I wanted to share the following article with you, borrowed from the Drug, Discovery & Development online magazine:
Drug development programs today have a 5% to 10% probability of success. Almost half of the failures are due to drug safety issues found very late in the clinical development process. The lack of improvement in outcomes, despite advances in technology and the near doubling of pharmaceutical R&D expenditures, highlights the need for novel approaches to drug development.
Currently, the identification of efficacy and safety risks for a lead compound primarily uses cell line and in vivo studies. Unfortunately, these experimental systems are black boxes that offer limited visibility into selected phenotypes and biomarkers and very little insight into the effects of a compound on important physiological pathways. Due to this lack of transparency into pathway effects, it is difficult to generate insights into system-level changes in the physiological network. This is often a reason for potential oversight of toxicity issues and incorrect assessment of efficacy.
In the era of molecularly targeted drugs that affect specific targets and pathways, developers must have insights into the off-pathway effects of drug candidates. Use of predictive methodologies that emulate human physiology to test the impact of the drug candidate prior to moving the drug into clinical testing is crucial to improve the drug development success rate. By predicting clinical outcomes early on, the success rate of drug development can dramatically be improved.
The development of a predictive system emulating disease physiology is feasible because of the massive amount of published reductionist information on signaling and metabolic pathway components and “omics” data coupled with advances in mathematical techniques and computing power. Coupling the massive library of published data to computing power enables researchers to connect the dots in a way not possible before and, therefore, predict clinical outcomes early on.
Predictive models offer the promise of predicting clinical outcomes early in the development process and give the ability to rationally construct efficacious therapies with lower potential for side effects. The large availability of data and information on the components of the biological networks and interactions has enabled the creation of such systems. This approach provides transparency to manipulate different pathways in the network and assay intermediate and endpoint biomarkers and disease phenotypes. The key criterion for deployment of such an approach is extensive validation of predictions with experimental studies.
About the author - Pradeep Fernandes has a background in semiconductor engineering and has applied the engineering approaches and technologies to create the Cellworks technology platforms. Shireen Vali has a background in molecular and cellular neurobiology and has worked extensively in developing the disease networks underlying complex multi-phenotype disorders.
Marketing & Communication Coordinator at Clinovo
It is a very exciting time for Clinovo! We are now officially launching our TechTrainings, a new opportunity for a successful career in the clinical trial industry. These hands-on classes enable entry-level or already experienced clinical trial professionals to improve their skillset. Real-world case studies were designed with 10+ years experienced professionals to help our students reach the next step in their career.
Please visit this page to check out the first session 101 Clinical SAS Programming by Jennifer Kang, Senior Statistician at the Palo Alto Medical Foundation Research Institute (PAMFRI). We know it takes time and effort to “go back to school” so we came up with a convenient format: one 3-hour class per week during 10 weeks. If you happen to know anyone interested in learning SAS, note that you can win a $50 giftcard and your friend can benefit from a discounted registration.
Some of our readers and followers expressed the need for other trainings in the future. If you think of another major topic for which Clinovo’s expertise is needed (CDM, EDC, CDISC, clinical trial design, etc.) feel free to comment this article.
Marketing & Communication Coordinator, lead for Clinovo TechTrainings.
Personally? I am working in Clinovo’s marketing team, conducting some industry research, monitoring our website and social media accounts, writing and designing marketing material, preparing client’s presentations, sending reach outs to you and occasionally… writing blog posts!
At Clinovo we believe mixing people is on the road to success. That is why we always keep room for that at the Silicon Valley BioTalks, our discussion and networking quarterly event for clinical trial professionals.
I am very thankful to the BayBio team for organizing and hosting this Summer Mixer. I am eagerly awaiting attending upcoming events! I hope I will meet you there and learn more about you.
Marketing & Communication Coordinator at Clinovo
On May 21st, 2012, I attended an event organized by the non-profit organization Women In Bio (WIB), and what a blast! It was a very original set-up (at least for me): A speed networking.
WIB is a non-profit organization of professionals committed to promoting careers, leadership, and entrepreneurship of women in the life sciences. Women In Bio actively supports entrepreneurship and career growth for women involved in the biosciences.
Have you ever felt awkward at a networking events because you don’t want to bark in the middle of a discussion or just randomly start talking to somebody? Well speed networking definitely enables to avoid that :)
The principle is of course very similar to speed dating: You have a couple of minutes to get to know a person and see how well you hit if off. The organizers had put four long tables, and every four minute when the gong would ring, we all had to move one chair on our right.
This is an efficient way to meet new people and network, I have to say. I don’t think I have talked to so many people, learned about what they do, what their business was about, and talked about my company, in such a little time frame. In addition, all the women that attend the WIB events are so passionate! Talking to these driven, great individuals is definitely inspiring.
This was one of the most fun industry events I attended. Kudos to the WIB group and the organizers of this event.
Visit their website for more events: http://www.womeninbio.org/
Author: Sophie McCallum, Marketing & HR Manager at Clinovo, email@example.com
This was the third consecutive year Clinovo attended PharmaSUG after Orlando in 2010 and Nashville in 2011. This time, we had the “home” advantage and this gave us the ability to bring many co-workers to this year conference. This year conference was one of the best PharmaSUG ever according to many of the participants. Everyone loves to visit San Francisco despite Mark Twain’s famous sentence: “The coldest winter I ever spent was a summer in San Francisco.” The organization was impeccable and the food succulent. The only quack was that a thief was able to get to the exhibit floor during lunch to steal equipment from exhibitors.
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
- Ale Gicqueau (Clinovo) President & CEO
- Carey Smoak made the point that the medical device world is on the move to implement CDISC standards. One has to be aware that the simple fact in putting data in an electronic database is quite new for some medical devices companies. Combination products in which medical device interact with a drug is favorable to the implementation of CDISC standards. Indeed, the medical device world is learning from the experience of the drug industry on CDISC standards.
- John Brega mentioned that 60% of FDA submissions are already done in CDISC standards. He also stated that smaller pharma companies adopt CDISC standards faster. Indeed, a lot of the bigger companies have already developed in-house standards and even though they see the benefits of CDISC standards, it takes money and time to transform their processes and change their habits. On the other hand, smaller players that have no or few standards in place are more prone to start using FDA approved CDISC standards.
- One of the advantages of CDISC standards is that it holds the clinical data to a greater level of readability and compliancy in regards of FDA requirements. A submission without SDTM can have a review period twice as long as one under SDTM standards. CDISC conversion allows submitters to find out problems or discrepancies even before the FDA does, which gives more data consistency and confidence for the FDA submission. It saves time and frustration on both sides.
- Carey Smoak said that the earlier the CDISC standards were utilized, the better. The best timing to implement CDISC standards is the database built. There is a real challenge to push CDISC standards upfront in the clinical trial process. He recommended to hire people with expertise on CDISC standards. One should educate themselves on this hot topic and only hire real experts and approved service providers.
- Dave Borbas mentioned existing CDISC conversion tools, such as the open CDSIC validator software, recognized by the FDA and freely available. He talked about CDISC Express, Clinovo’s free SAS-based SDTM mapping tool. Carey Smoak mentioned the development of new softwares, and that applications on smartphones are also mushrooming, but stated that quality, validation and compliancy were very tricky in this case and an upcoming challenge.
- Dave Borbas said that the FDA is getting more and more involved into CDISC standards. FDA calls it “their” standards now, which is new and great signal to the CDISC community.
Do you want to learn more on CDISC conversion?
Register for free for our next Webinar on March 28th at 9am:
CDISC® SDTM Conversion Made Easy with CDISC Express
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