Radiation Oncology Clinical Research

Juan Carlos Restrepo, MD, MHA.

Radiation Oncology

Email: **********@*****.***

Phone: +1-612-***-****

EDUCATION

Education Certificated Course, 2013

Javeriana University Cali, March-June 2013

Master in Health Care Administration, 2012

Walden University Feb 2010 – August 2012.

Practice course on IMRT, IGRT, 3DCRT, 2011

North Shore Hospital, Miami, FL.

May 1 to September 30, 2011.

Practice course on IMRT, IGRT, 3DCRT, 2002

Sirio Libanes Hospital, Sao Paulo, Brazil.

August 1 to October 15, 2002

Practice course on Gamma Knife, 1997

Sylvester Cancer Center

April 14 to June 10, 1997.

Brachytherapy HDR & LOW dose rate, 1997

Mercy Hospital, Miami, FL.

April 14 to June 10, 1997

Annual Endocurietherapy Workshop

Memorial Medical Center, Long Beach, CA.

February 13 thru May 12, 1989.

Radiation Therapy Specialist Program, 1989

Antioquia University, Medellin, Colombia

M.D. Physician and Surgeon Program, 1983

Institute of Health Sciences, Medellin, Colombia

(Doctorate award January 1984)

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PROFESSIONAL EXPERIENCE

ORIGEN SCIENCE RCO / CENTRO INVESTIGACION CLINICA CIC. Business Developer. Medellín, January 2023 to February 2024. HEMATO ONCOLOGOS SA.- Cali, Colombia

Radiation Oncology Advisor to develop a new Radiation Service in Tulua, Valle del Cauca Junio 2019 – Abril 2020

COSMITET LTDA – Cali, Colombia

Radiation Oncology Practice Eje Cafetero Junio 2019 -September 2022

DUMIAN MEDICAL S.A – Cali, Colombia

National Medical Advisor in Oncology, Radiation Oncology Practice April 2015 to September 2022

Clínica de Occidente S.A.- Cali, Colombia

Radiation Oncology Mayo 2011 – April 2014

Worked as FTE practice radiation oncology professional in a private hospital, Clinical Director Comprenhensive Cancer Center affiliated Miami University-Miller Hospital. PPD International, Colombia

Sr. Clinical Research Associate Jan 2011- April 2011 Site selection, screening, initiation, monitoring and closeout. Development of source document notebooks and study initiation deliverables (Research Site Evaluation Form, checklist for Site Initiation, Monitoring Visit, and Site closeout).Validation of inclusion/exclusion criteria for potential participants and Review of Informed Consent forms (ICs).Review of site study files for completeness, accuracy and IRB related documents. Review of CRFs for completeness, clarity, legibility, consistency, conformity to available source documentation, and adherence to protocol requirements, SOPs, and GCP guidelines. Identification of deficiencies and discrepancies .Ensuring timely CRF query resolution through remedial corrective action as required per SOPs, Protocol, ICH/GCP guidelines and regulations.

Clínica Del Rosario, Medellín, Colombia.

Oncology Consultant & Project manager: May –Aug 2010 Assisted with protocol development, implementation and changes across departments, other institutions and the project coordinating center. Assisted with the development of research project timeline, procedures, forms, scripts, manuals, and tracking systems. Worked collaboratively in a high functioning project team that supported the project goals and objectives. Responsible for implementing large business projects with a technical component. Translated goal into implementation plans to deliver results. Ensured details planning activities. Monitored and controlled performance to guarantee objectives was met. Supported project development and outcomes through data collection, statistical analysis and interpretation strategies Juan Carlos Restrepo, MD Page 3 of 7

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Pediatric Care Medical Group, Huntington Beach, CA Clinical Research Associate / Practice –financial manager Feb2009 – Jun2010 Clinical Research Associate

Site selection, screening, initiation. Developed source document notebooks and study initiation. Validated inclusion/exclusion criteria for potential participants and Reviewed Informed Consent forms

(ICs). Reviewed CRFs for completeness, clarity, legibility, consistency, conformity to available source documentation, and adherence to protocol requirements, SOPs, and GCP guidelines. Identified deficiencies and discrepancies. Ensured timely CRF query resolution through remedial corrective action as required per SOPs, Protocol, ICH/GCP guidelines and regulations. Worked on two sites to enrollment patients.

