CGH is a new product development innovation practice inspired by Certara’s drug development and scientific due diligence work for the Bill & Melinda Gates Foundation. CGH works with a broad range of Global Health stakeholders including governments, non-government, philanthropic and commercial organisations, to advance the development of therapeutics to address unmet medical needs in areas of market failure.

Drug development strategic advisor to Pharma, Biotech, Life-science Investors, Not For Profit (NFP) and Government. Accountable for Certara’s globally recognised leading consulting services in integrated drug development; including pharmacometrics, clinical and quantitative pharmacology, regulatory and drug development strategy and stewardship. 95% of FDA new drug approvals in 1H-2018 involved Certara.

Accountable for strategic growth of the business, P&L and performance of ~150 MD, PhD and PharmD consultants working in >27 Offices across US, Canada, UK, Europe, Japan and Australia, including some of the most experienced drug developers from across the industry and regulatory ecosystem.

Integrated drug development advisory services are provided to all Top Tier Pharmaceutical companies globally, extensively to biotech of all sizes, top-tier and emerging Not-For-Profit companies serving global health, life-science investment community including Venture Capital and Private Equity, research institutes and strategic advisory support to governments.

Globally accountable for consulting services relating to integrated drug development strategy and stewardship within d3 Medicine business unit post-acquisition. Within first 12 months, exceeded growth, revenue and profitability targets and secured global top-tier talent in clinical pharmacology and early development including expansion in Europe, US and Asia Pacific, growing team to 25 employees and an extensive consultant network.

Regular invited speaker on Innovative Practices in Drug Development with recent exemplars including:

• Value Focused Model Informed Drug Discovery and Development (MID3) (Ausbiotech Plenary, Adelaide, Nov 2017; PharmaconAsia Plenary, Singapore, Oct 2017; GSK Global Meeting, Philadelphia Nov 2017)
• Pharmacology to Payer: One Quantitative Drug Development Framework to Rule Them All (Global Webinar, Oct 2017)
• Determining the Optimal Dose of Moxidectin for Onchocerciasis (American Soc. Trop. Medicine and Hygiene[ASTMH] Plenary, Washington DC Nov 2017)

d3 Medicine applies product development partnership principles to provide the biopharmaceutical industry with unique access to a virtual drug development team of industry practice leaders with a passion to drive change in areas of unmet medical need.

From Melbourne, Craig founded the company, developed the inaugural business plan and is accountable for working with the executive team to refine and execute the corporate strategy in alignment with the company purpose and values. Craig is also client (C-suite and project team) facing fulfilling due diligence, product development/technical expert leader roles and driving thought leadership across the industry. d3 is recognised as being industry specialists in drug development, employing a core team of 9 employees and 7 consultants (with significant track-records from industry, FDA and academia) across three continents and achieving strong profitable financial performance.

d3 Medicine and Personal Achievements:

• Established business governance, systems and processes to support rapid growth from a start-up to a multi-national organisation including client relationship management, alliance management, strategy development and execution, quality, technology, budgeting and regulatory compliance
• Developed and maintained more than 30 product partnerships with individuals and organisations supporting the core team client activities and 3 academic-d3 fellowships supporting innovation projects
• Built an extensive client base including pharmaceutical and diagnostic companies (8 with >8,500 employees), more than 40 biotechnology companies, US and Australian government projects, life-science investment community, and the not for profit sector
• Designed and executed extensive projects with significant healthcare impact. Relevant exemplars include:
  • Industrialising scientific innovation: On behalf of a global NFP client, led technical, operational and corporate due diligence of an Australian research institution’s translational medicine approach. Findings and recommendations were used to significantly enhance the tool for antimalarial therapeutic/vaccine development globally. Project resulted in an extensive global collaboration and multimillion dollar investment in Australia.
  • Unlocking nascent national capability: On behalf of Australian Government, mapped and tested national product development capability for an international Medical Countermeasures consortium. Rayner-Lester report submitted to Federal government, established Medical Countermeasures consortium (MCPA). Conducted extensive engagement with Australian and US government agencies petitioning international cross-sector collaboration. Activities have positioned medical countermeasures as a strategic priority for Australia and $5m seed investment from government.
  • Accelerating value creation for industry and patients: a) Supported clinical pharmacology strategy for Alios Biopharma’s antiviral for Respiratory syncytial virus. Novel accelerated clinical trials path to paediatrics was accepted by regulator saving US$13m and 6 months development time, contributing to client being acquired by Johnson & Johnson for US$1.75bn. b) Supported new client in securing and executing US$200m government contract for medical countermeasures indication. c) Led due diligence of Ph2/3 pharma development program for Global PE firm with joint d3 Medicine and PE experts resulting in US$200M single investment d) Supported establishment of innovative risk-share agreement to support development and registration of moxidectin for onchocerciasis (“River Blindness”). e) Supported clinical pharmacology program stewardship of 6 clinical trials for Genentech/Roche leading to Alcensa breakthrough therapy approval lauded by peers and FDA in terms of quality and time.
• Developed extensive reputation for thought leadership. Regular invited speaker, exemplars include:
  • Graduation commencement speaker for Monash University Faculty of Pharmacy and Pharmaceutical Science (#2 globally ranked Pharmacy and Pharmacology school) “Job, career or vocation” (2016)
  • Chair of Panel on “Multi-sectoral Partnerships – Medicines for All” (United Nations, NY 2014)
  • Led Symposium “Novel interdisciplinary quantitative approach for linking Pharmacology to the Payer” (American College of Pharmacometrics, 2015)
  • External thought leader to define Global Pharma’s “drug development paradigm beyond 2020” (2015)
  • Advocate for advancing Australian R&D capability as speaker and participant in official forums, author of commentaries, professional mentor to peers and students, course advisor in pharmaceutical science

