Medical Affairs Insight Research GCC

The medical affairs role in the GCC commercial model

Medical affairs (MA) sits at the interface between clinical evidence and healthcare practice — a function that is legally and operationally distinct from commercial sales and marketing. In GCC markets, the MA function has expanded substantially since 2018. Regional MA teams are now routinely based in Dubai Healthcare City (DHCC) and Riyadh, with headcount ranging from two to three MSLs per country for mid-tier launches to eight to twelve MSL field personnel for large-market oncology or cardiology programmes. The MA team owns HCP relationships at the scientific level: convening advisory boards, facilitating medical education, engaging KOLs on clinical data, and managing IIS programmes — all governed by IFPMA Code, local SFDA Advertising Guidelines (SFDA Circular No. 10573 on promotional standards), DHA Advertising Permits, and applicable MOH codes in each Gulf state.

GCC regulators have progressively clarified the MA/commercial boundary. SFDA's 2022 update to its pharmaceutical advertising controls explicitly distinguishes scientific exchange activities — where MA can discuss unapproved indications in response to unsolicited HCP questions — from promotional activities requiring prior regulatory approval. DHA in Dubai and DOH in Abu Dhabi maintain analogous frameworks. This regulatory architecture creates both an opportunity and an obligation for MA teams: the opportunity to engage KOLs on nuanced clinical questions that commercial teams cannot address; the obligation to demonstrate that scientific exchange is evidence-led, objective, and non-promotional.

Insight research is the foundation of effective MA execution. Without systematic understanding of what GCC KOLs believe about a therapy area, what evidence they find compelling, what data they consider insufficient, and how they prefer to engage scientifically, MA teams operate on assumption. BioNixus conducts primary MA insight research that replaces assumption with structured, reproducible intelligence.

KOL identification, tiering, and mapping in GCC

KOL identification in GCC requires multi-source triangulation. No single registry or database captures the full landscape of scientific influence across Saudi Arabia, UAE, Kuwait, Qatar, Bahrain, and Oman. BioNixus combines publication database searches (PubMed, Scopus, Google Scholar with institutional affiliation filters), conference speaker and abstract presenter lists (ASMO, Gulf Congress of Cardiology, Saudi Society of Clinical Oncology, ACCF, SEHA annual congress, Gulf Thoracic Society), institutional faculty directories at academic medical centres, and social professional networks where GCC physicians are increasingly active — particularly LinkedIn and ResearchGate.

Saudi Arabia presents the deepest KOL pool in the GCC, anchored by KFSH&RC (King Faisal Specialist Hospital and Research Centre), which ranks among the top research-active hospitals in the Middle East by publication output. KAMC (King Abdulaziz Medical City, NGHA network) and King Khalid University Hospital are significant secondary centres. In oncology, the Saudi Oncology Society and SSCO (Saudi Society of Clinical Oncology) provide a structured community; in cardiology, the Saudi Heart Association. UAE's academic KOL base, while smaller than Saudi Arabia's, is growing rapidly through Cleveland Clinic Abu Dhabi, Mediclinic City Hospital Dubai, and academic affiliations with UAE University and Mohammed Bin Rashid University (MBRU).

KOL tiering at BioNixus uses a five-criterion framework: (1) scientific output (peer-reviewed publications, h-index relative to regional peers), (2) institutional authority (department head, division chief, professorial appointment), (3) guideline and policy influence (membership of national CPG committees, Saudi Health Council working groups, DHA formulary advisory panels), (4) congress presence (invited speaker, abstract presenter, session chair at key GCC meetings), and (5) peer network centrality (named as influential by other identified KOLs in snowball validation interviews). The resulting tiered map distinguishes Tier 1 national/regional scientific leaders (typically 5–10 individuals per therapy area per major GCC country), Tier 2 institutional influencers, and Tier 3 high-prescribing practitioners.

A standard KOL mapping programme covering 20–30 KOLs across one therapy area and two to three GCC countries costs between $30,000 and $65,000 and delivers within six to eight weeks, including a validated tiered landscape map, individual KOL profiles, recommended engagement sequencing, and a relationship entry strategy for each Tier 1/2 KOL.

Scientific exchange receptivity research: what GCC KOLs want from your data package

Scientific exchange receptivity research answers a question that many MA teams approach qualitatively but rarely measure systematically: which elements of the current clinical evidence package do GCC KOLs find most and least compelling, and what additional data would change their scientific position on the therapy? This research is distinct from brand perception tracking — it focuses on the evidence, not the brand — and is therefore governable under MA scientific exchange frameworks rather than promotional research rules.

BioNixus conducts scientific exchange receptivity research through in-depth interviews (IDIs) with Tier 1 and Tier 2 KOLs in the target therapy area. Sessions are 45–60 minutes, conducted by medically trained interviewers, and structured around a stimulus-based discussion guide that walks KOLs through the product's clinical evidence package: pivotal trial design and patient population, primary and secondary endpoints, subgroup analyses, comparator data, safety profile, and any published or presented real-world evidence. Interviewers probe: which data points the KOL independently weighs most heavily in clinical practice; where they have unresolved scientific questions after reviewing the evidence; whether the patient population represented in pivotal trials matches the GCC patients they treat; and what additional data — specific endpoints, duration extensions, GCC-specific RWE, head-to-head comparators — would increase their confidence in the therapy's clinical position.

In KSA and UAE, recurring themes in scientific exchange receptivity research include: concerns about ethnic population representativeness in cardiovascular and metabolic endpoints; requests for longer-term safety data in younger patient populations (GCC patients with chronic conditions often present at younger ages); interest in real-world adherence data reflecting GCC prescribing and patient behaviour; and specific queries about comparative performance against locally dominant treatment standards, which may differ from those in US or European trial designs.

Medical education needs assessment in GCC

Medical education needs assessment (MENA) research systematically identifies what educational topics GCC physicians consider priority gaps in their clinical knowledge or practice, and which formats they prefer for receiving that education. For pharma MA teams, MENA outputs directly inform symposium programming at congresses, independent medical education (IME) grant prioritisation, clinical compendium content, and medical writing resource allocation.

BioNixus conducts MENA research through online surveys (75–150 physician respondents per therapy area), supplemented by qualitative IDIs with 8–12 key informants. Survey instruments cover: self-rated proficiency across therapy area clinical domains (diagnosis, staging, treatment selection, monitoring, management of complications), identification of specific clinical scenarios perceived as under-addressed by current CME content, preferred educational formats, preferred language (Arabic vs. English — notable given that a significant proportion of Saudi and Kuwaiti physicians trained in Arabic, while UAE's expatriate physician workforce predominantly prefers English content), and preferred event types (international congress vs. local symposium vs. satellite meeting vs. digital webinar vs. printed case-based compendium).

Format preferences vary substantially by GCC country and physician profile. Saudi physicians, particularly those based outside Riyadh and Jeddah in regional centres, often have constrained access to international congresses and show higher appetite for in-country symposia and digital content. UAE-based physicians, many of whom hold international medical training, frequently attend international congresses and may rate IME at ESMO, ESC, or ASH as high priority. Arabic-language preference is more pronounced in Saudi Arabia, Kuwait, and Bahrain than in UAE, Qatar, or Oman, where the expatriate physician workforce favours English.

A standard MENA survey covering 75 HCPs in one therapy area across two to three GCC countries costs $20,000–$40,000 and delivers within five to seven weeks.

Evidence gap analysis: building the clinical data case for GCC

Evidence gap analysis is the systematic identification of where a product's current clinical data package fails to address the questions raised by GCC payers, formulary committees, or KOLs — and what new evidence generation (publications, IIS, RWE studies, HEOR analyses) would close those gaps. It is one of the most strategically valuable MA insight activities and directly feeds publication planning cycles, IIS priority frameworks, and HEOR evidence generation programmes.

