We are a not for profit organisation with the mission to put new and improved medicines into the hands of people who need them most.

Who We Are

We are an independent not-for-profit global health company dedicated to the development of affordable medicines and vaccines.

Medicines Development Limited (Medicines Development for Global Health) was founded in 2005 by Mark Sullivan. Our principals have in excess of 60 years combined drug development experience. As a not-for-profit, Medicines Development for Global Health uses all funds in excess of running costs for the development of medicines and vaccines that may have limited commercial opportunity, but which address important unmet medical needs.

Medicines Development for Global Health applies pharmaceutical industry development approaches in the global health setting.

Why We Do What We Do

There is a need for innovative solutions for development and delivery of medicines and vaccines for diseases that predominate in low and middle income countries. Opportunities identified regionally (for both candidate products and diseases unique to the region) are our focus.

We are driven by giving back.

How We Work

Our skill is in applying industry-proven methodologies and standard operating procedures to undertake all stages of regulatory-compliant drug and vaccine development.  We concentrate on providing project leadership, clinical research management and project management, sourcing the balance of the project team skills from expert service providers, no matter where they are located, to match the project.

We believe in a differentiated pricing model so that funds from commercial sales can be used to make medications accessible to those most in need. This model allows us to deliver on our social goals while also ensuring financial return for our funders.

Our development programs

Moxidectin Program

Onchocerciasis (river blindness) is a parasitic disease caused by the worm Onchocerca volvulus that is transmitted from person to person through the bite of black flies. The flies live and breed near fast flowing rivers and streams. Adult worms live in nodules under the skin for up to 15 years and continuously produce millions of microscopic larvae called microfilariae that infest the skin and eyes. Symptoms of the disease result from these larvae and cause impaired vision and blindness, severe itching, dermatitis, depigmentation and thinning of the skin, and swollen lymph glands.  In addition people suffer low self-esteem, experience social isolation, and worry that they will never marry. Poverty and famine are also increased as people move away from crop producing fertile river areas to less fertile areas to avoid the fly’s habitat and thereby risk of contracting the disease.

While considerable progress has been made in the treatment of river blindness, the disease has not been eradicated and still causes serious morbidity and mortality in sub-Saharan Africa. Moxidectin is an important potential new therapeutic option for river blindness and other neglected diseases affecting over 2 billion people. It has an excellent safety profile in preclinical and clinical settings, broad anti-helminth and ectoparasite activity.

From the late 1990s, the WHO-based Special Programme for Research and Training in Tropical Diseases (WHO/TDR) has worked extensively with industry, patient and community groups to evaluate the use of moxidectin for the treatment of onchocerciasis.  The final stages of human studies in river blindness have now been completed and moxidectin has been shown to be well tolerated and effective against the disease.

Our initial focus is the registration of moxidectin for the treatment of river blindness.  This process is being funded via a $US 10 million investment by the Global Health Investment Fund I, LLC (GHIF) which will be used to support the manufacture and testing of moxidectin, the performance of  further clinical studies as required and the compilation of the regulatory dossier as part of the New Drug Application. Upon successful registration of moxidectin, we have committed to deliver moxidectin for onchocerciasis treatment  on a  cost recovery basis  and, with GHIF, to continue to research other potential human uses of moxidectin.

Christopher Egerton-Warburton, Fund Manager at the Global Health Investment Fund and Mark Sullivan, CEO of Medicines Development, sign the $10 million funding arrangement.
Christopher Egerton-Warburton, Fund Manager at the Global Health Investment Fund and Mark Sullivan, CEO of Medicines Development, sign the $10 million funding arrangement.
Global Health Programs

Very few interventions can be as impactful as a medicine to treat or prevent a disease.

Medicine Development for Global Health

Medicines Development for Global Health has significant expertise in the execution of global health medicine and vaccine development.  The diagram above which summarises some of the programs we have undertaken, and include both Medicines Development for Global Health proprietary programs and those where Medicines Development for Global Health works in collaboration.  Medicines Development is Australia’s leading provider of  clinical and development management services to the biopharmaceutical industry.  We provide clinical research design and execution as a virtual member of the company’s team rather than an arms length, outsourced activity.  We coordinate the preparation of development plans focused on regulatory and commercial outcomes and develop logical budgets, then help to execute against those plans.

