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Navigating the Job Interview: How to Answer the Question, “Why Are You Changing Jobs?”

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Navigating the Job Interview: How to Answer the Question, “Why Are You Changing Jobs?”

Job interviews can be nerve-wracking, but one question that you can almost guarantee will come up is, “Why are you changing jobs?” While it may seem like a straightforward query, crafting a thoughtful and convincing response can significantly impact the outcome of your interview. In this blog post, we’ll explore how to answer this common interview question effectively.

1. Emphasize Career Growth and Learning Opportunities

One of the most positive reasons for changing jobs is to seek new challenges and opportunities for professional development. When an interviewer asks about your reasons for changing jobs, highlighting your desire for growth can be a compelling response.

Here’s a sample answer:

“I’m seeking a new opportunity that will allow me to further develop my skills and take on more challenging responsibilities. While my current job has provided a strong foundation, I believe that a change will expose me to a wider range of experiences and help me grow both personally and professionally. I’m excited about the prospect of learning new things and contributing my expertise to a new team.”

This response not only demonstrates your commitment to self-improvement but also shows that you are proactive in shaping your career.

2. Address Issues Respectfully and Positively

Sometimes, the reasons for changing jobs are less about seeking opportunities and more about addressing challenges or issues in your current position. Whether it’s a toxic work environment, lack of growth prospects, or a company’s values not aligning with yours, it’s crucial to address these concerns in a way that reflects positively on you.

For example:

“I’ve had a great experience with my current employer, but I’ve reached a point where I believe my skills and values could be better utilized elsewhere. I’m looking for a work environment that aligns more closely with my personal values and offers a stronger platform for my professional growth. I believe this change is a natural progression in my career, and I’m excited about the possibilities it presents.”

This response acknowledges the positive aspects of your current job while emphasizing your desire for a better fit elsewhere.

3. Showcase Alignment with the Company’s Values and Goals

Employers appreciate candidates who have thoroughly researched their organization and can demonstrate alignment with the company’s mission, values, and goals. When you’re asked why you’re changing jobs, take the opportunity to show that you’re not just looking for any job but one that aligns with your aspirations and the company’s objectives.

Here’s how you can do it:

“I’ve been impressed by [Company’s Name]’s commitment to innovation and its dedication to making a positive impact in the industry. I’m excited about the opportunity to contribute my skills and experiences to a team that shares my values and vision. This role seems like the perfect fit for my career goals, and I believe it’s a step forward in the right direction for both of us.”

This response illustrates that you’ve done your homework and genuinely believe in the company’s mission, making you a more attractive candidate in the eyes of the interviewer.

In conclusion, the question, “Why are you changing jobs?” is an opportunity to showcase your professionalism, commitment to growth, and alignment with the organization’s values. Crafting a well-thought-out response that focuses on these aspects can help you make a strong impression during your job interview and increase your chances of landing the position you desire.

Pfizer to Showcase Advancements Across Genitourinary Cancers at ASCO GU Cancers Symposium

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Pfizer to Showcase Advancements Across Genitourinary Cancers at ASCO GU Cancers Symposium

January 28, 2025: “Pfizer will present the latest results from its leading genitourinary (GU) portfolio at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium taking place February 13-15 in San Francisco, California.

Data from more than 20 company-sponsored, investigator-sponsored, and collaborative research abstracts, including five oral presentations, highlight advancements in developing new standards of care within prostate and bladder cancer across the company’s core scientific modalities, including small molecules and antibody-drug conjugates.

“Our long-standing commitment to the genitourinary cancer community has been foundational in our mission to transform the treatment landscapes for patients with bladder and prostate cancers,” said Karin Tollefson, Chief Oncology Medical Officer, Pfizer.

“Our strong presence at this year’s ASCO GU highlights the longer-term impacts of our approved leading medicines for patients in their respective indications. We are also looking forward to sharing updates from our rapidly growing pipeline of novel targets and combination approaches, which have the potential to help address the diverse needs of patients across various stages of disease.”

Pfizer’s GU portfolio includes seven approved medicines across bladder, prostate, and kidney cancers, as well as a growing late-stage pipeline of scientific modalities and combination approaches.

Key Pfizer presentations at ASCO GU include the detailed overall survival (OS) results from the Phase 3 TALAPRO-2 trial with TALZENNA® (talazoparib) plus XTANDI® (enzalutamide) in patients with metastatic castration-resistant prostate cancer (mCRPC), which will be featured in ASCO GU’s official Press Program.

In addition, updated analysis from the Phase 3 global EV-302 study of PADCEV® (enfortumab vedotin-ejfv) in combination with pembrolizumab in locally advanced or metastatic urothelial cancer (la/mUC) will be presented, highlighting the long-term efficacy benefits of the combination.

From the pipeline, the first randomized progression-free survival (PFS) data from the ongoing Phase 1 dose-escalation study for mevrometostat plus XTANDI reinforce the potential of this investigational combination for patients with mCRPC.

Additional pipeline presentations include updated data and real-world evidence for different types of bladder cancer, supporting the development of two potential transformative treatments, disitamab vedotin, an investigational antibody-drug conjugate (ADC), and sasanlimab, an investigational subcutaneous PD-1 blocker.

