Novartis Pharma AG | April 04, 2022
Novartis announced the introduction of a new organizational structure and operating model designed to support the company’s innovation, growth, and productivity ambitions as a focused medicines company in the coming decade.
“The simpler organizational model we are unveiling today is central to our growth strategy as it will make us more agile and competitive, enhance patient and customer orientation, unlock significant potential in our R&D pipeline and drive value-creation through operational efficiencies. With our portfolio of in-market medicines and up to 20 major pipeline assets that could be approved by 2026, Novartis is in a strong position to deliver above-peer-median sales and margin growth in the mid- and long-term.”
Vas Narasimhan, CEO Novartis
Integrating Pharmaceuticals and Oncology business units
Novartis will integrate the Pharmaceuticals and Oncology business units and create two separate commercial organizations with a stronger geographic focus—Innovative Medicines US and Innovative Medicines International. The two units will have full P&L responsibility across all therapeutic areas and ownership of customer experience, marketing and sales, and market access for their respective markets. The elevation and establishment of an independent US commercial organization strengthens Novartis’s ability to achieve its goal of becoming a top-five company in the US in terms of sales while maintaining and growing its leadership position internationally. The new model will also help Novartis bring increased focus and commitment to its core therapeutic areas of Cardiovascular, Hematology, Solid Tumors, Immunology and Neuroscience.
Marie-France Tschudin, currently President, Novartis Pharmaceuticals, will become President, Innovative Medicines International and Chief Commercial Officer. In her capacity as Chief Commercial Officer, Marie-France Tschudin will oversee global marketing, medical affairs and value and access across all therapeutic areas. Victor Bulto, currently Head of US Pharmaceuticals, will become President, Innovative Medicines US. They will both report to Vas Narasimhan effective immediately.
New Strategy & Growth Function
Novartis will create a new Strategy & Growth function combining corporate strategy, R&D portfolio strategy and business development. This function will help drive the company’s growth strategy end-to-end and will look across internal and external opportunities to strengthen Novartis’s pipeline with medicines that are both transformational and can make significant contributions to growth. This new function will be led by a Chief Strategy & Growth Officer who will become a member of the ECN and report to the CEO. The search is currently underway for this new leader, and in the interim the function will be led by Lutz Hegemann, M.D., Ph.D., President, Global Health.
Integrated Operations and Global Functions
Novartis will also combine its Technical Operations and Customer & Technology Solutions units to create a new Operations unit. This new unit will provide a stronger and simpler operational backbone that can accelerate multiple technology transformation initiatives more efficiently, create novel digital solutions at scale and increase productivity, while maintaining industry-leading quality and service levels. Effective immediately, Steffen Lang, currently Global Head of Novartis Technical Operations, will become President, Operations reporting to Vas Narasimhan. In addition, all G&A functions—Finance, People & Organization, Ethics, Risk & Compliance, Legal, and Communications & Engagement—will be integrated on global and country levels.
Change in Global Drug Development (GDD) Leadership
Novartis has appointed Shreeram Aradhye, M.D., as President, Global Drug Development and Chief Medical Officer effective May 16th, 2022. Dr. Aradhye, who is returning to Novartis, was most recently Executive Vice President and Chief Medical Officer at Dicerna Therapeutics where he led the development of multiple clinical stage RNAi assets. Previously, he was Chief Development Officer at Axcella Health. Dr. Aradhye has dedicated his entire professional career to improving patient lives, first as an academic clinician and then as a drug developer and business leader. He brings significant experience in global clinical development of innovative medicines across several therapeutic areas and has played a key leadership role in the development of multiple innovative therapeutics. During his 20-year tenure at Novartis, he held several global leadership roles including as development head for the company’s Neuroscience franchise and Global Head of Medical Affairs for the Pharmaceuticals business unit. Dr. Aradhye will report to Vas Narasimhan and join the ECN. With the changes in organizational structure and operating model, John Tsai, M.D., has decided to pursue opportunities outside Novartis effective May 15th, 2022.
“I would like to extend my deep gratitude to Susanne, Robert and John for their invaluable contributions to the company. Susanne has been an inspiring and dedicated leader at the company for 25 years, and she has played a pivotal role in strengthening our global Oncology business. Over the last four years, Robert has led a successful transformation of our business services and technology operations and helped create a strong Customer & Technology Solutions unit. Since taking over as Head of GDD in May 2018, John has played a key leadership role in advancing our mid-stage pipeline and delivering 18 major drug approvals to patients around the world. I wish them the very best in their future endeavors,” added Vas Narasimhan, CEO Novartis. “I would like to congratulate Marie-France, Shreeram, Steffen and Victor on their new roles, and extend a warm welcome back to Shreeram. I look forward to working closely with them as we embark on this new phase of our journey to reimagine medicine together.”
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments.
Telix Pharmaceuticals Limited | March 29, 2022
Telix Pharmaceuticals Limited announces that the United States Food and Drug Administration has granted Orphan Drug Designation for TLX66 for conditioning treatment prior to hematopoietic stem cell transplant. The granting of an ODD for TLX66 qualifies Telix for various drug development incentives, which may include FDA administered market exclusivity for seven years, waived FDA prescription drug user fees, and tax credits for R&D and clinical development costs.
Bone marrow conditioning is performed prior to HSCT, a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells (cells that can develop into different types of cells), to encourage production of new bone marrow that produces healthy blood cells. Traditional conditioning regimens are associated with morbidity and mortality from chemotherapy, limiting their use particularly in pediatric and rare diseases.
