Prime Medicine | July 29, 2022
Prime Medicine, Inc. a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, Prime Editors, to address the widest spectrum of diseases by deploying Prime Editing technology
“Prime Medicine is advancing a first-of-its-kind technology intended to expand the number of patients who may benefit from genetic medicines. We are thrilled to welcome Richard, Niamh and Fubao to the team. Together, they bring strong business acumen, extensive clinical and regulatory experience and leadership of successful teams that position us well to achieve our mission. These esteemed leaders have deep expertise across their respective focus areas, each of which is key to the advancement of our novel Prime Editing technology.”
Keith Gottesdiener, M.D., Chief Executive Officer of Prime Medicine
Richard Brudnick, Chief Business Officer, brings extensive industry experience, including leading successful business development transactions, across multiple stages of development and an array of therapeutic areas. Mr. Brudnick was previously Chief Business Officer and Head of Strategy at Codiak BioSciences and, before that, was Executive Vice President of Business Development and Alliance Management at Bioverativ, Inc., a company he helped found in 2016. Mr. Brudnick joined Bioverativ at the time of its spinoff from Biogen where, over the course of nearly 15 years, he initiated, led and completed numerous transactions, including for several of the company's marketed products and late-stage pipeline, including Tecfidera, Spinraza and its biosimilars joint venture with Samsung. Previously, Mr. Brudnick was the Chief Executive Officer of a regional pharmaceutical distribution business that he sold to a strategic buyer, co-founded two companies, and was a strategy consultant at Bain & Company. Mr. Brudnick earned his undergraduate degree in management science from MIT and his M.S. in management from the Sloan School of Management at MIT.
Niamh Alix, Chief Human Resources (HR) Officer, is a human resources leader who brings nearly 20 years of experience helping to grow teams from small, early-stage organizations to global enterprises. She joins Prime from Orchard Therapeutics, where she was Vice President, Global Talent and HR Business Partner. Prior to that, Ms. Alix held multiple global and regional roles at Lonza, including HR Business Partner for Americas, Mexico, and Canada where she led the HR team and people strategy for a 5,000+ employee population across corporate and manufacturing clients, and across multiple scientific platforms including cell and gene therapy. Prior to that, she held senior HR roles of increasing responsibility at Novartis and Bristol Myers Squibb. She holds a master’s degree in HR strategies from Dublin City University and a B.Sc. in management from the Technological University of Dublin.
Fubao Wang, Ph.D., SVP, Head of Regulatory, has substantial experience leading product development of genomic medicine products, as well as regulatory strategies and execution for both clinical and commercial-stage products. Before Prime, Dr. Wang served as Senior Vice President, Head of Regulatory Affairs at Asklepios BioPharmaceutical where he built and led the regulatory team to support the development of clinical-stage AAV-based gene therapy products. Earlier, he was Vice President, Head of Regulatory CMC at Sarepta Therapeutics, where he supported the development of AAV gene therapy and RNA products, including the FDA approvals of Vyondys and Amondys. He also served as Associate Vice President, U.S. Site Head, CMC Dossiers at Sanofi to support the BLA approval of Dupixent, a monoclonal antibody product. Prior to that, he held a 16-year tenure at Merck serving in research, development and regulatory roles of increasing responsibility, most recently as director, global and emerging markets regulatory affairs, led and contributed to the discovery and development of a variety of vaccine and biologics products. Dr. Wang holds a Ph.D. in molecular biology from Heidelberg University and completed his postdoctoral work in molecular biology at Stanford University.
About Prime Medicine
Prime Medicine, Inc. is a biotechnology company committed to delivering a new class of differentiated, one-time, curative genetic therapies to address the widest spectrum of diseases. The company is deploying Prime Editing technology, a versatile, precise, efficient and broad gene editing technology, which is designed to make only the right edit at the right position within a gene. With the theoretical potential to repair approximately 90 percent of known disease-causing genetic mutations across many organs and cell types, medicines based on Prime Editing, if approved, could offer a one-time curative genetic therapeutic option to a broad set of patients.
Integral Molecular | June 09, 2022
Integral Molecular and Optimeos Life Sciences announce a partnership to develop next-generation mRNA and DNA therapeutics that will use antibody-based molecular targeting to direct vaccines and gene therapies to relevant tissues in a patient's body. This partnership combines Integral Molecular's experience in antibody discovery and mRNA immunization with Optimeos' technology for nanoparticle-based drug delivery systems.
DNA and mRNA therapeutics harness a patient's own molecular machinery to encode proteins. Integral Molecular and Optimeos plan to encapsulate these therapeutic molecules within nanoparticle spheres that are decorated with antibodies on the outer surface. The antibodies can then target the particles to specific tissues. Currently, gene therapies and mRNA vaccines are delivered into the body via infusion or injection, but only a fraction of the molecules arrive at their intended site. The proposed molecular targeting strategy has the potential to transform the delivery of vaccines and therapeutics by dramatically reducing dosages, decreasing toxicity, and enabling scalable administration.
Integral Molecular will apply its industry-leading antibody discovery expertise against complex cell-surface proteins to provide targeting moieties for the therapies. Its specialized MPS Antibody Discovery platform is tailored to work with challenging membrane protein targets and routinely uses mRNA-based immunization strategies. "Precision targeting of an isolated cell type with gene therapy holds great promise for genetic diseases and may provide brand-new directions in cancer immunotherapy including in vivo CAR-T cell therapeutics," said Joseph Rucker, Co-founder and VP of R&D at Integral Molecular.
Optimeos' technology allows the robust and scalable incorporation of mRNA and DNA therapeutics and other biologics into customizable nanoparticles. "We are excited to work with Integral Molecular towards the next generation of gene-therapy that no longer relies on viral-based delivery systems," said Robert Prud'homme, Co-founder and Chief Technical Officer of Optimeos.
Integral Molecular and Optimeos will be attending the BIO International Convention in San Diego later this month.
About Integral Molecular
Integral Molecular is the industry leader in developing and applying innovative technologies that advance the discovery of therapeutics against difficult protein targets. With 20 years of experience focused on membrane proteins and antibodies, Integral Molecular's technologies have been integrated into the drug discovery pipelines of over 400 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.
About Optimeos Life Sciences
Optimeos Life Sciences has developed a novel, highly differentiated, non-viral, nanoparticle technology, for delivery of new therapeutic drugs to address important unmet medical needs. The technology is a patented and scalable polymeric drug delivery system, which was developed and refined in Professor Prud'homme's lab at Princeton University over 20 years. Optimeos' technology enables encapsulation of mRNA, DNA, peptides, proteins or small molecules, as well as their targeted delivery to cells and tissues beyond the liver.
Aculys Pharma, Inc. | July 13, 2022
Aculys Pharma, Inc. a company focused on the development and commercialization of new innovative drugs in the fields of neurology and psychiatry, has entered into a contract with SUSMED, Inc., a company that promotes digital medicine to conduct the world's first1 corporate-sponsored clinical trial using blockchain technology. The clinical trial utilizing this blockchain technology, provided by SUSMED, will be conducted in collaboration with CMIC Co., Ltd., a pioneer in drug development support (CRO), with the cooperation of several medical institutions.
With the sophistication of research and development and the increasing cost of new drug development, improving the efficiency of clinical trials is one of the challenges in the pharmaceutical industry that requires addressing. In such an environment, efficient use of resources and pursuit of efficiency are required. And improving productivity and quality of new drug development is also extremely important for society as a whole. Under these circumstances, Aculys Pharma is working to improve productivity and quality of clinical trials by utilizing AI and digital technologies for the development and commercialization of new drugs.
The clinical trial system developed by SUSMED enables the reduction of data entry work and monitoring work2 by medical institutions by using the SUSMED-patented technology that binds e-worksheets and eCRF using blockchain technology. In addition to publishing multiple medical papers3, the clinical research that SUSMED conducted with the National Cancer Center has been approved by the Cabinet Office regulatory sandbox4. The result of the verification test conducted by the regulatory sandbox was published in the International Medical Journal in June 20205. With this outcome, The Ministry of Health, Labor and Welfare issued a notice on December 4, 2020 that source data verification (SDV: Source Data Verification) using blockchain technology is permitted as an alternative method under the GCP ministerial ordinance.
CMIC will promote these efforts for attaining an efficient clinical trial by 1) supporting the operation of the system at the medical institution, 2) cooperating with development of the e-worksheet and eCRF, and 3) complementing the functions outside the scope of the system.
This clinical trial which utilizes blockchain technology significantly reduces the number of processes around data entry at medical institutions and SDV compared to conventional methods, and also contributes to reducing the number of required CRA visits to the medical institutions. In addition, by taking advantage of blockchain technology, it is expected to have the effect of increasing the reliability of the clinical trial data itself. Through these methods, we aim to improve the efficiency of the clinical trial-related work-streams necessary for new drug development, and to optimize new drug development costs without compromising reliability.
"We are delighted to be able to conduct a clinical trial utilizing blockchain technology in collaboration with SUSMED and CMIC as Aculys Pharma strives for providing new therapeutic modalities by making full use of the latest in digital technology. We expect this pioneering effort of three companies, which aim to improve the quality and efficiency of clinical trials, will realize digital transformation of clinical trial monitoring work and contribute to the optimization of new drug development costs. We will continue to actively introduce new technologies not bound by a conventional framework and aim to solve social issues surrounding Japanese healthcare by collaborating and partnering with external partners."
Kazunari Tsunaba, President and CEO of Aculys Pharma, Inc
Taro Ueno, President and CEO of SUSMED, Inc., stated as follows.
"In the clinical trials conducted in the development of new medical technology, prevention of data tampering and cost efficiency have been issues. While developing therapeutic apps in the healthcare field, we have come to focus on the possibility of using blockchain technology in clinical development and continued research and development. This time, we are delighted to be able to collaborate with CMIC to conduct the world’s first clinical trials using blockchain technology in a corporate-sponsored clinical trial of Aculys Pharma, a company that focuses on the development and commercialization of new innovative drugs. We believe that utilization of blockchain technology enables us to realize efficient and reliable clinical development and we also can contribute for optimization and sustainability of future social security.”
"CMIC was established in 1992 as Japan's first CRO and has supported a number of clinical trials of drug development. This time we are participating in the corporate-sponsored clinical trial of Aculys Pharma with SUSMED. While digitalization will furthermore drive acceleration of process efficiency, we will continue to pursue further improvement of quality and efficiency of clinical trials in monitoring work by utilizing CMIC's know-how based on numerous clinical trial experiences over the past 30 years."
About Aculys Pharma, Inc.
Aculys Pharma is a biopharmaceutical company focused on the development and commercialization of innovations in the fields of neurology and psychiatry. Its corporate name was created from the philosophy of "Catalyst to Access." Aimed to act as a bridge for innovative medical care in the field of neuropsychiatry, Aculys Pharma develops and commercializes novel pharmaceuticals and provides innovations for better medical care to patients, their families, healthcare professionals, and society.
DeepIntent | July 14, 2022
DeepIntent, the leading healthcare advertising technology company built to influence better patient health and business outcomes announced the addition of audience segments from Redi-Data, MedFuse, HealthWise Data, Prognos Health, and TV viewership data from LG Ads Solutions to the DeepIntent Audience Marketplace.
These segments are directly integrated into DeepIntent's demand side platform for immediate activation, with the ability to optimize campaigns in real-time toward audience quality and script performance using DeepIntent Outcomes™. Launched in September 2021, Audience Marketplace remains the industry's first and only healthcare-specific data marketplace with ready-to-activate and custom audience segments powered by a variety of medical and pharmacy claims, lab, genomic, contextual, and wellness data providers.
In total, DeepIntent now offers hundreds of patients and HCP segments from leading digital health data providers and publishers, including HealthLink Dimensions, Fluent, Doc Delta, and ShareThis. Additionally, over two dozen leading pharmaceutical brands and advertising agencies have made use of custom or ready-to-activate segments available on the marketplace to simplify their campaign planning and tap into Outcomes to optimize their third-party segments.
"Audience Marketplace meets an important need to have unique healthcare audience segments included in a healthcare-focused DSP with the ability to optimize towards pharma-specific KPIs, such as Audience Quality, all within a single platform. Many of our customers already use audience segments from our new partners, and their direct integration will make it much easier to execute, measure, and optimize campaigns."
Jen Werther, chief strategy officer at DeepIntent
Audience Marketplace users benefit from greater convenience, faster time-to-activation, and improved data integrity and reporting compared with conventional methods, which require the use of costly and time-consuming third-party platforms. Segments within the Audience Marketplace are also matched with DeepIntent's industry-leading identity graph to prepare advertisers for the cookieless future, and provide daily physician-level data reporting for healthcare provider audiences.
"Using integrated health data and Prognos Clinical Truths™ to ensure relevancy, healthcare marketers can rest easy knowing their messages are reaching the right physicians at the right time. Our partnership with DeepIntent makes the process of onboarding and activating HCP segments from Prognos seamless, and segments can further be optimized toward script performance in real-time when leveraging the advanced machine learning capabilities of DeepIntent Outcomes," said Matt Apprendi, vice president of marketing and media solutions at Prognos Health.
DeepIntent is leading the healthcare advertising industry with data-driven solutions built for the future. Built purposefully for healthcare marketers, DeepIntent's platform is proven to drive higher audience quality and script performance. It enables marketers to plan, activate, measure, and optimize their campaigns all within a single platform. Conceived by former Memorial Sloan Kettering data scientists, DeepIntent empowers nine of the top ten pharmaceutical companies and the leading healthcare advertising agencies to improve patient outcomes through the artful use of advertising, data science, and real-world health data.