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PharmaBlock Attended APRDL Shedding Light on CMC Challenges in Drug Development for Expediting New Drug Approvals

2019-04-19

Recently PharmaBlock attended APRDL 2019 (The Asia Pharma R&D Leaders Summit), which is designed to bring in fresh perspectives and scientific advancement on emerging therapeutic areas in Oncology, Immuno-Oncology, CAR-T & TCR Cell Therapy, Neurodegenerative Diseases & Diabetes which the global drug R&D industry are heavily investing in Asia. 


On the occasion, Dr. Shijie Zhang, Chief Technology Officer at PharmaBlock shared insight in his speech themed on CMC Challenges in Drug Development in the Era of Expedited New Drug Approvals.


 

Dr. Zhang delivered a speech at APRDL 2019


Below are some key points from Dr. Zhang's speech:


Reducing Time to Market for New Drugs

1. From business perspective, intensified competitive situation between drug candidates, the key to lowering R&D cost, and the capital pressure facilitate drug development to advance in high gear.

2. From policy perspective, positive progress has been made to expedite new drug approval process.

3. From scientific perspective, precision medicine changes development paradigm and makes shorter clinical trials available.


CMC Challenges of Drug Substance Scale-up

1. Clinical development timelines is potentially reduced from 7-10 years to 3-5 years

2. CMC must expedite drug substance scale-up significantly to support clinical development to ensure fast, sustainable, and safe supplies.

3. CMC must get ready for commercial production in much shorter timeframe without sacrificing quality



 



PharmaBlock's Commitment to Drug Development in the Era of Expedited New Drug Approval

1. Supports to move projects at full speed with practical process for building blocks and accumulated knowledges and know-hows.
2. Supplies RSMs and intermediates with consistent quality, thus to minimize unnecessary cost caused by unexpected impurities.
3. Embraces new chemistry and engineering technologies, including flow chemistry, applying fixed-bed catalytic reactors, biocatalysis etc. to tackle scaling-up challenges.
4. Fully complies with national and industrial regulations, along with strategic supplier management, to ensure sustainable supply from starting material to key intermediates.



During the panel in the afternoon, PharmaBlock Marketing Director Ms. Chen Chen, along with founders or chemistry heads from Roche, HEC Pharma, Eccogene, Jing Medicine, and Haiyan Pharma, discussed drug discovery collaboration strategy and guideline altogether.


 

Ms. Chen shared at the panel


Below are the panel excerpts

Dr. Hong Shen (panel facilitator and head of chemistry from Roche): How does Pharmablock make strategic decisions in building infrastructure and growing teams, talents and capabilities?


Ms. Chen: Over the past decades, we developed our teams, capabilities and infrastructures all around building blocks, for the strategic purpose to accelerate drug R&D throughout the whole process


Horizontally, we continue to expand the portfolio by designing the novel and enabling building blocks for drug discovery. With a belief in "focus makes us experts", we keep strengthening our expertise in specialized chemical series and tackling challenging chemistry with accumulated and intensive knowledges and experiences. 


Vertically, as more and more drug candidates applying our building blocks move into clinical development, we have been growing our teams in process R&D, manufacturing, chemistry technologies and compliance system to ensure the sustainable supply of building blocks, advanced intermediates or custom synthesis projects with higher quantity, lower cost, and consistent quality. Many of the team leaders have lots of experience working in CMC or Process R&D departments at top pharmaceutical or fast growing biotech companies.


Dr. Shen: How do you keep a balance between reasonable profit margins and clients' need for cost-saving?


Ms. Chen: Profit is important, but sustainable partnership deserves more attention. I believe that the industry is transitioning from a cost-saving model into an added-value model.To achieve this, you must keep expertise and innovative. When we keep designing the novel building blocks and be the first to supply as the scientists need, we win the market. When we keep investing in the new technologies and applying them to the projects, we create the value for clients by lowering the cost, reducing the environmental risks, and shortening the lead time; these will definitely bring you sustainable partnership and the long-term profit will follow.


 

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