Archives: Speakers

Heading up a change management office at Novo Nordisk to support digitalization, decentralized trials and new ways of working across the clinical drug development landscape. Has over 15 years of experience driving change across companies like AP Moller Maersk, Grundfos, GN Store Nord and Leo Pharma including supply chain and HR transformations, M&A, ERP deployment and organizational redesign.

Christian holds a master degree in molecular biology earned at the University of Wuerzburg (Germany). He looks back at 25+ years in life sciences, of which Christian spent 20 years in the CRO industry. Before PSI CRO, Christian served with other CROs in senior sales and marketing positions. Among those employers were Parexel, PRA and other global CROs. Assigned responsibilities covered leading teams up to 20 men strong and up to US$500+ million sales targets. Christian’s track record demonstrates consistent sales growth that has been achieved through structured account management, planning and execution, a vision and energy to build and lead teams from the front and a passionate commitment to the client.

Christian now leads the European / Asian sales team at PSI CRO. Christian is set to expand the client base in Asia and help Asian clients to succeed in their drug development goals.

Dr. Chih-Jung Chang is currently the CDMO Unit vice president of EirGenix, Inc. His responsibilities CDMO business includes R&D, production, QC, PM and BD functions now. He got Ph. D. degree in National Taiwan University and studied on business program in UW of Unit State. Before EirGenix he works as director of TOT Oncology Business Unit at TTY Biopharm. He was creating business and drug development strategies for licensing and collaboration in global/China NCE (Specialty)/Biologics (NBE/Biosimilars) projects. With both technical knowledge and business acumen, Dr. Chang has extensive experiences building up new biologics and specialty pipelines that fit the company’s development strategy.

In addition, Dr. Chang has extensive experiences managing international networking and relationships for value-added bridge between early to late stage drug development.

Azim Chowdhury, a partner with the law firm of Keller and Heckman LLP, counsels domestic and foreign corporations on U.S. Food and Drug Administration (FDA) and international regulatory compliance matters and on tobacco and e-vapor product regulation.

Mr. Chowdhury advises corporations in establishing clearances for food and drug additives in the U.S., Canada, and European Union, with an emphasis on indirect additives used in drug and food-contact materials. He has expertise in the tobacco and e-vapor product regulation relating to the implementation of the Family Smoking Prevention and Tobacco Control Act and spearheads the FDA Tobacco and Electronic Cigarette practice at Keller and Heckman LLP. 

Mr. Chowdhury has experience representing tobacco, e-cigarette and e-liquid manufacturers, suppliers and trade associations in matters of FDA regulatory and corporate compliance. He represents clients on tobacco, e-cigarette and e-liquid matters before the FDA and the Consumer Product Safety Commission (CPSC). He is also a frequent contributor to the Food and Drug Law Institute (FDLI) Update Magazine, has served on the Editorial Advisory Board of the Food and Drug Law Journal, and edited and co-authored FDLI’s recent publications, Tobacco Regulation and Compliance: An Essential Resource and FDA Regulation of Tobacco: A Comprehensive Guide – An FDLI Primer. Mr. Chowdhury is a frequent speaker and author.

Pharmaceutical and Biotechnology professional with over fifteen years of experience in manufacturing, packaging, labeling, and clinical supply chain management. Special expertise in forecasting, planning and budgeting of clinical supply chain. Supplied and managed clinical materials from preclinical through Phase III. Extensive abilities in project management and process improvement. Highly trained in GXPs and ICH guidelines, FDA, and EMA regulations.