BioNixus conducts evidence gap analysis through a three-stage process. Stage one is a structured literature and dossier review: BioNixus analysts map the current evidence landscape — published pivotal trials, supplementary analyses, real-world studies, HEOR publications, HTA submissions — against GCC-specific clinical and access requirements. Stage two is KOL qualitative research: IDIs with six to ten Tier 1 KOLs and relevant payer advisors (formulary committee members or market access consultants with visibility of SFDA, DHA, and joint procurement body review criteria) to identify what evidence they find absent or insufficiently robust. Stage three is gap prioritisation: a structured analytical matrix that ranks identified evidence gaps by clinical importance, commercial impact, evidence generation feasibility within the GCC research infrastructure, and estimated time-to-impact.

Common evidence gap categories in GCC drug launches include: absence of local population-specific clinical data, gaps in head-to-head comparator evidence relevant to GCC treatment standards, insufficient long-duration real-world safety data, and lack of locally adapted economic modelling supporting formulary submissions to SFDA or joint Gulf procurement bodies. Evidence gap analysis as a standalone programme costs $20,000–$45,000 and is frequently scoped alongside IIS planning and publication strategy work.

IIS landscape in GCC: academic capacity, IRB processes, and investigator identification

Investigator-Initiated Studies (IIS) — also termed investigator-sponsored trials or studies — are clinical or real-world studies conceived and executed by academic investigators, with pharma companies providing drug supply, funding, or both. In GCC, IIS activity has grown significantly since 2018, driven by expanding academic research infrastructure, Saudi Vision 2030's explicit emphasis on clinical research output, and increased KFSH&RC research funding.

KFSH&RC (Riyadh) is the leading IIS-capable institution in the Gulf for oncology, haematology, and rare diseases. Its IRB (Institutional Review Board) processes IIS applications within 6–10 weeks for amendments to existing protocols and 10–16 weeks for de novo studies. KAMC (King Abdulaziz Medical City, operated by NGHA) has active research offices at both Riyadh and Jeddah campuses. In UAE, Cleveland Clinic Abu Dhabi has demonstrated IIS capability in cardiology and critical care; Mediclinic City Hospital Dubai maintains a clinical research office; and Tawam Hospital (Abu Dhabi) has oncology research infrastructure supported by IARC affiliation.

IIS challenges in GCC include: patient recruitment timelines that are often longer than institutions project (12–24 months to full recruitment for most moderate-size studies); variable IRB rigor and timeline predictability across institutions; data management and biostatistics capacity constraints outside KFSH&RC; and procurement and drug supply logistics involving SFDA import permit requirements for investigational medicines.

BioNixus IIS planning research maps institutional capacity against scientific priority, identifies motivated investigators through KOL engagement research, and provides a ranked IIS opportunity matrix. This research helps MA teams deploy limited IIS budgets — often $50,000–$250,000 per study in drug supply equivalent — against the opportunities with the highest scientific return and commercial access impact.

MSL effectiveness research: measuring field MA impact in GCC

MSL (Medical Science Liaison) effectiveness research measures the quality, relevance, and impact of field MA scientific exchanges with specialist HCPs. In GCC, this research addresses specific operational challenges: MSL territories are large (a single MSL may cover Saudi Arabia, or all of GCC), HCP availability fluctuates seasonally (Ramadan period significantly reduces clinical appointment availability in KSA, Kuwait, and Bahrain), and hospital access policies in the UAE post-2020 introduced new restrictions on industry representative access at government hospitals.

BioNixus MSL effectiveness research combines HCP perception surveys (30–50 specialist physician interviews), MSL structured debrief interviews (all field MA team members), and CRM data review. HCP surveys assess: interaction frequency adequacy; scientific content quality; MSL's ability to address clinical questions with evidence rather than promotional material; preferred engagement format (in-person consultation room, congress-side meeting, digital video call, WhatsApp-based scientific exchange); and overall value of MSL interactions relative to other scientific information sources such as peer-reviewed journals, congress presentations, or medical society communications.

GCC-specific engagement dynamics that BioNixus captures include: the role of WhatsApp as a primary HCP communication channel (60–75% of GCC specialists use WhatsApp for professional communications including with industry MA contacts, per BioNixus fieldwork observations); the importance of congress-based scientific exchange at regional meetings (ASMO, Gulf Congress of Cardiology, Saudi Thoracic Society); and the rising use of LinkedIn for KOL relationship management, particularly among UAE-based international medical graduates.

