Proactive Communication Key to Managing Challenging Regulatory Agencies

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

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

Clinical Trial Management: Risk-Based Monitoring Represents Viable Oversight Solution

Sarah Ray, clinical trial management researcher
By Sarah Ray,
Senior Research Analyst

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

Planning Ahead to Meet Clinical Data Stakeholders’ Expectations

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

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 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 Continue reading

Three Steps Toward a Successful Regulatory Affairs Operation

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

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

The Drug Quality and Security Act Works Toward Ensuring Drug Safety

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

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 Aims to Launch Biosimilar Version of Enbrel

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

From Phase 3 to Post-Marketing Studies: The Journey of Aripiprazole IM (Abilify Maintena)

By Sarah Ray,
Research Analyst

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

FDA Closer to Regulating Dr. Smartphone

Pharma has been quick to take up its share of social media — companies have already staked out their space on Facebook, Twitter and even Pinterest.  Television ad spending is down as drug companies have increased their use of these new platforms to interact with patients and doctors.  Mobile health (mHealth) apps are on the rise.  And with an estimated 3.4 billion smartphone or tablet users with access to mobile health apps by 2017 (according to Research2Guidance), this market represents an enormous opportunity for pharma.  The market will continue to increase as smartphone use spreads into developing countries and as baby boomers age, two groups that could particularly benefit from improved healthcare information and access. Continue reading

Promising Oncology Drug Ibrutinib Receives Third Breakthrough Designation from FDA

Pharmacyclics Inc. recently announced that the FDA granted an additional Breakthrough Therapy designation for its investigational oral agent ibrutinib as a monotherapy to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with deletion of the short arm of chromosome 17. For those keeping score at home, this is ibrutinib’s third breakthrough therapy designation. In February 2013, the FDA granted breakthrough designations for ibrutinib’s use in relapsed or refractory mantle cell lymphoma (MCL) and Waldenstrom’s macroglobulinemia (WM). Continue reading