Supporting a biotech company’s phase 1b clinical trial in the US

Introduction

A biotech company developing a treatment for cancer and immune disorders planned to conduct their Phase 1b clinical trial in the United States (US). They approached Venn Life Sciences seeking a partner to provide comprehensive support for their pre-Investigational New Drug (IND) meeting and IND application to the US Food and Drug Administration (FDA).

The Challenge

The project’s complexity required expertise across multiple disciplines including chemistry, manufacturing, and control (CMC), nonclinical, clinical, and project management. The client needed a partner who could not only understand the intricacies of each discipline but also seamlessly integrate them into a cohesive strategy.

Solution

Venn Life Sciences, with its multi-disciplinary expertise and with a commitment to high-quality deliverables, provided the following services:

  • Project Management: Including the collaboration with the client’s US partner/contract research
    organization (CRO) who submitted the regulatory documentation to the US FDA.
  • Regulatory Affairs Support: Assisting with regulatory compliance & collaborating with the client to develop the pre-IND briefing package and prepare for meetings.

hVIVO plc (formerly Open Orphan plc), led by Cathal Friel, is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and long-standing client base of biopharma companies.

Click to view all articles for the EPIC:
Or click to view the full company profile:
    Facebook
    Twitter
    LinkedIn
    hVIVO plc

    More articles like this

    hVIVO plc

    Importance of Clinical Trials in the medical industry

    Clinical trials play an important role in helping to ensure new drugs can be discovered, tested for safety and efficacy, and ultimately make their way onto the market. Over a million people took part in clinical trials during

    hVIVO plc

    European Mediscience Awards 2024 shortlist announced

    The European Mediscience Awards is now in its 22nd year, having been held every year since inception in 2002*. The event is the largest annual gathering of private and publicly quoted healthcare, biotech and life sciences companies in Europe.

    hVIVO plc

    Hvivo expects Continued Growth with Record Year in 2023

    Hvivo, a pharmaceutical services company formerly known as Open Orphan, said it remained on track to hit its future growth targets after another record year in 2023. The company is set to begin paying annual dividends,

    hVIVO plc

    hVIVO to hold AGM on 13 May 2024

    hVIVO plc (LON:HVO), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, has confirmed that the Company’s Annual Report and Accounts for the year ended

    hVIVO plc

    Hvivo reports 44% Rise in earnings and Record Year in 2023

    Pharmaceutical services firm Hvivo, formerly Open Orphan, reported a 44pc rise in earnings in 2023 in a “record year across all financial and operational metrics.” Earnings before interest, taxes, depreciation and amortisation (Ebitda) increased to £13m

    hVIVO plc

    hVIVO Investor Conference

    hVIVO plc (formerly Open Orphan plc), led by Cathal Friel, is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials,