by Stephen Riddle

https://pharmaphorum.com

Mon, 11 Apr 2022 12:23:16 +0000
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UK grants early access to Novartis’ prostate cancer radioligand
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Mon, 11 Apr 2022 11:04:27 +0000

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The UK regulator has said eligible patients with prostate cancer will get early access to a radioligand therapy

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The UK regulator has said eligible patients with prostate cancer will get early access to a radioligand therapy developed by Novartis’  Advanced Accelerator Applications (AAA) subsidiary while it is under regulatory review.

The Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light for 177Lu vipivotide tetraxetan – approved last month in the US as Pluvicto – to be included in the Early Access to Medicines Scheme (EAMS).

The EAMS provides a route for clinicians and patients in desperate need of treatment options to try experimental therapies before formal approval, with the drug developer generally providing the drug at no cost.

The MHRA is currently reviewing 177Lu vipivotide tetraxetan for previously-treated patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), a group with limited treatment options, and is due to deliver a verdict on later this year.

In the VISION study reported at ASCO last year, Pluvicto given on top of standard care reduced the risk of death by 38% compared to standard care alone in men with PSMA+ mCRPC who had progressed after three or more prior anti-androgen and chemotherapy regimens.

“With over 11,500 prostate cancer deaths every year in the UK alone, and few alternative treatments, there is an urgent need to make new and improved treatments available,” said AAA’s  general manager for the UK & Ireland, Baltics and Nordics, Alessandra Dorigo.

“We are committed to continuing our work in collaboration with the NHS to improve access to innovative treatments,” she added.

The drug was the lead asset in Novartis’ $2.1 billion takeover of Endocyte in 2018, one of a series of recent deals made by the company in the radiopharma category, and is due to be launched in the US within the next few weeks.

AAA is also testing 177Lu vipivotide tetraxetan as an earlier-stage therapy for metastatic prostate cancer, which currently has a five-year survival rate of less than 30%, as well as in the pre-chemotherapy setting in CRPC.

Novartis reckons in time the drug could become a $2 billion-a-year blockbuster.

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Gaming health firm GripAble raises $11m for rehab platform
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Mon, 11 Apr 2022 10:30:44 +0000

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GripAble has raised $11 million in first-round financing that will be used to advance its digital health approach

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GripAble has raised $11 million in first-round financing that will be used to advance its digital health approach to rehabilitation for people with neurological and musculoskeletal conditions on the international stage.

The London, UK-based company has developed a platform that combines a hand-held sensor, gamified mobile app software, and telehealth consultations with therapists, which is designed to entertain users while they train at home. It is aimed at patients with conditions like stroke that can lead to upper limb weakness.

Crucially, while there’s no way to monitor conventional home-based rehabilitation exercises, GripAble gathers data that can be used by patients and their therapists to monitor progress and guide treatment.

To use it, patients squeeze, turn, or lift the handgrip, and it vibrates in response to their performance whilst playing. It can also be personalised to each patient’s ability level and recalibrated as needed.

GripAble says the technology was developed to enable therapists “to serve more patients, more efficiently, and deliver better outcomes – face-to-face or remotely – by incorporating technology with manual repetition exercises and treatment.”

The Series A – led by IP Group and matched by Parkwalk Advisors – will be used to expand the platform and expand in Europe and the US, said GripAble.

The company has already made progress in the North American market via a partnership with medical equipment distributor Medline, which is helping the company get the system into clinics across the US following pilot studies at several sites.

To date, GripAble has been used by more than 8,000 individuals, with over 109,000 activity sessions and close to 7,000 hours of training completed mainly in the UK, according to the company, which spun out of Imperial College London.

It has also signed multiple partnerships with pharmaceutical companies to explore the use of the platform in the testing and development of new therapies.

“The more rehab [patients] do and the more they adhere to professional guidance, the greater their chances of having better outcomes,” said Dr Paul Rinne, GripAble co-founder and CEO.

