Proceedings of a Workshop—in Brief

Training the Regenerative Medicine Workforce for the Future

Proceedings of a Workshop—in Brief

In 2022, the Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine developed and adopted a new strategic plan with the goal to spark exchange and inspire action among diverse interested parties to advance regenerative medicine for the benefit of all.¹ To explore one priority area of that plan—workforce development—the forum convened the public workshop Training the Regenerative Medicine Workforce for the Future on November 15, 2022. The workshop aimed to better understand (1) gaps in workforce development and potential solutions, (2) skill sets and other attributes needed for success in regenerative medicine, and (3) incentives and disincentives for expanding the workforce. Spanning many parties with varied needs, these considerations are as dynamic and complex as the field of regenerative medicine itself. The workshop was intended to serve as an opportunity to catalyze engagement and development of the regenerative medicine workforce by exploring current development gaps and potential solutions for expanding participation.

In opening remarks, Krishanu Saha, an associate professor of biomedical engineering and the Retina Research Foundation Kathryn and Latimer Murfee Chair, University of Wisconsin-Madison, explained that the workshop would consider two key perspectives: a broad view of the ecosystem and constituent systems (e.g., academia, industry, regulatory, government) and a view from specific individuals’ experiences within the workforce. Considering the future of regenerative medicine, Saha encouraged participants to take a forward-thinking approach by recognizing areas in demand across regenerative medicine—including types of workers, skills, and training—and to identify tools and programs that have worked well for learners and mentors to inform next steps.

Rapid growth in the regenerative medicine field is driving increased demand for skilled workers, highlighting the importance of considering how to shape the requisite workforce. These considerations are timely, Saha noted, given the “exodus” of young scientists who have recently earned doctorates in life sciences out of academia into industry. A recent survey found that over 40 percent of science doctoral graduates in 2021 migrated to industry, with a shrinking proportion staying in academia (Wosen, 2022). As the landscape of regenerative medicine continues to evolve, workers can prepare by developing specialized skill sets in a range of disciplines, from cell

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and molecular biology to bioinformatics (Green et al., 2021). Emerging areas in the biomanufacturing space could inform the workshop’s discussions; these include data science, artificial intelligence (AI), machine learning, automation, process development, and regulatory science, he explained (Kirouac et al., 2023; Plant et al., 2022).

The 2022 Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy also underscores the timeliness of the workshop, said Saha. The order sets forth policy to “coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security” (Executive Order 14801, 2022). Encompassing agricultural, bioindustrial, and biomedical activities, the “bioeconomy” is broader than regenerative medicine, yet the field is a core component of the bioeconomy via the production of pharmaceutical products, tissues, organoids, and devices to enhance medicine, Saha said (NASEM, 2020).

SYSTEMS-LEVEL GAPS AND POTENTIAL SOLUTIONS IN WORKFORCE DEVELOPMENT IN THE REGENERATIVE MEDICINE ECOSYSTEM

The first session, which was moderated by Jack Mosher, scientific advisor, International Society for Stem Cell Research, focused on systems-level gaps and solutions in workforce development in the regenerative medicine ecosystem. The objectives were to (1) explore systems-level gaps and solutions to better address workforce development in regenerative medicine, (2) discuss skill sets needed across different sectors of regenerative medicine, and (3) explore incentives for expanding the workforce, including improving diversity and inclusion.

Strengthening and Supporting Biotechnology Education Programs

As entry points into the field, biotechnology education programs are critical to expanding the biotechnician workforce, said Linnea Fletcher, department chair of biotechnology at Austin Community College and InnovATEBIO’s executive director. InnovATEBIO is a national network for biotechnology workforce education funded by the National Science Foundation’s (NSF) Advanced Technology Education program.² The InnovATEBIO network includes 134 college programs providing degrees and certificate programs in biotechnology and biomanufacturing. InnovATEBIO collaborates with manufacturing organizations, such as BioMADE and NIIMBL,³ and industry advisory boards help programs tailor training to the needs of local industry. The center fosters career paths in biotechnology through matriculation agreements with 4-year colleges, high schools, and dual-credit high-school partnerships as well as by supporting career development of alumni, said Fletcher. InnovATEBIO’s efforts to expand the workforce include increasing public awareness, promoting workforce diversity, fostering multiple entry and exit points from industry to education, supporting mastery of competencies validated by industry, delivering project- and student-based education, and supporting economic development of local industry.

Fletcher highlighted a perspective article about recommendations for workforce development in regenerative medicine biomanufacturing (Green et al., 2021). The authors recommend building an effective educational pipeline for the biosciences by linking high schools to community colleges to 4-year degree programs, as well as providing continuing education courses for the incumbent workforce. However, workers need greater flexibility to obtain additional education, Fletcher noted, because it is difficult for working professionals to earn credentials without leaving their current role for the classroom.

