Calyx | June 10, 2022
Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, announced it has been named an approved provider of centralized medical imaging services by Clinscience, a full service CRO offering smart, end-to-end clinical trial services to the global pharmaceutical industry.
"Calyx's commitment to reliably solving the complex aligns with our focus on designing integrated, smart solutions that are tailored to our customers' needs. Clinscience and Calyx are both motivated to help global clinical trial sponsors achieve their clinical development objectives in an agile, expeditious, and smart way."
Megan O'Keefe, Chief Commercial Officer at Clinscience
"The Clinscience team understands what's important to pharmaceutical and biotech organizations," said Elizabeth Dalton, Vice President, Channel Partnerships Solutions, Calyx. "We're honored to work with Clinscience and to deliver the reliable imaging services their customers need to accelerate and optimize their clinical trials."
Clinscience joins a long list of global pharmaceutical companies and CROs who repeatedly leverage Calyx's scientific expertise and experience to assess the safety, efficacy, and effectiveness of their compounds. To date, Calyx Medical Imaging has been used in over 2,600 clinical trials worldwide and has supported the approvals of over 270 medical treatments across a broad range of therapeutic areas.
Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and 30 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.
Clinscience is a global CRO company offering smart CRO Services, from protocol creation to final study report development. The Company has offices in Poland, Spain, Italy, Germany, and the US and provides its services in 6 European countries. More than 150 Biotechnology companies across Europe and the US trust the Clinscience brand. The Company's procedures and Data-driven approach, harnessed with the Genius Suite™ technology, work together to give the Clients power and flexibility to address even the most unique needs. Clinscience is part of a publicly-traded parent company, Neuca Plc, an organization in the pharmaceutical wholesaling and healthcare industry that provides the structure to meet the needs of commercial and non-commercial studies.
Akorn Pharmaceuticals | August 17, 2022
Akorn Operating Company LLC, a specialty pharmaceutical company, announces that it received FDA approval for a generic version of Cetrorelix Acetate for Injection, 0.25 mg. This is the first approved AP-Rated bioequivalent version of Merck Serono's Cetrotide®.1
"We are pleased to announce the first approved AP-rated generic option for women receiving fertility treatments. As an increasing number of infants are being conceived via the use of ART, Akorn is excited to be able to offer a competitively priced option to support women who undergo this series of treatments. This is a welcome addition to our portfolio of more than 200 specialty and injectable generics."
Akorn President and CEO Douglas Boothe
Assisted Reproductive Technology (ART) is defined as fertility treatments where eggs or embryos are handled for the purpose of establishing a pregnancy. 2
The FDA granted Akorn a Competitive Generic Therapy (CGT) designation for Cetrorelix, a designation intended to incentivize effective development, efficient review, and timely market entry of drugs for which there is inadequate generic competition. As the first approved applicant with the CGT designation, Akorn's Cetrorelix is eligible for 180 days of CGT market exclusivity, which will begin to run from the commercial launch of Cetrorelix.
According to IQVIA, U.S. sales of Cetrorelix through June of 2022 were approximately $63 million with full year U.S. sales projection of approximately $127 million.
About Cetrorelix Acetate for Injection 0.25 mg
Cetrorelix is used to prevent premature ovulation during controlled ovarian stimulation. Cetrorelix blocks the effects of a natural hormone, called gonadotropin‐releasing hormone (GnRH). GnRH controls the secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle. During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrorelix Acetate for Injection blocks such undesirable premature ovulation.
Akorn Operating Company LLC, develops, manufactures and markets specialty pharmaceuticals. Since 1971, as an industry leader in generic products in alternate dosage forms such as ophthalmics, injectables, oral liquids, otics, topicals, inhalants and nasal sprays, we focus each day on our mission to improve lives, through the quality, availability and affordability of our products.
Medidata | June 16, 2022
Medidata, a Dassault Systèmes company, announced its renewed, expanded partnership with Novotech, a leading contract research organisation to continue scaling clinical studies in various therapeutic areas from 2022.
Leveraging Rave EDC, Rave RTSM, eCOA and eConsent technology from Medidata, Novotech is equipped with flexible, configurable tools that can address clinical research needs at scale and facilitate accelerated drug and device development in Asia Pacific and the U.S.
Since its partnership in 2018, Novotech has doubled its growth and has also acquired CRO companies in APAC and the U.S. as well as invested in advanced DCT and data companies to deliver a seamless CRO platform amidst the increasing demand for clinical trials services in the region. The partnership extends access to a suite of end-to-end solutions from Medidata Clinical Cloud, the industry's only unified platform dedicated to clinical research. It also underscores Medidata and Novotech's commitment to work collaboratively towards accelerating clinical trials and research efficiently, while improving clinical trial timelines and patient experiences.
The Medidata Clinical Cloud is the only unified technology platform dedicated to clinical research, with solutions that leverage centralized data to address the holistic research process from start to finish. With the physical limitations and fragmentation of healthcare ecosystems caused by the COVID-19 pandemic, the need for digital integration for accelerated clinical development is crucial, and a unified platform allows for streamlined management of studies, sites, users, and access from a single location.
"The pandemic has underscored the importance of redesigning how trials are run, with more stakeholders realising the vital role that technology plays in clinical development. Medidata is pleased to continue our strong partnership with Novotech and is dedicated to providing support in their acceleration of clinical studies. Working with leading technologies, we can deliver better patient experiences and accelerate drug development in the new normal in clinical research."
Edwin Ng, Senior Vice President, Asia Pacific, Medidata
Andries Claassen, Senior Director Biometrics, Novotech, added, "We are excited to continue our partnership with Medidata, with their sustained support in driving clinical research and business growth with customers. Novotech has always invested heavily in the latest technology to provide our clients with better data visibility for improved decision-making. Together, we will help sponsors deliver more efficient, effective, and scalable trials."
Medidata is a wholly owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.
Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 2,000+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company (Euronext Paris: FR0014003TT8, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers.
About Dassault Systèmes
Dassault Systèmes, the 3DEXPERIENCE Company, is a catalyst for human progress. We provide business and people with collaborative 3D virtual environments to imagine sustainable innovations. By creating virtual twin experiences of the real world with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production to achieve a more sustainable world for patients, citizens, and consumers. Dassault Systèmes brings value to more than 300,000 customers of all sizes, in all industries, in more than 140 countries.
3DEXPERIENCE, the Compass icon, the 3DS logo, CATIA, BIOVIA, GEOVIA, SOLIDWORKS, 3DVIA, ENOVIA, NETVIBES, MEDIDATA, CENTRIC PLM, 3DEXCITE, SIMULIA, DELMIA, and IFWE are commercial trademarks or registered trademarks of Dassault Systèmes, a French "société européenne" (Versailles Commercial Register # B 322 306 440), or its subsidiaries in the United States and/or other countries.
Novotech is the leading Asia Pacific biotech specialist CRO with labs, phase I facilities, and drug development consulting services. Novotech has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally and serves biotechs globally leveraging deep relationships built with hundreds of Asia-Pacific sites over the last 25 years. As of May 2022, Novotech has over 2,500 FTEs working across our offices in 12 geographies in Asia-Pacific and the United States.
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.