“However, due to resource costs and poor logistics, current health systems cannot deliver the amount of therapy needed, with significant backlogs, and few patients receiving anywhere near what they require to get better,” he added.

In a clinical trial of 30 patients published in the journal Neurorehabilitation & Neural Repair last year, researchers found that the device enabled on average 104 upper limbs (UL) repetitions per day whereas conventional therapy achieved 15 UL repetitions per day.

Use of the platform also doubled the amount of time subjects carried out UL exercises to 51 minutes per day – adding 26 minutes of gamified therapy to the 25 minutes of conventional rehab therapy carried out daily.

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AACR: Affimed builds case for natural killer cell therapy
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Mon, 11 Apr 2022 09:50:03 +0000

https://pharmaphorum.com/?p=89468

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Affimed says new data from a phase 1/2 trial of its natural killer (NK) cell engager therapy AFM13

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Affimed says new data from a phase 1/2 trial of its natural killer (NK) cell engager therapy AFM13 provide further evidence of its efficacy in treating CD30+ Hodgkin and non-Hodgkin lymphoma patients, although not for the version that will likely be filed for approval.

The MD Anderson study now has data from 19 patients, with all responding and 13 (62%) having a complete response after treatment with AFM13.

The therapy is a bispecific antibody that targets both CD30 on lymphoma cells and CD16 on NK cells, which in this trial is given alongside cord blood-derived NK cells to stimulate an attack on the cancer. Treatment consists of chemotherapy to deplete the bone marrow, followed by four infusions of the bispecific antibody and NK cells given weekly.

At the moment, Affimed is testing AFM13 on its own, without the NK cell infusion, as it builds towards regulatory filings for the therapy, although it does have a combination AFM13/NK cell therapy in phase 1.

Relying on the patient’s own NK cells makes the therapy easier and cheaper to administer, but the big question is whether that will still be effective.

That aside, the new AACR data are at the very least another endorsement of its NK-directed therapeutic approach, which has attracted early-stage partnerships with Roche and Roivant.

A year ago, at the same meeting, Affimed was talking about four remissions amongst its first four patients treated with the drug, so the updated results are a clear indication that the first readout wasn’t a fluke – and remarkable given the subjects in the study had relapsed after previously receiving several earlier rounds of treatment.

Yago Nieto of MD Anderson Cancer Centre, who presented the study at the American Association of Cancer Research (AACR) congress, noted that for the 13 patients in complete response, seven remained so after a median follow-up of 6.5 months.

However, one patient with a complete response saw their disease progress after around eight months, and four of five partial responders have also seen their cancer progress within three to four months of treatment, raising some questions about the durability of the treatment.

“We have amended the study to allow patients to receive additional cycles, which may further increase the efficacy,” commented Dr Andreas Harstrick, chief medical officer at the Heidelberg-based biotech.

Now, attention will turn to the results of Affimed’s mid-stage REDIRECT trial of AFM13 as a monotherapy, which is due to report top-line results in the second half of this year. If the results are positive, Affimed reckons it could serve as a pivotal trial allowing it to file for regulatory approvals.

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AACR: BioNTech finds value in CAR-T/mRNA vaccine combo
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Mon, 11 Apr 2022 09:00:31 +0000

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Adding an mRNA vaccine to CAR-T cell therapy could be the key to unlocking activity in solid tumours,

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Adding an mRNA vaccine to CAR-T cell therapy could be the key to unlocking activity in solid tumours, according to German biotech BioNTech.

CAR-Ts have revolutionised the treatment of some blood cancers like B cell lymphomas, but have been largely unsuccessful at targeting solid tumours, in part as the cells do not penetrate tumour tissue as effectively as the bone marrow.

BioNTech’s answer to that is to combine an autologous (patient-derived) CAR-T with a tumour-targeted mRNA vaccine that codes for the CAR-T target antigen, attempting to both amplify the response to the cell therapy and stimulate a response by the patient’s immune system.

