Carolina brings more than 15 years of strategy, business development, commercial and operational experience within the biopharmaceutical and medical device industries. Carolina joins Just from Thermo Fisher Scientific, where she most recently was Global Managing Director, Business Development. In this role, she was responsible for developing strategic partnerships across the pharmaceutical and healthcare industries for the commercialization of oncology-based diagnostics and companion diagnostics. Carolina also contributed to the organization’s efforts in precision medicine by developing data-driven business models and bioinformatics strategy.

Previously, Carolina worked for Roche Molecular Diagnostics and managed all oncology and genomics business development efforts focusing on companion diagnostics with external pharmaceutical companies. Prior to Roche Molecular Diagnostics, she served as Director, Worldwide Strategic Market Development at Cepheid, demonstrating her successful track record of turning around underperforming markets and new market penetration.

Carolina’s diverse experience also includes strategic consulting at Monitor Group (Deloitte), technology commercialization at MIT, and working as a research scientist at UCSF and Max Planck Institute. Carolina has a M.B.A. from MIT Sloan School of Management and a Ph.D. performed in Atomic and Molecular Physics at C.S.I.C. (Spanish National Research Council), C.N.R.S. (French National Center for Scientific Research) and University of California, Berkeley, where she was Fulbright Scholar.

About Just Just is an integrated design company focused on the technology of biotherapeutics from molecule through manufacturing plant. We believe that technological innovation will accelerate development and dramatically reduce the cost of these vital medicines. Just is developing a portfolio of molecules that best leverages our technological strengths. The Just mission: design and apply innovative technologies to dramatically expand global access to biotherapeutics. Come join our team of experts to help shape a better future.

Just first approached LabKey about the development of the product in mid-2015, after their evaluation of available software products left them looking for a tool that was designed specifically to meet the needs of large molecule development.

The LabKey Biologics system was designed to accelerate lab workflows and automate project management and tracking, reducing the manual process burdens that scientists are facing and giving them the ability to spend more time on data analysis. Utilizing the mature data integration and management capabilities of the LabKey Server platform, LabKey’s flagship software solution, the LabKey team was able to build an intuitive new tool with a proven foundation, available as a hosted or on-premise solution.

This first version of the software platform has been implemented at Just Biotherapeutics, and will be refined throughout 2017 according to user feedback. The team is using LabKey Biologics for end-to-end management of their pre-clinical therapeutic development process and using insights gained through the system’s reporting capabilities to refine their workflows.

About LabKey – LabKey provides software solutions to help teams overcome the data management and workflow challenges faced in today’s biomedical research environment. LabKey works hand-in-hand with clients to understand the complex needs of modern labs and develop flexible, scalable, extensible systems to address them. To learn more visit http://www.labkey.com.

About Just. Founded in 2014, Just U.S. is led by an experienced team in the fields of protein, process and manufacturing sciences. The Just U.S. team came together to solve scientific and technical hurdles blocking access to life-changing protein therapeutics, ranging from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Its focus and passion are to create access and value for a global market for compelling biotherapeutics through scientific and technological innovation. To learn more visit http://justbiotherapeutics.com

This will be the first commercial facility for Just, a company formed to significantly reduce the cost of biologics to make them more accessible to a global population. In support of that goal, the Just China plant employs a flexible, rapidly deployable and efficient design that creates a new standard for bioprocessing industry facilities. A key feature in the plant will be the use of G-CON prefabricated cleanroom PODs®. In this application G-CON PODs will be referred to as J.Pods™, representing the fully equipped processing units capable of running highly intensified bioprocesses. G-CON will simultaneously build multiple PODs® in the U.S. in parallel with construction of the host facility in Hangzhou, to significantly reduce the overall project timeline and facility readiness. Off-site pre-qualification will help abbreviate on-site qualification work once the J.Pods™ arrive in Hangzhou. Additional PODs® can be quickly deployed, redeployed or repurposed to meet increasing product demand or flexibility requirements. Finally, the facility model will be the foundation for future Just facilities, reducing the costs and timeline for each subsequent biomanufacturing plant.

The PODs will also feature AES’s Pharma Wall System, an aluminum framed, non-combustible composite panel, featuring a uPVC finish. Such panels will provide a well-known interior finish that will absorb no moisture and is impact resistant. This project will be the first time that G-CON and AES have provided a joint solution since the announcement of their collaboration in April 2016.

The facility will be in the Hangzhou Economic & Technology Development Area, an area founded in 1993 as one of China’s first state level development zones. The HEDA is a international industrial, scientific and manufacturing zone producing a number of high value products including biologic drugs, microelectronics, mobile telecommunications, optical equipment products, automobile products, chemicals and computers.

