Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Rita C. Peters

	With a flurry of activity in the final two months of the year, FDA approved 45 novel new drugs in 2015 (1), the highest number of approvals since 1996 and second-highest ever (2). “But far more important than quantity is quality--and the valuable new roles many of these drugs can serve in advancing medical care and the health of patients,” said John Jenkins, director of FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (CDER) (3).

	The agency approved 87% of the applications on the first cycle of review and met or exceeded the goal dates under the Prescription Drug User Fee Act for all but two of novel new drugs approved. FDA’s expedited pathways for drug approval again proved successful in 2015:

		Fourteen drugs were designated by CDER as Fast Track, with the potential to address unmet medical needs.

		Ten drugs were designated as Breakthrough therapies, with preliminary clinical evidence demonstrating that the drug may result in substantial improvement on at least one clinically significant endpoint over other available therapies.

		Twenty-four drugs were designated Priority Review, in which CDER determined that the drug could potentially provide a significant advance in medical care and set a target to review the drug within six months instead of the standard 10 months.

		Six drugs received early approval under the Accelerated Approval program, which allows early approval of a drug for a serious or life-threatening illness that offers a benefit over current treatments.

		In addition, 16 new drugs (36% of those approved) were identified by CDER as first-in-class, with mechanisms of action different from those of existing therapies, and 21 new drugs (47% of those approved) were approved to treat rare or “orphan” diseases that affect 200,000 or fewer Americans. 

30 novel new therapies reported previously

 (4), the following new drugs were approved by FDA between Nov. 1-Dec. 31, 2015:

		Zurampic (lesinurad) from Ardea Biosciences to treat high blood uric acid levels associated with gout

		Uptravi (selexipag) from Actelion Pharmaceuticals to treat pulmonary arterial hypertension

		Bridion (sugammadex) from Organon USA to reverse effects of neuromuscular blocking drugs used during surgery

		Alecensa (alectinib) from Alexion Pharmaceuticals to treat ALK-positive lung cancer

		Kanuma (sebelipase alfa) from Alexion Pharmaceuticals to treat patients with lysosomal acid lipase (LAL) deficiency

		Empliciti (elotuzumab) from Bristol-Myers Squibb to treat people with multiple myeloma who have received one to three prior medications

		Portrazza (necitumumab) from Eli Lilly to treat patients with advanced (metastatic) squamous non-small cell lung cancer who have not previously received medication specifically for treating their advanced lung cancer

		Ninlaro (ixazomib) from Millennium Pharmaceuticals to treat people with multiple myeloma who have received at least one prior therapy

		Darzalex (daratumumab) from Janssen Biotech to treat patients with multiple myeloma who have received at least three prior treatments

		Tagrisso (osimertinib) from AstraZeneca to treat certain patients with non-small cell lung cancer

		Cotellic (cobimetinib) from Genentech to be used in combination with vemurafenib to treat advanced melanoma 

		Genvoya, a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide, from Gilead Sciences for use as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older

		Nucala (mepolizumab) from GlaxoSmithKline for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older.

, online, accessed Jan. 5, 2105.
	2. FDA, 

Summary of NDA Approvals & Receipts, 1938 to the present

, online, accessed Jan. 5, 2015.
	3. J. Jenkins, 

2015: Another Strong Year for Patients in Need of New Drug Therapies

, online, accessed Jan. 5, 2015.
	4. C. Challener, 

Articles

FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.

Expedited Approvals and Orphan Drugs Dominated 2015 Novel New Drugs

In the past 20 years, blockbuster drugs dominated the bio/pharma market in developed economies, and emerging nations increased their demand for treatments for chronic and specialized conditions. At the same time, drug owners approached the patent cliff by altering or terminating existing R&D programs and shifted to new research areas through mergers, acquisitions, and partnerships. Recent trends in drug approvals, business strategies by bio/pharma companies, and regulatory initiatives may present additional changes and challenges in 2016.

	The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 93 new medicines for marketing authorization in 2015, an increase from 81 in 2014. The 2015 approvals including 19 orphan drugs and 2 biosimilar products (1).