Consulting Services

What we do for biotechnology companies

Medicines Development is Australia’s leading provider of development management to the biopharmaceutical industry. We offer to biotechnology companies a fee for service program to assist with their development program by providing the ‘in house’ pivotal coordination role on a project by project basis to bring disparate elements toward regulatory compliant clinical development. We coordinate the preparation of development plans focused on regulatory and commercial outcomes and develop logical budgets, then execute against those plans.

Corporate highlights

Medicines Development has led and project managed the development of 14 pre-clinical and clinical candidates, and contributed to the development of many more. For more information on our commercial service provision, please email us.

Our Team

Principals

Mark Sullivan – Managing Director, Founder

Mark has over 20 years experience in the development of small molecules, therapeutic and prophylactic vaccines and microbicides. This experience includes 10 years with Glaxo (now GSK) at their research and development headquarters in London, United Kingdom, two years with Gilead Sciences at their head office in San Francisco, USA and three years at University of New South Wales. Mark has a clinical research background which encompasses first-in-human, proof-of-concept , pivotal phase II and III, phase IIIb and phase IV studies and regulatory submissions (two New Drug Applications).

Errol Malta – Principal

Errol has over 20 years experience in the development of new medicines. During this period, he worked with Amgen for more than 10 years, eight of which were served at its global headquarters in California, USA, as Product Development Team Leader. He was responsible for five successful new-molecule Investigational New Drug (IND) submissions to the FDA and other regulatory agencies, subsequent phase I/II programs, and a number of phase III and IV trials. Errol was a Director of Circadian Technologies Ltd and a Director of a number of ASX listed and private biotechnology companies in Australia. He has consulted to over 20 drug development companies in Australia and overseas.

Sally Kinrade – Principal, Clinical Development Consulting

Sally joined MDL in 2013 with twelve years clinical pharmacy and more than 20 years industry and management experience including 11 years in clinical research and operations, 2 years in commercial and 6 years in medical affairs at GlaxoSmithKline Australia. Three years as an independent industry consultant focussed on clinical operations and scientific writing for industry, research and government clients. Prior to joining Medicines Development, Chief Operating Officer at Phosphagenics Limited, a publically listed Australian biotechnology company with development projects in Phases I and II.

Richard Morgan – Emeritus Principal

Richard Morgan has over 25 years experience in pharmaceutical research and development. He has held various senior management positions within Preclinical Safety, including Head of Toxicology at Wellcome plc and International Head of Toxicology and Preclinical Outsourcing for Glaxo Wellcome plc. With Glaxo Wellcome (later GSK) he was responsible for the preclinical safety evaluation of over 100 new chemical entities, covering areas as diverse as central nervous system, cardiovascular, respiratory, metabolic, anti-infectives, oncology and vaccines.

Executive Team

Patty Fegan – Business Manager

Patty joined Medicines Development in 2010 to add her commercial talents to the team. At MDL Patty is responsible for the overall business management of the company including legal, financial, HR and statutory reporting aspects. Patty’s business background includes working in the toy and fashion industries in NYC as variously Director of International Sales, Sales Manager, Sales Representative and fit model for a large multinational firms where she was able to combine her ability to speak six languages with her astute business knowledge.

Amanda Handley – Director, Development Management

In 2005 Amanda joined Medicines Development where she led the development of a therapeutic vaccine for HIV and is currently working on a low cost birth-dose oral rotavirus vaccine. Amanda has 15 years local and international experience in HIV immunology and new product research and development. Amanda completed a Masters in Public Health before joining Bavarian Nordic GmbH in Denmark and Germany with experience gained in preclinical, Phase I and II smallpox and viral vector vaccine development. Her responsibilities included managing the clinical analysis group and participation in product development teams.

