Home / Craig Rayner CV

Craig Rayner CV

Curriculum Vitae

CRAIG R. RAYNER

Founded covidpharmacology.com
Bpharm, BPharmSc(Hons),
GCHE, PharmD, MBA, MAICD
craig.rayner@certara.com

PROFILE SUMMARY

  • Healthcare executive who founded, built and had acquired a purpose-driven multinational drug development consulting company seeking to create value by revolutionising the drug development paradigm to accelerate access of medicines to patients that need them.
  • Clinical pharmacologist and drug developer who regularly contributes to significant product development efforts across multiple therapeutic areas and especially Global Health and Infectious Diseases; a few highlights among many, include linezolid (Zyvox) and re-vitalised use of polymyxins against MDR bacteria, oseltamivir (Tamiflu) to treat influenza, moxidectin to eradicate river blindness, CSL112 for acute coronary syndrome.
  • Achievements informed by insights and experiences from a career spanning patient bedside, academia & industry and led by belief that science is the bedrock of innovation in healthcare. Translation to patients requires cross-discipline integration, deep understanding of product development and a focus on value creation.
  • High level of personal and professional integrity, dedicated to giving back by inspiring and empowering others to realize their full potential and committed to work collectively to improve the R&D ecosystem.
  • Exceptional track record of building and leading high performing teams by inspiring collaboration and a values-based culture of excellence and accountability in academic, biotech, pharma and clinical environments.
  • Committed to building and maintaining strong partnerships required to drive scientific innovation to address global healthcare challenges and established Certara Global Health that works with global philanthropic, non-government, government and industry stakeholders to develop medicines for global health purposes
  • Advocate for advancing Australian R&D capability as speaker and participant in official forums, think tanks, government engagements, author of commentaries, professional mentor to peers and students, course advisor in pharmaceutical science and drug development.
  • Exceptional interpersonal skills, authentic, self-aware and considerate, successful in influencing and negotiating across diverse internal and external stakeholders.
  • Broadly published (>100 peer reviewed conference abstracts, publications, book chapters) in scientific/medical literature in infectious diseases, HIV, medical countermeasures and clinical pharmacology, multiple competitive grants, and numerous international invited presentations.
  • JUNE 22, 2020 UPDATE:  Craig’s interview on Health Professional Radio on the COVID-19 Pharmacology Resource Center now available: https://healthprofessionalradio.com.au/covid-19-pharmacology-online-resource-center/
  • UPDATE: Member of World Health Organization’s COVID-19 Therapeutics Working Group

PROFESSIONAL EXPERIENCE SUMMARY

2020 – Present Certara President – Integrated Drug Development Consulting
2019 – Present Certara Co-leader, Certara Global Health
2018 – Present Certara SVP, Global Head – Integrated Drug Development Consulting
2013 – 2016 Monash University Adjunct Associate Professor
2016 – 2018 Certara President, Consulting Services (d3 Medicine)
2013 – 2016 d3 Medicine LLC Co-Founder, Chief Executive Officer
2010 – 2013 Roche Pharmaceuticals Ltd Director of Clinical Pharmacology, Team Leader
2009 – 2010 CSL Ltd Director of Clinical Development
2007 – 2009 Roche Pharmaceuticals Ltd Global Due Diligence Director
2005 – 2007 Roche Pharmaceuticals Ltd Director of Clinical Pharmacology
2003 – 2005 Monash University Co-Founder/ Director, Facility for Anti-Infective Drug Development
2000 – 2005 Monash University Lecturer/Senior Lecturer
1998 – 2000 Millard Fillmore Hospital Program Director, Infectious Diseases
1996-1998 Alfred Hospital Clinical Pharmacist

MEMBERSHIPS AND APPOINTMENTS

2018 – Present President – Integrated Drug Development Consulting
2013 – Present External advisor on Bachelor of Pharmaceutical Science at Monash University
2012 – Present Member of Ausbiotech and BioMelbourne Network
2000 – Present Member of the International Society of Anti-infective Pharmacologists
2013 – 2016 Chair of the Development Committee, Medical Countermeasure Products Australia
2012 – 2016 Executive Member Victorian Infection and Immunity Network Industry Alliance
2003 – 2005 Secretary, Australian Pharmaceutical Science Association
2003 – 2005 Executive Committee Member, Australian Society for Antimicrobials
2003 – 2011 Editorial Board Member, Diagnostic Microbiology & Infectious Diseases Journal
2001 – 2005 Expert Subcommittee Member for Surveillance/Antibiotic Resistance, Vic Government

WORK EXPERIENCE

Certara

2020 – Present President – Integrated Drug Development Consulting
2019 – Present Co-leader, Certara Global Health (CGH) Global – New Jersey/Melbourne

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.

2018 – 2020 SVP, Integrated Drug Development Consulting New Jersey/UK/Melbourne

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.

2016 – 2018 President, Consulting Services (d3 Medicine – A Certara Company)

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 LLC

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.

2013 – 2016 Co-Founder/Chief Executive Officer New Jersey/Melbourne

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

Roche Pharmaceuticals Ltd

2010 – 2013 Director of Clinical Pharmacology, Team Leader New Jersey/Melbourne

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

CSL Ltd

2009 – 2010 Director of Clinical Development Melbourne, Australia

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.

Roche Pharmaceuticals Ltd

2005 – 2009 Global Due Diligence Director and Director of Clinical Pharmacology Basel, Switzerland

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

Monash University

2003-2005 Co-Founder/ Director, Facility for Anti-Infective Drug Development Melbourne

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’

Millard Fillmore Hospital, Clinical Pharmacokinetics Laboratory

1998-2000 Program Director, Infectious Diseases and HIV Buffalo, New York

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.

Alfred Hospital

1996-1998 Clinical Pharmacist Melbourne

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.

EDUCATION HIGHLIGHTS

2020 – Present Melbourne Business School, University of Melbourne
Masters of Business Administration (Senior Executive)		 Melbourne
2006 INSEAD Business School
International Project Management		 Fountainbleu, France
2002 – 2004 Monash University
Graduate Certificate in Higher Education (GCHE)		 Melbourne
1998 – 2000 State University of New York
Doctor of Pharmacy		 Buffalo, New York
1996 – 1996 Monash University
Bachelor of Pharmaceutical Science (Hons)		 Melbourne
1992 – 1995 State University of New York
Bachelor of Pharmacy		 Buffalo, New York

SIGNIFICANT AWARDS

2018 Distinguished Alumni Award, Monash University (Pharmacy & Pharm Sciences)
2008 Melbourne Business School Foundation Scholarship
2008 Olympiad Gold medal for Research (Roche’s Highest Global Honor) for “innovation and outstanding execution” of the Tamiflu Fast Response Team
2002 Australasian Pharmaceutical Science Association New Investigator Award
2001 Semi-Finalist of ‘Young Australian of the Year’, Career Achievement Award

EXAMPLES OF COMPETITIVE GRANTS

Li J (Principal Investigator), Rayner CR, Turnidge J, Nation RL. Novel therapeutic strategy against multidrug-resistant gram-negative bacteria [2006-2008] $349,823

Rayner CR (Principal Investigator). Towards reducing resistance and haematological toxicity of linezolid [2004 2005] $135,825

Milne R, Rayner CR, Coulthard K, Li J, Nation RL (Principal Investigator). Towards optimising dosing of the ‘old’ antibiotic colistin methanesulphonate: enhancing efficacy and reducing resistance [2004-2006] $266,500

Note: Additional grants <50K from industry, Monash and Melbourne University, Collier Charitable fund. Upon transition to industry, withdrew as a chief investigator on successful multi-million dollar NIH grant for optimising polymyxin use.

