G. Michael Wall, Ph.D. Email & Phone Number

Texas, United States

University, Ms, Us

Boston, Ma, Us

Rockville, Maryland, Us

Advised virtual startup [confidential pharma company] in the development of NCE topical ocular antiinflammatory agent for the treatment of dry eye including formulation, container/closure, clinical trial design and Australian clinical trial. Advised virtual startup [confidential pharma company] in the development of sterile topical cream drug product for treatment of otic [unmet medical need]. Advised virtual startup [confidential pharma company] in the development of sterile topical cream drug product for treatment of chronic rhinosinusitis including formulation development, IP, preclinical, clinical, PreINDs, project management and prudent selection of Key Opinion Leaders as US consultants: Led FDA interactions. Led Australian development including preclinical (protocol design) and clinical (protocol design, IB, EC) efforts including prudent selection of Key Opinion Leaders as AU consultants.

Fort Worth, Texas, 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]

Seattle, Wa, Us

Lead pharmaceutical development of organoselenium NCE for the treatment of patients under 5 INDs (including fast track) (US) and 1 CTA (UK) including Meniere’s disease, sensorineural hearing loss, chemotherapy-induced ototoxicity, aminoglycoside-induced ototoxicity, Covid-19 (SARS-CoV-2) and bipolar disorder. Capsules; tablets; clinical trial material (CTM); investigational medicinal product (IMP); preformulation; solid-state; polymorphism; drug/device implants.

Provided consulting services to large and small pharmaceutical companies in the U.S., Europe, Middle East and Asia, for the development of branded or generic, sterile inhaled, injectable or topical, solutions, viscous solutions or suspensions (including nanosuspensions, involving ball-milling, Netzch milling, cryoprecipitation or microfluidization), as well as non-sterile oral (capsules, tablets), nasal and topical drug products, including formulation development, IP, preclinical, clinical, PreINDs, project management for virtual organizations, prudent selection of CROs and CMOs: -Led CMC development of solid oral dosage form for [confidential company] for [unmet medical need]; amorphous dispersions, hot melt extrusions, polymorphs, co-crystals -Effectively leveraged CROs/CMOs and led pharmaceutical development (PM, formulation, manufacturing, preclinical, clinical study designs) of new ophthalmic drug/device combination product [505(b)(2)] for treatment of [unmet medical need] for [virtual company confidential].-CMC development for NCE sterile inhaled biologicals (peptides, oligonucleotides) for treatment [unmet medical need] for [company confidential].-Led formulation development for otic NCE drug product for treatment of [unmet medical need] for [virtual company confidential].-Advised [virtual company confidential] regarding pharmaceutical development of otic NCE drug product for treatment of [unment medical need].-Drafted PreIND for [virtual company confidential] regarding development of otic NCE drug product for treatment of middle ear infection.-Advised [virtual company confidential] regarding pharmaceutical development of 505(b)(2) ENT drug product for treatment of [unmet medical need (infection)].-Advised [non-US company confidential] regarding formulation development of generic injectable drug product.-Advised attorneys regarding patent prosecution and successful defense in challenges to U.S. and European patents.

Plano, Texas, Us

Led CMC projects, CMC-RA activities in a virtual company environment for development and manufacture of solid, oral dosage forms, as well as topical dosage forms, of novel class of anti-inflammatory immunomodulators, including bardoxolone methyl, omaveloxolone (RTA 408) and analogs; managed CMC activities with external partners, Abbvie and Kyowa Hakko Kirin; developed CMC sections for INDs, IMPDs; outsourced manufacturing, packaging, labeling, distribution of global clinical trial material through CMOs and CROs; authored regulatory CMC sections and outsourced through CRO/CMOs the investigational product manufacture, packaging, labeling and distribution for 8 US clinical trials.

Otolaryngological product and business development; cochlear implant; medical device; nutritional supplements, bacterial sinusitis research; drug-eluting vaginal ring; generic drugs; over-the-counter drugs; pre-IND; NIH grant application

San Diego, Ca, Us

Lead all aspects of sterile injectable drug product development. Oversee and manage interactions with Key Opinion Leaders and Professional Societies. Maintain quality assurance for all IND-related activities.

Geneva, Switzerland, Ch

Led all aspects of global development for ophthalmic, otic and nasal drug products; led preclinical, clinical development and approval (including pediatric exclusivity) of Patanase® Nasal Spray for the treatment of allergic rhinitis in children and adults (Patanase® is the #1 intranasal antihistamine prescribed by U.S. pediatricians); strategically planned and managed annual budgets over $30M; directed scientific aspects of meetings with Antiinfective Division of US FDA, European national agencies; outsourced research to numerous universities, research institutes and CROs; Stage Gate Model, Program Management with Project Office and Planisware Software; liaison between R&D and Marketing, Sales and Key Opinion Leaders; alliance management involvement; technically assessed license opportunities. Cumulative 2004-10 sales of otolaryngology products developed exceeded $2 billion.

Geneva, Switzerland, Ch

Created two new successful therapeutic specialty areas, otic and nasal drug and device products; led preclinical, clinical development and approval for Ciprodex® Otic Suspension (two indications, AOE and AOMT in patients ages 6 months and older), now the #1 eardrop prescribed by ENTs and pediatricians in the U.S.; approved promotional materials; led Team to approval for Ciloxan® Ear Drops, Solution (infection) (International); led Team to approval of re-formulated Cipro®HC Otic Suspension (U.S., International); developed Sofenz® Cerumenolytic Solution, CE-marked medical device for Europe; directed meetings with Antiinfective, Pulmonary Divisions of FDA and EU agencies; outsourced research to universities, research institutes and CROs; led preclinical and/or clinical development programs for antiinfectives, antihistamines, corticosteroids, enzymes, viscoelastics and novel packaging

Geneva, Switzerland, Ch

Directed preclinical and clinical activities for ophthalmic, nasal & otic drug products; plan, budget, supervise and manage preclinical and clinical programs; represented sponsor in FDA/EMEA/CHMP meetings; responsible for international clinical/registration for AZOPT® (glaucoma), PATANOL® (ocular allergy), and TRAVATAN® (glaucoma).

Geneva, Switzerland, Ch

Supervised chemists responsible for global stability programs, 75,000 tests/year; released domestic and international clinical and toxicology supplies, 6000 tests/year; managed ~4000-ft2 computer-monitored stability facility, ~2500 studies in 29 chambers; directed design and planning for new 11,000 ft2 stability storage facility; directed implementation of company's first computerized LIMS system; led multidisciplinary teams in development of otic and ophthalmic products

Advanced Management Program #168

Ph.D., Medicinal And Pharmaceutical Chemistry, School Of Pharmacy

M.S., Medicinal Chemistry

B.S., Chemistry