Guest Speakers' Biographies

Enrico Corona serves as Formulation and Process Development Manager at Patheon Italia – Ferentino site. He holds a B.S. in Medicinal Chemistry and a B.S. in Pharmacy from Rome University "La Sapienza". Upon graduation in 1996, he joined the Pharmacy Research and Development Division of Intervet where he was involved in the formulation of sterile liquid and semi-solid products. He joined Patheon in February 2003.
While at Patheon, he has been active in the development of new liquid and lyo parenteral formulations for preclinical and clinical and for the marketplace. He conducts lyophilization cycle development and presides over scale-up to fill finish sterile suite.

Werner Stüber, Dr., is a Project Management and QA Consultant with experience in "Big Pharma", Biotech and Contract Manufacturing. His main focus is in the area of API (peptides and proteins) and drug product manufacturing, QA including GMP audits of service providers for APIs, drug products and logistics (drug supply). He has almost 30 years experience in projects from research to late stage development. In the last ten years he has served as the Managing Director (and founder) of WS Partners Management Consulting. He holds a Dr. rer. nat. of University Tuebingen, Germany (PEGylated Peptides).

Roman Hlodan, Ph.D., is a Biopharmaceutical Specialist at Patheon. He joined Patheon in July 2004 as a Biopharmaceutical Section Manager and was appointed to his current position of Biopharmaceutical Specialist in November 2009. Prior to Patheon, he worked for six years  as a Senior Scientist, at Cambridge Antibody Technology, carrying out early-stage preformulation studies and evaluating drug-delivery technologies for monoclonal antibodies. Prior to that, he worked at Cobra Therapeutics on the formulation of DNA containing particles. He holds a PhD in Biochemistry from the University of Newcastle upon Tyne.

Summary of experience:

• Experienced in analytical method development and validation for biologics
• Experienced in the development of liquid formulations for biologics
• Experience in the evaluation of drug delivery technologies for biologics
• Experienced in managing methods transfer/validation for clients
• Over 15 years industry experience
• Over 20 years experience as a protein chemist (including postdoctoral research in the US, at the Sloan Kettering Institute in New York)

Sue Marlow, Ph.D., is a Regulatory Affairs and Quality Consultant with experience working in both the Biotech sector and contract manufacturing environment as a Qualified Person for Investigational Medicinal Products (IMP's). She has developed a very good understanding of the quality and regulatory expectations for IMP's and the transition to commercial production. Dr. Marlow has over 18 years experience in early and late phase development of a wide range of drug products, including New Chemical Entities (NCE's), Biologicals and Advanced Medicinal Therapies (ATM's). Working with a number of small and medium sized companies in both the EU and US, she has been involved in compiling regulatory packages for successful clinical trial applications and IND submissions.