Dr. Mike Davies
Dr Mike Davies is the Founder, Chief Executive Officer and Chief Medical Officer of Carocell Bio Limited.
Mike has been in the pharmaceutical industry for over 20 years. He has spent time in large pharma (Pfizer, AstraZeneca), Medium Pharma (Shire, HealthPoint) and Biotech (Serentis, Renovo, Blueberry Therapeutics). Previous to Carocell he was co-founder and CMO of Bridge Therapeutics.
Mike is an experienced and competent professional with a significant record as a pharmaceutical research and developer whose career development to date has been achieved through an inherent thirst for knowledge and desire to achieve high impacting results that continually make a difference. Strong leadership qualities and the promotion of integrated team ethics and behaviours with a business function has achieved significant results in clinical trials and post marketing achievements while maximizing personal learning and growth for all those involved.
- Founder and Chief Executive Officer of Carocell Bio, a start-up biotech company focused on nanoparticle formulation and intracellular delivery of novel anti-inflammatory peptide therapeutics to treat serious inflammatory conditions.
- Co-founder and Chief Medical Officer of a biotech company focussed on nanoformulation of drugs to treat infection. I led and helped lead all aspects of the company driving their first compound into the clinic and led the pre-IND and IND interactions with FDA.
- Establish team environments that enhance everyone’s capabilities. This includes due diligence activities, new thoughts on clinical and commercial aspects of drug and device development, generation of all documents that support the ethical, quality and regulatory approval processes.
- Working as a global lead, with particular emphasis on European and US Clinical Trials, to lead the design and evaluation of ethical, high quality clinical trials in many therapeutic areas including gastro-intestinal (particularly IBD), dermatology, wound healing, tissue repair, diabetes, cardiovascular, respiratory, rare diseases, renal, rheumatology, oncology and haematology.
- Extensive device experience. Advised Medtronic on novel insulin pump and CGM technology. Worked on pre-filled syringe technology for biosimilars.
- Provide scientific and medical expertise and leadership to the global product strategy from concept through to registration and throughout the life-cycle of important and valuable medical compounds and devices.
- Developed new clinical trial concepts that successfully moved a new compound to treat scaring to Phase II proof of concept (POC) within 18 months, with the initial trial facilitating funding of US$33 million for further development.
- Developed over 15 patents for work in the discovery of anti-fungal, anti-inflammatory, wound healing, dermatology and cardiovascular compounds. Within these fields I was instrumental in the work on a new anti-thrombotic compound within pre-clinical development and lead an important post-approval trial to look into the effects of a statin on intracoronary lipid.
- Completed clinical research in all four phases of drug development and worked in a broad role gaining extensive experience in all areas of drug and device development and marketing.