Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Rita C. Peters

Amid the environment of a gradual economic recovery and continued consolidation of bio/pharmaceutical companies, scientists, technicians, and professionals involved in drug development expressed a mix of muted optimism and stagnant employment options. Readers of 

 shared their perspectives on the current employment situation in the magazine’s annual employment survey. The respondents represent a cross section of small- and large-molecule drug development functions from facilities in North America, Europe, and other locations. Approximately 60% of the respondents held advanced degrees, divided evenly between Master’s and doctorate degrees.

In 2013, more than half of the respondents said they were involved in a merger, acquisition, downsizing, or restructuring. This represents a significant jump from 2012, when 36.1% of survey participants experienced similar company changes. This activity could be a reason for the slight pullback in confidence in job security.

In the past two years, have you been through a merger,   acquisition, down-sizing, or restructuring?

Since 2010, confidence in job security has trended upward. Four years ago, 53% of the respondents said they were less secure in their position versus the previous year. In 2013, only 37.4% said they were less secure compared to 2012.  However, more respondents felt less secure in their positions in 2013 compared to 2012, illustrating a slight drop in job security confidence. 

Nearly two-thirds of those surveyed (63.3%) reported a salary increase in 2013. While 43% said they were paid fairly, almost 35% said their compensation was at the lower range of market value. Nearly 20% said they were paid below market value.  More than half reported an increase in the cost of health insurance.

Does your salary reflect a change over last year’s salary?

Rate your satisfaction with your current salary (for your   level of expertise and responsibility).

I am paid within market value,       but at the low end   of the range

However, respondents cited other factors as important to job satisfaction with challenging projects, intellectual stimulation, or good work/life balance as “the main reason I come to work.”

Work/life balance and salary were the two most important reasons respondents would change jobs, followed by job security and professional advancement. More than half were confident that they could find a job comparable to the one they currently hold, although 42% said it would take some time to locate a suitable position.

While respondents had some reservations about prospects for their own positions, they were more optimistic about business prospects for their organizations and the overall bio/pharmaceutical industry. Nearly 60% predicted business prospects for their company will improve in 2014, a jump of 11 percentage points over 2012. The percent of respondents who thought business would decline dropped from 18.1% in 2012 to 13.1% in 2013.

When considering the outlook for the overall bio/pharmaceutical market in the short- and long-term, 54.3% of the respondents predicted that business will improve, versus less than 6% who expect a decline in business. Interestingly, more survey participants expect business to improve overseas but not domestically (16.5%), versus those that expect improved conditions domestically, but not overseas (2.9%).

In evaluating the capabilities of new hires in the bio/pharmaceutical industry, 79% of those surveyed said the new employees were adequately trained, but not exceptional. More than 13% said the new hires were poorly trained.

2013 Pharmaceutical Technology Employment Survey

Note: Due to rounding, some percentages may not add up to 100%. Some questions allowed multiple answers. 

Articles

Pharmaceutical Technology's 2013 Employment Survey reveals some optimism for the industry's future performance, but ongoing concerns about individual job prospects.

Industry Optimism Outweighs Personal Job Security

This article was originally published in the December 2013 issue of 

Amid the environment of a gradual economic recovery and continued consolidation of bio/pharmaceutical companies, scientists, technicians and professionals involved in drug development expressed a mix of muted optimism and stagnant employment options in an annual employment survey conducted by 

 (1). The respondents represent a cross section of small- and large-molecule drug development from facilities in Europe.

In the past two years, have you been through a merger,   acquisition, downsizing or restructuring?

In 2013, about half of the European respondents said they were involved in a merger, acquisition, downsizing or restructuring. This response represents a significant jump from 2012, when 36.1% of survey participants experienced similar company changes. In a survey of bio/pharmaceutical professionals in North America, respondents reported similar experiences with company restructuring. Respondents from other parts of the world, however, felt more secure in their jobs than their counterparts in Europe.

