Scientific Considerations for Complex Drugs in Light of Established Regulatory Guidance
09 March 2012
The U.S. Food and Drug Administration (FDA) is currently working toward implementing the Biologics Price Competition and Innovation Act (BPCI) of 2009, which establishes an abbreviated approval pathway for biological products that are demonstrated to be "highly similar" to or "interchangeable" with a drug regulated under the Public Health Service Act. The yet-to-be finalized pathway raises questions that are far more complicated than those posed by traditional, small molecule generics including what type of pre-clinical/clinical data, safety, purity, immunogenicity and potency testing will be required by the FDA in the marketing application. Additionally, while current regulations do not make scientific distinctions between small-molecule drugs and non-biological complex drugs (NBCDs), NBCDs present many of the same scientific challenges to reproduce as biologics, and future regulations will likely be guided by lessons learned from the development of policy for biosimilars in the U.S. and abroad.
New York Academy of Science, NY, USA
http://www.nyas.org/Events/Detail.aspx?cid=eea36f38-0485-483b-84f4-5d87e65dd04f
Scientific Considerations for Complex Drugs in Light of Established Regulatory Guidance
09 March 2012 - 09 March 2012
Creating guidelines for a regulatory approval pathway for follow-on versions of complex drugs raises questions that are far more complicated than those posed by traditional, small molecule generics. While current regulations do not make scientific distinctions between small-molecule drugs and non-biological complex drugs (NBCDs), NBCDs present many of the same scientific challenges to reproduce as biologics, and future regulations will likely be guided by lessons learned from the development of policy for biosimilars in the U.S. and abroad.
This international, scientific conference will focus on considerations for the NBCD regulatory approval pathway given the established guidelines for biosimilars. Plenary sessions will address the most recent regulatory developments, experimental design, interchangeability and immunogenicity issues for follow-on versions of complex drugs from the perspective of key audiences, including industry, regulatory agencies, physicians and consumers.
The New York Academy of Sciences, 7 World Trade Center, 250 Greenwich Street, 40th Floor, New York, NY 10007
http://www.nyas.org/Events/Detail.aspx?cid=eea36f38-0485-483b-84f4-5d87e65dd04f
Vaccine World Summit
12 March 2012 - 16 March 2012
Vaccine World Summit India 2012 will be THE DEFINITIVE meeting place for vaccine industry's leaders from India and the rest of the world. Riding on the momentum generated by the successful 2011 event, which attracted over 130 delegates and 42 renowned speakers, Vaccine World Summit India 2012 promises to be an even greater experience. Set the stage for the next wave of innovation and discovery in vaccines today.
Hyderabad, India
http://www.imapac.com/index.php?page=VaccineWorldSummitIndia2012
Biomarker Partnering and Deal-Making Conference
15 March 2012 - 16 March 2012
Offering a unique opportunity, the Biomarker Partnering and Deal-Making Conference assembles leading players to discuss what needs to be accomplished to lead the industry into its next phase. The business of biomarkers has reached an exciting and critical stage and intelligence and strategic relationship building is more important than ever. Attendees will be able to set the stage for both at this leading event.
Paradise Point Resort & Spa, San Diego, CA USA
http://www.gtcbio.com/component/conference/?file=home&cn=Biomarker+Partnering+and+Deal-Making+Conference&cid=70
National Cancer Institute Second Symposium on Translational Genomics
15 March 2012 - 16 March 2012
This symposium will provide a dedicated forum for the advancement, implementation and exchange of information on noncoding RNAs, next generation sequencing, and epigenomics and genetic variation for translation into clinical practice with the ultimate goal to improve the health of patients with cancer.
Natcher Auditorium, NIH Bethesda, MD, USA
http://web.ncifcrf.gov/events/TranslationalGenomics/default.asp
8th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology
19 March 2012 - 22 March 2011
Istanbul, Turkey
http://www.worldmeeting.org/
PepCon - 2012
23 March 2012 - 25 March 2012
PepCon-2012 is an event for protein and peptide professionals. The success of PepCon in previous years has helped it to become an influential conference for protein and peptide professionals to discuss the latest breakthroughs in the field as well as potential business opportunities. During PepCon-2011 more than 800 participants from 48 countries and 80 exhibitors joined the conference. This year we will try to provide an even better platform to exchange information and foster collaborations.
China National Convention Center, 7 Tianchen East Road, Chaoyang District, Beijing 100105 China
http://www.bitlifesciences.com/pepcon2012/default.asp