The Austin Community College (ACC) biotechnology program is an example of how community colleges can serve as valuable entry points into the biotechnology field, said Fletcher. Across a large, 14-campus college system, ACC offers academic and workforce programs with a focus on improving diversity, equity, inclusion, and accessibility in biotechnology. For instance, forgoing minimum entrance requirements to remove barriers to entry promotes equal opportunity for prospective students. The institution aims to work with all interested

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learners to ready them for the program, said Fletcher, and commonly serves adult learners, career changers, and Hispanic and veteran populations. The pathway to becoming a biotechnician can vary depending on student background, she said.

Entry-level certificates can be earned in collaborating high-school programs and can be used to enter some workforce positions and earn credit toward a 2-year associate degree. At ACC, about half of students have a prior 4-year degree and enter the field by earning a postbaccalaureate advanced technical certificate. Biotechnology programs increase competency by filling gaps in important skill sets, Fletcher added. The biotechnology program at ACC offers advanced training in cell culture, medical diagnostics, bioprocessing, bioinformatics, next-generation sequencing, quality assurance and quality control, and other basic laboratory competencies in a regulated environment.

Collaborating with companies can provide solutions for hands-on training and experience, noted Fletcher. Bioscience incubator programs can combine economic development with education by facilitating collaboration between startup companies and community college or university programs. Through incubator partnerships, startups can offer resources for equipment and supplies, access to other industry partners, leading-edge information about emerging technologies, and applied learning opportunities for students. In exchange, community college programs assist startup companies with research and development, which can accelerate progress, decrease time to market, and reduce cost for industry partners. Furthermore, interdisciplinary collaboration can promote cross-learning about technologies that converge in regenerative medicine, Fletcher explained. For example, one InnovATEBIO project involves the collaboration of several companies and biotechnology programs for AI research and data collection. Overall, industry—academia collaboration can be mutually beneficial by developing solutions for companies while providing educational solutions for students through industry-based projects and hands-on learning opportunities, said Fletcher.

Addressing Systems-Level Gaps in Regenerative Medicine Workforce Recruitment

Barry Bates, bioscience technology program coordinator at Atlanta Technical College, discussed how to build an effective pipeline for the biosciences workforce by addressing systems-level gaps. Recruitment is a significant challenge in developing the next-generation regenerative medicine workforce, said Bates. Prospective students are often unfamiliar with bioscience, biotechnology, and related areas such as regenerative and translational medicine because the knowledge and skills required are not normally part of a high-school curriculum or everyday life. The limited awareness and exposure to bioscience careers within communities—especially minority populations—reduces recruitment (Boyce et al., 2019). However, it takes more than familiarity with the field to attract people to the workforce, Bates noted. An increasingly preoccupied generation needs to view the science as engaging, relatable, and relevant; hands-on work can help catalyze students’ interest, he suggested, and projects can both introduce students to opportunities available and facilitate the skill building needed for promising careers. Furthermore, because the pathway into a bioscience career is often unclear for prospective students, both industry and educators could clarify opportunities in bioscience, he said. Elementary, secondary, and higher education teachers who are knowledgeable about opportunities in biotechnology and bioscience could help guide prospective students into the pipeline and motivate more people into pursuing this line of work. Education administrators could better support teachers that are involved in this effort, while states’ curricula could address bioscience and biotechnology in more depth, he added. Industry could also participate in the recruitment process by stoking early engagement and exposure and playing an active role in training students.

Bates highlighted the increased demand in the bioscience labor market in Georgia, where the industry is flourishing yet facing a growing need for skilled workers. Although demand is high for trained individuals, especially at the technician levels, companies cannot find enough suitable workers despite significant investment, he noted. Currently, too few academic institutions have programs

to prepare the volume of students needed to sustain the workforce, and output from major universities is insufficient. Despite growth in fields like translational science and regenerative medicine, education is not shifting at the same pace to keep up with demand, he said. Moreover, 2-year colleges often have limited resources and space to incorporate equipment needed for proper training in the biosciences. Collaboration with larger academic institutions and local industry could help 2-year colleges incorporate practical learning and exposure, Bates suggested, sharing the story of a student who participated in a summer research program with the NSF Engineering Research Center for Cell Manufacturing Technologies (CMaT) and was motivated to go on to finish her bachelor’s degree.

Training Doctoral and Postdoctoral Scientists to Enter the Regenerative Medicine Workforce

Brigid Hogan, a professor in the Department of Cell Biology and the Developmental and Stem Cell Biology Program at Duke University School of Medicine, discussed training Ph.D. and postdoctoral scientists entering the regenerative medicine workforce. One pipeline for producing skilled workers is the National Institute of Health’s T32 training programs for doctoral candidates and postdoctoral fellows.⁴ Funded by the National Institute for Child Health and Human Development, the Developmental and Stem Cell Biology Training Program at Duke University School of Medicine is an example of a T32 program that is developing the next leaders and innovators in the field, she said.