Key ASCO GU Presentations

Prostate Cancer

  • TALZENNA plus XTANDI:Oral and poster presentations from the pivotal Phase 3 TALAPRO-2 trial of TALZENNA in combination with XTANDI will provide detailed results on the statistically significant and clinically meaningful improvement in OS in all-comers (cohort 1) as well as in those patients with homologous recombination repair (HRR) gene-mutated mCRPC (cohort 2), compared to XTANDI alone.

    TALZENNA in combination with XTANDI has been approved for use in over 35 countries globally for patients with certain types of mCRPC*. The OS results will be shared with global health authorities to potentially update the TALZENNA label.
  • XTANDI: Six abstracts continue to underscore the benefit of XTANDI across its approved indications, including two posters highlighting follow-up analysis from the EMBARK trial of XTANDI in combination with leuprolide in patients with non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high-risk for metastasis.
  • Mevrometostat: The first randomized PFS results from the ongoing Phase 1 dose-expansion study examine the potential of mevrometostat (PF-06821497), an investigational selective inhibitor of enhancer of zeste homolog 2 (EZH2), in combination with XTANDI in patients with mCRPC, compared to XTANDI alone.
  • Pfizer initiated two pivotal Phase 3 trials for mevrometostat plus XTANDI in 2024 and expects to start a Phase 3 study of mevrometostat plus XTANDI in first-line mCSPC during the first half of 2025.

Bladder Cancer

  • PADCEV: Long-term follow-up data from the groundbreaking Phase 3 EV-302 study of PADCEV in combination with pembrolizumab, including OS and safety data, continue to demonstrate consistent efficacy versus chemotherapy in a broad population, reinforcing the combination as standard of care in first-line treatment of la/muC.
  • Disitamab vedotin: Updated efficacy and safety data from an ongoing Phase 2 study (sponsored by Remegen) evaluating the HER2-targeting ADC disitamab vedotin plus toripalimab show encouraging results as a perioperative regimen in HER2-expressing muscle-invasive bladder cancer (MIBC).
  • These data add to the growing body of evidence supporting the continued development of disitamab vedotin across stages of bladder cancer.
  • Sasanlimab: Three real-world evidence poster presentations highlight the need for advanced treatment options for patients with non-muscle invasive bladder cancer (NMIBC), including presentations on Bacillus Calmette-Guérin (BCG) treatment patterns, impact of BCG shortages, and outcomes and treatment patterns in patients with high-risk NMIBC.

    Pfizer recently reported positive topline results for sasanlimab in combination with BCG as induction therapy with or without maintenance in patients with BCG- naïve, high-risk NMIBC. Detailed results from the Phase 3 CREST trial will be presented at an upcoming congress.

Additional information on key Pfizer-sponsored abstracts at ASCO GU 2025, including date and time of presentation, follow in the chart below.

*TALZENNA in combination with XTANDI was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with HRR gene-mutated mCRPC in June 2023.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-showcase-advancements-across-genitourinary-cancers

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

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FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

January 30, 2025: “The U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults.

Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.  

Journavx is the first drug to be approved in this new class of pain management medicines.

Pain is a common medical problem and relief of pain is an important therapeutic goal. Acute pain is short-term pain that is typically in response to some form of tissue injury, such as trauma or surgery.

Acute pain is often treated with analgesics that may or may not contain opioids.

The FDA has long supported development of non-opioid pain treatment. As part of the FDA Overdose Prevention Framework, the agency has issued draft guidance aimed at encouraging development of non-opioid analgesics for acute pain and awarded cooperative grants to support the development and dissemination of clinical practice guidelines for the management of acute pain conditions.  

“Today’s approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, J.D., M.D., acting director of the FDA’s Center for Drug Evaluation and Research.

“A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.

This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”

The efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy.

In addition to receiving the randomized treatment, all participants in the trials with inadequate pain control were permitted to use ibuprofen as needed for “rescue” pain medication.

Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo.

The safety profile of Journavx is primarily based on data from the pooled, double-blind, placebo- and active-controlled trials in 874 participants with moderate to severe acute pain following abdominoplasty and bunionectomy, with supportive safety data from one single-arm, open-label study in 256 participants with moderate to severe acute pain in a range of acute pain conditions.

The most common adverse reactions in study participants who received Journavx were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. Journavx is contraindicated for concomitant use with strong CYP3A inhibitors.

Additionally, patients should avoid food or drink containing grapefruit when taking Journavx.

The application received Breakthrough Therapy, Fast Track and Priority Review designations by the FDA.  

The FDA granted approval of Journavx to Vertex Pharmaceuticals Incorporated.”

https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain

Johnson & Johnson investigational therapy was recently granted U.S. FDA Priority Review for the treatment of gMG

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Johnson & Johnson investigational therapy was recently granted U.S. FDA Priority Review for the treatment of gMG

January 23, 2025: “Johnson & Johnson announced The Lancet Neurology has published results from the pivotal Phase 3 study of nipocalimab, an investigational FcRn blocker, evaluated in a broad population of antibody positive (anti-AChR+, anti-MuSK+, anti-LRP4+) adults with generalized myasthenia gravis (gMG).

The Vivacity-MG3 study met its primary endpoint demonstrating statistically significant and clinically meaningful improvement over 24 weeks in the MG-ADL score.

 Nipocalimab had a tolerable safety profile, with adverse events leading to discontinuation rates similar to placebo (5.1% with nipocalimab vs. 7.1% with placebo).

“Nipocalimab has been shown in multiple clinical studies to help reduce IgG, including autoantibodies, among this broad population of antibody positive adults with gMG.