	In comparison, the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) in 2015 approved 45 new molecular entity and new biologic license applications (2) and the first biosimilar drug for distribution in the United States. Many of the new molecular entities--47% of the approvals in 2015--were for rare diseases that target smaller patient populations and, therefore, require smaller quantities of drug doses compared to blockbuster drugs.

	CHMP expects the number of applications for initial marketing authorization in 2016 to remain constant with 110 applications in 2016 versus 112 in 2015. The number of applications for medicines containing a new active substance should remain stable, the agency reported in a press statement (3).


	According to a new report (4), improved patient access to chronic disease treatment and breakthrough drug therapies will help reduce the “medicine use gap” between emerging and developed markets, driving global spending on drugs to grow at a 4-7% compound annual rate over the next five years. Regional economic conditions and healthcare infrastructure, however, will dictate the types of drugs prescribed, number of medicine doses, and ultimately, the volume of pharmaceutical sales.

	By 2020, total patient spending on medicines will be $1.4 trillion, reports the IMS Institute for Healthcare Informatics (4); however, the global spending increase from 2015 to 2020, estimated to be 29-32%, is below the 35% increase of the prior five years.

	Global medicine use will reach 4.5 trillion doses in 2020, the study predicts, up 24% from 2015. Emerging markets will account for most of the increase, led by India, China, Brazil, Indonesia, and Africa. Generic drugs, non-original branded drugs, and over-the-counter products will account for 88% of total medicine used in emerging markets, the report says. More than 90% of the prescription drugs filled in the US in 2020 will be generic drugs, up from the present level of 88%.

	Brand spending in developed markets is expected to reach up to US$590 billion, a 34% increase in spending over 2015 on an invoice price basis, thanks to new product launches, and price increases in the US-which may be offset by discounts and rebates. Invoice price growth, which does not reflect discounts and rebates received by payers, is expected to continue at historic levels during the next five years; however, competition and payer resistance will keep net price increases to 5-7% annually. 

	Spending growth will be curbed by patent expiries, which will result in US$178 billion in reduced spending on branded products, including US$41 billion on biologics, as biosimilars become more widely adopted.


	Global spending on specialty medicines used to treat chronic, rare, or genetic diseases is expected to reach 28% of the total spending by 2020. The report estimates that more than 225 medicines will be introduced by 2020, with one-third focused on treating cancer; other development areas are hepatitis C, autoimmune disorders, heart disease, and rare diseases. Adoption of specialty medicines will be most prevalent in established markets.

	These numbers, and types of drugs approved, indicate that the drug-development market may be headed in a new direction, raising questions about the ability of the current R&D and manufacturing infrastructure to adapt to the changing market and meet global patient needs for drugs. This shift in production requirements-combined with lower profit margins for former blockbuster brand drugs now prescribed as lower-cost generic drugs-has implications for drug development and manufacturing processes.


	Attractive credit terms in recent years prompted some bio/pharma manufacturers to invest in facilities and equipment. Encouraging companies to make capital improvements to avoid future quality and manufacturing potholes, however, can be a tough financial and regulatory road to travel.

	In a 2015 survey of 100 executives from top bio/pharma companies (5), less than half said they planned to increase investments in late-stage R&D. Instead, marketing/distribution (79%), drug discovery/early stage R&D (70%), clinical trials (60%), technology acquisition (59%), and patenting (50%) were higher investment priorities.


	In 2015, bio/pharma companies and contact service organizations actively repositioned their business profiles though a stream of mergers, acquisitions, and collaboration agreements, as well as divestitures of specific product lines or business units.

	Senior executives of large biotechnology and pharmaceutical companies surveyed by ReedSmith (5) plan to stay on the investment track; 94% plan to initiate an acquisition over the next 12 months; more than one-third plan to divest assets. The search for external opportunities was a priority; more than half of the respondents said they are planning peer-to-peer research partnerships; 85% report that the plan to hire a contract research organization.

	More respondents (74%) said major pharmaceutical producers would target companies with strong drug discovery or early-stage R&D potential versus companies involved in late-stage R&D (69%). Companies focused on personalized medicine or diagnostics were expected to be popular targets by 70% of those responding.  Less than 30% predicted companies will look to build on their own areas of expertise through acquisitions; 58% said major pharmaceutical producers will seek companies outside their current areas of expertise (3).


