1. FDA SUBMISSION:
THE NEW RULES
An Event Sponsored by:
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2. Our panel
Christine Conroy
Affymax
Vice President, Regulatory Affairs And GCP
Compliance
Sandra Nino-Siddens
Geron
Executive Director Regulatory Affairs
An Event Sponsored by: Urte Gayko
Nodality
Vice President, Clinical And Regulatory
Affairs
As moderator: Dr. Anne-Marie Duliege
Affymax
Chief Medical Officer
3. FDA’s Mission Today
“The FDA is responsible for protecting the public health by
assuring the safety, efficacy and security of human and
veterinary drugs, biological products, medical devices, our
nation’s food supply, cosmetics, and products that emit
radiation.”
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“The FDA is also responsible for advancing the public health
by helping to speed innovations that make medicines more
effective, safer, and more affordable and by helping the
public get the accurate, science-based information they
need to use medicines and foods to maintain and improve
their health.”
Source: http://www.fda.gov/
4. Ensuring patient safety
An Event Sponsored by: 100,000
people die every year in the US
from Adverse Drug Reactions
Source:http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources
/DrugInteractionsLabeling/ucm114848.htm
5. The growing pressure on the FDA
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Source: http://www.fda.gov/
6. The Drug Life Cycle
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Source: Watermark Research Partners, Inc.
7. Evolutions at stake
Political
Pressure
Consumer
Activism
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Industry
Involvement
8. Approaching the FDA today
Clinical Data Scientific
Standards Evidence
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Clarity and New
Transparency Technologies
Source: http://www.pharmatek.com/pdf/PTEKU/Sept232008.pdf
10. Thank you!
Read the Silicon Valley Biotalks extracts on
clinovo.com/biotalks
See you soon at
An Event Sponsored by:
the next Silicon Valley BioTalks
Contact:
Sophie McCallum
marketing@clinovo.com
Join the group on Linkedin Phone: (408) 773-6258
Editor's Notes
Hello, my name is Leslie Kolman and I would like to welcome you this Wednesday, June 6 to our quarterly Silicon Valley BioTalks. This fourth discussion will be “FDA submission: The New Rules”. I want to thank you all for joining us this evening, along with thanking our three panelists Christine Conroy from Affymax, UrteGayko from Nodality, Sandra Nino-Siddens from Geron and our moderator Anne-Marie Duliege, CMO at Affymax. And of course Capgemini for hosting this event and providing us with delicious food & drinks. As it happens that our panel tonight is composed uniquely of women, we thought this event would be a great opportunity to briefly introduce you to a non-profit organization that we support: Women in Bio. Women In Bio actively supports entrepreneurship and career growth for women involved in the biosciences. Terry Corbin, co-chair of the communication committee for Women In Bio, is here tonight to explain a bit what they do for women in the industry.
LeslieGreat. So before we begin, I want to let you know that the event will end with a Q&A session with any questions you may have. Now I would like to introduce the moderator for this event, Anne-Marie Duliege, CMO at Affymax. Dr. Duliege has over 20 years of scientific and leadership experience in the pharmaceutical industry. She joined Affymax in 2004 as VP of clinical, regulatory and medical affairs. She was instrumental in raising capital and taking the company public. She was promoted to Chief Medical Officer in 2007. Under her leadership, her team completed an extensive development program and obtained FDA’s approval for the company’s lead product, OMONTYS®. As a member of the executive team, Dr. Duliege is responsible for the clinical and non-clinical research of the company and helps set company strategies, contributes to investor relations, and supports business development activities.Prior to joining Affymax, Dr. Duliege was a Senior Medical Director at Chiron Corporation with a record of significant accomplishments in executing Phase 1 through 4 clinical studies in pulmonary medicine, infectious disease and immunology. She held positions of Senior Research Physician at Genentech, Inc., working on HIV treatment and vaccine, and epidemiologist at the National Institute of Science & Medical Research in Paris.Anne-MarieTo add anything to personal background + introduce the panelists (bio document)
The FDA admits that100,000 people die every single yearas a result of taking FDA-approved pharmaceutical drugs. Citing figures from three different published studies, the figures also reveal that two million people a year suffer from serious ADRs, which include things like stroke, heart attack, and permanent neurological damage.What are the new initiatives to always improve the safety of the products?
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%.
Meanwhile, the biopharma sector has to balance risks, investments and potential for revenues. Each day a clinical trial extends over schedule, lost revenue ranges from $600,000 per day for a specialty drug to $8 million per day for a potential blockbuster*
>> New technologies and data standards:- Electronic submissions- FDA encouraging sponsors to continue the learning curve: in 1 or 2 years a minimum level of compliance will be expected for all submissions, and if not met, these “CDISC like” submissions will be treated as non-CDISC or legacy data and will take much longer to review
Around 7.30/7.45pmThank you Anne-Marie. Let’ snow take some questions from the audience if any.
Thank you everybody for joining us tonight. Join the linkedin group to get the key take-aways from the event that we will post shortly, and to be updated about our next session in September.