The positive results from the Vivacity-MG3 study further support the potential of nipocalimab to address the underlying cause of this debilitating autoantibody disease,” said Carlo Antozzi, M.D., Neuroimmunology and Muscle Pathology Unit of the Neurological Institute Foundation C. Besta of Milan, Italy.

“It’s promising to see this positive data published in The Lancet Neurology as there is a continued need for additional approved targeted therapies with demonstrated safety profiles that offer sustained disease control for a broad range of antibody positive patients living with gMG.”

gMG is a chronic, life-long, rare, autoantibody-driven disease, for which there currently is no cure. gMG impacts an estimated 700,000 people worldwide.

Nipocalimab, a fully human IgG1 antibody, is an immunoselective investigational therapy that has been shown in clinical trials to lower immunoglobulin G (IgG), including pathogenic IgG, one of the root causes of autoantibody diseases.

Data from the Phase 3 study showed up to a 75% reduction in the median pre-dose total IgG from baseline. Additionally, reduction in levels of common pathogenic IgG subclasses, including AChR antibody and MuSK antibody, was observed over 24 weeks of the study.

No changes were observed in total IgE, IgA, and IgM, highlighting the potential ability to maintain a protective immune system even after reduction of pathogenic IgG autoantibodies is observed.

Nipocalimab plus SOC demonstrated a significantly greater reduction in MG-ADL response (≥2-point improvement from baseline) compared with placebo plus SOC (p=0.0213).

For someone living with gMG, a 1- to 2-point change on MG-ADL may be the difference between normal eating and frequent choking on food, or shortness of breath at rest and requiring the assistance of a ventilator.

“The Phase 3 Vivacity-MG3 data demonstrates our steadfast pursuit of researching and developing potential innovative and transformational approaches for autoantibody-driven diseases, such as gMG,” said Sindhu Ramchandren, M.D., Executive Medical Director, Neuroscience, Johnson & Johnson Innovative Medicine.

“We are delighted by the publication of this robust Phase 3 data in The Lancet Neurology as well as the Priority Review granted by the FDA.

People living with gMG require additional effective immunoselective therapeutic options that can potentially preserve the ability to maintain a protective immune response even after reduction of IgG.”

Johnson & Johnson submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of nipocalimab in gMG on August 29 and September 11, 2024, respectively.

Nipocalimab was granted Priority Review by the FDA which was supported by findings from the Phase 3 Vivacity-MG3 study.

In addition, nipocalimab recently received U.S. FDA Breakthrough Therapy Designation for the treatment of adults with moderate-to-severe Sjögren’s disease as supported by results from the Phase 2 DAHLIAS study.

Bayer and Pula Foundation partner up to insure 10 million smallholder farmers in Sub-Saharan Africa and South Asia

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Bayer and Pula Foundation partner up to insure 10 million smallholder farmers in Sub-Saharan Africa and South Asia

January 23,2025: “Bayer Foundation and the Pula Foundation announced at World Economic Forum that they are planning to provide insurance coverage for 10 million smallholder farmers by 2030.

The collaboration aims to enhance climate resilience among smallholder farmers, protecting them against the growing impacts of droughts and floods, which threaten harvests, livelihoods, and global food security.

It will help build private-public collaborations and shape the insurance market for agriculture in Africa and Asia.

The Pula Foundation has developed scalable and data-driven agricultural insurance solutions designed to safeguard smallholder farmers’ investments in their farms.

By mitigating risks associated with extreme weather events such as droughts and floods, the Pula Foundation ensures that farmers receive financial compensation for yield losses, enabling them to recover, reinvest, and build long-term resilience in the face of climate uncertainty.

By 2030, Bayer Foundation’s grant for insurance premium support in the amount of 10 million euros – supported by a donation from Bayer’s Crop Science Division – will unlock a potential insurance coverage of 127 million U.S. dollars for 10 million farmers working with national governments in Bangladesh, Pakistan, Malawi, Ghana, Nigeria, Kenya and Mali.

The grant originates from Bayer Foundation’s Social Innovation Ecosystem Fund which targets mature and high-impact solutions for underserved communities.

“Smallholder farmers are already affected heavily by the impacts of climate change, and this will get worse going forward.

It is crucial that we enable them to feed their communities and contribute to global food security,” said Matthias Berninger, Executive Vice President Public Affairs, Sustainability and Safety at Bayer and Member of the Board of Trustees at Bayer Foundation.

“Our Crop Science division is committed to deliver innovative, farmer-focused solutions that drive sustainable growth and regenerative agriculture.

By unlocking climate finance and collaborating with partners like the Pula Foundation, we aim to deliver ecosystem-based approaches that empower smallholder farmers and their communities to overcome challenges and thrive,” added Rodrigo Santos, President of Bayer’s Crop Science Division, Member of the Board of Management of Bayer AG and Executive Director Bayer Foundation.

Pula Foundation and Bayer Foundation already demonstrated in 2021 that building such public-private partnerships to offer insurance protection at scale works: Together with the Zimbabwean Government and as part of the Zimbabwean Conservation Agriculture Program, they developed an insurance solution that protects the input investments farmers made.

With the catalytic support of Bayer Foundation for this pilot, 31,000 farmers were insured against climate risks such as droughts in the first year, which the public-private partnership network of Pula Foundation scaled to more than 1 million farmers after three years.