	For the past six years, Deloitte and GlobalData analysts examined R&D results for the top 12 publicly held, research-based life science companies (measured by R&D spending in 2008-2009); in 2015, four mid- to large-cap companies were added to the study. Analysis of the pharma industry’s performance in generating return on investment in new drug development revealed a continuing pattern of declining returns, from 10.1% in 2010 to 4.2% in 2015. While the cost to develop an asset increased 33%, from $1.188 billion in 2010 to $1.576 billion in 2015, the average peak sales per asset dropped 50%, from $816 million in 2010 to $416 million in 2015. The numbers, the report authors say, “do not add up for life sciences R&D to generate an appropriate return” (6).

	There was some good news; the mid- to large-cap companies outperformed the top 12 publicly held companies, indicating that different R&D business models could produce better results. 

	Despite the decline in return on investment, the companies in the study continued to increase investment in R&D as a proportion of cash generated, from 25.5% in 2004 to 29.4% in 2014. Investors, however, seek returns. Companies are more likely to return cash to shareholders through dividends and share buybacks than they are to invest in acquisitions, product licenses, and internal R&D, the study concludes.

	At larger R&D companies, legacy infrastructure, which may be difficult to improve, and excess overhead are major contributors to R&D costs. The smaller companies in the study did not have the large infrastructure, but risk becoming too complex and lose their R&D productivity advantage as they grow. Both groups must challenge additional investments at each phase and evaluate returns for each asset, the study reports.

	The authors suggest that focusing R&D efforts on stable therapy areas and specialty therapeutics will add to scientific, regulatory, and commercial value propositions. Agility, flexibility, and a focus on science will allow external sources of innovation to be optimized. Reducing development complexity by streamlining functions and addressing unproductive infrastructure can improve returns.

Bio/pharma professionals project 2016 prospects


	The big decisions about company acquisitions, mergers, and business development may be made in the boardrooms of bio/pharma companies, but the front line professionals-those involved in formulation, development, and manufacturing functions-can offer interesting observations about the impact those business strategies have on the day-to-day tasks of bringing a drug to market.

	Bio/pharma professionals from around the world participated in the 2015 

Pharmaceutical Technology/Pharmaceutical Technology Europe

 annual employment survey (7). Respondents expressed opinions about job security (73.6% feel secure in their current position), seeking new opportunities (55.8% would like to leave their job), and increasing dissatisfaction with salary levels. The respondents also expressed opinions about trends in the industry, how changes impact their daily work, and future business prospects.

	Business is better. More than 40% of EU-based respondents said business at their company increased in 2015, a drop from the 56% who reported an increase in 2014. More than one-quarter of the respondents (26.6%) reported that their company had been through a merger or acquisition in the past two years, up from the 19.7% reporting in the 2014 survey. A similar number of respondents reported a company downsizing or restructuring (28.2% in 2015 vs. 25.4% in 2014).

	Outlook is somewhat optimistic. Half of the respondents (50.4%) predicted that their company’s business will improve in 2016; more than one-third (36.1%) expected no significant change.  These numbers, while positive, were less optimistic than predictions made for 2015 and 2014 in previous surveys. 

	The EU-based segment was significantly less positive in their outlook for the bio/pharma industry: 39.5% said business would improve in 2016, compared with 55.3% who expected improvement for 2015. Respondents based in North America (52%) were significantly more optimistic that business would improve.

	The longer-term horizon (five years) was more optimistic; 59.6% of the EU-based respondents predicted that business will improve; however, 16.8% expect business to improve overseas, but not domestically.


	Early indications are for mergers and acquisitions activity to continue in 2016, and prospects for new drug approvals also are strong. Among these distractions, the industry must drive ahead to seek shareholder value and affordable, effective patient therapies at the same time.