The program currently trains 40 students, with an intake of 6 to 8 per year and an average time to graduation of 5 years. Around one-third of trainees are underrepresented minorities, and about 70 percent are female. The core curriculum focuses on modular, foundational coursework with an emphasis on developing skills in practical tool use, critical thinking, experimental design, communication, and research ethics. Students rotate through various research labs with opportunities across basic and clinical research. A critical component of the program’s success is the ongoing support and mentoring of both students and faculty, said Hogan. Program faculty receive training specifically in mentoring, as well as training in research integrity, diversity, equity, and inclusion.

Diversity and inclusion are also supported through the Duke BioCoRE Program,⁵ which provides additional mentoring and support for students from diverse backgrounds (e.g., racial, ethnic, those with disabilities, LGBTQ). Given that the grant has been renewed over several cycles, the T32 program is highly successful in terms of criteria that peer reviewers use to assess these applications; such measures of success include metrics such as student retention—especially for underrepresented minorities—time to graduation, student F31 grants, publications, posters, awards, and workforce entry.

As a pipeline for developing the future workforce, T32 programs do have weaknesses. Very few T32 training grants related to regenerative medicine are available, despite significant demand, and the Duke T32 program sees twice as many applicants as there are available positions each year, Hogan said. Positions are also only available to U.S. citizens and permanent residents. Furthermore, additional time could be dedicated to topics relevant to the application of basic science to human regenerative medicine and therapies, including subjects such as patenting, regulatory processes, and entrepreneurship, she suggested. Finally, discourse about regenerative medicine careers tends to focus on academic career paths, she said, and the T32 program lacks industry internships, which could broaden students’ horizons and connect them to other career opportunities. Additional outreach to undergraduate and high-school students could bolster interest and engagement, she added.

Hogan outlined other opportunities available to train the regenerative medicine workforce. The National

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Institutes of Health (NIH) awards individual F31 (Ph.D.) or F32 (postdoctoral) training grants, and other organizations—such as the New York Stem Cell Foundation—offer individual postdoctoral fellowships. Trainees can participate in skills-development activities embedded within NIH consortium grants (e.g., through the National Heart, Lung, and Blood Institute). Practical courses in regenerative medicine are delivered by organizations such as the Cold Spring Harbor Laboratory and the European Molecular Biology Organization. Limited training for undergraduates is available and includes Creating Opportunities through Mentorship and Partnership Across Stem cell Science (COMPASS) by the California Institute for Regenerative Medicine (CIRM) and a new course in regenerative biology and medicine at Duke University, Hogan noted.

Training the Next Generation of Cell and Gene Therapy Experts

Meagan Pasternak, senior manager in workforce training and regional development at the International Society for Cell & Gene Therapy (ISCT),⁶ discussed ISCT’s solutions for training the next generation of cell and gene therapy experts. ISCT advances cell and gene therapies with an emphasis on translational value, by connecting experts across scientific, regulatory, and commercial fields. ISCT connects professionals at all levels, in many disciplines, across the globe, leading to a comprehensive understanding of the needs in the industry. ISCT has gained insight into the greatest areas of opportunity through global membership trends, said Pasternak. Significant increases in demand for entry-level personnel—particularly for laboratory- and manufacturing-related positions—underscore the need for more baseline training programs. ISCT has taken several steps in workforce and career development including founding the Early Stage Professionals Committee, early stage professional mentoring and leadership programs, and foundational training courses. ISCT is starting a new workforce development committee to provide strategic guidance for its workforce development initiatives, she added, and is developing training programs on industry competency standards.

Such initiatives aim to meet ongoing workforce development needs through training and development opportunities and educational resources, said Pasternak. Key considerations in the development of the programs included wide accessibility, availability via several learning settings (e.g., online, in person, hybrid), and global applicability. Programs are curated by experts, tailored to regionally specific training needs, and cover regulatory criteria for various countries. Training programs include the Cell Therapy Training Course, in partnership with the American Society for Transplantation and Cellular Therapy, which addresses the need for in-depth training for early career individuals in the development and translation of cell and gene therapies. To meet training needs in biomanufacturing, ISCT offers the Educational Program on Advanced Therapy Manufacturing with the Andalusian Network as well as the Workforce Development in Biomanufacturing Course in partnership with CMaT, which leverages both industry and academic expertise.

Development opportunities include the early stage professionals mentoring and leadership programs, which focus on career and professional development through mentorship and participation on expert-led ISCT committees. Experts in the field have a crucial role in supporting the development of next-generation leaders by serving as mentors, said Pasternak, and ISCT is motivated to be part of the solution to support the continued and sustainable growth of the field through workforce development, training, and educational resources. Partnerships across organizations can expand workforce development and more effectively use resources to address the greatest needs, suggested Pasternak.

