About CBE

Our Mission

CBE’s mission is to enable our customers to be successful, efficient and compliant, delivering safe and effective products to their customers and patients.

Values

Client Focus: We are committed to continually meeting our customers’ needs and enabling their success.

Integrity: We are committed to honest, transparent and ethical communication and service.

Collaboration: We acknowledge different ideas, strengths, interests, and cultural backgrounds are necessary for our client success.

Quality: We are committed to delivery of best-in-class service, aligned with regulations to enable our clients to deliver high quality patient healthcare.

Our Team

CBE’s Directors have extensive senior management and technical experience with leading global Biopharmaceutical and Pharmaceutical companies. We work directly with customers and include leading compliance, quality systems, operations, project management, engineering, commercialisation, R&D and process validation experts. We have multiple decades of consulting experience and collaborate with a trusted team of regional affiliates and Associates.

CBE has capabilities across biopharmaceutical sectors including: Biologics, Blood Products, ATMPs, Vaccines, APIs, Drugs, Sterile Products, Diagnostics and Medical Devices.

Steve Williams

Steve Williams

With more than 45 years experience in the Biotechnology, Pharmaceutical and Medical Device industries, Steve provides strategic solutions to regulatory and compliance challenges, along with advanced training courses.

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Jeff Davies

Jeff Davies

With more than 30 years of leadership across the biopharmaceutical industry, Jeff was CSL’s Executive Vice President and GM Asia Pacific. He also had oversight of plasma products, influenza vaccines, anti-venoms, in licensed vaccines and pharmaceuticals as well as the diagnostic product business.

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Maurice Parlane

Maurice Parlane

Maurice has significant international experience as a subject matter expert and specialist trainer in science and risk based approaches to manufacturing across the biopharmaceutical industry, he is professional engineer drawing on 30 years’ experience in technical and consulting roles.

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Andrew Watson

Andrew Watson

Andrew has 25 years experience in the design, construction, commissioning, validation and operation of a wide range high tech facilities, including pharmaceutical manufacturing, high containment, industrial cleanroom, hospital pharmacy and specialist research facilities.

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Rachel Jensen

Rachel Jensen

Rachel Jensen has over 20 years of experience across the biotech industry in commercial operations, strategic compliance and business management. As a Director at CBE, she provides specialised consulting services that assist organisations with strategy and commercial development.

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Owen Tatford

Owen Tatford

Owen is a Scientist and an experienced R&D leader with a passion for process development and medical product realisation. With over 20 years biopharmaceuticals experience in Research & Development across process development, scale-up and technology transfer into commercial production.

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Associates

CBE’s Associates provide highly specialised assistance, within the biopharmaceutical sector and in allied fields, such as IT and communications. They work closely with CBE’s experts to ensure premium outcomes across all areas of activity.

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.

Mary Nasopoulos

Mary Nasopoulos has over 30 years experience in the Pharmaceutical Industry in Quality, Manufacturing and R&D. She has diverse expertise ranging from Small Molecules, Biologics, Blood Products, Recombinant proteins, Gene Therapies and Vaccines for Pre-clinical, Early/Late Phase Development and Marketed Products. She has extensive experience in designing, and implementing strategic projects, these have been key to delivery of compliant, fit for purpose Quality systems, manufacturing processes, products, and most importantly organisational design.

Her recent Global role involved building of Quality interfaces of R&D products to Commercialization. This involved defining the Quality strategies involving end to end processes, including integrations of organisations. She is a qualified lead auditor (GMP, GCP, GLP, GCLP) and led due diligence projects for R&D, Quality and overseeing transferring products to CMOs. As the head of Product Development for Quality Globally was responsible for TGA licencing of clinical trial manufacturing facilities in Australia, including certification of facilities for EU, and US. This included material supply for Pharm Toxicological studies and material Phase 1, 2 and 3 clinical trials. In addition, it encompassed the implementation of GCP, GLP and GCLP processes into organisations globally.

She has also held the role of IBC chair (Institutional Biosafety Committee) for Biosafety Governance for OGTR and DAWR for an Australian business and has extensive experience in those disciplines.

Neil Radford

Neil has nearly 30 years experience as a senior quality and operations leader in the Pharmaceutical and Medical Device industries, improving GxP Quality Systems and business processes across organisations in the US, UK, Europe, APAC, Latin America, the Middle East and beyond.

He is highly experienced with performing product, process, and system audits and specialises in preparing for and hosting regulatory inspections supporting FDA, EU/TGA/PICs and many other major global regulators. He has also led multiple remediation and organisational transformation activities at locations across the globe.

Neil is an experienced change agent, leading and driving global tech transfer programs, supporting due diligence and site acquisitions, and driving quality system improvement initiatives. He has also developed and implemented various GxP and operational training programs and is a highly experienced facilitator and presenter. Through his in-depth knowledge of Operational Excellence, Lean Manufacturing principles and GxP quality requirements, Neil has a proven track record developing highly effective teams that demonstrate a strong balance between compliance and efficiency.

Industry Associations

The CBE team are member of and provide pro-bono support to professional organisations including ISPE, PDA, Standards Australia, as well as working with, collaborating and supporting other industry associations across the sector.

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Affiliates

CBE works with several affiliate organisations. They include: Accelagen (supporting regulatory and clinical research projects in Australia and Asia Pacific Region); Biointelect (supporting a range of projects in Australia); Biotech East (supporting Biotech initiatives in Taiwan); Hong Kong Institute Biotechnology (supporting biotechnology programs in Hong Kong and China), New Wayz (GMP Consulting and contracting business in New Zealand), No Deviation (in Singapore), PSC Biotech (ACE software) and Scilucent scientific and regulatory affairs (supporting a range of projects in AsiaPacific and United States).

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