Mohamed Gouda

I am proudly handling the WWD responsibilities for the Saudi Affiliate fostering data-driven decision making mindset across the organization in several domains.

Saudi is one of the few affiliates implemented Fusion-full capabilities, and embraced state-of-the-art Tender Fulfillment optimization Fusion Use Case, along with the global team, we have successfully deployed a full application to track the movement of the goods to match the tough terms and conditions of tender delivery to ensure smooth patient access for medications and minimize the penalties.

This Use Case was presented during WWD Sep-2024 forum as one of the top 3 use cases in terms of capitalizing on Fusion and the local team (Supply Chain, Finance, Key Account Management) is using it on daily basis to enhance our tenders’ execution and management along with our distributors.

I have worked closely to rollout global dashboards, e.g OneView, eScore, ACEPT OCM dashboard, as well as we have a solid plan starting April 2025 for Next Best Actions (NBAs) implementation of Veeva Suggestions, we prioritized Gastro, Neuroscience and Oncology for 2025.

I have worked closely with the affiliate brand teams and created several local dashboards, that support business execution and provide insights using Power Bi platform.

Some of these dashboards are connected to the foundry datasets (Touchpoint, Cycle Plan, Time Of Territory and Empolyee Activity). e.g In-Field Fundamentals Dashboard.

As well, IQVIA IMS Database dashboards (National Level, Private Territories level and 9 Defined Markets in the Private Sector based on Market Research feedback),

Calls Analysis Dashboard, Veeva Approved Emails Dashboard, performance to the leadership team, Forge Ahead Amplified and Product Metrics Evolution dashboards.

Digital Transformation:

I have proudly led the Saudi Affiliate Digital Transformation Journey, through working closely with Brand Teams and educating the In-Field teams about the value of digital channels, importance of personalized message delivery through Customer Experience Flows, and content operations, which translated to MCM score evolution for Commercial from 2.91 in Nov-22 to 3.55 in Nov-23 to 4.26 (ranked 4th across Intercontinental and 6th across International Therapeutics) in Nov-24 as well for Medical team, from 2.97 in Nov-22 to 3.55 in Nov-23 to 4.55 in Nov-24 (ranked 1st across International Therapeutics) paving the way for passionate ACE Transformation, and implementation in Saudi Arabia, we are pioneers across International Therapeutics for Skyrizi PsO ACE Implementation with a Solid plan for expansion during 2025 / 2026 for several brands Rinvoq AD, Rheumatology RA and SpA, Botox and others.

In-Field Excellence:

I have supported the In-Field team to capitalize on the different resources and maximize the value of our engagements with our external stakeholders, keeping a healthy and evolving trend of KPIs over the past period and supported the rollout of global initiatives under the umbrella of ACE like IFT Fundamentals and IFT workstation currently under rollout.

I have been responsible for the Non-Interventional Studies planning and execution as well the contact point with Clinical Development Operations for Interventional Studies. In this period, I had a profound finger print of putting Saudi Arabia on the MAP of Clinical Research and across different studies including Multi-Country NIS:

1- VALUE study: RWE for Risankizumab in moderate-to-severe plaque psoriasis patients.

2- Uphold study: RWE of Upadacitinib in moderate-to-severe Rheumatoid Arthritis patients.

3- MEASURE-AD Study: RWE Epidemiologic study for the disease burden of Atopic Dermatitis.

4- VICTROY (local regional study): Venetoclax treatment outcomes and patterns of use in relapsed/refractory chronic lymphocytic leukemia (CLL) under routine clinical practice in Saudi Arabia and Gulf countries. 5- UpToDate local study: Real-World Experience of Upadacitinib in Moderate to Severe Atopic Dermatitis in Saudi Arabia: A Retrospective Chart Review.

Saudi Arabia's participation was successful, we met all the planned number of sites, patients enrollment and exceeded in some studies. In all these studies, I was responsible for the process and alignment of different stakeholders starting from evaluation of participation, study feasibility, planned site(s) feasibilit(ies), protocol training, site initiation, site monitoring, data operations, and study close out.

In this capacity, I was working closely with Saudi Medical Affairs team members, Therapy Area Leads at Intercontinental and MEAR levels, Global Medical Affairs Evidence Generation teams.

