CBE - Centre for Biopharmaceutical Excellence

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.

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.

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.

Mark Morgan

Mark has 25 years’ experience in the Pharmaceutical, Biotechnology and Medical Device industries across manufacturing, operations and supply chain. He has held key senior leadership roles with large multinational organisations throughout the APAC region, including Pfizer, Astra Zeneca and Baxter.

Mark has gained extensive operational and design experience in both sterile and non-sterile operations, as well as biopharmaceuticals. He had led teams in all areas of pharmaceutical operations, including Capital Projects, Production, Quality, Procurement, Planning, Engineering, Validation and Process Development.

Mark has a practical and pragmatic approach to simplifying operations, as well as designing and building robust manufacturing processes using a risk-based approach to drive operational efficiencies. He has experience in re-building quality management systems within emerging markets and built and executed on strategies for operational readiness for new manufacturing facilities.

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.