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Jan 10, 2025 | 
certara.com | Rajesh Krishna |Danielle Pillsbury
Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A defect in the Frataxin (FXN) gene causes FA. FXN is essential for the proper functioning of the mitochondria, and its deficiency leads to mitochondrial dysfunction, oxidative stress, and neuroinflammation. Patients develop ataxia, balance issues, loss of motor skills, speech impairment, weakness, visual impairment, and sensory loss. Patients with FA also have diverse non-neurological features.
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Aug 23, 2024 | 
certara.com | Rajesh Krishna
Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic steatohepatitis (NASH) is one type of NAFLD. Individuals with obesity and type 2 diabetes appear to be at greater risk of developing NAFLD. In recent years, NASH and NAFLD have been renamed MASH (metabolic dysfunction-associated steatohepatitis) and MASLD (metabolic dysfunction-associated steatotic liver disease), respectively.
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Aug 16, 2024 | 
ascpt.onlinelibrary.wiley.com | Mariam Ahmed |Rajesh Krishna |Certara USA |Noha Rayad
CONFLICT OF INTEREST Mariam A. Ahmed, Munjal Patel and Indranil Bhattacharya are employee of Takeda and have received salaries and stocks. Rajesh Krishna is employee of Certera and have received salary and stocks Noha Rayad is employee of Parexel and have received salary Amitava Mitra is employee of Kura oncoloyg and have received salary and stocks. Elizabeth Shang and Islam Younis are employees of Merck and have received salaries and stocks.
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Jul 26, 2024 | 
certara.com | Rajesh Krishna |Danielle Pillsbury
Your biotechnology start-up’s candidate asset has an intriguing proof of biology. Your investors are equally excited about it, and everything looks rosy regarding your future investments. You have a draft target product profile (TPP) that is all developed and squared away. Now, it is time to put your ideas into action! Admittedly, you run into some initial alarms. The patient population you want to recruit in your initial clinical trial is challenging. You’d be lucky to recruit 2-3 patients a month.
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May 10, 2024 | 
certara.com | Rajesh Krishna |Jim Gallagher
In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies deliver cytotoxic small-molecule drug payloads to cancer cells. The cytotoxic payload attaches to a monoclonal antibody (designed for binding to the target) through a linker. Having a solid clinical pharmacology strategy is essential to successfully developing these therapies.
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Apr 15, 2024 | 
certara.com | Rajesh Krishna |Jim Gallagher
New biologic development and approval of novel biological medications have significantly moved the needle for addressing unmet diseases. Scores of biologics scientists and developers have supported this modern-day marvel. However, a drug is only helpful if patients can access it. For example, monoclonal antibodies cost thousands of dollars per year. For rare, life-threatening diseases, these medicines may cost up to USD 400,000 per year making them out of reach for large swathes of society. Figure 1.
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Jan 19, 2024 | 
certara.com | Rajesh Krishna |Jim Gallagher
If you work at a biotechnology start-up, you’re probably excited about your compound assets, particularly if your development program has a single asset. Unfortunately, navigating the ocean of opportunity can become more of a pain than a blessing, especially when your disease area has significant investor activity. Focusing your excitement is essential! It’s beneficial to understand the scientific foundation your asset is best set up to negotiate.
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Sep 8, 2023 | 
certara.com | Rajesh Krishna |Danielle Pillsbury
The regulatory landscape for drugs to treat rare diseases is being disrupted. Gleaning from several recent health authority advisory committee deliberations have provided a glimpse into the science and complexity of new drug development for rare diseases. Health authorities, drug developers, and key opinion leaders alike struggle to attribute meaningful data signals in clinical studies for rare disease indications.
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Aug 18, 2023 | 
certara.com | Rajesh Krishna |Danielle Pillsbury
As a pharmacologist, I’ve always been curious about how drugs work. A favorite time-killer while waiting at a doctor’s office is reading drug labels (also known as package inserts) contained within the pages of “lifestyle” magazines. Ever wonder what a package insert looks like? Ask a pharmacist. By law, pharmacies are supposed to offer that to you, but hardly any commercial pharmacy ever parts with this without pressing. I am not sure why.
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Mar 3, 2023 | 
certara.com | Rajesh Krishna |Danielle Pillsbury
A new class of complex biologics has emerged in recent years. These are classified in a broad category of live biotherapeutic products, and regulatory guidances have been written across the spectrum of such new interventions. Unlike traditional new therapies, these products do not hit the pharmacological target nor engage with the target in any meaningful way like a small molecule drug.
