Kaouthar Lbiati, MD

Kaouthar Lbiati, MD

Independent Board Director @ Theralase Technologies (TSXV: TLT)

About

BioTech C-suite, Board Director, Mentor to Women In Tech, and Policy Advisor. Recipient of the EB2 National Interest Waiver green card (2022) for exceptional abilities in biopharmaceuticals. Recognized in Marquis Who’s Who (2024) and the association Fes Gate (2026) for impact and leadership in both the biopharmaceutical industry and global health. Awarded (2010) by the "Association des Morphologistes & URDIA" (Université Paris Descartes) for outstanding contributions to preventative medicine and prenatal care through radiotechnology. Columnist & Public Speaker (🔗YouTube @klbiati) ⚡️ Specialties & Expertise Strong in strategy formulation, Extensive experience in BD&L, JV, M&A. Skilled negotiator who influences stakeholders on the corporate and boardroom settings driving business objectives and maximizing value. R&D and Commercialization Product Planning: Leadership in both development and commercial strategy, resulting in six therapeutic product registrations, indication extensions and/or global market expansion across a wide array of therapeutic areas broadening patients access globally. Leadership & Operations: Guiding cross-continental, cross-functional teams across products’ lifecycle and market archetypes, ensuring business scalability, alignment with strategic goals, financial management, and value creation in the corporate landscape. Crisis Management: Track record in leading teams and companies through major transition (i.e. significant restructures, succession planning and strategic pivot). Corporate governance: A comprehensive real-life understanding of Board level governance, further enhancing my leadership skills in the Boardroom. 🌟 Entrepreneurship & Policy Leadership -Developer of the Next Generation of BioTech Leaders: Mentor to Select Global Women In Tech (SGWIT)(2025), - Judge at MIT Hacking Medicine (2025). Mentor & Judge at the Enterprise Lab Hackathon, Imperial College (2020,2021 consecutively). -Policy advisor to think tanks, and patients advocacy groups whose recommendations are consulted by governmental and non-governmental entities in Morocco and France. 🎙️ Let’s Connect

Country

United States

City

Boston

Industry

Biotechnology

Skill

Professional Mentoring, Mentoring, HEOR, Health Economics, Digital Strategy, Government, In-licensing, Licensing Strategy, Deal Execution, Leadership, Deal Sourcing, Thought Leadership, White Papers, Conference Speaking, Investment Decisions, Roadshows, Competitive Landscape, European Markets, Executive Management, Alternative Solutions

Experience

Theralase Technologies (TSXV: TLT)

Independent Board Director

Theralase Technologies (TSXV: TLT)

LinkedIn
2023-5 - Present · 3 yrs 5 mos

Toronto, Ontario, Canada

- Corporate strategy, governance oversight and business development.

Hepion Pharmaceuticals

Chief Executive Officer (Interim) & Board Director

Hepion Pharmaceuticals

LinkedIn
2025-6 - Present · 1 yr 4 mos

United States

Executive Summary — Led through a crisis and survival mode, Sought and won approval of board to be appointed CEO. Under my leadership, created a layered framework for the Board’s decision-making and successfully repositioned the company to become a leader in Precision medicine. Most critically, prioritized balancing near-term cash generation with long-term innovation, and clinical utility, giving the organization a much-needed runway. - Led a full corporate turnaround within six months, successfully repositioning the company away from a highly competitive NASH space toward a differentiated growth strategy that garnered attention from a broader swath of biotech ecosystem players. - Established the foundation of a new liquid biopsy franchise, defining a clear strategic roadmap and building a partnership ecosystem to support long-term value creation. - Strategically prioritized and advanced the commercial readiness of a legacy asset for early detection and surveillance of liver cancer. - Structured and executed the in-licensing of a novel ctRNA platform, and developed a 5-year business plan, - Recruited and managed a team of executive leaders and advisors, investors and capital markets

Hepion Pharmaceuticals

Independent Board Director

Hepion Pharmaceuticals

LinkedIn
2022-6 - 2025-6 · 3 yrs 1 mo

New Jersey, United States

- I served on the Audit Committee. Additionally, I chaired the Compensation Committee for ~ one (1) year and the Strategic Planning Committee for one (1) year, - As independent Board Director, I oversaw major organizational transitions, including significant corporate restructuring, succession planning as well as financial transactions.

International Trade Administration

Select Global Women In Tech (SGWIT) Mentor

International Trade Administration

LinkedIn
2025-3 - 2026-4 · 1 yr 2 mos

Washington DC-Baltimore Area

- I served as a mentor to immunitoAI Leadership Team, - ImmunitoAI raised ~$6 Million in Q4 2025, - ImmunitoAI is a company at the intersection of AI and biologics.

