The Heat Loss Study offered by APM Steam includes a detailed site walk and thorough review of hot water, steam, and chilled water plants and distribution systems. An engineering team delivers a full review of findings, offering actionable recommendations to repair faulty insulation or add insulation where energy losses are significant. Clients receive a summary report with a detailed scope of work and pricing. APM Steam also manages utility incentives, reducing project costs whenever applicable.

APM Steam provides specialized insulation for steam traps, valves, pipes, and other components throughout hot water and steam systems. This service ensures a lasting payback, positively impacting customers’ bottom lines by significantly reducing energy losses. The specialized cold-water insulation offered by APM Steam retains temperatures, lowers energy losses, and minimizes pipe sweating, ensuring efficient system operation and reduced maintenance costs.

In addition, APM Steam handles utility incentive applications from start to finish, ensuring maximum funding from local utility companies, further reducing the cost of insulation projects. The insulation jackets provided are high quality, removable, and custom-made in the USA. Typical payback without energy efficiency incentives is only 11 months, helping to reduce operating budgets by eliminating energy losses.

For more information about APM Steam’s HVAC insulation services and to schedule a Heat Loss Study, visit https://apmsteam.com/servicesparts/hvac-insulation.

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For US pharmaceutical manufacturers, a critical success factor in meeting this demand will be rapid manufacturing and delivery of new drug products. Time-to-market directly impacts a firm’s profitability and competitive advantage. The limited window of patent rights, plus the health of millions who wait and depend on these drugs means that products must get to consumers as fast as possible without compromising drug quality and safety.

In the race against time, once a drug is approved, pharmaceutical companies must rapidly design and build the facilities, or repurpose existing facilities, where the new drugs will be made–all while efficiently attaining FDA validation of the new medicine.

This is where Siemens partners with Pharmaceutical & Life Science teams for system design support, construction, and commissioning technologies.

Seek out the right combination of technical and industry expertise

To create a smart building in a timely fashion, customers and construction teams need to engage with Siemens early for design collaboration support and optimization of system delivery during construction.

Siemens helps reduce time-to-market in three important ways:

Early selection of switchgear for a facility is critical for timely delivery schedules -– Power systems are critical to a facility’s operational resilience and construction timeline.  Switchgear manufacturing lead time can be a major limiter during the construction phase, so planning and design must start early for long lead components.  Siemens engineers have decades of experience in modelling loads for the pharmaceutical industry to create the preliminary designs necessary for manufacturing collaboration.

Smart Buildings require advanced IT/OT networks with data security at the heart of it all – Siemens networking engineers and product experts are available for early engagement to ensure designs meet security requirements and employ the latest and most secure solutions available such as BACnet/SC (Secure Connect) for building automation systems.  Network planning and security will enhance remote support options to ease the demanding workload on advanced facility engineering teams tasked with maintaining a complex facility.  (It is also critical during construction phases to account for network connectivity and access to enable efficient system commission efforts.)

FDA approval support – Projects stall if validation resources are assigned too late or are unavailable. These expert human resources are hard to come by. Siemens Good Manufacturing Process (GMP) validation experts support validation of GMP environments to gain FDA approval in the shortest time possible.  Early collaboration on GMP documentation ensures accelerated commissioning and validation when a project nears completion.

To learn more about the ways Siemens can support your time-to-market acceleration efforts, contact Jeff Zacherl directly at https://www.linkedin.com/in/jeffzacherl/ or reach out to your local Siemens representative to engage Jeff and the Pharma / Life Science team. You can also learn more at https://www.siemens.com/us/en/industries/life-science.html

Author:

Jeff Zacherl
Siemens
PE, CEM, LEED AP | Industrial Vertical Market Lead – Pharma/Life Science @ Siemens

Siemens

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With over expected 8,000 visitors in the next three days, Vitafoods India 2025 continues to solidify its position as a leading networking and knowledge-sharing hub for the nutraceutical ecosystem. Amid projections of India’s nutritional supplements market reaching USD 68.42 billion by 2030 at a CAGR of 8.0%, the event serves as a critical platform for exploring innovations and opportunities driving the future of health and wellness.

