Novartis AveXis shifted top scientific leadership before Zolgensma data scandal erupted

FiercePharma | August 14, 2019

Novartis has said it shuffled staff at its under-the-gun gene therapy unit AveXis. Now we know who and when, at least when it comes to the top scientific leaders in that business. AveXis two top scientists were shunted aside in early May, right around the time Novartis confirmed internally that its gene therapy Zolgensmas approval application contained manipulated data but before it notified the FDA. AveXis former chief scientific officer, Brian Kaspar, and his brother Allan Kaspar, previously AveXis senior vice president of R and D, are no longer with the company, AveXis said Wednesday. In fact, they “have not been involved in any operations at AveXis since early May 2019.” And by the time the FDA was ready to go public with the data manipulation scandal, AveXis had a new scientific chief. The Kaspar brothers' jobs, rolled into one, went to Page Bouchard, most recently global head of preclinical safety for Novartis Institutes for BioMedical Research (NIBR). Bouchard stepped into the job Aug. 5, AveXis said, the day before the agency announced it was considering criminal and civil penalties for the faulty submission. Novartis CEO Vas Narasimhan has said the company was in the process of terminating “a small number of AveXis scientists” involved in Zolgensma data falsification. And the Kaspar brothers look to be among them. According to Narasimhan on a recent call with analysts, Novartis first received allegations of the manipulated data mid-March. Then an internal probe confirmed the allegation early May, though it didn’t inform the FDA until June 28, over a month after Zolgensma was approved by the FDA.

Spotlight

The global oncology market is expected to grow at a rate of 7.5% with top-ten companies accounting for more than one-third of the market share. Roche tops the list with three drugs in the high rankings accounting for nearly 45% of the revenues. Celgene’s Revlimid is the bestselling drug also showing a 20% growth rate from 2015.

Spotlight

The global oncology market is expected to grow at a rate of 7.5% with top-ten companies accounting for more than one-third of the market share. Roche tops the list with three drugs in the high rankings accounting for nearly 45% of the revenues. Celgene’s Revlimid is the bestselling drug also showing a 20% growth rate from 2015.

Related News

BUSINESS INSIGHTS

Aqemia Announces an Extension of Its First Collaboration With Sanofi About AI and Quantum Physics-driven Drug Discovery in Oncology

Aqemia | June 16, 2022

Aqemia, the next-gen pharmatech company leveraging artificial intelligence and quantum physics announced, today that it has entered a new research collaboration with Sanofi. This new agreement is a follow-up to a Research Collaboration initiated at the end 2020 by Sanofi to bring the unique technologies of Aqemia to the design and discovery of novel molecules in several projects in oncology, a priority therapeutic area for Sanofi. This initial collaboration resulted in promising molecules for an oncology program, for which Sanofi and Aqemia decided to pursue joint efforts. Aqemia will take responsibility for the AI-based design of optimized molecules that fulfill several small molecule design goals among which potency and selectivity in a priority project in oncology. Unlike most AI-based technologies that need experimental data to train their algorithms prior to starting the design, Aqemia will tackle the drug discovery project by generating its own data with quantum and statistical physics-based calculations. “We are really proud of the results obtained in the first Sanofi-Aqemia oncology collaboration and are very excited to continue working together to accelerate important projects in oncology.” He added, “This follow-up of our first collaboration project with Sanofi, a global leader in the Pharmaceutical industry, demonstrates our ability to quickly generate novel potent and selective compounds for a given target, and we can’t wait to scale it up to dozens of drug discovery projects.” Maximilien Levesque, CEO and co-founder of Aqemia “We are also extremely excited by the promising results obtained by Aqemia using their proprietary and disruptive technology to design potent inhibitors on given targets. We are eager to prolong our collaboration to speed up our candidate finding process for the sake of patients suffering from cancer,” said Laurent Schio, head of Integrated Drug Discovery of Sanofi France, About Aqemia Aqemia is a next-gen pharmatech company generating one of the world's fastest-growing drug discovery pipeline. Our mission is to design fast innovative drug candidates for dozens of critical diseases. Our differentiation lies in our unique quantum and statistical mechanics algorithms fueling a generative artificial intelligence to design novel drug candidates. The disruptive speed and accuracy of our technological platform enables us to scale drug discovery projects just like tech projects.

Read More

PHARMA TECH

House Rx to Launch Specialty Drug Dispensing Inside Rheumatology Clinics By Partnering with Three Leading Practices