As well, I was leading the Affiliate Publications with several projects on Middle East Africa, Central Eastern Europe levels, responsible. I have been privileged to work closely as well with HEOR teams in Saudi and Global for the publication of Cost-Effectiveness and Budget Impact Models, actually, I led the first submission of such kind of research from the region to ISPOR 2020 which was presented as poster, opening the door later for several project to proceed and impact the access landscape. Among the major achievements as well during this period that our MEA sub-analysis of MEASURE-AD was the first to be presented globally, Presented at the16th Jeddah Dermatology & Cosmetics Conference (JeddaDerm 2022), 9–12 February 2022, Jeddah, Saudi Arabia and followed by collaboration with Central Eastern Europe to mentor the Publication Lead and replicate our experience with successful presentation at the XVI Congress of Slovak and Czech Dermatovenereology Society (SDVS 2022) 9–11 June 2022, Slovakia. Compliance is at the heart of all what we do, and both domains I was leading are governed by several internal and external guidelines, I was privileged to have zero-findings for the Clinical Research domain during the 2021 Compliance Audit.

I have worked as well with Saudi Affiliate Medical Director, MEAR Regional Medical Director, International Medical Research Senior Director, MEAR Clinical Research Manager and prepared a comprehensive case for Saudi Geostrategy reinsertion for Interventional studies which paved the way for the inclusion of Saudi Arabia in these studies.

Publications that I have an author role:

1- Correlation between physician‑ and patient‑directed disease assessments in ulcerative colitis patients from Saudi Arabia and Kuwait: ICONIC study 2023 Saudi Journal of Gastroenterology | Published by Wolters Kluwer ‑ Medknow · Aug 23, 2023 https://journals.lww.com/sjga/fulltext/2023/29060/correlation_between_physician__and.8.aspx

2- Venetoclax Treatment Outcomes and Patterns of Use in Relapsed_Refractory Chronic Lymphocytic Leukemia Under Routine Clinical Practice in Saudi Arabia and Gulf Countries blood / American Society of Hematology · Nov 15, 2022 https://doi.org/10.1182/blood-2022-168049

3- The Real-World Burden of Atopic Dermatitis: Results From Multicountry MEASURE-AD Study in Central and Eastern European Region XVI Congress of Slovak and Czech Dermatovenereology Society (SDVS 2022) 9–11 June 2022, Slovakia · Jun 9, 2022 Poster presentation

4- The Real-World Burden of Atopic Dermatitis: Results from MEASURE-AD Multicountry Study in Middle East Region Presented at the16th Jeddah Dermatology & Cosmetics Conference (JeddaDerm 2022), 9–12 February 2022, Jeddah, Saudi Arabia · Feb 9, 2022

I was leading the affiliate NIS projects including several NIS studies briefly (ICONIC study - TOPAZ Study - SOLID Registry Partnership - A15-940 IIS HCV) and these studies publications. As well, all the Encore Publications projects for Saudi Arabia expanding the reach of our Clinical Research footprint in the region.

Oversight of Pharmacovigilance:

1. Ensures timely oversight of all required pharmacovigilance (PV) regulatory reporting compliance for their responsible territories.

2. Provides comprehensive compliance metric reports to the Area Medical Director (AMD) to ensure full visibility of compliance issues, at least quarterly.

3. Advises the business on the PV impact of local Organized Data

Collection (ODC) programs, such as patient support programs. Quality System / Standard Operating Procedures (SOPs):

1. Ensures local processes and procedures are in place to clearly define PV responsibilities within the Affiliate, in alignment with Global SOPs and local regulations.

Compliance:

1. Ensures compliance with the Corrective Action and Preventive Action (CAPA) process as outlined in QPP15-02-001 for the reporting and investigation of exceptions (nonconformance, potential nonconformance). Also, ensures a local tracking system is in place to ensure timely submissions of adverse events to AbbVie PPS.

2. Ensures the reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic Reports to the Regulatory Authority and Ethics Committees as required.

3. Reports compliance metrics and information to PPS or Research and Development Quality Assurance (RDQA) PV & Regulatory Affairs (RA) QA within the required timelines.

Adverse Event Reporting:

1. Ensures that local processes, procedures, and systems are in place for recording, processing, conducting follow-up, and translating adverse events and other safety information reportable to PPS from spontaneous and solicited sources and Serious Adverse Events (SAEs) from clinical studies.