Industry Perspective on Development of the Regenerative Medicine Workforce

The future of cell and gene therapies depends on meeting cell manufacturing requirements for the current generation of technology, said Robert Deans, chief scientific officer at Synthego. As the field of therapeutic regenerative medicine grows, the substantial workforce demand in CMC (chemistry, manufacturing, and controls) underscores the scale of the skilled workforce

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challenge. Synthego,⁷ a biotechnology company, uses cross-platform integrations to develop clinical-grade CRISPR products. Founded by engineers, the company blends an engineering perspective with that of the life sciences to build a composite workforce. The platforms leverage large datasets that can be analyzed to improve and optimize processes. A principal gap in workforce development for regenerative medicine, said Deans, is incorporating various perspectives on critical quality attributes from both the engineering and life science disciplines. These attributes lend insight into values, which differ across backgrounds and perspectives. Therefore, the ability to communicate across a range of interested parties with different perspectives is also critical for the future workforce to best work together across disciplines, he said.

Regulatory Perspective on the Development of the Regenerative Medicine Workforce

J. Kaitlin Morrison, assistant professor of medicine and executive director of clinical research at the Lineberger Comprehensive Cancer Center, University of North Carolina (UNC), discussed developing the regenerative medicine workforce from a regulatory perspective. The regulatory pathway for regenerative medicine is complex, and traditional regulatory strategies—such as the use of animal models—are often not applicable. Such unique characteristics of the field in regulatory strategy and in clinical operation, development, and design create further challenges in education or professional development, Morrison said. Furthermore, regenerative medicine sponsorship is split equally between industry and nonindustry, including academia (ARM, 2022).

Unlike other fields, academia is frequently both the sponsor and the manufacturer of the regenerative medicine product. In-house translation requires expertise; however, academia often has smaller teams and a less seasoned workforce, compared to industry, Morrison said. Academic institutions historically pay a lower salary than industry partners, and academia relies more on early stage professionals. Consequently, there are less formalized processes for the education and development of staff acting in regulatory capacities in academia, she noted.

The regulatory affairs workforce requires specific competencies and skill sets for success, said Morrison. Strategic perspective, creativity, and innovation are essential to work outside of traditional regulatory pathways. Adaptability is also valuable, as new knowledge emerges and the U.S. Food and Drug Administration (FDA) continuously publishes new guidance.

Negotiation skills are important for working with FDA and getting products from the bench to clinic to market. Solutions for workforce development include internal development and external collaboration, noted Morrison. Internal development consists of journal clubs, mentoring, and training programs. A journal club for regulatory scientists could focus on the latest guidance, industry news, and FDA approvals, as well as sharing knowledge as a team. Seasoned professionals who understand the regulatory environment can mentor new individuals, and there is a role for more formalized training programs, she added. External collaboration is also valuable for workforce development, said Morrison, citing the example of the Association of American Cancer Institute’s Clinical Research Initiative, which connects cancer centers across the United States and Canada through list servers, initiatives, and knowledge sharing.

To help develop the future workforce, academic regulatory staff have a notable opportunity to share knowledge of regulatory strategy and product development with students, said Morrison. Historically, complex regulatory work has been in the pharmaceutical industry’s domain; however, academia’s significant place in regenerative medicine sponsorship and manufacturing imparts the opportunity to share real-life experiences of what it means to work in the field with prospective students. For example, UNC has a lecture series in which both academia and industry professionals share their experiences working in the field, she said. Other examples include internships to expose Ph.D. students to regenerative medicine careers in clinical development and regulatory science.

To improve retention of the regenerative medicine workforce, additional training in management and leadership skills can help ensure that individual

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contributors are successful on the path from scientist to leader, Morrison suggested. Crucial career junctures could be identified and used as an opportunity to teach skills. Traditionally, training ends after a Ph.D. or postdoctoral period, and formal training in leadership development is absent, she noted, although general university trainings, clinical research-specific trainings, and conferences provide opportunities for individuals to develop into the leaders of the next generation.

Discussion of Challenges and Solutions in Developing the Regenerative Medicine Workforce

During the discussion, panelists explored challenges and solutions in developing the regenerative medicine workforce, including (1) training, diversifying, and retaining a skilled workforce, (2) developing industry-driven certification for training, (3) increasing training opportunities for careers in regenerative medicine, and (4) expanding regenerative medicine career opportunities nationwide (see Box 1).

