Blog
All our Blog posts can be found here, listed in chronological order beginning with the most recent post. To access blogs on specific topics, use the links below.
Regulatory Medical Writing: Who is your audience?
Whether it’s a clinical study report (CSR) for a single clinical study or a Clinical Overview that summarizes a complex clinical development program, it’s often best to consider who you’re writing for at the very start of a writing project. Regulatory medical writers...
How to Choose a Partner to Optimize INDs
Biopharmaceutical development is an extensive and complex process. Managing processes like Investigational New Drug (IND) applications or the manufacturing, quality, and regulatory side of the processes—collectively known as CMC, or the Chemistry, Manufacturing and...
Four Top Roadblocks to Successful IND Applications and How to Overcome Them
Bringing a new drug to market is a complex process that can take years with no guarantee of a successful outcome. The journey is highly regulated and includes numerous processes that require drug developers to have multiple levels of expertise within their teams. One such process is the Investigational New Drug (IND) application with the Food and Drug Administration (FDA).
Bridging Discovery and Delivery: The Essential Role of INDs in Biopharmaceutical Development
The IND Filing Process and Categories Federal law mandates that drugs have an approved marketing application for interstate transport, but developers of new drugs must distribute their potential products nationwide in order to conduct clinical trials, and so must...
Unlocking the Potential: The Power of Drug Repurposing in Modern Medicine
Drug development is a complex, expensive, and multistage process which could take 10 to 15 years to bring a new molecule from discovery to commercialization. Drug repurposing, also known as drug repositioning paves an alternate path for drug development which involves identifying new therapeutic indications or uses for the existing molecules that could have been initially approved for or have clinically failed in a different indication. The success rate for new drugs to reach the market is approximately only 10% whereas about 30% of repurposed drugs get regulatory approval.
Understanding Large Molecule Drug Development: From Biologics to Market
Developing biologics can be challenging. Their development protocols are significantly different from small molecule drugs, which provide a general response and comprise as much as 90% of the pharmaceutical drug market. Biologics are more complex, though, with...
Formulation Strategies for Large Molecule Drug Products
Large molecule drug products produce highly effective medicines, but formulation can be challenging because of their complexity, sensitivity, and potential for instability. It is crucial that formulation strategies ensure their bioavailability and efficacy to develop new and successful products.
Ensuring Aseptic Technique: Use of Isolators
By: Deb Quick, Ph.D. Senior Consultant Everyone knows that good aseptic technique is crucial when handling biological products, particularly in fill and finish operations. But for cellular therapies, good aseptic technique is essential throughout the entire process to...
What is a process control strategy and why is it important?
By Maria Wik, MS VP, CMC Development The ICH Q10 definition for a Control Strategy is: “A planned set of controls, derived from current product and process understanding, that assures process performance and product quality.” Understanding the essence of a process...
Three Characteristics of a Rock Star QC Partner
Biomedical startups experience a failure rate of 90% per year for various reasons, including flawed financial strategies, inexperienced management, subpar science, poor timing, and an aversion to risk. Another significant factor is quality control issues stemming from poor team selection and inadequate time and resources, which also applies to quality control (QC) partners. However, there are three key characteristics that reliable QC professionals bring to the table in a drug development organization’s process of creating new pharmaceutical products. These characteristics significantly improve the odds of regulatory approvals.
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