PUBLICATIONS, CONFERENCE ABSTRACTS,
INVITED PRESENTATIONS

Note: Excluding numerous clinical studies that are un-published due to confidentiality

Journal Publications

2020

7.Dodds M, Krishna R, Gonclaves A, Rayner CR. Model-Informed Drug Repurposing: Viral Kinetic Modeling to Prioritize Rational Drug Combinations for COVID-19. Authorea. DOI: 10.22541/au.159200535.51965254 (preprint) June 12, 2020.

1. Rayner CR, Smith PF, Hershberger K, Wesche. Optimizing COVID-19 candidate therapeutics: Thinking Without Borders. Clin Transl Sci. 2020 Mar 25. doi: 10.1111/cts.12790. [Epub ahead of print]
2. Rayner CR, Yeo K, Wesche D, Almond L, Dodds M, Smith PF, Sullivan M. Ivermectin and COVID-19: A report in Antiviral Research, widespread interest, an FDA warning, two letters to the editor and the authors’ responses. Antiviral Res 2020 Apr 21;178:104805
3. Hartman D, Kern S, Brown F, Minton S, Rayner CR. Time to step up: A call to action for the clinical and quantitative pharmacology community to accelerate therapeutics for COVID-19. Clin Transl Sci 2020.
4. Smith PF, Dodds M, Bentley D, Rayner CR. Dosing will be a key success factor in repurposing antivirals for COVID-19. Br J Clin Pharmacol 2020 doi:10.1111.bcp.14314
5. Charman WN, Rayner CR, Sullivan MT. Risks, challenges and the urgent need for an integrated approach to re-purposing approved medicines for COVID-19. Medical Journal of Australia 2020 (Insight Plus-On-Line edition)
6. Sullivan MT, Kirkpatrick CM, Mills EJ, Rayner CR. Rapid Response: Chloroquine and hydroxychloroquine in covid-19 – the need for rational approaches to evaluating new treatments..British Medical Journal 2020, June 2

2019

5. Polasek TM, Rayner CR, Peck RW, Rowland A, Rostami-Hodjegan A. Towards dynamic prescribing information: co-development of companion model-informed precision dosing tools in drug development. Clinical Pharmacology in Drug Development Clin Pharmacol Drug Dev. 2019 May;8(4):418-425

2018

6. Non-traditional Pharma Companies. PharmaVOICE October 2018
7. Kinrade SA, Mason JW, Sanabria CR, Rayner CR, Bullock JM, Stanworth SH, Sullivan MT. Evaluation of the Cardiac Safety of Long-Acting Endectocide Moxidectin in a Randomized Concentration-QT Study. Clinical and Translational Science 2018 Nov;11(6):582-589
8. Sullivan MT, Rayner CR. Virtual Team Enables Successful Approval of Moxidectin for River Blindness. Clinical Researcher. August 2018 (Volume 32, Issue 7)
9. Sullivan MT, Rayner CR. Good Management Practice: Partners Address Project Management Challenges for Neglected Tropical Disease Study. Clinical Researcher—February 2018 (Volume 32, Issue 2) [DOI: 10.14524/CR-18-4010]
10. Wu DBC, Chaiyakunapruk N, Pratoomsoot C, Lee KKC, Chong HY, Nelson RE, Smith PF, Kirkpatrick CM, Kamal MA, Nieforth K, Dall G, Toovey S, Kong DCM, Kamauu A, Rayner CR. Cost-utility analysis of antiviral use under pandemic influenza using a novel approach – linking pharmacology, epidemiology and heath economics. Epidemiology and Infection 02/2018; 146(4):1-12
11. Polasek TM, Pradera F, Seabrook S, Patel K, Woodward EJ, Rayner CR. Development of medical countermeasure products in Australia: Could pharmacometrics address capability and capacity gaps?. Drug Metabolism and Pharmacokinetics 01/2018; 33(1):S44-S45.

2017

12. Rayner CR. The Clinical Trials Technology Ecosystem. PharmaVoice June 2017
13. Kamal MA, Smith PF, Chaiyakunapruk N, Wu DBC, Pratoomsoot C, Lee KKC, Chong HY, Nelson RE, Nieforth K, Dall G, Toovey S, Kong DCM, Kamauu A, Kirkpatrick CM, Rayner CR. Interdisciplinary Pharmacometrics Linking Oseltamivir Pharmacology, Influenza Epidemiology, and Health Economics to Inform Antiviral Use in Pandemics. British Journal of Clinical Pharmacology 02/2017; 83(7)

2016

14. Rees V, Bulitta J, Oliver A, Tsuji B, Rayner CR, Nation RL, Landersdorfer CB Resistance suppression by high intensity, short duration aminoglycoside exposure against hypermutable and non-hypermutable Pseudomonas aeruginosa. Journal of Antimicrobial Chemotherapy 08/2016; 71(11)

2015

15. Kamal MA, Brennan BJ, Subramoney V, Lien YT, Morcos PN, Frey N, Rayner CR. Identification of new oral dosing regimens for the neuraminidase inhibitor oseltamivir in patients with moderate and severe renal impairment. Clin Pharmacol Drug Dev. 2015 Sep;4(5):326-36.
16. Reddy MB, · Yang KH, · Rao G, · Rayner CR, · Nie J, · Pamulapati C, · Marathe BM, · Forrest A, · Govorkova EA. Oseltamivir Population Pharmacokinetics in the Ferret: Model Application for Pharmacokinetic/Pharmacodynamic Study Design. PLoS ONE 10/2015; 10(10)
17. Kamal MA, Lien KY, Robson R, Subramoney V, Clinch B, Rayner CR, Gibiansky L. Investigating Clinically Adequate Concentrations of Oseltamivir Carboxylate in End-Stage Renal Disease Patients Undergoing Hemodialysis Using a Population Pharmacokinetic Approach. Antmicrob Agents Chemother. 2015 Nov;59(11):6774-81
18. Kamal MA, Gieschke R, Lemenuel-Diot A, Beauchemin CA, Smith PF, Rayner CR. A drug-disease model describing the effect of oseltamivir neuraminidase inhibition on influenza virus progression. Antimicrob Agents Chemother. 2015 Sep;59(9):5388-95
19. Rath BA, Brzostek J, Guillén S, Niranjan V, Chappey C, Rayner CR, Clinch B. Safety, virology and pharmacokinetics of oseltamivir in infants with laboratory-confirmed influenza: a Phase I/II, prospective, open-label, multicentre clinical trial. Antivir Ther. 2015 May 27.
20. Gibiansky L, Giraudon M, Rayner CR, Brennan BJ, Subramoney V, Robson R, Kamal MA. Population pharmacokinetic analysis of oseltamivir and oseltamivir carboxylate following intravenous and oral administration to patients with and without renal impairment. J Pharmacokinet Pharmacodyn. 2015 Jun;42(3):225-36
21. Patel K, Rayner CR, Giraudon M, Kamal MA, Morcos PN, Robson R, Kirkpatrick CM. Pharmacokinetics and safety of oseltamivir in patients with end-stage renal disease treated with automated peritoneal dialysis. Br J Clin Pharmacol. 2015 Apr;79(4):624-35
22. Chaiyakunapruk N, Wu D, Pratoomsoot C, Lee K, Yi HC, Nelson RE, Smith PF, Kirkpatrick CK, Kamal MA, Nieforth K, Dall G, Toovey S, Kong D, Kamauu A, Rayner CR. Oseltamivir use in an Influenza Outbreak: Linking Pharmacology to Pharmacoeconomics. Open Forum Infectious Diseases 12/2014; 1(suppl_1):S459-S460

