Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Rita C. Peters

	In late February 2019, the Senate Finance Committee called CEOs of major bio/pharmaceutical companies to Washington, DC to testify about the cost of prescription drugs. Following the pattern of previous meetings, elected officials bemoaned the cost burden on patients and the bio/pharma executives played up the expense of developing new drugs and a complicated payment system.

	For all the spectacle, expectations for real change are only slightly higher than in the past. Potential solutions under discussion include allowing Medicare to negotiate drug prices; controlling prices based on what is charged in other countries; allowing patients to import drugs from Canada; and eliminating pay-for-delay strategies that discourage generic-drug competition.

	Another solution is to bring more generic drugs to market. In recent years, FDA has accelerated the approval of generic drugs and stepped up education efforts to increase the quality of abbreviated new drug applications.

	The basic economic premise that increased competition will lead to lower product costs, however, does not always prove true for the pharma industry. Lower drug prices mean lower margins; convincing manufacturers to produce low-margin drug products-while maintaining quality standards-is not easy. Recently, prices for some generic drugs in short supply have been hiked significantly because the generic-drug manufacturer knew they had no competition.

	In response to high prices and drug shortages, a consortium of hospitals launched their own drug manufacturing company; legislation called for the federal government to manufacture or contract for the manufacture of generic drugs if the market cannot-or will not-provide drugs at affordable prices (1); and FDA announced a Competitive Generic Therapies pathway to encourage development of generic versions of branded drugs that are off patent but have no generic alternatives (2).

	Despite 15 approved biosimilar drugs and 60 in development, adoption of lower-cost biosimilars has been delayed, often due to legal tactics of innovator companies. In a December 2018 statement, FDA promised, “We’re not going to be partners to these deceptions,” and issued guidance documents designed to promote competition for biologic drugs, such as insulin (3).

	Perhaps the greatest consequence of cheaper generic drugs is that lower quality products may be entering the supply chain. Recent news reports (4–7) have detailed quality issues associated with generic-drug manufacturing in the United States and abroad, questioned how the drug industry conducts investigations and inspections, and highlighted failures of self-policing efforts by drug manufacturers. FDA responded with a rigorous defense of its oversight activity and the safety of generic drug products (8).

	Despite the debate, patients are left to consider if they are paying a price in questionable safety and quality when they demand affordable drugs.

	1. S.3775, US Senate, 115th Congress, 2nd session (Washington, DC), Dec. 18, 2018.
	2. FDA, 

Competitive Generic Therapies, Guidance for Industry

, Draft Guidance (CDER, February 2019).
	3. FDA, “Statement from FDA Commissioner Scott Gottlieb, M.D., on New Actions Advancing the Agency’s Biosimilars Policy Framework,” Dec. 11, 2018.
	4.  S. Lupkin, “

America’s Love Affair with Cheap Drugs Has a Hidden Cost

How a Tainted Heart Drug Made in China Slipped Past the FDA

, Jan. 30, 2019.
	7. A. Altstedter and A. Edney, “

Culture of ‘Bending Rules’ in India Challenges U.S. Drug Agency

, Jan. 31, 2019.
	8. FDA, “Statement from FDA Commissioner Scott Gottlieb and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, on the FDA’s Continuing Efforts to Maintain Its Strong Oversight of Generic Drug Quality Issues Domestically and Abroad,” Feb. 22, 2019. 

	When referring to this article, please cite it as R. Peters, “Caught in a Conundrum," 

Articles

Do patients get what they pay for when they demand cheaper drugs?

Caught in a Conundrum

	An annual report from the IQVIA Institute for Human Data Science Study (1) predicts slower growth in drug spending, outlines the need for technology adoption, and warns about implications for emerging therapies and policy decisions. The report, issued in late January 2019, noted that global drug spending reached $1.2 trillion in 2018 and is expected to top $1.5 trillion by 2023. While spending is predicted to continue to grow, the increase will be at a slower pace than previous years. The projected 2023 spending level, up 50% from 2016, will be accomplished despite lower growth of 3–6% on an annual compound basis compared to 6.3% over the past five years.

	The United States and pharmerging markets will drive growth over the next five years with 4–7% and 5–8% compound annual growth, respectively, the study reports. However, growth in the top-five European markets will be 1–4%, compared with 3.8% in the past five years; Japan’s predicted topline growth is -3–0%. Growth in China is expected to slow to 3–6%.

	Through 2023, IQVIA expects FDA to approve, on average, 54 novel drugs per year, up from an average of 46 drugs in the past five years. The annual average spending in developed markets on new brands is expected to rise slightly to $45.8 billion in the next five years.

