Biotech Whitepapers Filter by Date 2023 2022 2021 2020 2019 2018 Category Asia Pacific Landscape Cardiovascular Cell and Gene Therapy CNS Early Phase Gastrointestinal Infectious Disease Rare Disease Regulatory/ DDC/ FDA Vaccines Oncology Metabolic Disorders September 19, 2023 Whitepaper Infectious Diseases – Global Clinical Trial Landscape (2018-2023) In the twenty-first century, the world has been dealing with large outbreaks of infectious diseases, which have not o Download September 13, 2023 Whitepaper Cell and Gene Therapies Global Clinical Trial Landscape (2018-2022) With the potential to completely transform how we treat life-threatening diseases, cell and gene therapies are at the Download September 5, 2023 Whitepaper Rare Disease – Global Clinical Trial Landscape (2018-2022) Exploring the Rare Diseases Global Clinical Trials Landscape: Unveiling Challenges, Trends, and Promising Adv Download June 2, 2023 Whitepaper Oncolytic Virus Therapies– Global Clinical Trial Landscape - Focus On Asia Pacific Asia Pacific showed consistent and the fastest growth in Oncolytic Virus therapy trials in the past five years, excee Download May 2, 2023 Whitepaper RNA Therapies – Global Clinical Trial Landscape - Focus On Asia Pacific Asia Pacific had the fastest five-year growth rate compared to rest of the world in RNA therapy trials with the regio Download March 31, 2023 Whitepaper Antibody Drug Conjugates – Global Clinical Trial Landscape - Focus On Asia Pacific Asia Pacific ADC trials grew consistently to reach over 35% share of global trials in 2022, from just over 25% in 201 Download March 28, 2023 Whitepaper Navigating the FDA Approval Processes: Capitalize on Regulatory Expertise to Simplify the Complex While global turbulent conditions in the development market over the past few years have introduced novel forces to t Download March 2, 2023 Whitepaper Multi-Specific Monoclonal Antibodies – Global Clinical Trial Landscape - Focus On Asia Pacific Asia Pacific has been the fastest growing region in multi-specific monoclonal antibody trials since 2018, with the re Download February 8, 2023 Whitepaper Phase I Trials Global Clinical Trial Landscape – Focus On Asia Pacific Asia Pacific has been the fastest growing region in Phase I trials in the last ten years, reaching a share of 58% in Download December 16, 2022 Whitepaper Bispecific Antibodies - CMC Considerations Bispecific antibodies (bsAbs) are genetically engineered, recombinant antibodies that consist of two distinct binding Download December 13, 2022 Whitepaper State of the Global Biotech Landscape: Where the Opportunities Lie Over the last five years, the global biotech and pharmaceutical landscape has witnessed continued growth. Download December 12, 2022 Whitepaper Vaccines - Asia Pacific - Clinical trial landscape Between 2017 and 2021, there were close to 1,400 industry sponsored single country vaccine based clinical trials glob Download November 8, 2022 Whitepaper Non-Clinical Testing Considerations: Drugs vs Devices While drugs and devices differ in their development, clinical trial phases and regulatory guidelines, the most import Download November 8, 2022 Whitepaper Top Therapeutic Areas APAC-CT LANDSCAPE 2022 The global clinical trial landscape has changed significantly, with the Asia Pacific involved in more than a third of Download October 25, 2022 Whitepaper The China Biotech Landscape – Opportunities in China and the Path to USFDA Approval Global biopharma companies are looking to capitalize on value creation across different geographic regions through ut Download September 23, 2022 Whitepaper Understanding the benefits of the Analytical Target Profile (ATP) The 2022 revised version of ICH Q14 describes the ATP as a prospective summary of the performance characteristics des Download August 5, 2022 Whitepaper Immuno-oncology – Asia pacific – clinical Trial landscape Asia Pacific has shown significant increase in Immuno-oncology trials between 2017 and 2021 and contributes to more than a third of the global clinical development of Immune-oncology drugs. Download August 1, 2022 Whitepaper Modern Technologies Transforming Clinical Development in the APAC Region Traditional clinical trial models are outdated and causes multiple issues for patients, trial sites, and sponsors. Download June 28, 2022 Whitepaper The role of real world evidence to support US FDA and TGA registrations Real world evidence (RWE) can contribute valuable information to new medicine registrations, in particular for diseases that are difficult to assess in randomized clinical trials (RCTs) and for emerging technologies such as gene and cell therapies to help enhance our understanding of such products. Download May 26, 2022 Whitepaper Next Generation Sequencing NGS profiling improves patient outcomes while also lowering treatment costs and time to diagnosis for cancer patients Download May 26, 2022 Whitepaper Evolution of Clinical Trials in the Asia Pacific Region Compared to the US and the EU5 Over the last five years, the global clinical trial landscape has changed significantly. During the analysis period between 2017-2021 Download August 19, 2021 Whitepaper Clinical Development Strategies for Western Biotech Companies in China China’s evolving regulatory reforms have greatly impacted review and approval timelines, streamlined processes, and expedited the development of innovative drugs. Download May 26, 2021 Whitepaper The Benefits of Asia-Pacific Clinical Trials For Biotechs There has been a continued shift of innovation from big pharma companies to biotechs, with the latter paving the ways for advancements in the life sciences industry. Download August 27, 2019 Whitepaper Asia: Preferred Destination for Clinical Trials Asia is the fastest-growing medicines market globally, with China currently the world’s second-largest market after the US, with medicines spending of $137 billion in 2018, up $40 billion from a decade earlier. Download August 27, 2019 Whitepaper Australia: Preferred Destination for Early Phase Clinical Trials The clinical trials process is complex. It requires substantial investment and skilled human re-sources, and involves risks, not least, the navigation of complex regulatory processes. Download Load More