Maik Jornitz, CEO and President of G-CON Manufacturing, stated “We are seeing that our flexible, compact PODular cleanroom systems are becoming an attractive and cost efficient alternative for the industry, compared to traditional brick and mortar or stick built systems. Just Biotherapeutics has recognized that those traditional approaches are too inflexible and a principal driver to the higher manufacturing costs. We very much appreciate the teamwork together pursuing our facility innovation for their inaugural commercial scale facility. And we look very much forward continuing the team work to help change the drug manufacturing paradigm,” Jornitz added.

“Utilizing G-CON’s POD technology enables our mission of increasing access to important biologics worldwide. By creating J.Pods™ we focus our molecular and process technologies into an efficient, integrated design that enables low cost, flexible manufacturing,” said Jim Thomas, President and CEO of Just Biotherapeutics.

“J.Pod™ represents the next-generation smart manufacturing platform, providing unique advantages in fast-growing markets like China. Our aspiration is to become an innovation leader and by working with G-CON, we are confident that we will deliver high quality and affordable biologics to more patients worldwide,” added Yining Zhao, CEO of Just China.

About Just. Founded in 2014, Just is led by an experienced team in the fields of protein, process and manufacturing sciences. The Just team came together to solve the scientific and technical hurdles that block access to life changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just’s focus and passion is to create access and value for a global market through scientific and technological innovation. For more information about Just and its affiliated company Just China, visit the Company’s website at http://www.justbiotherapeutics.com/.

About G-CON G-CON Manufacturing founded in 2009 designs, produces and installs prefabricated, autonomous cleanroom PODs®. G-CON’s cleanroom POD® portfolio encompasses a variety of different dimensions and purposes, from laboratory environments to personalized medicine and production process platforms. The POD® cleanroom units are unique from traditional cleanroom structures due to the ease of scalability, mobility and the ability to repurpose the PODs® once the production process reaches the end of its lifecycle. For more information, please visit the Company’s website at www.gconbio.com.

Contact: G-CON Manufacturing email: media@gconbio.com www.gconbio.com

Just Biotherapeutics email: media@justbiotherapeutics.com

Hangzhou Just Biotherapeutics email: media@justbiochina.com

Just China will have access to Just’s dynamic tools for molecular design (Abacus™), process and product design (JP3®), and manufacturing plant design (J.Pod™), through services or license agreements with Just, to build an integrated platform for the accelerated development of low cost, high quality biotherapeutics.

“China’s biotechnology industry is innovating rapidly and Just China will bring the most advanced process and product design concepts and manufacturing processes to China, while at the same time continuing to develop high quality biotherapeutics and expand low-income populations’ access to potentially lifesaving medicines,” Dr. Yining Zhao, Co-Founder of Just and CEO of Just China added.

“Just strongly values its relationship with Just China in pursuit of our mission and will share in Just China’s success,” said Dr. Jim Thomas, Co-Founder and CEO of Just.

Just China‘s headquarters is located in the Hangzhou Economic & Technological Development Area (HEDA) – one of the key provincial development projects in the Zhejiang Province. HEDA hosts other high-tech companies in the biopharmaceutical and technology industries, as well as higher education academic institutions. Once completed, the Just China facility will be home to approximately 100 scientists and engineers.

To link to the Hangzhou Just page, click here: http://www.justbiochina.com

“We are grateful for this significant investment from the foundation, and for the loyal support of our Series A investors,” said Jim Thomas, CEO and co-founder of Just. “With this infusion of capital we will complete the buildout of our integrated lab infrastructure and add critical pilot plant and GMP manufacturing capabilities to Just.”

Previously, Just was awarded grant funding from the foundation (up to $24M, over 4 years) to develop novel technologies to lower the commercial cost of monoclonal antibodies (“mAbs”) in low income markets and to develop sequence optimized broadly neutralizing anti-HIV antibodies for low cost manufacture and improved stability. The foundation’s equity investment will enable its partners to test new low-cost products that may have a significant impact on fighting infectious diseases that disproportionately affect the world’s poorest people.

The initial Series A investment of $15M by Merck, known as MSD outside of the United States and Canada, LAV and ARCH was to advance development of a novel technology platform for biologic medicines.

About Just. Founded in 2014, Just is led by an experienced team in the fields of protein, process and manufacturing sciences. The Just team came together to solve the scientific and technical hurdles that block access to life changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus and passion is to create access and value for a global market through scientific and technological innovation.

