Merck Healthcare KGaA

The BioIVT team will also be attending several ADME-focused events this spring to fuel development and ongoing education in the space WESTBURY, N.Y., April 9, 2024 /PRNewswire/ -- BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, today announced it will host Small Molecules and Biologics: Advanced ADME Strategies & Techniques, a complimentary symposium and workshop on methodologies and techniques for in vitro ADME research. Hosted at BioIVT's office and laboratory in Brussels, this two-day event will take place from April 11-12 and feature speakers from industry, academia and BioIVT. The workshop will include workstations for attendees to see product demonstrations and talk to BioIVT product experts about how these products can be used in their research applications. Please visit BioIVT's website for registration and additional details here. "We look forward to hosting some exceptional scientists in the ADME space this week at our Brussels Symposium from top academia and the industry including Oxford University, UCB Biopharma and Merck Healthcare KGaA, Darmstadt to learn more about real-life case studies and their own research and findings in this increasingly important field of research," said Christopher Black, Senior Vice President, ADME-Tox Division at BioIVT. "This spring marks an exciting time for our team as we look forward to connecting with others in the ADME space at some of the top global events to fuel new developments and practices to bring our industry forward." Additionally, the BioIVT team will be headed to several ADME-focused industry events this spring including: Swiss Biotech Days: Taking place April 22-23, in Basel, Switzerland, BioIVT's team of experts will be attending the conference as sponsors to connect with industry professionals about BioIVT's ADME products that can support any in vitro program and study design. In addition to being the largest supplier of products for in vitro ADME studies, the company also will discuss the preclinical research services it offers, including designing and implementing in vitro ADME-Tox programs. Great Lakes Drug Metabolism and Disposition Group (GL-DMDG) Annual Meeting: Running from May 2-3, BioIVT's team will be attending to detail how the company assists customers with understanding the ADME properties and potential drug interaction risks of their compounds and Chris Bohl, PhD, Scientific Advisor at BioIVT, will host a presentation titled, "Plateable Hepatocytes in Non-Small Molecule Drug Development." DDI Marbach Workshop 2024: From May 26-28, BioIVT's team will travel to Öhningen, Germany to the DDI Marbach Workshop, a top event that offers comprehensive coverage of various important and timely topics related to drug-drug interactions (DDIs). MPS (Microphysiological Systems) World Summit: From June 10-14, the BioIVT team will be attending the conference in Seattle where Scott Heyward, Director of Research and Development & Scientific Affairs for BioIVT, will present a poster titled, "Optimization of siRNA Delivery in a Long-Term Hepatic Micropatterned Co-Culture (HEPATOPAC)." NE-ADME 2024: On June 13, Karissa Cottier, PhD, Senior Scientist, ADME Product & Application Development at BioIVT, will present at NE-ADME in Boston on "Fatty Liver Disease Modeling in a Micropatterned Primary Hepatocyte Co-culture (HEPATOPAC): Applications in Drug Development & Screening." About BioIVT BioIVT enables smarter science and accelerates medical breakthroughs by delivering high-quality personalized biospecimen solutions and research services to the life science and diagnostic industries. We specialize in control and disease state samples including human and animal tissues or preparations, ADME-Tox products and research services, cell and gene therapy products, blood, and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in ELEVATING SCIENCE®. For more information, please visit or follow us on LinkedIn. BioIVT Contact: Charlie Chungu, Vice President of Marketing, [email protected] Media Contact: Alex Connelly, PAN Communications, 401-486-7437, [email protected] SOURCE BioIVT

NERVIANO, Italy & MILAN--(BUSINESS WIRE)-- Nerviano Medical Sciences S.r.l. (NMS), a clinical-stage biotechnology company member of NMS group, announced the signing of a license agreement with Italfarmaco S.p.A. (ITF), a specialty pharmaceutical company, to develop and commercialize a novel peptide-drug conjugate (PDC). This press release features multimedia. View the full release here: Under the terms of the agreement, ITF will use NMS’s proprietary linker-payload technology to develop a novel PDC product candidate. NMS has implemented linker-payload GMP manufacturing and supply at a CDMO referred by NMS. ITF will be responsible for generating the target peptide and all non-clinical, clinical, and commercialization activities related to any resulting proprietary product candidates. Financial details of the agreement have not been disclosed. “NMS’s cutting-edge linker-payload technology will allow us to develop new peptide drug conjugates for the treatment of oncology indications with high unmet medical need, leveraging Italfarmaco’s state-of-the-art GMP peptide production capabilities,” stated Christian Steinkühler, PhD, Italfarmaco Group’s Chief Scientific Officer. “This is an important milestone in our mission to generate a highly diversified pipeline of innovative medicines.” “We are pleased that ITF, a company with a long-standing heritage both from pharmaceutical and chemical sectors, has selected our linker-payload first platform for developing a truly novel peptide-drug conjugate. This is a significant step to broaden the applicability of our technology,” said Hugues Dolgos, PharmD, Chief Executive Officer of NMS and NMS Group. NMS is focused on discovery and development of innovative cancer therapies based on proprietary kinase and linker-payload platforms, with approved targeted drugs licensed to pharma companies and proprietary innovative small molecule candidate drugs undergoing clinical studies. The development program will leverage NMS’s proprietary innovative linker-payload platform technology and ITF’s peptide-based oncology therapeutics technology. It will also allow NMS technology exploitation in conjugation with peptides. NMS’s linker-payload platform is carefully designed to generate