Silicon Valley BioTalks - The Quarterly Event for Clinical Trial Professionals

 

Silicon Valley BioTalks, the quarterly event of the San Francisco Bay Area for clinical trial professionals

FDA submission: The new rules

Wednesday, June 6th, 2012 - 6.00pm - 8.00pm PST

Register for free before May 26th, 2012

 

Clinical and regulatory experts will share their experience on June 6th to help you understand the evolving regulatory requirements and to better prepare for a successful FDA submission. The panel discussion will be followed by a networking session with food and drinks. Click here for event details.

How can clinical trial professionals overcome the increased complexity and cost of clinical trials?

Which best practices help adapt to the new trends and FDA requirements?

What are the do’s and don’ts for a successful FDA submission?
 

Register for free to the Silicon Valley BioTalks

 

NME approvals per 1000 clinical trials in the US

Abstract: FDA review is the final and most important step the in clinical trial process. In the last decade, the number of approvals per 1,000 US-based clinical trials has declined from 7.5 in 2004 to 3.1 in 2010. Simultaneously, industry experts are facing increased complexity and cost when managing clinical trials. A 2010 PhArma report argues that between 2000 and 2007, the median number of procedures per clinical trial increased by 49%. To give you the best understanding of FDA new rules, our top-tier industry experts will address the following topics:

  • Compliance. Industry professionals need to stay on top of the latest FDA regulations to avoid out of compliance submissions.
  • Safety. FDA regular warnings make clinical data safety a stumbling point of any clinical trial.
  • Standardization. To date, 60% of FDA submissions are done with CDISC standards. As FDA is becoming more and more involved in CDISC standards, adopting clinical standards increases the speed of FDA review.
  • Risk assessment. One of the FDA’s growing concern is to ensure that high-risk drugs and medical devices generate clinically significant results. This makes clinical data accuracy more important than ever before.
  • Communication. Our experts will share best practices for a smooth collaboration with all divisions of the FDA.

 

Speakers:

Dr. Urte Gayko
​Nodality
 
Urte Gayko, VP Regulatory and Clinical Affairs at Nodality
 
VP, Regulatory and Clinical Affairs
 
Dr. Christine Conroy
Affymax
 
Christine Conroy, VP Regulatory Affairs and GCP Compliance at Affymax
 
VP, Regulatory Affairs and GCP Compliance
 
Dr.Sandra Nino-Siddens
​Geron Corporation
 
Sandra Nino-Siddens, Executive Director Regulatory Affairs at Geron
 
Executive Director, Regulatory Affairs
 
Dr. Anne-Marie Duliege
Affymax
 
Anne Mariew Duliege, CMO at Affymax
 
Chief Medical Officer
Moderator
 

 

Event details:

 

Contact information: Sophie McCallum, Marketing Manager at Clinovo, sophie.mccallum@clinovo.com

 

Register for free to Silicon Valley BioTalks

 

An event sponsored by:

Capgemini South San Francisco                Clinovo, a leading CRO in the San Francisco Bay Area          French American Chamber of Commerce in San Francisco

 

 

About Silicon Valley BioTalks

Silicon Valley BioTalks is a series of regular discussion and networking events sponsored by Clinovo where industry professionals share knowledge about technology and best practices for clinical trials. Top-tier panelists from leading pharmaceutical, biotechnology and medical device companies share their experience and insight about the latest hot topics in the industry.

Join the Silicon Valley BioTalks group on Linkedin
to receive updates on the next session of this event. 

 

"A truly informative panel discussion"

"A great forum to hear some
very experienced clinical trial professionals"

"It attracted participants from
all over the Bay Area, and beyond"

 

 

Silicon Valley BioTalks return on event

 

Silicon Valley BioTalks: How CDISC standards streamline clinical trials

 

  

On March 7th 2012, Clinovo hosted the third Silicon Valley Biotalks, hosted by SNR Denton in their Palo Alto offices. The event welcomed over 60 professionals from the biotechnology and pharmaceuticals industry. The panel was composed of top-tier CDISC experts: John Brega (PharmaStat) CDISC Implementation and eCTD Submissions, Carey Smoak (Roche Molecular) Senior Manager, SAS Programming and CDISC Device Team Leader, Dave Borbas (Jazz Pharmaceuticals) Senior Director, Data Management, and Ale Gicqueau, President & CEO at Clinovo. Read the extracts.

On June 29th 2011, 50 professionals from the biotechnology and pharmaceuticals industry attended the event. The panel was composed of Victor Chen, Director of Clinical Affairs at Intuitive Surgical, Eric Morrie, Clinical Programming Manager at Abbott Vascular and Ale Gicqueau, President & CEO at Clinovo. Read the extracts.

Panelists from leading pharmaceutical and biotechnology companies will address key benefits and limitations of adaptive clinical trials. The panel includes representatives from Theravance, Xenoport, MAP Pharmaceuticals, ARA, Arincal and Clinovo. Leveraging years of experience and expertise, they will explain how adaptive designs help streamline the clinical trial process. Read the extracts.

 

Sophie McCallum, marketing & HR manager at Clinovo

Contact information

Sophie McCallum
Marketing Manager at Clinovo
408-773-6258
sophie.mccallum@clinovo.com