Please join us for Celerion’s Biosimilars Symposia entitled,“Biosimilar Product Development: from Science to Medicine.”

Program Agenda

Robert E. Zoubek PhD, Senior Consultant, Granzer Regulatory Consulting & ServicesRegulatory strategy, CMC and bio-similarity Why Biosimilars? Global regulatory context Quality by Design for Biosimilars Totality of evidence to prove Biosimilarity

Elliot Offman MSc, Senior Director, Clinical Pharmacology and Pharmacometrics, Celerion Evaluation of anatomical and physiological factors that lead to increased variability of biosimilar products Methodology to minimize pharmacokinetic variability in clinical trial design, including case studies

René Wuttke PhD, Bioanalytical Principal Investigator, Zurich, Celerion Laboratory challenges in biosimilar bioanalytical method development and validation The contribution of high throughput analysis via robotics to decreased sample variability

Karsten Roth PhD, Director Clinical Operations, Cinfa Biotech Clinical development strategies for biosimilars Regulatory environment – requirements for preclinical and clinical development programs Practical examples / study designs

Speaker Biographies

Robert E. Zoubek PhD, MSc, MBA, Senior Consultant, Granzer Regulatory Consulting & Services Robert has more than 15 years experience in the development of biologics and biosimilars. Prior to joining Granzer Regulatory Services, Robert worked in several positions at Formycon/Germany, a leading developer of biosimilars for regulated markets. As Director of Scientific Affairs he led Formycon´s drug product development and analytical services. Previously, Robert was Head of Protein Characterisation & Preformulation and Manager of Quality Operations. In both positions, he supervised Formycon´s GMP quality control and analytical labs, the core of quality biosimilar development. Robert earned his PhD from the University of Erlangen-Nuremberg and was awarded a Master of Business Administration from the University of Manchester.

Elliot Offman MSc, Senior Director, Clinical Pharmacology and Pharmacometrics, Celerion Elliot Offman is Senior Director of Clinical Pharmacology and Pharmacometrics at Celerion. He oversees a large, multidisciplinary, scientific team focused on protocol design and development as well as pharmacokinetic and biomarker data analysis. A pharmacist by training, Elliot has completed a MSc in pharmacology & toxicology and is a PhD candidate with a focus in pharmacometrics and translational science. As a senior scientist at Celerion over the last eight years, Elliot has provided clinical pharmacology and pharmacometrics support to small pharmaceutical and biotech clients and advised on the design of efficient first-in-human, drug-drug interaction and exposure vs. response studies. Prior to joining Celerion, Elliot worked in biopharmaceutics and clinical research for Mylan and Merck KGaA affiliates for five years. René Wuttke PhD, Bioanalytical Principal Investigator, Global Bioanalytical Services René Wuttke is Bioanalytical Principal Investigator at Celerion Switzerland. René studied biochemistry at the University of Potsdam and holds a PhD in physical biochemistry from the University of Zürich. He joined Celerion to support ligand binding bioanalytical studies on pharmacokinetics and immunogenicity assessment. He has been leading recent analysis on clinical biosimilar studies employing highly automated assays.

Karsten Roth PhD, Director Clinical Operations, Cinfa Biotech Karsten Roth leads the clinical development activities at Cinfa Biotech. He is responsible for the development and implementation of preclinical, clinical and post-approval clinical activities. In this role, he supervises the clinical operations team and manages the clinical stakeholders network. Karsten has over 20 years of experience in the pharmaceutical industry, having held various international executive positions with a strong focus on clinical development across several therapeutic areas. He gained substantial experience in setting up quality management systems, including SOP implementation. In his former positions, he contributed to marketing authorisation submissions for the US and EU, presentations at FDA, PMDA and EMA meetings, and was involved in setting up and leading global advisory boards. Karsten holds a PhD in Biochemistry, a postgraduate degree in pharmaceutical medicine and a master’s degree in project management from the George Washington University.

Event Details

Date: Tue, Nov 22, 2016Time: 9:00am - 10:00am: Registration 10:00am - 1:00pm: Presentations 1:00pm: Conclusion & Luncheon Venue: München Airport Marriott Hotel Alois-Steinecker-Straße 20 85354 Freising, Germany Limited Capacity RSVP by Nov 15

Register Here