Michael Saddekni, M.D., PgDip, BCMAS

• Act as the medical expert with specialised therapeutic expertise across indications, clients, and drug development.
• Initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts, and serve as a medical monitor for contracted projects.
• Delivers medical monitoring activities according to MMP during the study conduct
• Delivers all medical support required for successful delivery of the projects according to the contracted agreement with the sponsor.
• Participates in the development and review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc. in conjunction with clients and sponsors or in conjunction with other Parexel departments
• Participate in periodic rotas including night and weekend shifts for emergency medical contact and emergency unblinding phone requests for Parexel studies, as applicable and/or appropriate for the MD
• Delivers medical leadership to the project in close coordination with the Project Leader.
• Participates actively in study planning with feasibility leaders, solution consultants
• Participates in team project and investigator meetings
• Provides training of study teams on TA indication and protocol
• Communicates with relevant sponsor counterparts on challenges and accomplishments related to assigned project/study
• Provide risk assessment of clinical trials for local sponsorship as needed
• Provide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events.
• Support regulatory safety reporting activities
• Medical review of various documents, which might be audited by clients and regulatory agencies
• Provide medical expertise and training to other Parexel colleagues
• Write medical documents
• Consultancy on protocol development or drug development program
• Participate in activities to raise, coordinate and promote Parexel medical expertise both internally and externally including but not limited to internal therapeutic area meetings, training modules development, white papers, slide sets, publications etc.
• Support patient centricity, diversity and inclusion in all projects

• responsible for Lenacapavir's launch activities in the United States, collaborating cross-functionally with regulatory, field medical, and commercial teams.
• Collaborate on the development and implementation of the USMA HIV Treatment POA.
• lead and organize the first HIV Treatment MA Webinar.
• lead in the creation of the USMA's inflammation and HIV content.
• Medical reviewer for the HIV Promotional Review Committee (PRC) and Medical Review Committee (MRC).
• Collaborate closely with the Commercial Learning & Development team to develop medical education materials for new hires, as well as approved workshops/supplemental materials for the TS team.
• Partner with Medical Affairs' Learning and Development team to develop and provide educational materials for our recently appointed MS.
• Assist and direct the MS team with medical knowledge, support, and direction.
• Review and approval of materials for speaker training
• As the Team Editor for post-conference content delivery, I led the participation and planning of virtual international, national, and local conferences on HIV.
• Collaborate closely with and support the COVID-19 Team's development and expansion of research collaboration.
• Collaborate with the COVID-19 team to provide medical material that will provide our KOLs with the most up-to-date knowledge and data.
• assured continuous alignment, collaboration, and synergistic relationship with the global MA in all actions where our objectives are aligned.
• Collaborate closely with the field team's directors to ascertain current field insights and to supply approved medical items for field use.
• Leading the development of innovative digital communication platforms and engagement capabilities
• Providing global medical affairs support for critical cross-functional launch operations in the U.S.
• establishing and managing HIV Treatment Journal Clubs.
• Oversee the planning and delivery of our national meeting sessions.

• Leading rheumatoid arthritis and inflammatory bowel disease Filgotinib's post-launch activities in the United States , Japan, and Europe
• Co-create and implement the USMA Inflammation POA, and implement the USMA's first digital strategy
• lead many medical affairs advisory programs and Gilead's first digital strategy program.
• lead in the creation of the USMA's inflammation content
• As the Team Editor for post-conference content delivery, I led the participation and planning of 20 virtual international, national, and local conferences on rheumatoid arthritis and inflammatory bowel disease.
• Medical reviewer for the US Promotional Review Committee (PRC), and the US Medical Review Committee (MRC).
• reporting to the Vice President for Medical Affairs. establishing and leading a new MRC process across all therapeutic areas.
• I served on the Independent Medical Education (IMED) Committee, which reviewed and provided medical input on IMED proposals in the United States.
• Work cross-functional with regulatory, field medical, and commercial to launch Filgotinib in RA and IBD.
• Collaborate cross-functionally with marketing and commercial teams to strategize our Filgotinib launch plan in rheumatoid arthritis and inflammatory bowel disease (IBD).
• Medical lead for other molecules in our pipeline like Interleukin-1 Receptor-Associated Kinase 4 (IRAK-4) for chronic spontaneous urticaria, and ziritaxestat for IPF.
• Cross-functional collaboration with regulatory, commercial, and marketing teams to develop a strategic plan for worldwide and national conferences.
• Leading efforts in Rheumatology to generate data and build long-term medical affairs strategy plans
• Supervises USMA Interns in Inflammation
• Leading the USMA's endeavor to cooperate with the global team and foreign partners on inflammation, Galápagos must align its medical approach, provide materials, and cover international conferences.
• Direct the MS team with medical knowledge, support, and direction.
• Assured continuous alignment, collaboration, and synergistic relationship with the global MA in all actions where our objectives are aligned
• Collaborate closely with the field team's directors to ascertain current field insights and to supply approved medical items for field use.
• Leading the development of innovative digital communication platforms and engagement capabilities
• Providing global medical affairs support for critical cross-functional launch operations in the U.S.
• Leading cross-functional projects with HIV and COVID USMA teams.
• co-lead the development of the USMA team's inaugural webinar in collaboration with the Association of Women in Rheumatology (AWIR).
• Collaborate with the COVID-19 team to provide medical material that will provide our KOLs with the most up-to-date knowledge and data.
• Partner with Medical Affairs' Learning and Development team to develop and provide educational materials for our recently appointed MS.
• Oversee the planning and delivery of our National meeting.
• Collaborate closely with the Commercial Learning & Development team to develop medical education materials for new hires.

