Photo Courtesy of Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services recently announced that it will open a high-speed multi-purpose fill-finish line in its state-of-the-art commercial manufacturing facility in San Diego.

Photo Courtesy of Ajinomoto Bio-Pharma Services Ajinomoto Bio-Pharma Services recently announced that it will open a high-speed multi-purpose fill-finish line in its state-of-the-art commercial manufacturing facility in San Diego.

Local life science companies big and small have been going public and securing funding to advance their research and drug pipelines in what could be described as a biotech boom.

For many of these commercial companies, they turn to contract research organizations (CROs) and contract manufacturing organizations (CMOs) to help them get the job done. Additionally, the area’s life science research institutes have played a crucial role in meeting this moment of industry growth and delivering innovative work that translates to healthcare solutions.

The San Diego Business Journal connected with a few of the organizations that are supporting the life science industry and driving innovation.

Helping Companies Scale

In Q2 of this year, venture capital funding totaled $2 billion and almost half of these deals were with fast-growing life science companies. In recent months, startups have received funding, M&A deals have popped up and more than 10 biotech companies have gone public through IPOs and SPAC mergers.

Larger pharmaceutical companies often have the resources and manpower to conduct R&D operations in-house if they choose. With capital in hand, these smaller companies are moving fast and the need to scale leads many biotech companies to rely on contracting organizations to help them make it happen.

For instance, Metacrine, a clinical-stage biopharmaceutical company that specializes in therapies for patients with liver and gastrointestinal (GI) diseases, announced their IPO in September of last year. The company’s CEO and president, Dr. Preston Klassen said that as a small biotech they work with CROs and choosing the right relationship for your work is critical.

“As a small company do you go with a CRO that’s on the smaller side or do you go with one of the large CROs? Will you have enough share of mind? You really have to build the right relationships in the right way to have things work out,” Dr. Klassen said.

Kevin Lustig, CEO and founder of Scientist.com, the world’s largest AI-powered marketplace for medical research, said that San Diego has an extremely high concentration of CROs in the region. According to a website his team created about five years ago called ContractResearchMap.com, the San Diego region is home to more than 600 labs.

Lustig added that in addition to the influx of funding to the industry, the coronavirus pandemic has led biopharmaceutical and healthcare companies to reevaluate their supply chains. With this in mind, companies may opt to build relationships with contract organizations in their community for the accessibility and to minimize the risk of supply chain disruptions.

Comprehensive Solutions

Commercial biotech and pharmaceutical companies are not the only sector of the industry projected to grow. According to Grand View Research estimates, the 2021 U.S. pharmaceutical contract manufacturing and research services market is valued at $187.2 billion.

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Nobuhisa Shimba President & CEO Ajinomoto Bio-Pharma Services US

One of San Diego’s largest contract manufacturing organizations, BioLegend, recently agreed to be acquired for $5.25 billion by PerkinElmer. BioLegend is a global provider of high-quality reagents, assays, and other life science technologies. The company’s founder and CEO, Gene Lay, told the Business Journal that this deal allows them to expand into new sectors and offer their clients a more complete offering of services.

Working with a CRO or CMO that offers a variety of services is an attractive, one-stop shop option for growing biotech companies.

Ajinomoto Bio-Pharma Services US is a fully integrated contract development and manufacturing organization (CDMO), with sites in Belgium, United States, Japan, and India, providing comprehensive process development services, cGMP manufacturing and drug product fill finish services of small molecule and large molecule APIs and intermediates.

For a global CDMO with a local presence, Aji Bio-Pharma has the opportunity to impact a diverse range of life science sectors, said President and CEO Nobuhisa Shimba.

“One of the great things about being a CDMO is that we have the opportunity to impact many different diseases each year by working with a variety of clients to manufacture products currently in phase 1 clinical trials all the way up to commercial products,” Shimba said. “Last year we worked on over 50 different disease indications which is very meaningful for us. Our responsibility is to work with our clients to help make sure medicines are delivered on time to patients that need them.”

During the pandemic, the company also had the opportunity to work on a number of COVID-19 related products to help quickly meet the needs of their clients and adapt to the new way of work.

“On the client-side, the most meaningful change was the successful expansion of our virtual interactions with clients including enabling them to watch the operations performed on their products through remote viewing and conducting remote audits,” Shimba said.