2014

23. Kamal MA, Acosta EP, Kimberlin DW, Gibiansky L, Jester P, Niranjan V, Rath B, Clinch B, Sánchez PJ, Ampofo K, Whitley R, Rayner CR. The posology of oseltamivir in infants with influenza infection using a population pharmacokinetic approach. Clin Pharmacol Ther. 2014 Sep;96(3):380-9
24. Boak LM, Rayner CR, Bullitta J, Grayson ML, Paterson DL, Spelman D, Melvani S, Capitano B, Forrest A, Li J, Nation RL. Clinical population pharmacokinetics and toxicodynamics of linezolid. Antimicrob Agents Chemother. 2014;58(4):2334-43

2013

25. Kamal MA, Van Wart SA, Rayner CR, Subramoney V, Reynolds DK, Bulik CC, Smith PF, Bhavnani SM, Ambrose PG, Forrest A. Population pharmacokinetics of oseltamivir: pediatrics through geriatrics. Antimicrob Agents Chemother. 2013 Aug;57(8):3470-7
26. Dobrovolny HM, Reddy MB, Kamal MA, Rayner CR, Beauchemin CA. Assessing mathematical models of influenza infections using features of the immune response. PLoS One. 2013;8(2):e57088
27. Rayner CR, Bulik CC, Kamal MA, Reynolds DK, Toovey S, Hammel JP, Smith PF, Bhavnani SM, Van Wart SA, Ambrose PG, Forrest A. Pharmacokinetic-pharmacodynamic determinants of oseltamivir efficacy using data from phase 2 inoculation studies. Antimicrob Agents Chemother. 2013 Aug;57(8):3478-87

2012

28. Brennan B, Davies B, Cirrincione-Dall G, Morcos PN, Beryozkina A, Chappey C, Aceves-Baldó P, Lennon-Chrimes S, Rayner CR. Safety, tolerability and pharmacokinetics of intravenous oseltamivir phosphate: single- and multiple-dose phase I studies in healthy volunteers. Antimicrob Agents Chemother. 2012 Sep;56(9):4729-37
29. Poirier A, Belli S, Funk C, Otteneder M, Portmann R, Heinig K, Lazic SE, Rayner CR, Hoffmann G, Singer T, Smith DE, Schuler F. Role of the Intestinal Peptide Transporter PEPT1 in Oseltamivir Absorption: In Vitro and In Vivo Studies. Drug Metab Dispos. 2012 Aug;40(8):1556-65.
30. Toovey S, Prinssen EP, Rayner CR, Thakrar BT, Dutkowski R, Koerner A, Chu T, Sirzen-Zelenskaya A, Britschgi M, Bansod S, Donner B. Post-Marketing Assessment of Neuropsychiatric Adverse Events in Influenza Patients Treated with Oseltamivir: An Updated Review. Advances in Therapy 10/2012; 29(10):826-48.
31. Yang KH, Reddy M, Pamulapati C, Rayner CR, Forrest A. Development of a pharmacokinetic model for oseltamivir in ferrets using iterative two-stage analysis. Pharmacotherapy 05/2012; 32(5):E114-E115.

2011

32. Uchimura N, Kuwahara H, Kumagai H, Mishima K, Inoue Y, Rayner CR, Toovey S, Davies BE, Hosaka Y, Abe M, Prinssen EP. Absence of adverse effects of oseltamivir on sleep: a double-blind, randomized study in healthy volunteers in Japan. Basic & Clinical Pharmacology & Toxicology 2011 Oct;109(4):309-14
33. Smith JR, Rayner CR, Donner B, Wollenhaupt M, Klumpp K, Dutkowski R. Oseltamivir in seasonal, pandemic, and avian influenza: a comprehensive review of 10-years clinical experience. Adv Ther. 2011 Nov;28(11):927-59. Epub 2011 Nov 1.

2010

34. Donner B, Smith J, Dutkowski R, Reddy D, Peng M, Prinssen E, Rayner CR. The Tamiflu Example: What complete data analysis can mean. DIA Global Forum 2010 Dec
35. Dudhani R, Li J, Turnidge J, Coulthard K, Milne R, Rayner CR, Nation RL. Elucidation of Pharmacokinetic/Pharmacodynamic Determinant of Colistin Activity against Pseudomonas aeruginosa in Murine Thigh and Lung Infection Models. Antimicrob Agents Chemother. 2010 Mar;54(3):1117-24
36. Bloch M, Hoy J, Cunningham N, Roth N, Andrianopoulos N, Rayner C, Carr A. Adherence to HIV treatment guidelines for initiation of antiretroviral therapy in Australia. Journal of the International AIDS Society 11/2010; 13(Suppl 4).

2009

37. Hoffmann G, Funk C, Fowler S, Otteneder MB, Breidenbach A, Rayner CR, Chu T, Prinssen EP. Nonclinical pharmacokinetics of oseltamivir and oseltamivir carboxylate in the central nervous system. Antimicrob Agents Chemother. 2009 Nov;53(11):4753-61.
38. Lennon S, Barrett J, Kirkpatrick C, Rayner CR. Oseltamivir oral suspension and capsules are bioequivalent for the active metabolite in healthy adult volunteers. Int J Clin Pharmacol Ther. 2009 Aug;47(8):539-48.

