A Roadmap for Biotech Innovation Translation
Advancements in biotechnology hold immense promise to transform healthcare and improve human lives. However, the journey from scientific discovery to real-world medical impact is long and winding, filled with challenges at every turn. This roadmap guides biotech professionals through navigating the tricky translational terrain, from initial bench research to delivering approved therapies to patient bedsides.
Transitioning from Bench Work to Non-Bench Careers
The biotechnology industry has traditionally been associated with hands-on bench research and laboratory work. However, there are now expanding opportunities for biotech professionals to transition to non-bench roles that allow them to apply their scientific expertise in new ways. Although the image of the white-coated scientist hunched over a microscope still predominates, many skilled researchers are moving away from the bench to contribute to biotech innovation through different pathways.
Some of the most popular non-bench careers that leverage scientific skills include:
- Project managers oversee the planning and execution of biopharma and med-tech projects.
- They coordinate cross-functional teams and ensure alignment with timelines, budgets and quality standards.
- Biotech project management requires understanding the bench to bedside translational process.
- Regulatory affairs specialists are responsible for regulatory compliance and approval for new products.
- They assemble submissions and liaise with bodies like the FDA.
- Expertise in biotech R&D processes is needed to navigate regulations.
- Medical science liaisons build relationships between biotech companies and healthcare professionals.
- They provide clinical trial support and scientific expertise.
- Scientific and communication skills are vital for medical affairs roles.
For bench scientists looking to transition to these non-bench careers, developing a new skillset is crucial. Gaining project coordination experience through cross-functional initiatives and collaborations can pave the way for a move to project management. Similarly, getting involved with regulatory documents and submissions from the bench is excellent preparation for a regulatory affairs role. With some targeted training and purposeful career planning, the possibilities beyond the bench can open up.
Developing Skills for Non-Bench Roles
Transitioning from a bench scientist role to a non-bench career requires actively developing new competencies beyond your scientific expertise. While you leverage your existing knowledge, you need to expand your skillset to succeed in roles like project management, regulatory affairs, medical affairs and others.
Some of the key skills to build up include:
Behavioral Skills
- Communication – Writing, presenting, relationship-building
- Collaboration – Teamwork, matrix management, inclusivity
- Leadership – Influencing, coaching, motivating
Enhancing these “soft skills” is essential for most non-bench roles where you need to interact cross-functionally and lead projects.
Technical Skills
- Data analysis – Synthesizing data, trend analysis, visualization
- Project management – Planning, budgeting, risk management
- Regulations – Interpreting guidelines, vigilance, ethics
Developing proficiency in using tools, frameworks and processes will enable you to execute on the technical aspects of non-bench jobs.
Type | Examples |
Behavioral skills | Communication, collaboration, leadership |
Technical skills | Data analysis, project management, regulations |
Here are some tips to build this expertise:
- Take on cross-functional projects that let you interact more broadly
- Complete training programs and certifications in project management or regulatory affairs
- Find a mentor in your desired non-bench field to provide guidance
- Volunteer for assignments that exercise new skills like data analysis
With some proactive planning and effort, you can develop the full suite of abilities needed to make the transition from the bench to non-bench careers, while still leveraging your scientific foundation. Think about your destination role and work backwards to identify skill gaps you should fill through training, mentorship and practice opportunities.
Gaining Experience Through Cross-Functional Projects
One effective way for bench scientists to gain expertise valuable for a transition to non-bench roles is by taking on cross-functional projects that allow them to build new skills. Contributing to initiatives that require interacting with different teams and departments provides on-the-job training beyond your day-to-day lab work.
Here are some examples of how cross-functional project experience can bolster your skillset:
- Working on a process improvement project with the operations team builds project management, data analysis and leadership skills.
- Helping the regulatory affairs group assemble documentation for a new product submission develops regulatory knowledge.
- Collaborating with the medical affairs team to design clinical trial protocols strengthens clinical expertise.
- Coordinating with the quality team on validating lab processes exercises project planning abilities.
- Partnering with the business development group for scientific due diligence activities develops business acumen.