House Rx | August 04, 2022

House Rx, the platform for medically integrated dispensing of specialty medications, announced it has partnered with three new rheumatology clinics to integrate in-house specialty drug dispensing – also known as medically integrated dispensing (MID) – into the clinics' operations. The three practices are: Arizona Arthritis & Rheumatology Associates (AARA), Arthritis & Osteoporosis Consultants of the Carolinas (AOCC), and Arthritis Associates of Tennessee and represent an additional 68 providers that will dispense specialty medications through the House Rx platform, bringing the total number of providers on House Rx's platform to 137. While MID has grown in oncology, House Rx's partnership with these practices is one of the first to bring the model to rheumatology care. "It's very exciting to partner with key thought leaders in rheumatology to bring medically integrated dispensing to this specialty. Each one of these practices is a leader in their region, and we look forward to partnering very closely with them to define a new standard for a better patient experience and improved outcomes for patients living with rheumatic diseases." Ogi Kavazovic, Co-Founder and CEO of House Rx By bringing specialty dispensing into the physician's office, the partnership with House Rx aims to dramatically improve the specialty medication experience for patients. The MID care model provides a seamless and efficient way for patients to receive prescribed therapies directly from their doctor – which research has demonstrated improves outcomes, including quality of life and increased survivability, when contrasted with the Pharmacy Benefit Manager-controlled specialty pharmacy approach. "This partnership will increase patient satisfaction by providing prescription medication in-house, and House Rx's technology and expertise will help us achieve this," said Prakash Viswanathan, CFO of AARA. "It is motivating to help trailblaze a new path in rheumatology and be one of the first practices to bring specialty medication dispensing under our roof, making it far easier and quicker for patients to get the medications they need." "We couldn't be more excited about this partnership, which will bring immediate benefits for our patients," said Scott Gilomen, CEO of AOCC. "Having managed an oncology practice earlier in my career, I've seen first-hand the advantages of the MID model and look forward to how House Rx's approach to MID will propel the rheumatology field forward – with our practice at the forefront." "The House Rx model will transform how rheumatology care is delivered, making it more coordinated and improving our patients' experience," said Beth Simpson, DO and managing physician partner at AATN. "We look forward to our patients not being on hold for hours on end waiting to speak with a specialty pharmacy. Instead, they'll speak immediately with House Rx's integrated team of pharmacy experts who understand their rheumatologic conditions." While the concept of dispensing specialty medications in rheumatology is not new — a handful of clinics attempted dispensing in the past but ultimately were unsuccessful due to a lack of technological and operational support — House Rx's model approaches in-office dispensing in a new way. By providing clinics with specialized technology and operational support from pharmacists and pharmacy technicians who work integrated with the clinic, practices can keep the service under their roof while reducing the heavy lifting of implementing and maintaining a successful MID program. In addition, clinics can repurpose staff resources normally spent on prior authorizations and financial assistance for patients to focus on direct patient care or other activities critical to the viability and financial independence of community rheumatology clinics. About House Rx House Rx is a healthcare technology and services company focused on making specialty medication more accessible and affordable. The company partners with specialty clinics across the country to help these community clinics offer medically integrated dispensing, bringing together clinical and pharmacy expertise to better serve patients, lower the cost of care, and create a better experience for patients and their caregivers. Learn more at www.houserx.com. About Arizona Arthritis & Rheumatology Associates With 19 physicians, 30 advanced practice providers, and 10 clinics around the state of Arizona, AARA is one of the largest rheumatology practices in the country bringing world-class expertise to patients managing autoimmune conditions. A member of the American Rheumatology Network, and always at the forefront of rheumatology care, AARA has led the way in addressing the rheumatologist workforce shortage by integrating advanced practice providers into their practice, which has allowed the practice to scale clinical operations and meet the demand of a growing patient population. About Arthritis & Osteoporosis Consultants of the Carolinas Based in Charlotte, North Carolina, AOCC has 10 physicians and 5 advanced practice providers caring for patients across two clinics. Combining years of experience in private practice, academic teaching and clinical research, the clinic staff provides highly individualized and state-of-the-art care. About Arthritis Associates Founded in 1975, Arthritis Associates has been at the forefront of rheumatological care in Chattanooga, TN and is the only practice in the area treating both adult and pediatric patients. Arthritis Associates has an excellent, experienced and knowledgeable team including skilled nurses who can administer intravenous treatments onsite, supervised by a board-certified rheumatologist.

Read More

BUSINESS INSIGHTS

WuXi STA Opens New Large-scale Oligonucleotide and Peptide Manufacturing Facility

WuXi STA | July 07, 2022

WuXi STA, a subsidiary of WuXi AppTec, announced the opening of a new large-scale oligonucleotide and peptide manufacturing facility at its Changzhou campus. The new facility underscores WuXi STA's ongoing commitment to enhance its capacity and capability to meet the fast-growing customer needs for oligonucleotide and peptide therapeutics development and manufacturing worldwide, making more innovative therapies accessible to the patients. With the opening of the new 30,570 sq.ft. oligonucleotide plant, WuXi STA extends its leadership in oligonucleotide development and manufacturing worldwide, with four large-scale oligonucleotide production lines and more than 20 small- to mid-scale production lines that increase the overall manufacturing capacity of a single synthesis run from 1.9 mol to 6.0 mol. The new 22,260 sq.ft. peptide plant features three new production lines with reactors that can accommodate up to 1,000 L, increasing WuXi STA's overall Solid Phase Peptide Synthesis total reactor volume to 6,490 L. The new facility is an essential part of WuXi STA's comprehensive end-to-end Contract Research, Development, and Manufacturing Organization platform for new modalities. The platform supports oligonucleotides and peptides, including novel monomers and linkers, and complex conjugates, from early discovery to development and commercial production at any scale. With this enhanced manufacturing capacity and over 850 dedicated scientists, WuXi STA's new modality CRDMO platform can better enable global partners as their projects progress to late and commercial stages. In addition, WuXi STA offers injectable formulation development and manufacturing services, including Lipid NanoParticle technology as well as comprehensive analytical and Chemical, Manufacturing, and Controls dossier preparation services, which further accelerate the development of new oligonucleotide and peptide therapeutics for the market. "We are pleased to support our global partners in their efforts to develop new modality therapies for patients in need. WuXi STA is committed to enabling partners by enhancing our new modality CRDMO platform's capacity and capability to expedite the development and commercialization of more innovative therapies to benefit patients worldwide." Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA WuXi STA has a global network of multiple R&D and manufacturing sites across Asia, North America and Europe, including a new pharmaceutical manufacturing campus in Middletown, Delaware that is scheduled to open in 2024. About WuXi STA WuXi STA, a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry with operations across Asia, North America and Europe. As a premier Contract Research, Development, and Manufacturing Organization, WuXi STA offers our worldwide partners efficient, flexible, and high-quality solutions for integrated CMC solutions from preclinical to commercial uses.

Read More