2008

39. Sudhakaran S, Rayner CR, Li J, Kong DC, Gude NM, Nation RL. Inhibition of placental P-glycoprotein: impact on indinavir transfer to the foetus. Br J Clin Pharmacol. 2008 May;65(5):667-73
40. Jhee SS, Yen M, Ereshefsky L, Leibowitz M, Schulte M, Kaeser B, Boak L, Patel A, Hoffmann G, Prinssen EP, Rayner CR. Low penetration of oseltamivir and its carboxylate into cerebrospinal fluid in healthy Japanese and Caucasian volunteers. Antimicrob Agents Chemother 2008 Oct;52(10):3687-93.
41. Rayner CR, Chanu P, Gieschke R, Boak LM, Jonsson N. Population Pharmacokinetics of Oseltamivir when Co-Administered with Probenecid. J Clin Pharmacol. 48(8):935-47 (2008)
42. Wallace S, Li J, Rayner CR, Coulthard K, Nation RL. Stability of colistin methanesulphonate in pharmaceutical products and solutions for administration to patients. Antimicrobial Agents Chemotherapy 2008; 52(9):3047-51
43. Wallace S, Li J, Nation RL, Rayner CR, Taylor D, Middleton D, Milne RW, Coulthard K, Turnidge JD. Sub-acute toxicity of colistin methanesulfonate in rats: comparison of various intravenous dosage regimens. Antimicrobial Agents Chemotherapy 52(3):1159-61 (2008)
44. Toovey S, Rayner C, Prinssen E, Chu T, Donner B, Thakrar B, Dutkowski R, Hoffmann G, Breidenbach A, Lindemann L, Carey E, Boak L, Gieschke R, Sacks S, Solsky J, Small I, Reddy D. Assessment of neuropsychiatric adverse events in influenza patients treated with oseltamivir: a comprehensive review. Drug Saf. 2008;31(12):1097-114

2007

45. Morrison D, Roy S, Rayner C, Amer A, Howard D, Smith JR, Evans TG. A randomized, crossover study to evaluate the pharmacokinetics of amantadine and oseltamivir administered alone and in combination. PLoS ONE. 12;2(12):e1305 (2007)
46. Schentag JJ, Hill G, Chu T, Rayner CR. Similarity in pharmacokinetics of oseltamivir and oseltamivir carboxylate in Japanese and Caucasian subjects. J Clin Pharmacol. Jun;47(6):689-96. (2007)
47. Boak LM, Li J, Rayner CR, Nation RL. Pharmacokinetic/pharmacodynamic factors influencing emergence of resistance to linezolid in an in vitro model. Antimicrob Agents Chemother. 51(4):1287-92 (2007).
48. Fowler S, Lennon SM, Hoffmann G, Rayner CR. Comments on “Anti-influenza prodrug oseltamivir is activated by carboxylesterase human carboxylesterase 1, and the activation is inhibited by antiplatelet agent clopidogrel”. J Pharmacol Exp Ther. 322(1):422-3 (2007)
49. Sudhakaran S, Rayner CR, Ghabrial H, Kong DCM, Li J, Gude DM, Angus PW, Nation RL. Differential Protein Binding of Indinavir and Saquinavir in Matched Maternal and Umbilical Cord Plasma. British Journal of Clinical Pharmacology 63(3):315-21 (2007)

2006

50. Li J, Nation RL, Turnidge JT, Milne RW, Coulthard K, Rayner CR, Paterson DL. Colistin: the re-emerging antibiotic for multidrug-resistant Gram negative bacterial infections. Lancet Infectious Diseases 6(9):589-601 (2006)
51. Abe M, Smith J, Urae A, Barrett J, Kinoshita H, Rayner CR. Pharmacokinetics of oseltamivir in young and very elderly Japanese subjects. Annals of Pharmacotherapy 40(10):1724-30 (2006)
52. Boak LM, Li J, Spelman D, Nation RL, Rayner CR. Successful Treatment and Cerebrospinal Fluid Penetration of Oral Linezolid in a Patient with Coagulase-Negative Staphylococcus Annals of Pharmacotherapy. 40(7-8):1451-5 (2006)
53. Li J, Rayner CR, Nation RL, Owen RJ, Spelman D, Tan KE, Liolios L. Heteroresistance to colistin in multidrug-resistant Acinetobacter baumannii. Antimicrobial Agents Chemotherapy 50(9):2946-50 (2006)
54. Bergen PJ, Li J, Rayner CR, Nation RL. Colistin methanesulfonate is an inactive prodrug of colistin against Pseudomonas aeruginosa. Antimicrobial Agents and Chemotherapy. 50(6):1953-8 (2006).
55. Boak LM, Li J, Nation RL, Rayner CR. High-performance liquid chromatographic method for simple and rapid determination of linezolid in human plasma. Biomedical Chromatography. 20(8):782-6 (2006)

2005

56. Rayner C, Munckhof WJ. Antibiotics currently used in the treatment of infections caused by Staphylococcus aureus. Intern Med J. 2005 Dec;35 Suppl 2:S3-16
57. Sudhakaran S, Ghabrial H, Nation RL, Kong DCM, Gude DM, Angus PW, Rayner CR. Bidirectional transfer of indinavir in the human ex vivo placental perfusion model. Antimicrobial Agents and Chemotherapy. 49(3), 1023-1028 (2005)
58. Li J, Rayner CR, Nation RL, Deans R, Boots R, Widdecombe N, Douglas A, Lipman J. Pharmacokinetics of colistin methanesulfonate and colistin in a critically ill patient receiving continuous venovenous hemodiafiltration. Antimicrobial Agents and Chemotherapy. 49(11), 4814-4815 (2005)
59. Li J, Rayner CR, Nation RL. Colistin-associated acute renal failure: revisited. South Med J. 98(12):1229-30 (2005)

2004

60. Li J, Rayner CR, Dixson S, Nation RL. Simple method for the assay of linezolid in Brain Heart Infusion broth by high-performance liquid chromatography. Biomedical Chromatography. 18:1-5 (2004)
61. Rayner CR, Baddour LM, Birmingham MC, Norden C, Meagher AK, Schentag JJ. Linezolid in the treatment of osteomyelitis: Results of compassionate use experience. Infection. 32:8-15 (2004)
62. Levy, RW., Rayner CR., Fairley, CK, Kong, DCM, Mijch, A, Costello, K, McArthur, C, and the Melbourne Adherence Group. Multi-disciplined HIV adherence intervention – A randomised study. AIDS Patient Care and STDs. 18(12):728-735 (2004)
63. Li J, Rayner CR, Nation RL. Simple method for the assay of eperezolid in Brain Heart Infusion broth by high-performance liquid chromatography. Journal of Pharmaceutical and Biomedical Analysis 29:35(4);847-51 (2004)

2003

64. Rayner CR, Forrest A, Meagher AK, Birmingham MC, Schentag JJ. Clinical pharmacodynamics of linezolid in seriously ill patients treated in a compassionate use program. Clinical Pharmacokinetics. 42;(15):1411-1423 (2003)
65. Meagher AK, Forrest A, Rayner CR, Birmingham MC, Schentag JJ. Population pharmacokinetics of linezolid in patients treated in a compassionate-use program. Antimicrobial Agents and Chemotherapy. 47, 548 – 553 (2003)
66. Birmingham, MC, Rayner CR, Meagher AK, Flavin SM, Batts DH, Schentag JJ. Linezolid for the treatment of multidrug-resistant, gram-positive infections: experience from a compassionate-use program. Clinical Infectious Disease. 36, 159 – 168 (2003)
67. Fairley CK, Levy R, Rayner CR, Allardice K, Costello K, Thomas C, McArthur C, Kong DCM, Mijch A and The Melbourne Adherence Group. Randomised Trial of an adherence program for clients with HIV. International Journal of STD and AIDS. 14(12):805-809 (2003)
68. Smith PF, Birmingham MC, Noskin GA, Meagher AK, Forrest A, Rayner CR, Schentag JJ. Safety, Efficacy, And Pharmacokinetics Of Linezolid For Treatment Of Resistant Gram-Positive Infections In Patients With Neutropenia. Annals of Oncology. 14:795-801 (2003)
69. Tan E, Cranswick NE, Rayner CR, Chapman CB. Dosing information for paediatric patients: are they really “therapeutic orphans”? Med J Aust 18;179(4):195 (2003)
70. Taylor M, Rayner CR. Vancomycin, intermittently dosed, continuously debated. Journal of Pharmacy Practice and Research. 33(1):18-19 (2003)
71. Rayner CR. Vancomycin – digging bigger troughs? Journal of Pharmacy Practice and Research. 33(4):293-295 (2003)