Since 2011, the number of respondents who expressed confidence in the security of their jobs has declined from 14.3% to 11.5%. The percentage of respondents who said they were less secure in their position versus the previous year dropped from 46.2% in 2011 to about 40% in 2013. More people reported no change.

Nearly half of those surveyed (49.6%) reported no change in salary in 2013; almost 40% reported increases. While 34.6% said they were paid fairly, 41.3% said their compensation was at the lower range of market value and nearly one-quarter said they were paid below market value. 

Rate your satisfaction with your current salary
(for your   level of expertise and responsibility).

I am paid within market value,       but at the low end of the range

Nearly two-thirds of the respondents reported an increase in workload in 2013 versus 2012. However, this number is still below the 76.1% who reported an added workload in 2011.

However, respondents cited other factors as important to job satisfaction including intellectual stimulation, challenging projects or good work/life balance as “the main reason I come to work.”

Intellectual challenge and work/life balance were the two most important reasons respondents would change jobs, followed by professional advancement and salary. More than half were confident that they could find a job comparable to the one they currently hold; however, almost 35% said it may take a while to secure a comparable position. One-quarter said they expected a job search to be difficult.

While they held some reservations about prospects for their own positions, respondents were more optimistic about business prospects for their organisations and the overall bio/pharmaceutical industry. More than 54% predict business prospects for their company will improve in 2014, a jump of more than 16 percentage points over last year. The percent of respondents who thought business would decline dropped from 27% in 2012 to 11.7% in 2013.

However, when considering the outlook for the overall bio/pharmaceutical market in the short- and long-term, 37.5% of the respondents predicted that business will improve, compared to 45% who anticipated improvements in 2012. Interestingly, more survey participants expect business to improve overseas, but not domestically (21.8%)

2013 Pharmaceutical Technology/BioPharm International Employment Survey.
  


  Note: Due to rounding, some percentages may not add up to 100%. Some questions allowed multiple answers.

Industry mergers, acquisitions and downsizing contribute to uncertainty in job security in the European bio/pharmaceutical market.

Uncertainty in the Workplace in Europe

Compared to other manufacturing and technology industries, the bio/pharmaceutical industry has one of the longest product development timelines. The research, development, testing, and regulatory review process typically extends for more than a decade, often exhausting the financial resources and commitment of investors. For patients with unmet medical needs, the wait for an effective therapy can be long, frustrating, and even life threatening. Late-stage failures of promising drugs can be devastating to the developer and patient alike.

Bio/pharmaceutical companies continue to explore different research, collaboration, and funding strategies in the search for ways to accelerate drug development. Assistance may be coming from an unlikely source: US Congress.

The 16-day shutdown of the US government demonstrated the divisiveness and dysfunction that has characterized Congress. More than half of all FDA employees were furloughed; research programs stalled at National Institutes of Health; and investigators at the Centers for Disease Control were not available to track outbreaks of infectious diseases. However, two pieces of legislation that took effect in 2012 are showing signs of having a positive impact on bio/pharmaceutical development, encouraging business growth, and hopefully resulting in improved patient access to effective drugs.

The Jumpstart Our Business Startups (JOBS) Act, signed into law in April 2012, gives emerging growth companies an easier path to raise capital privately or to seek public financing. It also reduces financial regulatory and compliance burdens on certain new public companies, enabling them to focus more on scientific research and less on financial reporting. The Biotechnology Industry Organization (BIO) reports that more than 40 biotech companies have gone public using provisions available through the JOBS Act (1).

The Food and Drug Administration Safety and Innovation Act (FDASIA), which included reauthorization of the Prescription Drug User Fee Act through September 2017, also provided for the timely review of new drug and biologic license applications. Since the legislation took effect in October 2012, the Pharmaceutical Research and Manufacturers Association, BIO, and drug companies have commended FDA for improved communication and collaboration with sponsors. FDA’s breakthrough therapy designation was developed to expedite the development and review of drugs for serious or life-threatening conditions and provide more intensive FDA guidance on an efficient drug-development program. Other expedited programs are fast track designation, accelerated approval, and priority review. Although no drugs have been approved under the new designations, the pathways are proving to be popular.

