4th International Conference and Exhibition on Biologics and Biosimilars October 26-28, 2015 Baltimore, USA

Mariana Babayeva MD, PhD is an Associate Professor at Touro College of Pharmacy, New York, NY. In addition to her role at Touro, Dr. Babayeva is also an Adjunct Professor at RockefellerUniversity and Visiting Scientist at Arnold and Marie Schwartz School of Pharmacy of LIU.Dr. Babayeva has over 10 years of experience in clinical practice. She is recognized for her expertise in the pharmacokinetics and the use of animal and organ models. Dr. Babayeva has conducted several international research projects. Dr. Babayevahas been publishedin peer-reviewed journals and serving as an editorial board member of repute.

pharmacokinetics and the use of animal and organ models.

Abe Hershkovitz founded Hershkovitz & Associates, PLLC, in Alexandria, Va. in 2003. He is a former Director of the Office of Petitions at the USPTO, where he worked for more than 27 years. Prior to working in the Office of Petitions, Mr. Hershkovitz worked as a Patent Examiner and then as an Expert Primary Examiner in automotive technology. As Director of the Office of Petitions, he worked on setting policy-related USPTO guidelines and oversaw a staff charged with rendering over 10,000 petition decisions each year. Mr. Hershkovitz specializes in petitionable matters and prosecution of Ex Parte and Inter Partes Reexamination Proceedings. He assists clients with complex matters before the USPTO and serves as an expert witness in litigated cases. He has strong business ties with many intellectual property firms in Europe and Asia. He lectures frequently to Bar Associations and international IP organizations on various topics of patent laws and regulations and procedural tips on patent prosecution before the USPTO.

Biologics and Biosimilars

Professor Gregory Gregoriadis is the Founder (1997) of Xenetic Biosciences Inc, the creator of the company's PolyXen (polysialic acid) and ImuXen (liposome) technologies and a SAB member. He served as a Board member, Director and CSO (1997-2015). He was Head of the Centre for Drug Delivery Research(1990-2001) at University College London, and Head of the Liposomes Group at the Medical Research Council (1972-1990). In 1971 he introduced(with B. Ryman) liposomes for drug and vaccine delivery, and in 1991 introduced polysialic acid to improve the pharmacokinetics and pharmacodynamics of protein and peptide drugs. He has published nearly 400 research papers, reviews and articles, and 27 books on drug and vaccine delivery. Gregory's achievements have been honoured with the Controlled Release Society Founders Award (1994), the A.D. Bangham FRS Life Achievement Award (1995), a Fellowship in the American Association of Pharmaceutical Scientists (1998), a Fellowship in the Controlled Release Society(2013), a DSc from the University of London (2001), a Journal of Drug Targeting Life Achievement Award (2008), a Fellowship in the Academy of Pharmaceutical Scientists (2008), and the Founders Award of Liposome Research Days (2010), all for exceptional contributions to the field of drug and vaccine delivery. Gregory's seminal contributions are also reflected in his founding (1978) of the Gordon Research Conference series 'Drug Carriers in Medicine and Biology', his directorships of the NATO Advanced Studies Institute series 'Drug Targeting' and 'Vaccines' (1981-1999), his founding of the 'Liposome Advances' conference series (1991-2013), and his position of Professor Emeritus at University College London. He is in charge of the International Liposome Society(since 2003).

Drug Delivery Research

Krishna Menon is the Chief Scientific Officer at Celluceutix Corporation, USA

Biosimilars

Rodeina Challand is the Executive Director at PRA International, UK

Biosimilars

Dr Mohan Dewan is the principal of R K Dewan &Co, with over 40 years of experience in the field of Intellectual Property Rights. Dr Dewan is a practicing Advocate and Jurist. He is a registered Patent & Trademark attorney. Dr Dewan has the unique distinction of being an exceptional litigator along with being an expert in Patent & Trademark prosecution. Having drafted and successfully prosecuted several thousand patent specifications, he has come to be acknowledged as a specialist in patent specification drafting. Dr Dewan has obtained over 5000 patents for various Indian and foreign clients in almost every sphere of technology. His firm represents over 4000 clients worldwide.

Patents

Patrick Lucy has served as our Chief Business Officer since 2009. Prior to joining us, Mr. Lucy held the position of Director of Business Development at DowPharma, a business within The Dow Chemical Company, a chemicals manufacturer, from 2002 to 2009. From 1999 to 2002, he held the position of Director of Business Development at Collaborative BioAlliance, Inc., a biotechnology company, which was acquired by The Dow Chemical Company. From 1998 to 1999, Mr. Lucy worked as a Validation Manager and Capital Project Manager and from 1996 to 1998, as a Quality Control Biochemistry Supervisor at Lonza Biologics Inc., a chemicals and biotechnology company. From 1991 to 1996, Mr. Lucy held the position of Biochemistry Quality Control Supervisor at Repligen Corporation, a life sciences company. Mr. Lucy holds a Bachelor’s degree in Biology from Villanova University.

Biosimilars

Jianguo Yang is working as Vice President and CSO for Qiu Pharmaceuticals, China

Pharmaceuticals

Commercial biotechnology professional with a consistent track record of success in identifying market opportunities that increase revenues and balance corporate risk. Skilled in facilitating decision-making in complex situations, and leading cross-functional support to final, actionable solutions based on accurate data, insightful analysis and quality communications.

Corporate and Product Strategy, New Product Planning, Business Analysis, Forecasting, Negotiations, Licensing and Acquisitions, Corporate Valuation and Modeling

Heike Schoen is the Managing Director and Co-Founder of LUMIS International GmbH, headquartered in Germany. She has gained more than 20 years of experience in various management positions overseeing the conduct of international clinical trials Phase I to IV in different indications, within CROs and Biotech companies. She is an active member and regular speaker of the DIA (Drug Information Association) and ACRP (Association of Clinical Research Professionals). At ACRP she was 7 years a member of the voluntary Board of Trustees, and their Chairperson in 2010. She has gained Masters in Science (Psychology) and in Business Administration.

Clinical trials

Energetic & dedicated biopharma executive with nearly 10 years of Global Commercial Development & Market Access experience in Hematology, Oncology and most recently, Biosimilars at start-up biotechs, big pharma and now with one of the world's leading generic players. A strong penchant for success complimented by intense intellectual curiosity, excellent communication style and strong analytical skills. The ability to thrive in a demanding, dynamic environment through unwavering focus and a strong appreciation for business fundamentals. Specialties: • Commercial Go-to-Market Strategy Development (innovative & biosimilar Oncology biologics) • Market Access Strategy Execution (value story development, pt & payer pricing strategies) • New Market Opportunity Assessment (financial & commercial) • Market Research, Forecasting and Budget Impact models

Biosimilars

An extremely versatile executive level leader and scientist, with significant expertise within the Biopharmaceutical Development/Manufacturing and Biopharmaceutical Support industries. Direct experience in biologics: manufacturing, process development, research, and portfolio/program/project management. Technically well versed in the fundamental disciplines necessary for integrated pharmaceutical program development. Experienced in the Biopharmaceutical Support industry, managing people and processes that lead to the identification and development of disruptive new processing technologies including: expression system development, bioreactor/fermentation development, filtration development, chromatographic resin development, sensor technology development, and disposable systems development.