Redefining Cancer Care with Tailored Solutions and Regulatory Success!

 

One of the most arduous challenges among the numerous health concerns is oncology, a medical area dedicated to the study and treatment of cancer. With cancer becoming more prevalent and present treatments failing to successfully combat it, there is an urgent need for new techniques to address the gaps in cancer care.

Cancer is a complicated and varied disease that necessitates highly tailored and focused treatment strategies. However, many existing medicines have major side effects and low efficacy, leaving patients and healthcare providers seeking better options. In this difficult field, Biosyngen serves as a symbol of hope, ready to make a significant difference in the fight against cancer.

"Healthcare is becoming a key challenge globally, there are many unmet needs, especially in the field of Oncology. To be a part of the industry that can make a difference inspires me, and I believe Biosyngen can rise to the challenge," says Dr. Michelle Chen, CEO of Biosyngen. With these words, she conveys the primary reason for her leadership at Biosyngen, a progressing biopharmaceutical company at the forefront of healthcare development.

As co-founder and CEO, Dr. Michelle is an exemplary leader who has led the company to exceptional success in the biopharmaceutical field. Her experience in corporate management, funding, and commercial negotiations has been critical to Biosyngen's growth into a premier biotechnology company.

Under her strategic influence, Biosyngen has reached significant milestones, obtaining 8 Investigational New Drug (IND) approvals for its innovative products from regulatory agencies in both the United States and China. This achievement highlights Dr. Michelle devotion to cultivating ingenuity and providing impactful solutions to meet crucial healthcare requirements, especially within the Oncology sector.

With a deep-seated passion for transforming healthcare, Dr. Michelle has steered Biosyngen to become a prominent player in the biopharmaceutical sector through Singapore-China collaborations. Her strategic foresight and commitment have elevated Biosyngen to a pioneering position in the development of innovative therapies, bringing optimism to both patients and healthcare practitioners.

 

Below are the interview highlights:

 

Innovative ImmunoOncological Approach

Biosyngen, established in Singapore in 2016, is an immuno-oncological cell therapy company focused on developing First-in-Class products utilizing multiple proprietary technologies to target solid tumors. The company has outlined and is actively implementing a global strategy to meet unmet medical needs by providing Nova GMP cellular products designed to combat a range of solid tumors.

 

Immunotherapy Drug Development

Highlighting Biosyngen's utilization of proprietary technology platforms for R&D translation and the development of immunotherapy drugs targeting solid tumors, Dr. Michelle asserts that Biosyngen boasts in-house expertise across R&D, Clinical Development, and Technology Platforms, complemented by dual-site GMP Cell Manufacturing capabilities. She further illustrates its strategy of engaging stakeholders within the ecosystem to accelerate the drug development cycle, ensuring both speed and effectiveness in bringing innovative therapies to fruition.

 

A Comparative Analysis

In assessing Biosyngen's immunotherapies against other treatments, the key differentiators emerge in terms of clinical efficacy, reliability, and safety. Dr. Michelle elaborates on this, pointing to data from in-human trials conducted in clinical settings that have showcased promising outcomes. As a pioneering first-in-class immunotherapy, it has notably demonstrated a paramount factor: safety. Moreover, she stresses the observed efficacy, stability, and reliability reported by patients undergoing treatment with Biosyngen's immunotherapies.

 

Advancing Cancer Treatment in Phase I/II Trials

Dr. Michelle, representing Biosyngen, underscores its optimism regarding a forthcoming breakthrough in cancer treatment. Publicly available information shared by Biosyngen indicates a primary focus on addressing solid tumors, an area lacking approved immunotherapy options. The company's pipeline prominently features developments targeting Nasopharyngeal cancer, Liver cancer, Lung cancer, and Lymphoproliferative disease. Of these, leading candidates are progressing into Phase II clinical trials, while others are currently undergoing Phase I evaluation.

 

Balancing Operations

Biosyngen has been running smoothly for years, with its headquarters in Singapore and a significant clinical center in Guangzhou, as Dr. Michelle pointed out. She identified that this dual-site setup has been a crucial strategic advantage for Biosyngen. Additionally, it has established adaptable processes that can be shared between Singapore and Guangzhou, strengthening its global strategy.

 

Bringing Therapies to Market

In the field of Cell and Gene Therapy, where regulations are stringent, prioritizing patient safety and treatment effectiveness is crucial. Biosyngen understands the significance of adhering to regulatory standards and has chosen to be proactive by initiating early communication with regulatory bodies during the drug development phase.

This approach has proven to be highly effective, as Biosyngen has achieved notable success in obtaining multiple Investigational New Drug (IND) approvals within a remarkably brief period. Impressively, the company secured a total of eight IND approvals in just one year, including four approvals from the US Food and Drug Administration (FDA) and an additional four approvals from the Chinese National Medical Products Administration (NMPA).

By working hand in hand with regulatory bodies like the US FDA and CN NMPA right from the beginning, Biosyngen shows its adherence to upholding high standards while also speeding up the journey of introducing new therapies to the market. This proactive strategy not only guarantees adherence to regulatory guidelines but also enables swift access to cutting-edge treatments for patients who require them.

 

Collaborative Approach

Biosyngen's key relationships and activities demonstrate its allegiance to collaborative translational R&D and clinical development. She emphasizes their commitment to engaging stakeholders across the ecosystem. For example, to create its clinical network, Biosyngen has formed relationships with leading clinicians and cancer centres throughout the world. These cooperations span continents, including North America, Europe, Asia, and, notably, China. This network's notable partners include major clinical institutes like Stanford Medicine, Gustave Roussy, the National Cancer Centre Singapore, and Sun Yat-sen University Cancer Centre.

In addition to its extensive clinical partnerships, Biosyngen has invested in translational R&D through collaborative efforts with leading research institutions. Notably, the company has established a joint laboratory with the Agency for Science, Technology, and Research (A*STAR), a prominent R&D establishment in Singapore.

Biosyngen exhibits its fidelity to the advancement of translational R&D and clinical development in the field of oncology through these strategic partnerships and activities. Biosyngen seeks to expedite the discovery and development of novel treatments for the benefit of patients globally by utilizing the resources and experience of its partners.

 

Ensuring Scalability and Accessibility

In discussing Biosyngen's global coverage and scalability in cell therapy manufacturing, Dr. Michelle underscored its dedication to servicing the requirements of patients worldwide. She underlined the importance of contemplating patients outside their immediate surroundings, which is a critical component of Biosyngen's strategy implementation.

Biosyngen boasts dual GMP (Good Manufacturing Practice) facilities strategically located in Singapore and Guangzhou. These facilities are purposefully designed to cater to the diverse needs of patients across different regions. From its Singapore facility, Biosyngen extends its reach to cover a wide array of geographies, including Asia, the US, and Europe. Meanwhile, the Guangzhou facility specifically serves the vast population of China, in compliance with local regulations that necessitate a domestic manufacturing presence.

Crucially, both GMP facilities are equipped with the scalability required to meet fluctuations in patient demand. This flexibility ensures that Biosyngen can adapt swiftly to changing needs while maintaining the highest standards of quality and compliance in cell therapy manufacturing.

 

Translational Medicine Centre

Biosyngen's Translational Medicine Centre (TMC) is a critical component in the company's mission to become a major player in the biotechnology sector. It has used the TMC to establish critical linkages across the drug development value chain, enabling collaboration among important stakeholders such as government agencies, hospitals, physicians, regulatory authorities, and supply chain partners. This collaborative strategy not only speeds up medication development but also allows researchers to focus on scientific and clinical improvements, which drives progress in the biopharmaceutical ecosystem.

 

Vision for Future Growth and Impact

In envisioning its future growth and impact in the realm of immuno-oncology, Biosyngen places paramount importance on prioritizing patient well-being. "For us, it is the patients that come first," emphasizes Dr. Michelle. The company remains steadfast in its commitment to expanding its pipeline to address unmet needs, extending its reach beyond oncology. With proprietary technology platforms in-house and a robust R&D team, Biosyngen has demonstrated its capability in translational R&D. "This will allow the company to expand further," Dr. Michelle affirms.

 

Recognition and Client Testimonials

Biosyngen is proud to showcase its industry recognition through two prestigious awards received at the Cell and Gene Therapy Research & Development Congress Asia 2023. Its dedication and innovation have been acknowledged with the following accolades:

• Most promising Cell Therapy Pipeline in APAC

Lifetime Achievement Award: Prof. Jean Paul Thiery, Chief Scientist, Biosyngen.