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Biopharmaceutical3-300x192.jpgMindset is important to working in the biopharmaceutical industry. Three distinguishing behaviors will enable new entrants to build rich and fulfilling careers: keeping an open mind, serving a purpose for the benefit of a greater good, and making risk-based decisions. The range of experiences in our own careers can help to illustrate the broad array of opportunities that you can find in the life sciences when such a mindset is applied. Below, we discuss some of those experiences and lessons learned from the past 20 years.A

Mindset for Success
Lindberg: As Heraclitus wrote over 2,500 years ago, “Change is the only constant in life.” But some human aspirations are timeless, including striving for a sense of purpose and achievement in life. The biopharmaceutical industry offers both of those and presents career opportunities that are limited only by your time and approach. Advancements over the past 20 years are expanding this field to provide myriad pathways for professionals seeking to make a positive impact on the world.

Whitford: Recent university graduates understand better what they enjoy and are good at than their counterparts did just a few years ago. Today, individuals of all races, nationalities, and genders enjoy the liberty to choose almost any career or technical discipline to pursue. For the long term, it’s best to choose a pursuit that complements your personal taste and strengths. It’s perfectly fine to respect a field or technical discipline that just isn’t the one to which you will devote yourself.

It’s good to keep reexamining and refining your long-term goals. Successful professionals — even those at the tops of their fields — commonly report that their current reality is the result of many jumps and course corrections over time rather than following a straight line (1). So it’s okay to “fail” early on. People with focus, determination, and endurance can make the mistake of not knowing when to stop one pursuit and move on to another. Regardless of our early assessments and expectations, sometimes it becomes apparent that one path simply isn’t working out, and it’s best to “cut our losses” and find another. It might be that the current activity is truly worthwhile but just not right for the current time or for your personal circumstances. So don’t be discouraged by dead ends and tactical failures.

Be true to yourself. As in our personal lives, it’s easy to appropriate slowly and imperceptibly the style, habits, and/or positions of our colleagues or employers. Sometimes doing so can be educational and developmental; it just as easily can be a distraction (or worse) from our inner standards or goals. We all have to tolerate and accommodate opinions, positions, and activities that we don’t endorse ourselves, and over time it can be difficult to resist appropriating them anyway. As a young researcher, I worked with some colleagues who carried perspectives and habits that might be considered unacceptable or even outrageous today. And I’m glad I moved on from those environments.

State of the Science
Lindberg: My advice for life-science professionals at any stage in their careers is to be open to trying different things and finding areas where their skills and interest are the best match. Regardless of your specific role, you should value the importance of gaining experience. From start to finish, a rich career comes from spending time to learn, making lateral moves driven by curiosity, taking risks and challenging assignments, thinking outside the box, and learning leadership skills. The nature of our work on molecular, cellular, and genetic medicines — and all the associated processes needed to develop and produce such novel therapies — makes skills transferrable and complementary along the innovation and supply chain and across geographic borders. For anyone who enjoys uncovering “truths” and the satisfaction of solving complex problems, there is ample opportunity in this field.

Biotechnology has moved into personalized medicine, with some products offering cures rather than treatments and some tackling conditions that 20 years ago had no therapeutic options. This stage comes from scientists’ ability to understand disease at a molecular level, which makes targets definable and cells and genes manipulatable on a detailed level. A gene therapy now can treat in one dose a condition that once required daily care (2). In the past two decades, scientific advances in medicine have moved from microscale understanding to nanoscale applications.

A good example of that leap forward in knowledge is the Human Genome Project (3), which completed its 15-year goal of sequencing human DNA two years early in 2003 but raised many questions at the time. The same genome sequencing now could be done in one day at a fraction of the cost by several orders of magnitude (4). Meanwhile, applications abound from nanoscale to macroscale in production to suit individual career preferences and interests. Digital transformation of process information is bringing about a new era of understanding in the life sciences overall.

