Adebayo "Bayo" L.

Anavex Life Sciences Corp is dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, schizophrenia and other central nervous system (CNS) diseases, pain, and various types of cancer. I functioned in my role as the Senior Vice President for Nonclinical Development by: Providing leadership in support of nonclinical safety evaluation of new chemical entities including development of toxicology program strategies. Guiding the interpretation of complex nonclinical studies and activities to support regulatory filling and business development objectives Preparing the nonclinical section of regulatory fillings including briefing packages and IND submissions Engaging and negotiating with regulatory authorities regarding various phases of product development Writing insightful, scientific, and regulatory-driven responses to FDA comments Partnering (analysis and recommendations) with Business Development to pursue investments that further Anavex strategies. Providing written internal debriefing analysis on FDA Advisory Committee meetings and workshop based on more than 22 years of Supervisory experience at the FDA Addressing complex scientific and regulatory issues, and working collaboratively and innovatively in solving cross functional challenges Leading the design and execution of nonclinical development plan from candidate selection through IND submission including curating the nonclinical studies package supporting safety, toxicology and pharmacokinetics Presenting to internal and external stakeholders to ensure that nonclinical development strategy aligns with the overall goals and objectives of the company Managing external partners as related to nonclinical development including consultants, CROs and CDMOs.

Supervisory experience spanning Rare Diseases and Medical Genetics, Hematology, Medical Imaging and Radiation Medicine • Extensive FDA supervisory and management experience resulting in high performing team and provision of high impact advice to senior leadership. • Successful executions of challenging and high impact assignments within FDA, including FDA response to bioterrorism, medical counterterrorism programs; FDA response to Congress mandate on Positron Emission Tomography. • Review and supervisory experience in rare diseases, medical genetics, hematology, medical imaging, radiation medicine and medical counter terrorism. • Excellent written and oral communication skills. Lead author on guidance and regulatory policy manuscripts. Organized, chaired and presented at external workshops and scientific sessions, presented at Advisory Committee meeting. • Integrated scientific, technical and policy analysis skills. Provided guidance to sponsors for novel approaches to study design and endpoints. • Establishment of collaborative relationship with colleagues at other federal agencies (NIAID, BARDA, NCI) culminating in several successful workshops. • Served as mentor to reviewers and colleagues.

• Provided senior leadership in directing FDA’s presence, responsibilities, and initiatives, including information exchanges, collaboration on technical training, and collaboration with counterpart agencies. • Represented FDA in discussions and negotiations with high-level foreign government representatives and non-governmental organizations regarding FDA regulatory matters. • Assisted in oversight of the management of the FDA Sub-Saharan Africa Office, including supervision of locally engaged staff. • Developed and maintained strong liaison and close contact with officials in the various Directorates, host country/region, and the various Ministries of Health and other relevant Ministries in the region on relevant FDA issues.

• Evaluated the results of nonclinical Pharmacology/Toxicology studies submitted to support the safety of pharmaceutical drug products.