Nushev Biotech Advisory
Nushev Biotech Advisory
Independent advisory for emerging biotech and pharma companies navigating clinical development, fundraising, and regulatory milestones.
Get in touch See servicesEvery engagement starts with your specific goals, not a standard package. Services are tailored to where your company is and what needs to happen next, with a consistent focus on the outcomes that move your program forward. Click a card for details.
A plan built around your program's specific risks and timeline — trial design review, phase transition planning, and operational strategy focused on keeping you on track and investor-ready.
A narrative shaped around your data and your investors, not a template pitch — positioning, data room prep, and targeted investor outreach built around specific value-inflection milestones.
Landscape assessments and competitive intelligence tailored to your therapeutic area, giving you a clear, defensible position ahead of the milestones that matter most.
Pathway guidance built around your program's specific profile, coordinated closely with specialist regulatory counsel to keep your submission strategy on the fastest realistic route to approval.
Diligence scoped to the specific questions that matter for your deal — scientific and commercial review built to help investors and partners reach a confident, well-informed decision.
Partnership and licensing strategy shaped around your goals, focused on building the specific relationships that move your company toward its next milestone.
The clinical and operational background behind the consultancy.
20+ years in clinical research and operations across CRO and pharma environments, including 17+ years in oncology/onco-hematology and 9+ years in Phase I/early Phase II studies. My background spans global roles at organizations including Novartis, IQVIA, and WCG, along with CRO leadership positions across Europe.
I led the launch and clinical-data implementation of the first Entresto Post-Approval Study in the US & Canada, a milestone within Novartis' PLS Cardiology program, and built the clinical operations function for Bulgaria & Serbia at Accelsiors CRO, including direct FDA audit readiness. Over two decades I've executed 600+ routine monitoring visits and 200+ site initiation visits across Phase I–IV trials, spanning oncology, cardiovascular, immunology, rare disease, and CAR-T/first-in-human programs.
I hold an MD from the Medical University of Sofia and completed immunology coursework at Harvard Medical School in 2025. I now bring that operational and clinical depth to small-to-mid-sized biotechs as fractional leadership — without the cost of a full-time C-level hire.
Prior industry experience across CRO and pharma roles — not consultancy client engagements, but the operational foundation the consultancy is built on.
NSCLC (incl. EGFR-mutated metastatic disease), breast cancer, AML/MDS with IDH1 mutation, head & neck cancer, and solid tumor immune checkpoint blockade studies, Phase I–III.
Global Phase III/PAS programs for Cosentyx (psoriasis, nail psoriasis, psoriatic arthritis) across EU, LatAm, and APAC, plus chronic pruritus and autoimmune myopathy studies.
Coronary artery disease, acute coronary syndrome, chronic kidney disease, and the Entresto (heart failure) Post-Approval Study — a first-of-its-kind launch in the US & Canada.
Autologous CD19-specific CAR-T cell therapy in inflammatory myopathy, alongside other first-in-human and early-phase oncology programs.
Rare thyroid disorder in children, growth hormone deficiency, essential tremor, mild cognitive impairment/Alzheimer's, and PTSD studies involving central rating and diagnostic verification.
Type 2 diabetes and rare genetic obesity (melanocortin-4 receptor pathway) studies, alongside COPD and inflammatory bowel disease programs.
On-the-ground operational depth across Southeast Europe, paired with flexible ways of working together — scaled to fit how your organization prefers to engage.
On-the-ground trial operations coverage through local CRO partners in Serbia, Bosnia & Herzegovina, Montenegro, and North Macedonia.
Independent Clinical Research Associate coverage in Bulgaria, North Macedonia, and Serbia, extending monitoring reach without a permanent regional build-out.
Senior clinical development oversight for a program or partnership, without the cost of a full-time executive hire.
Regional CRO/CRA coverage, operational rescue, or protocol & strategy support delivered under a partner organization's existing engagements.
Two-way referrals for opportunities that fall outside either party's core scope, keeping both sides focused on what they do best.
Bundled proposals pairing strategic/clinical leadership with full-scale execution capacity for sponsors that need both.
Reach out to discuss your next clinical, regulatory, or fundraising milestone.