Cytovia Therapeutics

Vice President Strategy Corporate Development

Cytovia Therapeutics

LinkedIn
2020-5 - 2022-11 · 2 yrs 7 mos

Boston, MA

- Reported to CEO and closely engaged with the Board of Directors. -Team leadership: Direct report and close collaboration with legal and finance. - Product Strategy and Ecosystem building: Set the corporate goals and the portfolio strategy across various functions (R&D, regulatory, manufacturing), Prioritized (2) lead targets in liver cancer (HCC) and multiple myeloma (MM). Developed 3-years business plan including the identification of opportunities for R&D optimization and manufacturing efficiency including in terms of allocation of resources - Corporate development/BD: Lead the company’s growth strategy, collaborated with legal and successfully executed on key strategic deals (I.e joint-venture resulting in the establishment of the first iPSC NK therapy company in China) and the raise of $45mm before the company's successfully exit through merger.

ImPact Biotech

Strategy Portfolio Head

ImPact Biotech

LinkedIn
2019-10 - 2020-3 · 6 mos

New York, United States

- Reported to the President at the U.S. affiliate. - Secured $40m in grant for the execution of Portfolio Growth strategy in (4) oncology indications and the technical optimization of ImPACT® technology platform further strengthening the value proposition

Large Pharmaceutical Companies (AZ, Sanofi, GSK, Amgen)

Operations: Medical Affairs, Regulatory, Strategic Planning, HEOR & Market Access (Various Roles)

Large Pharmaceutical Companies (AZ, Sanofi, GSK, Amgen)

2007 - 2019 · 12 yrs

Paris, Dubai, London, LA

- Served as a member of the Product Strategy Committee and led the Global Cross-Functional Team at Amgen. - Developed the global strategic plans for the BiTE® platform, and lead successful product launches in the US and EU. - Secured $10m from the investment committee to fund Proof of Concept trial (Novel MoA, formulation & delivery methods) for Blincyto® and a strategic initiative using AI Technology for the Prediction of hyper-immune response, among other strategic initiatives, - Lead Immuno-Oncology Product's Strategic Planning across functions (development, regulatory, commercialization, distribution) and Directed Market access strategy in EU/UK & submission of Benefit/risk dossier to the European Medical Agency (EMA) -Elaborated market access strategy and applied Health Technology Assessment (HTA) methods to support FILGOTINIB® (Gilead’s product) pricing negotiations with payers across EU -Lead commercial opportunity assessment and cost-benefit evaluation of Gene therapy for the treatment of transfusion-dependent Beta-Thalassemia - Lead Regional Teams into successful Launch of VOTRIENT® in renal cancer (RCC) and soft tissue sarcoma across the GCC countries and achieved formulary listing in key regional accounts. -Launched Cabazitaxel (JEVTANA®) in metastatic prostate cancer resistant to castration (mCRPC) bridging from early/compassionate use programmes (across EU) to scalable commercialization operations. -Performed Symbicort® launch activities in Asthma and COPD, lead advisory boards, Generated data ranging from Patient Reported Outcome (PRO), pharmacoeconomic & observational studies & lead several medical education initiatives - Provided Technical Expertise into Clinical Technical Dossier (CTD) and Benefit/Risk regulatory dossiers across countries over (3) continents

Bionest Partners Finance

Summer Intern

Bionest Partners Finance

LinkedIn
2007 - 2007

Paris, Île-de-France, France

Opportunity assessment & commercial Planning in Europe for Tactevo®; a flu vaccine delivered intra-nasally with global indications in adults & pediatric populations. Tactevo® was developed by medimmune and acquired by AZ.

Education

The London School of Economics and Political Science (LSE)

The London School of Economics and Political Science (LSE)

LinkedIn

International Policy and Health Economics

ESSEC Business School

ESSEC Business School

LinkedIn

Strategy and Management in the healthcare industry

Gustave Roussy Éducation

Gustave Roussy Éducation

LinkedIn

Clinical Oncology

Mohammed V University in Rabat

Mohammed V University in Rabat

LinkedIn

Medicine

Doctorate Thesis : Repeated miscarriage - before 10 weeks - with immunological origins, (2)- year rotational fellowship in internal medicine at Paris Public University Hospitals (AP-HP); Hopital Européen Georges Pompidou “HEGP”, Antoine Beclere, Ambroise Paré, Paris, France (3)- year rotational specialized trainings in clinical, internal and surgical medicine at Avicenna University Centre Hospitals (UHC) in Rabat, Morocco (2) years of Theoretical knowledge in biology, physiology, biochemistry, histology, embryology, Anatomy, Public health Policy at the School of Medicine, Rabat, Morocco

Kaouthar Lbiati, MD's Contact Information

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