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.

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.

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.

Christine Kwok

Christine has more than 20 years experience of drugs development in the Biotechnology and Pharmaceutical industries, and a university. She has worked as a Chief Executive Officer, an R&D Director and Head of Manufacturing Operations in Hong Kong pharmaceutical companies. She has experience conducting different company internal audits, supplier GMP audits/gap analysis and GCP audits, throughout Hong Kong, Mainland China, South Korea, New Zealand, the USA and the UK. As well as experience in Chemistry, Manufacturing, and Controls (CMC) dossier preparation for different drugs, quality control tests and process development, virus validation, and the manufacture of an investigational medicinal product for clinical trials.

Christine is an industrial advisor of the Hong Kong Polytechnic University, for the Technology Transfer Advisory Committee and the IP Advisory Committee. She has experience in technology transfer to CMOs, and she is the inventor of many patents. She has a proven track record in bringing drugs from early drug development to the clinical stage, extensive expertise in Biologics, Blood Products and Recombinant Proteins development and manufacture.

Raymond Yeung

Raymond has over 35 years of experience in the pharmaceutical and healthcare industries across Asia Pacific and North America. He has held senior positions in preclinical and clinical research organisations (CRO, CDMO) in biotech and pharmaceutical industries, hospital clinical pathology laboratories, and community medical diagnostic laboratories.

As a CBE Senior Consultant, he has expertise across Regulatory Affairs, Quality Management Systems, Data Integrity and Good Laboratory Practice.

Lisa Bennett

Lisa Bennett is a seasoned professional in the pharmaceutical and medical device industry, with a diverse background spanning from R&D to aseptic processing and sterile medicine manufacture to Quality Management Systems and auditing.

Lisa has held roles in industry supporting the manufacture of biologicals and cell and gene therapies, and her consultancy and training services include various aspects of human and animal pharmaceutical manufacturing, including quality assurance, aseptic processing and good manufacturing practices.

Beyond her consulting work Lisa is passionate about collaboration and knowledge sharing across industry, she volunteers with the Parenteral Drug Association (PDA) and is an active member of the PDA Board of Directors, PDA Regulatory Affairs and Quality Advisory Board (RAQAB) and the PDA Australia Chapter Board. Through these roles she contributes to the PDA mission of advancing pharma manufacturing science and regulation so members can better serve patients.
Known for her commitment to quality and attention to detail, Lisa actively engages with industry stakeholders, collaborates on knowledge sharing opportunities such as conferences, workshops, training and publications, and stays abreast of medicine regulators’ expectations.