Michele Baxley

Our latest blog dives into the importance of cell density, even distribution and the science behind effective seeding techniques. Learn how understanding these steps can lead to more precise evaluations of cellular reactivity. https://lnkd.in/gYhukzVr blog&utm_term=&utm_marketing_tactic=aw #CellCulture #Cytotoxicity #CellSeeding

3

The BioSecure Act has just passed the House with strong bipartisan support and is now set for a crucial Senate vote. This landmark legislation aims to bolster the U.S.'s preparedness against biological threats by enhancing research and development, improving surveillance systems, and strengthening the collaboration between public and private sectors. With the rising focus on safeguarding against potential bioterrorism and pandemics, this act is a game-changer for the pharmaceutical industry. If enacted, the BioSecure Act could accelerate innovation in biodefense technologies, streamline regulatory processes for rapid response products, and foster new partnerships that drive resilience and preparedness. For biotech companies, this means more opportunities to engage in groundbreaking research and contribute to national security efforts. Stay tuned as this pivotal legislation moves forward. The impact on our industry could be profound, leading to advancements in safety measures and the development of next-generation therapeutic solutions. #BioSecureAct #Biotech #Pharmaceuticals #Innovation #Biodefense #Legislation #IndustryImpact #Executiverecruitment

5

In a significant step for autoimmune disease treatment, Aditum Bio and Leads Biolabs have announced the launch of Oblenio Bio. This new venture aims to advance LBL-051, a groundbreaking tri-specific T-cell engager (CD19xBCMAxCD3) designed to reset immune responses in difficult-to-treat autoimmune disorders. What makes LBL-051 compelling is its potential for broad, durable efficacy by targeting multiple pathological B-cell markers, addressing an unmet need for more effective therapies. This partnership showcases the power of international biotech collaboration, with Aditum's innovation incubator model driving rapid clinical advancement and Leads Biolabs’ cutting-edge LeadsBody™ platform setting the stage for future breakthroughs. With up to $614 million in milestone payments and shared global development rights, this alliance is poised to accelerate solutions for patients worldwide. #Biotech #Pharmaceuticals #AutoimmuneDiseases #Innovation #GlobalPartnerships #LifeSciences #TylerLakeConsulting #ExecutiveSearch #ExecutiveRecruitment

4

Bruce Thompson, CEO at Kincell Bio, discusses key challenges in cell therapy development and actions #CDMOs can take to streamline this process 🔬 🤝 Bruce notes that early collaboration between research and development teams is critical to navigating complex decisions. He also highlights how breaking down the development journey into more managable steps using stage-gates can help streamline the process. ➡️ This article is the first in a two-part series and focuses on the initial stages of product development—specifically, how to move from candidate selection to a Phase 1 Investigational New Drug (IND) application. Access the article from BioProcess Online below ⬇️ #CellTherapy #Biotech #Pharma #CDMO

51

2 Comments

A nice and short article by the FDA on biosimilars that was just updated on 20/JUN/2024. Biosimilars can be advantageous in clinical trials for various reasons including shelf life and pricing. If you are looking to source or considering biosimilars for your study, let's connect and discuss how Inceptua is helping sponsors with these products.

13

🙌 New Podcast Alert. 🚨 This week featuring ALCOA Consulting, LLC talking about the state of the job market in 2024 and all things clinical operations. Tune in now 👍 https://lnkd.in/e4hgQMxi