Craig’s appointment was based in Australia with direct reports in Switzerland and US, involving Global and Asia-Pacific responsibilities. These included leading the Global Tamiflu Clinical Pharmacology Team, cross-functional project teams and clinical pharmacology advisor in innovative development initiatives.

Achievements:

• Developed and secured emergency use approval of an intravenous formulation of oseltamivir for pandemic, gained FDA approval for oseltamivir to treat influenza in infants <1 year and executed an elaborate translational medicine program to optimise dosing against novel pandemic influenza strains
• Contributed to innovation initiatives involving technology convergence for personalized healthcare, ethnopharmacology, interdisciplinary pharmacometrics, data-mining, big-data/real-world evidence, systems biology, paediatric development, development in China, and industry-academic alliances to foster innovation

Craig was accountable for leading global clinical development strategies for novel therapeutic plasma and protein products and was responsible for leading the design and maintenance of scientifically rigorous and cost-effective clinical development plans.

Achievements:

• Clinical development expertise applied to various internal programs in inflammation, cardiovascular and oncology disease areas and in due diligence assessment, including early clinical development lead of CSL112 (reconstituted HDL for Acute Coronary Syndrome) which has now commenced Phase III clinical trials. Sole inventor on CSL112 patent on dosing paradigm.

Craig was accountable for leading multi-disciplinary due diligence teams to assess therapeutic candidates, technology and delivery platforms for compatibility with Roche portfolio. He was responsible for overseeing all aspects of an evaluation such as business case, patent protection, toxicology, safety, clinical pharmacology, medical science, regulatory risk, and capability assessment. Craig regularly presented to executive management on due diligence findings, risk assessment, clinical development plan, and financial impact.

Achievements:

• Led more than 15 due diligence projects across therapeutic areas, technologies and small molecules and biologics, on potential deals up to $1.5B, including publicised ~US$200m acquisition of Arius
• Invited presentations, including “Scientific Due Diligence: What’s inside the black box?” (Ausbiotech, 2008)

Achievements:

• Global clinical pharmacology lead for Tamiflu addressing safety concerns and pandemic planning. Expanded leadership duties included key member of the Tamiflu Integrated Fast Response Team and Dose-optimisation program for emerging pandemic strains of influenza
• Designed and delivered comprehensive clinical pharmacology programs under tight timelines (individual study budgets up to CHF10m) for paediatric and intravenous Tamiflu formulations. Optimised use against a potential influenza pandemic strain, examined potential drug interactions and programs addressing safety
• Regular presenter to Roche Clinical and Non-clinical Drug Safety Committees, presenter to Life Cycle Committees and Roche Board of Directors
• Lead presenter at 2007 FDA Paediatric Advisory Committee (PAC), Responder at 2005 FDA PAC, numerous presentations to European & Japanese Health Authorities, presented to governments and WHO

Craig co-established a translational anti-infective research facility with bioanalysis, in vitro and in vivo infection model capabilities. The laboratory complemented extensive global clinical research collaborations.

Achievements:

• Hired and managed a team of nine staff by directing workflow, delegating roles and responsibilities, prioritizing project issues, ongoing performance review and development planning
• Published and presented broadly, 3 competitive NHMRC Project Grants as chief investigator and was key contributor to successful NIH grants. Contributed to re-vitalising use of polymyxins against multi-drug resistant pathogens. Submitted provisional patent on ‘Therapy for Multi-Drug Resistant Microorganisms’

Craig had a clinical pharmacology role supporting patient care at Millard Filmore Hospital and Erie County Medical Center, and clinical research responsibilities supporting design and execution of clinical trials. Clinical research contributed to the approval and labelling for the antibiotic linezolid (Zyvox®) & multiple publications.

Craig was a clinical pharmacist with a joint appointment in Department of Clinical Pharmacology where he ran the Therapeutic Drug Monitoring Service and performed clinical research and drug-use evaluation projects.