Collaboration and Innovation

Before life changing treatments, from the COVID-19 vaccine to novel cell therapies, reach patients, it all starts with the dedicated work of life science research institutions. This past year, these researchers adapted not only their workflows but also their focus onto COVID-19 in addition to their core work.

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Rusty Gage President Salk Institute

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Jill Strickland SVP & Chief Administrative Officer Rady Children’s Hospital-San Diego

“I’m incredibly proud of how our researchers and administrative staff rose to the many challenges created by this pandemic, and the ability of our staff to be so effectively working from home and on-site safely,” said Rusty Gage, president of the Salk Institute for Biological Studies. “Essential work that continued included research relevant to COVID-19, such as immunity to severe respiratory viruses, but we also launched several new projects and collaborations to study such topics as the structure of the virus and whether genetic changes govern the course of the disease in the lungs.”

Salk Institute has also worked with CROs and CMOs in the San Diego community and one of the benefits of these collaborations is that it helps to bridge translation of the research discoveries and novel therapies that an industry partner will ultimately advance to the clinic.

Jill Strickland, senior vice president and chief administrative officer at Rady Children’s Hospital San Diego Research said that their team of researchers have been at the forefront of studies surrounding COVID-19, including the investigation of diagnostic options for children with MIS-C, as well as continuing cancer care, genomic sequencing for pathogen isolation and type 1 diabetes.

“In addition to continuing work on hundreds of current research studies, our team added 40 new studies to their portfolio during this timeframe, both as independent endeavors and in partnership with CROs/CMOs and external research sites,” Strickland said.

With their partners at UC San Diego and its School of Medicine they’ve cultivated a research environment that is inclusive of the regional and global communities as they search for treatment and cures to pediatric diseases, Strickland said.

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Matthew Jenusaitis, MSE, MBA Chief Administrative Officer — Oncology and Radiation Therapy UC San Diego Health and Moores Cancer Center

 

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Marcus Hompesch, M.D. CEO & Chairman of the Board ProSciento

“Within the ever-growing field of medical research, exploring ways to identify, treat, prevent and even cure pediatric health concerns presents a set of challenges that is often quite different from adult studies and trials,” Strickland said. “Because children have their own unique needs, pediatric-focused research is essential to advancing effective, safe and innovative pediatric-focused care — as we always emphasize, children are not tiny adults and deserve solutions created just for them.”

Connecting with Experts

Working with subject matter experts and specialized contracting organizations is also a key to what makes San Diego’s biotech community so vibrant and attractive for growing companies.

Matthew Jenusaitis, chief administrative officer, Oncology and Radiation Therapy at the UC San Diego Health and Moores Cancer Center said that as a leading cancer research institution, they have been one of the top innovators in the field. Recent funding to research institutions and commercial companies is really just providing the fuel to accelerate innovation that is part of the DNA of the industry.

“The university is working very collaboratively with the private sector, and it’s bringing together a lot of really active research that’s really changing the face of cancer, and changing the face of how we do things,” Jenusaitis said.

Additionally, right across the street from the Moores Cancer Center there are more opportunities for cutting edge research to grow into commercial solutions at the Center for Novel Therapeutics (CNT). Jenusaitis said that this facility, which was designed to accelerate cancer research to clinical trials and then to market, offers space for researchers to grow their discoveries into something bigger.

Having subject matter experts at the head of a commercial operation is a huge advantage for a startup both clinically and financially, said Marcus Hompesch, M.D., CEO and chairman of the board at ProSciento, a specialty CRO.

With 17 years of experience, ProSciento does the comprehensive planning of programs for life science companies, with a specific focus on non-alcoholic steatohepatitis (NASH), diabetes, obesity and related metabolic diseases.

Dr. Hompesch explained that having subject matter experts guide decisions early in the process is a huge benefit that pays off when making decisions for a company, especially a small biotech figuring out the best investment for their capital.

While it could be pricier in the short-term to invest in a local CRO versus an international one, building the relationship with a specialized company pays off in the long run.

“I think we are just at the beginning of seeing growth in the specialty CRO domain we’re really working with subject matter experts who know your indication by heart and deeply, care about the science and good science behind your integration, who can enable...early decision making for you,” Dr. Hompesch said. “You have every opportunity to discover every relevant safety or efficacy concern, early on, if you’re giving it the right thought.”


A clinical laboratory scientist works in the Rady Children’s Institute for Genomic Medicine lab. Photo by Earnie Grafton, courtesy of Rady Children's Hospital.