3

1 Comment

Great meeting Outsourcing Facility 503B and 503A compound manufacturing with FDA and industrial partners Under Section 503B of the FD&C Act Outsourcing facilities: - must comply with CGMP requirements; - are inspected by FDA according to a risk-based schedule; and - must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound. Learn from established outsourcing facility leaders about the challenges of forming a new outsourcing facility and keys for success. Perspectives will include a hospital system-owned outsourcing facility, a 503A pharmacy that transitioned to an outsourcing facility, an outsourcing facility developed within a pharmaceutical company, and an outsourcing facility formed as a start-up. A panel discussion will share experiences interacting with newly formed outsourcing facilities. - Tony Widenor, PUBLIC HEALTH ANALYST, FDA - Meghan Murphy, DIRECTOR, COMPOUNDING QUALITY CENTER OF EXCELLENCE, FDA - Joe Bagan, CEO, STAQ Pharma - Andrew Basso, SENIOR DIRECTOR OPERATIONS, Fagron Sterile Services US (FSS) Services - Travis Leeah, VP RESEARCH AND DEVELOPMENT, QuVa Pharma, Inc. - Eric Kastango, PRINCIPAL, @Kastango Solutions - Maabo Kludze, SENIOR DIRECTOR, Premier Inc., Inc - Jody Staggs, CEO, @SWK Holdings https://lnkd.in/ecSFmp8i https://lnkd.in/eNP93h-f

4

🔬 Big News Alert! 🔬 🌟 FDA, EPA, and USDA join forces to streamline regulation for biotech products! 🌟 Interesting times ahead for the biotech industry as these agencies collaborate to simplify pathways to market while maintaining rigorous safety standards. How do you think this will shape the future of biotech? 💥 #Biotech #Regulation #Innovation #FDA #EPA #USDA

20

Did you know that facility maintenance at your CDMO could impact your drug development? Charlie Hoff, JLL Life Sciences Contract Organizations Leader, emphasizes the crucial role of integrated facility maintenance in ensuring efficient operations and cost savings at CDMOs. From HVAC systems to pest control, proper maintenance is vital for regulatory compliance and product quality. Some CDMOs now outsource maintenance to specialized firms, potentially improving coordination and cost-effectiveness across sites. Read more in Outsourced Pharma: #JLLFacilitiesManagement #IFM #CDMO #FM #DrugDevelopment

11

Regulatory Affairs~ IT'S ALWAYS ABOUT THE "WHO" - BRINGING PEOPLE TOGETHER & SOLVING PROBLEMS! DID YOU KNOW? Last week we briefly highlighted our extensive track record specific to Chemistry, Manufacturing, and Controls (CMC) and Technical Operations. THIS WEEK WE HIGHLIGHT: StevenDouglas also possesses a strong success record intentionally specific to "Regulatory Affairs" professionals at the SVP, VP, Sr Director, and Director level. Double digit+ professionals placed in Florida, Ohio, North Carolina, California, & Massachusetts. Any ?'s reach out to our team leaders - Butch Hawking or Britt Voss Every search is different - We always seek first to understand you & your story! IdentifyAttractLandRetainOptimize - TOP 1% INDUSTRY TALENT #Pharma #Biotech #MedicalDevice #MedTech #ProfessionalProblemSolvers #AskListenProbe

2

The Q3 Job Market Report from BioSpace just dropped, and you definitely want to check it out! The life sciences job market is going through some big changes, and keeping up with the latest info is super important for navigating it all. According to the new BioSpace data, there are some challenges but also plenty of opportunities coming up! 🔍 Key Insights from BioSpace's Q3 2024 Report: 1. Decrease in Job Postings:   - There were 21,548 jobs live on BioSpace in Q3 2024.   - This is a 12% decrease from 24,503 jobs in Q3 2023. 2. Increase in Job Competition:   - The job response rate (percentage of people applying after viewing) jumped from 9.8% to 14.8%, a 51% increase year-over-year.   - Notably, from July to September 2024, the response rate surged from 14.5% to 18.4%, a 26.9% increase. 3. Top States for Job Openings:   - California: 3,769 jobs   - Massachusetts: 3,110 jobs   - New Jersey: 2,513 jobs   - Illinois: 2,452 jobs   - New York: 1,717 jobs 4. Impact of Layoffs:   - In Q3 2024, there were 54 rounds of layoffs in biotech and pharma, affecting at least 3,700 employees.   Significant layoffs included:    - FibroGen, Inc.: Let go of 75% of its U.S.-based workforce (~356 people).    - GRAIL: Laid off about 350 employees.    - BioMarin Pharmaceutical Inc.: Cut 225 positions globally.    - Johnson & Johnson & Bayer: Combined layoffs of 288 employees in New Jersey. 💡 What This Means for You: - Increased Competition: With fewer job postings and more professionals in the market, it's crucial to differentiate yourself. - Strategic Job Hunting: According to Carina Clingman, PhD, CEO of Recruitomics Consulting, fall is prime time for job hunting in biotech. Companies aim to fill positions before the budget cycle ends around Thanksgiving. 📈 Emerging Opportunities:  - Johnson & Johnson is investing $2 billion in a new biologics manufacturing plant in Wilson, North Carolina, expected to create 420 new full-time, highly skilled jobs. Construction begins in the first half of 2024.  - Eli Lilly and Company is committing $4.5 billion to build a facility in Lebanon, Indiana, housing research and manufacturing. Set to open in late 2027, it will employ about 400 new engineers, scientists, lab technicians, and operations personnel.  - MassBio's 5-Year Plan: Aiming to create hundreds of new biopharma and life sciences positions in Massachusetts by 2030, focusing on supporting early-stage biotech growth. 🚀 Tips to Stay Ahead: - Update Your Skills: Leverage this time to enhance your expertise and stay competitive. - Network: Engage with industry peers and attend virtual or in-person events. - Stay Informed: Keep an eye on emerging biotech hubs and companies expanding their workforce. - Be Proactive: Tailor your applications and highlight how you can add value in this dynamic environment. Share your experiences or tips below. #Biotech #Pharma #JobMarket #CareerGrowth #LifeSciences