Prior to 2002

72. Rayner CR, Galbraith KJ, Marriott JL, Duncan GJ. A critical evaluation of the therapeutic range of indinavir. Ann Pharmacother. 36(7-8):1230-7 (2002)
73. Yin C, Rayner CR, Read T, Fairley CK. Association between self-reported adherence to HIV therapy and disease markers. Journal of Pharmacy Practice and Research. 32, 315 – 319 (2002)
74. Rayner CR, Esch LD, Wynn HE, Eales R. Symptomatic hyperbilirubinemia with indinavir/ritonavir-containing regimen. Ann Pharmacother. 35(11):1391-5 (2001)
75. Birmingham MC, Rayner CR, Flavin SM, Meagher AK, Schentag JJ: Treating outpatients (outpts)with significant, resistant gram-positive infections with linezolid (LNZ). Clinical Infectious Diseases 07/2000; 31(1):224-224.
76. Birmingham MC, Rayner CR, Hafkin B, Todd MW, Flavin SM, Root JD, Zimmer GS, Batts DH, Schentag JJ. Critical care patients with significant, resistant, gram-postive infections enrolled in the linezolid compassionate use protocol. Critical Care Medicine 12/1999; 27(12)
77. Rayner CR, Ioannides-Demos LL, Spicer WJ, D’Agostino J, Bailey M, Krum H. Effect of collection tube on measured gentamicin and vancomycin concentrations. Am J Health Syst Pharm. 15;56(14):1457-8 (1999)
78. Rayner CR, Ioannides-Demos LL, Spicer WJ, D’Agostino J, Bailey M, Krum H: Measured vancomycin, but not gentamicin concentrations are decreased by the presence of a gel separator in a serum vacuette tube. Australian Journal of Hospital Pharmacy 01/1999; 56:1457-8
79. Rayner CR. PharmD or not PharmD, that is the question! Australian Journal of Hospital Pharmacy. 29, 121 – 122 (1999).
80. Rayner CR, Ioannides-Demos LL, Brien JA, Liolios LL, Spicer WJ. Initial concentration-time profile of gentamicin determines efficacy against Enterobacter cloacae ATCC 13047. Antimicrobial Agents and Chemotherapy. 42, 1370 – 1374 (1998)
81. Rayner CR, Ioannides-Demos LL, Vujovic O, Spicer WJ, Spelman D, Tong N, Krum H. A drug use evaluation of vancomycin at a major teaching hospital. Australian Journal of Hospital Pharmacy 28:394-399 (1998)

Book Chapters and Policy Documents

1. Rayner CR, Pradera F, Polasek T, Seabrook S, Patel K, Woodward E. Medical Countermeasures Initiative. Australian National Capability Audit 2017.
2. Rayner CR and Lester D, Mapping Australia’s Product Development Capability for Medical Countermeasures, Lester-Rayner Report to Defence Science and Technology Organisation. October 2013. Referenced in http://www.dtic.mil/dtic/tr/fulltext/u2/a603298.pdf
3. Nation RL, Rayner CR. Clinical pharmacokinetics, In: Parthasarathi, G., K. Nyfort-Hansen, M. Nahata (editors). A Textbook of Clinical Pharmacy Practice – Essential concepts and skills. 3rd ed. Orient Longman Private Ltd, Chennai, India (2012)
4. Nation RL, Rayner CR. Clinical pharmacokinetics, In: Parthasarathi, G., K. Nyfort-Hansen, M. Nahata (editors). A Textbook of Clinical Pharmacy Practice – Essential concepts and skills. 2nd ed. Orient Longman Private Ltd, Chennai, India (2009)
5. Rayner CR, Dooley MJ, Nation RL. Antivirals for HIV. In: Schentag, J.J., L.M. Shaw, W.E. Evans, M.E. Burton (editors). Applied Pharmacokinetics: Principles of Therapeutic Drug Monitoring. 4th Ed. (386 Refs, 27,000 words). Lippincott and Williams (2006)
6. Nation RL, Rayner CR. Clinical pharmacokinetics, In: Parthasarathi, G., K. Nyfort-Hansen, M. Nahata (editors). A Textbook of Clinical Pharmacy Practice – Essential concepts and skills. 1st ed. Orient Longman Private Ltd, Chennai, India (2004)

Conference Abstracts (Peer reviewed, posters and oral presentations at scientific conferences)