	Patent expirations, generic and new drug competition, and drug pricing pressures will contribute to slower growth, however. Competition from biosimilars in 2023 is predicted to be three times the level it is today; and half of spending on medicines will be for specialty drug products. Net manufacturer revenue will grow at 2–3% in 2019, down from a high of 10.3% in 2014.

	The loss of exclusivity of branded drug products is forecasted to be $31.5 billion in developed markets in 2019; the forecast impact through 2023 is $121 billion, including almost $17 billion for biologics. In the US, the impact will be $95 billion through 2023, with $15.8 billion for biologics.

	The US will continue to lag other developed markets in adoption of biosimilars; however, the report authors expect US policymakers to push for more biosimilar adoption by addressing reimbursement policies, perhaps in time for adalimumab biosimilars in 2023.

	The report also identified key factors that will influence healthcare costs including the use of machine learning and artificial intelligence to identify drug targets and monitor clinical trials, use of real-world evidence in clinical trials, a greater voice for patients in the development and administration of drugs, and pricing reforms. Other predictions include the following:

	Large pharma companies will increase investment in technologies and operational efficiencies.

	Emerging biopharma companies will represent a greater share of new drug launches. Big pharma companies will partner with smaller companies rather than acquiring them.

	Next-generation therapeutics will offer clinical benefits; however, high list prices, small patient populations, bioethical questions surrounding gene editing, and limited manufacturing capacities may dampen growth, resulting in only five to eight approvals in the next five years.

	New approaches to-and investment in-treatments for neglected tropical diseases will be sponsored by international organizations and philanthropic organizations.

	A seven-year decline in prescription opioid use in the US will continue, resulting in prescription declines of one-half to one-third the current level measured in 2018.

	Prescription digital therapeutics are a new emerging treatment modality and could be applied in areas where drug therapy alone has left unmet needs, such as behavioral health and cognition. Digital developers may seek partnerships with pharmaceutical companies.

The Global Use of Medicine in 2019 and Outlook to 2023: Forecasts and Areas to Watch

	When referring to this article, please cite it as R. Peters, “As Drug Spending Slows, Investment Must Pick Up," 

Biosimilars, pricing strategies, and technology will influence growth in spending on drugs. 

As Drug Spending Slows, Investment Must Pick Up

	Good news about a record-setting number of new drug approvals in 2018 was tempered by financial and political pressures external to the industry. Questions on Bio/Pharma’s 2019 agenda include pressure to lower drug prices and contain costs, and deal with a volatile investment market and contentious federal government.   

	In an annual GlobalData outlook report (1), 51% of respondents said drug pricing and reimbursement constraints will have the greatest negative impact on the pharmaceutical industry in 2019. While some drug companies self-imposed price freezes in 2018-under pressure from the Trump Administration and Congress-many kicked off 2019 with price increases for more than 100 drugs averaging 6.3%.

	The investor market resembled a roller coaster in 2018, ending on a downward trend. The Vantage 2019 Preview report (2) said it was difficult to predict how much further the market may fall, and those interviewed for the report expected a more volatile year.

	Companies looking for funding will have to work harder in 2019, but the report says financing options are not expected to dry up. While there is enthusiasm over new therapies, these products must prove commercial success to maintain investor interest in biologic products, the report said.

	A Deloitte report (3) in mid-2018 said the majority of US companies were interested in investing in R&D, business operations, and capital projects, including some US operations, as a result of the corporate tax reforms of the Tax Cuts and Jobs Act enacted in December 2017. The bio/pharma executives surveyed said they were likely or very likely to invest in R&D (67%), capital projects (57%), general business operations (50%), share buybacks (50%), and M&A (42%). Lower priority investments were compensation/pension funding (40%) and hiring (40%).

	The 2016 presidential election and tax reform debate of 2017 put some mergers and acquisition activity on hold, according to the Deloitte report; however, deals picked up in the first half of 2018.

	In three weeks spanning the end of 2018 and start of 2019, several large deals were reported. Pfizer and GlaxoSmithKline announced on Dec. 19, 2018 that the companies will merge their consumer healthcare products businesses and form a separate consumer-focused company. On Jan. 7, 2019, Eli Lilly announced an agreement to acquire Loxo Oncology for $8 billion. And, in one of the largest pharma acquisitions ever, Bristol-Myers Squibb announced on January 3 that it will acquire Celgene in a cash and stock transaction valued at $74 billion. 

	While the pharma industry-and the rest of the nation-awaited a resolution to the partial government shutdown, a white paper (4) based on input from seven former FDA commissioners, recommended FDA be reconfigured as an independent federal agency. A new structure is needed, they argued, to promote science-based decisions, increase transparency, streamline processes for developing regulations and guidance documents, and allow for more responsive and predictable decision making.