	1. European Medicines Agency, Statistics, www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/document_listing/document_listing_000256.jsp&mid=WC0b01ac0580099fbb
	2. FDA, Novel New Drugs Summary 2015, online, www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm474696.htm, accessed, 5 Jan. 2016.
	3. EMA, “EMA Management Board: highlights of December 2015 meeting,” Press Release (18 Dec. 2015)
	4. IMS Health, Global Medicines in Use in 2020 (Parsippany, NJ, November 2015). 
	5. ReedSmith, Life Lines: Life Sciences M&A and the Rise of Personalized Medicine (London, 2015).
	6. Deloitte Centre for Health Solutions, Measuring the Return from Pharmaceutical Innovation 2015 (London, 2015).
	7. 2015 


	When referring to this article, please cite it as R. Peters, Bio/Pharma’s 2016 Agenda," 

Regulatory, corporate restructuring, and manufacturing issues will challenge bio/pharma to meet the needs and expectations of patients around the world.

Bio/Pharma’s 2016 Agenda in Europe

	Ask the question “How is work?” and you are likely to get a range of responses. The Society of Human Resource Management reports that in 2014 39% of US employees reported being “very satisfied” and 47% “somewhat satisfied” (1). According to another survey, less than half of US workers are satisfied with their jobs (2).

’s annual employment survey (3) the editors sampled opinions about the current job market and job satisfaction for workers in the bio/ pharmaceutical industry. Overall, respondents from all demographic segments gave generally positive opinions of the job market and job satisfaction, while expressing a desire to seek better career opportunities.

	Male and female respondents reported similar responses to most questions, with a few notable differences. Male respondents dominated the corporate management and engineering job functions; more than half of the male respondents (55.1%) said they were in managerial roles, compared to 43.4% of females. Female respondents were younger and had less work experience than the male counterparts. Females held proportionally more Master’s degrees, but fewer doctorate degrees. Interestingly, more female respondents reported work experience outside of the bio/pharma industry; 40.6% said they worked for more than 10 years outside bio/pharma compared to 31.2% of the males reporting.

	More male respondents (37.6%) said they were paid fairly compared to female respondents (32.3%); 23.3% of female respondents and 19.4% of male respondents said they were paid below market value, considering their level of expertise and responsibility. A slightly higher percentage of females (56.4%) versus males (53.1%) reported salary increases compared to 2014. More significant differences showed in responses by gender to questions about career development opportunities. Almost one-third (31.7%) of females disagreed with the statement “I experience no discrimination for any reason at my current company” compared to 17.4% of male respondents. Similarly, nearly one-quarter of females (23.8%) and 9.2% of males felt gender was a factor in determining or limiting their professional development at their current company.

	Women were also less optimistic about opportunities for career advancement; a slightly larger percentage (58.7% female vs. 54.6% male) said they were likely to leave their job, given the opportunity. More than half of the women responding (53%) disagreed with “my company provides advanced training for employee professional growth,” compared to 37.8% of the men responding. In addition, 39.5% of women responding said they were less secure in their job than last year, compared to only 27.8% of men.

	When asked to rate how 15 factors weigh in the decision to change jobs, a higher percentage of females compared to males selected “I would change jobs for this alone” across the board. In particular, females placed a higher priority on professional advancement, intellectual challenge, work/life balance, scientific opportunities, salary, and job security. The survey results show that despite some unhappiness at work, most employees plan to stay in their current positions. However, bio/ pharma companies have more work to do to if they want to improve employee job satisfaction and retain qualified workers.


	1. Society of Human Resource Management, 

 (Alexandria, VA, 2015).
	2. The Conference Board, The Conference Board Job Satisfaction Survey (New York, September 2015).
	 3. 2015 

: 
	When referring to this article, please cite it as R. Peters, “The Search for Job Satisfaction,” 

Employers have work to do to improve job satisfaction and retain qualified workers.

The Search for Job Satisfaction

The bio/pharma industry has rebounded from the economic recession, and in some sectors, is enjoying a resurgence in funding, drug approvals, and growth. For many workers with hands-on responsibility for developing and manufacturing new therapies, however, increases in job and salary satisfaction have lagged the market improvement, despite a US unemployment rate of 5% in October 2015, the lowest in nearly eight years (1).

	The bio/pharma employees surveyed in the 2015 

 annual employment survey (2) reported similar opinions about the employment market as the 2014 survey (3), and also expressed more desire to seek better pay and career opportunities.

	Challenging projects, intellectual stimulation, a good work/life balance, and the company’s potential for success were the most frequently cited as “the main reason I come to work.” Professional advancement, work/life balance, intellectual challenge, and salary were the most frequently cited reasons “I would change jobs for this alone.” Low pay, however, was the single greatest factor identified for quitting a job.


