Eileen Ang, Head of Regulatory Affairs, Takeda APAC
Companies in APAC deal with rapidly changing risk and compliance challenges to remain competitive in the market. While identifying opportunities and roadblocks, it's essential to sharpen regulatory landscape conditions, encourage government initiatives, and nurture the regulatory ecosystems for harmonisation and bilateral relations that can close-nit the markets. Eileen Ang, Head of Regulatory Affairs, Takeda APAC shares the latest APAC regulatory ecosystem insights while navigating through Asia-Pacific markets to understand trends, requirements, and regulations. Edited excerpts;
Can strategic regulatory reforms empower a company to mitigate market access risks to promote its commercialisation, trade, and investment capabilities?
Regulatory agencies should continue working towards harmonising their guidelines with internationally recognised standards or move towards regulatory convergence whereby regulatory requirements become more aligned over time through the gradual adoption of internationally recognised technical guidance documents and standards. Flexibility should be adopted to allow for reliance on or recognition of the assessments already performed by stringent authorities such as the US FDA and EMA in order to accelerate product approvals. Regulatory bottlenecks such as local QC testing and pre-approval Good Manufacturing Practices (GMP) inspections should be removed.
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Esta historia es de la edición July 2022 de BioSpectrum Asia.
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Korea develops micro-structured artificial lung model using bioprinting technology
A team of Korean researchers has made a breakthrough that will greatly enhance the efficiency of respiratory disease research, garnering attention.
Philips names Ling Liu as Chief Region Leader of Greater China
Royal Philips, a global leader in health technology, has announced the appointment of Ling Liu as the Chief Region Leader of Philips Greater China.
PW Skills launches School of Healthcare to solve India's critical shortage of medical professionals
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Australian biotech incubator Proto Axiom announces $20 M Series B first close
Proto Axiom, the Australian biomedical technology incubator, has announced a $20 million first close of its targeted $30 million Series B, to bolster Australia's biotechnology sector through increased intellectual property (IP) retention.
Biogen, Beckman Coulter and Fujirebio to develop new tests for tau pathology
Biogen Inc., Beckman Coulter, Inc. (both based in the US) and Japan-based Fujirebio have announced a collaboration to potentially identify and develop blood-based biomarkers for tau pathology in the brain and to potentially clinically advance and potentially commercialise new tests for tau pathology in Alzheimer’s disease (AD).
Pfizer upgrades pharma production plant in Melbourne
Australia is stepping up to the global fight against antimicrobial resistance, as Pfizer Australia announces a major upgrade to its manufacturing facility in Melbourne, Victoria.
mRNA as novel active ingredient - Plasmid Factory providing the template for tomorrow's vaccines
PlasmidFactory GmbH was founded in 2000 in Bielefeld/Germany with 4 employees. In the meantime, under the founder and managing director Dr. Martin Schleef, the company has become a well-known contract manufacturer (CDMO) for plasmid and minicircle DNA. Today, PlasmidFactory has ~50 highly qualified employees, and has established a GMP manufacturing facility.
"Our priorities will include identifying and understanding the challenges while engaging regularly with industry leaders to address their concerns"
K Raja Bhanu has been elevated from Executive Director to Director General of the Pharmaceuticals Export Promotion Council of India (Pharmexcil), effective July 1, 2024. Bhanu brings a wealth of experience from his distinguished career in drug control and regulation. He has a proven track record in advancing drug quality, safety, and regulatory compliance. His leadership at the Drug Control Administration (DCA) was marked by significant initiatives that enhanced drug regulation standards and reinforced India's pharmaceutical reputation globally. In his current role, Bhanu is set to drive the expansion of India's pharmaceutical exports, boost global competitiveness, and adeptly navigate the complexities of international regulations, leveraging his extensive expertise to foster industry growth and global prominence. In an interaction with BioSpectrum, he shared his plans on addressing many challenges before the Indian pharma industry to stay compliant with international regulations. Edited excerpts:
"Australia has long been a global leader in research, yet our biotech sector has not lived up to its full potential"
Australia's first true biotech incubator, Proto Axiom, has secured $20 million in the first close of its $30 million Series B round to strengthen the nation's biotech sector through greater IP retention. Anthony Liveris, CEO of Proto Axio discusses the incubator's selection criteria, identifying the most promising biotech trends for global health, and outlining the key strengths that make Australian biotech globally competitive. Edited excerpts:
Unleashing Innovative Wound Care Solutions
The incidence of wounds is rising, especially in the Asia-Pacific (APAC) region. In Australia alone, 420,000 individuals are impacted by chronic wounds, leading to direct healthcare costs of AUD $3 billion, representing 2 per cent of the country's total healthcare expenditure. Similarly, data from Singapore between 2000 and 2017 revealed that the incidence of wounds among hospitalised adults was 300 per 100,000 for those over 18 and 800 per 100,000 for those over 50. Let's explore further.