1. Jamsen K, Kirkpatrick C, Opoku N, Attah S, Awadzi K (Deceased), Kuesel AC, Olliaro P, Olipoh G, Ryg-Cornejo V, Tan B, Sullivan MT, Fleckenstein L, Rayner CR. Determining the Optimal Dose of Moxidectin for Onchocerciasis via Pharmacokinetic-Pharmacodynamic (PK-PD) Modelling of Data from Healthy Volunteers and Patients with Onchocerciasis. American Society of Tropical Medicine and Hygeine. Washington DC Nov 7, 2017. A762
2. Milton P, Walker M, Kuesel AC, Opoku NO, Attah SK, Kanza E, Bakajika D, Howard H, Halleux CM, Rayner CR, Smith D, Pearce G, Sullivan MT, Basáñez MG. The potential for six-monthly mass administration of moxidectin to accelerate onchocerciasis elimination. American Scoiety of Tropical Medicine and Hygeine. Washington DC Nov 7, 2017. LB-5102
3. Milton P, Walker M, Kuesel AC, Opoku NO, Attah SK, Kanza E, Bakajika D, Howard H, Halleux CM, Rayner CR, Smith D, Pearce G, Sullivan MT, Basáñez MG. Modelling alternative treatment strategies for onchocerciasis: moxidectin for control and elimination. American Scoiety of Tropical Medicine and Hygeine. Washington DC Nov 7, 2017. A-1800
4. MCPA Steering Committee. The Australian Medical Countermeasures Consortium and Medical Countermeasures Products Australia (MCPA). 2014 MCMi Regulatory Science Symposium, FDA Headquarters, White Oak Campus, Silver Spring MD (June 2-3 2014).
5. Wu D, Chaiyakunapruk N, Pratoomsoot C, Lee K, Chong HY, Nelson NE, Smith PF, Kirkpatrick CM, Kamal M, Nieforth K, Dall G, · Toovey S, ·Kong DC, · Kamauu A, Rayner CR. Cost-Utility Analysis of Optimal Dosing of Oseltamivir Under Pandemic Influenza Using a Novel Approach: Linking Health Economics and Transmission Dynamic Models Value in Health 11/2014; 17(7):A807.
6. Wu D, Chaiyakunapruk N, Pratoomsoot C, Lee K, Chong HY, Nelson NE, Smith PF, Kirkpatrick CM, Kamal M, Nieforth K, Dall G, · Toovey S, ·Kong DC, · Kamauu A, Rayner CR. Oseltamivir use in an Influenza Outbreak: Linking Pharmacology to Pharmacoeconomics. IDWeek 2014 Meeting of the Infectious Diseases Society of America; 10/2014
7. Patel K, Rayner CR, Giraudon M, Kamal MA, Morcos PN, Robson R, Kirkpatrick CM. Oseltamivir dosing optimisation in patients treated with automated peritoneal dialysis. Population Approach Group of Australia & New Zealand, Dunedin, New Zealand; 01/2014
8. Smith PF, Kirkpatrick CM, Rayner CR Wu D, Chaiyakunapruk N, Pratoomsoot C, Lee K, Chong HY, Nelson NE, Nieforth K, Dall G, · Toovey S, ·Kong DC, Kamauu A, Kamal M. Estimating Health Outcomes of Antiviral Use in Influenza Outbreaks by Linking PK/PD and Epidemiology via a Transmission Dynamic Model: A Novel Approach. IDWeek 2014 Meeting of the Infectious Diseases Society of America; 10/2014
9. Lefebvre E, Enejosa J, Béliveau M, Jomphe C, Marier JF, Rayner CR, Smith PF, Gathe J. Exposure-Response Relationship of Cenicriviroc with Week 24Virologic Outcomes in Treatment-Naïve HIV-1-Infected Adults with CCR5-Tropic Virus. 14th European AIDS conference, Brussels, Belgium, 16-19 Oct 2013
10. Kamal M, Acosta E, Kimberlin D, Gibiansky L, Jester P, Niranjan V, Rath B, Clinch B, Sanchez P, Ampofo K, Whitley R, Rayner CR. Population pharmacokinetics define dosing recommendations of oseltamivir in neonates and infants with influenza. Options for the Control of Influenza VIII, Cape Town, South Africa, 5-10 Sep 2013
11. Weber CS, Fukushima Y, Guenther A, Jiang Q, Kim S, Li R, Lim Y, Lu P, Peck R, Rayner CR, Zhai S. Ethnic sensitivity assessment during drug development: past, present and future in a large Pharmaceutical company. ASCPT 2012
12. Rayner CR, Rath B, Brzostek J, Charoin-Pannier A, Chappey C, Abadir D, Wollenhaupt M, Niranjan V. The pharmacokinetics and safety of oseltamivir in infants <1 year with influenza. XIV International Symposium on Respiratory Viral Infections (ISRVI), Istanbul, Turkey, 23–26 March 2012
13. Rath B, Rayner CR, Brzostek J, Charoin-Pannier A, Chappey C, Abadir D, Wollenhaupt M, Niranjan V. Clinical and virological response to oseltamivir in infants <1 year with influenza. XIV International Symposium on Respiratory Viral Infections (ISRVI), Istanbul, Turkey, 23–26 March 2012
14. Rayner CR, Bulik CC, Kamal MA, Reynolds DK, Toovey S, Hammel JP, Smith PF, Bhavnani SM, Ambrose PG, Forrest A. Pharmacokinetic-Pharmacodynamic (PK-PD) Determinants of Oseltamivir Efficacy Using Data from Two Phase 2 Inoculation Studies. XIV International Symposium on Respiratory Viral Infections (ISRVI), Istanbul, Turkey, 23–26 March 2012
15. Yang KH, Reddy M, Pamulapati C, Rayner CR, Forrest A. Development of a Pharmacokinetic Model for Oseltamivir in Ferrets Using Iterative Two-Stage Analysis. American College of Clinical Pharmacy Virtual Poster Symposium, May 22–24, 2012
16. Brennan BJ, Cirrincione-Dall G, Morcos PN, Beryozkina A, Chappey C, Berns HK, Davies BE and Rayner CR. The safety, tolerability, and pharmacokinetics of oseltamivir following multiple intravenous infusions administered to healthy volunteers. XIII International Symposium on Respiratory Viral Infections (ISRVI), Rome, Italy, 13–16 March 2011
17. Kamal M, Brennan B, Subramoney V, Morcos PN, Frey N, Rayner CR. Identification of new oral dose regimens for the neuraminidase inhibitor oseltamivir (Tamiflu®) in patients with moderate and severe renal impairment supported by a population pharmacokinetic approach. American Conference on Pharmacometrics (ACoP) 2011, San Diego, USA, 3–6 April 2011
18. Davies B, Aceves Baldó P, Lennon-Chrimes S, Rayner CR. Safety, Tolerability and Pharmacokinetics of Intravenous Oseltamivir Phosphate in Healthy Volunteers: A Phase I Trial. XII International Symposium on Respiratory Viral Infections (2009)
19. Toovey S, Rayner CR, Prinssen EP, Chu T, Donner B, Dutkowski R, Sacks S, Solsky J, Small I, Reddy D. Post-marketing safety assessment of neuropsychiatric adverse event risk in patients with influenza treated with oseltamivir. International Symposium on Respiratory Viral Infections, Singapore, 28 February–2 March 2008
20. Toovey S, Rayner CR, Prinssen EP, Chu T, Donner B, Thakrar B, Dutkowski R, Hoffmann G, Breidenbach A, Lindemann L, Boak L, Gieschke R, Sacks S, Solsky J, Small I, Reddy D. Neuropsychiatric adverse events in influenza patients treated with oseltamivir: a comprehensive review. Seasonal and Pandemic Influenza, Arlington, VA, USA, 18–20 May 2008.
21. Gieschke R, Rayner CR, Chanu P, Boak LM, Jonsson N. Population Pharmacokinetics of Oseltamivir when Co-Administered with Probenecid. X International Symposium on Respiratory Viral Infections, Singapore, 28 February–2 March (2008)
22. Gieschke R, Jonsson N, Boak L, Cameron J, Kinnersley N, Rayner CR. A dose prediction model for optimising use of oseltamivir against emerging pandemic strain of influenza. X International Symposium on Respiratory Viral Infections, Singapore, 28 February–2 March (2008)
23. Gieschke R, Dutkowski R, Smith J, Rayner CR. Similarity in the pharmacokinetics of oseltamivir and oseltamivir carboxylate in Japanese and Caucasian children. Options for Influenza Conference, Toronto (2007)
