2020 was a year that none of us will ever forget. The COVID-19 pandemic upended our lives in ways big and small. From the challenges of working at home with small children underfoot to the heartbreak of losing more than two million irreplaceably precious people to this global viral scourge, 2020 was the year that changed everything.
Or did it?
Maybe it’s just a little spot on the internet, but we’re so proud to have completed our sixth year of blogging. Six years of telling you our biggest challenges and accomplishments in model-informed drug development; regulatory science; and evidence, value, and access. Despite all the disruptions of this past year, we kept on sharing with you our most exciting stories. We’re showcasing 10 of these blogs in this special collection. I hope that you, our loyal partners, will enjoy them.
Happy reading! Suzanne Minton, PhD Certara Blog Editor-in-Chief
The Research to Accelerate Cures and Equity (RACE) for Children Act
iDD | January 14 | Lynne Georgopolous
On August 18, 2020, the Research to Accelerate Cures and Equity (RACE), which amends the Pediatric Research and Equity Act (PREA) comes into effect. With the RACE for Children Act, the FDA is now authorized to require sponsors to submit an agreed initial Pediatric Study Plan (iPSP) with an original NDA or BLA oncology product that may target the growth or progression of a pediatric cancer. New cancer therapies with orphan-designated indications will no longer be exempt from PREA.
How PK CDISC Data Tech Solutions Can Accelerate Your Drug Development
Software (PMX) | January 18 | Kevin Trimm
If you work in pharma, you may have heard the following acronyms: CDISC, SDTM, ADaM. They sound much like alphabet soup. But, in reality, they relate to data standards for drug development.
So, what are data standards, and why were they created in the first place? And, how should pharmaceutical companies use them? In this blog, I’ll discuss the development of common pharmacokinetic (PK) CDISC data standards and the impact of building them for electronic regulatory submissions to the Food and Drug Administration (FDA).
Plain Language Summaries and Patient Engagement: Paving the Way
Synchrogenix (RCS) | January 21 | Theresa Shalaby
Engaging the patient is key to support clinical trial recruitment and have truly patient-centric drug development. Writing for patients and the general public is vastly different from writing for regulatory authorities or clinicians. Plain language summaries (PLS) of clinical trial results ensure that study participants are informed about study results and that they understand the value of their contribution to science and public health.
Virtual Twin Patients Can Bridge Data Gaps for COVID-19 Halted Clinical Trials
Simcyp QSP | February 14 | Hugo Geerts, Piet van der Graaf
COVID-19 has had a massive impact on clinical research globally. Researchers have had to pivot quickly to test on-market drugs for activity against SARS-CoV-2, while also investigating novel compounds, drug combinations and potential vaccines. Most non-pandemic-related clinical research was put on hold so that staff could focus on providing care for the rapidly growing numbers of COVID-19 patients and to reduce the risk of infection for trial participants. Those studies that did continue were predominantly for life-threatening conditions.
Regulatory submissions & transactions with Health Canada
Synchrogenix, Global Submit | February 18 | Rob Labriola
We’ve seen recent trends and activity with regards to pharmaceutical regulatory submissions to Health Canada. Several questions and queries have come into our regulatory operations department, and the following information will address a few popular topics.
How COVID-19 Affects Stakeholder Engagement & Value Communication
Software (Basecase) | February 11 | Tom Hemy
The COVID-19 pandemic has made the development and commercialization of pharmaceuticals and medical devices even more challenging. For example, in the value communication and stakeholder engagement area, many field representatives found themselves refused entry to hospitals and surgeries and unable to meet in-person with payers, doctors, and other key stakeholders.
These meetings are vital to ensuring a product’s position on local formularies and securing patient access to life saving therapies. Thus, many reps have had to improvise in how they connect with stakeholders. To find out how field employees have been overcoming these obstacles, we surveyed professionals involved in life science value communication and stakeholder engagement.
Prescription Drug Pricing: “The Times They Are A-Changin”
Synchrogenix (EVA) | February 25 | Ulrich Neumann
“Come senators, congressmen Please heed the call Don’t stand in the doorway Don’t block up the hall For he that gets hurt Will be he who has stalled”
Bob Dylan recorded his iconic “The Times They Are a Changin’” in 1963; the song was released on the 1964 album by the same name. One of Dylan’s favorite tracks and the saying that it has coined could not ring more true with respect to the healthcare policy debate on the cost of biopharmaceuticals. Not a day goes by without the words “drug pricing” in the headlines of a major international newspaper.
10 Things You Should Consider When Planning a COVID-19 Clinical Drug Trial
iDD | March 4 | Rajesh Krishna
Pandemics by nature are excellent fodders for disruptive innovation. They force you to think out of the box. The whole health care apparatus is on the COVID-19 frontlines with some more directly involved than others. If you are a scientist or a clinician researcher at a biotech company or an academic laboratory, you are likely thinking, “how can I made a real impact in saving human lives?” You might find credible ways to contribute to advancing human health. The answer might be literally sitting on your shelf! Craig Rayner and team exemplify these behaviors in a seminal commentary on innovating by thinking without borders.
Certara’s Simcyp MechDermA Model Achieves Regulatory Approval: Demonstrates Virtual Bioequivalence in Dermal Drug Development
Simcyp | March 11 | Sebastian Polak
Demonstrating bioequivalence (BE) remains the key regulatory hurdle for generic drug approval. However, this is a challenging process for today’s complex drugs and alternative delivery methods. Consequently, patients lack availability of thousands of generics. This problem is especially vexing for topical drugs and trans-dermal patches.
The Value of Modeling and Simulation in Vaccine Development
iDD | March 18 | Mike Dodds
To assess how well our model will fit with the existing trial study data, the timing model simulations were compared to the maternal vaccination data obtained from studies conducted by the Maternal Immunization Working Group in the Centers for Disease Control (CDC) in South Africa, Mali, and Nepal. The model was trained using the South Africa and Mali trial datasets, and the Nepal data was used as an external validation step.