more stable, efficacious, and safer drug conjugates to treat heterogeneous and chemotherapy-resistant solid tumors. The licensed linker payload includes optimized features, showing sub-nanomolar antiproliferative activity across a large panel of tumor cell lines and greater potency than MMAE and DXd (deruxtecan) in chemo-resistant cell lines expressing MDR system (Valsasina B. et al., Mol Cancer Ther 2023). In conjugation with targeting moieties, it shows an excellent therapeutic window and it is highly active in heterogeneous tumors thanks to the bystander effect, promotes immune system recognition of tumor cells to induce immunogenic cell death, and demonstrates activity in chemotherapy-resistant and poorly proliferating tumors. About Italfarmaco Group Italfarmaco Group is a specialty pharmaceutical company engaged in the discovery, development, manufacturing and marketing of branded prescription and nonprescription products in more than 60 countries on 5 continents. Italfarmaco Group’s research and development expertise is best demonstrated through its HDAC inhibitor development programs, addressing new therapeutic treatments of specialty and rare diseases. Through both marketed drugs and compounds in development, Italfarmaco Group is dedicated to serving patients whose needs remain largely unmet. About Nerviano Medical Sciences Nerviano Medical Sciences S.r.l. (NMS) is focused on discovery and clinical development of small molecule NCEs for oncology. We take innovative approaches on novel mechanisms of action and drug targets to bring first- and best-in-class personalized medicines to cancer patients. Our current pipeline consists of NCEs, which originate from our industrially renowned kinase inhibitor drug discovery platform comprising an ever-evolving chemical collection with broad intellectual property coverage, discovery know-how and technologies. Our kinase platform has enabled us to out-license IP rights on approved innovative medicines such as encorafenib and entrectinib and currently includes preclinical to clinical stage products, which are being developed both in house and with partners, including four proprietary clinical assets in Phase I/II studies. Moreover, the development of our payload linker platform allows an extension of our pipeline with innovative payload linkers for next generation ADC production. NMS combines the flexibility of a biotech with the quality of a big pharma. Here, an experienced management team leads a highly skilled staff of professionals with a global vision and a broad range of expertise in drug discovery and development. We collaborate with academia and clinical investigators as well as industrial partners worldwide to advance our programs from early discovery to clinical development of new drugs. NMS signed a collaboration agreement with licensing option with Merck Healthcare KGaA for the next-generation highly selective and brain penetrant PARP1 inhibitor NMS-293 and, more recently the four target out-licencing of the linker-payload technology to Solve Therapeutics, Inc. We seek further strategic collaborations to develop and commercialize our products in different territories as well as in-licensing opportunities of promising pre-clinical assets. About NMS Group NMS Group is the largest R&D company in Italy committed to the discovery and development of novel oncological therapies and through its three subsidiaries is the only institution able to manage the entire integrated R&D chain: from the first steps of the pre-clinical phase to the packaging of the finished product with more than 400 employees of whom more than half are highly educated individuals dedicated to innovative research, development and manufacturing. NMS Group three subsidiaries are: NMS S.r.l., focused on discovery and clinical development of new drug for oncology at Nerviano (Italy) and Boston (US) sites, Accelera, one of the few Italian CROs capable of providing support through all phases of drug research and development, and NerPharMa, a CDMO owing a wide and cutting edge organizational structure able to manage and handle highly active compounds, and to ensure the full development and production of active principles and finished products. View source version on businesswire.com: Contacts Source: Italfarmaco Group View this news release online at:

None The race for competitive advantage for pharma today is about far more than just innovative new molecules. Patients are increasingly active participants in their own care. They are becoming intolerant of high-friction, low-quality provision of care. Resource constrained health systems, meanwhile, urgently require partners able to help them do more with less.  Advantage in the life sciences, then, will increasingly go to those that can thread the needle -- developing new products, services and digital ecosystems in a new competitive landscape, while managing challenging economic and operational conditions.  When it comes to enterprise business strategy, that’s a lot to consider. How best to approach the process of addressing all this?  Start by dividing the transformation challenge into three categories: Shape the product A medication or device is no longer the end of a healthcare intervention. The experience that surrounds it matters more than ever. “The pill is the necessary part of the solution but no longer sufficient. Patients and healthcare providers want holistic solutions for economic value and convenience,” explains Emre Ozcan, Global Head of Digital Health, Merck Healthcare. “Hence, shaping the right care pathway with orchestrated services around the pill matter increasingly more. Shape the company  Modernizing the organization to be more agile and to make better use of data will drive more effective launches and enable faster response to emerging market opportunities. Leveraging multimodal datasets to better understand and segment patients for swifter and smarter trial selection is an example of the dividends that an agile, digital-first approach can pay, says Shwen Gwee, digital health consultant and former VP and Head of Global Digital Strategy at BMS. “The ability to accelerate and enhance the discovery process could be huge.”  