Saudi Vision 2030 and the evolving GCC medical affairs landscape

Saudi Vision 2030 is reshaping the environment in which pharma medical affairs teams operate. Three dimensions are directly relevant to MA insight research. First, the expansion of academic medical centres: NEOM's planned healthcare city, KFSH&RC capacity expansion, and MOH hospital upgrades under the National Transformation Programme are all increasing the pool of academically active Saudi physicians with institutional research support. This expands the KOL landscape and creates new IIS opportunities, but also means that KOL maps need more frequent refresh than in prior years. Second, growth in local publication output: Saudi-affiliated authorship in high-impact medical journals has increased year-on-year since 2018. KFSH&RC publications in oncology, cardiology, and rare disease disciplines now appear regularly in The Lancet Oncology, NEJM, and JACC. MA teams that do not track this local publication base miss emerging KOLs and fail to align their scientific narrative with locally generated evidence. Third, healthcare system restructuring: the shift from MOH-operated hospitals to semi-independent healthcare clusters (Vision 2030 healthcare cluster model) has created new formulary decision-making structures that MA teams need to map. Understanding which clinical leaders hold formulary authority in newly structured healthcare clusters requires dedicated MA insight research rather than assumptions based on historical MOH structures.

Key GCC scientific congresses for MA intelligence and KOL engagement

GCC scientific congresses are high-value nodes for both KOL identification and scientific exchange. BioNixus maintains active congress intelligence for key regional meetings:

• ASMO (Arabian Society of Medical Oncology) Annual Congress: The leading regional oncology meeting, typically held in a GCC city with 800–1,200 attendees. Critical for oncology KOL identification and competitive scientific exchange intelligence.
• Gulf Congress of Cardiology: Multi-day cardiology meeting co-organised by the Gulf Heart Association, drawing Saudi, UAE, Kuwaiti, and Bahraini cardiologists. Primary venue for cardiovascular KOL engagement in the Gulf.
• Saudi Society of Clinical Oncology (SSCO) Annual Meeting: Saudi-focused oncology meeting, increasingly attracting abstract submissions from KFSH&RC and KAMC researchers. Important for monitoring emerging Saudi oncology KOLs.
• ACCF (Arab Congress of Clinical Pharmacology and Therapeutics): Relevant for MA teams in therapeutic areas where clinical pharmacology and evidence-based prescribing are active academic topics.
• SEHA Annual Forum (Abu Dhabi Health Services): UAE government health system forum — important for MA teams seeking to understand DOH and HAAD policy directions and engage institutional leaders in Abu Dhabi's healthcare network.
• Saudi Thoracic Society Annual Congress: Primary venue for respiratory and pulmonology KOL engagement in Saudi Arabia.

BioNixus congress intelligence services map KOL presence, abstract submission activity, and scientific exchange opportunities at these meetings, integrating congress-sourced intelligence into ongoing KOL tiering and MA insight programmes.

Advisory board research in GCC: design, execution, and output quality

Advisory boards (AdBoards) are structured scientific consultations bringing together five to twelve KOLs to advise on clinical evidence interpretation, treatment guideline evolution, unmet medical need, and future evidence generation priorities. In GCC, AdBoards face specific design challenges: convening Tier 1 KOLs across multiple countries requires careful scheduling around clinical commitments, Ramadan, Hajj and Eid periods (which affect Saudi physicians particularly), and individual congress calendars; Arabic/English facilitation requirements; and appropriate honorarium structures compliant with IFPMA and local code standards.

BioNixus supports AdBoard design through pre-board qualitative research — IDIs with prospective participants to understand their scientific positions before convening, ensuring the agenda addresses genuine knowledge gaps rather than rehearsing consensus. We also provide post-board insight synthesis, translating discussion outputs into a structured intelligence report for the MA team covering: areas of participant consensus and disagreement, identified evidence gaps, recommended future evidence priorities, and participant-specific follow-up opportunities. A full GCC advisory board (5–8 KOLs, single meeting, one therapy area) costs $20,000–$45,000, including participant recruitment, facilitation support, and insight synthesis.