Media Contact: media@justbiotherapeutics.com

Under terms of the agreement, Just will receive up to $9.4M in funding over 4 years to develop sequence optimized broadly neutralizing anti-HIV antibodies for clinical evaluation. Building on the discovery efforts of several leading laboratories, partially funded by the Gates Foundation, Just will improve candidate molecules to lower the cost of manufacturing and to simplify distribution in low and middle-income countries by developing more stable therapeutics. “

Just will partner with some of the best laboratories in the field of HIV research, developing biologics for HIV prevention that could potentially reduce the spread of AIDS in low and middle-income countries,” said Jim Thomas, CEO of Just. “We are grateful for this exciting opportunity”.

About Just. Founded in 2014, Just is led by an experienced team in the fields of protein, process and manufacturing sciences. The Just team came together to solve the scientific and technical hurdles that block access to life changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus and passion is to create access and value for a global market through scientific and technological innovation.

Media Contact: media@justbiotherapeutics.com

Seattle-based Just Biotherapeutics, a startup led by some highly regarded biologics manufacturing veterans from Amgen Seattle, is planning to announce today it has lined up some well-known for-profit investors who want to develop new biologic drugs that people around the world can afford. Just has secured $15 million in its Series A equity financing from Merck, Lilly Asia Ventures, and Arch Venture Partners. That cash comes a few weeks after Just obtained a five-year, up to $15 million grant from the Bill & Melinda Gates Foundation.

Just, as the name suggests, wants to make drugs for a more just world. This team spent years working together on the intricate processes of biologics manufacturing, improving yields, lowering costs. When Amgen said in July 2014 that it was shutting down its R&D in Washington, it forced many of these people with rare talents in biotech drug manufacturing to look in the mirror and think about their life’s work.

What to do next? What if they could squeeze out another order of magnitude in cost savings, making a drug for 10 cents that costs $1 today? Could they still make a reasonable profit, and pass on the cost savings to consumers?

This might sound to some like heresy, or gauzy do-gooder sentiments, but Merck, Lilly Asia Ventures and ARCH are all profit-driven businesses. This isn’t a bunch of ex-Amgen burnouts looking for some rest at a cushy nonprofit. Just CEO Jim Thomas is “among the best in the world in understanding mammalian gene expression and implications for manufacturing,” said ARCH managing director Steve Gillis, a former chief scientist at Immunex, where Thomas worked. The team, which now has 30 employees, has worked together for years. Besides Thomas, the group includes chief operating officer Victor Fung and chief scientist Dean Pettit.

While the Gates Foundation grant is clearly focused on extending Just’s protein process sciences abilities into markets of the developing world, the other investors see cost savings opening up new markets, and potentially new scientific frontiers.

“The ability to produce recombinant proteins (antibodies) at heretofore unprecedented levels could allow for commercialization of a number of products that previously were deemed impossible (multiple antibodies covering a range of pathogen strains, to name one),” Gillis said.

Just’s founding team, in an interview at their cramped startup quarters in Seattle’s Fremont neighborhood, didn’t say much about what diseases they plan to go after first.

The company’s executives did talk about how Amgen, while winding down the Seattle facility, supported some work on Ebola, in partnership with MappBio and the Gates Foundation. Like many people at pharma companies, they saw the Ebola crisis unfold in Africa on TV, and heard about the ZMapp antibody cocktail that appeared to help one of the early American aid victims. It became clear that the tobacco plant-based manufacturing system could not produce the levels of ZMapp that might be required to blunt the spread of the virus. This provided a big opportunity to work with both Amgen and the Gates Foundation to potentially meet a world health concern while launching the new venture, Just.

That led to a frenzied few months of work together, while the group was still in transition.

By February, the team had 2,000 liter manufacturing bioreactors lined up and ready go, with mammalian cell lines and vectors in place necessary to express the proteins of interest. They were in contact with the FDA, ready to scale up if necessary. “We were pressing regulatory limits. We were on the envelope,” Pettit said.

As the Ebola epidemic subsided, Thomas thought of it more as a case study he could show to the Gates Foundation and investors. The team worked well together, had scientific chops, and the necessary startup tenacity to pursue more projects like Ebola.

Just isn’t actively working on Ebola anymore, but it is interested broadly in infectious disease, Thomas said. Multi-drug resistant bacteria are an area of interest. The company’s expertise could easily be applied to making lower-cost biosimilar knock-offs of established products, but Fung, the chief operating officer, said that’s not what the company wants to do. The team is more interested in working hand-in-glove with molecular biologists on getting the upfront biology right, or at least the proper ducks in a row, for the most efficient next steps in biologics manufacturing.

Working on exciting areas of science, and pairing it with biologics manufacturing science in the early days, could be one way to crack open markets that have been traditionally ignored, Thomas said. “We think there’s going to be a flip-flop in how companies look at these opportunities and the world market,” Thomas said.

