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- 03/25/2022

DCAT Week 2022 Interview: Jim Gage, Chief Scientific Officer, and Elut Hsu, Senior Vice President – Business Development, at Asymchem

Chimica Oggi-Chemistry Today
Jim Gage

Dr Gage has 29 years of experience in process chemistry, pharmaceutical development, and manufacturing. At Asymchem, he has focused on increasing the extent and depth of the company’s pharma development and manufacturing capabilities.

In every challenge is an opportunity

Highlights from our discussion with Jim Gage, Chief Scientific Officer, and Elut Hsu, Senior Vice President – Business Development, at Asymchem.

 

Access and supply

Supply chain issues have been an industry challenge over the past couple of years. However, while COVID is frequently blamed for many issues, it is worth noting that they were preceded by

quality and environmental issues in China, and in fact, those problems prepared Asymchem well for the troubles later to come.

“China had started tightening enforcement of chemical manufacturers before COVID,” points out Elut. “The number of raw material suppliers had been significantly culled even before COVID due to their inability to meet environmental regulations, so we had already responded to far-east supply chain interruptions by becoming our own custom raw material supplier.”

Thanks to this early response to pre-existing supply challenges, Asymchem was well prepared when COVID struck.

Elut Hsu

Elut Hsu has over 20 years of experience in Business Development. At Asymchem, she is responsible for management of US commercial operations and developing business in the US and Europe.

“We have more than doubled our internal capacity for back integration of starting materials and custom ‘raws’,” explains Jim. “We also expanded our network of trusted suppliers to whom we can transfer process methodology we developed to tackle these problems.  Downstream to our customers, we have become more adept at proactively addressing logistic issues that can hold up shipments.”

Asymchem’s recently-announced acquisition of Snapdragon Chemistry jump-starts the company’s plan to expand in North America.  While acknowledging increasing customer interest in on-shore manufacturing in response to perceived geopolitical risk, Jim believes that it can be easy to exaggerate this trend.

“As has always been the case, pharma partners are looking for capability:  quality, innovation, agility, and sheer muscle to muster resources,” he says. “The talent pool in Asia is very deep, and access to the market for feedstocks will continue to be unmatched for the foreseeable future.”

Improved efficiencies

Throughout the pandemic, Pharma thrived as demand grew for new and existing products to treat and manage COVID. The rapid deployment of resources to so quickly create and deliver effective vaccines and therapies was a significant success story, and Jim is keen to emphasise the integral role that contract manufacturers played in achieving that success.

However, as we emerge from COVID, it is important to remember that the world is also dealing with a climate crisis. In response to the increasing pressure, Pharma (and other industries) can expect additional constraints and regulations, and there is a continuing need to innovate to address these challenges – reducing emissions and waste, thereby improving efficiency and sustainability.

Flow manufacturing disrupted pharma manufacturing in the twenty tens as a viable option to address these challenges, and it’s an area in which Asymchem has invested heavily. 

“In 2020, Asymchem developed and implemented a flow process in a key step for a fast-moving program that enabled us to increase throughput into the range of tens of tons per month – something we could not have done nearly as quickly in batch,” explains Jim. “And of course, flow chemistry opens synthetic options for hazardous reagents (think diazomethane or ozone) that simply are not feasible in batch.”

Looking ahead

Jim and Elut are both optimistic about the future, although they are aware that staying at the top requires strategic planning, providing added value, and having a great team.

“There’s more investment flowing into pharma than ever before, as is evident in the number of annual NDAs relative to past decades and increasing number of new modalities like mRNA or ADCs,” says Jim. “While this makes it a boom time for contract manufacturers, it also makes it challenging to remain at the technological forefront.  There’s more space than ever for specialists who can help address these challenges.”

“It’s important to not just be another pair of hands, but to actively contribute technical knowledge that not only develops practical routes that are economically feasible for scaling,” adds Elut. “Newer drugs now are much more complex, and average <5mt at peak demand. The speed to launch has shrunk considerably in the last decade. The quality of the team across the board is ever so important to being able to bring a candidate to NDA filing.”

 

DCAT Week is the premier global event held annually in New York City for companies engaged in the Bio/Pharmaceutical manufacturing value chain. It is hosted by the Drug, Chemical & Associated Technologies Association (DCAT), a not-for-profit, corporate member-supported, and volunteer-led global business development association for companies engaged in the Bio/Pharmaceutical manufacturing value chain. Learn more at