Whitford: Prepare for unimaginable development in the tools of your trade. In monitoring the results of metabolic activities years ago, I used to add cell extracts to an upside-down glass Pasteur pipette filled with Sephadex G-25 resin, then collect drops of eluent in test tubes. I would measure each fraction with a manual spectrophotometer and record the results in a bound notebook. Today, we have a plethora of exquisite and powerful techniques, both existing and developing, to choose from. For example, commercially available instruments combine the nanoliter-scale separation process of capillary electrophoresis with mass spectrometry (CE-MS) to provide near–real-time, digitally interfaced biomolecule information in a single analysis. It’s impossible to imagine what the speed, results, and ease of analytical techniques will be in five or 10 years.

I’m sure it’s hard for today’s young professionals to imagine how slowly things developed at the end of the 20th century. Drivers of acceleration have included the increasing speed and power of computers and internet communications. Researchers in the 1970s would work with sterile cultures by moving submicron-filtered solutions in a biosafety cabinet through plastic gloves. Recording and analysis of consequent data required a pencil, paper, and hand-held calculator. All graphs (whether for analysis or presentation) were drawn tediously by hand. Today, the generation, acquisition, and processing of data all have changed dramatically — while the sterile work often remains remarkably similar to what we used to do. In the near future, however, automated processes (using robots or cobots) will perform nearly all sterile manipulations in sealed isolation cabinets (5). This current state illustrates how equipment and activities can remain remarkably stagnant in one arena while becoming all but unrecognizable in other settings. I believe that applications of such emerging technologies as machine learning, three-dimensional (3D) bioprinting, and microfluidics will provide surprisingly dramatic future changes.

We know it’s important to keep an open mind regarding new therapies, production modes, and analytical technologies. But however much we can gain by considering novel or even radical ideas — don’t forget that some popular trends will turn out to be either fads or prematurely hyped concepts (6). As a young researcher, I spent some time working on liposomes as drug-delivery agents in the laboratory of a famed lipidologist. We were very excited by the many possibilities of the technology. But I chose to move on when it appeared that, at the time, it was yielding only limited and disappointing applications. Today, however, we do see the dramatic success of a wide range of highly related mesophase and equilibrium structures: e.g., lipid nanoparticles to deliver vaccines against COVID-19 and extracellular vesicles that deliver drugs, proteins, and nucleic acids for both diagnostic and therapeutic functions. Even the developing field of upconversion nanoparticles in theranostics is showing promise (7).

Lindberg: We have witnessed paradigm shifts in both process and product understanding supported by an equal shift in their regulatory context. In the past 20 years, the industry has moved deliberately away from a compliance-by-rules regulatory framework and into a compliance-by-science approach. The idea that “the process is the product” from the 1990s changed in early 2000 with science- and risk-based approaches reflected in the pharmaceutical regulations. The early 2000s also started an era of acceleration in the understanding of human health. Completion of the Human Genome Project triggered a transformational phase in which gene editing and sequencing became widely accessible (3). Although the full genetic code was deciphered then, many unknowns remained in regard to the roles that all those genes played.

The new risk-based regulatory framework was outlined by ICH Q9 in November 2005 (8), and that marked a new path toward innovation and technological applications in the life sciences. By 2016, the “-omics” era was well under way as proteomics (9), glycomics, and metabolomics began to drive scientific knowledge about what goes on inside cells and how they interact with their environment. Now it’s well understood that “the central molecular biology dogma was reformulated. There is no unidirectional flow of information from one class of molecule to another. All the process is feedback interconnected” (10). The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) further opened the regulatory door for process optimization of pharmaceuticals with its publication in 2019 of ICH Q12 (11).

The revolutionary understanding of biology that has been developed through the past 20 years now provides a foundation for biopharmaceutical innovations such as cell and gene therapies, oligonucleotides, and nanoparticles. Underpinning such novel approaches is a need for product quality understanding and reliable process controls. Analytical sciences and product characterization are critical to those and thus offer current career opportunities that will last a lifetime.

The Best Is Yet to Come
Some aspects of building a career in biotechnology parallel those of most other fields. For example, the biopharmaceutical industry requires team members with interpersonal and leadership skills that are important in many management careers. Some basic aspects of modern social activities haven’t changed much through the past 2,500 years: Respect for others, teamwork, empathy, mentorship, and discretion are universal traits that enable success and advancement within all organizations.