The esteemed expo was graced by distinguished dignitaries, including Chief Guest Dr. Subrata Gupta, IAS, Secretary, Ministry of Food Processing Industries, Govt. of India ; Dr. Manoj Nesari, Advisor, Ayurveda, Ministry of AYUSH, Govt. of India; Mumbai; Dr. Meenakshi Singh, Chief  Scientist, Technology Management Directorate, Council of Scientific & Industrial Research (CSIR); Ms. Natasha Berrow, Executive Vice President – Food, Informa Markets; Mr. Yogesh Mudras, Managing Director Informa Markets in India and Mr. Rahul Deshpande, Sr. Group Director Informa Markets in India among other guests.

Addressing at the event Dr. Subrata Gupta, IAS, Secretary, Ministry of Food Processing Industries, Govt. of India, said “The global nutrition market, valued at approximately $520 billion, is witnessing a growing emphasis on traditional and preventive healthcare. India’s share, estimated around $8 billion, highlights the sector’s vast potential, particularly in Ayurveda-based nutraceuticals. The industry plays a pivotal role in bridging the gap between traditional knowledge and modern healthcare by ensuring accessibility, traceability, and quality of herbal and plant-based products. With increasing global demand, standardization, research-backed validation, and sustainable cultivation practices are critical to strengthening India’s position as a leader in the natural wellness sector. Addressing challenges such as quality planting materials, processing gaps, and export compliance can significantly enhance the sector’s contribution to farmers, employment, and foreign exchange earnings. By leveraging advanced processing techniques like gamma irradiation to improve shelf life and expanding institutional support for small and medium enterprises, India is poised to not only reclaim its 5,000-year-old legacy in Ayurveda but also emerge as a dominant force in the international wellness industry.”

Dr. Manoj Nesari, Advisor, Ayurveda, Ministry of AYUSH, Govt. of India, said, “The Ayurveda and nutraceutical sector is experiencing unprecedented growth, with the market expanding from $3 billion in 2014 to $18.2 billion by 2020 and currently valued at around $24 billion. With a projected target of $200 billion over the next decade, this growth is driven by increasing global acceptance, research advancements, and policy support. The industry is evolving beyond conventional supplements to embrace Ayurvedic Aahar, recognizing the immense potential of flavonoids and alkaloids found in medicinal plants and everyday foods. The thin line between food and medicine highlights the significance of functional ingredients like turmeric, amla, and triphala in promoting holistic well-being. Addressing key public health concerns, such as iron deficiency anemia, requires a shift from mere supplementation to improving nutrient absorption, a focus highlighted by initiatives like Mission Utkarsh. Moreover, amendments to the Food Security Act emphasize the importance of nutrition beyond caloric intake. With Ayurveda extending into veterinary applications and Agro Ayurveda ensuring a sustainable supply chain, India is well-positioned to integrate traditional knowledge with modern health solutions. As global interest in Ayurveda and medical value travel continues to rise, the sector stands at the forefront of fostering both industry growth and societal well-being.”

Salman Mehkri, Head of Business Development, Bio-gen Extracts  “The Indian nutraceutical industry is currently valued at approximately $5–6 billion and is witnessing rapid growth, with a projected CAGR of 12–13%. This strong momentum is expected to double the industry’s size within the next 4–5 years. With increasing consumer awareness, rising disposable incomes, and high-quality products entering the market, we see tremendous potential. The industry has also set an ambitious goal of reaching $100 billion by 2047, coinciding with India’s 100th year of independence. Government support is crucial for accelerating this industry’s expansion. Policies such as reducing the GST on nutraceuticals from the current 18% to a more consumer-friendly 5–12% and introducing PLI-based schemes for manufacturers would enhance affordability and accessibility, especially in tier-2 and tier-3 cities. With the right regulatory and policy support, India’s nutraceutical industry can become a global leader in health and wellness.”