Project Example | Skills Developed |
Process Improvement | Project management, Data analysis |
Regulatory Submission | Regulatory knowledge |
Clinical Trial Design | Clinical expertise |
No matter which teams you interact with, cross-functional projects enable you to:
- Understand priorities and challenges across different functions
- Exercise skills beyond your primary bench responsibilities
- Build relationships and credibility across the organization
This experience provides a trial run for aspects of non-bench roles you may want to pursue later. Instead of tackling an entirely new job, you can gain relevant expertise through collaborative projects while still at the bench.
Seeking out these growth opportunities requires proactive planning and effort. Have development conversations with your manager, raise your hand to volunteer, and actively identify problems across the business you can help solve. Moving beyond the confines of your immediate lab responsibilities prepares you to successfully transition from the bench to non-bench career options.
Training and Mentorship Opportunities
In addition to on-the-job training through cross-functional projects, there are other avenues bench scientists can pursue to develop expertise for non-bench roles. Seeking out formal training programs and mentorship opportunities is a great way to actively build your skills.
Formal Training Programs
- Certifications – Programs for project management, regulatory affairs, other specialties
- Workshops – Short sessions on leadership, communications, other soft skills
- Conferences – Events to build clinical, technical, business knowledge
- Online courses – Digital learning on specialized topics
Formal training like certifications, workshops and online learning can fill skill gaps and quickly ramp up your capabilities. These programs are designed to provide structured curriculums on defined competencies required for non-bench roles.
Mentorship Opportunities
- Internal mentors – Leaders in non-bench departments you want to transition to
- External mentors – More experienced professionals in your target field
- Job shadowing – Observing a non-bench role model perform their job
- Networking – Discussions with peers who have made the bench to non-bench switch
Type | Examples |
Formal Training | Certifications, workshops, conferences |
Mentorship | Internal/external mentors, job shadowing, networking |
Tapping experienced mentors for guidance provides insider knowledge you can’t get from books or courses. These mentors can demystify non-bench roles, give tailored advice, and make introductions to help your transition.
Pursuing a combination of formal training to build your base knowledge paired with mentor-guided learning in real workplace contexts is a powerful approach. This allows you to complement the theoretical understanding from courses with practical guidance from experts in your desired non-bench field. With determination and a proactive learning mindset, you can gain the expertise needed to make the switch.
Building Capabilities Beyond Scientific Expertise
Succeeding in the transition from bench scientist roles to non-bench careers requires building your capabilities beyond your existing scientific expertise. While leveraging your technical knowledge is important, you also need to develop a more multifaceted skillset.
Some of the key capabilities to build up for non-bench roles include:
- Leadership skills – To influence stakeholders, manage teams, oversee projects and drive execution in roles like project management.
- Communication skills – To interact with diverse groups, present compellingly, write persuasively for regulatory submissions.
- Business acumen – To understand corporate objectives, financials and strategy in order to align initiatives.
- Technical breadth – To draw connections between science and clinical, regulatory, quality, manufacturing.
- Collaboration ability – To engage cross-functionally, manage diverse teams, build relationships.
- Strategic mindset – To take a bird’s eye view, consider long-term impacts, identify what matters most.
Scientific Skills | Complementary Capabilities |
Deep technical expertise | Leadership, communication, business acumen |
Lab research skills | Technical breadth, collaboration, strategic mindset |
Here are some ways to start expanding your capabilities:
- Take on committee leadership roles in scientific societies to build leadership skills
- Present research findings at conferences to improve communication abilities
- Participate in organization-wide projects connecting science, business and operations
- Complete a mini-MBA or business fundamentals program to improve business acumen
- Do short rotations in other departments to gain well-rounded technical breadth
With a deliberate effort to complement your scientific core with other career capabilities, you will be well-positioned for the transition from bench work to the wide range of opportunities available in non-bench roles.
Bench to Bedside Model
A key theme in biotechnology is translating discoveries at the lab bench into solutions that impact patients at the bedside. This bench to bedside model involves moving research innovations through development and testing to become approved and commercially available medical products.
