For life sciences startups navigating various stages of financing, a critical success driver is having the right talent in place for each stage. Deploying a strategic resource plan consisting of both core team roles and specialized contractors is table stakes, as it gives startups the ability to function with a lean team while maintaining flexibility, scaling operations, and mitigating risk of over-investment as they move through these funding stages. This is important for any company, but especially important in the life sciences industry when each phase of drug discovery and development leads to new focus areas, new challenges, and new risks.
Seed Round Funding
Seed round funding is the first round of financing that a startup seeks from investors to help commercialize. This may be medical or biotechnology products, such as a medical device, treatment, or drug candidate.
This funding is typically used to:
- Develop an idea into a prototype
- Conduct initial research
- Establish proof of concept through preclinical
- Initial phases of clinical trials
In biotech and/or drug development, seed round funding focuses primarily on raising funds for research and development expenses, with an emphasis on:
- Chemicals analysis
- API and vendor sourcing
- Equipment purchasing
- Initial clinical testing
- Pre-clinical validation studies necessary to support an upcoming clinical trials plan
Since most biopharmaceutical startups are typically early in their discovery process, seed investments may also be used to fund foundational research, or to explore proof-of-concept in preclinical or animal models. Investors in seed rounds are typically angel investors, venture capitalists or strategic biopharmaceutical corporate partners. They offer capital and other resources such as pipelines, patents or distribution networks.
Seed funding is critical in fostering a startup’s progress because it helps early stage ventures bridge the gap between the research and development stage to biopharmaceutical and venture creation stages that provide opportunity.
Resource strategy for the seed funding stage
Critical roles for a biopharma startup during the seed funding stage are those essential to ensure that the company is able to properly position themselves to grow within a less clear environment or fact set, assess and manage uncertainties, and secure additional financing in order to build their drug product and continue funding clinical trials. Given that companies in this funding stage must be cautious of over-investment, many of the most critical roles can be brought on in either a project-based capacity or contract-to-hire, to assess fit as the asset progresses.
The following roles should be considered as soon as possible in the Seed funding stage, and are often suited to project-based, bespoke positions filled by subject matter experts. While some may remain as project-based roles, others may be integrated into full-time employment as the company grows. Considering an agile workforce strategy and customized expertise at this stage will limit personnel risk, support best hiring practices, and help you manage investment efficiently.
Ultimately, in the seed funding stage, the scientific research team must have a strong foundation in both scientific knowledge and understand regulatory compliances, while blending this into the commercial interests of the resulting drug development process as a team.
- Business/operations team: Understanding the financial management, development and maintenance of industry and sub-industry commercial operations, and ensuring sales and marketing efforts are in alignment with all regulatory requirements are critical to secure a favorable position with all possible investors, acquirers and regulatory agencies.
- Legal counsel: Biopharmaceutical/medical device intellectual property and regulation strategy development and implementation is key. Legal counsel at this stage secure and protect patent drafting/ideation, but also must be prepared to engage strategic partners for those purposes and to grow pipeline opportunities.
Series A Funding
Typically, the first round of financing after a seed round, Series A funding supports promising startups by helping them build a solid financial foundation for their businesses. It allows them to begin:
- Developing their product or service from prototype
- Moving into significant clinical trials
- Establishing the value of the product to its market
Investors in these rounds are typically venture capitalists who are willing to take on riskier investments for the potential of higher returns. Contract roles can be an effective way to bring in specialized expertise and support critical functions without committing to full-time hires.
Read also: The Value Of A Contingent Resource Strategy For Life Sciences Companies
Resource strategy for Series A funding
By leveraging contract roles when moving from Seed Funding to Series A, biopharmaceutical companies can access specialized expertise, manage costs, and maintain flexibility during the early stages of their growth. These roles can help address critical needs while the company focuses on advancing its scientific and development efforts. The following contract or contract-to-hire roles are typically most beneficial in this stage:
- Regulatory Affairs Consultant: Engaging a regulatory affairs consultant on a contract basis can provide valuable insights and expertise in navigating the complex regulatory landscape. They can assist with regulatory strategy, submissions, and compliance, helping the company meet regulatory requirements efficiently.
- Clinical Research Associate (CRA): Contract CRAs can support clinical trial operations by managing site monitoring, data collection, and ensuring compliance with Good Clinical Practice (GCP) guidelines. They work closely with clinical teams and investigators to streamline trial execution.
- Medical Writer: A contract medical writer can assist with developing regulatory documents, clinical trial protocols, investigator brochures, and other essential documents. They ensure accurate and concise communication of scientific and clinical information.
- Quality Assurance (QA) Consultant: A QA consultant can help establish and maintain quality systems, conduct audits, and ensure compliance with regulatory standards. They provide expertise in Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) to support manufacturing and quality control processes.
- Intellectual Property (IP) Attorney: Contract IP attorneys specialize in biopharmaceutical patent law and can assist in patent strategy, drafting and prosecuting patent applications, and providing advice on IP-related matters. They help protect the company’s valuable intellectual property.
- Project Manager: A contract project manager can provide expertise in planning, organizing, and executing projects within the biopharmaceutical space. They ensure efficient project management, facilitate cross-functional collaboration, and help meet milestones.
- Biostatistician: Contract biostatisticians can assist with study design, statistical analysis, and data interpretation. They play a crucial role in ensuring robust statistical methodologies and supporting decision-making based on clinical trial data.
- Data Management Consultant: As data plays a crucial role in biopharmaceutical research, a data management consultant can assist in designing and implementing data management plans, data collection tools, and data cleaning procedures. They help ensure data integrity and compliance with regulatory requirements.