Shape the market Increasingly, competitive advantage will also arise from thinking beyond therapies and moving further upstream in partnerships outside the organization and across the healthcare ecosystem. Recognizing this market dynamic is vital, says Merck’s Ozcan. “Our ability to differentiate [ourselves] comes down to the holistic solutions we work out with our partners. No one is asking for a single molecule anymore. They are asking for a care package with the right things done at the right time in the right way. We increasingly need to show that we are thinking beyond simply treatment and that we also think about the total patient journey end-to-end from prevention to diagnostics, treatment to follow-ups.” Pharma has seldom taken the right approach to aligning people to the cultural and mindset changes required to address these opportunities. Deciding where digital leadership resides in the organization is key to driving the multifaceted change needed here. Unfortunately, the answers to where digital transformations should be led from within the organization are not simple and will vary by company.  Part of the answer for many will be in how well they can devolve much of the digital transformation effort further down from the C-suite, says Walid Mehanna, Group Data Officer at Merck Group. “Transformation is not something you can easily centralize. Transformation needs to be global and encompass the organization. You can’t do it out of digital ivory towers.” Another challenge in building the new digital and data infrastructure is optimizing it to fit competing global and local requirements such that it frees business teams to focus more on customers and patients, adds Mehanna. “You centralize what makes sense to centralize. I believe it needs to be a combination of mix and match with a lean corporate hub and then for every business and function we have a local hub with a local data and digital officer.” Building a data ecosystem to optimize these competing requirements may take a bit more time to get right, since local parts of the business may not be as free to source their own discrete solutions from vendors, but it is likely to be worth it, says Mehanna. “In the long run it will make you massively faster.”  Embedding digital capabilities The culture change and mindset change required to embed the necessary digital capabilities and to drive effective digital transformation over time is hard to effect in existing corporate structures. The leaders of the future have too strong an incentive to follow traditional pharma career structures, says Gwee. “There is very little incentive to focus on a vertical like digital. There’s no digital career path, therefore it is hard to do well and that is why we see people move between companies to build a career path.” The far more collaborative context in which pharma operates both internally and externally demands significant changes in the way teams are configured and incentivized, says Vyom Bhuta, Global Head of Commercial Innovation, Life Sciences at Cognizant. For example, while most pharma organizations have been investing in the technological and data capabilities needed for omnichannel, most have yet to master omnichannel’s far more collaborative operational requirements. “To drive through omnichannel, you need tightly integrated, multidisciplinary commercial teams to support global markets, countries and franchises,” Bhuta says. “Commercial sales and marketing groups have to work closely with market access, patient services, and medical affairs to drive a coordinated customer experience while accounting for compliance. Integrated within this team should be the business insights and digital technology group within the organization.” Business insights and digital technology teams have an enormous contribution to make since they will be key to driving and making the most of increasingly real-time customer interactions. The key to unlocking this challenge is an organizational one. Internal silos need to be taken down to enable cross-functional technology, data science, medical, clinical, commercial and marketing teams to be convened. “It needs a deep, strategic restructuring. One of things we are proposing is that these [multidisciplinary] teams should operate in pods organized by franchise and brands,” says Bhuta. Such teams can operate on a national, regional or even district level, each with the resources they need across functions. This requires not just an investment in people but also in automation and AI, he adds. “To create a data insights ecosystem you have to invest in analytical bots, so to speak, so that an insight generation and recommendation engine works on a real-time basis.” Bringing talent in from outside healthcare and the life sciences as well as being prepared to bring in external partners to complement internal teams is another worthwhile consideration. Life beyond launch This direction and co-ordination also need to go beyond the moment of commercialization. Pharma is not used to supporting products post-marketing and it must develop product teams capable of embracing the entire journey of digital products, including when patients use them. Digital therapeutics, for example, follow a different lifecycle to molecules or even software. The software-as-a-medical-device lifecycle requires different management and even regulatory processes, says Gwee.  “We need product teams that see the end journey of the digital product. Often their work starts at launch. Understanding those pieces is important. Having product teams to oversee, guide and manage it especially post-launch is required here, not just handing off to IT for maintenance. “The organizing principle should be: ‘how are we helping the product and helping enhance its value? How are we coordinating across the business units as that product is developed and commercialized?’” Cognizant's Life Sciences business leaders are committed to advancing science to improve patient outcomes by partnering with clients to drive continuous improvement in the way they do business. Cognizant helps its clients set the pace in clinical development, strengthen their regulatory infrastructure, modernize manufacturing, and increase market competitiveness. The Cognizant Life Sciences team provides domain-aligned consulting, technology, and business process solutions globally, serving the world’s leading pharmaceutical, biotech and medical device companies. For more information, visit Cognizant.com/LifeSciences.