4

🎙 The BioHub Episode with Amit Kumar is LIVE! 🎙 In this episode, we sit down with Amit Kumar, Chairman, President and CEO at Anixa Biosciences, Inc. Biosciences We're excited to dive into his journey, the challenges and successes along the way, and what's next for Anixa and the broader biotech space. 👉 Catch the full episode via the link in the comments

18

1 Comment

Demonstrating the technical leadership of SK pharmteco! 🧬 Catch up with our team at ASGCT to discuss how SKPT can support your #cellandgene development!

9

1 Comment

Industry leaders, the FDA has released a guidance draft document on data integrity for in-vivo bioavailability and bioequivalence studies. This document is now open for comments. Data integrity is a critical component to ensure the accuracy of data submitted for INDA and NDA's, and the FDA guidelines on this are very welcoming. Certain data handling practices in CROs have always been questioned by authorities, making this guidance document a crucial step in ensuring the integrity of data in the industry. Share your thoughts and comments on this important topic. QvalFocus #IndustryLeaders #DataIntegrity #Bioavailability #Bioequivalence #FDA #CROs Follow us at #QvalFocus for current trends and jobs in the industry.

17

Every time I think things are on the rebound I see something like this. When are things finally going to stabilize and head in the right direction? If there is anyone that may be affected by this, let's connect and have a discussion about your career. #career #discussion #connect

13

Johnson & Johnson to pour $2B into North Carolina biologics plant, add 420 jobs On the same day that Johnson & Johnson confirmed layoffs at its home base in New Jersey, the company made waves with a major manufacturing announcement in Wilson, North Carolina.  J&J is planning to build a state-of-the-art biologics plant to provide supplies for treatments across the oncology, immunology and neuroscience treatment areas, J&J said in a Tuesday press release. Construction is slated to begin in the first half of 2025, and the site will have a workforce of 420 once fully operational.  The company's total investment in the site is expected to reach "more than $2 billion," according to J&J's release. "We are investing in capacity and new technologies to enhance our industry leading capabilities and ensure a resilient supply chain for the future," Dapo Ajayi, J&J's vice president of innovative medicine supply chain, explained in the release. "North Carolina is an important hub for biopharmaceutical manufacturing and talent, and we are pleased to join this thriving life sciences ecosystem and become part of the Wilson community.” At a Tuesday meeting of the state's Economic Investment Committee, officials approved a 12-year reimbursement grant worth nearly $13.7 million, according to a press release from North Carolina Gov. Roy Cooper. The money is contingent on J&J meeting certain job creation and investment targets. Over the 12-year span, the manufacturing site is expected to grow the state's economy by $2.3 billion, according to the release. https://lnkd.in/eU9Cc97k

