19-20 APRIL 2018 - Double Tree by Hilton, McLean, VA, USA

Biosimilars & Follow On Biologics

19-20 April 2018 - Double Tree by Hilton, McLean, VA, USA

Establishing biosimilar drugs could potentially save healthcare spending in the United States by billions of dollars over the next 10 years. According to a new analysis released in October 2017, biosimilars will lead to $54 billion less in direct spending on biologics over the next decade. The range of the new savings estimate given reasonable ranges of key assumptions, such as the price of biosimilars versus reference biologics and biosimilar market share, varied from $24 billion to $150 billion from 2018 through 2027. (The Rand Corporation)

The increasing pressure to decrease healthcare expenditures, growing demand due to its cost-effectiveness, expanding occurrence of different diseases, increasing numbers of biologics losing their market exclusivity, positive outcomes in ongoing clinical trials and rising demand in various therapeutic applications are all contributing factors for growth of the biosimilars market. Between 2015 and the end of 2019, 39 biologics with combined US sales of $41 billion, representing 30% of the total market will lose their marketing exclusivity. This resulted in huge interest by big pharma and biotech company venturing into the Biosimilar sector in order to gain a slice of multibillion worth of biologics market. Other factors increasing the demand for biosimilar drugs include rising disease incidences across the globe and better access to healthcare for all nations.

Circumstance such as high manufacturing complexities and costs, rigorous regulatory requirements in countries, and innovative strategies by biologic drug manufacturers to restrict the entry of new players are restraining the growth of this market.

In this congress, we will cover a diverse range of topic and address the challenges and obstacle encountered by the industry from development to successful market of biosimilars.

This will also offer and provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more.

Gain Latest Insights On:

• Learn the current global regulatory guidelines and considerations for developing and bringing the next generation of Biosimilars to the market
• Describe key components of pre-clinical packages required for Regulatory approval of biologics
• Know the strategies in place in developing and manufacturing biosimilars in emerging markets
• Establishing and integration of biosimilarity and comparability into developing Biosimilars
• Identify challenges encountered with Extrapolations and interchangeabilityand assessing immunogenicity
• Describe key pharmacovigilance concepts including safety risks
• Explore CMC regulatory challenges and considerations for Biosimilars drug development and manufacturing
• Discuss the utility of biomarkers in the development of biologics including oncology products
• Study the pre-clinical and clinical challenges associated with the development of biosimilars
• The importance of establishing partnerships and successful collaboration for Biosimilars business
• Learn the latest updates, trends and current Biosimilars market situations in different regions
• What does the future hold for Biosimilars and Biologics
• Walk away with an understanding of the preclinical studies used to support the phases of clinical trials
• Network with experts and leading drug developers, regulators and investors in the industry

Featuring Key Industry Expert Speakers

Anshuman Patwardhan, PhD, MBA, VP, Global Licensing & BD – Biologics, Lupin Pharmaceuticals
Stephan O. Krause, PhD, Director of QA Technical Support, AstraZeneca Biologics, USA
Rakesh Dixit, PhD., DABT, Vice President, Research & Development, Medimmune
Francis J. Rienzo, Vice President, Government Relations and Advocacy, Medicaid Health Plans of America
Richard Di Cicco, Co-founder, Harvest Moon Pharmaceuticals
Sarfaraz K. Niazi, PhD, SI, FPAMS, FACB, FRSB, Founding Executive Chairman, Karyo Biologics, LLC
Partha Roy, Vice President, Technical, PAREXEL Consulting
Bruce Leicher, Sr. Vice President and General Counsel, Momenta Pharmaceuticals, Inc.
Michael A. Swit, Esq., Legal Counsel, Law Offices of Michael A. Swit
H. Fai Poon, Chief Scientific Officer, Zhejiang Hisun Pharmaceutical Co., Ltd
Djoubeir Makhlouf, Regional (EEMEA) Head of International Pharmacovigilance, Roche
Ajay Ahuja, MD, MBA, Chief Executive, The Nexus Embassy
Dr. Seraphin Kuate, PhD, MBA, RAC, Assoc. Director, Global CMC, Biologics, Boehringer Ingelheim
Oxana Iliach, PhD, Sr. Director Global Regulatory Strategy & CMC, Biosimilars Center of Excellence, IQVIA
Jim Cucinotta, RRT, MPH Sr. Director, Global Clinical Operation Oncology/Hematology, BioSimilars, Teva
Dr. Kei Kishimoto, Chief Scientific Officer, Selecta Biosciences
Thomas Haag Ph.D. Partner, Intellectual Property Department, Seyfarth Shaw LLP
Dean L. Fanelli Ph.D. Partner, Intellectual Property Department, Seyfarth Shaw LLP
Jamaica Szeliga, Partner, Litigation Department, Seyfarth Shaw LLP
Parithosh K. Tungaturthi, Ph.D. Patent agent, Intellectual Property Department, Seyfarth Shaw LLP

Expert Speakers

Stephan O. Krause

Stephan O. Krause

AstraZeneca Biologics, USA



MedImmune Inc



Momenta Pharmaceuticals

Who Should Attend?

Chief Executives, Executive Directors, Vice Presidents, Heads and Team Leaders and Managers working within:

• Follow on Biologics/Follow on Proteins/Biosimilars
• Biologics/Biotechnology/ Biogenerics
• Biopharmaceuticals/ Biotherapeutics
• Legal and Regulatory Affairs
• Intellectual property
• Clinical and Nonclinical Development
• Pricing and Reimbursement
• Clinical Immunology
• R & D
• New Product Development
• Quality Affairs/ Quality Control
• Principal Scientist
• Pharmacovigilance
• Chief Scientific Officer
• Drug Safety & Risk Management
• Manufacturing
• Process Control and Analytical Technologies
• Business Development and Market Strategies
• Commercial Affairs
• Legislation and Policy Advice
• Licensing
• APIs
• Seasoned drug developers transitioning into biologics

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