We are looking for 2019 Fiercest Women in Life Sciences

Fiercepharma | July 22, 2019

Its becoming a familiar refrain- Women are making headway in the workplace. In 2019, more women are serving in Congress than ever before, and various industries the life sciences included are well into implementing programs to boost diversity. Hows pharma doing. By one measure, pretty well. The biggest pharma companies on the London Stock Exchange nearly tripled the number of women on their executive committees between 2018 and 2019. But that sort of progress didn't extend to all top job titles, and some long-familiar challenges for women remain—in the industry and without. Take the U.S. national women’s soccer team, which has been petitioning its governing body for equal pay even as it wins more championships and brings in more revenue than the men’s team. Its players sued U.S. Soccer in March for years of “institutionalized gender discrimination,” three years after a wage discrimination complaint filed with the Equal Employment Opportunity Commission went nowhere. Things don’t look much better for women in the corporate world overall. In its latest “Women Count” report, which studies the 350 largest companies trading on the London Stock Exchange, U.K. gender diversity business The Pipeline found that a measly 3.7% of companies had a female CEO—down from 4.6% in 2017—and that more than 85% had no female executives on their boards. One of those companies was GlaxoSmithKline with its CEO, Emma Walmsley. And pharma companies did a little better than their peers within their executive committees. Pharma's Financial Times Stock Exchange companies almost tripled female representation on exec committees to 26% from 9% in 2018.

Spotlight

Robert Reich explains why prescription drug prices are so high in the United States, and how we can make them more affordable. The prices of brand-name prescription drugs are typically much higher in the United States than in other developed countries, but right now there are strict limits on when and how consumers can buy drugs from other countries. Setting up a system that would ensure the safe and legal importation of less expensive prescription drugs could help put pressure on drug prices and allow consumers to save on medications.

Spotlight

Robert Reich explains why prescription drug prices are so high in the United States, and how we can make them more affordable. The prices of brand-name prescription drugs are typically much higher in the United States than in other developed countries, but right now there are strict limits on when and how consumers can buy drugs from other countries. Setting up a system that would ensure the safe and legal importation of less expensive prescription drugs could help put pressure on drug prices and allow consumers to save on medications.

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PHARMA TECH

Specifica Announces Antibody Discovery Platform Transfer Agreement with Sanofi

Specifica | June 03, 2022

Specifica, a privately held antibody engineering company focused on innovative in vitro antibody libraries and discovery tools, announced an agreement with the global healthcare company Sanofi under which Specifica’s patented Generation 3 Antibody Discovery Platform will be transferred to Sanofi. The comprehensive technology transfer package will enable the integration of Specifica’s Gen 3 platform into Sanofi’s antibody discovery programs. “We are absolutely delighted to partner with Sanofi and their cutting-edge antibody discovery teams by providing our complete antibody discovery platform through a combination of Gen 3 libraries, antibody optimization solutions, and integrated discovery tools. We look forward to the realization of our collaboration with Sanofi as they continue to pursue the development of life-changing treatments.” Ken Sharples, CEO and co-founder of Specifica Specifica’s Gen 3 libraries combine clinically validated antibody frameworks with compatible binding loop sequences (CDRs) from natural human antibodies that have been purged of sequence-based developability liabilities. The Gen 3 discovery platform consistently yields a broad diversity of specific and developable antibodies with very high affinities, thereby avoiding downstream hit-to-lead optimization bottlenecks such as affinity maturation and developability optimization. About Specifica Specifica is a rapidly growing antibody engineering company specializing in the creation of exceptional antibody libraries, using next-generation sequencing for quality control at all steps of construction and validation. Specifica’s patented Generation 3 Antibody Library Discovery Platform yields drug-like antibodies directly from selections, minimizing the need for downstream affinity and biophysical engineering. Specifica provides its partners with exclusive libraries, each created from a unique donor diversity set not used for any other library, ensuring that each Gen 3 library is one of a kind. Specifica offers antibody library platforms in Fab, scFv and VHH formats. In addition to in-house antibody library designs, Specifica also collaborates closely with partners to create custom libraries in which essential elements are optimized according to partner needs. The power of the Generation 3 Platform may be accessed by engaging Specifica to execute antibody discovery and optimization campaigns, or by full transfer of the platform technology. Additionally, Specifica recently introduced AbXtractTM, a powerful suite of antibody informatics tools, through its software partner OpenEye. Specifica is headquartered in Santa Fe, New Mexico