24. Rayner CR, Andes D, Marchillo K, Conklin R, Stamstad T, Craig WA. Comparison of Fluoroquinolone (FQ) Dose effect Relations by Interval & FQ against Pseudomonas aeruginosa ATCC 27853 (PSA) in Neutropenic Murine-Thigh Infection Models. 44th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, USA, Oct 2004
25. Sudhakaran S, Rayner CR, Ghabrial H, Kong DCM, Gude NM, Angus PW, Nation RL. Placental Transfer (PT) of Indinavir (I) Modulated by P-glycoprotein (Pgp) 44th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, USA, Oct 2004
26. Rayner CR, Dooley MJ, Nation RL. Inhibitory quotient variability should be considered if used to assess the potency of an anti-HIV-1 protease inhibitor regimen. 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, Illinois, USA, Sept 2003. (Abstract H-1997)
27. Tan E., Rayner C.R., Chapman C., Cranswick N. MIMS annual: How much can hospital pharmacists rely on it for information on paediatric dosing? Society of Hospital Pharmacists of Australia, 27th Federal Conference in Hobart, November, 2002.
28. Rayner C.R., Baddour L., Birmingham M.C., Norden C., and Schentag J.J. Linezolid in the treatment of osteromyelitis:Results from compassionate use experience. In Proceedings from 8th Western Pacific Congress on Chemotherapy and Infectious Diseases, Perth, 1st -5th Dec, 2002 (Abstract 184)
29. Rayner C.R., Baddour L., Birmingham M.C., Norden C., and Schentag J.J. Linezolid in the treatment of osteromyelitis:Results from compassionate use experience. In Annual Conference of the Australasian Pharmaceutical Science Association, Melbourne 8-11 December 2002 (Poster 63)
30. Huang P., Kong DCM., Sanip A, Rayner C.R., Hooi PY, Choo S, Tong N, Storey E, Ioannides-Demos L., and Krum H. Ambulatory Neurology Pharmacy Service – Key to provision of seamless pharmaceutical care. Society of Hospital Pharmacists of Australia, 27th Federal Conference in Hobart, November, 2001.
31. Birmingham MC, Rayner CR, Flavin SM, Meagher AK, Schentag J.J. Outcomes of Treating Patients with Malignancies and Significant, Resistant Gram-Positive Infections with Linezolid. 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, Ontario, Canada, Sept 2000
32. Root JD, Birmingham MC, Rayner CR, Flavin SM, Schentag JJ. Results of Treating Patients with Significant, Resistant, Gram Positive, Intra-abdominal Infections with Linezolid. 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, Ontario, Canada, Sept 2000.
33. Birmingham MC, Zimmer GS, Flavin S, Rayner CR, Welch KE, Smith PF, Root JD, Meagher AK, Schentag JJ. Results of Treating Bacteremic Patients with Linezolid in a Compassionate Use Trial for Resistant, Gram-Positive Infections. 5th International Conference on the Macrolides, Azalides, Streptogramins, Ketolides and Oxazolidinones (ICMAS-KO), Seville, Spain Jan 2000
34. Smith PF, Forrest A, Adams JM., Rayner CR, Wood R, Proulx L. Integrating Viral Dynamics and Pharmacokinetics of DOTC in HIV Positive , Antiretroviral Naïve Patients. XIII International AIDS Conference, Durban, South Africa, July, 2000.
35. Forrest A, Smith PF, Rayner CR. Pharmacokinetic and Dynamic Modelling of “Proof of Concept” Trial Data. 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, Ontario, Canada, Sept 2000.
36. Forrest A, Rayner CR, Meagher AK, Birmingham MC, Schentag JJ. Pharmacostatistical Modelling of Effects of Linezolid on Platelets in Seriously-Ill Patients. 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, Ontario, Canada, Sept 2000.
37. Forrest A, Rayner CR, Meagher AK, Birmingham MC, Schentag JJ. Population PK/PD/TK of Linezolid: Application to Dose Optimization. Population PK/PD Symposium. Montreal, Canada, October 2000.
38. Rayner C.R., Forrest A., Meagher A.K., Birmingham M.C. Schentag J.J. Population Pharmacodynamics of Linezolid in Seriously-Ill Adult Pa­tients from a Compassionate-Use Protocol. 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, Ontario, Canada, Sept 2000.
39. Meagher A.K., Forrest A., Rayner C.R., Birmingham M.C. Schentag J.J. Population Pharmacokinetics of Linezolid in Seriously-Ill Adult Pa­tients from a Compassionate-Use Protocol. 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, Ontario, Canada, Sept 2000.
40. Birmingham M.C., Zimmer G.S., Flavin S., Rayner C.R., Welch K.E., Smith P.F., Root J.D., Meagher A., Schentag J.J. Results of Treating Bacteremic Patients with Linezolid in a Compassionate Use Trial for Resistant, Gram-Positive Infections. 5th International Conference on the Macrolides, Azalides, Streptogramins, Ketolides and Oxazolidinones (ICMAS-KO), Seville, Spain Jan 2000.
41. Birmingham M.C., Zimmer G.S., Flavin S., Rayner C.R., Welch K.E., Smith P.F., Root J.D., Meagher A., Schentag J.J. Results of Treating Bacteremic Patients with Linezolid in a Compassionate Use Trial for Resistant, Gram-Positive Infections. 37th Annual Meeting of the Infectious Diseases Society of America (IDSA), Philadelphia, PA, Nov 1999.
42. Birmingham M.C., Zimmer G.S., Hafkin B., Todd M., Batts D.H., Wilks N.E., Flavin S., Rayner C.R., Schentag J.J. Outcomes with Linezolid from an Ongoing Compassionate Use Trial of Patients with Significant, Resistant, Gram Positive Infections. 39th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA Sept 1999.
43. Birmingham M.C., Zimmer G.S., Hafkin B., Todd M., Batts D.H., Wilks N.E., Flavin S., Rayner C.R., Schentag J.J. Linezolid given Intravenously or Orally for Compassionate Use in Patients with Significant, Resistant, Bacterial Infections – Preliminary Results. 21st International Congress of Chemotherapy (ICC), Birmingham, UK. Journal of Antimicrobial Chemotherapy July 1999;44 (suppl A):112.
44. Birmingham M.C., Zimmer G.S., Hafkin B., Todd M., Batts D.H., Wilks N.E., Flavin S., Rayner C.R., Schentag J.J. Use of Linezolid in Critical Care Patients with Resistant Gram Positive Infections. Critical Issues in Respiratory and Critical Care Medicine Science and Technology Symposium, St. Jean Cap Ferrat, France June 7-9, 1999.
45. Birmingham M.C., Zimmer G.S., Hafkin B., Todd M., Batts D.H., Wilks N.E., Flavin S., Rayner C.R., Schentag J.J. Interim Results from a Linezolid Compassionate Use Trial in Patients with Significant, Resistant, Bacterial Infections. Gram Positive Infections in Humans, The Capital Hill Washington DC, March 26-27, 1999.
46. Rayner C., Brien J., Ioannides-Demos L.L., Liolios L., and Spicer, W. J. The Effect Altering Rate of Clearance has on the Pharmacodynamics of Gentamicin Against Enterobacter cloacae. Australasian Society of Clinical and Experimental Toxicologists, Annual Meeting, December, 1996.
47. Rayner C., Brien J., Ioannides-Demos L.L., Liolios L., and Spicer, W. J. Pharmacokinetic and Pharmacodynamic Considerations of Gentamicin Against Enterobacter cloacae. Society of Hospital Pharmacists of Australia, Victorian State Conference, November 15-17, 1996.
48. Rayner C., Ioannides-Demos L., Vujovic O., Spicer W.J., Spelman D., Tong N and Krum H. A drug use evaluation of vancomycin at a major teaching hospital. Society of Hospital Pharmacists of Australia, 23rd Federal Conference in Adelaide, November, 1997.