TLX66 has the potential to add to the depth of conditioning, thereby removing additional disease-causing cells. In addition, TLX66's potential to reduce the toxicity of existing conditioning regimens could increase the number of patients that are eligible for transplant.
HSCT is being used increasingly in malignant hematological conditions, such as multiple myeloma and acute myeloid leukemia, and in non-hematological malignancies and rare / immune-mediated diseases. In 2018, 22,729 HSCTs were performed in the United States.
During 2021, the Company reported initial results for safety and tolerability for the Targeted Radiotherapy for AL-amyloidosis, a Phase I trial conducted at the University of Southampton, United Kingdom. The study found that TLX66 was well-tolerated in patients with systemic amyloid light chain amyloidosis, enabling successful engraftment of the patients' own transplanted stem cells without the need for toxic chemotherapy in this rare immune condition with a poor prognosis.
"The granting of an Orphan Drug Designation by the FDA for TLX66, combined with recent encouraging data from prior studies in hematological malignancies and autoimmune disease provides a strong impetus to advance our development plans for TLX66. This treatment has potential application in a number of hematological cancers and rare diseases and potentially also in the future for conditioning for cell and gene therapies."
Telix Chief Medical Officer, Dr Colin Hayward
TLX66 has also previously been granted ODD status by the European Medicines Agency in Europe for treatment in hematopoietic stem cell transplantation. TLX66 has not received a marketing authorisation approval in any jurisdiction.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange.
PROTECT PHARMACEUTICAL Corp | June 28, 2022
Protect Pharmaceutical Corporation has acquired the 100% of the shares of CJSC “Inaiapp”, a Belarusian developer of corporate software for business digitalization.
With 8 years of blockchain development experience and list of long term clients, Inaiapp will bring its qualification and management processes to a new level.
“Robotic process automation, AI systems and machine learning systems, blockchain-based solutions, Data Science tools for business growth - we closely follow global trends in IT technology and are now ready to create the most profitable solution for your business.”
Nick Greb, President of PRTT
PRTT offers range of services and software products, to solve painful problems.
The company is using time-tested practices in the field of robotics, artificial intelligence, machine learning and blockchain, creating first-class solutions that meet current business needs.
“Now we will combine the US market presence with extensive technical expertise that enable us to develop products that accelerate and streamline business processes through autonomy, transparency and security.” - Nick adds.
Protect Pharmaceutical Corporation is a full-cycle software development and delivery company that produces, releases, and supports digital products for the business-to-business and business-to-consumer markets. The company’s expertise lies in custom software development and consulting services in Business automation, Artificial Intelligence, Machine Learning, Data Science, Big Data, Image recognition, Blockchain development, and cloud services. Its domain focus includes Supply chain, Logistics, Healthcare, Finance, Real estate, Legal, Insurance, Advertising, and more.
CCT Research | February 18, 2022
CCT Research has announced an exciting partnership with BEKHealth. The collaboration streamlines access to electronic medical records (EMR) data, across CCT sites and drives a data-driven approach to trial execution and management.
CCT has established itself as an innovator in conducting clinical trials. Using BEKHealth, a provider of software solutions for enhancing clinical research processes, will enable CCT to more accurately identify and fit studies to its sites. The deep commitment by both companies to improving the outcomes of clinical trials made the relationship a natural fit.
“One of CCT’s driving forces is to promote an environment of innovation and continuous improvement. Our partnership with BEKHealth strengthens our ability to identify potential research participants, ultimately creating greater accessibility to clinical trials.”
Jennifer Kocour, President, CCT Research
More than just a “technology” partnership, this collaboration with BEKHealth is also patient-centric– which remains a top priority for CCT. Once studies are awarded, it will power onsite research by identifying patients who fit studies best, saving sites, patients, and staff time and hassle.
“At the individual site level, our goal is to optimize research to be as beneficial to the practice and its patients as possible with minimal disruption to the clinics day-to-day operations. We view data and technology as central to that strategy and couldn’t be more excited to work with BEKHealth,” said Kyle McAllister, Vice President, Data & Analytics, CCT Research.
“The breadth and depth of CCTs network was an exciting opportunity. The ability to leverage technology to centralize key drivers of success such as feasibility, site selection, patient recruitment and analytics drives a new paradigm in clinical research,” said Jason Baumgartner, CEO and Founder, BEKHealth. “Our platform is secure and activation creates a minimal burden on IT teams. What this means for the provider and patient is our collaboration will have a major impact quickly.”
“We provide an integrated clinical operating platform that enables companies to streamline research across multiple key processes,” said Josh Ransom, PhD, Vice President, Customer Experience, BEKHealth. “Ultimately this means our partners can scale their businesses faster by improving operational efficiency while taking out manual and inefficient steps.”
About CCT Research
CCT Research is a network of clinical research sites embedded in the offices of skilled physicians conducting clinical trials to offer patients with innovative medical treatments and safe, effective care options.
CCT Research was founded in 2017 and has more than 20 locations across Arizona, Georgia, Kentucky, Nebraska, Nevada, and Utah. The sites are located within physicians’ offices, within ACO networks, and several dedicated research centers.
CCT supports research in Neurology, Family Practice, and Dermatology, with plans to include additional therapy areas soon. The company's unique model simplifies the process for trial participants and provides pharmaceutical sponsors with high-quality data.