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

32. Thank you

PiVOT Introduction Deck

PiVOT Introduction Deck

Recomendados

Mais conteúdo relacionado

Similar a PiVOT Introduction Deck

Similar a PiVOT Introduction Deck(20)

Último

Último(20)

PiVOT Introduction Deck