	The white paper stopped short of recommending a new model for agency operations but defined several major shortcomings of current operations. With federal government operations on hold over political squabbling, it was nice to see constructive efforts to address what ails the industry.

The State of the Biopharmaceutical Industry–2019

, January 2019.
	2. A. Brown, J. Gardner, and E. Elhmirst, 

, December 2018.
	3. D. Green, M. Zellars, and C. Chang, “Life Science Companies More Bullish on US Investment Post Tax Reform,” 

 Seven Former FDA Commissioners Recommend: FDA Should be an Independent Federal Agency

	When referring to this article, please cite it as: R. Peters, “Internal and External Challenges to Pharma in 2019,"

Pricing pressures, investment volatility, and government disfunction greet Pharma in 2019.

Internal and External Challenges to Pharma in 2019

 article noted a pharmaceutical industry “secret;” as the industry develops “futuristic new drugs, its manufacturing techniques lag far behind those of potato-chip and laundry-soap makers” (1). Since the article was published, the introduction of quality-by-design practices, new monitoring technologies, and advances in science and engineering have improved some bio/pharma manufacturing processes. In too many cases, however, manufacturing and quality practices are still inadequate or too expensive.

	The number of drugs approval by FDA-as well as innovative “firsts” designed to address patient needs-accelerated in the past two years. Following the 2017 approvals of the first cell therapies and gene therapies, 2018 saw the approval of new treatments for infections, the first novel antiviral treatment for the flu in 20 years, the first drug with an indication for treatment of smallpox, the first non-opioid treatment for the management of opioid withdrawal symptoms, and the first drug that contains a purified drug substance derived from marijuana.

	The upswing in approvals of novel therapies indicates that bio/pharma companies are embracing innovation in R&D. However, analysts report that R&D efforts show diminishing returns. And, the ongoing pace of FDA warning letters, observations, recalls, and drug shortages demonstrates that the bio/pharma industry still has work to do to achieve efficient, cost-effective manufacturing, quality, and analysis to ensure a safe, sufficient drug supply.

	A Deloitte/GlobalData study (2) reported that R&D returns at 12 Big Pharma companies hit 1.9% in 2018, the lowest level in nine years, down from 10.1% in 2010. Costs to bring a biopharmaceutical drug to market have almost doubled since 2010 from $1.18 billion to $2.18 billion while forecast peak sales per asset have fallen from $816 million in 2010 to $407 million in 2018, the report notes.

	Four small, specialized biopharma companies analyzed for the report fared better than the Big Pharma companies with returns on R&D of 9.3%. Higher development costs ($2.8 billion) were offset by higher anticipated sales ($1.17 billion).

	In light of ongoing criticism of the high cost of drugs, raising prices may not be the answer; bio/pharma companies need to find innovative ways to improve efficiencies.

	In 2016, the number of warning letters issued by FDA for good manufacturing practice infractions doubled and maintained that high level in 2017 and 2018. The number of drug products recalled by FDA’s Center for Drug Evaluation and Research (CDER) has declined in the past two years; however, the number of recall events increased to the second highest level in the past 10 years (3). While efforts over the past five years have cut the number of new shortages from 251 in 2011 to 35 in 2017, as of Jan. 3, 2019, FDA listed 114 drugs as “currently in shortage” and 207 as discontinued (4).

	Two examples demonstrate the implications of substandard quality and ineffective drug manufacturing on patients and company bottom lines.

	Recalls of angiotensin II receptor blocker (ARB) drug products from multiple manufacturers-due to the presence of probable human carcinogens traced to API manufacturers-were launched in 2018 and continued in early 2019. As the recalls widened, regulatory authorities around the world scrambled to identify the root cause of the impurities and implications for patients.

	Frustrated with the high cost and chronic shortages of medicines used in hospitals, seven health organizations representing 500 US hospitals formed Civica Rx, a not-for-profit generic drug company; the new organization plans to manufacture drugs for use by patients at the member hospitals. In September 2018, the company announced that it has identified 14 hospital-administered generic drugs and will either directly manufacture generic drugs or sub-contract manufacturing to contract manufacturing organizations (5).

	The Deloitte study authors stressed the need for a “transformational change” in R&D productivity that uses technology-artificial intelligence, robotic process automation, natural language processing and generation, and machine learning-to replace or augment work done by humans. Partnerships, collaborations, and non-traditional operational models will be necessary to compete in a digital environment and companies will have to compete with non-pharma organizations for the technical talent needed to operate a digitally-driven company.

