Oncobiologics, developers and manufacturers of complex biosimilar therapeutics, will be presenting two exclusive sessions at SMi Group’s 4th annual Biosimilars North America conference in New Jersey this November.
Principal Scientist Hiten Gutka will discuss considerations for drug product and formulation development. The presentation will focus on excipient quality and influence on biosimilar drug product quality and stability, as well as container closure effect on stability of the biosimilar.
Rajani Srikakulam, also a Principal Scientist, will present a session on functional similarity assessment which talks about the importance of functional assays/bioassays in biosimilar development and why they are as important as in-depth structural characterization. The talk will also discuss how to select appropriate bioassay methodologies as well as tiering of functional attributes based on mechanism of action and known clinical relevance.
Hiten and Rajani join a speaker line-up comprised of experts shaping up the biosimilars landscape in North America including representatives from Sandoz, Harvest Moon Pharmaceuticals, Momenta, FUJIFILM Diosynth, Pfenex, Adelio, Covance, Zuckerman & Spaeder and more.
The full roster of speakers and their topics can be found on www.biosimilars-northamerica.com.
SMi’s Biosimilars North America conference will explore significant developmental topics within the sector including the impact of FDA’s newly implemented biosimilar interchangeability guidelines, the US market access landscape, and biosimilars of orphan drugs.
Registration is now live on the event website and there For more information visit: www.biosimilars-northamerica.com/mnd.
4th Biosimilars North America
November 15 & 16, 2017
Renaissance Woodbridge Hotel, Iselin, NJ, USA
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk