by | ClinLab Staffing
The Food and Drug Administration (FDA) is being congratulated on a breakthrough in the conventional belabored FDA approval process. Ben Steele, contributor to Eye for Pharma reported that the pharmas Johnson & Johnson and Vertex Pharmaceuticals spoke out in support of the new approval process, which cuts years off the time it takes for breakthrough drugs to reach the market. A blood cancer therapy, Ibrutinib, developed by Johnson & Johnson and Vertex is two years ahead of the planned schedule thanks to new FDA policies. Phase II studies are showing that the drug is set to make a huge impact on the cancer therapy market. Jay Seigel, head of regulatory affairs for Johnson & Johnson and Dr. Jeffrey Leiden, CEO of Vertex Pharmaceuticals, both stated that the new FDA process was proactive and iterative. The FDA was focused and fully involved allowing a quicker and smoother approval process. The FDA reports that it has developed three distinct and successful approaches to bring certain drugs to market quickly – priority review, accelerated approval, and fast track. Fast track aims to expedite the process of drugs to treat serious illnesses where there are few alternatives. Priority review is a process for drugs that have demonstrated significant improvements over existing therapies. Accelerated approval uses a surrogate endpoint to approve drugs in a shorter amount of time. Janet Woodcock, Director of the FDA’s drugs division confirmed that the new program was targeting certain therapies for genetic mutations. However, the program did not guarantee approval of any drug. A total of 67 applications had been submitted to the FDA as of July 12, 2013,...
by | General IT
Kenneth Corbin from IT News reported on recent events at meetings between leading IT industry representatives, White House officials and members of Congress. These meetings represent efforts to lobby for policy action. The policies that technology stakeholders hold dear relate to the availability of skilled labor and maintaining a competitive and innovative IT industry that can sustain a strong presence in the global market. Immigration. Many IT firms find difficulty in recruiting high-level talent and rely on skilled foreign workers admitted to the US on H-1B visas. The industry would like to see immigration reform that raises current visa limits to increase the availability of much needed resources. According to Kenneth Corbin of IT News, approximately 120,000 applications for H-1B visas are submitted each year for which only 85,000 are available. Critics lament that this is a ploy for companies to exploit cheap labor. Some are concerned that foreign workers who are trained in the US are ultimately sent back to their country and join companies that compete with US firms. STEM education. The IT industry is lobbying for improved K-12 education in science, technology, engineering, and math. Only 2,500 high schools offer an AP computer science course. A spokesperson from Microsoft stated that inadequate education in the US, and failing to allow enough skilled workers from other countries, is causing jobs to move elsewhere. Intelligence Gathering. Intelligence gathering practices have been detrimental to IT companies and innovations such as cloud technology. Companies such as Microsoft, Google, and Yahoo are demanding transparency in government access to digital information. Other policies that the IT industry is emphasizing include faster broadband...
by | HR & Management
It’s easy to be distracted by warm sunny days and the anticipation of summer vacation. Many individuals are also facing chaos at home with children home from school and the organization of summer camps and child care. How Can You Keep Employees Focused, Engaged, and Productive? Patrick Hull, contributor to Forbes highlights Zappos as an example of a company that emphasizes keeping employees happy as the key to maintaining their commitment. Supporting employees and providing flexible options can cement loyalty and encourage productivity. Offer flexible options, especially in the summer months, to allow for schedule management, child and aging parent care, and time off for summer vacations. Allow work from home options if the situation calls for it, and hire temporary employees to supplement for staff on leave. Institute casual Fridays or change the dress code in the summer so that staff can be more comfortable and less formal. Employees who can be productive while also managing their personal lives will be less stressed and more likely to be enthusiastic and engaged. A relaxed attitude can lift moods and even boost creativity. Use the summer to offer rewards and incentives such as tickets to sporting events and theme parks. Add some fun to the workplace and host charity events such as fun runs and connect with the local community. Have your staff take part in local events to boost your reputation as an employer. Plan social events that are outside and that involve employee families such as picnics or other outings. Institute occasional opportunities for training or community involvement. Such events are not wasted time but represent a valuable...
by | General IT
The IT skills shortage is not a new phenomenon; it is merely an exacerbated one. Hiring quality and talented coders and their ilk is complex because of three dynamics. Constant technology changes demand professionals armed with the latest IT knowledge in a world where education is expensive and sometimes inadequate. Sub-par assessment tools and recruitment processes fail to discern the best from the average, and there is increasing industry competition for the best employees. Rich Hein, CIO and contributor to IT News, offers a solution – IT skills and people architecture – which boils down to a recruitment strategy for IT skills. Here is the framework behind the strategy that recognizes a good team can successfully realize a company vision. Future planning is key to hiring sufficient talent. Analyze current and future needs and align them with growth plans. Determine areas where you may be lacking, such as network engineers or analysts who understand big data. Develop transparent and consistent HR policies. These should include revised job titles, separating management roles that demand people skills from IT specialized roles that require tech-specific skills. Ensure that compensation for each job type is competitive with industry standards for that skill. Design ways to engage, retain, and attract talent. Define IT roles not job titles and design career paths around them. For example, an IT architect path for system builders, project manager paths for those who oversee projects, an analyst path for those who have knowledge and assets that can be applied to specific cases, and an engineers and specialist path for those who team with the architects and find approaches and...
by | ClinLab Staffing
Drug developers are spending billions on R&D and extensive studies on treatments for high cholesterol based on genomic sequencing. According to Damian Garde of Fiercebiotech, Amgen is the current leader and may be the first to launch a new drug; the company is completing Phase III studies with evolocumab. Sanofi has partnered with Regenero and is in late-stage studies with alirocumab. Bocozizumab by Pfizer has entered Phase III studies. Approximately 71 million Americans suffer from high cholesterol and the new drugs, which can be used in addition to or in place of the current popular statins, are expected to create a $10 million market. The drugs use an antibody to reduce LDL levels. LDL levels are controlled by a gene called PCSK9 that regulates LDL receptors and patients with high LDL possess overactive copies of the gene. The new drugs block that gene. Many pharma and biotech companies are conducting R&D on PCSK9 and include Roche, Bristol-Myers Squibb and Alnylam in addition to Amgen, Sanofi, Regenero and Pfizer. Amgen’s evolocumab was tested with 4,000 patients and reduced cholesterol by 57 percent compared to a placebo. Combined with statin therapy, that statistic rose to 75 percent. Sanofi and Regeneron showed similar results in initial Phase III trials of alirocumab. These companies plan to issue late-stage trials in 2014 with data from 6,000 patients. Pfizer’s bococizumab is in late-stage testing with 22,000 patients. However, a reduction in LDL does not necessary mean improved quality of life, and there is a concern that long-term data may be required before the new, more expensive drugs are accepted by doctors. Therefore, leading companies have...
by | IT Financial
The Pew Research Center recently reported results from a January 2014 survey; 18 percent of individuals had personal information stolen such as social security numbers, bank account information, and credit cards from online accounts and 21 percent had an email or social network account hacked. Trusted retail giants such as Target and Niemen Marcus have fallen victim to malware that can access customer credit and debit card data. IT News reports that data breaches numbered 25,566 in 2013, more than double the number recorded in 2009 of 10,481. Data breaches occur as a result of hacker theft from an individual or group, terrorist activity, or from the loss of electronic devices. Targets for data breach can be any online source such as individuals, companies, public institutions, financial institutions, governments, and retailers. The Government Accountability Office recently issued recommendations for government IT groups in the event of a data breach; however, the recommendations can also be applied to firms and other organizations. Organizations should commit a dedicated team to data breach response. This team should include the chief information officer, the lead communications officer, management, and the manager of the affected unit. Employees should be trained in rapid and appropriate response to data breach. Regular training should be provided concerning privacy and security issues, and staff who are not trained should not be given access to information and information systems. Staff should undergo periodic refresher training. Any breaches should be assessed, documented, and reported to the necessary internal and external units. Procedures for such reporting should be in writing and readily accessible to all concerned staff. Once the risk has...
by | HR & Management
According to Jan Wieczner of The Wall Street Journal, approximately 90% of employers provide health care programs with wellness incentives or financial rewards to employees. In 2008, that number was 57%. The programs are designed to encourage employees to take action towards improved health that will reduce health care expenses for employers. A survey by Fidelity Investments and the National Business Group reveals that the average incentive for employees has doubled from $260 in 2009 to $521 today. In some cases, penalties are applied. While it should be desirable for an employer to care about an employee’s wellbeing, penalizing an employee for personal habits or overall lifestyle choices seems misplaced. Although some workplace programs can be considered effective, Leah Binder of Forbes magazine outlined some of the disadvantages of ineffective worksite wellness programs in an article dated April 2014. Employees are often asked to complete online questionnaires that delve into personal habits and health status; refusal can mean penalties in the range of $1,000 in some cases. This renders such programs possible privacy, health, and business risks that can alienate employees. There is a danger in informing employees that they should stop smoking, eat more vegetables, and exercise. Similarly, an employer that demands 50 hour work weeks and who indirectly instructs an employee to take up yoga and get a heart check is ironic, patronizing, and unlikely to be taken seriously. It is debatable whether wellness programs save money for the employer. The programs themselves cost money to establish and the additional health screenings, treatment, and the education services are costly too. Additionally, employees could be subject to...
