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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.

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

Bayer extends Partnership with Peking University to foster Pharmaceutical Innovation in China

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Bayer extends Partnership with Peking University to foster Pharmaceutical Innovation in China

July 10, 2023: “Bayer and Peking University (PKU) will collaborate to foster the translation of basic pharmaceutical research into drug discovery and development, while accelerating scientific research on cutting-edge technologies across the pharmaceutical value chain.

The collaboration will focus on selected key areas of interests, such as oncology, cardiorenal, immunology, as well as cell and gene therapy.

Under the agreement, Bayer will provide funding and support for joint research projects, as well as to scientists at PKU in recognition of their research excellence in life sciences and drug innovation.

This new agreement builds on a strategic academic partnership between Bayer and PKU under which a joint research center at Peking University has been founded to advance the translation of drug discovery and research.

“We look forward to a new chapter of the partnership between Bayer and Peking University moving forward,” said Dr. Friedemann Janus, Acting Head of Business Development & Licensing and Open Innovation, Bayer Pharmaceuticals.

“This partnership reflects Bayer’s consistent commitment to China as we see more exciting and disruptive innovation coming from China. We will continue to reinforce our collaboration with Peking University and to explore open innovation models.

These could translate scientific breakthroughs into innovative treatments, thus making a meaningful impact to lives of patients.”

“Peking University has been actively integrating internal and external resources and undertaking the important task of scientific and technological innovation through discipline construction and personnel training.

I look forward to working together with Bayer to promote the development of life sciences and medical technology, to achieve a win-win situation for both academia and industry, and to ultimately benefit patients in China and around the world,” said Hong Wu, Chair Professor of School of Life Sciences in Peking University and Senior Investigator of Peking-Tsinghua Center for Life Sciences.

Academic collaborations have been an integral part of Bayer’s long-standing commitment to fostering drug innovation originated in China and the translation of drug discovery and research. Bayer established strategic collaborations with Peking University and Tsinghua University respectively.

Bayer and the two prestigious universities are carrying out joint research projects, including discovery and structural analysis of novel targets, pathogenesis and drug mechanism of action research, drug screening, efficacy evaluation as well as exploration on new modalities, new synthetic methods, and innovative formulations.

About Bayer’s Collaborate to Cure Hub China
Bayer’s Collaborate to Cure Hub China was established in 2022.

The hub’s team is fully dedicated to developing regional business development strategy and driving key partnering initiatives and deal making, as well as managing strategic alliances covering both commercial and academic collaborations for Bayer Pharmaceuticals in China.

As an integral part of Bayer’s partnering network worldwide, the team is committed to strengthening connection with the China innovation ecosystem and collaborations with local stakeholders and partners, including biopharma, biotech companies and start-ups, as well as universities and research institutions.

Its experts focus on scouting local innovation across the entire value chain of drug innovation, exploring partnering opportunities and facilitating dealmaking.”

https://www.bayer.com/media/en-us/bayer-extends-partnership-with-peking-university-to-foster-pharmaceutical-innovation-in-china/

FDA Approves First Nonprescription Daily Oral Contraceptive

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FDA Approves First Nonprescription Daily Oral Contraceptive

July 13, 2023: “The U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription.

Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.  

The timeline for availability and price of this nonprescription product is determined by the manufacturer.

Other approved formulations and dosages of other oral contraceptives will remain available by prescription only. 

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”

Nonprescription availability of Opill may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider. Almost half of the 6.1 million pregnancies in the U.S. each year are unintended. Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes. Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts.

The contraceptive efficacy of norgestrel was established with the original approval for prescription use in 1973. HRA Pharma applied to switch norgestrel from a prescription to an over-the-counter product. For approval of a product for use in the nonprescription setting, the FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional. Studies showed that consumer understanding of information on the Opill Drug Facts label was high overall and that a high proportion of consumers understood the label instructions, supporting their ability to properly use the drug when it is available as an over-the-counter product. When properly used, Opill is safe and effective.

Opill should be taken at the same time every day; adherence to daily use at the same time of day is important for the effectiveness of Opill. Using medications that interact with Opill can result in decreased efficacy of Opill or the other medication, or both, potentially resulting in unintended pregnancy. 

The most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating. 

Opill should not be used by those who have or have ever had breast cancer. Consumers who have any other form of cancer should ask a doctor before use. Opill also should not be used together with another hormonal birth control product such as another oral contraceptive tablet, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection or an IUD (intra-uterine device).

Use of Opill may be associated with changes in vaginal bleeding patterns, such as irregular spotting and prolonged bleeding. Consumers should inform a health care provider if they develop repeated vaginal bleeding after sex, or prolonged episodes of bleeding or amenorrhea (absence of menstrual period). Individuals who miss two periods (or have missed a single period and have missed doses of Opill) or suspect they may be pregnant should take a pregnancy test. Consumers should discontinue Opill if pregnancy is confirmed. 

Opill is not for use as emergency contraception and does not prevent pregnancy after unprotected sex.

Oral contraceptives do not protect against transmission of HIV, AIDS and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. Condoms should be used to prevent sexually transmitted diseases.

The FDA granted the approval to Laboratoire HRA Pharma, recently acquired by Perrigo Company plc.”

https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive

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