Examples of Invited Presentations

1. AAPS Pharm Sci 360 Annual Meeting, October 25-28 (2020) The role of MIDD in drug development for COVID
2. Webinar. New Opportunities and Implications for the Future of Drug Development in Emerging Economies May 7 (2020)
3. Webinar. COVID-19: Trials, Designs and Tools for Promising Results. April 23 (2020)
4. Webinar. Accelerating Therapeutics for COVID-19. April 13 (2020)
5. Webinar. Early Development and Translational/Quantitative Pharmacology Strategies in Pediatric Drug Development (2016)
6. AusBiotech National Conference. Adelaide, October (2017) Plenary: Value focused MID3 (Model Informed Drug Discovery and Development)
7. PharmaConAsia. Singapore Sep 20-21, (2017). Plenary: Drug Development in fast forward: Lean, value-focused drug development strategies of the future.
8. Chief Medical Officer Summit. Boston, May 10/11 (2017). Adaptive Design Clinical Trials
9. Webinar. Early Development and Translational/Quantitative Pharmacology Strategies in Pediatric Drug Development (2016) https://www.certara.com/webinar-archive/early-development-and-translationalquantitative-pharmacology-strategies-in-pediatric-drug-development/?ap%5B0%5D=CSC&UTM_LeadSource=07282016
10. Monash University, Faculty of Pharmacy and Pharmaceutical Sciences Graduation Address. 2016 Job, career or vocation? https://www.youtube.com/watch?v=onOd16Ll7fw&feature=youtu.be
11. World Conference on Pharmacometrics, Brisbane, Australia, 2016 Co-Chair Symposium 1: The optimal design, analysis, and translation of infectious disease human challenge models
12. Webinar. Pharmacology to Payer: One Quantitative Drug Development Framework to Rule Them All (2016) https://www.certara.com/webinar-archive/pharmacology-to-payer-one-quantitative-drug-development-framework-to-rule-them-all/?ap%5B0%5D=CSC&ap%5B1%5D=CSC&UTM_LeadSource=10042017
13. 6th American Conference on Pharmacometrics (ACoP6), Crystal City, VA, Oct 4-7 2015: A novel interdisciplinary pharmacometric approach: A systems approach to support pharmacology to the payer.
14. United Nations Symposium (Chair). United Nations ECOSOC, New York, USA, 8th April 2014: An Integrated Future: Medicines for All. https://vimeo.com/101681779
15. Monash Faculty of Pharmacy and Pharmaceutical Science Prize and Awards Address, Parkville, 25 June 2014: Keynote Address – Job, career or vocation?
16. BioMelbourne BioBreakfast Walter and Eliza Hall Institute, Parkville 23rd October 2014: The Readiness is All: Melbourne’s R&D capacities in emerging infectious diseases
17. ASCEPT Annual Meeting, Melbourne, Australia 1-4 Dec 2013: Breaking down the silos – academia, industry and the government collaboratively developing medicines.
18. BioMelbourne BioBriefing, Deloitte, Melbourne. 23rd April 2013: Driving Global Best Practice in Drug Development in Victoria: Malaria case study
19. BioMelbourne BioBreakfast Spring Street, Melbourne, 5th March 2013: Facilitated discussion on views on Biotechnology from Mr Adam Bandt MP and Ms Kelly O’Dwyer MP.
20. AusBiotech Business Development Forum, Gold Coast, Queensland, 15-16 March 2012: Trends and insights into Pharma-Biotech Business Development (Panel Discussion)
21. XIV International Symposium on Respiratory Viral Infections (ISRVI), Istanbul, Turkey, 23–26 March 2012: Pharmacokinetic-Pharmacodynamic (PK-PD) Determinants of Oseltamivir Efficacy Using Data from Two Phase 2 Inoculation Studies.
22. XIII International Symposium on Respiratory Viral Infections (ISRVI), Rome, Italy, 13–16 March 2011: The safety, tolerability, and pharmacokinetics of oseltamivir following multiple intravenous infusions administered to healthy volunteers.
23. Aubiotech 2008 Annual Conference. Melbourne, Australia Oct 28th (2008): Scientific Due Diligence: What’s inside the box?
24. FDA-Pediatric Advisory Committee Hearing: Bethesda, MD Nov 27th (2007): Roche Presentation: Part 2 – Evaluation of Possible Pharmacological Mechanisms for Neuropsychiatric Events
25. World Health Organization – Global Influenza Program. Geneva, Switzerland November (2007): Updates on Oseltamivir Dose Prediction Model for Emerging Pandemic Strain of influenza and New Data on Neuropsychiatric Safety Profile for Oseltamivir.
26. Roche Non-executive and Executive Board of Directors: Welwyn, UK Sep (2006): The Role of drug Development in Lifecycle Management
27. 5th International Symposium on Antimicrobial Agents and Resistance (ISAAR) Seoul, South Korea, April (2005): Antibiotic tissue concentrations – do they really matter?
28. Antimicrobials 2005, Antimicrobial Society of Australia, Lorne Feb 24th-26th (2005): Multiresistant gram-negatives – Therapeutic challenges
29. Infectious Diseases Society of America, 42nd Annual Meeting, Boston, MA Sep 30th-Oct 4th (2004): Antibiotic options for multi-drug resistant gram-negative infections
30. Western Pacific Congress on Chemotherapy and Infectious Diseases, Perth, 1st -5th Dec (2002): Antimicrobial Pharmacodynamics- The science of dosing (Principles)
31. Australasian Pharmaceutical Science Association Conference, Melbourne, 6th-10th Dec (2002): The role of pharmacists in the development of a new antibiotic: The linezolid story
32. Australasian Pharmaceutical Science Association Conference, Melbourne, 6th-10th Dec (2002): Infectious diseases: Beyond the genome
33. Antimicrobials 2002, Antimicrobial Society of Australia, Sydney Feb 28th-Mar 2nd (2002): Pharmacodynamics of Home IV Therapy
34. Antimicrobials 2002, Antimicrobial Society of Australia, Sydney Feb 28th-Mar 2nd (2002): Pharmacodynamics Workshop
35. GlaxoSmithKline, Philadelphia (2001): Integration of population PK/PD/TK in the decision making process during drug development
36. Interscience Conf on Antimicrobial Agents & Chemother, 40th Annual Meeting, Toronto, ON (2000): The population pharmacodynamics of linezolid in seriously-ill adult pa­tients from a compassionate-use protocol

Examples of Social Media Commentaries

1. ABC State Wide Interview. https://www.abc.net.au/radio/programs/vic-statewide-drive/drive/12204124 at 2:46 on Defence Report on Australia’s Medical Countermeasures Preparedness
2. Thinking about the finishing line earlier! – Value focused development http://drcraigrayner.com/2012/12/07/thinking-about-the-finishing-line-earlier-value-focused-development/
3. Creating value for society is not only measured in terms of publications and grants http://drcraigrayner.com/2012/12/03/creating-value-for-society-is-not-only-measured-in-terms-of-publications-and-grants/
4. Stranded Sea Turtles Could Help Australia Transform Locally Discovered Molecules into Global Medicines http://drcraigrayner.com/2012/11/30/stranded-sea-turtles-could-help-australia-transform-locally-discovered-molecules-into-global-medicines/
5. Cross sector collaboration yields FDA approval for Tamiflu in infants http://drcraigrayner.com/2012/12/22/cross-sector-collaboration-yields-fda-approval-for-tamiflu-in-infants/

United Nations Address

2016 Graduation Address