	Many of the predicted applications of information technology focus on drug discovery, clinical trial, and patient monitoring applications. There are, however, opportunities to adopt other new technologies for drug formulation, process development, manufacturing, and supply chain phases.

	Advanced manufacturing technology needed

	While bio/pharma companies have demonstrated success at turning out new therapies, the uptake of advanced manufacturing technologies to produce these products, or better ways to manufacture existing products, has been slower.

	Manufacturing issues, delays or capacity issues, and loss of manufacturing site account for two-thirds of the causes of drug shortages, FDA reports (6). Capital costs, lost production time for retrofitting, and the need for regulatory review for process changes deter some companies from investing in new technologies for established product lines. For new drug products, the race to get the drug to market is incentive to stick to proven technologies that may not be efficient or cost-effective in the long term.

	Some advanced manufacturing technologies-such as continuous manufacturing for solid-dose drugs, 3D printing of drug products, and single-use bioreactors-have demonstrated effectiveness. Recent FDA approvals of continuous manufacturing processes for oral solid-dose drugs has spurred interest and innovation for advanced manufacturing processes. The Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) at Rutgers University (NJ) works with industry and FDA to modernize pharmaceutical manufacturing processes focusing on continuous processing with predictive control and the next generation of dosage forms.

	“There is a lot of technology out there, but the largest challenge remains in bringing it all together in a timely and cost-effective manner,” says Douglas B. Hausner, associate director of C-SOPS. “This is a challenge with modern advanced methods that have greater complexity and require greater upfront effort and investment to then run smoothly thereafter. Much of this pertains to software, sensor, and control integration. Some companies are looking to form partnerships and ‘pre-integrate’ where possible to minimize this.”

	Many technological advances and materials are needed to reduce the costs of biopharmaceutical manufacturing, says Ruben G. Carbonell, chief technology officer at the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a public-private partnership that advances biopharmaceutical manufacturing innovation and workforce development. In-line process analytical technology (PAT) for product quality and process control is one of the areas of greatest need, to enable continuous and hybrid processes, he says.

	Automated bioreactors and purification processes for cell-therapy manufacturing; rapid adventitious agent (AA) detection and novel materials for viral clearance; and other technologies to reduce release times for biotherapeutics are other areas of need, he says. The availability of advanced technologies does not necessarily mean they are widely adopted, however. For example, “significant advances are being made in rapid AA detection utilizing next generation screening that are yet not being broadly throughout the industry,” Carbonell explains.

	The equipment, instrument, or process-related steps that bio/pharma should take to improve development and manufacturing varies from organization to organization based on a number of factors, Hausner says. “In general, though, for powder-based manufacturing, an investment in physical property characterization coupled with advanced data analytics of the resulting data can greatly improve organizational familiarity with ingredients and what works for various applications. This enables organizations to gain formulation manufacturability experience, which is additive, and can greatly expedite process development over time.”

	Bio/pharma companies operate in a regulated environment and face pressures to control end-product prices while driving investor return on costly R&D efforts. The tendency to take a conservative approach to the adoption of new technologies or materials is not surprising.

	“There are significant efforts within large biopharma companies and suppliers in the testing and evaluation of novel approaches to cost-effective manufacturing,” says Carbonell. “Adoption of these technologies has been slow because of perceived risks of not being approved for new products or processes.”

	Hausner notes that when assessing new technologies or processes to advance drug production, companies are initially cautious and calculated, skeptical of regulatory acceptance, followed by enthusiasm and looking for rapid solutions and regulatory clarity.

	“Given the significant costs associated with biopharmaceutical products, it is not surprising that biopharma companies take a conservative approach to innovation because they strive to ensure acceptance by regulatory agencies,” says Carbonell. “One of the main barriers to adoption of new technologies is indeed the perceived risk of not achieving regulatory acceptance. The biopharma industry, manufacturers and suppliers, should work side by side with regulatory agencies to evaluate new technologies to ensure rapid adoption.”

	“There is the obvious financial cost/benefit and the fact that unknowns and unproven tech are always harder, but beyond this it often seems to come down to organizational readiness,” says Hausner. “Many new technologies are complex and require additional expertise often in the form of new hires or at least vendor/consultant relationships. There needs to be true organizational buy in for an advanced integrated technology. It can be much closer to buying or building a new plant than a new piece of hardware like a tablet press.”

	FDA actively encourages the adoption of advanced manufacturing processes. In 2014, the agency initiated an Emerging Technology Program, which enables meetings between drug development companies and FDA Emerging Technology Team members to address potential concerns about a novel technology prior to filing a regulatory submission.