	More than 500 bio/pharma professionals from around the globe responded to the 2015 survey, which was fielded in September and October 2015. Nearly one-third (31.8%) of the respondents were from innovator bio/pharmaceutical companies; 24.1% were from generic-drug manufacturing companies. Representatives of contract research and manufacturing organizations (14.4%), consulting firms (7.7%), academic institutions (6.9%), equipment and raw materials suppliers (4.7%), and government/regulatory organizations (3.2%) also were represented.

	The companies that employ the respondents develop or manufacture both small- and large-molecule drugs (38%), small-molecule drugs only (33.7%), or large-molecule drugs only (11.5%); 3.65% are involved in cell therapy or regenerative medicine. The respondents are employed at a mix of privately held companies (48.7%), publicly traded companies (34.1%), and non-profit/academic/government groups (12.2%).

	Nearly 20 job functions were represented; quality control/assurance and validation (19.2%) and research/ development/formulation (18.2%) were the top selections, followed by corporate management (8.3%), production/ manufacturing/operations (6.5%), regulatory affairs (6.3%), and technical services/analytical development (6.1%). Other functions included process development, engineering, and tech transfer.

	Geographically, 47.4% of the respondents were from the United States; 27.1% were from Europe, 12.5% from Asia, 6.3% from Central and South America, and 2.8% from the Middle East. Nearly two-thirds of the respondents were over age 40, and 70% were male. Almost 30% held doctorate degrees; 38.5% held Master’s degrees. The respondents were split between managers of people (52.3%) and individual contributors (47.7%).

	The respondents had a range of experience in the bio/pharma industry; 25.5% had less than 10 years of experience, 33% had 10–20 years, 33% had 20–35 years of experience, and 8.5% have worked in the industry for more than 35 years. More than half of the respondents (53.4%) worked in other industries besides bio/pharma for less five years.


	While reported workloads remain stable or decreased slightly compared to 2014, most respondents are working more hours than they are contractually obligated. In 2015, 60.7% of the respondents reported an increased workload, down slightly from the reported 62.5% in 2014 and 63.4% in 2013. More than one-third of the respondents (36.4%) say they worked more hours in 2015 than two years ago, similar to responses in 2014. Business increases without staff increases (61.9%), increased regulatory pressure (41.4%), and exploring new technologies (32.5%) were the leading reasons for increased workloads.

	While more than 56% of the respondents reported they are contracted to work approximately 40 hours per week, only 22.4% report working 40 hours. Approximately one-third (34%) are contracted for more than 40 hours per week; more than 70% of the respondents say they work 40 or more hours per week.


	In 2015, compensation discontent continued to increase with almost 62% reporting dissatisfaction with their salaries; more than 41% of the respondents said they were paid at the low end of the salary range for their job function for their expertise and responsibility; nearly 21% said they were paid below market value. In 2014, 57.2% said they were paid at the low end or below market value; 54.6% reported similar dissatisfaction in 2013.

			Rate your satisfaction with your current salary.			

					I am paid excessively for my level of expertise and responsibility.

					I am paid fairly for my level of expertise and responsibility.

					I am paid within market value for my job function, but at the low end of the range, considering my level of expertise and responsibility.

					I am paid below market value, considering my level of expertise and responsibility.

	Fewer pay increases may contribute to the dissatisfaction. In 2015, 53.5% reported a salary increase; a drop from the 61.4% of respondents reporting increases in 2014 and 63.4% in 2013. Nearly two-thirds reported receiving a cash bonus in 2015, however, up from about 50% of those responding in 2014.

	Despite the unhappiness with compensation, a strong majority of respondents said their work is fully valued by their employer (34.4% strongly agree; 49.1% agree). Nearly three-quarters (73.6%) agreed or strongly agreed that their job was secure.


	The bio/pharma industry demands specialized knowledge and skills, but respondents were mixed in evaluating the types of training offered by employers. Nearly 80% agreed or strongly agreed that their company provided adequate training for basic job skills.

