Fractional Expertise from Pre-IND to Post-Marketing.

Expert Guidance for Emerging Biotech

We deliver strategic, on-demand support to early-stage biotech companies, helping you advance efficiently without full-time overhead.

About

Meet the Team

Our team includes experts across key functions who can provide guidance and/or fractional support for early stage and emerging biotech companies. We leverage decades of experience in multiple modalities from the PIND stage through postmarketing.

Kemi Olugemo, MD, FAAN

President and Chief Executive Officer

Kemi Olugemo is a Physician-Scientist and Philanthropist with over 2 decades of clinical and pharmaceutical industry experience. As Chief Medical Officer at Korro Bio, she led the company’s transition to a clinical-stage company and the cross-functional development team through the topline data readout for the lead candidate in Korro Bio's RNA-editing platform. Prior to joining Korro, Kemi held progressive leadership roles at Ultragenyx Pharmaceutical, Parexel, and Ionis Pharmaceuticals, and has contributed to the development of several globally marketed products.

Kemi has served on the scientific committee of the International Society for CNS Clinical Trials and Methodology (ISCTM) and the Leadership Council of CNS Summit since 2019. She is the recipient of numerous awards from leaders and peers in the pharmaceutical and nonprofit sectors, and maintains a strong passion for professional development and being the bridge between scientific progress and community impact.

Kemi completed her medical training and Neurology Residency at the University of Maryland School of Medicine, and an additional Fellowship in Neuroimmunology & Multiple Sclerosis at the Maryland Center for MS. She is a Fellow of the American Academy of Neurology.

Julie Hagan, MS

Chief Regulatory Officer

Julie has more than 20 years of Regulatory Affairs experience in AAV and CRISPR/Cas9 gene therapies, RNA/LNP therapies, autologous cell therapies, and monoclonal antibodies, and has spent the majority of her career working in the rare and orphan disease space. She has experience filing and maintaining Orphan Drug Designation applications, Fast Track Designation applications, and Regenerative Medical Advanced Therapy (RMAT) applications. She led a variety of successful IND applications and BLA filings to both CBER and CDER. She has also been a global Regulatory lead for applications in Canada, Australia, New Zealand, and Europe/UK.

Julie held the position of Vice President, Regulatory Affairs at Korro Bio, Tune Therapeutics, and eGenesis. Julie was also the US Regulatory Lead for the Metachromatic Leukodystrophy (MLD) Program at Orchard Therapeutics, Head of the Regulatory Department at Apic Bio for AAV gene therapies and was responsible for the successful filing of AAV gene therapy IND applications at RegenxBio. Julie was also a member of the Regulatory team at Human Genome Sciences (HGS) (acquired by GSK) where two successful BLAs were filed for both raxibacumab, an anthrax anti-toxin, and for BENLYSTA® (belimumab), a treatment for Lupus.

Prior to her industry experience, Julie worked for 7 years at the Genetic Resources CORE Facility (GRCF), at the McKusick-Nathans Institute of Genetic Medicine, DNA Analysis Facility, at the Johns Hopkins University School of Medicine. Julie performed oligonucleotide synthesis, DNA sequencing, SNP genotyping, and DNA isolation from whole blood and buccal swabs.

Julie has a Master of Science (MS) in Biotechnology from the Johns Hopkins University in Baltimore, Maryland and a bachelor’s degree in biology from Gettysburg College in Gettysburg, Pennsylvania.

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On-demand expertise in clinical development and regulatory strategy for early-stage biotech, from Pre-IND through post-marketing.

Contact

  • kemi.olugemo@gmail.com

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