“Climate resilience is not just about recovery but also about dignity and empowerment. We believe that insurance enables smallholder farmers to prepare themselves for an increasingly volatile climate, rather than waiting for handouts. We have witnessed firsthand how farmers bounce back stronger after climate shocks when they have the right tools and support,” said Rose Goslinga, Director of Pula Foundation.

“This partnership with Bayer Foundation will enable us to expand our reach and ensure that millions more farmers can secure their livelihoods and build resilience against climate risks.”

According to FAO, in 2023, around 2.33 billion people globally faced moderate or severe food insecurity.

Smallholder farmers make a significant contribution to food security and supply in their countries: more than half of the food consumed in low- and middle-income countries (LMICs) is produced by smallholders.

Yet, they face heavy challenges that pose severe constraints to their ability to serve their communities. Examples are lack of climate change adaptation tools, lack of access to agricultural inputs and inadequate credit and insurance services.

Bayer aims to support a total of 100 million smallholder farmers in LMICs by 2030 by improving their access to agricultural products and services. This also includes collaborations with partners.

To achieve this, Bayer strives to create market models that generate benefits and reduce business risks for all partners in the value chain, including smallholder farmers.

This is implemented by helping smallholder farmers gain access to the agricultural value chain and increase their productivity and income, as well as by creating resilience to ensure the long-term food security of smallholder farmers, their families and rural regions in LMICs.”

https://www.bayer.com/media/en-us/bayer-and-pula-foundation-partner-up-to-insure-10-million-smallholder-farmers-in-sub-saharan-africa-and-south-asia

First participants randomized in AskBio Phase II gene therapy trial for Parkinson’s disease

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First participants randomized in AskBio Phase II gene therapy trial for Parkinson’s disease

January 14, 2025: “AskBio Inc, a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced that the first participants have been randomized in its Phase II clinical trial in patients with Parkinson’s disease (PD).

“The randomization of the first participants in REGENERATE-PD is positive news for people living with Parkinson’s disease and the physicians treating them,” said Dr Rajesh Pahwa, MD, Director, Parkinson’s Disease and Movement Disorder Center, University of Kansas Medical Center, USA, and REGENERATE-PD Principal Investigator.

“There is a significant need for neurorestorative therapies in Parkinson’s and seeing the advancement of an important investigational gene therapy in a Phase II clinical trial gives hope to patients and the medical community.”

In 2024, AskBio initiated recruitment in the United States arm of REGENERATE-PD. The objective of this randomized, double-blind, Phase II clinical trial is to evaluate the safety and efficacy of AB-1005 delivered to the putamen in adult participants aged 45–75 years with moderate-stage PD.

REGENERATE-PD is estimated to enroll approximately 87 participants across clinical centers that are being opened in the United States, Germany, Poland, and the United Kingdom.

AskBio also presented 36-month Phase Ib data at the International Congress of Parkinson’s Disease and Movement Disorders, which was held in Philadelphia, Pennsylvania, from September 27 to October 1, 2024.

The data demonstrated that administration of AB-1005 was well tolerated with no attributed serious adverse events.

The Moderate PD cohort showed trends for improvement or stability on several motor scales at 36 months, including Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and motor diaries, and trends in reductions in Parkinson’s medications (levodopa-equivalent daily dose [LEDD]).

Most participants in the Mild PD cohort showed an overall stable clinical status with little change in MDS-UPDRS, the self-reported PD motor diary, or LEDD.

“AskBio continues to mark significant milestones in the clinical development of the investigational gene therapy AB-1005 as we strive to bring a safe and effective gene therapy to patients with moderate stage Parkinson’s disease,” said Canwen Jiang, MD, PhD, Chief Development Officer and Chief Medical Officer, AskBio.

“With REGENERATE-PD participants now being randomized, we are excited by our progress with AB-1005 and look forward to sharing further updates at an appropriate scientific forum as the program advances through next year and beyond.”

“The advancement of AskBio’s Parkinson’s program is a significant milestone that highlights our commitment to exploring the potential of gene therapy in an area of significant unmet medical need,” said Christian Rommel, Member of the Executive Committee of Bayer’s Pharmaceuticals Division, and Global Head of Research and Development.

“We believe that therapeutic modalities like gene therapy can change the treatment landscape for people living with the debilitating effects of Parkinson’s disease and look forward to seeing what we will learn in this next phase of research and development for AB-1005.”

AskBio is also exploring AB-1005 beyond Parkinson’s disease and is currently enrolling participants in the United States with the parkinsonian subtype of multiple system atrophy (MSA-P) in a Phase I clinical trial to assess the preliminary safety, tolerability, and efficacy for this rapidly progressing condition.

AB-1005 is an investigational gene therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated.

About Parkinson’s disease
Parkinson’s disease (PD) is a progressive neurodegenerative disease. It has a significant impact on a person’s daily life. In PD the death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function.

Symptoms include tremors, muscle rigidity, and slowness of movement. Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, congestive issues, and depression.

Symptoms typically intensify over time and make everyday tasks increasingly demanding. The prevalence of PD has doubled over the past 25 years. More than 10 million people worldwide are estimated to be living with PD.

This makes it the world’s second most prevalent neurodegenerative disease. It is also the most frequent movement disorder. At present there is no cure, and current treatment options lack the holistic management of symptoms, so new therapies are needed.

About REGENERATE-PD
REGENERATE-PD is a Phase II, randomized, double-blind, sham-controlled trial of the efficacy and safety of intraputaminal AB-1005 in the treatment of adults (45-75 years) with moderate-stage Parkinson’s disease.

