Reflecting on a Remarkable 2024; See You in 2025!
December 23, 2024

It’s our favorite time of the year, which means our team is out of the office from December 24 through January 3, taking a well-deserved break with family and friends.


As 2024 draws to a close, I want to express my heartfelt gratitude to the Georgia Bio community for an extraordinary year. Together, we have continued to advance our shared mission of fostering innovation, collaboration, and growth within the life sciences sector. Last week, we also hosted the final meeting of the year with the Georgia Bio board, sharing our vision for the association’s future growth. A special thank you to our board chair, Steve Damon, for your leadership and vision during a transitional year where we re-emerged as a 501c6 non-profit allowing us to further our policy and advocacy work which our previous designation did not allow. This significant change prepares us to have a stronger voice as we get ready to enter the 2025 legislative session. 


Our rapidly growing membership is a testament to the energy, diversity, and strength of our community. Your contributions—whether through new ideas, partnerships, or engagement—continue to propel our industry forward and solidify Georgia as a leader in life sciences innovation. Looking ahead to 2025, we are excited to build on the momentum in 2025. Our focus will be to create high-value programs, strengthen collaborations, advocate for the industry and our members at the state and federal level, and open doors to new opportunities that drive progress and improve lives through science. Together, we will tackle challenges, celebrate achievements, and continue shaping the future of the life sciences.


On behalf of Georgia Bio, I wish you a joyous holiday season filled with peace, happiness, and inspiration. I look forward to welcoming members at the Georgia Bio State Affiliate Reception at JPMorgan in early January and invite you to Save the Date for a Georgia Bio Member Appreciation reception the evening of Feb. 11th. 


Thank you for your unwavering support and commitment to our mission. Cheers to a bright and impactful 2025!

Maria

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While we're out, we invite you to share in one to two words, what you are most optimistic about for 2025. Maybe your team is growing, you are starting a clinical trial or expanding your portfolio, excited about a transformative trend in the industry, or maybe you’re a optimistic about changes to the capital markets or regulatory landscape.