• Participating in peer-to-peer scientific communication effectively communicates scientific, medical, technical, or product (reactive) content.
  Identifying key opinion leaders (KOLs) and collaborators within the assigned territory
• Developing relationships with key opinion leaders (KOLs) in the assigned territory through scientific exchange.
• Take part in and co-lead the MA advisory board.
• Supporting HCP field education, training, and drug safety
• Company-sponsored research, investigator-initiated research, external collaborative research, and product-related publications are all supported.
  obtaining scientific and clinical insights based on scientific information and clinical data sharing in order to optimize medical communications and coordinate strategy and tactics across the organization
• I am responsible for ensuring appropriate communication of clinical and scientific information regarding FDA-approved and pipeline products in a timely, ethical, and customer-focused manner.
• Responding to MIRFs as soon as possible with an initial contact
• Contributing to the scientific content of a project or initiative and/or assisting in the creation of materials in support of the project or initiative
• Lead team activities at the American College of Rheumatology and the Association of Rheumatology Professionals' Annual Meeting (ACR/ARP 19), the Congress of Clinical Rheumatology West, the 13th Annual Rheumatology Winter Clinical Symposium, and other meetings in the assigned territories.
• Take on the role of PsA and RA expert.

• Delivers medical monitoring activities according to MMP during the study conduct
• Collaboration with regional medical teams to ensure that regional activities support the medical strategy.partner with regional medical teams to ensure regional activities are aligned with medical strategy.
• Contribute to the review and approval of research initiated by investigators.
• Conducting a review of current trial enrollment and assisting principal investigators in under-recruitment sites
• Leading efforts to implement global medical strategies, including data creation and communication plans, and data management plans.
• Assisting with the review of abstracts, training, advisory boards, and other data communication possibilities
• Preparation, review, and oversight of the submission of four DSMB reports successfully
• Participating in site initiation visits and delivering training to key subject matter experts and their employees
• Prepare, review, and lead the annual PAS report submission successfully
• Conduct medical reviews of ICSRs and medical coding; develop pertinent medical inquiries; contact site investigators to discuss case if necessary; draft analysis of similar occurrences for expedited cases.
• Submitting the most comprehensive MDR and vigilance reports
• Review and offer medical input on the Complaint Investigation Report (CIR) form, including the preparation of medical narratives, as well as approving
• Review and provide input on Safety plan, DSMB meeting, Post-approval studies (PAS)and CEC Adjudication events
• Collaborate with regulatory affairs to identify reportable adverse events and develop clinical narratives for submission to ANSM, FDA, and other regulatory bodies.
• Train CRAs in all aspects of safety management, including AE reporting, SMP, DSMB, common errors, and coding norms (AE/SAE).
• Review and offer feedback on regulatory, clinical, and safety papers, such as protocols, IBs, annual safety reports, safety reporting forms, and SAPs.
• Examine database for consistency and medical logic with respect to pertinent clinical data, which may include, but is not limited to, patient demographics, past medical history, concomitant medicine, adverse event and serious adverse event listings, and protocol deviation listings, and prepare appropriate data clarification forms as needed
• Generating medical queries
• Supervise and collaborate with the ISAResearch Center to resolve any adverse event queries that arise during the review of source documents (SD)
• Contributing medical expertise to AE/SAE medical coding
• Examining and approving online and paper Medical Dictionary for Regulatory Activities (MedDRA) code listings for medical accuracy in accordance with study specific requirements Plan for Data Management
• Supervise monthly AE/SAE reviews with the purpose of identifying incidents to forward to the CEC adjudication committee.
• Support and knowledge in medical safety for internal and external stakeholders
• Successfully led and ensured that the Data Management Plan was implemented (DMP)