The trial will include an estimated 87 subjects with trial sites located in the United States, Germany, Poland, and the United Kingdom. For more information about the REGENERATE-PD clinical trial, visit clinicaltrials.gov (NCT06285643), or visit askbio.com.

About AB-1005
AB-1005 is an investigational gene therapy based on adeno-associated viral vector serotype 2 (AAV2) containing the human glial cell line-derived neurotrophic factor (GDNF) transgene, which allows for stable and continuous expression of GDNF in localized regions of the brain after direct neurosurgical injection with MRI-monitored convection enhanced delivery.

In nonclinical studies, GDNF has been shown to promote the survival and morphological differentiation of dopaminergic neurons. Recombinant GDNF has long been evaluated as a potential treatment for diseases, such as Parkinson’s disease (PD), marked by progressive degeneration of midbrain dopaminergic neurons. 

Through a combination of an investigational gene therapy and innovative neurosurgical delivery approach, we can now test the GDNF hypothesis in PD by getting this neurotrophic factor to these degenerating nigrostriatal neurons in a potentially more clinically relevant fashion.

https://www.bayer.com/media/en-us/first-participants-randomized-in-askbio-phase-ii-gene-therapy-trial-for-parkinsons-disease

Johnson & Johnson initiated submission of NDA application with U.S. FDA for TAR-200 for BCG-unresponsive high-risk non-muscle-invasive bladder cancer

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Johnson & Johnson initiated submission of NDA application with U.S. FDA for TAR-200 for BCG-unresponsive high-risk non-muscle-invasive bladder cancer

 January 15, 2025: “Johnson & Johnson announced it has initiated the submission of an original New Drug Application with the U.S. Food and Drug Administration for TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

This submission is being reviewed by the FDA through the Real-Time Oncology Review (RTOR) program, which allows the FDA to review data before the complete application is formally submitted and helps ensure treatments are available for patients as soon as possible.

“Upon approval, TAR-200 promises to be a meaningful additional treatment option for certain patients with NMIBC, addressing a critical need for people who have had relatively limited therapeutic alternatives.

Many patients face life-altering surgical options such as radical cystectomy, which is complete bladder removal,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Innovative Medicine.

“By combining our expertise in innovative medicine and medical devices, Johnson & Johnson is uniquely positioned to transform how we treat certain types of bladder cancer through the first and only intravesical drug releasing system for this disease. We look forward to working with the FDA in review of this application.”

The submission of this innovative intravesical drug releasing system is supported by data from the Phase 2b SunRISe-1 registration study.

Data collected through the second quarter of 2024 and presented at the European Society for Medical Oncology (ESMO) 2024 Congress as a late-breaking oral presentation showed an 83.5 percent complete response (CR) rate and highly durable CRs without the need for reinduction – at a median follow-up of nine months, 82 percent of responders maintained response.

At data cutoff in May 2024, safety and tolerability data presented at ESMO demonstrated a low occurrence of Grade 3 or higher treatment-related adverse events (TRAEs) (9 percent); five patients had TRAEs leading to discontinuation (6 percent) and no treatment-related deaths were reported.

TAR-200 is an investigational intravesical drug releasing system designed to provide sustained local delivery of gemcitabine into the bladder. It is placed into the bladder by a healthcare professional using a co-packaged urinary placement catheter in an outpatient setting in under five minutes and without the need for anesthesia.

In December 2023, the FDA granted Breakthrough Therapy Designation (BTD) to TAR-200 for the treatment of adult patients with BCG-unresponsive HR-NMIBC with CIS who are ineligible for or have elected not to undergo radical cystectomy.

About SunRISe-1, Cohort 2
SunRISe-1 (NCT04640623), Cohort 2, is a randomized, parallel-assignment, open-label Phase 2b clinical study evaluating the safety and efficacy of TAR-200 monotherapy alone for BCG-unresponsive HR-NMIBC carcinoma in situ (CIS) patients who are ineligible for, or elected not to undergo, radical cystectomy.

The primary endpoint for Cohort 2 is CR rate at any time point. Secondary endpoints include duration of response (DOR), overall survival (OS), pharmacokinetics, quality of life, safety and tolerability.

About High-Risk Non-Muscle-Invasive Bladder Cancer
High-risk non-muscle-invasive bladder cancer (HR-NMIBC) is a type of non-invasive bladder cancer that is more likely to recur or spread beyond the lining of the bladder, called the urothelium, and progress to invasive bladder cancer compared to low-risk NMIBC.

HR-NMIBC makes up 15-44 percent of patients with NMIBC and is characterized by a high-grade, large tumor size, presence of multiple tumors, and CIS.

Radical cystectomy is currently recommended for NMIBC patients who fail BCG therapy, with over 90 percent cancer-specific survival if performed before muscle-invasive progression.

Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.

The high rates of recurrence and progression can pose significant morbidity and distress for these patients.”

https://www.jnj.com/media-center/press-releases/new-drug-application-initiated-with-u-s-fda-for-tar-200-the-first-and-only-intravesical-drug-releasing-system-for-patients-with-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer

What is Decentralized clinical trials?:Benefits and challenges of implementing DCT

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What is Decentralized clinical trials?:Benefits and challenges of implementing DCT

Decentralized clinical trials (DCTs) are an innovative approach to conducting clinical research, where some or all trial-related activities occur at locations other than traditional clinical trial sites. These locations can include participants’ homes, local healthcare facilities, or nearby laboratories.