	Nearly 43%, however, felt their companies did not provide advanced training for employee professional growth. A similar number (42.1%) do not feel there is room for career advancement in their present companies; nearly 40% do not feel there are opportunities for professional development. Still, 82.5% agreed or strongly agreed that they were using their skills and training to the fullest extent.

	More respondents in 2015 (55.8%) agreed somewhat or strongly that they would “like to leave their job, given the opportunity,” up from 49.2% in the previous year. A majority of respondents (62.4%) plan to stay with their positions next year, compared with 64.9% in 2014.

	More than 21% of the respondents, however, agreed or strongly agreed that they would like to change careers and leave the bio/pharma industry.

	Confidence levels of those seeking new positions within the industry in 2015 were similar to the 2014 responses; 18.5% said it would be straightforward to find a comparable new job; nearly half said it may take a while, but they would be able to find a comparable position. Of the less optimistic responses, 16.1% said it would be straightforward to find a job, but it probably would not be as good as the current position; and almost 19% anticipated a difficult search and they would have take the position that was available.

			If it were necessary for you to change jobs this year, how would you assess the job market?			

					It would be straightforward to find a job comparable to the one I have now.

					It would take a while, but I would be able to find a job comparable to the one I have now.

					It would be straightforward to find a job, but it probably wouldn't be as good as the one I have now.

					I would have to search hard and be prepared to take what I could get.


	The survey results revealed many similarities between the small-molecule and large-molecule market segments, such as confidence in job security; however, some differences stood out.

	Respondents from the large-molecule segment reported longer work experience in the bio/pharma industry; 83.3% reported more than 10 years of experience compared with 72% for small-molecule segment workers.

	While the majority of workers in both segments are contracted to work 40 hours per week, a greater percentage of workers in the large molecule segment report working more than 40 hours per week (83.3% vs. 70% for small molecule segment). More biologics- segment workers (22.6%) did report, however, that they worked fewer hours in 2015 than they did two years ago, compared with the small-molecule segment (11.4%).

	On compensation, the small-molecule segment respondents were more satisfied than their counterparts in the biologics segment. Nearly 40% of the small-molecule workers said they were paid fairly, compared with 31.5% in the large-molecule segment. Nearly 28% of the biologics segment respondents-compared with 16.5% of the small-molecule segment-said they were paid below market value, considering their level of expertise and responsibility.

	In general, workers in both segments agreed that their work is valued by their employers, they feel secure in their positions, they do not face discrimination at work, and have opportunities for advancement. The biologics segment workers, however, were slightly less positive in responses about using their skills and training to the fullest extent and saw fewer opportunities to engage in professional development.

	Despite these slightly negative opinions, biologics-segment workers were more positive than the small-molecule counterparts about remaining in their present positions; only 16.7% said they would like to leave their job, if given the opportunity; 37.8% said they do not expect to leave their job in the coming year.


	1. US Bureau of Labor Statistics, Labor Force Statistics from the Current Population Survey, http://data.bls.gov/timeseries/LNS14000000, accessed Nov. 16, 2015.
	2. 2015 

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

: 
	When referring to this article, please cite it as R. Peters, “Mapping a Career Path Forward in Bio/Pharma,” 

Bio/pharma employee dissatisfaction with pay and progress may direct some to new career pathways.

Mapping a Career Path Forward in Bio/Pharma

Bio/pharma employees based in Europe worked more hours in 2015, received fewer salary increases, and expressed a greater desire to change jobs than in previous years. While they were optimistic about the prospects of finding a new position, the majority of those surveyed said they would most likely stay in their current position.

 annual employment survey (1) reported similar opinions about the employment market as the 2014 survey (2), and also expressed more desire to seek better pay and career opportunities. Confidence in job security slipped in 2015; 13.4% said they felt more secure now than they did last year. In 2014, 16.4% felt more secure than in 2013. Approximately the same percentage felt less secure (29.4%); the percentage of those reporting no change (57.1%) rose slightly. The number of respondents reporting that their company experienced a merger, acquisition, or restructuring was 54.8%, up from 45.1% in 2014. More than half said the change had no significant effect on their work.

	Intellectual stimulation, challenging projects, a good work/life balance, and relationships with colleagues were the most frequently cited as “the main reason I come to work.” Intellectual challenge, professional advancement, a good work/life balance, and salary were the most frequently cited reason for “I would change jobs for this alone.” Low pay, however, was the single greatest factor identified for quitting a job.