• Conducting a thorough medical review of the patient in order to accurately identify pertinent clinical evidence indicating the presence of a medical diagnostic or a more precise medical diagnosis
• In the East Bay KP, I lead a team of nine medical consultants. Oversee the East Bay team's medical reviews of cases involving a variety of specialties: Internal Medicine, Rheumatology, Dermatology, Nephrology, Cardiology, Hematology, Oncology, Endocrinology, Psychiatry, Pulmonary Disease, and Gastroenterology are just few of the specialties covered.
• Ranked top in 2018 with a YTD average of 292.2 clinical cases reviewed. 214 is the average for the entire team.
• Provides a succinct summary of findings to treating physicians for their evaluation and future investigation
• Successfully led critical initiatives that resulted in the addition of over ten new medical problems to the program.
• Conducts data, process, and root cause analysis in order to enhance the clinical review process and documentation.
• Successfully collaborated with physician leaders, project managers, and other clinical personnel to identify and handle clinical issues and process gaps.
• Assume the primary medical leadership role and serve as the clinical expert in Rheumatology and Immunology.
• Oversee the East Bay team's response to acute disorders such as multiple myeloma (MM), neutropenia, pancytopenia, thrombocytopenia, aplastic anemia, ostomy, cachexia, and hypogammaglobulinemia.

Department of Medicine, Division of Clinical Immunology and Rheumatology

The Center of Education and Research on Therapeutics(CERTs)

Center of Research Translation(CORT) in Gout and Hyperuricemia

• Diagnosis and treatment of up to 15 patients per day suffering from a variety of medical and rheumatic diseases.
• Diagnosis and treatment of patients suffering from a variety of medical and rheumatologic conditions
• Three days a week, I worked in Rheumatology, Osteoporosis, and Gout clinics.
• Reporting and following up with Kenneth Saag, M.D. on patient treatment and diagnosis
• Developed, established, and implemented a protocol for reviewing clinic results on a timely basis, with follow-up steps for abnormal findings or results.
• I designed and implemented a new Gout note that will be used by other providers.
• Among the responsibilities are the following: Management, conduct, recruitment techniques, and clinical support for clinical trials
• Engage in scientific debates with an awareness of the attitudes and research interests of Key Opinion Leaders
• Prepare and analyze quarterly aggregate safety reports for submission to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAM), as well as providing support for DSMB meetings.
• Designed the SURPHER trial, a P50 NIH-funded study on gout and hyperuricemia conducted by the Center for Research Translation (CORT). The purpose of this study was to determine the effect of urate lowering therapy (ULT) on endothelial dysfunction. As initial author, I published the design paper.
• Contribute to the design of clinical trials by bringing scientific and medical knowledge to the table.
• Lead research design, scientific input through lecture searches, and protocol drafting in: "examine the effects of Prolia with ULT on gout erosion, supported by AMGEN, and second study with AMPEL." "Reduce the immunogenicity of Pegloticase by administering immune modulators"
• Supervised, coordinated, and monitored patients’ visits for SURPHER study, by performing the protocol producers, monitoring participant adherence to protocol, performing regular data cleaning, doing data analysis, and assessing drug side effects
• Principal investigator on an NIH P50 auxiliary study to the SURPHER project funded by the National Institutes of Health. The study's findings were presented as a poster at the 2016 American College of Rheumatology annual meeting in Washington, DC, and the 2017 European League Against Rheumatism annual meeting in Madrid, Spain.
• For other clinical trials, monitor and report adverse occurrences to safety officers. Interactions with investigators regarding clinical trials, research, and portfolio questions in rheumatology and immunology
• Attend scientific meetings on a national and international level, including but not limited to ACR, EULAR, and CCRs.
• Collaborated with investigators to initiate clinical trials with a variety of firms, including SOBI, AMPEL, Astrazeneca, Horizon, Amgen, and Takeda.
• Significant clinical trials include the following:
• "Double-blinded, crossover trial in which participants are randomly assigned to 300 mg of allopurinol as ULT or placebo to evaluate the effects of urate lowering therapy on inflammation, endothelial function, and blood pressure (SURPHER) study" funded by the National Institutes of Health.
• A phase 2 therapeutic exploratory trial comparing SQ anakinra to IM triamcinlone in the treatment of acute gouty arthritis" Sobi
• "A randomised multicenter pilot trial to assess if adding denosumab to intensive urate-lowering medication resulted in a reduction in computed tomography (CT) erosion scores in patients with gout or chronic tophaceous gout." funded by Amgen.
• "A randomised, prospective comparison of an interactive voice response (IVR) telephone questionnaire/flare reporting system versus RheumPRO (a smartphone research application) with crossover." funded by Astrazeneca
• "A Randomized, phase 2 therapeutic exploratory, double blinded, active control, multi center, efficacy and safety of SQ anakinra compared to IM triamcinlone in the treatment of acute gouty arthritis" funded by Sobi
• "Randomized multicenter pilot trial to evaluate if the addition of denosumab to intense urate-lowering therapy will lead to reduction in computerized tomography (CT) erosion scores in patients with radiographic damage caused by gout or chronic tophaceous gout " funded by Amgen
• "Exploratory open label, phase 2, multicenter study to evaluate the effectiveness of a 16-week high zone tolerance regimen of pegloticase on response to therapy" funded by UAB.
• “Observational phase 4 study of use of KRYSTEXXA (pegloticase) in adult hyperuricemic patients with gout refractory to conventional Therapy” funded by Savient Pharmaceuticals
• "Rheumatology and Arthritis database and Repository (RADAR), to identify genetic and other factors that determine severity of different rheumatic diseases " funded by UAB
• " A prospective, randomised study comparing an interactive voice response (IVR) telephone questionnaire/flare reporting system to RheumPRO (a smartphone research application), with crossover " funded by Astrazeneca.