In a phase 1/2 trial reported at the American Association of Cancer Research (AACR) congress, there were preliminary signs that the approach could work.

BioNTech said its CAR-T (BNT211) and mRNA vaccine (CarVAC) combination – both targeting the cancer-associated antigen claudin-6 – was shown to be safe and well-tolerated in a group of 16 solid tumour patients, with preliminary signs of efficacy.

Patients received the CAR-T alone at ascending doses in the first part of the trial, moving on to combination use with the mRNA vaccine afterwards. It is too soon to see if the combination is working better, but the first results indicate that targeting claudin-6 in patients is a valid strategy to pursue.

Six of 14 evaluable patients with testicular or ovarian cancer achieved a partial response six weeks after treatment, a rate of 43%, with four of the responders getting the CAR-T on its own, while two were also treated with the mRNA shot.

Another five subjects in the study – which also included patients with endometrial cancer, fallopian tube cancer, sarcoma, and gastric cancer – had stable disease and shrinking of some target cancer lesions, giving an overall disease control rate of 86%.

The researcher presenting the data at AACR, John Haanen of the Netherlands Cancer Institute, said there was evidence of a “deepening and durability” of the tumour responses over time. With one patient achieving a complete response after 18 weeks. On the other hand, there was also evidence of the treatment effect wearing off in some patients.

“Claudin-6 was never targeted with cellular therapy before, but in this study, the approach is already showing an efficacy that may be better than the data from other CAR-T trials in solid tumours,” he said.

The treatment had manageable side effects, including cases of cytokine release syndrome (CRS) – a known hazard of CAR-T therapy – that resolved after treatment with Roche’s anti-inflammatory drug Actemra (tocilizumab).

Additional data from the ongoing trial will be available later this year, said BioNTech, currently riding high on the success of its COVID-19 vaccine.

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Digital investment promises to accelerate the use of wearable sensor data in clinical trials
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Mon, 11 Apr 2022 08:37:33 +0000

https://pharmaphorum.com/?p=89163

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In an interview with Dudley Tabakin (CEO, VivoSense), Chris Garabedian (CEO, Xontogeny) and Tanja Dowe (CEO, Debiopharm Innovation

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In an interview with Dudley Tabakin (CEO, VivoSense), Chris Garabedian (CEO, Xontogeny) and Tanja Dowe (CEO, Debiopharm Innovation Fund), pharmaphorum discusses the recent announcement of the closing of a $25 million Series A financing round to scale up the innovative VivoSense® software, which uses wearable sensor data in clinical trials, and for the development of novel digital biomarkers.

Dudley Tabakin, CEO of VivoSense, describes how this financing is set to accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments.

He explains that VivoSense® software is designed to deliver real-world evidence from wearable sensors, which will help to advance patient-focused drug development and precision medicine for patients with cancer, Alzheimer’s, rare disease and other therapeutic indications.

“VivoSense software is developed specifically for analysis of data from wearable sensors”, explains Tabakin.

“The problem with most wearable sensor data is that it tends to be variable and ‘noisy’. You’re wearing it on your body while walking around doing day-to-day activities. The VivoSense platform is developed specifically to be able to handle that type of variability.”

Tabakin goes on to highlight how output measures are therefore more relevant, accurate and meaningful to the patient, clinician and – in the case of regulatory approvals – the pharmaceutical sponsor.

“ECGs are a great example of this,” Tabakin continues. “You need the purest waveform to measure heart rate accurately, but when you’re moving around, a wrist-worn device may integrate a lot of ‘noise’ in the data. With most devices, that data is interpreted, and an estimate is made for the period where the true data cannot be read (the ‘noise’). In VivoSense software, we have the ability to find those regions and remove that period of time. In this way, you’re eliminating that variability.”

“The problem with most wearable sensor data is that it tends to be variable and ‘noisy’. You’re wearing it on your body while walking around doing day-to-day activities. The VivoSense platform is developed specifically to be able to handle that type of variability.”