Understanding the typical bench to bedside process of preclinical research, clinical trials, and regulatory approval provides valuable context both for scientists doing the core translational work and those in complementary roles enabling this translation. For bench scientists looking to transition their careers, having a solid grasp of the bench to bedside pathway can open your eyes to the diverse non-bench roles across research, clinical, regulatory affairs, manufacturing, and business functions that contribute to bringing new therapies to patients. Knowing the key steps and stakeholders involved enables you to find the best fit for applying your expertise.
The bench to bedside process typically comprises three main stages:
Preclinical Research
- Early bench research – Exploring new compounds, targets, mechanisms
- Lead optimization – Identifying promising candidates
- In vitro and in vivo studies – Assessing safety and biological activity
Preclinical research involves extensive lab work to investigate potential new therapies and assess feasibility.
Clinical Trials
- Phase 1 – Initial safety and dosing in a small group
- Phase 2 – Efficacy and side effects evaluated in larger cohort
- Phase 3 – Fully testing safety and efficacy in broad population
Rigorously controlled clinical trials on human subjects provide data to evaluate the therapy’s safety and effectiveness.
Regulatory Approval
- Submission compilation – Dossiers with all technical, preclinical and clinical data
- Agency review – Thorough evaluation by bodies like FDA
- Labelling – Approved product specifications and prescribing information
Navigating regulatory approval processes like FDA submissions leads to marketing authorization.
Stage | Description |
Preclinical | Early bench research through in vivo studies |
Clinical Trials | Phases 1-3 testing safety and efficacy |
Regulatory Approval | Submission and review leading to approval |
The bench to bedside model provides a structured pathway to translate early innovations into approved biotechnology products that improve patient lives. While lengthy and complex, this process allows discoveries at the scientific bench to achieve real-world impact at the patient bedside.
Multidisciplinary Collaboration
Successfully moving biomedical innovations from the research bench to the patient bedside requires multidisciplinary collaboration across diverse stakeholders. By working together, scientists, clinicians, industry partners, and healthcare providers can translate scientific discoveries into approved therapies.
Some of the key areas for collaboration include:
Across Fields
- Bench scientists – Discover new therapeutic approaches
- Clinicians – Provide patient perspectives and trial expertise
- Regulatory professionals – Advise on approval requirements
- Business developers – Assess commercial viability and strategy
Field | Role in Translation |
Science | Discover new innovations |
Clinical | Design rigorous trials |
Regulatory | Enable regulatory approval |
Business | Commercialize successfully |
Cross-pollination across these disciplines ensures the end product meets healthcare needs.
Academia, Industry, Healthcare
- Academic labs – Conduct early stage research
- Biotech companies – Undertake product development
- Healthcare systems – Provide patient access and data
Getting perspectives from these different environments leads to a robust bench to bedside translation process.
Fostering connections through scientific conferences, partnering days, and joint publications can enable this multidisciplinary collaboration. Professional societies and trade organizations also play a valuable role.
Making space for stakeholders across fields to actively participate in the translation process is key. This facilitates the combining of diverse expertise needed to transform scientific discoveries into real-world healthcare solutions.
Focus on Patient Needs and Outcomes
Amid the scientific and technical complexity involved in bench to bedside translation, maintaining a central focus on addressing patient needs and improving health outcomes is critical. This patient-centered mindset should anchor the entire process from initial research to product approval and availability.
Some ways to embed a patient focus include:
- Involve patient advocates in shaping research priorities and clinical trial design
- Gather patient insights through surveys and interviews to understand unmet needs
- Design patient assistance programs to improve access and affordability of new therapies
- Share patient stories to motivate teams and illustrate real-world impact
- Track patient-centered metrics beyond clinical data such as quality of life improvements
- Provide patient education to enable better utilization of new innovations
Example | Description |
Patient advocates | Advise on research and trials |
Patient insights | Identify unmet needs through engagement |
Patient stories | Inspire teams by conveying human impact |
This focus on the patient experience, not just scientific data, helps ensure the solutions developed truly make a difference for patients.
