Biotech Whitepapers

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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

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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

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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

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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

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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

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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

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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

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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

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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

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December 16, 2022 Whitepaper

Bispecific Antibodies - CMC Considerations

Bispecific antibodies (bsAbs) are genetically engineered, recombinant antibodies that consist of two distinct binding

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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.

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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

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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

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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

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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

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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

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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.

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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.

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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.

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May 26, 2022 Whitepaper

Next Generation Sequencing

NGS profiling improves patient outcomes while also lowering treatment costs and time to diagnosis for cancer patients

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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

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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.

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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.

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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.

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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.

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