G. Michael Wall

About G. Michael Wall

Broad pharmaceutical industrial experience, leading all development activities for solid oral, injectable, topical, inhalation, sterile or non-sterile, drug products, drug/device and medical devices. Accomplished technical leader of international, culturally diverse, multidisciplinary, and virtual teams. Enjoys blend of science, medicine and business in interactions not only with scientific partners and regulatory bodies but also with marketing, medical affairs, sales and key opinion leaders in the development of new therapeutic agents, Phase I-IV. Experienced in seeking angel and venture capital funding as well as virtual company operation. Significantly experienced in pharmaceutical development under Australian Government’s generous R&D Tax Incentive program.Specialties: anticounterfeit; consultant; pharmaceutical; biotech; Australia; New Zealand; USA; EU; Iceland; combination drug product; formulation development; medical device; nitrosamines; oral; capsule, amorphous; resupendability; tablet; spray dried dispersion; injectable; sterile; intravitreal; implant; topical; nasal spray; otic; post-surgical ocular inflammation; blepharitis; ophthalmology; ophthalmic; insert; ocular; post-vitrectomy; cataract; presbyopia; pediatric; allergy; infection; inhalation; dermatology; dermatitis; radiation; otomycosis; nebulized; nebulization; peptide; oligonucleotide; biological; drug product; analytical; medicinal; preclinical; clinical trial material supplies; investigational medicinal product (IMP); phase 1 2 3 4; promotional; launch; medical affairs; regulatory affairs; antibiotic; amino acid; aminoglycoside; antioxidant; glutathione; fluoroquinolone; N-chloro-taurine; anti-inflammatory; selenium; chemotherapy; pneumonia; ear; lung; melanoma; oncology; Friedreich\'s Ataxia; myocardial myopathy; neurology; orphan; ball milling; Netzch; microfluidization; nanosuspension; polymorph; co-crystal; pulmonary fibrosis; age-related macular degeneration; anterior posterior segment; chronic kidney disease; Covid-19 (SARS-B CoV-2); cystic fibrosis; diabetic retinopathy macular edema diabetes; prostaglandin; fenofibrate, HCCAA, adrenergic; beta-blocker; retinitis pigmentosa; Usher; otolaryngology; neurotology; sensorineural; noise-induced; hearing loss; Meniere\'s disease; cystinosis; motor neuron disease; ALS; ototoxicity; alliance; patents; intellectual property; program project management; licensing; diligence; quality; USP, CMC; IND; preIND; ISO; CTD; IMPD; EMA; FDA; NDA; MAA; BTD; Fast Track; HREC; IB; orphan; rare pediatric disease designation; voucher; RPV.

Experience

1. SVP & CSO

   Nacuity Pharmaceuticals, Inc

   Dec 2016 — Present · Fort Worth, TX, US

   Lead CMC (GMP), nonclinical, clinical, regulatory developmental activities in US and Australia for antioxidant NCEs, oral, sterile topical ophthalmic eye drops, inserts and intravitreal implants, for the treatment of [unmet medical needs including orphan designation, rare pediatric disease designation]

Education

• Harvard Business School Executive Education

  Advanced Management Program #168

• University of Mississippi

  Ph.D., Medicinal and Pharmaceutical Chemistry, School of Pharmacy

• Auburn University

  B.S., Chemistry

• Auburn University Harrison College of Pharmacy

  M.S., Medicinal Chemistry

Skills

• CRO
• Toxicology
• Oncology
• Nda
• Cmc
• Allergy
• Pharmaceutical Development Liaison Medical Affairs Kol
• Pharmaceutical Industry
• Sop
• Fda
• Glp
• Medical Devices
• Clinical Research
• Otolaryngology Medical Device
• Pharmaceuticals
• Ind
• Spray Drying
• Therapeutic Areas
• Pharmacology
• Ctms
• Sterilization
• Regulatory Affairs
• Lifesciences
• Clinical Trials
• Drug Development
• Gcp
• R&D
• Kol
• Ophthalmology
• Chemistry
• Pharmaceutics
• Drug Discovery
• Biotechnology
• Medical Affairs
• Clinical
• Medicinal Chemistry
• Hplc
• Quality Assurance
• Product Development
• Technology Transfer