Awaiting FDA nod, Novartis touts latest data on gene therapy Zolgensma

fiercepharma | May 06, 2019

As Novartis waits for FDA action on its gene therapy Zolgensma, expected this month, the company has rolled out yet another round of data on the spinal muscular atrophy treatment. Novartis’ AveXis, which developed the gene therapy, touted interim data through March 8 from a phase 1 study in Type 2 SMA patients, plus later-stage studies in Type 1 and presymptompatic SMA patients. In the Strong study, which is testing Zolgensma in patients with Type 2 SMA, the drug demonstrated “rapid motor function gains and milestone achievements,” AveXis said.  All 30 patients in the Strong study were still alive, the company reported. Investigators tracked two treatment-related adverse events, both transaminase elevation. But even with just 6.5 months of follow-up after treatment, 10 patients achieved 22 motor milestones.

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Suvoda and N-SIDE Announce Agreement to Deliver Integrated Clinical Trial Optimization and IRT Solutions for Real-Time Demand Planning

Suvoda LLC | May 13, 2022

Suvoda LLC, a global clinical trial technology company that specializes in complex studies in therapeutic areas such as oncology, central nervous system, and rare disease, today announced they have entered into an agreement to partner with N-SIDE — a deeptech company that empowers organizations in the clinical trials industry to make better decisions and optimize the use of critical resources.  To date, the two companies have successfully partnered on more than 100 clinical trials in drug development, activating machine learning based on real-time data and increased efficiency in trial supply. Suvoda's IRT enables the implementation of optimized resupply strategies with adapted IRT algorithms that seamlessly integrate N-SIDE's forecasting and mathematical optimization recommendations. This results in significant cost savings through reduced drug wastage and accelerated trial timelines. Partnership Delivers Faster Start and Flexible Supply Strategy The most successful forecasting and optimization strategies consider the end-to-end supply chain, including impact assessments of trial design decisions. Efficient strategies — like the ones jointly deployed by N-SIDE and Suvoda — must be carefully evaluated and implemented, and have the flexibility to adapt in real-time to the unknowns that come with clinical trials. "As global clinical trials grow more complex, clinical trial professionals need the right partners and tools to help them gain control and account for the 'what ifs' as quickly as possible. N-SIDE has a history of excellence in clinical supply optimization that is unrivaled in the industry, and Suvoda is known for delivering clinical trial technology solutions that are built to manage change quickly. Our seamless integration and deep expertise will enable study teams to focus on other day-to-day decisions, while giving them peace of mind in their drug supply strategy." Anthony Encarnacao, Vice President, Global Partnerships for Suvoda This partnership allows for the inclusion of a flexible IRT solution during the development of the trial protocol, giving Suvoda greater visibility into the supply chain parameters based on the protocol discussions and finalization. Moving IRT more upstream in the startup process helps mitigate the risks and time constraints associated with last minute IRT implementations. Clients also gain access to N-SIDE's real-time monitoring of recruitments, demands, and inventories, supported by Suvoda's data. Coupled with N-SIDE's optimization, sponsors and CROs will experience an expedited IRT contracting, set-up, and build process, with greater optimization after study go-live. "In a world where decisions are made every day by different teams, with different objectives, it is easy to forget the impact that decisions have outside of one's team," explains Amaury Jeandrain, head of BD engineering at N-SIDE. "We connect clinical operations, supply chain, manufacturing, and IRT to ensure a global optimum that reduces drug waste while increasing patient centricity and accelerating trial timelines. And, working with partners like Suvoda, who understand this challenge and are able to bring flexibility and efficiency within their solutions, is a big step towards this objective." About Suvoda Suvoda is a global clinical trial technology company that specializes in complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest, Romania and Tokyo, Japan. The company consistently boasts a Net Promoter Score (NPS) of close to 70, far exceeding the technology industry average of 50, and has been selected by trial sponsors and CROs to support more than 1000 trials across 65 countries. About N-SIDE N-SIDE is a deeptech company that empowers organizations in the life sciences to make better decisions and optimize the use of critical resources. We're doing so by combining deep industry expertise with applied mathematics and artificial intelligence into easy to use and cutting-edge software that transforms uncertainty and complexity into clear decisions. We have been an active player in clinical trial supply chain management for over 20 years and work with the majority of the top 20 pharmaceutical companies. With our software solution, the N-SIDE Suite, and expert services, we streamline the clinical supply of pharmaceutical and biotech companies by accelerating clinical plans, mitigating risks and curbing drug waste. We empower clinical leaders to make better, faster, and safer decisions for patients waiting for life-changing medications. Our successes on over 10,000 trials include an average of 20%-60% of drug waste and cost reduction, with no delays due to drug shortages and an acceleration of 2-6 months of clinical trial timelines.