399

Fellow biopharma professionals, The job market is experiencing significant shifts, and staying informed is more important than ever. Recent data from BioSpace's Q3 2024 Job Market Report highlights trends that directly impact us all. 📉 Decrease in Job Postings - Total Jobs Live: There were 21,548 jobs live on BioSpace in Q3 2024, a 12% decrease from 24,503 in Q3 2023. - This decline indicates a tightening in available opportunities within our industry. 📈 Increase in Job Competition - Job Response Rate: The percentage of people applying after viewing a job rose by 51%, from 9.8% in Q3 2023 to 14.8% in Q3 2024. - Notably, this rate climbed from 14.5% in July to 18.4% in September—a 26.9% increase within the quarter. - The heightened competition is likely due to ongoing layoffs and fewer available positions. 🏢 States with the Most Job Openings Despite the overall decrease, some states continue to offer more opportunities: California: 3,769 jobs Massachusetts: 3,110 jobs New Jersey: 2,513 jobs Illinois: 2,452 jobs New York: 1,717 jobs 🔻 Layoffs Impacting the Workforce The third quarter saw a continuation of workforce reductions: Total Layoff Events: 54 rounds affecting at least 3,700 employees. Notable Layoffs: FibroGen, Inc.: Reduced 75% of its U.S. workforce (~356 people). GRAIL: Laid off approximately 350 employees. BioMarin Pharmaceutical Inc.: Cut 225 positions globally. Johnson & Johnson and Bayer: Combined cuts of 288 employees in New Jersey. 🌱 Opportunities on the Horizon Amid these challenges, there are developments that signal future growth: MassBio's Five-Year Plan: Aims to create hundreds of biopharma and life sciences jobs in Massachusetts by 2030. Focuses on supporting early-stage biotech to accelerate growth and job creation. Johnson & Johnson's Investment: Building a $2 billion biologics manufacturing plant in Wilson, North Carolina. Expected to create 420 high-skilled jobs upon completion. Construction starts in the first half of 2024. Eli Lilly and Company's Expansion: Committing $4.5 billion to a new facility in Lebanon, Indiana. Facility to open in late 2027, employing about 400 new staff across various specialties. 🍁 Why Fall is Prime Time for Job Hunting According to Carina Clingman, CEO of Recruitomics Consulting: - Seasonal Hiring Surge: Post-Labor Day often brings increased hiring activity as companies look to fill positions before annual budgets are finalized around Thanksgiving. - Actionable Advice: Now is an opportune time to update your resume, network, and apply for positions. 💡 Key Takeaways - Stay Informed: Understanding market trends can help you navigate your career path strategically. - Be Proactive: Leverage times of increased hiring activity to your advantage. - Network: Engage with industry peers and organizations to uncover hidden opportunities. - Adaptability is Key: Flexibility in location and role can open doors in a competitive market.

6

🔬 Biopharma Layoffs: Navigating Challenges in a Shifting Landscape Recent trends in biopharma layoffs have left many scientists reeling. Here are key takeaways from a recent STAT article: 67% of life science layoffs in H1 2024 were at large biopharma companies (>$1B annual sales), up from 47% in 2021-2023. Job postings in biotech dropped from 21,366 to 12,300 between early 2021 and 2024. Scientists face unique challenges in job searches, including maintaining confidentiality about previous work. Visa constraints add pressure for international workers, limiting job search time. Networking remains crucial: Some successful companies are hiring primarily through personal connections. The industry sees this as part of a cyclical pattern, influenced by patent expirations and acquisitions. Despite these challenges, opportunities still exist. Adaptability, networking, and a broader job search approach are key for scientists navigating this evolving landscape. What strategies have you found effective in weathering industry changes? Share your thoughts below! #BiopharmaJobs #CareerTransition #LifeSciences #Networking

3

Don’t wait to take control of your career: A Q&A with Mark Bunnage of Vertex Pharmaceuticals Mark Bunnage, senior vice president and head of global research at Vertex Pharmaceuticals, offers his perspective on bridging the gap between academia and industry. 👉 Read the full article:

2