Practice Manager.

Being responsible for the efficient, effective and safe management of the Practice and its finances, and ensured the well-being of patients, doctors and staff, and the successful smooth running of the Practice. Convened, attended, participated in and being responsible for the minutes of meetings when required. Organized and participated in staff meetings. Arranged confidential partnership matters (i.e., mortgages, agreements, partners’ salaries, partnership contracts and retainers). Managed the selection and recruitment and advertising of staff, registrars and clinicians. Ensured proper conditions of employment, to include current employment legislation and recognized good practice. Recruited and maintained an efficient and cost-effective level of staffing. Encouraged team working and development. Dealed with patient complaints. Supervised the updating of practice leaflets and notices and ensured that appropriate information was available to patients. Supported the staff in any difficult contact with patients. Effected and maintained Practice insurance policies; public and third-party liability, employers’ liability, premises and equipment. Ensured security of personnel and property. Being responsible for supplies, both medical and administrative. Managed and supervised Practice ledgers, petty cash, bank reconciliation, cash flow forecasts, and income (fees and allowances and maximize private income) and expenditure plans. Supervised the preparation of the appointments book, searches, data recording, and other upgrades as necessary. Knowledge of Windows, Excel, PowerPoint, internet, e-mail, accounts and payroll software. Sall Research Medical Center, Artesia, CA

QA Medical Research Studies Jun –Jul 2009

Screening initiation and monitoring studies.

Advanced Pain Institute, Clinical Research Center, Arcadia, CA. Project Manager Oct 2007- Nov2008

Being responsible for overseeing the daily activities of Phase 1-3 by ensuring that high quality and valid data. Participated in the design and development of clinical study protocols and CRFs across a range of therapeutic areas to ensure monitoring efforts fully complement the drug development process within established timelines.

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Krieger Research Center, Inc.

Clinical Research Associate May 2008– Oct2008

Site selection, screening, initiation, monitoring and closeout. Developed source document notebooks and study initiation deliverables (Research Site Evaluation Form, checklist for Site Initiation, Monitoring Visit, and Site closeout). Validated inclusion/exclusion criteria for potential participants and Reviewed Informed Consent forms (ICs). Reviewed of site study files for completeness, accuracy and IRB related documents. Reviewed CRFs for completeness, clarity, legibility, consistency, conformity to available source documentation, and adherence to protocol requirements, SOPs, and GCP guidelines. Identified deficiencies and discrepancies. Ensured timely CRF query resolution through remedial corrective action as required per SOPs, Protocol, ICH/GCP guidelines and regulations. SUSALUD, Cali, Colombia

Oncology Consultant 2007- 2014

Responsible for evaluate the new and old cancer patients, recommend the appropriate treatment in surgery, radiotherapy or chemotherapy that any of the patients require according with the practice guideline for each entity, and provide the written support to the physician auditors to follow each case. Develop the appropriate patient clinical report to each case, which will be sent to government reimbursement according to the Health System “Law 100”, high-cost medications and procedures independent to be a Private Health Insurance Company. Clínica CES, SUSALUD, COMFAMA, Clínica Vida & Institute Health Sciences, Medellín, Colombia

Oncology Consultant and Project Management Designer Oncology Department 2007 Assisted with protocol development, implementation and changes across departments, other institutions and the project coordinating center. Assisted with the development of research project timeline, procedures, forms, scripts, manuals, and tracking systems. Coordinated administrative, technical and scientific day-to-day operations of the study to assure project goals and timelines were met; quality data was collected and managed in a timely and accurate manner, and assured participant and/or data confidentiality. Worked collaboratively in a high functioning project team that supports the project goals and objective. Translated goals into implementation plans to deliver results. Ensured details planning activities. Supported project development and outcomes through data collection, statistical analysis and interpretation strategies. Astorga Oncología Clínica, Medellín, Colombia

Medical Practitioner 2005-2007

Developed all the activities regarding a full-time private practice as radiotherapy oncology professional.