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medical leverage, a communications company positions itself for 2022 growth

medical leverage | January 15, 2022

medical leverage, a communications company is pleased to announce the promotion of Justin Reed to VP of Finance, Alexandra Rivers to HR and Training Manager, and Janeanne Josephson to Associate Marketing Manager. These changes drive the company's mission to meet the challenges of today's unique market. With the additional hiring of several project managers to the team, ml is positioning itself well for growth in 2022. These promotions are all important shifts in responsibility that will ensure ml's service levels are enhanced during its expansion efforts. "Our 2022 expansion efforts started at the stroke of midnight on the new year, thus spring-boarding our talent acquisition initiatives. We continue to attract top-notch thinkers and doers by focusing on creating a culture where we offer improved operations, continued staff training, and product enhancements to best serve our current and future clients. As always, our expansion approach is guided by our core values and steered by our Executive Leadership Team." medical leverage's president, Dave Oury ABOUT medical leverage is a medical communications company that provides full-service solutions to pharmaceutical, biotech, biopharmaceutical, medical device, and medical diagnostic companies. We elevate healthcare communications through education by partnering strategically with life science companies and providers. For over twenty years, we have had the distinct honor of working with marketing, medical affairs, sales training, and market access teams within US and international companies. We know that behind every program there is a product and behind every healthcare professional there is a patient. We focus on our clients, so they can focus on healthcare professionals and, ultimately, their patients.

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Ellipses Pharma and SunRock Biopharma Enter Into a Licensing Agreement for a First-in-class Bifunctional HER3:TRAIL Fusion Protein

SunRock Biopharma S.L | May 26, 2022

SunRock Biopharma S.L. a biopharmaceutical company that is developing a portfolio of innovative bispecific antibodies to treat incurable cancer, and Ellipses Pharma Limited a global drug development company focused on accelerating the development of new oncology treatments, announce that they have entered into an exclusive licensing agreement for SRB22, a fully human bifunctional HER3:TRAIL fusion protein, which going forward will be known as EP0017. Under the agreement, Ellipses has been granted global rights to develop and commercialise EP0017 and will assume the full cost and responsibility for the remaining pre-clinical and clinical development of the compound. In line with its strategy, Ellipses intends to out licence EP0017 for commercialisation if it proves safe and effective in clinical trials. SunRock will continue to be involved in the development of EP0017 to ensure efficient translational activities through a service agreement with Ellipses. If Ellipses out-licences EP0017, SunRock will also receive milestone payments and royalties. EP0017 is a first-in-class bifunctional fusion protein with a dual mechanism of action. It selectively targets HER3, which is overexpressed in several different tumour types, and additionally, binds to the tumour death receptors DR4 and DR5, inducing tumour cell death. Promising data has been generated in a range of preclinical models that demonstrate the potential of EP0017. Laureano Simón, Ph.D., CEO of SunRock Biopharma, said “The agreement with Ellipses will speed up the development of EP0017, moving this potentially life-changing asset towards the clinic and then hopefully towards cancer patients who desperately need novel approaches to fight invasive tumours.” Rajan Jethwa, MD, CEO of Ellipses Pharma “Our mission is to rapidly develop innovative cancer therapies, to get these therapies into the clinic as quickly as possible and potentially save more lives. We are excited about the opportunity to progress the development of this promising asset and look forward to working with SunRock to expedite the preclinical work.” About SunRock Biopharma S.L. Since its inception in 2014, SunRock has developed a comprehensive pipeline of seven therapeutic antibodies, bispecific antibodies and fusion proteins with proven therapeutic effects against several types of tumours that currently lack a treatment. The innovative spirit of SunRock defines the development of all its molecules, that are the result of a disruptive technological platform that has led to pioneer therapies with an innovative format, including first-in-class bispecific antibodies and fusion proteins that target both novel and well-known therapeutic targets. SunRock’s project portfolio is generating great expectations among patient associations, major hospitals, and biopharmaceutical companies. The Government of Galicia participates in SunRock through the Galicia Innova Tech Fund, FICC. About Ellipses Pharma Limited Ellipses Pharma is a global drug development company based in London, focused on accelerating the development of cancer medicines and treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection with an uninterrupted funding flow to minimize the time it takes to advance lead products through clinical trials and reach patients.

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Angelini Pharma, a New Partner in Epilepsy

Angelini Pharma | March 26, 2022

On the occasion of Purple Day an annual international event aimed at raising awareness of epilepsy, Angelini Pharma, international Italian pharmaceutical company, is committed to provide patients and healthcare professionals with innovative solutions improving the care of patients with epilepsy. Epilepsy is a common neurological disorder that typically results in seizures of various types, with focal seizures being the most common one.1 The essential treatment goal of epilepsy therapy is seizure freedom.2 The global disease burden of epilepsy is high. 3,4 A diagnosis of epilepsy confers significant disability on the individual, including physical, psychological, and social issues that negatively impact self-esteem, family environment, relationships, leisure and working life. 3,5 Long-term outcomes for patients who have not responded to at least 2 antiepileptic drugs remain without significant improvement for more than 2 decades despite the availability of many new antiepileptic drugs. 6,7 Indeed, even today 40% of all patients with epilepsy do not achieve seizure freedom despite treatment with 2 different drugs.6,8 The probability of achieving the therapeutic goal of seizure freedom decreases significantly with each failed treatment. 6 Aware of the existence of an unmet medical need, Angelini Pharma is committed to make available a new anti-epileptic drug. The product received the Market Authorization from the European Medicines Agency in March 2021 and many Early Access Program authorization across European countries, including in France. The product is already marketed in Germany, Austria, United Kingdom, Sweden, and Denmark. About Angelini Pharma Angelini Pharma is an international pharmaceutical company, part of the Italian privately group owned Angelini Industries. Angelini Pharma is committed to helping patients in the therapeutic areas of Mental Health Rare Diseases and Consumer Healthcare. In particular, Angelini Pharma is committed to brain health working every day to reduce and mitigate neurological disorders, while restoring and protecting mental health and cognitive function.

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