2. Ensures comprehensive data collection and follow-up, such as lot/batch number, age or age group, medically relevant information, for all case types, including Post-Marketing Observational Studies (PMOS). 3. Ensures local language medical or scientific literature not included in the PPS global literature review is reviewed to identify possible adverse events or special situations reportable to PPS, and that any reports are promptly reported to PPS.

Reconciliation of Safety Data and Product Complaints:

1. For more information, see Q-15-01-010. Completes adverse event (AE) reconciliation and ensures AE identification effectiveness sampling consistent with global procedures, forwarding any identified AEs to PPS.

Organized Data Collection Programs: (including Patient Support, Market Research, and Social Media Programs):

1. Ensures all Organized Data Collection Programs are assessed for impact on adverse event generation and that PV requirements are in place and aligned with Global and Local SOPs.

2. Ensures any new programs or significant changes in existing programs are tracked and updated in the PPS program inventory.

3. Communicates proposed audits of Organized Data Collection Programs service providers/vendors to AVE and R&D QA PV Compliance before the audit. For more information, see Q-01-02-011. 4. Supports local QA and RDQA PV & RA QA in conducting vendor audits and completing vendor Corrective Action Plans (CAPs).

Safety Data Exchange Agreements (SDEA) and other PV Agreements: 1. Maintains compliance with local agreements and ensures the content of local SDEAs and other PV agreements conforms to AbbVie standards per Q-15-01-018 and local requirements. For more information, see Q-15-01-018 and 0-15-01-008-W003.

2. Responsible for requesting or providing copies of all AE files for local product acquisition and divestitures. And others as well.

1. Develop and maintain in depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance / participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self-study of the national/Area literature.

2. Provide expert medical/scientific advice for assigned products and related therapeutic areas, including responding to requests for scientific/technical information, contribute to the development and medical and scientific accuracy of core dossiers generated by the medical department (i.e. pricing and reimbursement dossiers, HEOR dossiers, medical information packs, clinical expert reviews etc.).

3. Establish and maintain professional and credible relationships with key thought leaders / external experts and academic centers, this will involve participating in scientific congresses, coordinating advisory boards, round-table meetings, discussion fora etc.

4. Deliver scientific presentations and medical education programs to healthcare professionals individually or in groups (meetings, clinical sessions, etc.), where appropriate.

5. Screen relevant literature and other information from relevant scientific societies meetings and conferences and develop summaries of key messages for use within the Company (e.g. key areas of scientific/company interest, new trends in diagnosis, monitoring and treatments in the therapeutic area, etc.)

6. Deliver training to sales forces and other departments, develop and update relevant training materials.

7. Clinical Research Activities:

a. Design and implement clinical research projects within defined standards and budgets (e.g. Phase IV, post marketing clinical activities such as registry/database projects, epidemiological surveys, and PMOS studies).

b. Provide the required oversight to manage review, approval and conduct of IIS studies.

c. Support the affiliate Clinical Research Department in the management of clinical studies, as appropriate (e.g. review new clinical study protocols, identifying potential investigators/sites, conducting feasibility surveys).

8. Review and preparation of promotional material. Ensure the medical/scientific content is correct and fully compliant with Abbott’s internal policies and guidelines.

9. Provide medical/scientific input into marketing strategy and key commercial initiatives, as required. Monitor the environment for competitive intelligence (e.g. product strategies, studies, commercial messages, positioning, etc.) and communicate, where appropriate, within the Company.

10. Ensure compliance with all applicable national laws and regulations, guidelines, codes of conduct, AbbVie’s policies and procedures and accepted standards of best practice.

Similar to the Medical Advisor role with more focus on the field activities.

Responsibilities:

1- Conveying Marketing Messages for Products under responsibilities to HCPs.

2- Ad-hoc member of Neonatology Brand Team to discuss market feedback and shape the strategy and messaging to KOLs.

3- Initiating all promotional activities planned for the territory under responsibility.

4- Supporting Medical department for educational activities and engaging KOLs in AbbVie initiated meetings.

Major Achievements:

• Introduction of Synagis to Al Qounfodah General Hospital.

• Achieving 111% sales over plan of Synagis in 2013.

• Achieving 100% sales over plan of Survanta in 2013.

• Maximizing penetration of late preterm for Synagis in King Abdel Aziz Hospital resulting in 68% growth in season consumption.

