Past experiences of FDA regarding 10-20 year life cycle changes of biologics has paved the way to entering into biosimilars – a new paradigm is emerging. In spite of the rich and varied European experience the FDA takes its own unique course. FDA advisory style meetings in a first step would determine eligibility of a new biosimilar candidate and for further meetings fees are charged as part of the new BsUFA . What genuine opportunities are there for harmonised US/EU and worldwide development? The selection of reference product dosage form and presentation has become more strategic than in the past years. Controversies towards regulatory clinical milestones need also to be crtically considered.
The session will focus on establishing the swiftest pathway for registration of Biosimilars in USA
8:45 AM – 09:15 AM
Spot Registration + Breakfast + Introduction
09:15 AM – 10:30 AM
Biosimilars US and EU regulations and guidances:
Compare and contrast
Deep insights and practical solutions
10:30 AM – 10:45 AM
10:45 AM – 12:15 PM
Developing a Biosimilars Program with US focus :
What to consider
Lessons learned from past EU and US experience
Quality testing and essential supportive in vitro testing
Advisory 1st FDA meeting
12:15 PM – 01:15 PM
01:15 PM – 02:45 PM
Nonclinical development: too much, too little?
Planning for clinical work
FDA BsUFA meetings
02:45 PM – 03:00 PM
03:00 PM – 04:45 PM
Clinical program- consulting FDA (and advantages of Scientific Advice from EMA?)
04:45 PM – 05:00 PM
Q&A – Conclusion
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(*Earlybird Discounted Fees – valid till 30th June 2014 – Actual Fees USD $699)
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Dr. Hoss A Dowlat, Vice-President, Regulatory Affairs, Global Strategy, leads an outstanding biosimilars international team at PHARMABIO CONSULTING Germany, with a branch in Boston. He currently consults for companies with regional and international presence in drug development and registration. He routinely provides strategic international regulatory support and Due Diligence to Pharma industry and Financial institutions.
He is also a well-established international trainer and presenter in EU/US regulatory affairs, scientific advice, the Common Technical Dossier (MAA/NDA/BLA), labeling (prescriber and patient), clinical safety, pharmaceutical development, combination drugs, biologics, and biosimilars. Hoss has direct experience preparing clients for FDA meetings and has led, managed and attended FDA meetings, in particular, formal Type B and NDA/BLA presubmission meetings, with different divisions of the FDA. He is also very experienced with MAA presubmission EMA meetings, MAA presubmission Rapporteur/Co-rapporteur meetings, Rapporteur/Co-rapporteur D120 and D150 Clarification meetings, SAWP/CHMP/EMA meetings and CHMP/EMA Scientific Advice. This affords him unique insights into the FDA-EMA. Hoss has more than 31 years of drug development experience in over 15 therapeutic areas in the European and North American pharmaceutical industry, 21 years of which have been in regulatory affairs.
He is consulting on both novel and biosimilar monoclonal antibodies, in addition to most other biosimilar therapeutic proteins approved or planned. Additionally, he has substantial Orphan Drugs experience of biologics and small molecules. Furthermore, he has developed combination drug/biologics medicines or medicine/devices.