by | General IT
The Internet of Things (IoT) refers to objects that support Internet structures. For example, radio-frequency identification and tagging, such as the use of bar codes, allows computers to collect big data. This technology is advancing so rapidly that effectively managing big data is a challenge. The potential for mining and applying such intelligence with respect to CRM is a focus for innovative IT companies. IT News contributor, J.D. Sartain, emphasizes that customer relationship management (CRM) technology is embracing mobile technology, social media, and analysis tools such as web analytics. Companies are eager to invest in multichannel technology products that will enhance customer engagement and facilitate customer loyalty to brands and products. CRM encompasses cloud technology, big data technology and, more recently IoT. IoT is poised to alter industries such as hospitality, construction, and healthcare as sensors and identifiers will facilitate superior performance from customer service centers and marketing groups. Already, CRM processes monitor social network platforms such as Facebook and LinkedIn to provide data and customer information for innovation. New mobile gadgets, the tablet is the most recent example, are challenging the IT community as it struggles to keep up with customer demand for service and support. Smartphone Internet connections are predicted to exceed PC connections by the end of 2014. Big data is being collected and is available for marketing purposes, but there is a lack of skills and resources to analyze and apply the plethora of intelligence that is available. The race is on among IT companies to develop the appropriate tools and expertise to exploit this intelligence. Cloud, social, mobile and big data technology are demanding...
by | ClinLab Staffing
Many pharma companies are developing new cancer treatment drugs to meet the demand by doctors and patients. According to FierceBiotech, regulators are helping pharmas bring these new treatments to market by reducing the required clinical trial phases for certain promising experimental drugs. The leading experimental cancer drugs for 2013 were outlined by FierceBioTech. Ibrutinib (PCI-32765) is currently under development by Pharmacyclics and Johnson & Johnson to treat B-cell malignancies including diffuse large B-cell lymphoma and multiple myeloma. The drug was approved by the US FDA in November 2013. Pharmacyclics is now valued at over $5 billion. Nivolumab (BMS-936559), under development by Bristol-Myers Squibb, is a leading immunotherapy. It functions with immune responses to bolster attacks on cancer and tumors. Bristol-Myers has rights to both drugs following a 2009 buyout of Medarex for $2.4 billion. Pfizer’s palbociclib (PD-0332991) is promising in the treatment of breast cancer and can be taken in combination with the established drug, Novartis’s Femara. Palbociclib is also being considered for the treatment of ovarian cancer, multiple myeloma, and acute lumphoblastic leukemia. Estimated potential annual sales are $5 billion. Obinutuzumab (GA101) is under development by Roche Glycart. It is an anti-CD20 antibody that is designed to treat leukemia and other blood cancers. It will compete with Rituxan by Biogen Idec. Early results in testing show that cancers remained stable for 23 months and tumors shrank by 76 percent. Biogen Idec has rights to 35 percent of the drug after an agreement was reached with Roche’s Genentech, which shared the R&D expenses. Lambrolizumab (MK-3475) by Merck treats melanoma. In 85 out of 132 patients, there was a 51 percent response rate and a nine...
by | IT Financial
Innovation requires failure. IT leaders recognize this and budget accordingly. Effective IT leaders provide the time and resources required for R&D. They expect that their innovators will experiment and fail in the pursuit of a successful product. Employees are empowered, given room to experiment, and are not punished for failure. However, certain failures are not budgeted for and are preventable. For example, a wrong decision concerning the choice of supplier or a breach of data security can have substantial fiscal consequences. A recent article by Rich Hein for IT News, offers lessons from IT mistakes that companies may find useful. Create a safe-to-fail environment that avoids the “blame game.” Instead, adopt a team approach to problem analysis and problem solving. A supportive structure will encourage employees to take risks rather than be reluctant to experiment for fear of failure. Companies that adopt such a strategy encourage teamwork and employees will help others to ensure success. The team accepts the responsibility for failure but also accepts the achievements. A company’s reaction to a failure is everything. React badly, and additional errors will compound the situation. A better approach is to analyze what went wrong, have processes in place to do so, and develop strategies to avoid the same mistake in the future. The world is constantly changing, and processes must be constantly adapted. A culture where leaders accept and own-up to their mistakes will encourage the same in their employees. If a mistake is less threatening, the environment can be healthier and more transparent. Additionally, early acknowledgement of mistakes can ensure early resolution to problems. Ensure that project analysis is...
