In November 2017, the pharma industry was granted an extension of the Drug Supply Chain Security Act (DSCSA) enforcement date to November 2018. Regulators told the market that they would not actively enforce the new serialization requirements until this date.
Standfirst:There is growing awareness of the valuable role that diagnostics can play, both in the early identification and treatment of dangerous or infectious diseases as well as genetic disorders.
Compliance is a serious issue for India’s pharmaceutical manufacturers, distributors, and retailers; due to the complicated nature of the pharmaceutical supply chain. Serialization requires pharmaceutical manufacturers to invest in new technology and adapt their current processes and systems.
What is a biosimilar?
Whereas generic drugs are identical copycats of small-molecule chemical products, biosimilars are only similar to biologic products; innately more complex than chemical products, biologics are large-molecule, organic drugs, subject to natural variability and vulnerability due to climate changes during the manufacturing process, and as such, it is impossible to produce an exact replica of a biologic—hence the adoption of the nomenclature, “biosimilar.”
Every day, the United States loses 116 lives to the opioid epidemic.(1) Pharmacists are asking what can be done to combat the opioid epidemic and treat pain effectively.
CRM, CLM, KAM, Big Data, customer focus, patient centricity… for the last 20 years,buzzwords and concepts have been raining down on the Pharmaceutical Industry, generating a flurry of projects, proof of concepts, pilots and even some successful implementations.
The emergence of regenerative medicine as a viable therapy class has created an urgency to review and improve upon the current quality systems distribution standards that are employed in support of these therapies.
Automation has expanded its base in various sectors of the manufacturing industry and the application of robotics is gaining wide acceptance in well – defined processes like the FMCG industry, automotive, healthcare industry, pharma industry, etc. Even with the inclusion of latest technological advancements, the pharmaceutical industry faces a few issues.
Around the world, the pharmaceutical market is rapidly evolving, driven by greater access to medicines, an increased focus on patient needs and the emergence of innovative therapies for chronic conditions such as diabetes, multiple sclerosis and rheumatoid arthritis.
Environmental concerns in China leading to closure of factories that make the basic raw materials and key starting materials required for the API industry to be dearer?
The relationship between pharmaceutical and biopharmaceutical companies and drug delivery system manufacturers has evolved over the past 20 years. In the past, the relationships were purely transactional, but this has changed over the last two decades.
Significant innovation in disease treatment, including the increased focus on complex biologic therapies1, has resulted in important industry trends that have had an impact on many aspects of aseptic processing.
The year 2018 marks a notable milestone in the history of stem cell and regenerative medicine. It was twenty years ago, in 1998, that James Thompson and John Gearhart published methods for the creation of the first human embryonic stem cell (hESC) lines.
Digital technology has been driving change throughout the life science industry for years, however the sector is currently standing on the precipice of revolutionary development – some organizations have already taken the jump towards a more digital future.
The Falsified Medicines Directive 2011/62/EU, which is due for adoption in February 2019, will require pharmaceuticalcompanies to apply serialisation codes to every applicable pack (OTC and some minor exemptions).
While the requirements for serialization in the pharmaceutical supply chain are generally regarded as inevitable counterfeiting is simply too large of a problem to not be addressed there is some uncertainty around the specifics,particularly globally.
When it comes to the manufacturing of drugs, particularly highly sensitive biologics, a high-level of expertise is required. Typically, small and medium-sized pharma and biotech companies lack the knowledge and know-how necessary to cover all the processes independently prior to completion of the entire final product.
“IGNITE is a creative environment that fosters innovative thinking and encourages new ideas and enables users to have their voice heard in overcoming challenges that are faced to find new ways to better deliver quality data, speed up clinical development, lower cost to drug and device developers, and, to improve patient safety.”
Historically, injectable drugs havemostly been packaged aseptically, with pharmaceutical laboratoriescarrying out the sterilization of the primary packaging components internally.
Aurolab, the manufacturing division of Aravind Eye Hospital, at Madurai, Tamil Nadu that supplies high quality ophthalmic consumables at affordable prices to developing countries.
Do you providecompanies with innovative solutions to improve supply chain efficiency?