However, certain aspects of employment in life sciences reflect the specific science and state of technological development. Thankfully, some people are energized by pursuing the technical and applied tracks such as engineering, research, and manufacturing operations. One specific characteristic of our field is that it is highly regulated. New entrants must appreciate the associated restrictions in creativity and spontaneity for final-process execution.

Another characteristic of the biopharmaceutical industry is the current rapid pace of innovation in relevant technology development and implementation. We cannot predict the impending implications of such ongoing initiatives as digitalization, artificial intelligence, data science, microfluidics, automation and robotics, synthetic biology, and sustainable practices. So key personality traits for professionals in this field are an interest in continual learning and incorporating new approaches, an eagerness to think outside the box, and an ability to envision the applications and consequences of new technologies.

Driven by the growth of such new techniques as genome editing and single-cell platforms, with such applications as mRNA vaccines and gene therapies, biotechnology now offers some of the most promising employment opportunities available today.

1 How Did Elon Musk Become Successful? The InCAP, 24 December 2021; https://theincap.com/how-did-elon-musk-become-successful/?amp=1.

2 Nienhuis AW, Nathwani AC, Davidoff AM. Gene Therapy for Hemophilia. Mol. Ther. 25(5) 2017: 1163–1167; https://doi.org/10.1016/j.ymthe.2017.03.033.

3 Collins FS, McKusick VA. Implications of the Human Genome Project for Medical Science. JAMA 285(5) 2001: 540–544; https://doi.org/10.1001/jama.285.5.540.

4 The Cost of Sequencing a Human Genome. National Human Genome Research Institute: Bethesda, MD, November 2021; https://www.genome.gov/about-genomics/fact-sheets/Sequencing-Human-Genome-cost.

5 Markarian J. Automating Aseptic Manufacturing. Pharm. Tech. 45(10) 2021: 16–21; https://www.pharmtech.com/view/automating-aseptic-manufacturing.

6 Gartner Hype Cycle. Gartner, Inc.: Stamford, CT, 2022: https://www.gartner.com/en/research/methodologies/gartner-hype-cycle.

7 Liang G, et al. Recent Progress in the Development of Upconversion Nanomaterials in Bioimaging and Disease Treatment. J. Nanobiotechnol. 18(154) 2020; https://doi.org/10.1186/s12951-020-00713-3.

8 ICH Q9. Quality Risk Management. US Fed. Reg. 71(106) 2006: 32105–32106; https://database.ich.org/sites/default/files/Q9%20Guideline.pdf.

9 Strasser L, et al. Proteomic Landscape of Adeno-Associated Virus (AAV)-Producing HEK293 Cells. Int. J. Mol. Sci. 22(21) 2021: 11499; https://doi.org/10.3390/ijms222111499.

10 Morales F, Goes A. A Decade of Human Genome Project Conclusion: Scientific Diffusion About Our Genome Knowledge. Biochem. Mol. Biol. Educ. 44(3) 2016: 215–223; https://doi.org/10.1002/bmb.20952.

11 ICH Q12. Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. US Food and Drug Administration: Rockville, MD, May 2021: https://www.fda.gov/media/148476/download. 

Corresponding author William G. Whitford is the life science strategic solutions leader for DPS Group’s Strategic Consulting Team, supporting innovative therapeutic development and manufacturing processes. He has published over 300 articles, book chapters and patents in the bioproduction arena and has served on the BPI Editorial Advisory Board for much of the publication’s 20-year history; [email protected]. At the time of writing, Anna Lindeberg was a principal consultant for DPS Strategic Consulting Group, focusing on technology transfer and new product introduction strategies, connecting life-cycle product and process comparability with laboratory and manufacturing decisions. Now a technical team manager for Pfizer, she has spent over 25 years in leadership and technical roles across the product life-cycle spectrum at biopharmaceutical companies, from preclinical to commercial manufacturing of biologic drug substances.

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