Lou Vaickus, MD, FACP



  • 35+ years in medicine and the pharmaceutical industry
  • 20+ years of executive pharma leadership

Physician Executive, Executive Leadership, Clinical Development and Medical Affairs, Preclinical Development, Regulatory Affairs/Quality Assurance, Business Development/Fundraising, Commercial Marketing, Medical Writing/Communications, and C-suite Activities.
Extensive experience at start-up, small-, medium-, and large-sized companies in all aspects of drug development and clinical medicine, including new chemical/molecular entities, biologics/biosimilars, cell therapies, devices, diagnostics, and assay development.
MD – Loyola University’s Stritch School of Medicine, with postdoctoral training in Immunology, Internal Medicine, and Hematology/Hematologic Malignancies at the Mayo Clinic and in Hematology/Oncology at Stanford University. Faculty – University of Iowa College of Medicine and SUNY Buffalo/Roswell Park Cancer Institute before joining industry in 1993.
Board-certified in Internal Medicine, Hematology/Hematologic Malignancies, and Medical Oncology.
Popular speaker at numerous events, with more than 60 peer-reviewed academic and industry-focused publications.

  • CEO and Founder, akta Pharmaceutical Development
  • Interim Chief Medical Officer – Antigen Activated T Cell Therapy Start-up
  • Interim Chief Medical Officer – Gene-altered Lymphocyte Cellular Therapy Start-up
  • Interim Chief Medical Officer – Vedanta Biosciences, Inc.
  • Interim Chief Medical Officer – Verastem, Inc.
  • Interim Chief Medical Officer – InVivo Therapeutics Corporation
  • Other consulting experience includes:

Preclinical Discovery and Clinical Development: RNAi interference technology. Privately-funded start-up.
Preclinical, Clinical, and IND Development: Proprietary in situ chemovaccination platform for anti-tumor immunity. Privately-funded start-up.
Phase 2/3 Study Design and Preclinical Development: Oncology/immunity biosimilar Mabs. Publicly-traded small biotech.
Independent Safety Evaluation Committee and Phase 1/2 Clinical Study: tRNA analog endogenous immunity and inflammation modulator. Rare muscle diseases/inflammatory myopathies. Privately-funded biotech with successful IPO.
Pre-IND/IND: Inhaled antifungals for CF, asthma, and pulmonary infections in ICH. Privately-funded biotech start-up.
Clinical Development Program: Peptide vaccine/diagnostic/device for immune tolerance in autoimmunity. Privately-funded, biotech start-up.
Pre-IND/IND/Ph 1: Genetically modified bacteria for ultra-rare metabolic diseases. Privately-funded, biotech start-up.
Medical Monitor, Clinical Development, Phase 1/2: Heparan sulfate mimetic. Oncology. Small, publicly-traded biotech.
Product Development: NCEs to modulate protein homeostasis and chaperones. Multiple indications including cystic fibrosis. Private start-up with successful IPO.
Diagnostics Development: Diagnostic platform technology in immune-regulated diseases to diagnose and monitor disease status and therapeutic response. Chronic and latent infectious diseases, oncology, autoimmunity, and inflammatory states. Small publicly-funded biotech.
Post-marketing Surveillance, Clinical Trials Transparency, Regulatory Affairs: NCEs in neuroscience, rare diseases, gastrointestinal, and internal medicine. Publicly-traded, large, specialty biotech.
Chief Development Officer/ Development Consultant: Privately-funded, venture capital, asset-centric development companies with two distinct products: GRAS nutritional and probiotics for immunological changes to gut microbiota in oncology and autoimmune indications.
Clinical Development Expert: Monoclonal antibodies for infectious disease indications. Privately-funded biotech.
Immunology Expert: BLA/MAA submission, oncology indication. Publicly-traded, small biotech.

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