Key Features of DCTs:

Benefits of DCT:

DCTs are gaining momentum, especially after the COVID-19 pandemic highlighted the need for flexible and remote healthcare solutions. They represent a significant shift towards more patient-centric and efficient clinical research.

Example of a successful decentralized clinical trial

One notable example of a successful decentralized clinical trial is the ACTIV-6 trial, which was conducted to test outpatient treatments for COVID-19. This trial was part of the National Center for Advancing Translational Sciences (NCATS) program and utilized decentralized methods to reach a broader participant base.

The ACTIV-6 trial leveraged digital technologies and community partnerships to conduct the study beyond traditional clinical sites. This approach allowed for more efficient and inclusive participant recruitment, especially from underrepresented communities. 

The trial demonstrated that decentralized clinical trials (DCTs) could be more efficient, effective, and equitable, bringing treatments to a wider population more quickly.

Lets discuss few more examples of successful decentralized clinical trials (DCTs):

  1. The REMOTE Trial: This was one of the first fully decentralized trials conducted by Pfizer. It aimed to evaluate the efficacy and safety of a drug for overactive bladder. The trial utilized digital tools for patient recruitment, consent, and data collection, significantly reducing the need for physical site visits.
  2. The CHIEF-HF Trial: Conducted by Bristol Myers Squibb, this trial focused on heart failure patients. It used a decentralized approach to monitor patients remotely through wearable devices and mobile apps, allowing for continuous data collection and improved patient engagement.
  3. The VERKKO Study: This study, conducted by Sanofi, aimed to evaluate a new diabetes treatment. It was notable for its use of telemedicine and home health visits, which enabled participation from a diverse patient population across different geographic locations3.

These examples highlight the potential of DCTs to enhance patient recruitment, improve data quality, and make clinical trials more accessible and efficient.

What are the challenges of implementing DCTs?

Implementing decentralized clinical trials (DCTs) comes with several challenges:

  1. Technology Barriers:
    • Access and Literacy: Not all participants have access to the necessary technology or the digital literacy to use it effectively.
    • Data Security: Ensuring the security and privacy of patient data collected remotely is crucial and can be complex.
  2. Regulatory and Compliance Issues:
    • Regulatory Variability: Different regions have varying regulations, making it challenging to standardize DCTs globally.
    • Compliance: Ensuring that all aspects of the trial comply with regulatory requirements can be more difficult when activities are decentralized.
  3. Data Management:
    • Data Integration: Combining data from various sources and ensuring its accuracy and consistency can be challenging.
  4. Participant Engagement:
    • Retention: Keeping participants engaged and motivated throughout the trial can be harder without face-to-face interactions.
    • Support: Providing adequate support to participants remotely, especially for those with complex needs, can be difficult.
  5. Operational Challenges:
    • Logistics: Coordinating the delivery of trial materials and medications to participants’ homes can be logistically complex.
    • Training: Ensuring that both participants and local healthcare providers are adequately trained to perform trial-related activities.Despite these challenges, the benefits of DCTs, such as increased accessibility and convenience, make them a promising approach for the future of clinical research. Continuous advancements in technology and regulatory frameworks are helping to address these challenges.
  1. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-clinical-trials-decentralized-elements
  2. https://www.fda.gov/drugs/cder-conversations/evolving-role-decentralized-clinical-trials-and-digital-health-technologies
  3. https://ncats.nih.gov/news-events/news/ncats-report-highlights-decentralized-clinical-trials-challenges-opportunities
  4. https://www.obviohealth.com/resources/decentralized-clinical-trials-a-comprehensive-synopsis

FDA Takes Steps to Ensure Safety of Cinnamon Products Sold in the US

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FDA Takes Steps to Ensure Safety of Cinnamon Products Sold in the US

March 06, 2024: “The U.S. Food and Drug Administration is taking several additional steps to address concerns about elevated lead levels in cinnamon following the recent incident associated with certain cinnamon apple sauce pouches that resulted in lead poisoning in young children.

The agency sent a letter to all cinnamon manufacturers, processors, distributors and facility operators in the U.S., reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including ground cinnamon products.

The agency is also recommending the voluntary recall of certain ground cinnamon products sold by a number of brands at six different retail chains that were found to contain elevated levels of lead.

The agency notified the distributors and manufacturers of products found to contain elevated levels of lead and recommended that the manufacturers voluntarily recall these products because prolonged exposure to them may be unsafe.

The products were identified during an FDA-initiated sampling and testing effort to assess cinnamon sold across numerous retail stores.

No illnesses or adverse events have been reported to date related to the ground cinnamon products listed below, but the FDA is concerned that, because of the elevated lead levels in these products, continued and prolonged use of the products may be unsafe. 

The FDA is advising consumers to throw away and not to buy the ground cinnamon products with the lot codes listed below because samples of these products were found to contain elevated levels of lead.

Consumers can find lot codes listed on the product’s label. The FDA is working with the firms listed below to voluntarily recall the products, with the exception of the MTCI cinnamon.

The FDA has been unable to reach MTCI to share its findings and request that the company initiate a recall. “

https://www.fda.gov/news-events/press-announcements/fda-takes-steps-ensure-safety-cinnamon-products-sold-us

FDA Clears First Over-the-Counter Continuous Glucose Monitor

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FDA Clears First Over-the-Counter Continuous Glucose Monitor

March 05, 2024: “The U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM).