• Division of Cardiovascular Disease of the Department of Medicine
• Observe rotation in Cardiac Catheterization Laboratories: observed procedures such as cardiac catheterization (via femoral or radial artery access) including coronary angiography and ventriculography, intra-aortic balloon pump placement, conventional balloon angioplasty and stenting, rotational atherectomy, directional atherectomy, rheolytic thrombectomy, and peripheral angioplasty and stenting including the subclavian, renal, and iliac arteries
• Rotational clinical experience in the Cardiac Care Unit. Was exposed to a broad range of difficult cardiology issues in critically sick patients, including hemodynamic monitoring, hemodynamic support, and ventilator management. Observed acute and chronic heart failure patients being managed with inotropic and mechanical assistance
• Attendance at all Cardiovascular Symposiums/Grand Rounds, Research Seminars, and Journal Clubs

• Observe clinical rotations in Hepatology and Gastroenterology consult services on hospitalized patients in both surgical and medical services, as well as in various intensive care units, under the supervision of Dr. C. Mel Wilcox, MD.
• I reviewed the specialty fellow's patient charts, rounded with the team, and discussed the care plan.
• Observed regular gastrointestinal procedures associated with hepatic illness, including endoscopic variceal hemorrhage therapy and liver biopsies.
• Observed regular gastrointestinal procedures such as esophagogastroduodenoscopy and colonoscopy.
• Prepared and presented a talk on pancreatic Divisum based on a case on the floor.
• Clinical Conferences/Grand Rounds, Research Seminars, and Journal Clubs were all attended.

• Coordinated patients' admissions and discharges, coordinating any additional care needs with family members and case managers.Conducting a history and physical examination, devising an assessment and treatment plan, conducting rounds, keeping track of patient progress, and ordering tests, examinations, drugs, and therapies
• Interpreting test results, coordinating discharge and follow-up care, and executing procedures.
• Test findings and information acquired during examinations are thoroughly examined to ensure appropriate diagnosis of illnesses and conditions.
• Referred patients on a regular basis to medical specialists or other practitioners for more specialized treatment. With patients and their families, patiently explained prescribed procedures and reviewed test results.
• Assessed patient health during admissions and on a frequent basis to stay current on changing medical conditions.
• Coordinated patients' admissions and discharges, working closely with family members and case managers to line up any additional care needs.

• Initial and continuous evaluation of the patient's medical, physical, and psychosocial status by handwriting or dictating admission notes, progress notes, procedure notes, and discharge summaries
• Conducting a history and physical examination, devising an assessment and treatment plan, conducting rounds, noting progress, and prescribing tests, examinations, drugs, and therapies. Interpreting test results, planning for discharge and follow-up care, and executing operations are all part of the job description.
• Educating and counseling patients regarding their health state, laboratory test findings, disease processes, and discharge planning
• Served as a resident's elected associate chief
• Referred patients on a regular basis to medical specialists or other practitioners for more specialized treatment regimens