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Tag: Christina Smolke

Secretary of State Antony J. Blinken Tours Antheia, Discusses the Importance of Biotechnology Innovation in the United States

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Visit demonstrates U.S. commitment to bolstering the domestic biotechnology industry and onshoring critical supply chains, including pharmaceuticals Menlo Park, Calif., May 6, 2024 – Antheia, the pharmaceutical ingredient manufacturer transforming essential medicine supply chains, today hosted Secretary of State Antony J. Blinken for a tour of its state of the art labs, as well as a discussion on biotechnology innovation and leadership in the United States. During his visit, Secretary Blinken met with a panel of industry and policy experts from Atomic AI, Ginkgo Bioworks, MycoWorks, Stanford University, and Twist Bioscience. The discussion was moderated by Christina Smolke, Ph.D., CEO and co-founder at Antheia and focused on the critical role of biotechnology to U.S. national and economic security, the need for strong international partnerships to develop solutions for global good, and the urgency to maintain U.S. leadership in this critical emerging technology.  “We are grateful to Secretary Blinken for his time and attention today, as well as the U.S. government’s continued commitment to advancing biotechnology and biomanufacturing,” said Dr. Smolke, CEO and co-founder, Antheia. “With the ongoing support of both the public and private sectors, a future with resilient, sustainable pharmaceutical supply chains, minimal disruptions to critical drug supplies, and equitable access to essential medicines for all is well-within reach.”  On September 12, 2022, President Biden issued Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” According to the White House, “global industry is on the cusp of an industrial revolution powered by biotechnology.” As part of the scope of the biomanufacturing executive order, the Department of State is working to promote and protect U.S. technologies and the global bioeconomy.  By Antheia’s estimates, advanced biomanufacturing can enable domestic production of over 50 percent of the key starting materials (KSMs) and active pharmaceutical ingredients (APIs) underlying essential medicines at a fraction of the time and cost of conventional manufacturing. Antheia’s first product, thebaine, is a key ingredient used in the production of several drugs on the U.S. Food and Drug Administration and the World Health Organization’s Essential Medicines lists. Antheia’s processes have been validated at scale, demonstrating this technology’s viability, commercial-readiness, and societal impact. About AntheiaAntheia is the next-generation pharmaceutical ingredient producer transforming essential medicine supply chains to end drug shortages. Using its novel whole-cell engineering approach, Antheia’s biomanufacturing platform enables the reconstruction of biosynthetic pathways of unprecedented complexity in yeast cells and the scaling of fermentation processes to commercial levels. This highly flexible approach enables on-demand, agile, and resilient biomanufacturing of critical pharmaceutical ingredients, replacing legacy approaches that cannot support the needs of modern healthcare. For more information, visit www.antheia.bio. MEDIA CONTACT:  Mission North for [email protected]

Antheia CEO Keynotes at OECD Global Forum on Technology: Building our Bio Future  

Last week, Antheia CEO and co-founder, Dr. Christina Smolke joined OECD’s Global Forum on Technology: Building our Bio Future as a keynote speaker. OECD (Organization for Economic Co-operation and Development) is an international organization bringing together government, academia, and industry to build global policies that foster prosperity and well-being for all. In her keynote address, Dr. Smolke discussed the transformative power of synthetic biology, its role in solving major challenges across industries including pharma supply chains, and how policy can support a flourishing synthetic biology industry.   This forum brought together some of the brightest minds across the synthetic biology field from around the world. A recurring theme from the event’s discussions, both on- and off-stage, was the need to align stakeholders from all aspects of this international industry. The urgency to develop sustainable manufacturing solutions is rapidly increasing as natural resources are depleted and supply chains repeatedly falter. The global population is at risk of failing supply chains, but with a coordinated effort between industry, academia, government – specifically, policy, governance, and regulation – synthetic biology has the potential to fundamentally transform these legacy systems to better support the public at large.   As a pioneer in the field of synthetic biology with more than 20 years of experience, Dr. Smolke offered a unique perspective on the evolution of this technology and its current role as an advanced manufacturing technology for critical pharmaceutical ingredients. Pharma is one of the most vital global supply chains, but it is also one of the most fragile and unreliable, with serious consequences (e.g. drug shortages, inadequate patient care) for human health when something goes awry. Synthetic biology offers an innovative solution to build resilient, agile, and sustainable supply chains for pharma, as well as other critical industries like food, agriculture, and industrial materials.   As a global community, countries need to consider how to support and incentivize the advancement of synthetic biology to unlock benefits for all people and the planet. This could take the shape of public-private partnerships, funding, or policies that provide incentives to bring these innovative solutions to global markets. Synthetic biology is a powerful technology for solving major, global problems and is on the precipice of reaching its full potential. With the right policy, support, and prioritization from leaders like those present at OECD’s Global Forum on Technology event, we will continue to see growth and transformation stemming from synthetic biology innovation.   Follow Antheia on LinkedIn and X/Twitter. 