Hospital Pablo Tobón Uribe, Medellín, Colombia

Director Radiation Oncology Department 2002-2005

Worked as FTE practice radiation oncology professional in a private university hospital. Hospital Universitario Valle “Evaristo García”, Cali, Colombia Director Radiation Oncology Department 1992-2002

Worked as FTE practice radiation oncology professional and professor in a state university hospital. Juan Carlos Restrepo, MD Page 5 of 7

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LICENSES & CERTIFICATIONS

• Physician and Surgeon Program -MD – Medical Register No. 3466 - Colombia.

• National Register 00190-86

• Radiation Oncology Specialist - Specialist Register No. 6842 – Colombia.

• Protection Radiology Category 1 MED. ESPEC.

• Certified Clinical Research Associate – Krieger Research Center – Oct 2008

• Clinical Foundations Certificate PPD Wilmington, NC. -Jan 2011

• Master in Health Care Administration, Walden University August 29, 2012 PROFESSIONAL DEVELOPMENT

• Master HealthCare Administration, Walden University (MMHA) February 2010 - September 2012. Graduated Certification.

• IMRT, IGRT, SBRT, 3DCRT& Rapid Arc Therapy, Clinical Practice RADM Oncology Center & North Shore Hospital Cancer Center, Miami, FL May - October 10 2011.

• Senior Clinical Research Associate Certificated PPD International (training available to PPD upon request).

• Certificate Clinical Research Associate. (ICH GCP Training, Clinical Site Monitoring, Pharmacology for Clinical Research Professionals), Krieger Research Center, IN, 2008

• Brachitherapy Training LDR Permanent Seeds in Prostate Cancer, Mercy Hospital, Miami FL, 1997

• Brachitherapy and Hyperthermia Course, Memorial Medical Center, Long Beach, CA, 1989

• Radiation Planning and Physics Course, University of Arizona, Tucson, AZ, 1988 Mentions

• Honorable Mention as a Distinguished Person,

Hospital Universitario del Valle, Colombia. 1996

• Order of the Independence of Santiago de Cali, The Degree of Knight’s Cross-. Valle, Colombia. 1997

PROFESSIONAL AFFILIATIONS

• Member of the Association of Clinical Research Professionals since 2008

• ALATRO since 2005

• ASTRO since 1997

COMPUTER EXPERIENCE

• Windows 95-98, MS Word, Word Perfect, MS Excel, MS Access, CTMS Juan Carlos Restrepo, MD Page 6 of 7

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LANGUAGES

• Proficient in Spanish and English

CLINICAL TRIAL EXPERIENCE

Endocrine / Metabolic Disorder: Phase II Efficacy of the Lowering effect of Investigative Study Medication on blood concentrations of low-density lipoprotein cholesterol (LDL-) in patients with Hypercholesterolemia.

Endocrine / Metabolic Disorder: Phase II Study the Efficacy of the healing effect of Investigative Study Medication on diabetic foot ulcers.

Oncology: Phase I Study the safety and dose determination of Immune-Stimulatory Therapy Agent for Bladder Cancer, Melanoma, and Colon Cancer.

Endocrine / Metabolic Disorder: Phase IV Survey: Proper Use and Cost Reduction strategies for prescription and non-prescription drugs.

Respiratory: A Study to Evaluate the Efficacy of Investigative Study Medication in Atopic Asthmatics. Respiratory: A Study of investigative Study Medication in Subjects with Moderate to Severe Persistent Asthma.