Training, Diversifying, and Retaining a Skilled Workforce

Deans highlighted the challenge of retaining a skilled workforce in the regenerative medicine industry. Lucrative salaries and career-progression opportunities can divert trained personnel out of universities and into other settings. However, demand for competent workers is so high that talent often stays in jobs for only 6 months to a year before moving on to other opportunities. Poor retention undermines innovation and training, Deans said. Moreover, diversity in terms of culture, knowledge, and training is critical for innovation in the biotech space, and it is key to not only tap into the diversity pool but also ensure that diversity remains stable in the private sector, he added. A focus on engaging more stable populations—such as veterans—could help improve workforce stability, sustainability, and diversity, suggested a workshop participant. The regenerative medicine field would benefit from more mentors and role models, especially from underrepresented minority populations, to help trainees envision their career paths and stay in the field, said Mosher and Maria Millan, president and chief executive officer of the California Institute for Regenerative Medicine (CIRM).

Krishnendu Roy of the Georgia Institute of Technology emphasized the importance of training medical technicians and providers in administering cell therapy and producing regenerative medicine products for clinical trials. Providing training in administration and

delivery of cell and gene therapy could also help diversify clinical trials outside of urban academic centers and into rural clinics, he noted. Diversifying clinical trials will require going into community hospitals, said Morrison, but academic institutions often lack the resources or infrastructure necessary to extend their clinical research into community hospitals.

Developing Industry-Driven Certification for Training

Fletcher and Deans discussed the value of certification to standardize competency assessment, reward on-the-job experience, and train the workforce. As an alternative to obtaining traditional degrees, certification-based training could also help retain skilled technical workers in the field, Deans said. Panelists also considered how certification may be overseen and accredited. Industry, rather than academia, is best positioned to drive certification efforts, said Fletcher and Deans. Furthermore, there is an important role for larger interested parties in certification to prevent fracturing and extraneous “micro-credentials” resulting from a lack of coordination among many small groups, said Fletcher. The credentialling curriculum may be standardized and validated by industry to ensure that widespread training efforts are equivalent and appropriate, as no one organization can meet the demand alone, said Roy. Industry and industry partners such as CIRM, ISCT, the International Society for Stem Cell Research (ISSCR), and the Alliance for Regenerative Medicine could be well suited to lead the effort, suggested Deans.

Increasing Training Opportunities for Careers in Regenerative Medicine

Panelists discussed training opportunities and career pathways for individuals interested in pursuing regenerative medicine. Duke University has successfully brought M.D./Ph.D. students into regenerative medicine labs, said Hogan. Additionally, clinicians have gained experience in research labs and partnered with postdoctoral trainees to learn benchwork, she said. At UNC, resident and fellowship physicians can partner with experienced physicians to train in regenerative medicine, Morrison added. Fellows and residents are taught how to run regenerative medicine clinical trials, which eases the transition into the field.

Millan described ongoing and future opportunities provided by CIRM. California has dedicated funding for stem cell research, and CIRM has invested large amounts in educational programs, from high school to postdoctoral, she explained, noting that CIRM’s programs embed diversity, equity, and inclusion with a focus on underserved and underrepresented communities. As a requirement for funding, mentorship training is also a focus, she added. CIRM has provided funding for clinical trials conducted by both academic institutions and for-profit companies and will be supporting GMP facilities,⁸ creating opportunities for practical training. Interconnected with biotech programs at community colleges and state universities, CIRM educational programs have successfully trained thousands, and many participants are now leaders training the next generation,⁹ said Millan.

Processes for cell and tissue manufacturing are often unique to each product, which limits the ability to generalize training, noted a workshop participant. Training programs can be flexible and train broadly, said Deans, suggesting that programs could account for how different segments of industry may be more limiting than others. For instance, experience with platform technologies may be more adaptable and suitable for broader application than experience working at therapeutics companies, which may be highly disease specific; certification could be used to provide performance standards in platform technologies and tools, he said.

Expanding Regenerative Medicine Career Opportunities Nationwide

Panelists discussed how the geographic concentration of opportunities on the East Coast and West Coast of the United States affects workforce development. Yet, opportunities are emerging throughout the country, said Fletcher. For example, Kansas City Kansas Community College and Shoreline Community College have growing biomanufacturing and biotechnology programs, respectively. As industry expands in Georgia, curricula

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are adapted to better place graduates in positions and address current as well as future workforce needs, said Bates. Morrison noted that with the expansion of remote work, the workforce has extended further across the country. For instance, work in regulatory affairs, project management, computational biology, and data management in regenerative medicine is commonly remote. More faculty are moving to industry because of the flexibility to work from home, Fletcher added.

