, and devices • Designed for publication to peer-reviewed journals or to support the decision to pursue large scale FDA registration trials • Compliance with applicable requirements such as Data Privacy Laws, Good Clinical Practice, and applicable regulatory requirements and guidelines • Services include protocol development, regulatory affairs services, monitoring, data management and analysis, and report writing
  • 26. Post Marketing Surveillance (PMS) and Real World Evidence (RWE) Services • Combined experience in monitoring and processing more than 20,000 subjects for PMS • Compliance with applicable requirements such as Data Privacy Laws, Good Clinical Practice, and applicable regulatory requirements and guidelines • Services include protocol development, monitoring, data management and analysis, and report writing
  • 27. Pharmacovigilance Services • End-to-end 24 hour monitoring and aggregate regulatory reporting service • Complemented by a EMA and US FDA compliant software • Highly experienced staff in adverse event (drug, device, cosmetic) case intake, triage, case processing, CIOMS form generation, regulatory reporting, and submission • Available for Medicinal Products and Medical Devices (including technical complaints) • Pharmacovigilance Training (for internal employees and affiliates) • Audit & Inspection Preparation and Readiness Program (including System and SOP audit)
  • 28. Medical Writing and Health Economics and Outcomes Research Services Medical Writing • Accomplishing Company and Drug-focused Risk Management Plans • Study reports required by regulatory authorities Health Economics and Outcomes Research (HEOR) • Evidence identification and KOL validation through HCP/Hospital Survey • Economic Evaluation including model adaptation, analysis and/or reporting • Dossier development, including HTA Report for Philippine National Formulary • Submission and hospital formulary inclusion
  • 29. Investigator-Initiated Research (including registries) Services • We help the Filipino researcher write grants and manage the research to reach deliverables set by the grant agencies • Our team of experienced individuals can advise researchers on grant application, research contract negotiations, intellectual property protection and management, technology transfer, and commercialization • Journal writing and publication can also be outsourced to PiVOT
  • 30. Other Unique and Specialized Services Services Bioavailability (BA) and Bioequivalence (BE) Studies • GLP Certified BA/BE Partner in Malaysia • Inspected by the US FDA and the French Regulatory Authority (ANSM) Experienced staff capable in conducting the following trainings and audits: • Good Clinical Practice (GCP) • Good Manufacturing Practice (GMP) • Good Pharmacovigilance Practice (GPVP)
  • 31. Contact Person: Joseph Cheng jocheng@pivot-cro.com +63 2 8370 5942 +63 917 527 5639 www.pivot-cro.com Office Address: 6th Floor, Tower 3 Rockwell Business Center Ortigas Avenue, Pasig City Metro Manila, Philippines We hope to hear from you soon Contact Us