Searching for the right solution

Chris Garabedian, CEO of Xontogeny, describes how his past experiences as CEO of Sarepta Therapeutics have led him on an exploration for technology that can effectively leverage wearable data in clinical trials.

“The wearable market was starting to proliferate, and people were starting to ask questions. How can this data be incorporated into clinical trials?”

He explains that there existed an unmet need to bolster the data sets for drug development. There was a huge opportunity for regulators to leverage real-world evidence and patient-reported outcomes data, captured through wearables, in addition to traditional clinical data.

“But the field was still pretty nascent at that point. I was left frustrated that there wasn’t the type of solutions that I was looking for. This brings us to VivoSense. We believe that VivoSense is ‘the tip of the spear’ in this category.”

Garabedian and his team plan to support VivoSense, not just with their funding package but with their industry network and connectivity.

“We were really searching for the right investment in this emerging digital space. We’ve always been intrigued by wearables, but there just haven’t been a lot that have measured up. We think wearables that use these types of technologies will have an edge and be differentiated from those that use existing platforms in future clinical trials.”

“The wearable market was starting to proliferate, and people were starting to ask questions. How can this data be incorporated into clinical trials?”

Tabakin agrees. “In 2010, when we founded VivoSense, we developed a software platform for analysis of wearable sensor data and electronic patient-recorded outcomes (PRO) and patient diary information. But as Chris says, back then, it was really early days. There were very few CEOs out there that, like Chris, were looking for this type of solution.”

Tabakin explains that he now sees a big change, especially since the COVID-19 pandemic. Pharmaceutical sponsors are actively looking for solutions. With their team’s collective experience in the field, Tabakin and his investors believe VivoSense is best positioned to provide these solutions.

Tanja Dowe, CEO of Debiopharm Innovation Fund, describes how Debiopharm had invested in a number of digital therapeutics companies in the oncology sphere prior to the partnership with VivoSense. They had already perceived the next step to be collecting passive data through wearables, in order to better serve patient outcomes, whether in cancer or in other indications.

“When we came across VivoSense, we immediately knew that this was the company that we had been looking for”, explains Dowe.

“The team has that entrepreneurial background, a long history of technical competency and knowledge in wearables, and they had the same vision as us about how patients can be passively monitored.”

The inherent value of passive data collection

Tabakin is keen to explain how passive data collection has many benefits for outcome measurement. Data can be collected by patients at home, in the real world, enabling the pharmaceutical industry to tap into digitally connected devices, which is something regulatory authorities have been asking for, he says. He even goes so far as to ponder whether in-clinic trials are, in fact, subjective, where real-world evidence is the more objective form.

“Regulatory authorities are asking for real-world evidence as opposed to in-clinic data, which we know has bias. That is why you want to measure passively as much as possible and why VivoSense was really created in the first place.

Take the six-minute walk test for movement disorders. In the clinic, the patient is motivated to walk as far as they can in six minutes, whereas in the real world, you can get data that shows the patient’s true everyday walking activity. Nobody is motivating them to go on a six-minute walk.

Especially with the proliferation of (and need for) de-centralised trials, with pandemics, it’s even more important to collect this passive data, as part of a clinical trial.”

“The team has that entrepreneurial background, a long history of technical competency and knowledge in wearables, and they had the same vision as us about how patients can be passively monitored.”

Exploring the wider impact on digital healthcare

Garabedian and Dowe both feel that this type of software is of critical importance for the wider life sciences industry. They believe the field will grow rapidly over the next few years.

“In the longer run, the largest opportunity for improvement is in standard patient follow up,” Dowe explains. “I believe we will use digital biomarkers to keep patients safe by detecting and predicting side effects, for example.

From the patient perspective it’s really about feeling safe, knowing that the clinician that treats them can see how they’re doing in-between visits. Whether it’s quality of life or symptoms, the patient knows that their care is based on exact, accurate, real-world data. Clinicians can then take advantage of knowing their patients better, knowing how they’re doing.”