The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels.

Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition. 

“CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

“Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients.”

The Stelo Glucose Biosensor System uses a wearable sensor, paired with an application installed on a user’s smartphone or other smart device, to continuously measure, record, analyze and display glucose values in people 18 years and older that are not on insulin and who do not have problematic hypoglycemia.

Users can wear each sensor up to 15 days before replacing with a new sensor. The device presents blood glucose measurements and trends every 15 minutes in the accompanying app. Users should not make medical decisions based on the device’s output without talking to their healthcare provider. 

Data from a clinical study provided to the FDA showed that the device performed similarly to other iCGMs. Adverse events reported in the study included local infection, skin irritation and pain or discomfort.

As part of the Center for Devices and Radiological Health’s strategic priority to advance health equity, CDRH will continue to support innovation that addresses health equity by moving care and wellness into the home setting.”

https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor

FDA, Industry Actions End Sales of PFAS Used in US Food Packaging

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February 28, 2024: “The U.S. Food and Drug Administration is announcing that grease-proofing materials containing per- and polyfluoroalkyl substances (PFAS) are no longer being sold for use in food packaging in the U.S.

This means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers and pet food bags is being eliminated. 

PFAS are a diverse group of thousands of chemicals that resist grease, oil, water and heat. The FDA has authorized certain PFAS for limited use in cookware, food packaging and food processing equipment.

Exposure to some types of PFAS have been linked to serious health effects.

The FDA helps to safeguard the food supply by evaluating the use of chemicals as food ingredients and substances that come into contact with food, such as through food packaging, storage or other handling to ensure these uses are safe.

Today’s announcement marks the fulfillment of a voluntary commitment by manufacturers to not sell food contact substances containing certain PFAS intended for use as grease-proofing agents in the U.S.

This FDA-led effort represents a positive step forward as we continue to reevaluate chemicals authorized for use with, and in, food.

It underscores an important milestone in the protection of U.S. consumers from potentially harmful food-contact chemicals. 

This ‘win’ for public health is the result of FDA research and leadership, combined with cooperation from industry.

In 2020, the FDA engaged companies to cease sales of grease-proofing substances that contain certain types of PFAS following our post-market safety assessment.

The research FDA scientists conducted and published played a large part in helping the agency obtain commitments from manufactures to voluntarily phase out the use of these substances containing PFAS in paper and paperboard food packaging products. 

Assessing progress of these efforts takes time. Various parts of the industry are implementing changes and there are lags in data reporting.

However, we are encouraged that through collaboration and a shared interest in the health and welfare of the public, together with industry we can achieve positive health outcomes.

The FDA will continue to conduct research and update our evaluations using the most up-to-date science to ensure that our risk determinations continue to be accurate and based on current science.”

https://www.fda.gov/news-events/press-announcements/fda-industry-actions-end-sales-pfas-used-us-food-packaging

Regulatory Applications Accepted in the U.S. and Japan for BMS Breyanzi in Relapsed or Refractory FL and Relapsed or Refractory MCL

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Regulatory Applications Accepted in the U.S. and Japan for BMS Breyanzi in Relapsed or Refractory FL and Relapsed or Refractory MCL

30 Jan 2024: “Bristol Myers Squibb announced three regulatory acceptances from the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) for Breyanzi® (lisocabtagene maraleucel).

In the U.S., the FDA has accepted the company’s two supplemental Biologics License Applications (sBLA) for Breyanzito expand into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor (BTKi).

The FDA has granted both applications Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 23, 2024 for Breyanzi in relapsed or refractory FL and May 31, 2024 for Breyanzi in relapsed or refractory MCL.

Japan’s MHLW has also accepted Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for Breyanzi for the treatment of relapsed or refractory FL.

“Patients living with follicular lymphoma and mantle cell lymphoma often experience cycles of remission and relapse with multiple lines of treatment, and we are committed to delivering innovative treatment solutions to this population,” said Anne Kerber, M.D., senior vice president, Head of Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), Bristol Myers Squibb.

“Breyanzi offers the potential for durable response, and these filing acceptances in the U.S. and Japan support our commitment to delivering our best-in-class CAR T cell therapy treatments to as many eligible patients as possible.”

Clinical Trials Supporting Regulatory Applications for Breyanzi in FL and MCL

In relapsed or refractory FL, the applications for Breyanzi in the U.S. and Japan are based on results from the TRANSCEND FL study, which represents the largest clinical trial to date evaluating a CAR T cell therapy in patients with relapsed or refractory indolent B cell non-Hodgkin lymphoma (NHL), including high-risk second-line FL. In the study, Breyanzi demonstrated high rates of complete responses.

In relapsed or refractory MCL, the application for Breyanzi in the U.S. is based on results from the MCL cohort of the TRANSCEND NHL 001 study, in which Breyanzi demonstrated statistically significant and clinically meaningful responses in heavily pre-treated patients, with the majority of patients achieving a complete response.

In both studies, Breyanzi demonstrated a consistent safety profile with no new safety signals reported.

Results from both trials were presented at the 2023 International Conference on Malignant Lymphoma (ICML) in June 2023 and at the American Society of Hematology (ASH) Annual Meeting in December 2023.

A sBLA for Breyanzi for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received a prior BTKi and B-cell lymphoma 2 inhibitor is also currently under Priority Review with the FDA with an assigned target action date of March 14, 2024.