“We believe the world will be different in 10 years or 20 years, as economies progress. It won’t be like Western economics. We need to drop the cost of therapeutics–not just the manufacturing cost, but the development cost. We need to meet in the middle. It will create markets. When we ignore the majority of the world as markets, there is a compassion element to this, but there’s an economic drive here, too.”

Thomas, who has spent his entire career in the behind-the-scenes work of process sciences, is a low-key, understated personality – not the kind of CEO who seeks to dominate the room. He specifically wanted his fellow co-founders to sit in on the interview with me, and patiently watched them do most of the talking. But he’s also no shrinking violet. He’s competitive about the science, and business, at Just. “We want to be the absolute best we can possibly be in this space. The Harvard or MIT,” Thomas said.

Seattle | September 18 | 2015 – Just Biotherapeutics, Inc., an organization dedicated to expanding global access to important protein therapeutics, today announced it has secured $15M in Series A financing. The Series A funding, from Merck, Lilly Asia Ventures and ARCH Venture Partners, will enable the design of innovative technologies that accelerate development and low cost manufacturing of complex biotherapeutics. Most of the world cannot afford the breakthrough medicines of modern biotechnology,” said Jim Thomas, CEO of Just. “Designing integrated product development and manufacturing technologies will lower production costs and expand patient access. We may also enable therapies or approaches previously too expensive for the developed world as well.” In addition to the equity investment, Just and Merck, known as MSD outside the United States and Canada, have entered into an agreement to jointly develop innovative technologies for lowering the cost of manufacturing biologics. Aligned with its commitment to expand global access, Just is exploring additional opportunities with LAV and ARCH to create value by use of its technologies to bring products to a broader global population, starting with China. Just also plans to apply its innovations in manufacturing technology toward production and commercialization of new products in developed markets on its own and through collaboration with future partners.

 

About Just. Founded in 2014, Just is led by an experienced team in the fields of protein, process and manufacturing sciences. The Just team came together to solve the scientific and technical hurdles that block access to life changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. This will create value not only for the developing world, but for the developed world as well.

Media Contact: media@justbiotherapeutics.com

Seattle | September 2 | 2015 – LabKey Software and Just Biotherapeutics, Inc. have signed a multi-year agreement to develop a new software product that helps biotechnology R&D teams produce more effective and affordable biotherapeutics by optimizing development processes. The new solution will enable preclinical research groups to accelerate lab workflows, automate project tracking, and gain immediate insight into molecules, processes and resources. With data intelligence on hand, teams can focus on developing high-quality therapeutics instead of battling bottlenecks in data entry, integration and analysis. “LabKey builds software solutions that help research scientists integrate, analyze and share biomedical data, speeding their efforts to treat and cure diseases. We’re thrilled to be working with a team focused on innovation in biotherapeutics,” says Michael Gersch, CEO of LabKey Software. “We are very impressed with the Just team and their inspiring vision of bringing biologic medicines to global markets. We’re delighted to partner with them on this new product.” The two companies will design, develop and implement a LabKey Software product for biotherapeutics R&D development based on Just’s specifications and requirements. The product will also be available for other companies to use. “Today’s software solutions aren’t geared toward the problems that Just and other companies are working to solve with large molecule development,” says Jim Thomas, CEO of Just. “This partnership and resulting innovative product will make it easier for companies to accelerate the development of biotherapeutics.”

About Labkey Software. LabKey Software develops secure data solutions that help biomedical organizations integrate, analyze and share complex research and clinical information, opening doors to new modes of insight and collaboration. LabKey solutions build on the LabKey Server open source platform, so users benefit from more than a decade of past investment. LabKey Software originated at the Fred Hutchinson Cancer Research Center and has offices in Seattle and San Diego.

About Just. Founded in 2014, Just is led by an experienced team in the fields of protein, process and manufacturing sciences. The Just team came together to solve the scientific and technical hurdles that block access to life changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. This will create value not only for the developing world, but for the developed world as well.

Media Contact: media@justbiotherapeutics.com

Seattle | August 9 | 2015 – Just, an organization dedicated to designing and applying innovative technologies to expand access to biotherapeutics, today announced it has received funding from the Bill & Melinda Gates Foundation. Under terms of the agreement, Just will receive up to $15M in funding over 5 years to develop technology platforms to manufacture innovative and cost effective biologic medicines for diseases in low income markets. “Just believes that no matter where you live or what your income, every person should have access to life changing medicines,” said Jim Thomas, Just CEO. “The foundation has given us an opportunity to design innovative technologies that will help remove cost barriers to biotherapeutics.”

About Just. Founded in 2014, Just is led by an experienced team in the fields of protein, process and manufacturing sciences. The Just team came together to solve the scientific and technical hurdles that block access to life changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. This will create value not only for the developing world, but for the developed world as well.

Media Contact: media@justbiotherapeutics.com