5 Fastest Growing Biotech Startups to Watch in 2021

    How can you ensure your life science startup succeeds? Start by modeling your growth path after those that have come before you and gotten the results you're hoping for.

    Fortunately, there are plenty of great growth stories to model your approach after. As an industry-leading eQMS partner, we've worked alongside some amazing life science startups and scale-ups. We've seen the growth path that these organizations have followed firsthand.

    In most cases, growing biotech startups share a few distinct commonalities, including a strong proof-of-concept, venture capital, and clinical safety for regulatory approval.

    Further, a strong baseline of compliance is crucial from day one to ensure that there are no barriers to obtaining FDA approval.

    5 Fast Growing Biotech Startups to Watch in 2021

    To ensure FDA compliance, many growing biotech startups have made significant investments in quality management software (QMS) from the outset. This software unites a company's team, processes, and data—making it that much easier to comply with FDA guidelines.

    Qualio's easy-to-use eQMS platform empowers quality teams to move from paper-based spreadsheets to digital systems. As a result, all employees can support the organization's quality management objectives more efficiently.


    In addition to investing in a modern quality management system, we recommend keeping tabs on the following biotech startups in 2021 and beyond.

    1. CURE Pharmaceutical

    CURE Pharmaceutical is a vertically integrated drug delivery and development company that makes a unique delivery platform called CUREform. The company is focused on developing new ways to deliver medicines, supplements, and cosmetics.

    The CUREform platform aims to support the optimal delivery of therapeutic activities by automatically combining the right dosage and the right formulation. Moreover, the CUREform platform includes a signature oral dissolvable film called CUREfilm, which helps make medications easier to produce while increasing efficacy. Additionally, the company is working on developing a novel chewable drug delivery system called CUREpods, which will support high doses with increased solubility and absorption.

    2. Cerevel Therapeutics

    In 2018, Pfizer and Bain Capital joined forces to create Cerevel Therapeutics, a clinical-stage biopharmaceutical company that studies the biology of the brain and uses advanced chemistry and pharmacology to design innovative therapies.

    Cerevel's work is focused on curing neuroscience diseases, including Parkinson's, epilepsy, and schizophrenia.

    3. Passage Bio

    Passage Bio is focused on a niche area: treating rare monogenic central nervous system disorders. The biotech firm prides itself on putting patients at the center of every decision it makes. Key elements of the company's efforts include:

    • A focus on rare, underserved CNS indicators
    • Rapidly advance lead product candidates into clinical development
    • Extend existing and new relationships with patients and advocacy groups
    • Continue to developing proprietary manufacturing capabilities

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    4. HiberCell

    HiberCell develops therapeutic molecules that overcome the foundational barriers that prevent patients from living longer, cancer-free lives. The company was launched in 2019 by ARCH Venture Partners and other leading investors in life science.

    By building on pioneering tumor dormancy research conducted by the Julio Aguirre-Ghiso Lab at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, HiberCell has become a multi-asset company dedicated to cancer research and clinical trial development.

    5. Qpex Biopharma

    Qpex Biopharma is invested in treating and managing infectious diseases in both inpatient and outpatient environments. The company — which has demonstrated success in the discovery, development, and approval of medicines that target these diseases — boasts a well-rounded product portfolio and pipeline.

    Recently, Qpex announced a Phase 1 clinical study of QPX7728, a novel ultra-broad-spectrum beta-lactamase inhibitor.

    “Today marks another important milestone for Qpex as we begin advancing three novel product candidates into clinical trials during the coming months,” explained Michael Dudley, Pharm.D., president and chief executive officer of Qpex Biopharma. “We believe that QPX7728 has demonstrated a preclinical profile that exceeds that of recently marketed beta-lactamase inhibitors, as well as those in ongoing clinical trials."

    Unlock Quality Management Success in 2021

    If you're looking to take your biotech to the next level in 2021, an eQMS that's designed specifically for medical device manufacturers and biotech startups can simplify and streamline startup success.

    With the right eQMS in place, your organization can achieve highly specific regulatory requirements for data capture, retention, and documentation.

    For this reason, Qualio is a favorite eQMS vendor among growing medical device manufacturers, biotech companies, and contract service providers.

    That said, not all eQMS systems are the same. Before selecting an eQMS, we recommend downloading our free guide: 12 Questions to Ask Before You Buy an eQMS. Read it to learn more about how to select an eQMS option that:

    • Is tailored to your company's growth stage
    • Provides the level of support you need
    • Delivers the tools to help you identify industry-specific regulations
    • Fits your current budget
    • Offers increased flexibility

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