EARLY CAREER PERSPECTIVES ON OPPORTUNITIES IN REGENERATIVE MEDICINE

The second session of the workshop featured six early career panelists who shared their perspectives on opportunities in regenerative medicine. The panel was comoderated by Kaivalya Molugu, a scientist at Editas Medicine, and Clinton Smith, graduate research assistant, University of Florida. The objectives were to (1) learn about training experiences that have been influential in the professional development of early career individuals, (2) discuss gaps in expertise or support that individuals experience at key junctures early in their careers, and (3) explore solutions to career-related challenges that may encourage and inspire other students. The panelists discussed financial and health challenges, the value of supportive environments and structured training opportunities, the importance of mentorship, and the need to build awareness about career pathways in regenerative medicine (see Box 2).

Addressing Financial and Health Challenges

Many trainees face financial hardships, said Nisha Iyer, an assistant professor at Tufts University. Because students cannot use laboratory work as a federal work-study to earn money, financial stress can prevent undergraduate students from conducting research. Many students have a job in addition to academic responsibilities, which undercuts efforts to improve diversity and inclusion since underrepresented students are often the most in need of financial resources, Iyer added. Students also face higher costs of living on the East Coast and West Coast of the United States where regenerative medicine opportunities are concentrated, she said. Additionally, funding is important for professional development because it allows trainees to engage in opportunities such as attending conferences and participating in professional organizations.

Maintaining mental and physical health is also a major challenge in training according to the panelists. COVID-19 and its residual symptoms—such as fatigue and brain fog—have affected performance for many students, said Elana Cooper, a Ph.D. candidate in biomedical engineering at the Georgia Institute of Technology and mentoring chair of the North America Regional Executive Board, ISCT. The inability to take time away from work owing to the round-the-clock nature of cell culturing can exacerbate physical or mental health issues, added Iyer. Furthermore, work–life balance can be a challenge in regenerative medicine training.

The industry biomanufacturing pipeline is often more systematic and therefore more accommodating, but because of smaller teams, limited funds, and the nature of the experimental process, academia regularly relies on students working 7 days a week to manage cell cultures, Iyer noted. Although this demanding schedule can deter students from the field, it is necessary to gain mastery, she said. Still, it is often unfeasible for 4-year and community colleges to offer sufficient training in cell culturing, a critically needed skill, Iyer remarked. Evan Graham, applications consulting scientist at Biosero and chair of the Early Career Scientist Committee, ISSCR, emphasized the prevalence of burnout among trainees—which is often driven by an unsupportive workplace culture—and suggested that the solution to burnout is not resilience, but balance. Solutions to burnout include workplace flexibility, compromise, and effective interpersonal communication, suggested Cooper.

Building Supportive Training and Workplace Environments

Both Graham of Biosero and Maryam Pasdar, a cellular therapy laboratory associate at Children’s National Hospital, emphasized that team-based collaboration is essential to finding balance. Distributing cell culturing work among several personnel and sharing projects with teammates would ease pressure on individuals. Panelists discussed the importance of a supportive environment for individual success. Part of building an effective workplace culture is ensuring that the workforce feels fulfilled, valued, and motivated, said Graham and Xinh-Xinh Nguyen, a translational science interagency fellow at the National Center for Advancing Translational Science, National Institutes of Health. Worker retention and satisfaction could be improved by creating a trusting, fulfilling environment, suggested Graham. Academia and industry could also monitor key leadership performance indicators and provide leadership training to ensure an amenable environment, he said. Pasdar underscored the importance of workforce diversity in fostering a welcoming environment for learning. Decoupling support for students from traditional research grants could enable students to have more diverse training and professional development opportunities, said Iyer.

Establishing Structured Training Initiatives

The panel considered the role of workforce training initiatives in expanding the workforce. Reimagining educational pathways to broaden training options could lead to a workforce better adapted to evolving technology such as bioautomation, Graham said. Cooper, Iyer, Nguyen, Pasdar, and Graham highlighted the value of training and guidance for doctoral students in workforce competencies, such as career skills for scientists, leadership, cross-discipline skills, interpersonal skills, translational research, and regulatory sciences. Graham and Iyer both remarked on the challenges encountered during career transitions, respectively, from academia to industry and from a postdoctoral position to running a laboratory.

Integrating structured career pathing in training programs could improve preparedness outside of academia and reduce the steepness of the learning curve during transition, suggested Graham. For instance, programs could offer career counseling and rotations through different areas of regenerative medicine to assess student interest and better guide career progression, said Cooper and Graham. Given that professional skills and development vary across different careers, programs could provide work experience and guidance for a range of potential career paths in academia and industry, suggested Cooper. For example, a teaching requirement may benefit Ph.D. students planning to remain in academia more so than industry-focused individuals.