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By Maria Thacker Goethe February 13, 2025
Georgia Life Sciences (GLS), representing nearly 4,000 establishments across the state, whom are engaged in the research, development, and manufacturing of pharmaceuticals, biotechnology-based medicines and foods, medical devices, biomedical technologies, life-saving technology distribution, and clinical trial management, expresses deep concern over the recent National Institutes of Health (NIH) guidance to limit funding for medical and life sciences research at universities. This decision will significantly impact Georgia’s innovation economy, workforce, patient community, and its ability to sustain its current leadership in cutting-edge research and development. This guidance will have an array of devastating effects, particularly for patients who rely on groundbreaking research to develop new treatments and cures. NIH funding has been instrumental in advancing therapies for cancer, neurological diseases, rare genetic disorders, and countless other conditions that affect millions of Americans. Patients in Georgia—and across the country—are counting on continued investment in medical innovation to extend and improve their lives. Cutting research funding slows the progress of scientific discoveries, delays critical clinical trials, and ultimately, hinders the ability to bring life-saving treatments to those who need them most. Our industry also relies heavily on Georgia’s universities and research institutions, which are at the forefront of discoveries in medicine, biotechnology, and life sciences. These advancements are made possible through critical NIH funding that supports both research and the training of the next generation of scientists, clinicians, and innovators. In 2023, Georgia institutions received over $778.1 million in NIH funding, up 24 percent since 2019, underscoring the state’s leadership in life sciences research and its commitment to improving public health. This NIH guidance severely restricts funding and undermines Georgia’s ability to compete nationally and globally, jeopardizing the state’s position as a hub for life-saving innovation. The impact of this decision will reach far beyond the laboratory. Georgia’s life sciences sector is a significant driver of economic growth, supporting over 215,000 jobs, contributing $50.2 billion in economic output, and generating over $920M in annual tax revenue. Reduced NIH funding will lead to fewer research projects, fewer opportunities for collaboration with industry partners, and ultimately, job losses in both academia and the private sector. This disproportionately affects Georgia’s communities, where life sciences research and related jobs at institutions like Emory University, Georgia Institute of Technology, Georgia State University, Augusta University, and research centers such as the Centers for Disease Control and Prevention (CDC), Winship Cancer Institute, and the Shepherd Center serve as a foundation for local economic growth. Additionally, these cuts will harm Georgia’s thriving agribusiness sector, which depends on life sciences research to develop innovative agricultural biotechnology, improve food safety, and combat plant and animal diseases. Georgia is a national leader in agricultural research, with institutions such as the University of Georgia and the USDA Agricultural Research Service playing a crucial role in ensuring food security and sustainability. Reduced funding will impede advancements in crop science, animal health, and precision agriculture, putting farmers and agribusinesses at a disadvantage in an increasingly competitive global market. This guidance also directly threatens Georgia’s ability to attract top talent and investment. The average wage in Georgia’s life sciences sector is $102,434—49 percent higher than the private sector average and one of the highest paying sectors in the state. A strong innovation ecosystem, fueled by federal research funding, is essential for retaining world-class researchers, entrepreneurs, and businesses. Limiting this support sends a troubling signal to the scientific community and could deter future investments in Georgia’s life sciences industry. Georgia Life Sciences urges the Administration to reevaluate this guidance and recognize the vital role NIH funding plays in driving medical breakthroughs, supporting economic growth, and improving public health. We stand ready to work alongside policymakers to ensure Georgia remains at the forefront of life sciences innovation, providing researchers with the resources they need to continue pioneering advancements that benefit patients, families, and key industries across the state.
February 6, 2025
The Georgia Life Sciences team has been on the road traveling from Plains to Columbus to Savannah over the last week talking life science careers! We hosted booths and made presentations at the Georgia Science Supervisors Association and Georgia Science Teachers Association Conference and at the Healthcare Science Technology Educators Association conference. Additionally, Georgia Life Sciences partnered with miniPCR to host five teachers at our Equipment Depot in Tucker for a workshop on miniPCR's Protein Expression and Purification lab. After the workshop, participants were invited to "shop" in the warehouse and took home supplies that will benefit over 1600 students. This weekend Georgia Life Sciences is holding our regional in-person biotech teacher training workshop at Chattahoochee Technical College in Canton. The final in-person workshop for this year will be March 14 and 15 at Southern Regional Technical College in Thomasville. We are still seeking industry speakers and onsite volunteers for these workshops . Please reach out to Megan Heaphy ( MHeaphy@galifesciences.org ) if interested.
By Sheran Brown January 28, 2025
ROSWELL, Ga, DUBLIN and HAMILTON, Bermuda, January 28, 2025 – Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for SL1009, Sodium Dichloroacetate Oral Solution (DCA). DCA will be used with a proprietary genetic test to treat an orphan pediatric mitochondrial disease, Pyruvate Dehydrogenase Complex Deficiency (PDCD)1. The FDA granted Priority Review for the NDA and has set a goal date of May 27, 2025, under the Prescription Drug User Fee Act (PDUFA). Priority review is designated to applications for drugs that, if approved, would provide a significant improvement in safety or effectiveness of the treatment, prevention or diagnosis of a serious medical condition. SL1009 has previously been granted Orphan Drug and Fast Track Designations. SL1009 has also been granted a Rare Pediatric Disease Designation by the FDA and thus is eligible for a Priority Review Voucher (PRV). PDCD is a rare and life-threatening mitochondrial disorder of carbohydrate oxidation that mostly affects the nervous system and skeletal muscle and leads to decreased ATP production and energy failure. DCA is a targeted therapy that inhibits Pyruvate Dehydrogenase Kinase (PDK) to stimulate residual Pyruvate Dehydrogenase Complex (PDC) activity and increase energy (ATP) production by mitochondria. "This NDA acceptance brings us one step closer to addressing the critical health challenges faced by these children and their families, where no approved treatment is currently available," said Dave Penake, Chief Executive Officer of Saol Therapeutics. “Reaching this regulatory milestone is both a significant scientific achievement and a deeply meaningful moment for everyone who has dedicated themselves to advancing this therapy. Further, designating our application for priority review reaffirms that the FDA views PDCD as a serious condition” The NDA is supported by results from a Phase 3 double-blind placebo-controlled cross-over study (SL1009-01) and a survival study (SL1009-02). The totality of evidence submitted for review in the NDA includes mechanistic characterization, along with nonclinical and clinical evidence to demonstrate the safety and clinical benefit of DCA in PDCD patients. DCA is not currently approved for any indication in the United States. About Pyruvate Dehydrogenase Complex Deficiency (PDCD) PDCD is a mitochondrial disorder of carbohydrate oxidation that mostly affects the nervous system and skeletal muscle and leads to decreased ATP production and energy failure. It is estimated that 300-500 patients are treated in expert centers in the US, and the overall prevalence is thought to be as high as 2,000. PDCD is the most common cause of congenital lactic acidosis, a life-threatening condition that may occur as early as the neonatal period. Patients suffering from PDCD may also exhibit extreme tiredness (lethargy), poor feeding, rapid breathing (tachypnea), and other signs of neurological and neuromuscular dysfunction such as developmental delay, low muscle tone (hypotonia), abnormal eye movements and seizures. Signs and symptoms usually begin soon after birth but may appear later in childhood2. There are currently no FDA-approved therapies for PDCD. About Saol Therapeutics Saol Therapeutics (pronounced "Sail") is a privately held, clinical-stage, pharmaceutical company with operations in Roswell, GA, Dublin, Ireland and Hamilton, Bermuda. Saol is focused on development activity in CNS disorders such as spasticity and pain management, and orphan diseases. Saol is committed to providing and advancing therapeutic options for patients and the physicians treating these populations. For more information, visit www.saolrx.com . Saol Therapeutics Contact Brian Nappi, Senior Vice President, Strategy bnappi@saolrx.com Source: Saol Therapeutics announces FDA acceptance of New Drug Application for SL1009 for treatment of Pyruvate Dehydrogenase Complex Deficiency – Saolrx
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