Dr. Meenakshi Singh, Chief Scientist, Technology Management Directorate, Council of Scientific & Industrial Research (CSIR), said “The nutraceutical sector holds immense potential, given India’s rich heritage in botanicals, traditional knowledge, and our leadership in fruits and vegetable production. Recognizing the sector’s challenges, we formed a dedicated task force under the guidance of the Principal Scientific Advisor in 2021, in collaboration with CSIR and key industry leaders. The mission is to address critical gaps, such as the absence of standardized codes for export tracking and regulatory clarity, to foster growth both domestically and globally. We believe that food is not just nourishment but a powerful source of preventive medicine, aiming to reduce healthcare costs through better nutrition. Moving forward, we seek stronger collaboration between industry and research institutions to generate comprehensive scientific data that will propel the nutraceutical industry to new heights.”

Mr. Sanjaya Mariwala, Executive Chairman & Managing Director, OmniActive Health Technologies, said” “India’s rich agricultural potential, coupled with its pharmaceutical expertise, provides a strong foundation for innovation in nutrition, health, and wellness industries. With the right synergy between government policies and industry initiatives, the sector can unlock immense growth opportunities, much like India’s success in the software industry. Given the country’s manufacturing capabilities and scientific talent, achieving a $100 billion market in nutraceuticals is a realistic goal. A focused and collaborative approach can propel India to the forefront of the global nutraceutical landscape, driving industry expansion and enhancing its contribution to global health and wellness.”

Nishant Chachra, Vice President, Business Development, KSM-66 Ashwagandha, said “At KSM-66 Ashwagandha, we take immense pride in being the global leader in Ashwagandha, holding over 67% of all Ashwagandha exports from India. With exports spanning 53 countries, North America remains our largest market, followed by Europe and the Asia-Pacific region. As per NBJ report, Mood and Mental Health is among the fastest-growing condition category in supplements. In 2023, sales increased by 6.9% to hit $1.53 billion and is expected to remain in the 6.5% to 7% range through 2027 driven by increasing consumer demand for mental wellness products addressing anxiety, stress, and cognitive health. As the global demand for Ashwagandha-based solutions rises, we continue to set industry benchmarks with innovation and clinical research, reinforcing our position as the most trusted name in Ashwagandha.”

Speaking on occasion of Vitafoods India 2025, Mr. Yogesh Mudras, Managing Director, Informa Markets in India, said, “Vitafoods India stands as a definitive platform for the nutraceuticals and dietary supplements industry, reflecting its rapid evolution and immense potential. In 2024, the sector experienced remarkable growth driven by consumer demand for personalised and science-backed health solutions, and 2025 is set to build on this momentum. With increasing emphasis on supply chain transparency, digital health integration, and regulatory compliance, stakeholders are well-positioned to address emerging challenges and seize opportunities in this dynamic market. Nutraceuticals now dominate the pharma -supplement market, with evolving regulations like those from FSSAI set to attract investments and foster growth. Vitafoods India continues to play a pivotal role in driving innovation and shaping the future of this thriving industry.”

Vitafoods India 2025 received a strong backing from leading associations, including AHNMI (Association of Herbal and Nutraceutical Manufacturers of India), AFSTI (Association of Food Scientists & Technologists) India (Mumbai Chapter), CASMB (Chamber for Advancement of Small & Medium Businesses), GCCI (The Global Chamber of Commerce & Industry), HADSA (Health Foods and Dietary Supplements Association), SHEFEXIL (Shellac and Forest Products Export Promotion Council) and WIN (Women in Nutraceuticals) .

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This guide by TriHaz Solutions explores the classifications of pharmaceutical waste, examples of waste types, and effective disposal methods tailored to your facility’s needs.

Who Produces Pharmaceutical Waste?

Pharmaceutical waste is generated by a variety of sources, including:

1. Pharmaceutical Manufacturing Plants

Plants produce waste, such as unused products, chemical residues, and contaminated cleaning materials. To avoid water and soil contamination, disposal must follow strict protocols.

2. Healthcare and Extended Care Facilities

These facilities generate waste from expired drugs, syringes, and medical packaging. Proper disposal prevents environmental harm and protects communities from exposure to controlled substances.

3. Personal Care Product Manufacturers

These manufacturers handle chemical residues, spent containers, and wastewater from equipment cleaning like pharmaceutical plants.

4. Veterinary Clinics

Veterinary offices produce a wide range of pharmaceutical waste, including unused medications, syringes, and waste from various medical procedures.

Who Regulates Pharmaceutical Waste Disposal?