About TRANSCEND FL

TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL), including follicular lymphoma (FL) and marginal zone lymphoma. The primary outcome measure is overall response rate.

Secondary outcome measures include complete response rate, duration of response, and progression-free survival.

About TRANSCEND NHL 001

TRANSCEND NHL 001 (NCT02631044) is an open-label, multicenter, pivotal, Phase 1, single-arm, seamless-design study to determine the safety, pharmacokinetics and antitumor activity of Breyanzi in patients with relapsed or refractory B-cell NHL, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, FL Grade 3B and mantle cell lymphoma.

The primary outcome measures are treatment-related adverse events, dose-limiting toxicities and overall response rate. Secondary outcome measures include complete response rate, duration of response and progression-free survival.

About FL

Follicular lymphoma is the second most common, slow-growing form of NHL, accounting for 20 to 30 percent of all NHL cases. Most patients with FL are over 50 years of age when they are diagnosed.

FL develops when white blood cells cluster together to form lumps in a person’s lymph nodes or organs.

It is characterized by periods of remission and relapse, and the disease becomes more difficult to treat after relapse or disease progression.

About MCL

Mantle cell lymphoma (MCL) is an aggressive, rare form of non-Hodgkin lymphoma (NHL), representing roughly 3 percent of all NHL cases. MCL originates from cells in the “mantle zone” of the lymph node. MCL occurs more frequently in older adults with an average age at diagnosis in the mid-60s, and it is more often found in males than in females.

In MCL, relapse after initial treatment is common, and for most, the disease eventually progresses or returns.

About Breyanzi

Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. 

Breyanzi is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment.

Breyanzi is approved by the U.S. Food and Drug Administration (FDA for the treatment of adult patients with LBCL, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal LBCL, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy, or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age, or relapsed or refractory disease after two or more lines of systemic therapy. 

Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.

Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding cytokine release syndrome and neurotoxicity.

Breyanzi is also approved in Japan and Europe for the second-line treatment of relapsed or refractory LBCL, and in Japan, Europe, Switzerland, United Kingdom and Canada for relapsed and refractory LBCL after two or more lines of systemic therapy.”

https://news.bms.com/news/corporate-financial/2024/Regulatory-Applications-Accepted-in-the-U.S.-and-Japan-for-Bristol-Myers-Squibbs-Breyanzi-lisocabtagene-maraleucel-in-Relapsed-or-Refractory-Follicular-Lymphoma-FL-and-Relapsed-or-Refractory-Mantle-Cell-Lymphoma-MCL/default.aspx


BlueRock Therapeutics exercises exclusive option to license iPSC cell therapy candidate OpCT-001 for Primary Photoreceptor Diseases

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BlueRock Therapeutics exercises exclusive option to license iPSC cell therapy candidate OpCT-001 for Primary Photoreceptor Diseases

January 23,2024: “BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned, independently operated subsidiary of Bayer AG, announced that it has exercised its option to exclusively license OpCT-001, an induced pluripotent stem cell (iPSC) derived cell therapy candidate for the treatment of primary photoreceptor diseases, from FUJIFILM Cellular Dynamics and Opsis Therapeutics.

OpCT-001 is the lead cell therapy candidate being developed under the strategic R&D collaboration between BlueRock, FUJIFILM Cellular Dynamics, and Opsis Therapeutics that was forged in 2021.

Under the terms of the agreement FUJIFILM Cellular Dynamics, and Opsis Therapeutics receive an undisclosed license fee and are eligible to receive payments upon achievement of certain development and commercial milestones.

“We believe that cell therapy has great potential for restoring vision in patients who are living with retinal diseases,” said Ahmed Enayetallah, Senior Vice President and Head of Development at BlueRock Therapeutics.

“Our collaboration with the FUJIFILM Cellular Dynamics and Opsis Therapeutics team has allowed us to execute important IND-enabling activities, and we are excited to advance OpCT-001 toward the clinic, with an IND filing planned for this year.”

Primary photoreceptor diseases are a subgroup of inherited retinal disorders that includes retinitis pigmentosa and cone rod dystrophies. These diseases affect the structure and function of the photoreceptor cells in the retina, leading to irreversible vision loss in both children and adults. No treatment options currently exist for this patient population. OpCT-001 aims to restore vision loss caused by these diseases by replacing degenerated tissue in the retina with functional cells.

About BlueRock Therapeutics LP 

BlueRock Therapeutics LP is a clinical stage cell therapy company focused on creating cellular medicines to reverse devastating diseases.

We are harnessing the power of cell therapy to create a pipeline of new medicines for patients suffering from neurological, cardiovascular, immunological, and ophthalmic diseases.

Our lead clinical program, bemdaneprocel, (BRT-DA01) is in Phase I clinical trials for Parkinson’s disease. We were founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation.

In late 2019, BlueRock became a wholly owned, independently operated subsidiary of Bayer AG as a cornerstone of its newly formed Cell & Gene Therapy platform.

Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit www.bluerocktx.com   

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

Bayer is committed to driving sustainable development and generating a positive impact with its businesses.

At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros.”

https://www.bayer.com/media/en-us/bluerock-therapeutics-exercises-exclusive-option-to-license-ipsc-cell-therapy-candidate-opct-001-for-treating-primary-photoreceptor-diseases-from-fujifilm-cellular-dynamics-and-opsis-therapeutics/

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