Senior management

Paradigm’s strategic management is driven by a team with significant experience in drug development and the execution of clinical studies.

July 2019

Paradigm is thrilled to welcome new members to our team, consolidating and strengthening the depth of expertise and experience that has driven the success of our clinical programmes to date.

Sharon Charles – Global Head, Strategic Development

Michelle Coffey – Global Head, Regulatory Affairs

Karla Knower – Associate Director, Regulatory Affairs

Jill Forrest – Project Manager, Clinical Operations

Our Non-Executive Chairman, Mr Graeme Kaufman, has broad experience in the development and commercialisation of pharmaceutical drugs (prior executive roles including CFO at CSL Limited, executive VP of Mesoblast Ltd).

 

Our Chief Executive Officer, Mr Paul Rennie, has been involved in drug development and a number of pre-clinical and clinical trial programs (was the inaugural COO of Mesoblast and most recently as Executive VP, New Product Development at Mesoblast Ltd). Mr. Rennie has extensive experience in commercialising Intellectual Property.

Our Chief Operations Officer, Dr Claire Kaufman, is an experienced Veterinary Surgeon. After 8 years of clinical veterinary and organisational experience in private practice and animal welfare organisations, Claire pursued work in pre-clinical Immunology research and was responsible for co-ordinating preclinical therapeutic trials. Claire also has extensive experience with the use of Pentosan Polysulphate Sodium (PPS) in clinical veterinary practice.

Our Clinical Operations Manager, Melanie Duiker, joined the Paradigm team in 2017. With over 25 years of experience in clinical research, she is responsible for the coordination and oversight of our clinical research activities within Australia and abroad. Her industry experience includes managing clinical operations at local, as well as international level, with 8 years managing clinical operations with Europe.  Melanie brings broad experience in clinical study development and operations, including: Feasibility, Forecasting and budget management, Quality Management, Audit Management and Vendor Management.

Our CFO and Company Secretary, Mr Kevin Hollingsworth, has previous experience with publicly listed biopharmaceutical start-ups such as Mesoblast Ltd and Patrys Ltd.

 

Our Chief Medical Officer, Dr.Donna Skerrett, joined the Paradigm team in September 2019. With more than 30 years’ experience in transfusion medicine, cellular therapy, and transplantation, she brings a wealth of experience in medical, clinical, and regulatory affairs. Donna served previously as Chief Medical Officer at Mesoblast. She was Director of Transfusion Medicine and Cellular Therapy at Weill Cornell Medical Center in New York (2004 – 2011), and prior to that was Associate Director of Transfusion Medicine and Director of Stem Cell Facilities at Columbia University’s New York-Presbyterian Hospital.  She previously chaired the New York State Council on Blood and Transfusion Services and currently serves on the Board of Directors of the Fox Chase Cancer Center in Philadelphia, Pa.

Our Chief Scientific Officer, Dr Ravi Krishnan, is a basic scientist with a long-standing interest and experience in experimental pathology, transplantation immunology, gene and stem cell therapy. He has also had significant experience in investigating novel compounds with immune modulatory effects, anti-inflammatory and anti-angiogenic properties.

Our Global Head of Clinical Development, Sharon Charles, has over 30 years’ experience in the healthcare sector across geographies, with 24 years in clinical and commercial development. She has a strong track record in developing world-class products and services and growing regional business. Sharon has worked at world leading biotech companies, including Amgen and CSL, and brings a depth of biotech development understanding and skill.

Our Global Head of Regulatory Affairs, Michelle Coffey, has over 20 years global experience in the pharmaceutical industry (Chemical and Biological), covering the life cycle of a product from early stage clinical right through to commercial launch and maintenance.  She has extensive knowledge in global regulatory requirements, working on areas including emerging treatments and clinical protocols for cell therapy products and technologies. She has worked on cross-functional teams in order to develop effective product strategy, and ensure submission timelines and global regulatory requirements are met.

Our Associate Director of Regulatory Affairs, Karla Knower (PhD), has extensive knowledge in managing global Regulatory strategies and submissions for diverse product portfolios. Karla’s expertise spans across the progressive stages of product development, from R&D through to marketed products and life-cycle maintenance. Karla has delivered regulatory oversight on the conduct of Phase II, Phase III, and Pivotal Clinical trials both in the USA and in the Europe. It is through these processes that Karla’s regulatory intelligence has broadened and strengthened to set up a solid foundation for well-considered, tactically planned regulatory filings for the advancement of clinical development plans.

Our Project Manager, Jill Forrest, has over 30 years’ experience working in healthcare, with 20 years in the clinical research industry. Her experience in clinical research ranges from working as a study coordinator, clinical research associate and clinical research consultant across phase I-III trials. Jill has worked at world leading pharmaceutical companies, including Pfizer and AstraZeneca, and brings with her a broad understanding of project and site management.