MDGH Update - March 2022

March 1, 2022

Welcome to our Q1 2022 Newsletter, highlighting the latest activities for Medicines Development for Global Health.

Mark Sullivan awarded Officer of the Order of Australia in the Australia Day Honours List

Mark Sullivan, the Managing Director of Medicines Development for Global Health, received the Officer of the Order of Australia (AO), one of Australia’s highest civilian honours, in the Australia Day Honours List (26 January 2022). Instituted in 1975 by Queen Elizabeth II, the award is “an Australian society honour for according recognition to Australian citizens and other persons for achievement or meritorious service.”

Mark established Medicines Development for Global Health in 2005 as a not-for-profit, independent biopharmaceutical company dedicated to the development and delivery of affordable medicines for the people who need them most. Under Mark’s inspirational leadership, Medicines Development for Global Health has made significant contributions to the development of new medicines for neglected diseases.

On receiving the Officer of the Order of Australia award, Mark Sullivan said:

“This is a wonderful recognition of our work at Medicines Development for Global Health, and it is particularly meaningful as the nomination for the Order of Australia comes from our peers. But this award belongs to us all at Medicines Development for Global Health, as well as our partners, collaborators, and supporters. It is their outstanding efforts and tireless work that have made this possible. The recognition of those efforts is, indeed, an honour.”

Support by the World Health Organization for pilot Community Directed Treatment Programs

In December 2021, the World Health Organization’s Onchocerciasis Technical Advisory Subgroup (OTS) supported the use of moxidectin in pilot community directed treatment programs. These programs are intended to provide “real world” data on introducing moxidectin into more widespread use and are a helpful transition from regulatory approval into broad implementation. This support comes following review of moxidectin clinical trial data.

Pilot projects under discussion with implementing partners and program managers include national border areas in Africa which face treatment coverage challenges, areas that have received many rounds of ivermectin treatment but without elimination, and regions more recently identified for treatment. The goal is to accelerate elimination efforts.

Following the endorsement from the OTS, Medicines Development for Global Health has been meeting with the national regulatory authorities and program partners of interested countries to confirm importation pathways, and work with implementation and finance partners to develop treatment and surveillance protocols and fund supply and logistics.

Highlights from the Second Scientific Roundtable Meeting

Medicines Development for Global Health in collaboration with the Abu Dhabi-based Global Institute for the Disease Elimination convened its second scientific roundtable meeting in December 2021. The purpose of the roundtable was to gain insights from key scientists into the data supporting moxidectin’s use in onchocerciasis treatment programs. Discussion explored where moxidectin could be used to address challenges in reaching elimination of disease transmission in endemic countries.

Participants were from a broad range of disciplines, representing academia, industry, governments, funding organizations and neglected tropical disease-related non-governmental organisations. Dr Julie Jacobson, immediate past President of ASTMH and Principal at Bridges to Development, moderated a lively discussion among the participants.

MDGH welcomes new team members

L-R: Sarah Kilpatrick, Lydia Iannazzo, PhD, Joanne Kepple

As development activities for both moxidectin and CC-11050 have accelerated, so has the need for additional staff to support those efforts. We are very pleased to announce the arrival of three new members of the MDGH family:

Sarah Kilpatrick as Principal Manager, Global Regulatory Affairs

Sarah joined Medicines Development for Global Health in February 2022 from Pfizer. Sarah started her regulatory affairs career at Pfizer in 1999 and has held positions of increasing responsibility in Veterinary and Human Medicine including in the areas of Infectious Diseases, Inflammatory Bowel, Cardiovascular & Metabolism.

Sarah joined the Sterile Injectables Development team with Hospira in 2013 and transitioned to the Hospira/Pfizer Process Optimization team in 2016 where she was instrumental in supporting integration efforts following the acquisition of Hospira by Pfizer. Sarah had been managing and developing a team that supports the Global Regulatory Leads with clinical, safety and labelling activities since its inception in 2018.

Sarah has a BSc in Animal and Plant Biology from the University of Sheffield, United Kingdom and a Master’s Degree in Biotechnology from the University of Kent at Canterbury, United Kingdom.

Lydia Iannazzo, PhD PMP as Principal Development Manager

Lydia began her new role in October 2021 and is managing CC-11050 development activities for leprosy type 2 reaction and tuberculosis. Lydia brings a wealth of experience from the biopharmaceutical sector. She worked most recently at Pfizer in the role of Director, Program Manager in global product development, and prior to that at CSL as Senior Project Manager and as a Regulatory Affairs Associate.

As a project manager, Lydia has led multiple cross-functional global teams to deliver successful dossier submissions, approvals, and commercial product launches of critical medicines. She has worked with manufacturing, quality, and regulatory functions to lead new product commercial launches in the European Union, United States and Japan.

Lydia holds a PhD in Pharmacology, a PMP certification and is currently completing her MBA.

Joanne Kepple as Associate Director, Clinical

Joanne (Jo) joined Medicines Development for Global Health in January 2022. She will be leading the clinical function to drive our current and future clinical programs across investigational medicines and disease areas.

Jo joins Medicines Development for Global Health with a wealth of clinical operations experience over more than 30 years, in her previous roles as study coordinator, study manager, clinical pharmacology scientist, project manager, clinical operations manager, site manager and monitor. She has previously worked for Novartis and several contract research organisations in the United Kingdom and New Zealand. She set up and managed a successful 12-bed Phase I unit in New Zealand. Most recently, Jo held a position as Clinical Lead at Syneos Health, a medium-size global full services CRO working at all stages of development across a range of therapy areas. She was a co-founder of the National HIV Nurses Association (United Kingdom) and has qualifications in Nursing and a Master of Science in social research methods.