• Participation in the Penetrate project with Market Access Manager to arrange two lectures with External Experts, Dr.Ali Mersal (NICU Consultant - KFSH) and Dr.Jubarah Alallah (Senior NICU Consultant - KAMC).

• Participation in the arrangement and coordination of the 3rd Protect Forum held in Dubai in 2013.

• Arrangement of World Prematurity Day in King Abdul Aziz Hospital - Jeddah on 17/11/2013.

• Growing season consumption in Mature TPH by 26% over last season while total kingdom growth in TPH is 4%.

• Growing season consumption in MOH by 34% compared to last season.

• I was awarded for SFE achievement in 2013.

• Achieved Synagis 120% sales over plan.

• Achieved Survanta 105% sales over plan.

• Representing Neonatology Unit during AAAME (Asia, Australia, Africa, Middle East) director Jells Picard visit to Saudi Arabia with field visit to King Faisal Specialist Hospital and Research Center and meeting with Dr.Ali Mersal and Dr.Amal Zubani.

• Establish RSV clinic in all MOH hospital in my area to achieve patient inclusion 431 patients

• Successful Growth of Total Area Consumption 29% in Synagis consumption.

• Achieved 100% score in Global PKS.

• Contribution to the Protect Forum organization for the whole doctors representing the western region with the Product Manager.

• Co-Operation with my college Hassan Al Najjar for the process of including the Synagis to Al Qounfdah City in the SGH 35 tender.

Major Achievements per Product (2011):

Synagis: 180% sales versus target:

• Growing the business in Mature Hospital through gap analysis e.g. Al Hada Military Hospital: Acquired 2 Direct Purchase Orders in one Year with very healthy closing stock.

• Penetration of 33 to 35 weeks GA segment for the RSV Prophylaxis in KKNGH-Jeddah.

Survanta: 125% sales versus target:

• Implementation of Single-Use of Survanta vials in King Abdel Aziz Specialist Hospital in Taif (Tertiary Hospital for All Taif Area) and all other MOH and TPH under responsibility.

• Implementation of Best Practices and Recommendation of American Academy of Pediatrics and European Guidelines for the Use of Surfactant (Survanta) in the Neonatology regarding Prophylaxis Protocol, Rescue Protocol, Multiple Dose, Different Patient Profiles that require this Product in KFH – Al Baha.

Major Achievements per Product (2010):

Synagis: 128% sales versus target.

• Introduction of Synagis in KFH, Al-Baha Area by Direct Purchase.

• Establishing of RSV Clinic in KFH and KAAH & OC.

• Developing Local Guidelines for RSV Prophylaxis in KAAH & OC.

• Starting RSV clinic in KSMC in Riyadh and all the MOH for the first time during Emergency Leave of my colleague Hend Fadel.

Survanta: 125 % sales versus target.

• Implementation of Single Use of Survanta Vial in KFH, KFSH and KAAH & OC.

• Develop a Single Use Memo of Survanta in KFH. Lupron: 130 % sales versus target.

• Introduction of New Strength (22.5 mg) in Al Hada Military Hospital, this representing the first MODA hospital to add this strength to the formulary.

• Introduction of the Pediatric Form to Taif MOH and supplying the product by direct purchase to Main Hospitals like Maternity and Children Hospital in Jeddah.

• Recommendation to Add Lupron to MOH Formulary from Maternity and Children Hospital in Jeddah and Pediatric Hospital in Taif and King Fahad Hospital in Al Baha.

• Preparation of Comparison Presentation between Lupron and Zoladex used in the introduction phase of Lupron to SGH tender with cooperation of KAM team

Responsible for all the commercial activities within the assigned territory:

• Branding Reductil as the missing element for a comprehensive and effective weight loss regimen.

• Awareness Campaign about Obesity as a disease defined by WHO in 1998.

• Promotion based on scientific data supporting Sibutramine as FDA and EMEA approved medication for the management of Obesity.

• Conducting and Contribution in many group meetings for Health Care Professionals and Speaker Tours to raise the awareness about Obesity.

• Free service to community in Public Gathering places like malls and pharmacies of measuring weigh, body fat, and medical hint through HCP to them.

• Counteracting the herbal approaches to this market which use advertisement as sole promotion way because there is no scientific evidence behind the use of herbals in management of Obesity.

• Achieved 62% Market Share versus all other commercially available products for weight management.