Expanding Mentorship Opportunities

Panelists considered the value of mentorship and networking in career development. Mentors can support and guide students in learning about regenerative medicine careers, navigating the discipline-specific culture, and filling in knowledge gaps, said Iyer. More guidance in choosing career pathways and navigating environments could help ensure individuals are best positioned for success, Pasdar said. Students can use informational interviews with working professionals to understand their roles, career paths, and work culture, Pasdar added. Mentorship can also guide career advancement; however, the number of available mentors is insufficient, as many potential mentors do not have time to devote outside of research. Having a network of multiple career and peer mentors can provide the support needed without overburdening one person, said Iyer. It can be beneficial to seek out multiple mentors in various career stages and areas of regenerative medicine, including academia, professional societies, and industry, Cooper added. Incentives from institutions or organizations that fund grants could encourage investigators to invest in mentoring, Iyer suggested.

Mentorships often happen informally and over long periods of time, noted Cooper, making it difficult to find an entry point. Social media can be a helpful networking tool for finding mentors, said Iyer. When reaching out to a potential mentor, she advised setting specific goals for the relationships, rather than leaving it open-ended. Explicitly establishing clear goals can improve the success rate of requesting mentorship. Mentors who focus on a mentee’s unique skill sets, contributions, and interests are the most effective, Graham noted. Accessibility of professional networks and potential mentors can greatly depend on geographical location, Iyer continued. The challenge of finding connections outside of biotechnology hotspots could be addressed through initiatives to develop online networking events in which smaller, geographically remote institutions could join, she suggested. Although expansion of virtual networks would increase accessibility to mentors, incentives for mentors to participate in virtual spaces are lacking, said Iyer. Beyond incentives for mentoring, a shift in culture and expectations for investigators to support career building in mentees could be beneficial, said Cooper and Graham.

Building Awareness of Career Pathways in Regenerative Medicine

An individual student’s initiative to take advantage of and seek out opportunities to learn about different perspectives and skills is also foundational to developing a well-rounded skill set as a professional in the field, said Pasdar, adding that raising awareness of regenerative medicine careers would encourage workforce recruitment. Personal experiences or knowing someone who needed regenerative medicine therapy can inspire people to choose a career in regenerative medicine, shared Pasdar and Iyer. Awareness initiatives such as engagement activities and outreach may help expose career options, said Smith, while Graham highlighted the value of trade shows and conferences as ways to find inspiration and opportunities to make connections, emphasizing that early career professionals should attend such events prepared and with purpose.

PROSPECTIVE APPROACHES FOR TRAINING THE REGENERATIVE MEDICINE WORKFORCE

The workshop closed with a final discussion among all panelists and closing reflections from Patrick Hanley, chief and director of the cellular therapy program at Children’s National Hospital and associate professor of pediatrics, The George Washington University. Hanley asked panelists to comment on actions that could be taken by the Forum on Regenerative Medicine or other

organizations to coordinate these initiatives more broadly. As a leader in the field, the forum could use the workshop as a catalyst for broader engagement, Pasdar suggested. Saha remarked upon both a dichotomy and a complementarity between NSF and NIH in how they support programs and initiatives, and suggested they could coordinate even further, as well as bring other entities to the table (e.g., FDA, ISCT, ISSCR).

Finding more opportunities for federal interagency collaboration in training programs could provide trainees with a broader range of institutional perspectives and activities, Nguyen said. In considering how federal agencies can collaborate to share best practices—and potentially share funding of initiatives—it is important to bear in mind that each of the federal agencies has a clearly defined mission and well-established culture, which can make collaboration challenging, a workshop participant said. For instance, NIH and NSF approach training and education differently, in that NIH does not generally include workforce and training development within research grants, while NSF does. Thus, NSF grants have training components incorporated, while NIH supports separate training grants.

More funding for training programs is needed, Hogan said, suggesting the strategy of explicitly highlighting the economic benefits that training this workforce can yield for a state or a community, as well as articulating this link between job training and jobs for the future. Even small amounts of funding can be impactful, Iyer noted; for example, relatively small travel scholarships for students and trainees to attend meetings can help them network and bolster the crossover between industry and academia. Supplemental funding for child care could also help diversify the types of people who are able to participate in conferences.

Panelists were asked what they would do differently because of the workshop’s discussion. Hanley suggested having upfront conversations with trainees themselves about how to better provide for them and what they want and need from mentorship. Mentors and principal investigators who are overwhelmed by training responsibilities could alleviate that pressure and reduce their workloads by taking advantage of the many centralized resources available online, Iyer said. Pasdar suggested creating a mentoring “buddy system” to pair new trainees with higher-level technicians to reduce the slope of the learning curve. Millan said that the workshop had strengthened her resolve to find more ways to partner with federal initiatives and other interested parties, suggesting that students and trainees can serve as ambassadors of collaboration across different agency cultures and practices.