In addition to our primary packaging for solid doses, unit dose packaging and secondary packaging services, we also provide integrated supply chain services, such as postponement packaging or late-stage customisation to help our customers cope with small-scale market requirements.
In June 2017, the FDA announced that it will delay the active enforcement of the Drug Supply Chain Security Act (DSCSA) for pharmaceutical manufacturers to November 2018 due to industry-wide concerns that many members of the pharmaceutical supply chain are behind in implementing serialization systems and processes.
The market for organs-on-chips (OOCs), the cell culture chips that imitate the activities, mechanisms and responses of organs, will be worth $284 millionby 2021, according to research from The Business Research Company in its report Organ-On-Chip (OOC) Global Market 2011-21.
Rivaroxaban plus aspirin improves survival and reduces stroke and heart attack in patients with stable coronary or peripheral artery disease, according to late-breaking results from the COMPASS trial presented today in a Hot Line – LBCT Session at ESC Congress1 and published in the NEJM.
The numbers are daunting – 15% of the global population suffers from hearing loss, including a significant number of children, teenagers, and the elderly. Hearing loss presents a growing public health problem, due to ageing and an urban way of life that features excessive noise exposure.
The average cost of bringing a new drug to market is $2.6 billion, according to a 2014 report published by Tufts Center for the Study of Drug Development. This is a rise of 145%, adjusted for inflation, compared to just a decade earlier and is driven in part by the increasing complexity of clinical trials.
Biotechnology and pharmaceutical companies within the United States and Europe face an increasing number of hurdles when undertaking clinical trials within their own country or region; problems such as over saturated patient pools, difficulties meeting and maintaining enrollment numbers, increasing costs and lengthy time delays.
Stem cell science has made huge progress since the early 1960s when Canadian researchers James Till and Ernest McCulloch discovered blood stem cells and advanced medical research across the globe.
Despite the wide array of information systems available for biopharmaceutical manufacturing, we need to adopt a “follow-the-workflow” approach to overcome the process inefficiencies generated by quality and production silos.
In late 2015, I was approached by the board of Nativis, Inc.to take on the leadership of the company, by then a 13-year-old “startup.”
CURE Pharmaceutical has developed innovative drug delivery technology in CureFilm, an oral film strip that dissolves in the mouth, allows for multiple active ingredients in one dosage, and features higher bioavailability.
In recent years the pharmaceutical industry has seen a significant change to the way its manufacturersand supply chains operate, due to the establishment of several serialization and track and trace regulations mandated globally.
Patient-centricity has become an important focus for drug developers and an essential element of clinical studies aimed at showing that a new therapy addresses real patient needs. How companies define patient-centric trials sometimes differ.
Clinical trials are evolving away from trials based solely at investigator sites, moving on to the patient’s home, requiring direct-to-patient services in order for patients to participate.
Life Science companies, both large and small, are seeking more strategic partnerships with vendors.
Worldwide, around 47 million people have dementia, and there are 9.9 million new cases every year, according to recent data from the World Health Organization (WHO)1.Alzheimer's disease (AD) is the most common cause of dementia and may contribute to 60–70% of cases.
1. What makes the market demand rising for integrated delivery system?
The market demand for integrated delivery systems which combine an injectable drug, its container and the system used to administer it—continues to grow due, in large part, to the popularity of self-administered therapies for rheumatoid arthritis, diabetes and other chronic conditions.
A method of testing drugs thatprompt the immune system to attack and destroy cancer cells has been developed which can speed up drug discovering andreducethe unnecessary use of mice in drug screening programmes.
Orphan genetic diseases have become an increasingly popular area for drug development through a variety of novel mechanistictherapeutic approaches.
Automation in its broadest sense has expanded from its original industrial manufacturing base to laboratories and businesses.
The deadlines for serialisation compliance in the EU and the U.S. are drawing closer. For many pharmaceutical companies, the journey towards implementing a full serialisation solution is well underway, but for others the complexity of the task means that there is still a lot to do.
At the discovery and early stages of drug development, the aim is to evaluate the pharmacology, pharmacokinetics and toxicology of a compound using a simple liquid formulation.
The last decade has seen an increased emphasis on research and development into personalized medicines, including cell, gene and immunotherapy treatments