	While the agency has issued guidance on emerging technologies and promotes the adoption of advanced technologies at industry meetings., a broader effort by the agency is needed, wrote FDA Commissioner Scott Gottlieb in a July 2018 blog (7).

	“The bottom line is this: drug makers won’t switch to these systems until we create a clear path toward their adoption and provide more regulatory certainty that changing over to a new manufacturing system won’t be an obstacle to either new or generic drug approvals,” wrote Gottlieb. “The FDA recognizes that it’ll require additional investment in policies and programs that’ll provide regulatory clarity to enable these new methods to be more quickly and widely adopted.”

	The fiscal year 2019 budget includes $58 million to accelerate the development of the regulatory and scientific architecture, Gottlieb wrote. In August 2018, the agency issued nearly $6 million in grants to Rutgers University, the Massachusetts Institute of Technology, and the Georgia Institute of Technology to study improvements to continuous manufacturing, monitoring, and control techniques (8). An additional $2.4 million in grants were awarded to six universities to investigate improvements to continuous manufacturing for biologic-based drugs (9).

	Increased transparency by regulatory authorities about review and enforcement processes could inform other bio/pharma companies about potential pitfalls in development or manufacturing processes. The need for confidentiality and protection of trade secrets, however, restricts information that can be released.

	FDA warning letters disclose a limited amount of information about violations. Observations reported on Form 483 documents often are not revealed. Issues noted in complete response letters are rarely publicized. And, pharma companies have released information about clinical trials that was contrary to FDA findings (10). The FDA commissioner has authority under 21 Code of Federal Regulations 20.82 to disclose records under certain circumstances, but rarely does.

	Although the complexities of drug manufacturing may exceed that of other industries-including snack foods and laundry soaps-can bio/pharma learn from other industries about adopting new technologies?

	“I would like to say yes, but in my experience the answer is no. The difference in how bio/pharma develops products with clinical trials and is regulated relative to most other industries makes a big difference,” said Hausner. “In other industries, it is much easier to try other technologies, but this is more costly and more risky in pharma. What results is the need for some sort of perceived advantage in order for the cost/benefit analysis to work, and this often comes in the form of regulatory acceptance, exclusivity (biosimilars), expedition (breakthrough designation), etc.”

	Pre-competitive efforts have paid off in other industries, explained Carbonell. “Years ago, the microelectronics industry created large, pre-competitive non-profit consortia of manufacturers, academic and research institutions, and government agencies to evaluate new technologies, such as SEMATECH, to standardize and harmonize equipment, connectors, and measurement devices and approaches,” he said. “These efforts played a key role in reducing costs and advancing the chip manufacturing industry in the US.”

	“Pre-competitive industry organizations play a major role by helping to inform the public consensus on new technology. This aids in regulatory understanding, acceptance, and approval,” said Hausner. “These groups perform a soft harmonization on technology and nomenclature ahead of more official groups like regulatory bodies and standard-setting organizations.”

	“Industry-university-non profit-government consortia such as NIIMBL can play a key role in accelerating the adoption of novel manufacturing approaches. New technologies that show promise in the laboratory can be tested and de-risked in an industrial setting taking into account regulatory expectations,” said Carbonell. “These consortia reduce the costs of technology development and significantly reduce the risk to an individual company of developing a new approach that may not be approved because it is not broadly accepted.”

	Contract services organizations play a key role in developing and manufacturing drugs; in 2014, the Pharma & Biopharma Outsourcing Association (PBOA) was formed to represent drug industry contract manufacturing organization/contract development and manufacturing organizations (CMO/CDMO).

	“PBOA has worked with a cross-industry consortium on FDA’s Quality Metrics guidances, providing feedback from a CMO/CDMO perspective about this well-intended but potentially damaging program,” says Gil Roth, president of PBOA. “We’ve also worked with FDA’s serialization team and their new drug shortages task force.”

	In 2019, PBOA will continue work on drug shortage issues, the implementation and rollout of the Drug Supply Chain Security Act and other regions’ serialization laws. In addition, Roth says, they plan to educate FDA about the potential drawbacks of its quality metrics program and address state and local bio/pharma laws that may impact CMO/CDMOs.

