CBE - Centre for Biopharmaceutical Excellence

Mark Forbes

Mark provides strategic communications guidance to corporate clients and institutions. An award-winning journalist and editor, he specialises in reputation building communications strategies. He is the founder of Forbes Consultancy.

Daniel Price

Daniel is a highly experienced computer systems validation specialist with extensive international experience working with integration and governance of enterprise level and process automation and computerised systems. He assists CBE with CSV projects when required.

Katrina Williams

With experience across Australia and United Kingdom managing programs, communications and customer service, as well as qualifications in journalism, communications and digital culture, Katrina is well positioned to deliver CBE programs.

Katrina is the Program Manager for the GMP Uplift training programs, managing program communications, scheduling and planning and participant coordination. She also assists with market research and other CBE projects.

Richard Russell

Richard is an experienced engineering professional with over 25 years working internationally across industry covering pharmaceutical, medical devices, construction and food. Richard has worked for and held key roles with some market leaders (Johnson & Johnson, GSK, Pfizer) gaining extensive experience in sterile, non-sterile and APIs in the medicinal products space and the associated regulations. He has directly managed projects worth over $60m in value and supported projects in excess of $120m, as well as being accountable in the delivery of validation programs.

As an experienced Project Manager, Richard has also been involved in setting up and managing QMS documentation (Engineering, Validation, Operations), operational readiness, running investigations and continuous improvement programs using Six Sigma tools.

Wayne Adcock

Wayne Adcock is a biologics biopharmaceutical leader with over 30 years of experience in Manufacturing, Quality, R&D, Continuous Improvement and Contract Management. Wayne has a reputation for having an energetic and pragmatic leadership style, with strong interpersonal relationship skills and a strategic approach to delivering outcomes.

Experienced in multiple regulated industries:, including biologics, sterile pharmaceutical, medical device, supply chain and quality. Wayne have developed strategic solutions to operations, regulatory and compliance challenges (TGA, ISO, DoH, FDA, PICs) and has delivered business success by embedding a culture of quality into people, processes and products at all levels to drive continuous improvement.

Wayne now supports clients to access data using IoT technologies and uses advanced data analytics, including machine learning to provide data insights that facilitates process understanding and optimisation (through identifications of CPP’s and their interdependencies with product yield and CQA’s), real-time condition monitoring of critical assets and yield and quality improvements. Wayne is a director at ThingWave, an IoT company.

Lauren Lai

Lauren is a registered Pharmacist and a registered Authorized Person in Hong Kong. She has over 20 years of quality management experience in the pharmaceutical industry, having been a Quality Director, Authorized Person and Pharmacist-in-charge working across a number of companies.

She has experience in the PIC/s GMP and NMPA compliance audits in Hong Kong and Mainland China. Lauren lead the approval for a series of scale-ups and upgrades for a sterile biopharmaceutical facility to allow for the manufacture of an investigational medicinal product for clinical trials, as well as the commercial production of a sterile biopharmaceutical product. She is also specialized in Hong Kong pharmaceutical laws, including regulatory affairs and wholesale distribution of pharmaceutical products. With wide range of experiences, Lauren services CBE clients as an AP, in training programs and consulting projects.

Paul Fletcher

Paul specialises in leading complex projects in Pharmaceutical, Biopharmaceutical and Life Science companies and is currently heading the Business Team in the design, build and global implementation of new SAP and GLIMS systems for a major multinational pharmaceutical manufacturer. He was previously business lead of SAP deployment for CSL Behring across Australian and New Zealand.

With over 25 years experience in Pharmaceutical manufacturing, project management, qualification, validation and consultancy, Paul was Operations Manager for the Red Cross in NSW and the ACT, where he drove improvements in customer satisfaction and productivity through operational efficiencies. He also worked at Sandoz, AstraZeneca, Schering-Plough, Seer Pharma and iNova.

He has deep knowledge of manufacturing and quality principles across pharmaceutical operations and working constructively with complex and diverse teams. He has the technical capacity to deal with the factory floor and the strategic mindset to engage with leadership teams to improve processes, remove complexity and boost business efficiency. Paul was a CBE Partner, and has transitioned to work on project based work as a CBE Associate.

Glenys Crawford

Glenys Crawford is a highly respected Management Consultant with 30 years’ experience assisting businesses, government and community organizations with their business development and rapid growth.

She focuses clients on the specifics required for business growth by conducting in-depth market research – customer research, competitor research, research into new markets. This information is then used to develop sound strategies for implementation. Glenys has a true passion for what she does that is hard to beat, and this is reflected in the results achieved for clients.

She was Director and Founding Partner of Bass Group Worldwide, a business consulting firm specialising in franchising, business development and marketing established in 1991. She has a prior background in sales management, training, and education.

Marcello Simoncini

Marcello is an experienced Engineer, with over 25 years’ experience in Pharmaceutical engineering, manufacturing and quality systems. He has held various key roles in BMS (Bristol Myers Squib), CSL, IDT, as well is a business partner/Director of Production Engineering Technology P/L.

He is skilled in all facets of sterile pharmaceutical manufacturing, packaging, facility redesign commissioning, equipment sourcing, qualification/validation, safety systems, managing maintenance departments, project management and more recently the cannabis industry. He also has experience in mentoring, developing, motivating teams.

As a consultant, Marcello specialises in identifying solutions to issues of design, compliance, validation, maintenance and quality, as well as sourcing production equipment and performing FAT for customers.

Owen Tatford

Owen is a Scientist with a PhD in Immunology, and experienced R&D leader with a passion for process development and medical product realisation. He has worked at Exopharm, Sienna Cancer Diagnostics and CSL Behring.

With over 20 years in biopharmaceuticals, Owen has worked across biologics, diagnostics and novel exosome technologies. He has led R&D activities across upstream and downstream processing, the development of GMP product manufacturing capabilities, process and analytical improvements and technology transfer and scale up from R&D to commercial production. Experienced across smaller companies to a large global organisation, Owen can flex his style to suit the organisation's stage and brings his skills to consult across R&D management, R&D projects, process development, GMP manufacture and operational excellence.

Haley Scarborough

Haley is a Pharmaceutical Engineer and is experienced in the project management and delivery of engineering capital projects, introduction of new manufacturing platforms and facility upgrades; spanning the design, construction, commissioning and validation phases.

With senior roles at Hospira, Pfizer and BioCina across Validation, Engineering and Operations, she has gained a deep knowledge of manufacturing and quality principles in highly regulated operations, leveraging science and risk-based design.

As a consultant, she has a passion for continuous improvement and engages cross-functionally to drive the strategic delivery of projects to minimise complexities and optimise operational efficiencies. Her consulting expertise spans facility design and engineering, validation, electronic systems, documentation and QMS, regulatory audit preparedness and training.

Andrew Hoxey

With over two decades of experience in Quality Management, Andrew Hoxey is a highly skilled professional in the field. His expertise lies in quality manufacturing within the pharmaceutical industry, with deep experience in sterile injectables, vaccines, and medical devices. Throughout his career, Andrew has designed and conducted quality audits, assessing compliance with various regulations including US FDA, EMA/MHRA and TGA-PIC/s, as well as local and international standards. His auditing experience extends globally, including the USA, Europe, Africa and Asia, with a focus on India. Andrew has prepared businesses for regulatory audits and supported uplift to address identified quality gaps and opportunities.

In his most recent role as the Head of Batch Release for Seqirus, Andrew was responsible for providing quality technical, operational, and strategic leadership. He ensured site compliance for Release for Supply, overseeing products including influenza and COVID vaccines, antivenoms and in-license products.