Larry Ward – Director Development

Larry joined MDL in 2012 as a highly experienced biotechnology executive with broad R&D, product development, operational and general management experience, including manufacturing, pre-clinical and clinical development and regulatory affairs. He has direct experience in the development of therapeutic vaccines for HIV, HBV and cancer targets. He has more than 14 years’ experience in the biotechnology industry at companies including AMRAD and Virax in positions spanning from Laboratory Director through to CEO. Larry’s medical research experience is drawn from in excess of ten years’ as a senior medical researcher in leading Australian and international institutes.

Board

David Cooper – Board Member

David Cooper BSc (Med) MBBS (Syd), MD, DSc (UNSW), FRACP, FRCPA, FRCP, FAA is Scientia Professor and Director of the Kirby Institute. A global opinion leader in HIV/AIDS, his interests are clinical research in HIV/AIDS including antiretroviral therapy, drug toxicities, immune-based therapies, primary HIV infection, vaccines, cellular immune response to HIV, chemoprophylaxis and other biomedical methods of prevention of HIV infection and access and implementation of antiretroviral therapy in the developing world.

Lorna Meldrum – Board Member

Lorna has enjoyed a successful 25-year career in the pharmaceutical industry, encompassing clinical research, business development, marketing and sales, all across a wide variety of therapeutic areas, including Respiratory, CNS, Cardiopulmonary, Metabolic, Psychiatry, Neurology, HIV and Vaccines. She has worked in the US, Europe and Asia Pacific. She immigrated to Australia in 2002 and worked for GSK Australia as the Commercial Vice President for five years. In 2009, she established Ikaria Australia Ltd Pty., a biotherapeutics company that commercialises drugs and devices for intensive care medicine. Lorna is currently Vice President, Commercial Operations of bioCSL Ltd Lorna graduated with a PhD in Neurobiology (University College London); BSc in Pharmacology (University of Glasgow) and went on to hold academic positions at the Cardiothoracic Institute at the Royal Brompton Hospital (London) and at the Royal Post Graduate Medical School (London).

Mark Sullivan – Board Member

Mark has over 20 years experience in the development of small molecules, therapeutic and prophylactic vaccines and microbicides. This experience includes 10 years with Glaxo (now GSK) at their research and development headquarters in London, United Kingdom, two years with Gilead Sciences at their head office in San Francisco, USA and three years at University of New South Wales. Mark has a clinical research background which encompasses first-in-human, proof-of-concept , pivotal phase II and III, phase IIIb and phase IV studies and regulatory submissions (two New Drug Applications).

Andrew Wilks – Board Member

Andrew Wilks BSc PhD was most recently Chief Scientific Officer and founder of Cytopia. Prior to starting Cytopia, Andrew was at the Ludwig institute for Cancer Research in Melbourne where he discovered the JAK kinases. He holds an Honorary Professorship at Monash University (Melbourne), and was the inaugural winner of the Australian Biobusiness Award in 2007. Based in Melbourne Australia, Andrew co-founded SYN|thesis in 2007 and now oversees global operations.

News

Medicines Development for Global Health has received AU$1.5 million from the Australian Tropical Medicines Commercialisation fund with matching funding from the Global Health Investment Fund for a total of AU$ 3 million to used to run a pivotal Phase II dose finding trial for moxidectin for scabies elimination. For more information, please see MDL press […]

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Kate E. Mounsey et al discuss the true global health burden of scabies, the inadequacy of current treatments and the new hope that moxidectin brings to show that improved control of scabies in endemic communities is achievable.  For the full article, please see Mounsey K 2016 PLOS NTD Prospects of moxidectin for scabies control

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In the editorial accompanying the NEJM publication of Romani, L., et al. (2015). “Mass Drug Administration for Scabies Control in a Population with Endemic Disease”, Professor Bart Currie highlights the inclusion of scabies on the World Health Organization’s list of Neglected Tropical Diseases (NTDs) noting that at any given time approximately 130 million people are […]

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