Antheia’s 2023 in Review: A Year Of Transformation

Dear colleagues, friends, and supporters: As we approach 2024, we want to take a moment to look back over an absolutely astounding year of progress for our business and give thanks to the many who made it possible.  Nearly a decade of hard work culminated in an industry-first achievement here at Antheia. In August, we announced our first successful commercial-scale fermentation run of our debut product, thebaine. For Antheia, it represented a moment in our history where an entirely new model for pharmaceutical supply chains was proven viable. This achievement also marked an industry inflection point, heralding a new frontier of scalable biomanufacturing of highly engineered microbial organisms with 25-30 complex, heterologous biosynthetic steps and more than 20 enzymes. Over this past decade, we’ve taken this scientific innovation from theory, to lab bench, to viable commercial production. With this year’s debut of our first products in a pipeline of 70+ key starting materials (KSMs) and active pharmaceutical ingredients (APIs), we’ve only just scratched the surface of what’s possible in terms of using this platform to produce critical pharma ingredients for essential medicines. As early pioneers in this field and stewards of this proven and scaled technology, our determination to bring this biomanufacturing solution to the world has only grown with this year’s progress.  The need and urgency for this solution persists; this year the healthcare industry faced relentless shortages in critical drug classes, including central nervous system therapies, antimicrobials, fluids/electrolytes, hormones, and chemotherapies, while the pharmaceutical industry continued to struggle to resolve these shortages in a timely and effective manner. Over the past five years, we’ve seen the occurrence of new molecule shortages triple, with a striking 84% of the drugs in shortage being generics. Combined with the persistence of up to 50 new drug shortages annually and an average shortage duration of 1.5 years, pharma supply chains underpin a dire situation in healthcare that demands immediate attention and comprehensive resolution. Fortunately, we see a brighter future. Our estimates show that more than 50% of the drugs on the U.S. FDA Essential Medicines list can be made via biomanufacturing technology. With this reality now within reach more than ever before, the U.S. – and more broadly, the world – is quickly realizing the potential of synthetic biology as an advanced, and much-needed manufacturing solution. Just this year, we were proud to contribute to The National Action Plan for U.S. Leadership in Biotechnology. The plan outlines a series of policy recommendations with the end goal being an “agile, rapidly-scalable, distributed biomanufacturing base that efficiently produces the majority of essential medicines and makes affordable medicines available to everyone who needs them.” As further legislative efforts have – and continue to – emerge, we are encouraged to see the industry and the U.S. government moving in the same direction, toward the same shared goal: to capture the full potential of synthetic biology and unlock solutions that will materially improve the availability and supply chains of essential medicines.  As we approach 2024 and this next chapter of our business, we want to take a moment to recognize what truly makes Antheia so great. It isn’t just the continued scientific innovation or our operational development that makes 2023 such an impressive year of transformation, but the phenomenal team of people behind it. We believe in a world where patient care and health equity are never jeopardized by global pharma supply chain vulnerabilities, and our growth would not have been possible without the exceptional colleagues that are dedicated to this mission each and every day.  Our wins this year, and our success next year and beyond, are thanks to our team and our many supporters – we look forward to another big year as we advance our commercial strategy in 2024.  Cheers, Christina Smolke, PhD | CEO and Co-Founder Kristy Hawkins, PhD | CSO and Co-Founder

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Richard Sherwin

Head of Commercialization

Richard is an industry veteran with more than 30 years of experience in the KSM, API, and intermediate markets. He is responsible for leading the commercialization and revenue generation for Antheia’s robust pipeline of products. Richard brings an exceptional track record of leading international sales teams, driving revenue growth, building strategic partnerships, and delivering innovative products to market, including ANDA and NDA developments. Richard led commercial efforts at some of the leading global pharmaceutical companies and most recently, built his own consultancy business advising a range of clients, including $1B divisions of major multinationals.

Appropriate regulatory submissions will be prepared and submitted to support Antheia’s customers who need to reference and access necessary process-related information.

