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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.

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/

FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization

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FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization

January 08, 2024: “The U.S. Food and Drug Administration is announcing that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices, recognizing VHP’s long history of safety and effectiveness.

The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization.

This update will facilitate broader adoption of VHP as a sterilization method for the medical device industry, is part of the agency’s multi-pronged approach to reducing the use of ethylene oxide (EtO) where possible and further supports the agency’s efforts to advance medical device supply chain resiliency. 

Effective sterilization processes are necessary for certain devices to be safe because sterilization inactivates or kills potentially harmful microorganisms.

In addition to effectively inactivating or killing potentially harmful microorganisms, sterilization processes must not damage devices.

For many devices marketed as sterile, a premarket submission must contain information sufficient to show the sterilization process is effective and consistent with internationally accepted consensus standard(s) that the FDA has recognized. 

EtO is the most commonly used sterilization method for medical devices in the U.S., with more than 20 billion devices sold in the U.S. every year sterilized with EtO, accounting for approximately 50% of devices that require sterilization. Since 2019, the FDA has promoted the development of alternatives to EtO and has implemented a number of programs and initiatives to support innovation in medical device sterilization.

This includes developing Sterilization Master File Pilot programs to support certain changes to sterilization processes, launching innovation challenges to encourage new strategies to reduce EtO emissions and the development of new sterilization methods or technologies and proactively engaging with industry to help advance innovative alternatives to EtO. 

“The FDA’s commitment is to protect public health, a critical mission in today’s complex medical device ecosystem,” said Suzanne Schwartz, M.D., M.B.A., director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health.

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages.

As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health.”

Methods with a long history of safe and effective use on medical devices are considered Established Category A sterilization methods and include moist heat, dry heat, EtO and radiation.

With the recent FDA recognition of the ISO standard 22441:2022, the FDA is adding VHP to Established Category A, which the agency expects will strengthen industry’s capacity to adopt alternative sterilization processes that pose less potential risk to the environment and communities in which they operate. 

The FDA remains committed to reducing adverse impacts to the environment and public health and to developing solutions that avert potential shortages of devices that the American public relies upon.”

https://www.fda.gov/news-events/press-announcements/fda-facilitates-broader-adoption-vaporized-hydrogen-peroxide-medical-device-sterilization

GSK enters exclusive license agreement with Hansoh for HS-20093

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GSK enters exclusive license agreement with Hansoh for HS-20093

December 20, 2023: “GSK plc and Hansoh Pharma, a Chinese biopharmaceutical company committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders” announced that they have entered into an exclusive license agreement for HS-20093, a B7-H3 targeted antibody-drug conjugate (ADC) utilising a clinically validated topoisomerase inhibitor (TOPOi) payload.

Under the agreement, GSK will obtain exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) to progress clinical development and commercialisation of HS-20093.

Hesham Abdullah, SVP, Global Head Oncology, R&D, GSK, said: “B7-H3 is highly expressed in a broad range of solid tumours where there remains a significant need for novel treatment options.

We look forward to progressing this potential new treatment across several indications and in future potential combination approaches with our established portfolio.”

This agreement provides GSK with a second clinical-stage ADC that complements GSK’s existing capabilities and strengths in developing medicines to address unmet medical needs in various solid tumours.

HS-20093 is currently being investigated in ongoing phase I and II trials in China.

Data from the ARTEMIS-001 phase I trial (NCT05276609), for HS-20093 in advanced solid tumours, was presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting in which initial clinical activity was observed in small cell lung cancer, non-small cell lung cancer and sarcoma with multiple confirmed responses and a manageable safety profile.

Eliza Sun, Executive Director of Board, Hansoh Pharma, said: “HS-20093 is a novel B7-H3 targeting antibody-drug conjugate showing encouraging early clinical signals in lung cancer.

We are excited to enter this new license agreement with GSK, our existing licensee on HS-20089, furthering Hansoh’s goal of bringing a potentially transformative treatment option to cancer patients globally.”

GSK plans to begin phase I trials for HS-20093 outside of China in 2024.

In October 2023, GSK and Hansoh entered into an agreement for HS-20089, a B7-H4 targeted ADC currently in phase II clinical trials in China. HS-20089 has best-in-class potential in ovarian and endometrial cancer with opportunities in other solid tumours.

Federal Court Enters Consent Decree Against Pharmasol for Distributing Adulterated Drugs

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Federal Court Enters Consent Decree Against Pharmasol for Distributing Adulterated Drugs

December 14, 2023: “The U.S. District Court for the District of Massachusetts has entered a consent decree of permanent injunction ordering Pharmasol Corporation, a Massachusetts-based company, and President Marc L. Badia to stop distributing drugs until the company complies with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in the consent decree.

According to the complaint, which was filed along with the consent decree by the U.S. Department of Justice, Pharmasol and Badia unlawfully distributed adulterated drugs, meaning they do not comply with manufacturing quality requirements within the U.S. marketplace. 

“When drug manufacturers violate the law and disregard safety standards, they put consumers at significant risk.

In this case, the defendant’s company distributed adulterated, poor-quality drugs without regard for patients and consumers,” said Jill Furman, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.

“The FDA plays an important role in protecting consumers, and we will continue to work with our law enforcement partners to pursue and bring into compliance those who do not prioritize the health and safety of the American public.” 

Pharmasol manufactures and distributes over-the-counter drugs, as well as human and animal prescription drugs such as topical corticosteroids and inhalant anesthetics. Pharmasol is under contract with multiple pharmaceutical companies. 

According to the complaint, the defendants violated federal law under the FD&C Act by introducing drugs into interstate commerce that fail to comply with current good manufacturing practice requirements; therefore, these drugs are adulterated. 

The most recent inspection of the company’s facilities in 2022 found the majority of the inspectional observations repeated those found in past FDA inspections and detailed in a 2019 warning letter. Violations mentioned in the complaint include failure to: 

  • fully investigate errors and ensure that the responsibilities and procedures applicable to the quality control unit are in writing and fully followed, including reporting drug defects to customers; 
  • follow written procedures that describe the handling of written and oral complaints regarding a drug product; and, 
  • adequately clean and maintain equipment. 

In the 2019 warning letter, the agency cited customer complaints of product leakage out of the container and the company’s failure to investigate. Despite repeated warnings, the company and Badia continued to violate the law. 

The consent decree prohibits Pharmasol and Badia from directly or indirectly manufacturing, preparing, processing, packing, repacking, receiving, labeling, holding and/or distributing any drug, at or from their facilities, unless and until defendants meet certain requirements to ensure that Pharmasol operates in compliance with the FD&C Act, the FDA’s regulations, and the decree, and defendants receive written notice from the FDA that they appear to be in compliance with these requirements.”

https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-pharmasol-distributing-adulterated-drugs

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