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PHARMA TECH

Silverback Therapeutics and ARS Pharmaceuticals Announce Merger

Silverback Therapeutics and ARS Pharmaceuticals | July 22, 2022

Silverback Therapeutics, Inc. and ARS Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which ARS will merge with Silverback in an all-stock transaction. The combined company will focus on the potential regulatory approval and commercialization of neffy, ARS’s investigational epinephrine nasal spray for the treatment of Type I allergic reactions including anaphylaxis. The combined company is expected to have approximately $265M in cash, cash equivalents and marketable securities at closing. Upon stockholder approval, the combined company is expected to operate under the name ARS Pharmaceuticals and trade on the Nasdaq Capital Market under the ticker symbol “SPRY.” The merger is currently expected to close in the fourth quarter of 2022. Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 25 million people in the United States who experience Type I severe allergic reactions. Of those, only 3.3 million currently have an active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency. ARS designed neffy to provide injection-like absorption of epinephrine, in a small, easy-to-carry, easy-to-use, rapidly administered, and reliable nasal spray device. With its needle-free administration, neffy may help eliminate the anxiety and hesitation associated with using an autoinjector. “We are extremely pleased to announce this proposed merger with Silverback, which we believe enables ARS to maximize the paradigm-changing opportunity of neffy. neffy is on the cusp of achieving what has not been possible before – the ability to deliver epinephrine with comparable pharmacokinetics to an intramuscular injection, but with a simple to administer nasal spray. We have completed a comprehensive registration program with neffy and based on a favorable pre-NDA meeting with the U.S. Food and Drug Administration (“FDA”), we are preparing to submit our New Drug Application (“NDA”) in the third quarter of 2022. This merger positions ARS and our experienced team to execute on the potential launch of neffy in 2023 by providing the requisite capital needed for launch. ARS was founded with a mission of solving many of the issues that patients and caregivers express about their epinephrine autoinjectors. Today is an important step toward bringing this novel treatment to patients and caregivers to improve their treatment options for these serious and potentially life-threatening allergic reactions.” Richard Lowenthal, M.Sc., MSEL, co-founder and chief executive officer of ARS Data across three registration studies supports that neffy should meet all clinical endpoints recommended by regulators and that its pharmacokinetics are within the range of approved efficacious epinephrine injection products. In addition, neffy has been well-tolerated to date with more than 500 individuals having received at least one dose, and many with repeat administration. The majority of adverse events in clinical trials were mild in nature and comparable to injection products. Based on the totality of data, ARS is preparing to submit its NDA for neffy for use in adults and pediatric patients who are 30 kg or greater in the third quarter of 2022. If approved, ARS is planning to launch neffy in the United States in 2023. “This transaction represents the result of a thorough and thoughtful strategic review process by Silverback,” said Laura Shawver, Ph.D., chief executive officer of Silverback. “ARS is an exciting late-stage company with compelling clinical data demonstrated with neffy, a path to near-term commercialization in a large and dissatisfied market, and an expert team with proven experience in launching and commercializing market-leading nasal spray products, such as NARCAN. I believe we have found the optimal partner to provide value for our stockholders, and even more so, the potential to transform treatment for millions of people with or at-risk for Type I severe allergic reactions.” About the Proposed Merger Under the terms of the merger agreement, assuming that Silverback’s net cash at closing is $240 million, Silverback equity holders are expected to own approximately 37% of the combined company and pre-merger ARS equity holders are expected to own approximately 63% of the combined company on a fully-diluted basis on a treasury stock method. The percentage of the combined company that Silverback’s equity holders will own as of the close of the transaction is subject to certain adjustments as described in the merger agreement, including the amount of Silverback’s net cash at closing. Upon closing of the transaction, Silverback will be renamed ARS Pharmaceuticals, Inc. and will be headquartered in San Diego, California. Richard Lowenthal, M.S., MBA, will serve as chief executive officer and president of the combined company. The merger agreement provides that the Board of Directors of the combined company will be comprised of ten members, including seven from ARS and three from Silverback. The merger agreement has been approved by the Board of Directors of each company, and the transaction is expected to close in the fourth quarter of 2022, subject to approvals by the stockholders of each company and other customary closing conditions. About Silverback Therapeutics, Inc. Silverback Therapeutics, Inc. is a biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of chronic viral infections, cancer, and other serious diseases. Silverback’s platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Silverback Therapeutics is located in Seattle, Washington.