Infections/parasitic Diseases: Study Immunogenicity and Safety of Biological MMRV Vaccine vs. Investigative Study Medication in Children 12-14 Months of Age Infections/Parasitic Diseases: Immune, Safety of Vaccine Investigative Study Medication Given at Age of 12-15 Months 15-18 Months Post-Priming With investigative Study Medication Vaccine . Infections/Parasitic Diseases: Immunogenicity of MMR Vaccine vs. Investigative Study Medication, When Given with Routine Vaccines at 12-15 Months of Age Respiratory: A Randomized, Double-Blind, Active-Controlled, Phase 3 Extension Study Investigating the Safety and Efficacy Over 40 Weeks of 2 Doses of Investigative Study Medication in Asthmatic Children (12 Months to 8 Years Old at the Time of Enrollment into the investigative Study Respiratory: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Study Investigating the Safety and Efficacy Over 12 Weeks Treatment Period of Investigative Study Medication in Asthmatic Infants and Children 12 Months to 8 Years of Age Respiratory: A Randomized, Double-Blind, Double-Dummy, Multi-Centre, 4-Way Cross-Over Study to Compare the Single Dose Bronchodilator Effect of Investigative Study Medication in Combination with comparator Delivered Via Pressurized Metered Dose Inhaler (pMDI) to Placebo Delivered Via pMDI in Children Aged 5-11 Years Old With Persistent Asthma Infections/Parasitic Diseases - Study of the Safety of Investigative Study Medication Vaccine When Administered with Other Pediatric Vaccines to Healthy Toddlers Infections/Parasitic Diseases-Nervous System/Sense Organs - Evaluate the safety and efficacy of Investigative Study Medication AF Ophthalmic Solution compared to comparator AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older. Dermatology: Five-Year Safety Study of Investigative Study Medication Cream 1% in Infants 3 to Less Than 12 Months of Age with Mild to Moderate Atopic Dermatitis Endocrine/Metabolic Disorder: A multicenter randomized, double blind, active controlled study to evaluate the durability of the efficacy and safety of Investigative Study Medication compared to comparator when used in combination with Investigative Study Medication in subject with type 2 DM. Endocrine/Metabolic Disorder: A randomized double-blind placebo-controlled, 2 arm parallel group, multicenter study with a 24-week main treatment period and an extension assessing the efficacy and safety of Investigative Study Medication in patients with type 2 diabetes insufficiently controlled with basal insulin.

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Endocrine/Metabolic Disorder: A phase 2 randomized two stages, open label, multicenter 24-week study to evaluate the efficacy safety and tolerability of Investigative Study Medication in subjects with type 2 diabetes mellitus.

Endocrine/Metabolic Disorder: A randomized, double blind, placebo controlled, 2 arm parallel group, multi-center study with a 24- week main treatment period and an extension assessing the efficacy and safety of Investigative Study Medication on top of comparator in patient with type 2 diabetes not adequately controlled with comparator.

Endocrine/Metabolic Disorder: A multi-center, randomized, double-blind study to evaluate the efficacy of long-term safety of Investigative Study Medication modified release as add on therapy to metformin in patients with type 2 diabetes.

Endocrine/Metabolic Disorder: Randomized open label, parallel group, comparator-controlled, multi- center study to evaluate the glycemic effects, safety, and tolerability of Investigative Study Medication once weekly in subjects with type 2 diabetes mellitus. Endocrine/Metabolic Disorder: A proof-of-concept study to evaluate the co administration of Investigative Study Medication given daily and comparator given once weekly for four weeks in patients with type 2 diabetes mellitus.

Oncology: A Phase 3, Randomized, Double Blind, Multicenter trial Comparing Investigative Study Medication plus Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer that Has Progressed During or Following Docetaxel- based Therapy. Oncology: A Phase 3, Randomized, Double Blind, Multicenter Trial Comparing Investigative Study Medication Plus Prednisone with Placebo Plus Prednisone in Patients with Chemotherapy- Naïve Metastatic Castration – Resistant Prostate Cancer. Recommendations:

1- Antonio Dager, General Director, Clínica de Occidente, S.A. Cali, Colombia. Phone: (57-312-***-**** / (57-2) 660 3000 2- Andrés Aguirre, MD General exdirector Hospital Pablo Tobón Uribe Medellín, Colombia. Phone: (57-4) 441 5252 / (57-4)445 9267. 3- Hernán Darío Restrepo, Cirujano laparoscopia Bariátrica, Clínica Medellín Medellín, Colombia. Phone: (57-310-***-****

I have reviewed this document and confirm that the information is accurate and complete.

Signed: Initials: JCRR

Print Name: Juan Carlos Restrepo, MD.

Date: February 2025

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