About Biogenerics Australia Pty Ltd
History
At the time BGA was formed in early 2005, a clear pathway for obtaining marketing authorisation (or regulatory approval) for FOBs did not exist in Australia, Europe or the USA. It is in that context BGA sought to identify and develop what it considered appropriate scientific tests and clinical studies that would permit the Therapeutic Goods Administration (TGA) to grant BGA marketing authorisation in Australia for these products.
The EMEA has since released guidelines for the registration of FOBs in Europe, which have been adopted by the TGA, and legislation was recently enacted in the US to establish a regulatory pathway for FOBs. However, there remains a deal of conjecture about how the regulatory pathways for FOBs in the key pharmaceutical markets will function and further how the various regulatory requirements for FOBs in those markets once determined will co-ordinate with one another.
Some FOBs have gained marketing approval as “biosimilars” in Europe by following the EMEA guidelines. However, reported sales of those FOBs indicate that they have not achieved a market share in Europe at a level similar to that typically achieved by chemical generic pharmaceutical products.
BGA remains of the view that the key to gaining market share commensurate with that typically achieved by chemical generic pharmaceutical products is for the FOB to establish clinical equivalence with the originator biological product and thereby achieve registration as “interchangeable” or “substitutable” with the originator biological product. BGA has developed a clinical study methodology that BGA is confident will provide data sufficient to sustain a grant of marketing approval for an FOB as interchangeable or substitutable with the originators’ biological.
Board
Chairman and Managing Director: Peter B Simpson (M Pharm)
Mr Simpson over 35 years experience in the development of pharmaceutical products for international markets. He was Research and Development Manager with David Bull Laboratories for 8 years prior to being appointed Chief Executive Officer of Biota Holdings Limited in 1987. At Biota he oversaw the research and development of an effective cure for influenza and the licensing of that discovery to Glaxo Limited. Mr Simpson is currently associated with a wide range of biotechnology and pharmaceutical interests, predominately associated with the conduct of late stage clinical studies and the commercialisation of Australian biomedical discoveries. Mr Simpson is also the Chairman of Biogenerics Australia Pty Ltd.
Director: Erik R Thornton B Pharm, Grad Dip Bus (Marketing) FAICD
Mr Thornton has been involved in the pharmaceutical industry since the early 1980’s when he graduated as a Pharmacist. In a 7 year period from his late 20’s he grew a small pharmaceutical wholesaler to be the leading supplier of pharmaceuticals to WA hospitals. Following the sale of his business to a listed biotech company he served for 5 years as a Director and later Managing Director of the listed entity. He has extensive knowledge of the retail and hospital pharmacy markets, in particular marketing and distribution to them.
Senior Management
Clinical Research Director: Sladjana Stankovic MD
Dr Stankovic has extensive international experience in the development of pharmaceutical products, clinical study methodologies and co-ordinating and managing the conduct of clinical studies. Following graduating in medicine and after a period working as a medical practitioner, Dr Stankovic commenced clinical research and development within pharmaceutical industry. She was a Clinical Research Manager for Astra-Zeneca in Europe with responsibility for product development and clinical research in various therapeutic areas, which included developing, managing and supervising numerous clinical studies including large phase 3 studies. Dr Stankovic has considerable international experience with regulatory compliance as it relates to clinical research, product development and drug safety, which includes direct communication with the FDA and EMEA. In addition she was also responsible for coordinating and liasing with KOLs in support of clinical development strategies. Before she joined BGA she held positon of Medical Director with Omnicare Clinical Research and Manager Clinical Oncology with Novogen Ltd in Australia. At BGA, she is responsible for developing and drafting the clinical study methodology and the supervision and co-ordination of clinical studies.
Chief Operating Officer: Anthony Davidson (B Sc, Grad Dip Eng, MBA)
Mr Davidson has nearly 30 years experience in the manufacture of pharmaceutical products including chemical generic pharmaceuticals. He has vast experience in quality assurance and compliance, research and development, manufacturing including design and constructing of manufacturing facilities gained Delta West Pty Ltd, David Bull Laboratories Pty Ltd. And Inovax Ltd He also has Sales and Marketing experience within large multinational pharmaceutical companies. Mr Davidson is responsible for ensuring that the FOB’s comply with relevant regulatory requirements including the requirements for good manufacturing practice (GMP). He also provides critical input into the design and development of the BGA clinical study methodology to ensure it will satisfy relevant regulatory requirements regarding GMP.
Regulatory Affairs Director: Patricia Soon-Shiong (Dip Pharm, MSc(Med) Graduate Certificate in Pharmacoeconomics )
Ms Soon-Shong has extensive experience in international pharmaceutical regulatory affairs. Her early career years were spent in community and hospital pharmacy before she joined the pharmaceutical industry in 1984. She led various teams as Regulatory Affairs Manager at Sandoz and at ICI in South Africa, then as a Worldwide Regulatory Affairs Director with AstraZeneca in the UK, and subsequently as Head of Regulatory Affairs at Faulding Pharmaceuticals and at CSL Bioplasma. In these roles, in addition to being involved in drug development and negotiation with various major health authorities, she also oversaw Drug Safety at Faulding . Ms Soon-Shong is responsible for obtaining marketing approval of BGA’s FOBs, which includes co-ordinating and liaising with relevant regulatory authorities including the TGA, the FDA and the EMEA regarding product registration and associated requirements as and when available for establishing “interchangeability”. Ms Soon-Shong also provides critical input into the design and development of the BGA clinical study methodology to ensure it will satisfy relevant regulatory requirements.
General Counsel & Company Secretary: Gary Werts (LLM, LLB, BPharm),
Mr Werts has extensive experience in the pharmaceutical and biotechnology industries covering the entire product development cycle including research and development, commercialisation, product registration, marketing, government pricing policies and product liability. He was formerly a senior associate at a major national law firm specialising in the pharmaceutical and biotechnology industries, was legal counsel at GlaxoSmithKline for 2 years and prior to that was a practicing pharmacist in the retail and hospital sectors for 15 years. Mr Werts is responsible for the company’s legal compliance and company secretarial functions including contract negotiations and drafting, corporate policy development, product marketing, government grants and support arrangements, and liaising with government and regulatory authorities regarding product registration requirements and product pricing arrangements. He also co-ordinates the patent strategy for the company’s clinical study methodology, including patent drafting, provides input into the development of the clinical study methodology and the conduct of the clinical study with the view to ensuring compliance with relevant ethical and regulatory requirements.