One cannot be successful in a life sciences company if one is not also prepared to meet some level of failure. By this, I’m referring to the fact that many products and indications fail to earn regulatory approval. This is true not only of early-phase clinical trials but also of claims based on patient-reported outcomes (PROs). Continue reading
Since its inception in 2012, the industry group TransCelerate has developed many clinical initiatives, from clinical data standards to site qualification and training. Each of these ongoing programs is aimed at improving research and development practices across the biopharmaceutical industry. The group’s risk-based monitoring initiative—also launched in 2012—aims to help life science teams maximize site monitoring outcomes by developing site visit schedules based on potential trial risk. Continue reading
Dealing with regulatory agencies to earn product approvals can prove quite difficult for life sciences companies. Some representatives can be quite passionate about their therapeutic area which can affect their judgment, for instance. In other instances, one investigator can simply prove more difficult than others.
To respond, pharmaceutical and other life sciences companies use several strategies to handle working with difficult regulators, according to Cutting Edge Information’s conversations with regulatory affairs executives. Open communication with the regulator assigned to a product is absolutely essential — and should begin early in the development process. By openly communicating with agencies early on in the development process, companies can seek input from the individual responsible for reviewing the product. This communication ensures that there are no surprises on either side and that potential misunderstandings can be addressed promptly. Continue reading
With the growth in companies pipelines, clinical trial management becomes essential. One aspect of study oversight, monitoring trial risk, has evolved in recent years. In traditional clinical studies, clinical research associates (CRAs) typically visit each investigative site every four to eight weeks. However, regularly scheduled visits are fairly uniform in nature and do not always consider site experience and level of patient enrollment — factors which could potentially define a site as being either higher or lower risk. Conceivably, under this type of structure, CRAs could visit sites that hadn’t enrolled a single patient — and do so with the same frequency as sites with high patient volumes. Continue reading
Clinical data transparency has become one of the hottest issues for pharmaceutical and biotechnology clinical development and regulatory teams. From new disclosure policies at PhRMA and the EFPIA to working with the AllTrials initiative, many companies are determined to become proactive when it comes to data disclosure.
Over the past decade, various patient advocacy and regulatory clinical data stakeholders have pushed for greater transparency. Under the FDA Amendments Act of 2007, companies in the US have until 21 days after the first patient is enrolled to register their clinical trial on ClinicalTrials.gov. These teams also have up to one year after their clinical trials conclude to post results. More recently, in Europe, the EMA released an updated version of the European Clinical Trials Database (EudraCT) which aligns its summary results with those already found on ClinicalTrials.gov. Continue reading
As regulatory affairs groups in the pharma industry continue their shift into more strategic roles with greater influence on product development, it is vital that these groups are structured efficiently and communicate well both internally and externally. A successful regulatory affairs operation builds on clear organizational structure, cross-department coordination and strong regulatory agency communication. Continue reading
As pharma moves into 2014, new technologies will allow medical affairs teams to shape their strategies to be increasingly and innovatively patient-centric. Although a case could be made to stop using the term, whatever we call it, the strategy is the same: deliver a product best aligned with patient need to create the strongest value proposition. Continue reading
Recent events have highlighted the need for increased government regulations to uphold the pharmaceutical supply chain and improve existing drug safety measures. Since the contamination of steroidal injections in 2012 — which led to over 750 cases of fungal meningitis — ensuring drug safety has been top priority within the pharma industry and for legislators alike. More specifically, the FDA has sought to increase its oversight on compounding facilities. While the FDA regulates pharmaceutical companies, compounding pharmacies are subject to rules created by individual state boards of pharmacy. Continue reading
Sandoz, a generic subsidiary of Novartis and an industry leader in the development of follow-on biologics, is launching a Phase III clinical trial of a biosimilar version of Enbrel (etanercept) – one of Amgen’s biggest sellers. Enbrel fights autoimmune diseases by acting as a tumor necrosis factor (TNF) inhibitor to treat inflammatory conditions like rheumatoid arthritis and psoriasis. Generic production of biologics is tricky because biologics are proteins derived from cells of living organisms and cannot be perfectly duplicated. Instead, Sandoz hopes to demonstrate the biosimilarity of its product to Enbrel. The new clinical trial will investigate the ability of the molecule to elicit the same immune response in patients with moderate to severe plaque-type psoriasis. Safety and efficacy will also be determined. Continue reading
Schizophrenia is a complex psychological disease state that distorts patients’ cognitive and emotional responses. Patients may experience positive symptoms such as delusions, hallucinations or disorganized thought patterns. Patients may also exhibit negative symptoms like those typically associated with depression; things like lack of pleasure in everyday life and lessened emotional range. The World Health Organization estimates that schizophrenia affects up to 24 million individuals globally. In the US, an estimated 1% of the adult population — 2.4 million — have schizophrenia. Continue reading