Citoxlab Symposium
April 03, 2019
We invite you to attend "21st Century Trends in Drug Development"
Two programs, two locations!
San Francisco, CA: May 7 | San Diego, CA: May 9
In 2018, FDA CDER approved a total of 59 novel drugs including 32% that were first-in-class. As expected, a significant proportion of the approvals were in oncology but an impressive 58% were approved for rare diseases. A rapid evolution of technologies applied to drug discovery and development combined with an evolving regulatory landscape have set the stage for an increasingly science-oriented environment. This symposium will discuss regulatory strategies along with non-clinical case studies involving NCE and biologics. An opportunity to network with non-clinical experts and discuss toxicology, pharmacology and regulatory science.
Details and registration links are below.
Two programs, two locations!
San Francisco, CA: May 7 | San Diego, CA: May 9
In 2018, FDA CDER approved a total of 59 novel drugs including 32% that were first-in-class. As expected, a significant proportion of the approvals were in oncology but an impressive 58% were approved for rare diseases. A rapid evolution of technologies applied to drug discovery and development combined with an evolving regulatory landscape have set the stage for an increasingly science-oriented environment. This symposium will discuss regulatory strategies along with non-clinical case studies involving NCE and biologics. An opportunity to network with non-clinical experts and discuss toxicology, pharmacology and regulatory science.
Details and registration links are below.
San Francisco, CA Preliminary Agenda:
Embassy Suites by Hilton South San Francisco Airport
Tuesday, May 7, 9:30am
•Simon Authier, Senior Director of Scientific Operations and Veterinary Science / Deputy Chief Scientific Officer at Citoxlab
•Dana Minnick, PhD, DABT, RAC, Senior Research Scientist at RHO, INC :
''Risk vs Benefit: Abbreviated and Expedited Development Programs for Serious,
Life Threatening, and Rare Diseases''.
•Jeff Tepper, PhD, DABT, DSP, Pharmacology/Toxicology Drug Development Consultant at Tepper Nonclinical Consulting:
''Thinking Out of the Box” 3 Case Studies Non-Standard Nonclinical Safety Packages"
•Lindsay Donald, DABT, VP Pharmaceuticals & Healthcare at Intertek:
''Outside the Box Development of Inhaled Prostacyclin to Control Pulmonary
Hypertension During Surgery''
•Yurong Lai, PhD, Senior director of Drug Metabolism, Gilead Sciences:
''Role of Transporter in Drug Development and Organ Toxicity''
Please note that this complimentary event is by reservation only, and includes lunch, refreshment breaks and afternoon cocktails.
Please click HERE for additional information and registration!
San Diego, CA Preliminary Agenda:
The Alexandria at Torrey Pines
Thursday, May 9, 9:30am
•Simon Authier, Senior Director of Scientific Operations and Veterinary Science / Deputy Chief Scientific Officer at Citoxlab
•Dana Minnick, PhD, DABT, RAC, Senior Research Scientist at RHO, INC
''Risk vs Benefit: Abbreviated and Expedited Development Programs for Serious,
Life Threatening, and Rare Diseases''
•Sanjeev Thohan, PhD, Senior Director Preclinical Safety at Xeris Pharmaceuticals
''Drug Discovery and Development: the How, the Why and Then Some''
•Denis Roy, PhD, Director, Nonclinical Safety & Development at SciLucent
''Use of Excipients in Investigational Pharmaceutical Products – Simple is Not Always Easy''
•Lindsay Donald, DABT, VP Pharmaceuticals & Healthcare at Intertek
''Thinking Out of the Box: 3 Case Studies Non-Standard Nonclinical Safety Packages''
•Caroline A. Lee, PhD, Senior Director, Nonclinical Development & Clinical Pharmacology, Arena Pharmaceuticals
''Application of Drug Transporters in Drug Development and Regulatory Guidance''
Please note that this complimentary event is by reservation only, and includes lunch, refreshment breaks and afternoon cocktails.
Please click HERE for additional information and registration!
Next entry: Charles River Laboratories Completes the Acquisition of Citoxlab
