Capabilities

Australian Stock Exchange (ASX) compliance, liaising, announcement preparation and reporting,

National Associations of Securities Dealers Automated Quotations (NASDEQ) Securities and Exchange Commission (SEC) S-1 listing preparation,

Investor relations and investor presentation preparation and management,

Broker management and presentations,

Company and product valuations,

Company program and financial management and program risk mitigation,

Company corporate governance implementation, practice and advice,

Licensing and acquisition negotiations,

Capital Raises through: (i) Private: Angel, Venture Capital (VC) and Private Equity/ Portfolio Fund Managers, (ii) Public: Investor Placements and Rights Issues and (iii) non-dilutive government grants,

Composition of Matter, Method and Technology patent applications and capture,

Intellectual property strategy and defence,

Board reporting,

Company subsidiary relationship management for skills leverage and corporate strategic alignment,

Consultant and Key Opinion Leader sourcing and management,

Australian Federal Government Research and Development tax rebate preparation and management,

Preclinical and clinical research program initiation, principal investigator management, program management and funding (general cancer, respiratory disease, neurodegenerative disease, diabetes, osteoarthritis, viral disease and articular disease),

Preclinical Research and pre-investor gap analysis, hypothesis generation and readiness of preclinical programs for seed funding,

API screening and selection,

API formulation strategies to select and produce drugable product,

GMP pilot and scaled active pharmaceutical (API) manufacture,

Alignment of reformulated and repurposed drugs to known safety profiles,,

GMP pilot and scaled tablet production for Clinical Trials

International drug manufacturing stakeholder relations (USA, India, China and Australia),

Investigative product trial labelling and packaging compliance,

Australian drug importation (from India and USA) and exportation (to USA and New Zealand) applications, insurance and oversight of GMP manufactured API and drug product for use in clinical trials,

Drug labelling strategies,

Product price point recommendations and insurance diligence,

Human and veterinary clinical trial multicentre management (Victorian, New South Wales, Western Australia, Queensland and Canberra, USA, New Zealand, Europe and the UK),

Clinical trial site diligence for regulatory compliance and trial subject accrual competence,

Contract research organisation contracting and management (CROs; drug manufacturers, trial managers, data managers, analytical chemistry and resource providers),

Australian Veterinary and Medicines Authority (APVMA) veterinary and Therapeutics Goods Administration (TGA) human Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) clinical trial regulatory stakeholder management,

Phase I, 2 and 3 Clinical Trial Government Regulatory Authority applications, management and reporting: Australia (APVMA and TGA), USA (Federal Drugs Administration FDA/ Centre for Veterinary Medicine CVM), Europe (European Medicines Agency EMA and Medical Health Research Association MHRA), Singapore (Health Science Authority HSA) - including orphan designations,

First in human drug dose selection,

First in pet dog drug dose selection,

Pharmacokinetic analyses,

Phase 1, 2 and 3 clinical trial design, primary and secondary outcome determination, safety parameter designation, protocol writing and investigator brochure writing,

Phase 1, 2 and 3 clinical trial financing and budget management,

Phase 4 repurposing strategies, encompassed in Phase 1, 2 and 3 clinical trials design, financing and management above,

Phase 1 and 2 Clinical trial Notification (CTN) Human Research Ethics Committee (HREC) submissions and management,

Phase 1 and 2 clinical trial Study Manual, Safety Monitoring, Informed Consent and Pharmacy Manual preparation,

Australian State and Territory Research licence applications, management and reporting: Victoria, Western Australia, New South Wales, Queensland, Canberra and Northern Territory,

Preclinical and clinical peer reviewed publication writing,

Research conference preparations and presentations and

Digital media and marketing