Biosimilar Drug Development World - list of speakers

Dr. Carsten Brockmeyer is the owner and Managing Director of Brockmeyer Biopharma GmbH (www.brockmeyer-biopharma.com), a consulting firm providing strategic and operational support for novel and biosimilar biopharmaceutical development. Dr. Brockmeyer is a pioneer in the development of biopharmaceutical and biosimilar medicinal products. He has...

Crawford co–founded Eden Biodesign in 2000 and prior to this he was Director of Product Development responsible for developing and manufacturing the biotech product pipeline at Celltech–Medeva. Among his achievements Crawford managed and led a successful pan–European submission for a complex recombinant vaccine which included an EMEA sponsored...

Paul CHAMBERLAIN is a biopharmaceutical product specialist who specialises in presenting immunogenicity risk assessments to European and North American regulatory agencies. He works with Sponsors to develop strategies for evaluating the probability that a product might induce an undesirable immune response, as well as preparing expert reports on...

Rajiv Dua is currently Analytical and Stability coordinator, at Lupin Ltd (Biotech division), India. He is responsible for designing and conducting stability studies involved in multiple projects, coordinating in exploratory and comparative studies. He holds Masters in Biochemistry and B.Sc (Chemistry major) from University of Pune, India, as well ...

As Vice President of Global Bioanalytical Services, Dr. Farmen leads one of the preeminent bioanalytical groups in the industry. In this role he is responsible for the bioanalytical groups in Lincoln, NE USA and Zurich, Switzerland. These groups offer exceptional expertise in both small and large molecule method development and sample processing...

Ms. Fox focuses her practice on counseling pharmaceutical and biotechnology companies in patent and related transactional matters. As both a research scientist and patent attorney, she has over 15 years of experience in the pharmaceutical and biotechnology industries. Prior to joining Brinks, Hofer, Gilson and Lione, Ms. Fox was the head of the...

03.11.55: Born in Offenbach, Germany 1974: High school diploma (Abitur) 1974-1975: Army service, Germany (15 months) 1977-1981: Student of biology, J.W. Goethe Univ. Frankfurt 1979-1982: Assistant at the faculty of biology, J.W. Goethe Univ. Frankfurt 1979: Entomological...

Leading the team of scientists involved in: • Establishing the Pichia Pastoris as expression system for manufacturing the recombinant bio-therapeutics • Dowsntream process development and tech transfer to manufacturing of recombinant bio-therapeutics from E.coli and Pichia Pastoris expression systems • Complete technical knowledge of process...

Dr. Stanley Hong is currently a Senior Vice President of Celltrion, Inc. in charge of R&D including biosimilar development. He has many experience in development of biopharmaceutical area as well as industrial enzymes. Dr. Hong joined Celltrion from the begining(2002) and made lots of contribution to the establishment of Celltrion which is...

Brian Hosung Min is currently Vice President of Strategic Business Development at Samsung Group. He is in charge of biosimilar process development and business development for antibody manufacturing and biosimilars. Before moving to this position, he was the Head of Antibody Engineering at Samsung, in charge of developing novel antibody-based...

Cyrus Karkaria is currently President of the Biotechnology division of Lupin Pharma is based in Pune. Prior to that he was Vice President at Celldex Therapeutics and CuraGen Corporation in New Haven, Connecticut, USA heading Operations and Biopharmaceutical Process Sciences. He has also held positions at Biogen Idec and Scios. He has been part of...

I am currently working at NDA Regulatory Science Ltd as a Senior Consultant. Prior to joining NDA, I worked at two regulatory consulting groups and have over 10 years experience in the biopharmaceutical industry within the fields of regulatory affairs and product development. I have been involved in the development of regulatory and product...

Having graduated from the Department of Chemistry at the University of Warsaw, he then received his Ph.D. from the Institute of Biochemistry and Biophysics, Polish Academy of Sciences. During his studies he spent a year as a visiting student at the Yale University Medical School, and then did his postdoctoral training at the Sloan - Kettering...

Anita M. O’Connor, MS, PhD, has over 20 years of experience in regulatory affairs and drug development for the pharmaceutical, medical device, food, and animal drug industry. She worked for FDA for 16 years in the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Veterinary...

• 8 years of academic experience of teaching in Medical colleges • 19 years of professional experience in the Pharmaceutical Industry • More than 50 scientific publications in national and international journals • More than 20 Guest Lectures in national and international conferences • Member of Medical Sub-Committee of IDMA, OPPI • Member of DCGI...

After studying Toxicology and Pharmacology at the London School of Pharmacy (UK), he stayed on the complete his PhD by studying the predictability of the combined effects of mixtures of anti-tumour drugs. In 2006, he joined the Pharmacovigilance Department of the Vigilance and Risk Management of Medicines Division at the UK Regulatory...

As Vice President of Global Drug Development at Celerion, Dr. Pritchard leads a global team of drug development and regulatory affairs experts, project management professionals and alliance managers that work actively with clients to bring their drug products efficiently through early clinical testing. Dr. Pritchard brings 30 years of drug...

Dr Susanne Richter currently is responsible for downstream process development of biopharmaceuticals and biosimilars derived from mammalian cell culture at Sandoz Biopharmaceuticals, Schaftenau/Austria. She is an expert in process development and characterization following the QbD concept. She evaluates high throughput screening methods in DSP...

Karin Sewerin is Sr VP of Quality and Regulatory Strategy at BioPharmaLinx AB working with quality and regulatory advice for development and registration of Biopharmaceuticals. She has over 30 years of industrial experience from Kabi-Pharmacia and AstraZeneca in Sweden and Genentech in USA. Her experience is in development and validation of...

Meenu Wadhwa is Head, Cytokines and Growth Factors Section in the Biotherapeutics Group at the National Institute for Biological Standards and Control (NIBSC). She is responsible for a number of diverse projects in the cytokine and growth factor area. She has over 15 years experience in preparation of cytokine standards and/or reference...

Representative Henry A. Waxman represents California's 30th Congressional District, which includes the cities of Santa Monica, Beverly Hills, Agoura Hills, Calabasas, Hidden Hills, Malibu, Westlake Village and West Hollywood, as well as such areas of Los Angeles as Beverly-Fairfax, Pacific...

Dr. Joerg Windisch is the Global Head of Technical Development at Sandoz Biopharmaceuticals, leading the technical development of Sandoz’ pipeline of biosimilars and a team of nearly 400 associates at several sites. Dr. Windisch has been working on the development of both, innovative and follow-on biologics for his entire professional career. He...

Dr. Joe Zhou was invited to take the CEO position of the company on Oct of 2008. Previously, Dr. Zhou was Scientific Director at Amgen, Thousand Oaks, USA. Dr. Zhou has proven bio-industrial leadership in scientific innovation and technology evaluation, and is well known for implementation of membrane chromatography in mAb large-scale...