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BUSINESS INSIGHTS

Septerna Strengthens Leadership Team to Advance Novel Small Molecule GPCR Medicines

Septerna | July 29, 2022

Septerna, a biotechnology company discovering and advancing novel small molecule medicines targeting G protein-coupled receptors announced the addition of Liz Bhatt, MS, MBA, as Chief Operating Officer, and Ran Xiao as Vice President of Finance and Business Operations to its leadership team. Septerna launched in January 2022 and is growing a pipeline of differentiated products using its GPCR Native Complex™ platform to unlock the vast untapped potential of GPCR drug targets for a wide range of diseases. We are thrilled to welcome Liz and Ran as we continue to build our exceptional team. Together, they bring deep experience in corporate, commercial, and business strategy. They also have significant operational expertise building and supporting both private and public companies,” said Jeffrey Finer, MD, PhD, Chief Executive Officer and Co-founder of Septerna and Venture Partner at Third Rock Ventures. “Since our launch in January, we’ve made rapid progress advancing our platform and early discovery programs, and now expanding our focus to strategic growth and operational excellence is absolutely critical so that we can fully realize the untapped opportunity space for new GPCR medicines.” “Septerna launched with the ambitious plan to expand the GPCR target landscape by developing and industrializing new drug discovery technologies and processes that can convert this target-rich superfamily of proteins into impactful new therapies for patients across a range of therapeutic areas. I’m excited to be working with a team of talented GPCR scientists and drug hunters and look forward to using my experience leading teams and developing corporate and product strategies to build Septerna into a robust company poised for long-term growth.” Ms. Bhatt Liz Bhatt brings more than 25 years of strategy, deal-making and company-building experience across a range of biotech and pharmaceutical companies. Liz was previously Chief Business & Strategy Officer at Applied Molecular Transport where she oversaw corporate development, portfolio and project management, and commercial strategy. Prior to AMT, Liz was Chief Operating Officer at Achaogen where she held various strategic and operational roles. Liz spent over a decade at Gilead Sciences as VP, Corporate Development leading deals across all therapeutic areas and as Senior Director, Commercial Strategy leading long-term global commercial and strategic planning, and supporting the launch of several products. Liz also held management roles at Eli Lilly and Maxygen and started her career in research at Affymax. She currently serves as an independent director on the board of eFFECTOR Therapeutics. Liz earned a BA in chemistry from Pomona College, an MS in biomedical sciences from the University of California San Diego, and an MBA from the Kellogg School of Management at Northwestern University. Ran Xiao has more than 20 years of experience in corporate accounting, finance, and business operations in the biotech industry. Prior to Septerna, Ran was the VP of Finance and Corporate Controller at Ambys Medicines, Inc, where she supported the company launch and managed various general and administrative functions through a rapid growth period. Before joining Ambys, Ran was the Corporate Controller at Corvus Pharmaceuticals, where she played a key role in the company’s initial public offering. Prior to Corvus, Ran held various managerial positions at Intermune, Natus Medical, Celera Genomics and CV Therapeutics. Ran has a BS in accounting from Shanghai University of Finance and Economics and an MBA from the Illinois Institute of Technology. Ran is a Chartered Financial Analyst. About GPCRs G protein-coupled receptors are the largest and most diverse family of cell membrane receptors, and humans have hundreds of different GPCRs, each involved in controlling specific biological functions. GPCRs on the surface of each cell bind a wide range of external signaling molecules from throughout the body, and the GPCR transmits the signal across the cell membrane to drive internal cellular mechanisms. GPCRs have been widely studied as drug targets and are the largest family of proteins targeted by approved drug products. An estimated 700 approved drugs target GPCRs, representing approximately one-third of all currently approved drugs. Despite the pharmacological success of GPCRs as a drug class to date, the large majority of potential therapeutic GPCR targets remain undrugged. About Septerna Septerna, Inc., is a biotechnology company creating broad new drug discovery opportunities across many disease areas for the abundant drug target class of G protein-coupled receptors. The company’s Native Complex™ Platform recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular environment to enable new technologies for industrial-scale drug discovery for the entire GPCR target class for the first time. Septerna has an emerging pipeline of GPCR-targeted small molecule drug discovery programs, along with growth potential to reach many GPCRs that have been undruggable and unexploited to date. Septerna was launched in 2022 by scientific founders who have made groundbreaking GPCR discoveries and by founding investor Third Rock Ventures.

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