	1. L. Abboud and S. Hensley, “New Prescription for Drug Makers: Update the Plants,” 

, Sept. 3, 2003.
	2. M. Steedman, et. al., Unlocking R&D Productivity. Measuring the Return from Pharmaceutical Innovation, Deloitte, 2018.
	3. FDA, 

.
	5. Civica Rx, “Not-for-Profit Generic Drug Company Officially Established, Attracts Interest of More Than 120 Health Organizations,” Press Release, Sept. 6, 2018.
	6. FDA, 

FDA Budget Matters: Investing in Advanced Domestic Manufacturing

FDA Supports Critical Research to Spur Innovation for Continuous Manufacturing Technology to Support and Advance Drug and Biologics Development

FDA Awards Grants to Foster Innovation for Advanced Manufacturing Technology as Part of the Agency’s Efforts to Ensure a Robust and Reliable Supply of Biological Products

, Sept. 20, 2018.
	10. J. Sharfstein, et. al., 


	Vol. 43, No. 1
	January 2019
	Pages: 16–23

	When referring to this article, please cite it as: R. Peters, “Bio/Pharma Needs Ideas and Incentives to Advance Manufacturing, "P

While pharma is proving its capabilities to develop novel therapies, the industry still needs to work on manufacturing innovation.

Bio/Pharma Needs Ideas and Incentives to Advance Manufacturing

The bio/pharma industry has found itself under the microscope as executives search for answers to criticisms about high drug prices, shortages of vital therapies, and the industry’s role in the opioid epidemic. Meanwhile, a record number of new drug approvals and the emergence of innovative therapies demonstrate the potential of bio/pharma R&D efforts.

	Bio/pharma development and manufacturing relies on skilled and knowledgeable workers. Hiring and retaining this expertise should be a top priority. With the unemployment rate at record lows, career opportunities for US-based bio/pharma employees should be promising. Insight provided by respondents to 

’s annual employment survey (1) suggests that employee satisfaction is tied to the challenges presented by the work and the employer’s potential for success. (See the infographics for an overview of survey results.)

	Salary ranked ninth on a list of 12 factors contributing to job satisfaction. Intellectual stimulation and challenging projects were the top “main reasons I come to work,” followed by supportive management, the company’s potential for success, a good work/life balance, relationships with colleagues, job security, and tolerance and opportunity for all employees. Employees based in Europe placed more emphasis on intellectual stimulation and challenging work, compared with all respondents. North America-based workers leaned more toward salary and benefits factors than the Europe-based peers.

	Nearly 80% of all respondents, however, said that short timelines and insufficient budgets and resources to accomplish a task contributed to job dissatisfaction. Nearly 70% voiced “issues with management” as a source of dissatisfaction.

	More than 335 bio/pharma professionals from around the world responded to the survey, which was fielded in November and December 2018. Respondents primarily were full-time, permanent employees (87.3% of respondents) at innovator bio/pharmaceutical companies (29.5%), generic-drug manufacturing companies (17.9%), and contract research and manufacturing organizations (16.7%).

	The represented companies develop or manufacture both small- and large-molecule drugs (48.1%), small-molecule drugs only (28.7%), biologic-based drugs only (5.2%), vaccines (3.1%), and cell therapy or gene therapies (2.1%).

	 Respondents reported a range of job responsibilities including formulation, quality control/assurance, R&D, analytical studies, process development, validation, drug delivery, and manufacturing. More than 41% of respondents work for companies with more than 1000 employees; more than 49% work for companies with fewer than 500 employees.

	Nearly 40% of the respondents held doctorate or higher degree; one-third held at least a Master’s degree. Compared with previous years, the respondents reported more experience working in the bio/pharma industry; 21.9% had fewer than 10 years of experience, 24% had 10–20 years, 42.4% had 20–35 years of experience, and 11.8% have worked in the industry for more than 35 years.

Salary dissatisfaction increased slightly compared with the 2017 survey (2). More than 20% said they were paid below market value; 38% said their pay was at the low end of the salary range for their expertise and responsibility. Just over 41% said they were paid fairly or excessively, compared with 46% in 2017.

	The most significant-and negative-survey response involved salary increases. In 2018, only 54.1% reported an increase, compared with nearly 63% in 2017. Nearly 9% reported a decrease in salary in 2018, compared with 4.7% in 2017.

	Of all respondents, 23.1% reported that they used their full allotment of vacation, personal, and sick time. Nearly 30% said they used less than half of the available time off.

	Bonuses, profit sharing, and retirement benefits were largely unchanged year over year. However, one-quarter reported an increase in the cost of health insurance.

	Fewer respondents reported increased workloads in 2018 compared with previous years. Only 56.1% reported heavier workloads in 2018, compared with 60.9% reporting increases in 2017. More than one-third of the respondents (37.8%) say they worked more hours in 2018 than two years ago, similar to responses in previous years.

	Globally, one-third of respondents said they stayed with the same employer, on average, for five or fewer years. Nearly 36% stayed for 11 or more years. US-based respondents were more mobile; more than 40% said they stayed with one employer, on average, for five or fewer years. The responses were consistent with the 2017 responses.

