Leadership

Over 25 years of experience, leading teams of up to 700 in ensuring quality and compliance in biopharmaceutical manufacturing. I have had the opportunity to work around the globe, across multiple technologies and interacting with all major regulatory agencies. I have participated in facility start up; expansions; new product launches, and product retirement. I have worked with small molecule, large molecule, viral and bacterial, vaccines and plasma across a variety of presentations including vials, syringes and cartridges. I have harmonized quality systems and established standards, driving to ensure compliance in a flexible, effective and efficient environment. From ensuring ongoing compliance to overseeing massive remediation efforts, improving and maintaining quality compliance has been a focus of my career. Although focused primarily on aseptic manufacturing, I have also supported drug substance, clinical and development.

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.

Being 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.

Beyond her work with PDA, 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.

For most of my career, I have worked on characterization and CMC development strategies of biopharmaceuticals, in different universities and pharmaceutical companies. I have gained this 20+ years’ experience first as a researcher, subsequently as technical team manager, and then as Head of Analytical Development in Technical Development- Italy, at Novartis Vaccines (now GSK Vaccines).

In 2012, I have been a technical lead for the implementation of Quality by Design (QbD) for process/ product/ analytical development at Novartis Vaccines, working across different sites in Europe and US.

After acquisition of Novartis Vaccines by GSK, I have driven the QbD integration program, aimed at the definition of a global, integrated QbD approach at GSK Vaccines, covering Italy, Belgium and US R&D sites.

I have then been appointed as Head of Science and Development practices in Technical R&D, GSK Vaccines, with oversight on QbD implementation, Knowledge Management and CMC development roadmaps, covering all Technical R&D sites (Belgium, Italy and US).

My current role is global Technical R&D Advisor. I have been nominated GSK Vaccines Fellow in April 2019 (Senior Fellow since 2023), with involvement in scientific advocacy on CMC strategies and innovation.

In January 2023, I joined the Parenteral Drug Association (PDA) Board of Directors, as elected member.

Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded medical product regulatory and industry experiences. He is a member of the board directors for CASSS- Sharing Science Solutions and a member of the board of directors for PDA. At his current capacity as a VP, Regulatory Policy & Intelligence, Global Regulatory Affairs, Novo Nordisk, he provides strategic leadership on regulatory and quality related Policy, external affairs, strategic advice and solutions to quality and regulatory related challenges. Since 2013, Andrew has represented Novo Nordisk at several work groups in industry trade organizations, e.g., PhRMA and BIO to advocate patient and industry’s interests by developing position papers and participating liaison meetings with the regulatory authorities.

Prior to industry, Andrew had served more than 11 years at US FDA most recently as an Associate Director for Policy and Regulation and Acting Deputy Director in the Division of Haematology, CBER. He was responsible for managing dossier review and inspections for the Division. Andrew received numerus high level FDA awards for his exceptional and outstanding performance on regulatory review and management, GMP inspection, and policy.

Andrew has extensive ICH experience. He was FDA deputy topic lead for ICH Q5E EWG, PhRMA topic expert and topic lead for ICH Q12 EWG and IWG, respectively, and he is currently representing BIO as a topic lead for ICH Q6 (R1).

Andrew’s formal scientific training includes post-doctor in immunology from the National Institutes of Health, Ph.D. in Biochemistry from the State University of New York, BSc in Pharmaceutical Chemistry from China Pharmaceutical University.

Highly technical and motivated individual with extensive experience in microbiology and related regulations across global markets. Demonstrated technical expertise, leadership and process improvement in pharmaceutical/cosmetic, food & beverage, medical and academic/research industries.

Specialties: cGMP, Contamination Control, Environmental & Water sytems monitoring, Aseptic Production (Media Fills), Microbiology Lab Design, Investigations (CAPA), Rapid Microbiological Methods (RMM), Non-Sterile Manufacturing control.

A pharmacist with an MBA(HRM). With over 3 decades of work experience spread over Resource Management, Operations/Quality Functions, and Teaching. Specialized in developing training & educational activities, for pharmaceutical-biopharmaceutical manufacturing operations of API-Drug Substances, Formulations-Drug Products, Quality Assurance, and institutionalizing Culture Change initiatives. A Certified Professional for Behavioral and Value Analysis.

Specialties: In-depth understanding of regulatory requirements for (nonsterile & sterile) APIs', drug substance, drug product manufacturing, documentation, unit operations, procedures & processes.

Critical understanding of Aseptic processing, Sterility Assurance, Filtration/filter validation, Clean Areas & Environmental Monitoring, Microbiological Logic for shopfloor implementation & validation practices for assurance of quality.

Curation of customized crucibles for learning cohorts.

Consulting, Auditing of operations, Gap Analysis for assessing operational & learning efficiency, creating creative and lasting education/training experiences for enhancing learning skills, and "Implementation" of Learning to ensure compliant unit operations, backed by positive shift for people & processes.

Experienced professional with a demonstrated history of working in the biotechnology industry as well as the government administration. Skilled in leading Laboratory Operations, Manufacturing, Technical Operations and QA. Strong, collaborative, decision maker with deep technical knowledge (holds a Ph.D. in Microbiology and Molecular Genetics from Rutgers, The State University of New Jersey).

My career comprises 30 years of experience within the biopharmaceutical industry and includes work assignments in Asia, South America, USA and Europe. A common denominator for my work has been to ensure a holistic and broad perspective on biomanufacturing challenges from idea to established facilities. My key focus area is to ensure fully compliant and cost-effective production through optimal use of all relevant, available knowledge and technologies, as for instance single-use systems and continuous processing. I aim to combine my technology expertise with thorough business understanding supported by a great personal interest in stakeholder relations and change management – an approach that seems to have led to success for all parties, including the involved companies, the individual employees and not least the patients, whom it is my highest wish to help best possibly.

I am highly motivated by sharing knowledge and experiences in how best to meet key objectives of the pharmaceutical industry, which is why I prioritise and appreciate being actively involved in international industry organisations such as ISPE and PDA. Furthermore, I am honoured to be appointed as member of scientific committees for various international conferences, as well as member of CMC Biologics Technical Advisory Committee, PDA Biotechnology Advisory Board and Advisory Board for Master studies at Copenhagen University on Industrial Drug Development and Regulatory Affairs.

Specialties

• Biopharmaceutical Manufacturing
• Design of Pharmaceutical Facilities
• Validation of Pharmaceutical Processes and Facilities
• Single-use Systems
• Continuous Manufacturing
• Strategic Customer Partnership
• Business Development
• Change Management
• Stakeholder Relations
• Recognised technical presenter at international conferences
• Organising and facilitator at conferences
• Establishing networks and partnerships

Our passion at Vetter is complex and sensitive drugs, such as monoclonal antibodies and oligonucleotides, that have the potential to improve or advance existing treatments for patients around the world who depend on them for their health and well-being. In this regard, we support global pharmaceutical and biotech companies in clinical development, commercial filling and packaging. My team and I are responsible for both, existing and new Vetter products and services, marketing and public relations. Therefore, we are always interested in current topics, trends that affect our industry to further develop our offering.

Prior to joining Vetter in 1996, I began my career in 1983 in various positions in the sales organizations of companies such as Hilton International and TNT Express Worldwide. Although these are different industries, they are also always about people and service. I would not want to miss these experiences, even though today I can say that I cannot imagine a more exciting industry than pharma/biotech.

Since 2005 I have been active in the PDA and have served on a variety of committees and initiatives. I believe that this work has helped me to improve my knowledge and experience in the pharmaceutical industry and to develop my leadership skills.