Biotech leaders pushing for patient-driven innovation during DIA conference

Print 20 October 2015
Shannon Ellis / BioWorld

SHANGHAI – Since July, innovation has been on a remarkable roll in the world of new drug discovery and development in China.

It started in August, with the welcome promise of sweeping regulatory reforms announced by the State Council. That was swiftly followed by two recordbreaking out-licensing deals for Chinese biotechs – Hengrui Medicine Co. Ltd. selling its PD-1 drug to Incyte Corp., and Innovent Biologics Inc.'s mega-partnership deal with Eli Lilly and Co. – both signaling to Chinese drugmakers that innovation can pay even when the market is a long way off. (See BioWorld Today, Sept. 4, 2015, and Oct. 12, 2015.)

Meanwhile Luye Pharma Group Ltd., a Chinese pharma, found it was a step closer to the U.S. market after receiving an FDA nod for its schizophrenia drug, another first for a Chinese novel candidate. And last, but certainly not least, China won its first Nobel for medicine last week, for the antimalarial artemisinin. (SeeBioWorld Today, Oct. 7, 2015.)

The cherry on top could be the first DIA China Drug Discovery Innovation Conference, which convened this week. When the organizer, Haijun Dong, DIA Greater China managing director, conceived of the event two years ago, it was unclear there would be enough content or attendees. But due to the support of biotech leaders such as Li Chen, of Hua Medicine, event chairman, and the industry's overall advances, the speakers, discussions and the 500-strong participants are satisfyingly robust.

Exclusively broaching that topic is also a first for the DIA, the U.S.-based Drug Information Association: It's the only time the organization has held an event on innovation and discovery, its usual fare being in the realm of later stage clinical and regulatory affairs.

But Dong and fellow biotech leaders are keen to see China's pharmaceutical industry make tangible advances that are meaningful to patient's lives. That will mean moving away from endless generic copycats with little benefit to patients and toward new, high-quality, innovative drugs – but only if that innovation actually benefits patients.

'EVERYTHING IS BOOMING'

The meeting kicked off with a message given by the well-respected Chen, saying, "We must address China's unmet medical needs and that means being patient-oriented." He then added, "The patients in China need advanced medicine; this requires global harmony worldwide," referring to technological advancement as well as regulatory requirements.

That was followed with an award presentation to Ge Li, chairman of Wuxi Apptec, who was honored with the first DIA Drug Discovery Leadership Award.

Aiming to be a one-stop shop for drug discovery, development and manufacturing, Wuxi Apptec has assisted many biotechs get a start via its VC arm but most importantly, through its plethora of preclinical and other contract research organization services, it has accelerated the outsourcing model, having a global industry-wide impact, said Dong.

Ge Li was not able to attend the conference, but accepting in his stead was Steve Yang, executive operating officer and senior vice president of Wuxi Apptec. He gave a speech illustrating the phenomena known as China-speed – where the speed of change may seem slow on a day-to-day basis but looked at over time is impressive.

Yang recalled a 2008 meeting of returnees, members of the invitation-only BayHelix group, attended by well-known industry leaders today. From the vantage of 2008 peering toward 2015, they attempted to make predictions – the leaders grouping themselves into pessimists, middle-of-the-roaders and optimists – looking at criteria such as biotech market capitalization, private equity and/or venture capital investment, global multinational corporation (MNC) R&D headcount and the number of innovative drugs approved and on the market. In in almost every area, even the optimists fell short of predicting the actual gains achieved by 2015.

Yang pointed out that Wuxi, with 21 labs around the globe, 10,000 employees – 70 percent of whom are advanced degree-holders – is actually a young company, though not by the standards of its 14-year history; rather, he pointed to the average age of the employees: just 29. As a result, technology uptake of tools such as the communication platform Wechat or adopting disruptive strategies inspired by Uber – whereby clinical services and equipment is managed "just like taxis" – are commonplace.

An example is the newly launched OncoWuxi App that provides a portable database of 1,000 cancer patient-derived xenograft (PDX), human cancer cell-derived xenograft (CDX), and syngeneic mouse tumor models. Under their service scope, it would seem no area is left untouched. Yang also shared that Wuxi has services in CAR-T chimeric antigen receptor, is moving into CRISP-R and CAS-9 and will go deeper into genetic sequencing.

He likened the seismic shift in China's biotech scene to an important event in evolutionary biology – the Cambrian explosion – when after a millennia little change was followed by a massive diversification of complex organisms that created what we recognize as our ecosystem today.

"My metaphor relates to the past decade. It feels like we are living in a highly concentrated and accelerated history, everything is booming and a variety of business models have been given a trial," Yang said. "We are entering a sea change of reform . . . we are very fortunate to be in this optimal time."

But that positivity was nonetheless anchored to the reality that still much work needs to be done to provide Chinese patients the solutions they need.

BENEFITING PATIENTS

The opening plenary was rounded out by another first – a unique panel comprising three head clinical physicians under the Chinese Medical Association – responsible for Rheumatism and Immunology, Oncology and Endocrinology. In a frank discussion, those high-ranking officials spoke of the enormous patient populations in their therapeutic areas and a dire lack of medical treatment options, beseeching drug developers in the audience to come up with significant solutions.

"A lot of domestic drugs are similar to the MNC products but, for example, many biosimilars are not as good as the originals. We need to have more innovative domestic drug products; we cannot simply copy other products. We need to focus on originality," said the medical expert with a focus on diabetes.

According to Dong, it is rare that drug developers and this caliber of clinical experts – the heads of China's largest teaching hospitals, running many major clinical trials with deep firsthand understanding of patient needs – meet in a forum such as this. In a country with few or weak nongovernment organizations lobbying on behalf of patients and caregivers, those experts become the voice of patients.

"We incorporated these clinical physicians to emphasize the point that drug discovery needs to start with a patient focus in mind," explained Dong.

"Specifically, these experts know if a medicine is really relevant in people not just in animals," Dong added. "Look at the Nobel win. It is not about how many patents you file; it is about how many patients you can help."

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