	Salary was the third most cited single reason for job change, trailing professional advancement and intellectual challenge. Job security and scientific opportunities were other leading reasons noted.

	Most respondents were confident they would be able to secure a job comparable to the one they currently hold; 27.4% said it would be straightforward to find a new position; 44.3% said the search would take a while.

Nearly 56% said they would like to leave their jobs, given the opportunity, up slightly from 2017 responses. Almost two-thirds said they do not expect to leave in the coming year; nearly 17% expect to leave. A similar number, 18%, said they would like to change careers and leave the bio/pharma industry, down from nearly 23% in 2017.

	Respondents were divided almost evenly when assessing the pool of qualified candidates and available job openings; 30.3% said there are few qualified candidates for open scientific/technical positions, 34.2% said there were more qualified candidates than open positions, and 35.6% said there was moderate competition for open positions. Respondents were not impressed by the skill sets or knowledge of new hires for their job function; 75.2% said the new hires were adequately trained but not exceptional; 17.8% said they were poorly trained.

	Respondents reported a slight increase in employer-provided training for basic skills compared with previous years; however, training for advanced functions declined slightly.

	Geography influences job security and business outlook

	Respondents were split on job security. Almost one-quarter of respondents said they felt more secure in their position compared with the previous year; only 19.1% felt more secure in 2017. However, 30.6% of all respondents said they were less secure, compared with 27.8% who said they felt less secure in 2017.

Geographic differences, and perhaps uncertainty created by the Brexit, resulted in a more negative outlook for business prospects by European-based respondents.

	While 52.7% of all respondents expect business to improve, fewer than 40% of European-based respondents had a positive outlook. Nearly one-quarter (22.7%) of the Europe-based respondents expect business to decline; 37.9% expect no significant change. In comparison, 17.2% of all respondents project business will decline; 30.2% expect no significant change.

	In the past two years, nearly one-third of the respondents reported that their companies had been through a downsizing or restructuring, and 18.1% experienced a merger or acquisition. Nearly 40% reported a change in responsibilities due to the changes in company structure. Only 10% said they left the company due to an acquisition, downsizing, or restructuring.

	One-quarter of the respondents said they voluntarily changed jobs in the past two years; among the reasons cited-with multiple choices allowed-were to pursue a better career opportunity (48.7%), find more challenging work (31.1%), or to seek a better work-life balance (20.3%).

2018 Pharmaceutical Technology/Pharmaceutical Technology Europe Employment Survey

2017 Pharmaceutical Technology/Pharmaceutical Technology Europe Employment Survey


	Vol. 43, No. 1
	January 2019
	Pages: 24–28

	When referring to this article, please cite it as: R. Peters, “Solving Bio/Pharma Employee Career Advancement Demands, “

Keeping valuable employees happy-and on the job-may test bio/pharma business decisions.

Solving Bio/Pharma Employee Career Advancement Demands

Editor’s Note: This article appeared in the January 2019 issue of

A career in bio/pharma can be dynamic and stressful. Scientific advances challenge formulators to develop effective drugs. Quality demands push process development and manufacturing professionals to establish, monitor, and adhere to strict standards. Business decisions pressure bio/pharma professionals to adjust research and development efforts to meet tight deadlines. And, unanswered questions about the implications of Brexit may have created uncertainty among bio/pharma professionals working in Europe.

Pharmaceutical Technology/Pharmaceutical Technology Europe

 employment survey (1) assessed satisfaction with employment conditions, salary, benefits, as well as employee perspectives on future industry and career prospects.

	Overall, the Europe-based respondents reported fewer pay increases, more salary decreases, and more concern about job security compared with peers in other areas of the world. They also expressed more interest in the type and quality of work versus financial compensation.

	In one indicator, salary ranked next to last on a list of 12 factors contributing to job satisfaction. Intellectual stimulation and challenging projects were the top “main reasons I come to work,” followed by a good work/life balance, and job security. In comparison, North America-based workers emphasized salary and benefits factors.

	Nearly 90% of the Europe-based respondents, however, said that short timelines and insufficient budgets and resources to accomplish a task contributed to job dissatisfaction; 80% said the work/life balance caused unhappiness on the job. More than 75% said “issues with management” were a source of dissatisfaction.

More than 335 bio/pharma professionals from around the world responded to the survey, which was fielded in November and December 2018. Respondents primarily were full-time, permanent employees (87.3% of all respondents) at innovator bio/pharmaceutical companies (29.5%), generic-drug manufacturing companies (17.9%), and contract research and manufacturing organizations (16.7%).

	Respondents reported a range of responsibilities including validation, quality control/assurance, analytical studies, formulation, process development, R&D, drug delivery, and manufacturing. More than 41% of respondents work for companies with more than 1000 employees; more than 49% work for companies with fewer than 500 employees.

