B.R.I.S.K. Consulting

Alex Bica: Scientific Advisory for Drug Development

Science-first advisory built on decades of translational and clinical safety experience.

Alex Bica

Alex Bica

MD, MPH, ExecMSc (Hons), FRSPH

Founder & Senior Scientific Advisor

Alex Bica is a board-certified physician and senior pharmacovigilance leader with over 15 years of global experience in drug safety, clinical development, and regulatory strategy across pharma, biotech, and public health. He is a Fellow of the Royal Society of Public Health in London, a Fellow of the Academy of Science in Siena, and a Faculty Member at the University of Siena, Italy.

He earned his medical degree from the University of Medicine and Pharmacy in Iasi, Romania (2006), and went on to specialise in infectious diseases and medical epidemiology (2012). He holds a Master of Public Health with a focus on Health Management, Bioinformatics, and Biostatistics, as well as an Executive MSc in Vaccinology and Pharmaceutical Clinical Development with Honours from the University of Siena (2016). His continuous professional development includes a Certificate in Global Health from the Karolinska Institutet, ICH GCP certification from the Royal College of Physicians (London), and advanced training in Novel Clinical Trial Design at the University of Cambridge (2025).

At CSL Behring in Marburg, Germany, Alex built and led the company's first Early Development and Translational Safety organisation, bridging preclinical and early clinical development across hematology, immunology, cardiovascular, renal, transplant, and vaccines. As Global Therapeutic Area Head for Immunology, he directed the safety strategy that enabled the regulatory approval and launch of Andembry, serving as the primary liaison with the FDA, EMA, PMDA, and TGA. He has overseen all COVID-19 clinical research safety activities and chaired Safety Management Teams across multiple therapeutic areas.

Before CSL, Alex led clinical development and pharmacovigilance strategy for prophylactic mRNA-based and recombinant vaccine programmes at CureVac AG, covering oncology and infectious disease assets. At GSK Vaccines in Siena, he conducted post-marketing safety analyses and benefit–risk evaluations for the global vaccine portfolio.

Earlier in his career, Alex served as Head of the Epidemiology and Disease Control Department at the National Public Health Authority of Romania within the Ministry of Health, where he coordinated national immunisation programmes, infectious disease control, and epidemic and pandemic preparedness. He has collaborated extensively with the World Health Organization (WHO), the European Medicines Agency (EMA), and the European Centre for Disease Prevention and Control (ECDC) on clinical and epidemiological research as well as public health initiatives related to migrant health.

This breadth of experience — from public health systems to first-in-human trials, from post-marketing surveillance to regulatory strategy at the highest level — is the foundation of B.R.I.S.K. Consulting. I founded this practice to put structured decision-making at the service of organisations developing medicines, closing the gap between excellent data and defensible decisions.

What Sets My Work Apart

Decision-Centric by Design

I structure engagements around decisions, not deliverables. Every piece of work is anchored to a specific decision point in your development program.

Integrated Across Development

I treat translational safety, clinical evidence, and governance as a unified architecture — not as separate workstreams handled by different teams.

Explicit About Uncertainty

I make assumptions, trade-offs, and probability ranges transparent. Stakeholders see not just what was decided, but why, and what alternatives were considered.

Governance-Ready from Day One

Everything I produce is designed for regulatory, board, and investor scrutiny. Documentation is never an afterthought.

How I Engage

Senior, expert-led advisory — I am personally involved in every engagement.
Embedded at critical inflection points in your development program.
Independent and non-operational — I provide strategic clarity, not operational execution.
Scaled to decision criticality — from a focused review to ongoing advisory.
Framework

The B.R.I.S.K. Decision Intelligence Framework

My proprietary framework provides explicit mapping of assumptions and trade-offs, scenario comparison under uncertainty, and governance-ready documentation of decision rationale.

Formalised reasoning supports expert judgement — it does not replace it.