The potential benefit of improving accuracy of representative data extends well past the patients, all the way to the biopharma companies working to treat them. Garabedian goes on to add that “what this technology allows is the creation of a much greater volume of data around how a patient behaves with a given intervention.” He highlights that every company bringing a programme in clinical trials is trying to separate the ‘signal’ of their drug working from the ‘noise’.

“What wearables data allows is far greater statistical power. But you can’t just look at the data in a vacuum. You need to put context around that.”

Industry experience is key here, evaluating and identifying what is and isn’t valuable data. Garabedian believes it’s not as simple as strapping on a wearable in a clinical trial and gathering data.

“VivoSense has the right clinical experience. They’ve been continuing to re-shape algorithms to make sure that they provide meaningful data for years now.”

Goals and milestones for the path ahead

Dowe is acutely aware that these types of solutions require validation for use in clinical trials. She believes that there is also a certain element of market education needed.

“Everyone is talking about using wearables in clinical trials, but to have larger market adoption you need to have the wearable data validated for clinical outcome assessment,” Dowe explains.

“You need someone to do the work of research and validation. VivoSense is bringing that solution to life.

Debiopharm well knows the difficulties with adoption of digital technologies within pharmaceutical development. But we also know how these barriers can be overcome, so we plan to help navigate some of the challenges ahead.”

Garabedian explains that his goal as an investor is to ensure that VivoSense can engage with more clients while maintaining the quality of the work, in addition to expanding the number of markers that can be captured in clinical trials.

“We think this will create a lot of value for the industry, and we believe VivoSense has the right team and the right technology at the right time.”

Dowe summarises her thoughts by explaining that the field of wearables is rapidly developing, that sensor technologies are becoming more accurate, and that more data than ever is being analysed.

“I believe that we will see wearables integrated into every clinical study in the future, and pharma should start taking steps towards that,” she states.

“Every consumer has a wearable nowadays, and these consumers are patients. If you think that you can avoid analysing wearable data from patients that are using a drug, you should think again. This data will exist whether you collect it as part of a clinical trial or not. If pharmaceutical companies do not use this data, someone else will. It’s just a matter of time.”

About the interviewees

Dudley Tabakin is CEO and co-founder of VivoSense. He studied biomedical engineering, and sport and gait biomechanics at the University of Cape Town, South Africa. His interest in clinical research analysis, motion capture, biomechanical modelling and wearable sensors is the foundation of VivoSense’s mission and core values (see more on LinkedIn).

 

Chris Garabedian is the founder, Chairman and CEO of Xontogeny. He has more than 30 years’ experience in the biopharmaceutical industry. In 2017, Garabedian joined Perceptive Advisors to develop their Venture Fund strategy, which invests in early-stage companies across biotech, medtech and healthtech. He served as the President and CEO of Sarepta Therapeutics from 2011 to 2015 and led corporate strategy for Celgene from 2007 to 2010 (see more on LinkedIn).

Tanja DoweTanja Dowe is the CEO of Debiopharm Innovation Fund, the strategic investment arm of the Swiss pharmaceutical company Debiopharm. A former entrepreneur and strategy and transaction consultant, she steers the fund to invest in start-ups with disruptive technologies that transform the pharmaceutical industry (see more on LinkedIn).

About VivoSense

VivoSense, Inc., is an agile end-to-end scientific solutions company developing novel digital endpoints from wearable sensor data. We are focused on healthcare research & delivery, clinical trials and patient wellness. For more information, visit www.vivosense.com or follow us on Twitter @vivosense.

 

 About the Perceptive Xontogeny Venture Fund

The Perceptive Xontogeny Venture Fund is Perceptive Advisors’ investment vehicle focused purely on early-stage, private venture investments in life sciences companies. For more information, visit www.perceptivelife.com.