In fiscal year 2013, the Center for Drug Evaluation and Research received 92 breakthrough requests, approved 27, and denied 41; the remaining requests are pending approval. For almost 98% of the requests, action was taken within 60 days of receipt of the request. The Center for Biologics Evaluation and Research denied 8 of the 10 requests it received through Aug. 31, 2013 (2). 

Both the JOBS Act and FDASIA passed with bipartisan support. In a few months, as members of Congress engage in the next round of budget and debt-ceiling debates, perhaps they should take a lesson from these bipartisan efforts and reach a consensus that makes sense for the nation as a whole.

Frequently Asked Questions: Breakthrough Therapies


Rita Peters is the editorial director of 

The JOBS Act and FDASIA show early signs of accelerating drug development.

New Funding and Approval Pathways Prove Popular

	US government agencies, including FDA, faced the first shutdown in 17 years when the House of Representatives and Senate failed to reach agreement on a budget. While national parks and landmarks, including the Statue of Liberty were closed on October 1 and thousands of government workers were idled, FDA expects to retain approximately 55% of its staff during the current partial government shutdown.

 statement, FDA will continue limited activities related to its user fee-funded programs. The agency will also continue “select vital activities including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues.”

	The agency reports that it will not support the majority of its food safety, nutrition, and cosmetics activities and may have to cease safety activities such as “routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making.

	Reviews of pending approvals for several drugs, originally scheduled for early October, were uncertain as of Oct. 1.

	A provision by House Republicans to delay the implementation of the Affordable Care Act appears to be the major sticking point to an agreement. If elected officials get past this roadblock, the next big debate, over increasing the debt ceiling, is just two weeks away.

US government agencies, including FDA, faced the first shutdown in 17 years when the House of Representatives and Senate failed to reach agreement on a budget.

Budget Showdown Leads to Partial FDA Shutdown

In June, the US Supreme Court issued major legal decisions that may change the way pharmaceutical and biopharmaceutical companies conduct business and address drug safety.  

ederal Trade Commission v. Actavis, Inc., et al

., the Court ruled that financial deals between innovator drug companies and generic manufacturers to delay generic substitutes from getting to market can be legally challenged, but such payments are not presumptively illegal. 

Association For Molecular Pathology, et al. v. Myriad Genetics, Inc., et al.

, the justices ruled that naturally occurring human genes and gene fragments are not patent-eligible. An analysis of the decision and its implications begins "New Gene Patent Rules". 

Mutual Pharmaceutical Co., Inc. v. Bartlett

, a patient who was prescribed sulindac, a generic nonsteroidal anti-inflammatory (NSAID) pain medicine, developed toxic epidermal necrolysis, which resulted in serious, permanent injuries. In 2009, the patient sued Mutual Pharmaceutical, the generic drug's manufacturer, in New Hampshire arguing under the state's product liability laws that the drug label did not specifically warn that the drug could cause toxic epidermal necrolysis, and the drug was defective and unreasonably dangerous. (FDA later recommended that all approved NSAIDs warn against toxic epidermal necrolysis.) A trial court awarded the plaintiff $21 million in damages; the award was upheld under appeal. 

, the Supreme Court had ruled that generic-drug manufacturers are not liable under state failure-to-warn laws because the US Food, Drug, and Cosmetic Act (FDCA) requires generic-drug manufacturers to copy the packaging inserts of innovator drug manufacturers. Thus, federal law prevents generic-drug manufacturers from changing warning labels. 

 decision, the Supreme Court, in a 5–4 split vote, extended the 

 decision to the design-defect argument, concluding that FDCA requires a generic drug to have the same active ingredients, dosage form, and strength as an innovator drug. The Court rejected the Bartlett's argument that a generic manufacturer can comply with federal and state laws—and avoid liability—by not manufacturing the drug. In effect, a brand-name drug manufacturer can be sued over a drug's warning label, but the manufacturer of a chemically identical generic drug cannot be sued. 