	Bio/pharma professionals from around the globe responded to the 2015 survey, which was fielded in September and October 2015. Nearly one-third (29.2%) of the respondents were from innovator bio/ pharmaceutical companies; 25.6% were from genericdrug manufacturing companies. Representatives of contract research and manufacturing organizations (15.3%), academic institutions (11%), and other industry segments also were represented. A greater percentage of respondents from Europe work for companies that develop or manufacture small-molecule drugs only (41.9%), compared to the global audience (33.6%); however, a smaller percentage of respondents work for companies that manufacture biologics (7%) compared to the global audience (11.5%). In addition, a greater percentage of respondents (57.1%) are employed at privately held companies compared to the global audience of respondents.

	Research/development/formulation (21.9%) and quality control/assurance and validation (16.1%) job functions were the top selections, followed by corporate management (10.2%) and production/manufacturing/ operations (5.8%). Other top functions included consulting, professor/ instructor, regulatory affairs, and technical services/analytical development, process development, engineering, and tech transfer. More than two-thirds of the respondents were over age 40, and 68.7% were male. More than one-third held doctorate degrees; 40.3% held Master’s degrees. The respondents were split between managers of people (54.5%) and individual contributors (45.5%). The respondents had a range of experience in the bio/pharma industry; 25.8% have less than 10 years of experience, 32.3% have 10–20 years, 31.6% have 20–35 years of experience, and 11.3% have worked in the industry for more than 35 years. More than half of the respondents worked in other industries for less five years.


	While reported workloads remain stable or decreased slightly compared to 2014, most respondents are working more hours than they are contractually obligated. In 2015, 55.5% of the respondents reported an increased workload, down from the reported 61.8% in 2014 and 65.5% in 2013. More people are working more hours; 30.8% of the respondents say they worked more hours in 2015 than two years ago. In 2014, 26.4% said they worked more hours than the previous two years. While nearly two-thirds (64.9%) of the respondents reported they are contracted to work approximately 40 hours per week, only 32.3% report working 40 hours. While 16.5% said they are contracted to work more than 40 hours per week, a far greater percentage, 61.7% of the respondents, say they work 40 or more hours per week.


	Europe-based bio/pharma workers were slightly more satisfied with their compensation this year, although 57.5% do not feel they are paid fairly. In 2015, 44.9% said they were paid at the lower end of market value, given their expertise and responsibility; in 2014, 31.3% graded their compensation at this level. In 2014, however, 28.8% said they were paid below market value; in 2015, only 12.6% reported pay below market value.

Rate your satisfaction with your current salary.

	Respondents reported fewer pay increases; in 2015, 33.9% reported a salary increase; a drop from the 41.3% of respondents reporting increases in 2014. The percentage is significantly lower than the 53.5% of global respondents who reported a salary increase for 2015.

	Despite the mixed opinions about compensation, a strong majority of respondents said their work is fully valued by their employer (30.3% strongly agree; 52.5% agree). Nearly 70% agreed or strongly agreed that their job was secure.


	More than two-thirds agreed or strongly agreed that their company provided adequate training for basic job skills. Nearly 41%, however, felt their companies did not provide advanced training for employee professional growth; a similar number (44.4%) do not feel there is room for career advancement in their companies. More than one-third (35.8%) do not feel there are opportunities for professional development. Still, 83.6% agreed or strongly agreed that they were using their skills and training to the fullest extent.

	The survey respondents were not impressed with the expertise and training of industry newcomers. Three-quarters said the new hires were adequately trained, but not exceptional; 15.6% said the new hires were poorly trained. Only 6.3% said new hires were extremely well trained to do their jobs. Compared to 2014, more respondents in 2015 (55.3%) agreed somewhat or strongly that they would like to leave their job, given the opportunity,” up from 43.5% in the previous year. Despite the desire, however, a majority of respondents (60.1%) plan to stay with their positions next year, similar to opinions in 2014.

	More than 21% of the global audience respondents agreed or strongly agreed that they would like to change careers and leave the bio/pharma industry. Workers in the European market were slightly more content; only 16.3% would consider a move to a new industry.

