The company is well poised to enable local development and manufacturing in India to drive affordable and accessible CGTs by academia and industry for Indian as well as global patients. In conversation with BioSpectrum Asia, Dr Boris Stoffel, Chief Executive Officer and Managing Director of Miltenyi Biotec, talks about the real challenges associated with the use of CGT, and the way forward.
Could you elaborate on the narrative behind Miltenyi Biotec’s invention of the groundbreaking technology that has led to the development of new procedures for treating diseases through Cell and Gene Therapy? How was this achieved?
Miltenyi Biotec, being a private entity, stands as the pioneer in next-generation technology within the field of Cell and Gene Therapy (CGT). The significance of this technology persists even after 35 years, as it emerged in 1989 at a time when the concept of disruptive technology was still nascent. Looking back 35 years, it's evident that our innovation was disruptive because, at that time, only a handful of labs worldwide utilised large-scale cell sorters. Specialised operators were required to sort immune cells from blood, making it a cumbersome process.
The invention of MACS technology revolutionised this landscape by enabling every researcher to utilise a simple column and antibodies coupled with small microbeads in a magnetic field to separate cells within a short timeframe. This democratisation of technology meant that researchers were no longer reliant on expensive, specialised equipment available only in select labs. At that time, Germany, for instance, had only two such sorters, one of which was located at the Institute of Genetics of Immunology, where Stefan Miltenyi, the founder, was a student.
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New South Wales government injects $5M for critical research to address Silicosis crisis
The New South Wales (NSW) government in Australia has committed $5 million in critical funding for silicosis research and a patient support programme for individuals and their families navigating the health risks associated with exposure to silica dust.
Singapore approves new asthma indication for GSK's Trelegy Ellipta
GSK Singapore has announced that the Health Sciences Authority (HSA) has approved a new indication and a new strength for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol 'FF/UMEC/VI') for the maintenance treatment of asthma in patients aged 18 years and older who are not adequately controlled with a combination of a long-acting beta2-agonist (LABA) and an inhaled corticosteroid (ICS).
What's APAC's Recipe of Success in CLINICAL TRIALS MARKET?
Asia-Pacific APAC) is emerging as one of the most promising and resilient markets for clinical trials. According to a report by Clinical Trials Arena, between 2017 and 2022, the region posted growth in clinical trials of around 10 per cent, outstripping growth in other major regions including the US, Europe and the rest of the world RoW). Asiaâs growth far exceeded the overall average figure of 5.3 per cent per year. As of 2023, the number of trials reached 14,346 in APAC. Let's delve into the thriving clinical research landscape in the region and explore the trends driving its growth.
From Haematologic to Autoimmune DiseaseThe CAR-T Therapy Second Revolution
Cell and gene therapies have revolutionised the field of medicine, offering new treatment options for patients with various diseases that, by type of disease or severity, were considered untreatable until a few years ago. Rapid technological advancements in genetic and biological engineering and improvements in the quality and standardisation of the manufacturing process are fostering a marked increase in clinical development of these advanced therapies, generally named cell and gene therapies CGT), and they are expected to receive more approvals in the near future.
"Biotech startups still need support in terms of talent, and resources to bring their innovations to market"
Raymond Chow has recently stepped in as the Vice President, Asia Pacific at USheadquartered Cytiva, a global provider of technologies and services for biological therapies, formerly known as GE Healthcare Life Sciences.
"We are exploring opportunities to collaborate with startups and incubators"
Agilent Technologies, a global leader in analytical and clinical laboratory technologies, has named Padraig McDonnell CEO-elect and Chief Operating Officer (COO), succeeding current President and CEO Mike McMullen.
"Australia offers a simple, supportive and robust regulatory process to initiate human trials efficiently"
US-based Uvax Bio, LLC, a spin-off vaccine company from Scripps Research, employs proprietary 1c-SApNP platform technology invented by Dr Jiang Zhu of Scripps Research to develop and commercialise prophylactic vaccines for challenging infectious diseases.
"Regulatory encouragement of advanced tech, including AI will accelerate clinical trials in APAC"
Lokavant Holdings, a US-based clinical trial intelligence technology company provides clinical trial intelligence that enables study teams to make data-driven decisions, as well as risk-based quality management and monitoring services to pharmaceutical companies and contract research organisations (CROs).
What Are the Main Challenges of Modern Clinical Trials?
With a cumulative total of almost 478,000 globally registered trials from the year 2000 to 2023, and growing at around 10 per cent a year in the last five years, the pharmaceutical industry continues to invest in clinical trials as the gold-standard test of therapeutic safety and efficacy. In addition, as the worldâs economies and populations move in new directions, the share of non-US trials has reached 54 per cent, a trend that is likely to continue, driven by demographics and epidemiology. As the pace accelerates, trial managers and clinicians face a significant challenge: the explosive growth of data volumes. To succeed in the future, clinical trials need to increase efficiency and better utilise clinical trial data to support informed clinical and operational decision-making.
How APAC Has Turned into Clinical Trial Behemoth
From being a consistent participant in clinical trial conduct worldwide, the APAC has emerged as a major power. A number of causes, including the region's thriving drug development innovation and the ongoing presence of international pharmaceutical corporations conducting multiregional studies, are driving this growth.