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Advancing the U.S. Bioeconomy and Building Resilient Pharmaceutical Supply Chains

We continue to see the U.S. government setting policy priorities that underscore the importance of both building a robust American bioeconomy and strengthening domestic pharmaceutical supply chains – two core pillars of Antheia’s business and technology.

ln 2021, the Administration released the Supply Chains Executive Order, which outlined the need for “resilient, diverse, and secure supply chains to ensure our economic prosperity and national security.” The executive order outlines four critical supply chains that have a direct and significant impact on both economic and national security: high-capacity batteries, semiconductors, critical minerals, and notably, active pharmaceutical ingredients (APIs).

Jumping forward to 2022, President Biden released the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The bioeconomy executive order called for sweeping investment and bolstering of domestic biomanufacturing technologies and infrastructure that can transform industries as varied as pharma, energy, and agriculture.

As a company leveraging synthetic biology to solve urgent supply chain problems for key starting materials and active pharmaceutical ingredients, we are uniquely positioned at the intersection of two executive orders that have catalyzed action across the U.S. government. The following reports are a product of these executive orders and represent a comprehensive analysis of the opportunity and path forward to establish a world-leading biomanufacturing ecosystem and onshore critical supply chains:

  • The White House Office of Science and Technology Policy along with several agencies, including the DOE, DOD, HHS, Commerce, and USDA released its Bold Goals for U.S. Biotechnology and Biomanufacturing. These goals aim to guide policymakers and the private sector for the next two decades as they together establish R&D priorities that will be critical to advancing the bioeconomy. The report highlights the vast potential of biology, noting that, “Recent global disruptions, geopolitical conflicts, and weather events exposed the vulnerability of U.S. supply chains critical for industrial production,” and citing synthetic biology as a solution, “to replace existing production processes, such as for precursor materials, and to create new products, resulting in new opportunities for diversifying production pathways and alleviating supply chain chokepoints. For example, realizing biomanufacturing breakthroughs for active pharmaceutical ingredients (APIs) has the potential to create environmentally sustainable, domestic alternatives to API production, which is currently heavily concentrated abroad.”
  • The Senate Committee on Homeland Security and Governmental Affairs explored the pharmaceutical supply challenges we face as a country in a new report: Short Supply: The Health and National Security Risks of Drug Shortages. From 2021-2022, new drug shortages increased by nearly 30% with a record five-year high of 295 active drug shortages at the end of 2022. The average drug shortage lasts about 1.5 years and more than 15 critical drug products have been in shortage for over a decade. The report states that, “Overreliance on foreign and geographically concentrated sources for critical drugs and their key starting materials and limited domestic manufacturing capabilities create health and national security risks.” This report reinforces the Supply Chains Executive Order, which recognizes APIs as one of four critical U.S. supply chains. While the other three supply chains have been addressed with legislative bills (e.g., the CHIPS and Science Act and the Inflation Reduction Act), APIs still require a legislative push that will direct resources to the public and private entities that can transform these pharmaceutical supply chains, onshore production, and end shortages of essential medicines. This is an urgent problem and will require legislation that drives increased investment in domestic advanced manufacturing – such as biomanufacturing – for critical drugs.
  • Antheia was proudly involved in the development of a strategic action plan from the Special Competitive Studies Project. Co-founder and CEO, Christina Smolke contributed to the development of The National Action Plan for U.S. Leadership in Biotechnology, which outlines a series of policy recommendations to ensure American leadership in this critical industry. The recommendations range from incentivizing commercialization to developing the key biomanufacturing infrastructure to cultivating the next generation of biotechnologists. A desired end state from the report includes, “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,” stating that, “modernization of pharmaceutical supply chains drives more equitable health outcomes globally.”

As a company, we remain steadfast in our mission to transform pharmaceutical supply chains and ensure more equitable access to essential medicines. From establishing a thriving U.S. biomanufacturing infrastructure to building more resilient pharmaceutical supply chains, Antheia sits squarely at the intersection of several of the U.S. government’s key imperatives.

We are proud to see such close alignment across two of the Administration’s executive orders and several recent reports that reinforce the importance of fermentation as the leading manufacturing technology of our generation. We look forward to seeing continued action from these agencies and departments that will help propel our efforts in building resilient pharmaceutical supply chains with synthetic biology.

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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.

U.S. Secretary of State Antony J. Blinken visits Antheia to discuss biotechnology innovation

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