The Highlights in Model-based Drug Development for 2014

The Highlights in Model-based Drug Development for 2014

As the end of the year draws near, I want to thank all of our customers for letting us be your biosimulation and model based drug development solution provider. We feel honored to be able to play a small, but crucial role in your success in bringing safe and effective drugs to patients. 2014 has been a year of accomplishments in PK/PD modeling, PBPK modeling, CADD, and regulatory writing. I’d like to share with our readers some of our proudest moments from this year.

  1. We started 2014 strong in January with the news that Medivir AB, a Swedish pharmaceutical company had chosen D360 as their global integrated solution for the query, analysis and visualization of drug discovery and development data. While D360 has proven its effectiveness in discovery, in 2014, it became firmly established as an indispensable tool for preclinical bioinformatics.
  2. In February, our hearts were (figuratively) set aflame thinking about the Cardiac Safety Simulator and its potential to inform assessing the cardiac liability of new drug candidates.
  3. At the March ASPCT meeting, Biothera presented pharmacokinetic data that support the dose and schedule regimens for its cancer immunotherapy, Imprime PGG. Dr. JF Marier and his team contributed to the findings through population PK modeling of Imprime PGG to support the dosing rationale and assess potential drug-drug interactions with cetuximab, with and without irinotecan.
  4. The highlight of April was the addition of the Synchrogenix team to our Certara family. Based in Wilmington, DE, Synchrogenix is the largest independent regulatory-writing group in the world. It has more than 50 permanent regulatory writers and editors on staff, located in seven offices in North America, Europe, and Asia. The company provides preclinical, clinical, CMC and drug safety writing, and global regulatory submission services. Read how they delivered 6500 Narratives in 6 Weeks under a tight time line and budget.
  5. In May, we got a glimpse of some of the exciting new features that would be coming with the release of Phoenix 1.4. Watch this webinar to learn more about how Phoenix Connect supports CDISC data standards.
  6. The PAGE meeting in June is always a highlight of the summer. Our scientists presented a number of posters on their research at this venue.
  7. July brought the introduction of SIVA, a user-friendly platform, specifically designed to assist scientists with the analysis of complex data generated from in vitro studies using whole cells, tissue samples and solid dosage forms to assess the metabolism, transport and dissolution/solubility of drugs. Simcyp consortium members who are interested in trialing SIVA can contact us to get more information.
  8. The pace of innovation at Certara certainly did not let up under the intense heat of the summer! At the ACS meeting in August, we released Muse Invent, a molecular design tool that allows researchers to design synthetically feasible drug candidates. Do you think that you could tell the difference between virtual and actual chemical synthesis pathways? Read how a group of chemists did in the Man vs. Machine challenge!
  9. In September, Certara scientists Drs. Amin Rostami, Masoud Jamei, and Sebastian Pollack published a paper in Clinical Pharmacology & Therapeutics that combined in vitro–in vivo extrapolation, PBPK, and systems pharmacology of electric currents in the heart to predict the direction and magnitude of PK/PD changes with co-administration of multiple drugs. At the annual Simcyp Consortium meeting, we also announced the latest version of the Simcyp Simulator. This PBPK modeling platform has been increasingly used to advance drug development and regulatory approval. In fact, the Simcyp Simulator was specifically named in the recent drug approval for Cerdelga®, Genzyme’s drug for treating Gaucher’s disease type 1.
  10. This also has been a great year for our pharmacometrics consulting group, who helped get 4 new drugs approved. Many of these drugs were for special populations, such as pediatrics. In October, Applied Clinical Trials published an article highlighting our work on orphan drugs.  While typically applied to conventional pharmaceuticals, our scientists have also leveraged model based methods to evaluate the risks and potential benefits of e-cigarettes.
  11. On November 3rd, we were proud to announce the release of Phoenix 1.4, the industry-leading PK/PD platform. To provide our customers with even more value, we are now offering Phoenix Quantum, which allows attractively priced groups of products to be deployed across an organization.
  12. We wrapped up the year with some exciting new developments regarding cardiac safety. In late December, Dr. Christine Garnett presented the results from a pivotal study at the Cardiac Safety Research Consortium. The study results support replacing the expensive and time-consuming TQT study with QT assessment in early clinical development.

Our customers are at the heart of everything that we do. 2015 is sure to be another exciting year as we partner with you to solve the toughest problems in drug development. For a glimpse at upcoming trends, please read our Clinical Researcher article  by our CEO Edmundo Muniz, MD, PhD “The Future of Drug Development is Virtualized and Personalized.”

From all of us at Certara, we wish you a very Happy New Year!

All information presented derive from public source materials.

Suzanne Minton

About the Author

Suzanne Minton

Scientific Communications Manager, Certara

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Dr. Suzanne Minton is the scientific communications manager at Certara. She helps develop the science-focused, value-oriented content that our customers go wild for. When she's not writing about the hottest problems in drug development, Suzanne enjoys spending time with her husband and two young children.