[Global Bio Conference 2019] updates.
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This article is prepared by YJ from the GBC Secretariat.
It is not an official view of the MFDS (Korea Ministry of Food and Drug Safety).
[GBC 7] Innovative Technology Forum
[GBC 3] Recombinant Protein Products Forum
[Networking] R+T Meeting and so on
Innovative Technology Development of Biopharmaceuticals and the Regulatory Perspective
The newly formed GBC7 Innovative Technology Forum will discuss core technologies in the 4th industrial revolution age. Let us take a look at what those technologies are.
#1. CM (Continous Manufacturing)
Everyone would know "the goose that laid golden eggs" in Aesop fables. The studio at the 5th Avenue in NY generating a stable monthly rent or the profitable stocks which share high dividends are likened to the goose laying golden eggs in present times. What would they have in common?
They demonstrate the attributes of clearly guaranteeing the output based on the input. There is an attribute of producing high-quality products in a consistent manner. The would the biomedicine production lay golden eggs by innovating its manufacturing measures? A lot of people have thought hard and global pharmaceutical companies are already adopting the concept of CM (continuous manufacturing) - the technology skipping the stop process from one unit to another (pause) allows consistent care (Control, the essence of QbD) and quality revision and check, and maintenance. This solution which raises equipment activation rate reduces complexity and as a result, reduces process development time and then shortens product launching period. In other words, it effectively decreases all the production, operation and footprint cost but has challenges. These are issues on technologies including long-term cell strain stability, process effectiveness examination, real-time PAT, and online monitoring control as well as issues on abiding by regulatory environments. During the first session of [GBC7] Innovative Technology Forum, CM technology adopted cases shall be studied followed by discussions on how to effectively collaborate under the regulatory environment.
#2. RWD(Real World Data) and RWE(Real World Evidence)
The 4th industrial revolution all started with Big Data. Furthermore, the healthcare which is the core field for industrial 4.0 is directly connected with Big Data. (Please visit GBC Archive page for more information on the hyper-connected, the heart of the 4th industrial revolution).
Big data in the healthcare industry is represented by RWD(Real World Data) and RWE(Real World Evidence). RWD covers information including △ Electronic health records △Claims requests and billing activities △Product and disease registries △records from health-monitoring devices. RWE is evidence based on the analysis of RWD.
Such information will serve as indexes which will represent my status more accurately than myself and this information could further be used when designing or conducting clinical trials, reviewing and making decisions over the data applied and when researchers are in the process of developing effective personalized pharmaceuticals.
The [GBC7] Innovative Technology Forum 2nd session will discuss the development of rare disease treatment using RWD and RWE, the addition of new indications, and check how developed are we on fulfilling the post-approval safety requirements, and further discuss the regulators' perspectives and our future direction.
In the movie, Ocean's Eleven (2001) the sophisticated thieves steal fingerprints and even the iris patterns to achieve what they want. Watching it could be fun and thrilling yet if it becomes your story and your information, it is no longer fun. The discussion over medical Big Data such as RWD and RWE raises concerns over whether my private genetic information or disease records might be collected or used without my consent. What could be the technology you can depend upon which could safely protect my invaluable information?
The last session of [GBC7] Innovative Technology Forum will touch upon the security features of the encryption network technology of blockchain which shares the DLT (Distributed Ledger Technology) on the P2P network, and the ideal service of PHR(Personal Health Records) where blockchain technology is adopted and then take a look at the PHR platform development using public blockchain and its future forecast.
Development Status of ADC(Antibody-drug conjugate) and the Future of Cancer Treatment
The national cancer statistics in Korea disclosed that every year over 200,000 people are newly diagnosed with cancer and circa 70,000 people are dying of cancer. Will the long struggle against cancer come to an end with the application of innovative technologies? We shall look at the most recent technology trend on ADC(Antibody-drug conjugate) which tweaks antibody in charge of the immune system, treated cases, and the future outlook.
First Biosimilar Approved by the FDA and Biosimilar Updates Maria Teresa Gutierrez Lugo, US FDA
The best experts from the various field have all gathered together. You can establish a close network among the leaders from regulatory authorities including MFDS and USP, speakers from academia, and corporation including MSD, Samsung BioLogics, Y Biologics, SCM Life Science, Pharmabcine, Quratis, Curiosis, Bio-graphene, Kobiolab, Utilex, PlantForm Corporation, and more.
Date: June 27(THU) Part 1(10am-12pm) / Luncheon(12pm-2pm) / Part 2(2pm-4pm)
Venue: Grand InterContinental Seoul Parnas Rose (5th Floor)
Pre-registration for GBC 2019 continues until June 19 (Wed.)
GBC is hosted by MFDS (Korea Ministry of Food and Drug Safety) and is completely free of charge to everyone who participates. Furthermore, open fora provide simultaneous interpretation (Korean- English) services.