Often the promise of a new therapy on paper does not fully translate into real-world benefits for patients. By proactively seeking patient perspectives, having patients be part of the process, and measuring what matters most to patients, the likelihood of success improves.
While navigating the intricacies of bench research, clinical testing, and regulatory approvals, maintaining a patient-centered mindset anchored in improving lives helps the process stay on track. This ethos of helping real people by turning science into approved treatments keeps teams motivated and inspired through the long bench to bedside journey.
Communication Between Functions
Smooth bench-to-bedside translation relies on clear communication between scientific, clinical, regulatory, and business functions within an organization. Cross-functional collaboration is powered by strong connections between teams enabling the sharing of knowledge and coordinated effort.
Here are some ways to drive productive communication:
- Hold regular project team meetings with representatives from each function to track progress and issues.
- Establish shared databases and document repositories for data accessibility across groups.
- Rotate staff on cross-functional assignments to build mutual understanding between departments.
- Foster casual interactions through open houses, talks over coffee, and team lunches.
- Host scientific seminars where researchers share bench progress with clinical and business partners.
- Create collaborative spaces with whiteboards and open seating areas for impromptu conversations.
Function | Role in Translation | Communication Needs |
Research | Scientific discovery | Share emerging data to enable translation |
Trial design and execution | Provide feedback on patient feasibility and outcomes | |
Regulatory | Navigating approval processes | Advise on requirements and submission readiness |
Business | Product development & commercialization | Plan market introduction and lifecycle management |
Breaking down silos is key to smooth bench to bedside execution. Enabling early involvement of all functions creates alignment. Two-way dialogue between groups avoids surprises and costly rework when passing the baton between research, clinical testing, regulatory review and commercialization.
Dedicated time and tools to communicate across disciplines ensures efficient flows of information, resources, and decisions. This prevents progress from stalling and facilitates the collaboration essential to translate bench science into real world impact for patients.
Partnerships Between Academia and Industry
Strategic partnerships between academic labs and biotech companies can accelerate bench to bedside translation by combining complementary strengths. These collaborations that bridge academia and industry are a powerful way to advance research from foundational science towards approved treatments.
Some benefits of academia-industry partnerships include:
- Academic expertise – Cutting-edge discoveries and techniques
- Industry resources – Funding, infrastructure, project management
- Multidisciplinary teams – Mix of research, clinical, regulatory skills
- Shared risk – Academics reduce reliance on grants while companies access innovations and talent
Partner | Value to Collaboration |
Academia | Innovative science, talent development |
Industry | Funding, development capabilities, commercialization expertise |
Types of partnerships include:
- Sponsored research – Companies fund academic labs to pursue defined projects
- Technology licensing – Academics license intellectual property to companies for commercialization
- Joint ventures – Hybrid entities jointly owned and operated by academic and industry players
- Capability centers – Labs co-located at academic medical centers staffed by company scientists working closely with university researchers
Blending the deep science expertise within academia with industry’s product development rigor and resources can accelerate translation of discoveries to the market where they benefit patients.
Careful management of culture differences and incentives is key for successful academia-industry partnerships in bench-to-bedside translation. But the investment is worth it. Combining strengths of each environment can unlock innovation and progress that would not be possible working separately.
Conclusion
The route from scientific breakthrough to patient benefit relies on smooth transitions between research, clinical testing, regulatory approval, and product delivery. For biotechnology professionals, this also represents a possible career journey from hands-on bench research to complementary roles enabling translation.
This roadmap covers key elements to traverse the long bench-to-bedside path. Of course, each product and technology will have unique challenges. But a collaborative, patient-focused mindset along with awareness of the full continuum of expertise gives both scientific discoveries and professional careers the best chance of successfully reaching their final destination.
With patience and perseverance, promising discoveries can become transformative new therapies that help patients. And bench scientists can find fulfilling new careers applying their expertise. The winding bench-to-career road awaits.
For further guidance, download our free eBook “30 Non-Bench Career Paths for Biotech Scientists”. Or search other non-bench and bench biotech jobs at Greatness.bio.