Discovery support, formulation, CMC, DMPK, toxicology, regulatory, non-clinical development, early clinical development, strategic leadership, global project management. All on your terms. All on your timeline and budget. A vast number of moving parts are involved in getting a new therapy into the...
The plenary session for this session is the same as the ‘Novel platforms’ session in the ‘Engineering antibodies’ track, featuring Enkelejda Miho and Rebecca Croasdale-Wood on benchmarking the impact of AI biologics discovery and optimisation for pharma. Thereafter, there will be another three...
CMC (Wt%)(B): 0.007; Pour Point: -8; CAS No.: 24937-78-8; Formula: [C2h4o]N; EINECS: 429-840-1; Appearance: White Powder or off-White Powder; Usage: Oil Drilling Auxiliary Agent, Water Treatment Chemicals, Rubber Auxiliary Agents, Plastic Auxiliary Agents, Coa...
The benefits of faster drug development are evident, especially for products addressing unmet medical needs. While it is important to initiate clinical studies of promising lead drug candidates as soon as possible and align the CMC development program with an accelerated cli...
9 RegisterLog in Sign up with one click: Facebook Twitter Google Share on Facebook AcronymDefinition CDMOContract Development and Manufacturing Organization(pharmaceutical industry) CDMOCompact Disc Magneto Optical CDMOCentre de Droit Maritime et Oceanique(French: Maritime and Oceanic Law Centre; University...
References in periodicals archive ? Project Gotham set the benchmark, and TOCA Race Driver 2 is up there with it. Culture: Take a shine to Harvest Moon It's here that TOCA Race Driver shows its first streak of originality - this is the only ``serious'' racing game to have a story...
While you do have a point there, I'd like to point out that pretty much anything that overperformed to the degree of celestial ele got nerfed back in 2014. Back then there was an entire balance team. Now we have CmC sometimes not working on the new X-pac...(you'd think that after...
At PharmaDirections, PLs and PMs have very different roles in the project. The PL is the one who, together with the client, sets the operational strategy and direction for the project and keeps everything on track at the macroscopic level. The PM manages individual vendors and tasks, making...
and combination products. She has held leadership positions in both Big Pharma and virtual start-up organizations, overseeing the regulatory submission and maintenance programs for multiple products. Hansen’s expertise includes CMC, clinical, and non-clinical modules and extends to both U.S. an...
Its consultants bring over 100 years of combined experience specific to the cell and gene therapy industry, having deep CMC experience, focused on Advanced Therapeutic Medicinal Products (ATMPs) and their regulation by the FDA, the EMA and other jurisdictions. Arcline Investment, Dark Horse Consulting...