![[Pasted image 20240321133618.png]] - rare disease is growing fast (phase2 data focused; ) - in new modality (regulatory approval - first one goes to new indication) - mrna vaccine (covid; fda gave smooth (clinical decreased from 7 years to several years)) - discovery (10k moledculr), preclinical (300), clinical (700m, 5molecule) ### how did china followed up - starting from 15 as eliminating ma backlog, defined new drugs def 16, approved 40 drugs (most of them from us) in 18, new patent law in 20, highest investment in chain in 21, going global in 22, after covid investment decreased by half (sell assets back o us) - comparing us and china (new drug due to clinical, target identification to new clinical), pd-1, glp-1, (5 times faster than ); ??i&d instead of clinical then sell data back to us - intial concept comes from manufacturing - china is leading advanced treatemtn (i&d studies) - us is the best place to do drug discovery (too many trial ; competing studies) ; ?? published 4 times - iit (investigated inital trial); hospital based ethical committee, no gmp study, no glp tax, run the risk of quality data? (don't have to wait china approavl); iit data could not be used for (international ; clinical data is much better for advanced trial ; no immune system) - highest market (astro aenka acquire grid cell, $1.7b; onlyhas iit data) - iit trial data is applied to gene theraphy? (china is bad place to start trial) - iit has treatment effect (massive ind; phase1,2 combined trial) - dual rack regulation model in chain (medical tech, drub; ) - derive product any product ### new architecture - sequential and parallel: regular (discovery, preclinical, ind, clinical , bla, post-market ) vs unconventional (discovery, preclinical, ind, clinical, bla, post-market) the latter separated , "IIT in CN" so that it can de-risk clinical (just like i use 2023 hw to insert in 2024 hw) - dual track regulation mode in china where cell therapies affect both med tech and drugs which are each supported by NHC, IITs and NMPA, INDs - feasibility protocol, integrated db exists for ministry of health but each companies need to establish internal db: people insurance (inclusin, exclusion) - give product (fee is waived), site, training need - combined timeline for validated target (manufacturing 12-18month ) - process development database, # Compliance with GLP/GMP GENERI BIOTECH is a GLP/GMP-certified quality-focused provider of outsourced services to the pharmaceutical, biotechnology and medical device industries, mostly specializing in (pre)clinical development. Our quality system meets the most stringent requirements from regulatory authorities. **GLP** refers to a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical and pharmaceuticals non-clinical safety tests. Laboratory tests under GLP are mostly required by companies developing new drugs. **GLP** system is audited by national drug and administration authority. **GMP** – Good manufacturing practice – system audited by national drug and administration authority. It is required for those tests that are ordered by pharma companies to release a batch of a drug to the market. **GMP** system is audited by national drug and administration authority. quality of product VS quality of delivery mech (how much inserted has arrived to liver (taregt dest)) - quality of product can affect quality of process (% of capped mrna affects safety )