Dr Philips provides statistical consultancy services to the Pharmaceutical Industry based on 35+ years of experience working in the Pharmaceutical and Clinical Research Organisation (CRO) industries. Alan has experience of regulatory submissions in many therapeutic areas such as Biosimilars (Rituximab, Herceptin), CNS (depression, insomnia, Generalized Anxiety Disorder), Cardiovascular (Hypertension), Oncology (Breast Cancer) and Womenโs Health (Hormone Replacement Therapy, Oral Contraceptives). For example, Alan developed and justified the sample size and statistical analysis strategy for managing missing data for a biosimilar development program for the FDA. He have also recently provided statistical support for clinical development plans in Osteogenesis Imperfecta, Sarcopenia and Chronic active antibody-mediated rejection (AMR) in Kidney transplant recipients. He represents clients at FDA and EMA regulatory meetings, as well as being an expert statistical member on DMCs.