FDA is proposing rule changes that the agency says would "create parity" between innovator and generic-drug manufacturers "with respect to submission of CBE (changes being effected) labeling supplements." Generic-drug manufacturers could update their drug warning labels if the company discovers risks to patients, without waiting for the brand drug manufacturer to make a change. 

Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,

 would amend the regulations for new drug applications, abbreviated new drug applications, and biologics license applications "to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change." The rule would allow generic-drug makers to make changes in their labeling, but also could expose the companies to potential liability. 

While the timing of the proposed rule is interesting, given the recent court decision, the changes have been discussed for some time. In 2011, Public Citizen, a consumer organization, petitioned FDA to revise generic-drug labeling practices. The Generic Pharmaceutical Association has stated that the warning labels should be the responsibility of FDA, not individual companies. FDA plans to issue the rule, which will be open for public comment, by September. The discussion should be interesting. 

As the Supreme Court ruled on generic-drug liability, FDA outlined new rules for warning labels.

Filling a Gap in Drug Safety

Change can be difficult. Whether an individual is trying to break an old habit, an organization is restructuring the way it does business, or society is adapting to technological and economic trends, the process is never easy. Discussions at two recent conferences illustrate emerging healthcare trends that could change the way pharmaceutical and biopharmaceutical companies do business. 

Elias Zerhouni, president, global R&D, Sanofi, outlined four areas—patient needs, regulations, payer-driven markets, and science—as key challenges for drug research and development during a keynote address at an innovation and funding summit hosted by BioNJ's Diagnostics & Personalized Medicine Initiative. 

Understanding patient needs and scientific approaches are closely tied. Early successes in animal models and genomics gave the drug research community a false picture and those findings did not translate to humans, Zerhouni said. He urged a shift in research strategy to one that looks first at the patient population and is based on a better understanding of disease biology.  

This new approach will require a change in the way drug companies conduct R&D business. Closed R&D campuses are a thing of the past in other industries, but pharmaceutical companies have resisted, Zerhouni said. 

 Traditional business, medical, and personal-health practices also face upheaval; event speakers identified examples in medical diagnostics. New diagnostic devices based on smartphone technology can monitor heart rates, blood pressure, blood sugar, and more. While many of these devices and applications are still unproven, the appeal for lower-cost diagnostic technologies is strong in emerging nations.  

US firms are developing technology that the US market does not want to adopt due to existing payer models, entrenched practices, and regulatory hurdles, said G. Steven Burrill, CEO of Burrill & Company at the BioNJ event.  

These technologies may allow emerging nations to "leap-frog" established countries and implement better healthcare systems, said Frank Prendergast, MD, PhD, professor of Biochemistry & Molecular Biology and Professor of Molecular Pharmacology & Experimental Therapeutics, The Mayo Clinic. 

While technology may allow a patient to turn to their smartphone for routine diagnostics, the high cost of medical care may force patients and doctors to adopt such technology. In 2010, the US spent 17.6% of its gross domestic product on healthcare. The average per-person-cost of $8,233 per year is more than 2.5 times more than most developed nations, according to the Organization for Economic Co-operation and Development.  

For the medical establishment, including drug companies, the price people will pay for medical care is a deciding factor in how products are produced or if the products are produced at all.  

In mid-June, the International Society of Pharmaceutical Engineers (ISPE) released results of a survey on drug shortages, which examined manufacturing and quality issues that contributed to the recent spike in drug shortages. However, the survey did not address economic or business choices that may have had an impact on the shortages. Participants at the ISPE/FDA conference, 

Ensuring a Reliable Supply of Quality Medicines

, where the study was released, noted financial factors often drive corporate decisions about which products should be manufactured.  

New drugs are expensive to develop and produce. Some prove too expensive to be consumed. Others are too cheap to be manufactured for a profit. Change to achieve a patient-centered solution that still meets business goals will be difficult, but necessary. 

Pharma and biotech companies, with the rest of the health care industry, must face change.