About Debiopharm’s strategic digital health fund

As Debiopharm’s strategic corporate fund, the Debiopharm Innovation Fund invests in digital health, smart data, and innovative tech start-ups. Find out more about seeking digital health start-up funding.

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Innovation across the healthcare system is needed to realise the value of medicines
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Mon, 11 Apr 2022 08:00:12 +0000

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value of medicines

Janssen’s Catherine Taylor, vice-president, EMEA medical affairs, therapy area strategy, discusses the importance of systemic innovation across the

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value of medicines

Janssen’s Catherine Taylor, vice-president, EMEA medical affairs, therapy area strategy, discusses the importance of systemic innovation across the healthcare system to realise the full value of medicines.

Medicines and vaccines are among the most powerful interventions that can help improve quality of life for people across the world. As an oncology trained medical doctor who practiced in the UK NHS for 10 years, I have seen the benefits first-hand, as patients live longer lives, free from symptoms, and are able to return to work.

Beyond that, there are positive impacts for wider society, healthcare systems and economies. It is essential, therefore, that we continue to streamline the development, regulatory and access process, so that patients have faster access to better and safer medicines.

Cultivating a pro-innovation environment

To achieve this, it will be critical to maintain a pro-innovation environment. Systemic innovation isn’t limited to discovering new molecules; it’s a mindset we must continue to apply across the board. We need to be able to think outside the box and find new interventions and new delivery methods that lead to better and more sustainable standards of medical care.

Because, despite the great improvements made across the industry in recent years to accelerate innovative development, we still face many challenges. Innovative ‘next-generation’ medicines are met with a series of hurdles such as increased cost of development, regulatory challenges and delays, and longer and more complex clinical trials. And it all fuels the debate: are medicines a cost or an investment?

The answer to this question comes back to our definition of value. Value-based healthcare is a delivery model in which providers are rewarded based on the value and difference they bring to patients’ lives, rather than volume of treatments provided.

A few months ago, I spoke with Professor Joaquin Mateo, chair of the ESMO Translational Research and Precision Medicine Working Group. We agreed that one of the key future foci of innovation in medicines lay in the treatment of patients with medicines targeted specifically towards the molecular signature of their disease.  The ideal state is that one day patients only receive (and the healthcare system only provides) medicines that will improve their condition.  While we have made great progress with some diseases, we are not there yet, and we need to ensure that focused investment into research continues to bring the value that patients truly deserve.

The role of innovation in value-based healthcare

Delivering value for patients doesn’t start and end in our R&D labs; actions can be implemented across all stages of the drug development lifecycle to encourage and embrace a pro-innovation environment.

For example, alongside stable, transparent and long-term policies or research plans, incentives can encourage innovation from those willing to take risks and tackle areas of unmet patient need. Effective intellectual property systems are also essential in stimulating research and sustainable innovation for the future.

And strong collaboration from all involved in health research is another key component of a value-based healthcare approach. From patients, patient bodies, pharmaceutical companies, and academia, to regulatory bodies, public institutions, and small and medium-sized enterprises (SMEs), all key stakeholders must come together to help the patients who most need new medicines to access them as quickly as possible.

The European Commission’s Pharmaceutical Strategy for Europe, adopted in November 2020, outlines a series of concrete actions to ensure accessibility, availability, and affordability of medicines. The Strategy also highlights the importance of drawing lessons from the COVID-19 pandemic to enhance crisis preparedness and response mechanisms, and so help make the healthcare industry more prepared and resilient.

How can innovation within Medical Affairs drive value?

Medical Affairs is at the forefront of driving innovation across our industry, making it an exciting and ever-evolving area to work in. From innovative evidence generation to accelerating medical treatment adoption and transforming medical engagement, our teams play a huge role in helping to deliver much-needed treatments to patients across the world.