	Nearly 40% of the respondents held doctorate or higher degrees, and 41% held at least a Master’s degree. Compared with the global audience, the Europe-based respondents had more experience working in the bio/pharma industry; 14% had fewer than 10 years of experience, 18.3% had 10–20 years, 46.2% had 20–35 years of experience, and 21.5% have worked in the industry for more than 35 years.

	The most significant-and negative-survey response involved salary increases. In 2018, only 51.1% of the Europe-based respondents reported an increase, compared with 58.7% in 2017. Nearly 11% reported a decrease in salary in 2018, compared with 2.7% in 2017.

Lower compensation levels also reflected in salary dissatisfaction, which was higher than reported in the 2017 survey (2). More than 20% of the Europe-based respondents said they were paid below market value compared with 14.7% in 2017; 38% said their pay was at the low end of the salary range for their expertise and responsibility; 41% said they were paid fairly or excessively, compared with 4.3% in 2017.

	Similar to the responses of the global audience, nearly one quarter of the Europe-based respondents reported that they used their full allotment of paid time off. Nearly 30% said they used less than half of the available paid time off. Bonuses, profit sharing, and other benefits were largely unchanged year over year.

	Workloads continued to increase, especially for those based in Europe; 61.2% of the Europe-based respondents reported increased workloads in 2018; only 56.1% of the global audience reported heavier workloads in 2018. One-third of the respondents said they worked more hours in 2018 than two years ago, similar to responses in previous years.

	Europe-based respondents stayed with the same employer longer compared with the global audience responses. Only 18.1% of Europe-based employees stayed with one employer, on average, for five or fewer years; 45% stayed for 11 or more years. North America-based respondents were more mobile; more than 33% said they stayed with one employer, on average, for five or fewer years.

	The Europe-based respondents also were more likely to stay in their current positions. Nearly 56% of the global audience said they would like to leave their jobs, given the opportunity; only 46.6% of the Europe-based respondents expressed a desire to change. More than 70% of this group said they do not expect to leave in the coming year; and less than 14% said they would like to change careers and leave the bio/pharma industry, down from previous years.

	Less than one-quarter of the Europe-based respondents cited salary as the single reason for job change; intellectual challenge, work/life balance, professional advancement, job security, scientific opportunities, and a tolerant workplace were cited as more important reasons to change jobs.

Most European respondents were confident they would be able to secure a job comparable to the one they currently hold; 23.9% said it would be straightforward to find a new position; 43.8% said felt they would find a comparable job, but the search would take a while.

	Europe-based respondents were divided in assessing the pool of qualified candidates and available job openings. While 31.9% said that employers compete for the few qualified candidates for open scientific/technical positions, 37% said there was only moderate competition for open positions. The remaining 30.8% (up from 21.6% in 2017) said there were more qualified candidates than open positions, indicating a tighter job market.

	In addition, respondents were not impressed by the skill sets or knowledge of new hires for their job function; 72.5% said the new hires were adequately trained but not exceptional; 23.1% said the new hires were poorly trained.

	Geographic differences, and perhaps uncertainty created by the Brexit, resulted in a more negative outlook for business prospects by European-based respondents.

	Only 15.2% of the Europe-based respondents said they felt more secure in their positions versus the previous year compared with 24.7% for global respondents. The percent who said they felt less secure was up slightly to 28.8%, similar to the global audience response.

	While 52.7% of the global audience respondents expect business to improve, fewer than 40% of European-based respondents had a positive outlook. Nearly one-quarter (22.7%) of the Europe-based respondents expect business to decline; 37.9% expect no significant change. In comparison, only 17.2% of all respondents project business will decline; 30.2% expect no significant change.

	Nearly one-third of the respondents reported that their companies had been through a downsizing or restructuring in the past two years; 18.1% experienced a merger or acquisition. More than one-third of the Europe-based respondents reported a change in responsibilities due to the changes in company structure; 7% said they left the company due to the restructuring.

	One-quarter of the Europe-based respondents said they voluntarily changed jobs in the past two years; among the reasons cited-with multiple choices allowed-were to pursue a better career opportunity (41.2%), find more challenging work (29.4%), to seek a better work-life balance (29.4%), or to find a more stable/successful company (23.5%).


	Vol. 31, No. 1
	January 2019
	Pages: 22–26

	When referring to this article, please cite it as: R. Peters, “Apprehension Shapes Employee Satisfaction,"

Intellectual challenge, work/life balance, compensation, and an unclear business outlook create uncertainty among European bio/pharma employees.