In part two of our discussion with BeiGene’s Diana Francis, VP Quality & Compliance, we turn her attention back to two concerns with China: IP theft and quality breaches. Then I’ll wrap up our overall discourse to date, with two observations on what we’ve learned this past year about China’s growing connection to the global biologics industry.
It was time within our ruminations on China to speak directly with a quality executive at a drug developer and manufacturer based there. That’s now accomplished via a discussion with Diana Francis, Vice President, Quality & Compliance, BeiGene, Ltd., a biopharma some have dubbed as a potential “Genentech of China.” Francis spoke openly about her role, BeiGene’s global strategy, and outsourcing within and from China.
We’ve heard the calls for help: “We’re drowning in oceans of data.” But I’ve learned that those further “downstream” may end up high and dry when it comes to having sufficient data to allow drug developers and manufacturers to fully actuate artificial intelligence (AI) and machine learning (ML). Here’s what some experts had to say.
“… the people you’ve been talking with are just not seeing all the components of the global biopharmaceutical industry — and this huge market opportunity. China will become a big player in biologics. This is only natural; there’s good reason for that.” Here’s a more positive outlook on the current situation in China, from Eric Langer, President, BioPlan Associates, Inc.
We ended our last editorial wondering about a regeneration of start-up service provides, after so much M&A in recent years. Will biotechs particularly have smaller service providers to help with their specific drug development and manufacturing needs? Well, there's at least one new option in town. It could be a sign of things to come.
Private equity is providing the M&A fuel for CDMOs, fill-and-finish specialists, and clinical and commercial packaging partners. Big Pharma readily encourages this industry consolidation. But not everyone is on board. Two experienced financiers agree both investors and Big Pharma have their reasons for pushing consolidation, but the verdict is still out on to what degree, big is better for the industry as a whole.
Often the team [for a biopharma company or NGO/donor] deciding on a grantee or production partner for vaccines does not include both: (a) someone who can predict the credibility of the candidate based on the potential for a sustainable quality system, and (b) diagnose the reliability of the company's promises.” In other words, what's needed is a process to access the culture of drug development and manufacturing partners, particularly in developing countries …
“Basically, industry perceives, reports, and expects no major capacity crunches” related to global bioprocessing needs. So concludes an editor of BioPlan Associates, Inc.’s Fifteenth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (April 2018), in a response to my recent editorial saying as much. Now we have the data to back the assertions up.
Vadim Klyushnichenko of The Scripps Research Institute works with some 10 CDMOs at any given time. He's developed methodologies for handling due diligence, project and product quality for both drug substance and drug product, and timelines and budgets. But perhaps most instructive is his management — and best practices — for handling all the analytical services his programs require through development and manufacturing at his service providers.
Vadim Klyushnichenko, PhD, CSCP, VP Pharmaceutical Development and Quality, California Institute for Biomedical Research (Calibr) and The Scripps Research Institute (TSRI), excels at enumeration.