“The future of our workforce is holding each other accountable to creating a more welcoming and helpful environment…[that] needs to be at the forefront of everybody’s mind as we go forward,” said Pasdar, because that is how to retain and attract people to the field to improve this work and advance the technologies. Graham remarked that the panelists described instances of failure to attain their full potential not as due to lack of skill, but rather due to the lack of appropriate opportunity or environment. Thus, although developing skills is critical, it is equally important to ensure that everyone—regardless of background—has the opportunity to enter the field. He emphasized that people need skills, but they also need to feel like they belong in the workplace when they get there.

Final Reflections on the Workshop

In concluding remarks, Hanley highlighted three essential themes for developing the future regenerative medicine workforce that emerged during the workshop: (1) certification, (2) diversifying the workforce, and (3) mentorship. He encouraged industry to take a leadership role in shaping and defining certification that is standardized to avoid fragmentation and “micro-certification.” Developing a certification that is validated by industry would help ensure that it meets the industry’s needs, clearly defines the requisite skills and knowledge, helps to retain skilled technical workers in the field, and moves the industry forward, Hanley summarized.

A workforce that encompasses all types of diversity—including age, race, gender, location, skill sets, and other dimensions—is key to the future of the field,

Hanley reflected. Some presenters discussed strategies to promote workforce diversity. For instance, eliminating entrance requirements in community colleges could expand opportunities for certificates, degrees, and other types of training and make them more accessible, particularly for groups such as older students and veterans. Several participants also highlighted the importance of workforce recruitment at earlier stages, including efforts to target younger students—as early as high-school age—by engaging them in practical, hands-on, meaningful work, Hanley added. Relating regenerative medicine to people’s everyday lives could help highlight how important the field is and how rewarding it is to be part of it, he said. Furthermore, building awareness about the benefits and opportunities associated with careers in regenerative medicine with educators, administrators, and mentors could improve recruitment.

The importance of mentorship permeated both sessions, remarked Hanley. A few panelists discussed the need to uncouple trainees from federal grants that require productivity and to provide incentives to mentors through dedicated or protected efforts (e.g., NSF grants). Training for mentors about how to provide high-quality mentorship to trainees can be beneficial, as demonstrated in the T32 training program. Mentors in various stages and at different places—for example, in the workplace and in professional societies—can illuminate a diversity of valuable perspectives. Many professional societies already provide mentorship and mentor–mentee opportunities. Trainees can be encouraged to seek mentorship opportunities beyond their direct academic supervisor to gather career advice, support, and advocacy, Hanley said. Workshop participants emphasized that mentorship is a two-way street, consisting of mentors who are willing to engage and mentor and students and trainees who play a proactive, assertive role in their own success by actively seeking mentorship.

REFERENCES

DISCLAIMER This Proceedings of a Workshop—in Brief has been prepared by ANNA NICHOLSON, SAMANTHA N. SCHUMM, and SARAH H. BEACHY as a factual summary of what occurred at the workshop. The statements made are those of the rapporteurs or individual workshop participants and do not necessarily represent the views of all workshop participants; the planning committee; or the National Academies of Sciences, Engineering, and Medicine.

REVIEWERS To ensure that it meets institutional standards for quality and objectivity, this Proceedings of a Workshop—in Brief was reviewed by ANNE PLANT, National Institute of Standards and Technology, and KRISHNENDU ROY, Georgia Institute of Technology. LESLIE SIM, National Academies of Sciences, Engineering, and Medicine, served as the review coordinator.

STAFF SARAH H. BEACHY, SAMANTHA N. SCHUMM, KATHRYN ASALONE, MEREDITH HACKMANN, LYDIA TEFERRA, and APARNA CHERAN.

SPONSORS This workshop was partially supported by contracts between the National Academy of Sciences and Advanced Regenerative Manufacturing Institute; Akron Biotech; Alliance for Regenerative Medicine; American Society of Gene & Cell Therapy; Burroughs Wellcome Fund; California Institute for Regenerative Medicine; Centre for Commercialization of Regenerative Medicine; Department of Veterans Affairs; Food and Drug Administration: Center for Biologics Evaluation and Research; International Society for Cellular Therapy; International Society for Stem Cell Research; Johnson & Johnson; National Institute of Standards and Technology; National Institutes of Health: National Center for Advancing Translational Sciences; National Eye Institute; National Heart, Lung, and Blood Institute; National Institute on Aging; National Institute of Biomedical Imaging and Bioengineering; National Institute of Dental and Craniofacial Research; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Neurological Disorders and Stroke; New York Stem Cell Foundation; and United Therapeutics Corporation. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

For additional information regarding the workshop, visit https://www.nationalacademies.org/our-work/training-the-regenerative-medicine-workforce-for-the-future-a-workshop.

Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2023. Training the regenerative medicine workforce for the future: Proceedings of a workshop—in brief. Washington, DC: The National Academies Press. https://doi.org/10.17226/27013.

Health and Medicine Division Copyright 2023 by the National Academy of Sciences. All rights reserved.