The Year in Review for Biosimulation and Regulatory Writing

The Year in Review for Biosimulation and Regulatory Writing

Happy New Year! 2015 was a year of huge growth— both personally and professionally— for our Certara® family. We’re so grateful for our clients who give us the privilege of supporting them in their work to bring safer and more effective treatments to patients. In this blog post, I’ll be looking back at the top 10 most popular Roundtable posts from 2015.

  1. 9 Things Your Boss Wishes You Knew About PK/PD Modeling: Dr. Nathan Teuscher, Certara VP of Scientific Training and Education, has taught the theory and practical applications of pharmacokinetic/pharmacodynamic (PK/PD) modeling to hundreds of scientists. In this blog post, he shared some of his most popular tips for solving common difficulties encountered by pharmacometricians.
  2. Meet FDA Bioequivalence Criteria with WinNonlin RSABE Templates: A study by the FDA Office of Generic Drugs (OGD) reviewed over 1000 bioequivalence (BE) studies of 180 drugs, of which over 30% were highly variable (HV). Because of this high variability, studies designed to show whether generic HV drugs are bioequivalent to their corresponding HV reference drugs may need to enroll large numbers of subjects, even when the formulations themselves have no significant mean differences. This increases the expense of BE studies, places more subjects at risk, and ultimately, limits the availability of generics. In this post, Ana Henry, Certara Director of Scientific Training and Education, discussed an approach that addresses this problem as well as a tool that can help you streamline this type of analysis.
  3. Common Misconceptions about Computer System Validation: Drug development professionals frequently use computer systems to help them understand the PK/PD of investigational drugs. To satisfy regulatory expectations, these computer systems should be validated. Failure to do computer system validation for the software functionality that a user intends to use, with data sets that mimic the data sets that the user expects to use, can lead to a user failing to discover that a computer system provides erroneous results. Clearly, computer system validation is an important activity, one that is often met with dread, frequently caused by misconceptions about this topic. In this blog post, Certara Quality Assurance Manager, Debra Fontana, explained what computer system validation is and what regulations/guidelines require it, clarified some common misconceptions, and provided information about how to make your Phoenix® WinNonlin® validation easier.
  4. Positive Stats about PK/PD Modeling in the Pharmaceutical Industry: PK/PD modeling and simulation (M&S) is an important tool that can help researchers gain a better understanding of their drug’s efficacy— especially at the early stages of drug development. In this blog post, I discussed some positive statistics uncovered in a recent IQ Consortium survey that examined the current landscape for preclinical PK/PD M&S in the pharmaceutical industry.
  5. That’s So Meta: How Model-Based Meta-Analysis Informs Drug Development: Making the right choices in drug development often means the difference between getting a new medication to patients and it ending up in the scrap heap of failed programs. There is a surfeit of publicly available information on approved drugs as well as those currently in development. How can sponsors turn clinical trial data into understanding that helps chart the course for investigational drugs? In this blog post, Dr. Mark Lovern explains why you should invest in model-based meta-analysis (MBMA), an emerging methodology that quantifies clinical trial efficacy, tolerability, and safety information to enable strategic drug development decisions.
  6. Strategic Regulatory Writing for Drug Development Success: The regulatory landscape shapes our approach to drug development. A well-thought out plan for developing high quality submission documents is essential to the successful development and approval of new therapies. In this blog post, Synchrogenix President Kelley Kendle discusses what regulatory writing encompasses as well as how to turn it into a strategic asset.
  7. Clinical Data Transparency Mandates Are Reshaping Regulatory Writing: European and U.S. clinical trial data transparency initiatives — such as EMA Policy 70 — are creating additional disclosure compliance requirements for pharma and biotech companies. In this blog post, Keith Kleeman, Synchrogenix VP of Innovation and Strategic Development, discussed the implications of these data transparency initiatives and presents potential solutions for addressing this emerging business challenge.
  8. Fighting Superbugs: Supporting FDA Approval of a New Antibiotic: According to a report from the Centers for Disease Control and Prevention (CDC), in the United States, at least two million people become infected with antibiotic resistant bacteria and at least 23,000 people die annually as a direct result of these infections. At the same time, the pipeline for novel antibacterial drugs remains alarmingly low. To incentivize investing in developing new antibiotics, the Generating Antibiotic Incentives Now, or GAIN, provision was signed into law as part of the Food and Drug Administration Safety and Innovation Act in 2012. This legislation extends by five years the exclusivity period during which antibiotics that treat serious or life-threatening infections can be sold without competition from generics. In this blog post, Michael Eckstut, Chief Operating Officer of Certara Strategic Consulting, discussed how Certara helped Cubist obtain FDA approval for Zerbaxa™ (ceftolozane/tazobactam), a new antibiotic to treat adults with complicated infections.
  9. Pediatric Clinical Trials and Tribulations: The subject of pediatric drug development is complex and often heartbreaking. In many ways, it’s a “Catch 22.” Enrolling children in clinical trials is extremely challenging (both logistically and ethically). Yet without a proper and approved clinical process, physicians are left with inaccurate dosing and therapeutic approaches for children. The result is a continuation of the off-label, experiential ‘wild, wild west’ of prescribing. In this blog post, Certara Chief Marketing Officer, Ellen Leinfuss, explained how emerging regulatory and industry trends are improving the field of pediatric drug approvals.
  10. Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko: Pharmacometrics uses mathematical models of biology, pharmacology, disease, and physiology to describe and quantify interactions between drugs and patients, including beneficial and adverse effects. Dr. Lesko was Director of the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) for 16 years until his retirement in July 2011. He currently serves as Clinical Professor and Director of the Center for Pharmacometrics and Systems Pharmacology at the University of Florida, College of Pharmacy at Lake Nona in Orlando, FL. In this blog post, I talked with him about the history of pharmacometrics and how it will continue to shape drug development in the future.

All information presented derive from public source materials.

From our family to yours, we wish you all the best in 2016!

2016 is sure to be another exciting year as we partner with you to solve the toughest problems in drug development. To learn more about how to integrate regulatory writing and biosimulation into the drug development process, read our white paper.

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.