- Manufacturing and Supply Chain Consultant: Engaging a contract consultant with expertise in biopharmaceutical manufacturing and supply chain management can provide guidance in optimizing manufacturing processes, ensuring quality control, and establishing efficient supply chain strategies.
- Financial Consultant: A financial consultant can assist with financial modeling, forecasting, budgeting, and valuation. They provide insights on financial strategies and fundraising efforts to support the company’s financial health and growth.
Series B Funding
After the startup has proven its viability and traction in the Series A funding stage, investors look for evidence of success in:
- Revenue assessment and/or growth
- Customer assessment, market targeting, or growth
- Company acquisition
This type of investment allows companies to scale their operations, hire more staff, and expand their market reach. In the biopharmaceutical industry, Series B investors look for signs of progression in a company’s product pipeline. Key milestones toward regulatory approval and the defined goals of clear value proposition are met or exceeded.
Signs of success Series B investors expect in biopharmaceutical companies include:
- Phase 1 and possibly Phase 2 clinical trial data, demonstrating the safety and efficacy of the proposed drug/product
- Intellectual Property that has shown to add value
- Specific Rights that have been achieved or agreement with clinical research partners/target users, partners or investors
- Partnership achievements with established pharmaceutical companies or biotech firms which assists increase credibility
- A strong team with experience in drug development. This looks like:
- Team understanding of regulatory approval processes
- Efficient clinical trials workflows
- Capability to predict any changes in the industry regulations
Ultimately, the Series B investors in the biopharmaceutical field will be looking for evidence that the company has a well-articulated long term business plan, pays close attention to research efficiency, and continually accesses controls of negative IP data.
Resource strategy for Series B funding
When biopharmaceutical companies transition from Series A funding to Series B funding, they typically experience significant growth and expansion. While building a permanent team is critical, contract, and contract-to-hire positions play a valuable role in supporting specific functions and offer flexibility while companies scale their operations.
Critical long-term roles:
- Head of Operations
- Head of Regulatory Affairs
- Head of Business Development
- Head of Finance
- Head of Commercialization/Marketing
- Head of Human Resources
- Head of Intellectual Property (IP)
- Data Science and Bioinformatics Experts
Critical contract roles:
- Clinical Operations Consultant: A contract clinical operations consultant can provide expertise in managing complex clinical trials, optimizing trial protocols, and overseeing site selection and monitoring activities. They ensure efficient trial execution while maintaining compliance with regulatory requirements.
- Regulatory Affairs Strategist: Engaging a contract regulatory affairs strategist can help develop and execute a comprehensive regulatory strategy, navigate regulatory pathways, and support interactions with regulatory authorities. They ensure regulatory compliance and facilitate the smooth progress of product development.
- Quality Assurance (QA) Consultant: A contract QA consultant can assist in establishing and maintaining quality systems, conducting internal audits, and ensuring compliance with GMP and GLP standards. They provide guidance on quality control processes, document management, and regulatory inspections.
- Biostatistician/Data Analyst: Contract biostatisticians or data analysts can support statistical analysis, data interpretation, and reporting. They assist in study design, sample size determination, and provide insights into clinical trial data, helping to guide decision-making and publication of study results.
- Medical Writer/Scientific Communicator: A contract medical writer or scientific communicator can help prepare regulatory documents, clinical study reports, scientific publications, and presentations. They ensure effective communication of scientific and clinical information to various stakeholders.
- Intellectual Property (IP) Attorney: A contract IP attorney specializing in biopharmaceutical patents can assist in evaluating patent landscapes, drafting and prosecuting patent applications, and conducting patent searches. They help protect the company’s intellectual property assets.
- Project Manager: A contract project manager can provide expertise in managing complex projects, ensuring efficient resource allocation, and coordinating cross-functional teams. They help drive project timelines, milestones, and facilitate effective communication among stakeholders.
- Market Research Consultant: Engaging a contract market research consultant can provide insights into market dynamics, competitive analysis, and commercialization strategies. They conduct market research, gather intelligence on customer needs, and support product positioning and pricing decisions.
- Supply Chain and Manufacturing Consultant: A contract consultant with expertise in biopharmaceutical supply chain and manufacturing can assist in optimizing production processes, managing vendor relationships, and ensuring efficient supply chain logistics. They help streamline manufacturing operations and support scaling efforts.
- Financial Consultant/Analyst: A financial consultant or analyst can provide expertise in financial planning, modeling, and analysis. They assist in fundraising activities, financial forecasting, and valuation, supporting the company’s financial strategy during the transition to Series B funding.
Overall, the effective deployment of project-based and contract to hire roles throughout the seed funding, Series A, and Series B funding stages allows life sciences startups to access specialized expertise, manage costs, maintain flexibility, and scale operations while navigating the complexities of drug discovery and development. By strategically hiring the right talent, startups can increase their chances of success and maximize their potential for growth in the competitive life sciences industry.
At Tandym Life Sciences, our team is comprised of leaders with decades of experience in every stage of drug discovery and development. As your hiring needs evolve, our experts are here to connect you with the talent you need for success at every stage. Connect with us here.
About Lynda Parker
Lynda brings over 25 years of pharmaceutical industry experience to Tandym Group, including 20 years of senior-level leadership in commercial strategy, business development, account management, and operations. She has deep experience across the pharma/biotech industry, having held executive leadership roles both on the manufacturer side of the business as well as various service providers. Lynda is passionate about working with life sciences clients to understand their challenges and build solutions to meet their needs for the benefit of the patients they serve.