Biologic Therapeutics have revolutionised the treatment of many diseases and biosimilars are having a similar therapeutic efficacy with potentially lower costs to the health care system.
The approval of the first
biosimilar in the US is expected to save the healthcare industry and patients $5.7 billion over the next decade. However, it is a complex landscape with complexity of manufacturing biologics making the development of biosimilars more challenging than the development of generics.
In addition to this, the upcoming patent cliffs facing manufacturers of blockbuster biologics are daunting – with over $60bn in branded biologic sales coming off patent in the next several years.
The
biosimilars and biobetters industry is likely to become a lot more dynamic and strategic than we’ve seen with small molecule generics; there will begin to become a premium on flexibility and willingness to take chances in an ever-shifting competitive and regulatory environment.
The US
biosimilars market is expected to reach $1,954 million by 2018 and with the first
biosimilar approved recently in America, this is an exciting time for the
biosimilar field with approval in the US expected to increase during the next ten years. The regulatory landscape is evolving rapidly so it is important to understand the developments in the
biosimilar guideline framework and the cohesion in legislation between the US and Europe.
The learning objectives in the US should be to fully understand the product lifecycle and all aspects of
biosimilar research and development.
Benefits of Attending
This two-day conference will focus on debate, enhanced interaction and learning objectives focussed on the below;
- Evaluating the regulatory landscape and pharmacovigilance of biosimilars
- Assessing and challenging the BPCIAs dispute resolution process
- Understanding and recognising the technical challenges in biosimilars
- Discussing how to strategically plan and revolutionise biologics manufacturing
- Reviewing the status on biosimilars - Clinical development and continued progress
- Recognising commercialization strategies & improving market development
- Developing further awareness on biobetters; are they the future?
- Examining unexpected in results in Immunogenicity testing
Plus Two Interactive Half-Day Post-Conference Workshops | Wednesday 18th November 2015
A: A Regulatory Perspective on BiosimilarsWorkshop leader: Ravi S. Harapanhalli, Vice President, ParExel and former Senior Executive, FDA
8.30am-12.30pm
B: Development, Regulatory & Commercial Needs for Global BiosimilarsWorkshop leaders: Gerry McGettigan, CEO & Regulatory Expert, Kinesys Consulting Ltd & Graeme Deuchar, Product Development Expert, Kinesys Consulting Ltd
Liz Yamashita, VP, Regulatory & Clinical Affairs, Oncobiologics, Inc.
1.30pm-5.30pm
Speakers
- Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety
- Carsten Brockmeyer, CEO, Formycon AG
- Cliff Mintz, Senior Writer/Correspondent, Life Science Leader
- Dominic Adair, Partner, Patent Litigation, Bristows
- Gerry McGettigan, Founder & Director, Kinesys Consulting
- Graeme Deuchar, Product Development Expert, Kinesys Consulting Ltd
- Jim Nelson, Senior Principal and Owner, Adversarial Proceedings/Pharma & Biotech, Schwegman Lundberg Woessner
- Jordanis Joy, Biopharmaceutical Regulatory Affairs, Sandoz Inc
- Liz Yamashita, VP, Regulatory & Clinical Affairs, Oncobiologics
- Magdalena Leszczyniecka, Founder and CEO, STC Biologics Inc
- Michael Kleinrock, Research, Director, IMS Health Inc
- Michael Tovey, INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan
- Mina Song, Director- Alliance Management, Biosimilars, Merck and Co.
- Raju Shantha, Scientific Director, Biologics Research, Janssen Pharmaceuticals, Inc.
- Rakesh Dixit, Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune Inc
- Ravi S. Harapanhalli, Vice President and Former FDA Senior Executive, Parexel International
- Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
- Robin Chadwick, Principal, Biotechnology, Schwegman Lundberg Woessner
- Sam Mukherjee, Associate Director Biosimilar Commercial Strategy and Portfolio Management, Dr. Reddy's Laboratories Inc.
- Steinar Madsen, Medical Director, Norwegian Medicines Agency
- Takashi Kei Kishimoto, Chief Scientific Officer, Selecta Biosciences
- Ted Carver, Principal Consultant, PAREXEL
Please fill in your name and email to receive the conference agenda of this event.
The agenda is available as PDF under downloads at the right side of the page.
Venue
Renaissance Woodbridge Hotel
515 US Highway 1 South, 08830
Iselin, NJ, United States
Who Should Attend
Job titles include but are not restricted to: CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, from the following roles:
- Biopharmaceuticals/ Biotherapeutics
- Follow on Biologics/Follow on Proteins/Biosimilars
- Biologics/Biotechnology/ Biogenerics
- Legal and Regulatory Affairs
- Intellectual Property
- Health Economics
- Pricing and Reimbursement
- Clinical Immunology
- Process Control and Analytical Technologies
- Analytical Characterisation
- Regulatory Compliance
- Pharmacovigilance
- Drug Safety & Risk Management
- Quality Affairs/ Quality Control
- New Product Development
- Process Science
- Portfolio Management
- Research & Development
- Business Development
- Business Operations
- Scientific Affairs
- Commercial Affairs and Strategic Planning
- Legislation and Policy Advice
Venue
Renaissance Woodbridge Hotel515 US Highway 1 South
Iselin, New Jersey 08830
USA