Selected Publications & Presentations

  1. 1.Glassman F, Lawo JP, Bica MA, Roberts A, Kormann D, Chialda L, Miethke S, Dziadowiec I, Caltabiano S, Puchalski T. A Phase 1 Randomized Study: Garadacimab Pharmacokinetics, Safety, and Tolerability After Administration via Autoinjector/Pre-Filled Pen Versus Pre-Filled Syringe in Healthy Participants. J Clin Pharmacol. 2025.
  2. 2.Pencelli V, Clemens R, Bica MA, Clemens Costa SA. Pandemic preparedness and response: a survey among experts from high- and low-middle-income countries about the “100 Days Mission.” Front Public Health. 2025.
  3. 3.Glassman F, Lawo JP, Bica MA, Roberts A, Pawaskar D, Akama H, Jain M, Goodson S. Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous and Intravenous Garadacimab Following Single-Dose Administration in Healthy Japanese and White Adults. J Clin Pharmacol. 2024.
  4. 4.Craig T, Levy DS, Reshef A, Lumry W, Martinez-Saguer I, Jacobs JS, Yang WH, Ritchie B, Pürsün EA, Keith PK, Busse P, Feuersenger H, Bica MA, Jacobs I, Pragst I, Magerl M. Garadacimab for hereditary angioedema attack prevention: long-term efficacy, quality of life, and safety data from a Phase 2, randomised, open-label extension study. Lancet Haematol. 2024.
  5. 5.Glassman F, Lawo JP, Bica MA, Roberts A, Kormann D, Miethke S, Dziadowiec I, Caltabiano S, Jacobs I, Puchalski T. A Phase 1, Randomized, Open-label, Parallel-group Study Comparing Pharmacokinetic Properties of Garadacimab Administered By Subcutaneous Pre-filled Syringe Assembled To Autoinjector/Pre-filled Pen Versus Pre-filled Syringe Assembled To Needle Safety Device In Healthy Adults. J Allergy Clin Immunol. 2024.
  6. 6.Craig T, Anderson J, Jacobs JS, Tachdjian R, Farkas H, Yang WH, Ohsawa I, Pollen M, Lawo JP, Bica MA, Jacobs I, Magerl M. Integrated safety and efficacy of garadacimab for hereditary angioedema prophylaxis across 3 clinical trials. AAAAI Congress. 2024.
  7. 7.Goodson S, Bica MA, Roberts A, Lawo JP, Jain M, Glassman F. Phase 1 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Garadacimab (CSL312) in Healthy Japanese and Caucasian Adults. 72nd Annual Meeting of the Japanese Society of Allergology. 2023.
  8. 8.Reshef A, Magerl M, Saguer IM, Bernstein JA, Farkas H, Yang WH, Jacobs JS, Li PH, Lumry WR, Pürsün EA, Ohsawa I, Katelaris C, Longhurst H, Hakl R, Guilarte M, Stroes ESG, Feuersenger H, Bica MA, Jacobs I, Craig TJ. Garadacimab for hereditary angioedema prophylaxis: long-term efficacy and safety from Phase 3 VANGUARD and first interim analysis of OLE. 13th C1-Inhibitor Deficiency & Angioedema Workshop. 2023.
  9. 9.Craig TJ, Reshef A, Lumry WR, Saguer IM, Jacobs JS, Yang WH, Pürsün EA, Keith PK, Busse P, Magerl M, Feuersenger H, Bica MA, Glassman F, Pragst I, Levy DS. Garadacimab for hereditary angioedema prophylaxis: efficacy and safety from a Phase 2 open-label extension trial. 13th C1-Inhibitor Deficiency & Angioedema Workshop. 2023.
  10. 10.Papi A, Stapleton RD, Shore PM, Bica MA, Chen Y, Larbig M, Welte T. Efficacy and Safety of Garadacimab in Combination with Standard of Care Treatment in Patients with Severe COVID-19. Lung. 2023.
  11. 11.Glassman F, Goodson S, Bica MA, Roberts A, Akama H, Asami Y, Jain M, Acharya M. Phase 1 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Garadacimab (CSL312) in Healthy Japanese and Caucasian Adults. J Allergy Clin Immunol. 2022.
  12. 12.Papi A, Stapleton RD, Shore PM, Bica MA, Chen Y, Larbig M, Welte T. Efficacy and Safety of Garadacimab in Combination with Standard of Care Treatment in Patients with Severe COVID-19. ERS International Congress. 2022.
  13. 13.Bica MA. Efficacy and safety of garadacimab in patients with hereditary angioedema in a Phase 2 open-label extension study. EAACI Congress. 2022.
  14. 14.Aldrich C, Leroux-Roels I, Huang KB, Bica MA, Loeliger E, Schoenborn-Kellenberger O, Walz L, Leroux-Roels G, von Sonnenburg F, Oostvogels L. Proof-of-concept of a low-dose unmodified mRNA-based rabies vaccine formulated with lipid nanoparticles in human volunteers: A phase 1 trial. Vaccine. 2021.
  15. 15.Patel AS, Treadwell MC, Borra S, Machnig T, Bica MA, Hsu F. Hereditary angioedema and pregnancy complications and outcomes in a population-based cohort. AAAAI Congress. 2020.
  16. 16.Bica MA, Glismann S, Clemens R. Immunization policymaking in the EU/EEA Member States: the complexity behind reality. ESCAIDE, ECDC. 2018.
  17. 17.Bica MA, Clemens R. Measles Vaccination in Europe — Failure to Harmonize and its Consequences for Outbreaks and Migrant Health. International Conference on Migration Health. 2018.
  18. 18.Bica MA, Clemens R. Vaccination policies of immigrants in the EU/EEA Member States — the measles immunization example. Eur J Public Health. 2018.
  19. 19.Alberer M, Gnad-Vogt U, Hong HS, Mehr KT, Backert L, Finak G, Gottardo R, Bica MA, Garofano A, Koch SD, Fotin-Mleczek M, Hoerr I, Clemens R, von Sonnenburg F. Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial. Lancet. 2017.

Credibility in drug development is built one defensible decision at a time.

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