Ed Price
Active Pharmaceutical Ingredients (APIs) are the lifeblood of critical drug treatments and can make or break the sponsoring organization marketing them. But, getting a new drug from discovery through clinical trials to approval can take a minimum of ten years, with costs upwards of billions of dollars. For such an expensive endeavor, with a lot riding on its success, sponsoring organizations work diligently to select the right Contract Development & Manufacturing Organization (CDMO) for the job.
Erik J. van Asselt, PhD, Rafik H. Bishara, Ph.D., Zvonimir Majic PhD
Temperature is a critical process parameter for many pharmaceutical products as it impacts one of more critical quality attributes like label claim and formation of degradation products. As a result, it must be monitored and controlled in the end-to-end pharma supply chain during manufacturing, storage and transportation to ensure that products comply with the critical quality attributes to the end of shelf life. The measured temperature data and supporting meta data should be stored and compliant to all relevant regulatory requirements towards security and data integrity, which ensures that all collected and recorded data is complete, consistent, and accurate throughout the data lifecycle.
Matt Cooper
Costing and contracting has caused headaches and delays for life science companies since the inception of the multi-site study. Matt Cooper, Director of Business Development and Marketing of the NIHR Clinical Research Network Coordinating Centre, explains how the UK is tackling this universal issue head-on by introducing a new standardized national approach to costing and contracting for all National Health Service (NHS) sites in England conducting commercial clinical research.
Jeff Clement
Companies developing lifesaving therapeutics often address the challenge of product stability and cold-chain management by developing a lyophilized dosage form for their drug product. The advantage and goal of a lyophilization cycle development program is to increase product stability at more favorable storage conditions; for example, developing a lyophilized dosage form with storage at 2-8°C or ambient for a liquid formulation where previously -20°C storage was required. LSNE receives development requests for a wide variety of products from the biotechnology, pharmaceutical, and medical device industries, and one question that is asked frequently from prospective clients is: “Is there any kind of standard lyophilization cycle that we could use for our product?”
Dr. Frank Wissing, Dr. Thorsten Ruppert
The objective of clinical trials is to find and examine more and more safe and effective ways for prevention, diagnosis, or treatment of various diseases. So, every drug that is used in treatment today was once studied in clinical trials in order to confirm its safety and efficacy. Along with basic research, results from clinical trials thus represent the basis of medical advances. Conducting patient-oriented clinical trials is of tremendous importance, as clinical research is the essential requirement for the successful development and market approval of new pharmaceuticals and other forms of therapy and constitutes an important foundation of evidence-based medical care.
Kenneth S. Henderson, MSc PhD
In experiments that rely on rodents as research models, the control and monitoring of both genetics and health status are key steps to mitigate variability. Current research demonstrates that the gut microbiome is a significant and overlooked variable that has only recently been considered in rodent models. Specifically, the research community has found that therapeutic response can be directly linked to the health of a model’s gut microbiome.
The pharma industry is facing multiple challenges when it comes to API sourcing.
Improvements in standards of living mean we are living longer, but as our bodies age it is most likely that we need to take medications for our ailments.
Oriol Serra Ortiz, MS, Mohanish Anand, PhD, MS (Pharm Med)
The global investigative site landscape has reached an inflection point. Mergers and acquisitions, and companies sharing and pooling data, are some of the strategies aimed to make site selection more effective, yet rumor has it that sponsors and CROs are not satisfied with site identification and site selection efforts. Can we challenge the status quo to truly develop a more efficient approach to select the right site the first time? At Pfizer we are on a quest to answer this question.
Kyle Hogan
Electronic data capture (EDC) solutions have been used to collect important information in clinical research for more than 20 years. Today the technology is widely used across the pharmaceutical industry to help reduce development timelines and increase productivity. In fact, EDC has become the method-of-choice for drug and medical device companies and clinical research organizations (CROs) for conducting more efficient, cost-effective clinical trials—so much so, that an estimated 90% of sponsors and clinical research organizations are currently using some sort of EDC solution.
Aiden Flynn
The modern world is home to a host of real-world data sources, from electronic health records and health surveys to smartphone apps and medical insurance claims. They offer invaluable insights on patient populations or particular disease areas that can inform the drug development process, from its early stages to post-authorization. Suitably harnessed, it offers a broader overview and understanding of outstanding clinical needs and commercial opportunities in drug development, augmenting the insights from randomized controlled trials (RCTs).
David O. Rosenberg, J. Adrian Hawkins
As the network of companies that make products for the pharmaceutical industry continues to grow, the suppliers that support them and the regulatory agencies that oversee them are forced to evolve. Quality regulations, that ensure pharmaceutical products are safe and effective, are a key component of the medicinal industries. Because pharmaceutical procurement departments are often the first to do business with companies outside their regulated industry, they are frequently tasked with having to bridge the communication between their own industry and suppliers outside of it. Some regulatory areas are not always well understood and it is good to have, on both sides of the pharmaceutical company/supplier equation, an understanding of how regulations influence the decisions pharmaceutical companies make.
Lauren Levac, Timothy Ramsey, Jonathon Salsbury
Container closure integrity testing (CCIT) by laser-based headspace oxygen can be performed for samples with an air headspace for the detection of both small (=20 micron) and large (0.5-2 mm) defects, evaluating the container closure integrity (CCI) of a sample at any point in the product-package life cycle. This article will discuss developing and validating a CCI method using oxygen headspace analysis for air headspace samples, including considerations for different container sizes and fill volumes.
Sunny Christian, MS, Hemant N. Joshi, Ph.D., MBA, Neelam Sharma, MS,
This quarterly review on new drug applications contain data for applications approved for the first time during the second quarter of 2019 which includes new molecular entities (NMEs) and new biologics. A total of 30 applications were approved by FDA during these three months (April-June).