According to EFPIA, there are over 7,000 medicines currently in development globally. As part of this, innovative treatments such as CAR-T therapy and retinal gene therapy are emerging as ways to target rare diseases, multiple indications and underserved populations. Such therapies present significant challenges to our current regulatory and access processes, but these are challenges we must overcome if patients are to benefit.

The key, of course, is to always start with the end goal in mind – what change do we want to bring to patients? So, alongside developing and providing the treatment itself, it’s also important to provide comprehensive medical education, and to explore new patient pathways and delivery systems. That way, everyone understands the value of the treatment, and the route to getting it to the right patients at the right time is clear.

Data will always be central to everything we do, as it has the power to communicate the potential of a new treatment to change a person’s life. If we are to move towards a value-based healthcare system, then we must utilise the power of both clinical trials data and real-world evidence, to produce the best possible data package for regulatory submissions. Effective data analysis can lead to accelerated access and improved outcomes for patients. And building the voice of the patient into our business innovation is crucial – we need patients’ unique perspectives and experiences to keep us focused on solutions that will have the largest impact on their lives.

At Janssen, we strive to improve access to our innovative medicines and vaccines and achieve the best possible outcomes for patients across the world. Where I feel Medical Affairs can move the needle is as the scientific bridge, engaging with key stakeholders like clinicians, researchers, payers, policymakers, and regulators. Our role is to help translate the data and impactfully articulate the demonstrated medical value of a medicine, and to collaboratively explore how the value of that medicine could be improved. Ultimately, we want to ensure that those patients who could benefit most from our treatments are able to receive them – that’s what drives our Medical Affairs purpose.

About the author

dr catherine taylorDr Catherine Taylor is vice president, medical affairs therapy area strategy in EMEA (Europe, Middle East and Africa) at the Janssen Pharmaceutical Companies of Johnson & Johnson. Dr Taylor is the head of medical affairs for all Janssen’s disease areas in EMEA, with a focus on innovation, evidence generation, and innovative treatments. Prior to this role, Dr Taylor worked in the Middle East as the regional medical director, EMEA Emerging Markets for Janssen-Cilag Middle East Ltd.

Between 2016-2019, she was the medical affairs therapeutic area lead in haematology for Janssen Oncology across the EMEA region. Dr Taylor holds an MD from King’s College London and is a member of the UK Royal College of Physicians. Before joining the pharmaceutical industry, she trained and practiced in Clinical Oncology in London for 7 years. She also holds the Diploma in Pharmaceutical Medicine and has completed her UK specialty training in Pharmaceutical Medicine. Prior to joining Janssen in 2015, she held positions in UK, EMEA regional and global medical affairs at Pfizer and Astellas.

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Seagen wins Enhertu patent dispute with Daiichi Sankyo
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Sun, 10 Apr 2022 20:21:26 +0000

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A US jury has decided that Daiichi Sankyo and AstraZeneca’s breast cancer drug Enhertu infringes a patent held

The post Seagen wins Enhertu patent dispute with Daiichi Sankyo appeared first on .

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A US jury has decided that Daiichi Sankyo and AstraZeneca’s breast cancer drug Enhertu infringes a patent held by US biotech Seagen, awarding almost $42 million in damages.

Seagen claims Enhertu (trastuzumab deruxtecan) – an antibody-drug conjugate (ADC) targeting HER2 – infringes a patient it holds (No. 10,808,039) covering ADCs that include auristatin compounds coupled to an antibody via a linker molecule.

The jury in the US District Court for the Eastern District of Texas agreed with the biotech that the infringement was wilful, awarding it a sum based on past royalties that should have been paid on Enhertu sales in the US to date.

Daiichi Sankyo said that it disagreed with the verdict and was looking into its options – including potential post-trial motions and an appeal – and added that the court has not yet ruled on Seagen’s request for royalties on future sales “and whether to enhance damages in view of the jury finding of wilful infringement”.

It also said the US Patent and Trademark Office has granted a request to review the patent’s validity, so it looks like the legal wrangling could go on for some time.

Seagen hailed the outco–>

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