	Confidence levels of those seeking new positions within the industry in 2015 were more positive than the 2014 European-market responses and the 2015 global audience responses. Of the European audience, 25.6% said it would be straightforward to find a comparable new job, compared to 18.5% of the global audience responses; 42.7% said it may take a while, but they would be able to find a comparable position.

If it were necessary for you to change jobs this year, how would you assess the job market?

	Of the less optimistic responses, 12.8% of the European audience said it would be straightforward to find a job, but it probably would not be as good as the current position; and almost 19% anticipated a difficult search and they would have to take the position that was available.

	This article was originally published in 

 When referring to this article, please cite it as R. Peters, “Facing Crucial Career Choices,” 

Intellectual challenge, job security, and opportunity for advancement contribute to employee happiness, but the ultimate prize may be a satisfactory salary for bio/pharma employees in Europe.

Facing Crucial Career Choices

	The 2015 CPhI Worldwide exposition was held in Madrid, Spain in mid-October and showcased a variety of new products and services in the pharmaceutical industry. During the event, technologies, systems, and services that present new, innovative options for drug manufacturing, formulation and process development, APIs and excipients, packaging, supply chain and logistics, leadership, and outsourcing were recognized with CPhI Pharma Awards.

	This year, the judging panel reviewed a record number of applications, considering the technologies, features, and innovations provided by the entries, as well as the impact the technology or service has on the pharmaceutical development and manufacturing industry. The 16 finalists gave presentations on the first day of CPhI Worldwide, and the judges, after extensive deliberations, announced the winners at a ceremony held Tuesday, Oct. 13.

	Innovation can be defined many ways. Steve Jobs, Apple founder, has been quoted as saying “Innovation distinguishes between a leader and a follower.” Thomas Edison, one of the most prolific inventors, is quoted as saying genius is “one percent inspiration and ninety-nine percent perspiration.” The finalists for the 2015 Awards demonstrated the desire to lead, the inspiration to improve a product or process, and the willingness to invest hard work to achieve their goals.

	The pharmaceutical industry faces many scientific, technical, regulatory, and business challenges. The companies that provide materials, equipment, instruments, and services to the pharmaceutical industry play a vital role in overcoming these hurdles. The award finalists and winners should be commended for their efforts to accelerate the development and manufacture of safe, effective, cost-efficient therapeutics.

		Best Innovation in Supply Chain & Logistic Management: TraceLink

		Best Innovation in Manufacturing Technology-in cooperation with 

		Best Innovation in APIs and Excipients: OMYA International AG

		Excellence in Partnering & Outsourcing-in cooperation with 

		Best Innovation in Process and Formulation Development: Catalent

		CEO of the Year-in cooperation with Pharma Boardroom: Vivek Sharma, CEO-Pharma Solutions, Piramal Enterprises Ltd


	Scott V.W. Sutton, a consultant, frequent author and speaker on microbiology topics, and Pharmaceutical Technology Editorial Advisory Board member, died suddenly on Oct. 19, 2015. He was owner of The Microbiology Network, a consultancy for contamination control, environmental monitoring, microbiological control, and lab operations issues.

	During his 30-year career, Sutton worked at Vectech Pharmaceutical Consultants, Alcon Laboratories, and Bausch & Lomb. He was the recipient of the 2008 PDA Distinguished Author Award and the 2012 IVT Journal of GXP Compliance Paper-of-the-Year Award.

	Sutton was active in industry organizations, serving on the 2010-2015 revision cycle on the United States Pharmacopeial Convention (USP) Committee of Experts, Microbiology and Sterility Assurance and as a member of the USP project team 18 (PAT); Working Group 6 (Rapid Microbiology Methods). He also was active in the Parenteral Drug Association. In addition, Sutton was a frequent author on a range of topics including compounding pharmacies, contamination control, environmental monitoring, objectionable organisms, QC microbiology testing, QC microbiology lab operations, and USP.

	Memorial contributions may be made to the Scott Sutton Memorial Fund, PO Box 193, North Chili, NY 14514.

: 
	When referring to this article, please cite it as R. Peters, “Industry Suppliers Honored for Innovative Advances,” 

The CPhI Pharma Awards celebrate innovations in the pharma industry.