Yihui Zhu, PhD

Head of Fermentation

Yihui leads the fermentation team at Antheia. With over 25 years of hands-on experience in the field, he brings in-depth knowledge and expertise in microbial metabolism and fermentation process development. He is also skilled in developing comprehensive fermentation data collection, analysis, and visualization systems. Prior to joining Antheia, he served as a fermentation lead at Intrexon and Codexis where he successfully built fermentation labs and teams and led multiple biofuel and biochemical projects to reach stretch milestones and tech transfer. Yihui is passionate about the potential of fermentation and is dedicated to advancing the field through innovative research and development.

Yen-Hsiang Wang, PhD

Head of Strategy, Partnerships, and Finance

Yen-Hsiang leads strategy, partnerships and finance at Antheia. He completed his M.S. and Ph.D. in Bioengineering at Stanford, with extensive research experience in synthetic biology, metabolic engineering and computational modeling. Before joining Antheia, he worked at McKinsey and Tencent with a strong focus in corporate strategy and big data/advanced analytics. At Tencent, he served as Director of Strategy and Business Development for the AI Lab, leading corporate initiatives in healthcare AI/ML applications and commercialization. He also served in AI4H (Artificial Intelligence for Health), a collaboration between WHO and ITU, to establish global standards for AI in healthcare.

Audrey Wang

Head of Financial Planning and Analysis

Audrey leads financial planning and analysis at Antheia. With an MBA from Washington University in St. Louis, Audrey is passionate about leveraging financial analysis, digital technology, and data analytics to guide companies in making optimal investments and strategic business decisions. Audrey has a decade of experience in helping companies solve unique problems and creating long-term impact with unconventional approaches. Before joining Antheia, she was at Vir Biotechnology and Merck where she led various FP&A workstreams, including investment valuation, asset prioritization, and manufacturing sites operation finance support. Audrey completed CFA Level II and passed the U.S. CPA exam in 2011.

Antonij Tjahjadi, CPA

Head of Accounting

Antonij Tjahjadi leads accounting at Antheia and holds active CPA license. He joined Antheia with more than 20 years of experience in corporate accounting, bringing deep expertise in ramping up accounting operations for start-up companies, SEC reporting/technical accounting, and SOX implementation efforts. Before joining Antheia, he held various leading roles in both public and private company settings, including directing accounting functions at Ambys Medicines, where he successfully implemented Netsuite with Point Purchasing integration and set up various accounting policies and processes, and played a key role in the initial public offering of Nutanix, Inc.

Ken Takeoka

Head of Biology

Ken leads the Biology team at Antheia, which incorporates both strain and protein engineering functions. He has more than 16 years of experience in the synthetic biology field, working with leading companies, including Amyris and Novartis. One of his passions is molecular biology tool development and he previously worked to build the foundation for the automated strain engineering pipeline at Amyris. At Novartis, he modernized the molecular biology techniques and established a platform to model mechanisms of antibiotic resistance in a range of organisms.

Suzanne Sato

Head of Downstream Processing

Suzy leads downstream chemistry processes at Antheia. She has 19 years of experience in process development, including route development through synthetic chemistry and scale-up of small molecule APIs for GPCR targets under cGMP for Phase I-III trials. Before joining Antheia, Suzy led a full DSP team at Amyris where she successfully pivoted developments from biofuels hydrocarbon products to pharmaceutical intermediate, flavor, fragrance and nutraceutical products. She led a team that scaled 11 products and took five products to commercial manufacturing.

Farrah Pulce, PMP

Head of Project Management

Farrah leads program and project management at Antheia. She has over 20 years of experience leading program and project management, operations, and engineering for companies across the CPG, aerospace, and automotive industries. Prior to joining Antheia, Farrah implemented and led the sustaining program management team at Impossible Foods. She also led product operations, project management, and cost optimization at Blue Bottle Coffee and Tyson Foods to develop and commercialize new products. As a certified project management professional (PMP), Farrah has a proven record of successful project delivery, improving project management practices, and building collaborative teams.

Jordyn Lee

Head of Communications

Jordyn leads communications and external affairs at Antheia. She brings a decade of multidisciplinary communications experience in helping companies make complex science and technology accessible to broad audiences, all while maintaining technical accuracy and integrity. She has a passion for visionary storytelling and translating impact across the entire communications ecosystem – her work has spanned from public relations to corporate communications to marketing. Jordyn has served as an advisor to a number of different life sciences companies and most recently led corporate communications at Amyris.

Ben Kotopka, PhD

Head of Data Science

As Head of Data Science at Antheia, Ben manages in-house software development and external partnerships for storing and interpreting research data, executing bioinformatics analyses, and streamlining business processes. Prior to Antheia, Ben worked as an academic researcher at the intersection of machine learning, bioinformatics, and synthetic biology. Following this, as an entrepreneur and consultant, he developed and deployed data science solutions for biotechnology applications ranging from metabolomics-driven compound discovery to MRI segmentation.

Guerin Kob

Head of Supply Chain

Guerin is responsible for leading the design, development, management and improvement of Antheia’s end-to-end global supply chain. He has over 15 years of experience leading high-performing supply chain and procurement teams at leading biotechnology and specialty chemical companies, with extensive experience in process development and end-to-end supply chain optimization. Prior to joining Antheia, Guerin served as Senior Director of Global Supply Chain for Sumitomo Chemical’s biotechnology division with Valent Biosciences, where he led the end-to end supply chain including procurement, logistics and distribution, integrated business planning, materials management, customer service, and supply planning functions globally.

Pavel Aronov, PhD

Head of Bioanalytics

Pavel leads the Bioanalytics team at Antheia. He has 20 years of experience in analytical and clinical chemistry, mass spectrometry, chromatography, and metabolomics. Pavel built and led the original Chemistry and Analytics team at Impossible Foods enabling strain development, fermentation, DSP, regulatory, QC, and scale-up of leghemoglobin biomanufacturing. During his academic career at UC Davis and Stanford University Pavel developed a vitamin D assay used by all major clinical diagnostics laboratories and pioneered metabolomics studies to investigate kidney disease and microbiome.

Jesse Ahrendt

Head of Quality Assurance and Regulatory Affairs

Jesse has more than 25 years of experience in regulatory affairs, quality systems, manufacturing quality, and regulated industries, ranging from early- to late-stage pharmaceuticals, biomanufacturing, consumer care, and medical devices. He has supported global product launches and the underlying quality supply chain components in industries that require strict adherence to internationally accepted quality standards. Before Antheia, he led quality efforts at Zymergen and Sandoz, and supported many global pharmaceutical companies during his time in Biotech Consulting at NSF International, all to bring quality to the forefront in manufacturing, standardize global processes, and support customer regulatory requirements.

Heidi Pucel

Chief People Officer

Heidi is a results-driven human resources executive and HR business partner who leverages decades of experience in empowering, motivating, and inspiring to drive transformation within high-performing and rapidly-growing workforces. A certified executive coach and passionate advocate for people-oriented solutions, Pucel serves as a partner to executive teams to design programs that support employee development, engagement, and recruitment and retention. Pucel most recently served as Chief People Officer for Countsy, where she worked as an interim HR executive for clients in the biotechnology and software industries, such as Ceribell and Tune Therapeutics.

Zack McGahey

Chief Operating Officer

Zack is a leading executive in operations management, specializing in bioprocess engineering and manufacturing management. He has over 20 years of experience leading manufacturing functions for companies across the pharmaceutical, synthetic biology, diagnostics, and automotive industries. Before joining Antheia, Zack was VP of manufacturing and capex project management at Zymergen. He also gained experience managing commercial scale facilities operations for Tesla, where he was responsible for managing 10 million square feet of factory, lab and warehouse space during the Model 3 ramp.

Kristy Hawkins, PhD

Co-Founder & CSO

Kristy has over 20 years of experience in the field of synthetic biology, focusing on yeast metabolic engineering for the production of small molecules. She did the founding work on the benzylisoquinoline alkaloid pathway during her graduate studies and gained valuable industry experience at Amyris and Lygos. Kristy is an expert in tool development, high-throughput screening, and host strain and heterologous pathway engineering.

Christina Smolke, PhD

Co-Founder & CEO

Christina is a pioneer in synthetic biology and metabolic engineering, where she has over 20 years of experience. As Professor of Bioengineering and Chemical Engineering at Stanford University, her laboratory led the breakthrough research to engineer baker’s yeast to produce some of the most complex and valuable medicines known. Under her leadership, Antheia’s synthetic biology platform enables new possibilities for drug discovery and efficient, sustainable, transparent, and on-demand drug manufacturing at scale. Her vision and accomplishments have garnered numerous awards, including the Chan-Zuckerberg Biohub Investigator, NIH Director’s Pioneer Award, Nature’s 10, Novozymes Award for Excellence in Biochemical Engineering, and TR35 Award.

Antheia Secures Second BioMaP-Consortium Project Valued at $12M

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Appropriate regulatory submissions will be prepared and submitted to support Antheia’s customers who need to reference and access necessary process-related information.