National Cell and Gene Manufacturing Blueprint
With the rapid and ongoing global growth of cell and gene (C&G) products, there is an opportunity for Australia to be a regional C&G hub. This report was commissioned by AusBiotech and delivered by Biointelect to build on 2021’s Regenerative Medicines Consortium Programme and produce a National Blueprint for the strategic growth and development of […]
Pioneering A New Children’s Food Allergy Treatment
With the evolution of biotechnology, addressing allergy treatments for children offers hope for a future where the young can lead lives unrestricted by common food allergens.
A pre-clinical stage Biotech Company aimed to develop its first product for novel food allergy treatment in children through clinical proof of concept before partnering with a global pharmaceutical firm and its currently raising capital to support pre-clinical development program.
With the collaborative assistance of Biointelect, the company’s venture to secure investors was strategically streamlined, ensuring their pioneering approach to children’s food allergy treatments was robustly supported, well-researched, and optimally positioned in the market.
Nanoparticle Drug Reformation: A Biointelect Product Development Strategy
With oncology treatments rapidly growing in interest, the quest to refine and perfect drug delivery mechanisms is paramount. Utilising nanoparticles, a biotech company stands on the verge of reformulating three approved oncology drugs, targeting the expansive US and EU markets.
Biointelect has played a critical role in sculpting the company’s strategy, from inception to investor readiness. It is with Biointelect’s assistance that the biotech company could pivot from concept to a formidable market contender, with a clear and strategic vision for investor engagement.
Protected: Bringing Nuvaxovid™ to Market: A Novavax Case Study
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Bringing Patient Centricity to Life in Australian Healthcare
The current healthcare environment in Australia offers various opportunities for stakeholders, including patients, to engage with the health system and government in reform efforts. These opportunities arise from factors such as increased awareness of the importance of efficient approval processes for medicines and vaccines due to the COVID-19 pandemic, ongoing reviews of health technology assessment […]
A Regulatory Strategy For Innovative Drug Device Combination
In the realm of drug and device regulations, having a partner to navigate the complexities can significantly alter a company’s trajectory.
Biointelect collaborated with an early-stage Australian manufacturing firm, crafting a preliminary regulatory strategy for their innovative drug device combination, ensuring they’re not just compliant but also competitive.
At the crossroads of innovation and regulation, the firm sought a strategic compass which they found in Biointelect. This partnership ensured the firm was not only set on a path of compliance but also primed for success in the competitive drug-device landscape.
HTA Roadmap For a New Vaccine in Australia
The landscape of vaccines in Australia is marked by stringent guidelines and a competitive marketplace and above all a focus on patient outcomes.
Biointelect partnered with a pharmaceutical company, well-versed in the Australian market but new to the vaccine domain, to develop a roadmap that would not only introduce their new vaccine but also potentially secure it a coveted position on the National Immunisation Program (NIP) with premium pricing.
Streamlining Quality & Safety: Development in QMS and Pharmacovigilance
In the rapidly evolving world of biotech, adhering to global quality and safety standards is paramount.
A US-based biotech company faced this exact challenge, requiring a Quality Management System (QMS) and Pharmacovigilance (PV) system that would stand up to the exacting standards of major regulatory authorities.
Biointelect collaborated with the client to ensure compliance without compromising efficiency. It was this alignment of expertise and insight that propelled the company to a new level of global operational readiness and compliance.
Navigating European Market Access: A Strategic Blueprint for Novel Vaccines
Introduction The European medical market is the second-largest medical device market following the US, requiring newfound innovation for pharmaceutical companies to reach success. A US Biotech firm, on the cusp of introducing a groundbreaking first-in-class vaccine, sought Biointelect’s expertise to illuminate their path in this intricate and highly saturated market. With Biointelect’s strategic guidance and […]
Developing a Winning Business Case: Securing NHMRC Grant for an Antibiotic Solution
Antibiotic resistance is a looming global health challenge, with the ESKAPE pathogens leading the charge. Amid this urgent need, a university research group has broken new ground with a patented product that promises to dismantle this resistance.
Biointelect’s partnership was enlisted to bolster their pursuit of the esteemed NHMRC Development Grant, offering an integrated approach leading to a strengthened grant application, optimised strategy, and subsequently, successful grant acquisition.