In the U.S., pharmaceutical waste disposal is governed by:

• Environmental Protection Agency (EPA): Responsible for hazardous waste under the Resource Conservation and Recovery Act (RCRA).
• Drug Enforcement Agency (DEA): Regulates controlled substances.
• Other Agencies: DOT, OSHA, FWS, and state-level authorities.

Failure to comply with these regulations can lead to significant fines and environmental damage.

Types of Pharmaceutical Waste

Hazardous Waste

The RCRA categorizes hazardous pharmaceutical waste as:

1. Listed Waste:

Examples: Xylene, acetone, mercury, chemotherapy drugs.

Often includes solvents and manufacturing byproducts.

2. Characteristic Waste:

Ignitability, corrosivity, reactivity, and toxicity define this waste.

3. Acute Hazardous Waste:

Includes highly toxic substances like arsenic trioxide, epinephrine, and warfarin.

Non-Hazardous Waste

While not regulated as hazardous, non-hazardous waste still requires careful handling to prevent harm. Examples include:

• Over-the-counter medications.
• Nicotine replacement therapies (in some states).
• Antibiotics, hormones, and contraceptives.

Proper Disposal of Pharmaceutical Waste

1. Prescription Drug Waste

Never throw medications in the trash or flush them down the drain. Partner with a licensed waste management company for safe disposal.

2. Pharmaceutical Wastewater

Generated during the cleaning of manufacturing equipment, wastewater must be treated by a professional facility to prevent contamination.

3. Contaminated Materials

Items like gloves, masks, and syringes should be collected and disposed of by specialized waste management services.

How TriHaz Solutions Can Help

At TriHaz Solutions, we offer comprehensive pharmaceutical waste management services to ensure safety, compliance, and environmental protection:

1. Containerized Waste Disposal:

Safe handling and disposal of waste stored in drums or totes.

2. Waste-to-Energy Services:

Convert waste into usable energy through incineration.

3. Tank Cleaning Services:

Properly clean tanks and dispose of pharmaceutical wastewater to meet regulatory standards.

4. Secure Destruction:

Safeguard proprietary information with confidential destruction services for materials and chemicals.

The post Types of Pharmaceutical Waste and How to Dispose of Them appeared first on Pharma Advancement.

CPHI Middle East will be the largest ever gathering of pharma companies in the region as Government officials, global pharma companies, biotechs and manufacturing partners are meeting to kick off the next phase of Kingdom’s plans to build world-class R&D and manufacturing infrastructure.

Ahead of a keynote address, Hala Audi, CEO of UNIZIMA—a consultancy specialising in public and private partnerships for bioproduction facilities in emerging markets—remarked: “The event’s success is just another indicator of the significant investment underway in the region. The rate of change is only accelerating, and the Kingdom is building pharma infrastructure at pace. The Government is rightly driving the momentum, by focusing on its strengths – a sizeable domestic market, growing scientific and medical talent, and financing power. I believe that with the right technology partnerships, the region is poised to build a biotech ecosystem that will compete with the best globally. Next generation technologies for vaccines and therapeutics including for instance RNA based treatments offer an opportunity for KSA and the region to leapfrog and lead the way in biotech.”

One key group looking to harness Saudi’s potential are Indian CDMOs, which are supporting emerging biotechs with product development in India and helping transfer manufacturing learnings and process development skills to the region’s burgeoning regional manufacturing base. Of the 400 companies exhibiting at CPHI Middle East, more than 80 will join from India, 65+ from Europe and over 90 from China.

The event is held under the patronage of the Saudi Ministry of Health, who will be among more than 160 experts presenting at the event. A Ministerial Panel on 10 December will outline the Kingdom’s strategy to develop a biopharma ecosystem, in alignment with the Kingdom’s vision to be the leading biotech hub in MENA by 2030 and globally by 2040. The Kingdom has ambitious plans to reduce its reliance on imported drugs. In fact, currently, Saudi Arabia imports over 81% of its generic medicines and 94% of its medical devices, however, by 2030, the Kingdom aims to produce 40% of its drug needs domestically.

The event’s extensive conference agenda, which spans four show-floor theatres, will deliver key announcements and vibrant discussions on a wide array of topics vital to the future of Middle East pharma development. Among the keynote highlights, Hala Audi, CEO of UNIZIMA (a part of Univercells), will share insights on building biologics capabilities in emerging markets. The event will also feature prominent panel discussions, including a session on expanding Saudi Arabia’s domestic manufacturing hub, moderated by Eleonora Brero, Head of Consulting and Financial Institution Consulting at IQVIA Middle East & Africa.

April Hung, Brand Manager for CPHI Middle East, added, “CPHI Middle East is set to be the portfolio’s most successful launch to date – with incredibly impressive attendee and exhibitor numbers. This level of interest reflects the region’s ambitions and strong demand for partnerships. The public-private collaboration here is impressive, and by bringing CPHI to Saudi Arabia, we’re helping accelerate the development of partnerships and supply ecosystems that will fuel growth over the next five years. We’re thrilled to launch the show and play a role in building a new ‘heart of pharma’ in the Middle East.”

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However, women’s roles seem predominantly limited to critical patient care and entry-level or middle-management roles at 70% to 75%³, with fairly low representation in top-level policy-making or C-suite positions at 32%³. Only 29% of the most influential leadership and governance roles are held by women⁴. In contrast, 69% of global health organisations are headed by men, and 80% of board chairs are male1, which is indicative of a broader issue: while women make up the majority of the healthcare workforce, they are less visible in the shaping of key policies and decisions.

Women leaders in biopharma

Studies consistently show that companies with greater gender diversity in leadership tend to perform better. A McKinsey report found that organisations with more women in executive roles are 21% more likely to outperform their male-dominated counterparts financially and 27% more likely to have superior value creation6.

However, as of 2023, only one woman held the chief executive officer (CEO) position among the top 10 pharmaceutical companies by revenue⁵. At the senior executive level across the industry, women account for only one quarter of leadership teams2.

Deborah Seifert, Malaysia, Indonesia, Singapore & Philippines (MISP) Cluster Lead at Pfizer, comments, “Patient-centred innovation is critical in the biopharma industry, which is why it stands to benefit from women in leadership roles. Having diverse teams — including more women in leadership — is critical, as it reflects the diverse nature of the communities we serve. Only a diverse range of perspectives and experiences enable the fostering of collaboration which could lead to the development of more innovative products that meet the needs of a wide variety of patients⁸.

She adds, “It has also been shown that diverse teams are better equipped to navigate complex challenges. For companies, this translates into enhanced decision-making, greater adaptability in dynamic markets, and stronger business performance, which would ultimately benefit the industry, patients and the wider community⁹.

Pfizer is an example of a biopharmaceutical company who has made consistent efforts to champion women leaders. Between 2019 and 2021, Pfizer increased female representation at the vice president (VP) levels and above from 33% to 42%.⁷ This shift is particularly noteworthy in markets such as Malaysia, where 66% of Pfizer’s employees are women, with half of its senior leadership positions held by women⁷. Likewise, nearly 66.7% of Pfizer’s Emerging Markets teams are led by women, showcasing the company’s commitment to promoting women to leadership roles.

Ravi Subramaniam, Pfizer’s People Experience Lead for the MISP Cluster, says, “As an equal opportunity employer, Pfizer’s development initiatives are gender agnostic and available for everyone. Women make up about 70% of our organisation¹⁵, and we are focusing on promoting more women to senior leadership roles at the country and regional levels. It has been proven time and again that diverse teams are more collaborative, more able to balance between being prudent and taking risks, and more effective in a global environment.”

A ripple effect

The impact of promoting women to senior roles extends beyond the boardroom. In Asia, cultural and societal barriers have a significant impact on the type of careers women and men pursue, as well as leadership opportunities between genders, and these disparities tend to emerge at a fairly young age.

Studies show that at the primary and secondary school levels, girls outperform boys in mathematics and science across ASEAN countries¹⁰. Yet, only 19.3% of women – compared to 39.8% of men – obtain Science, Technology, Engineering and Mathematics (STEM) degrees across all ASEAN countries¹¹, and only less than 10% of biopharma chief executive officers (CEOs) are women¹².

“When girls see women in senior leadership and top-level policy-making positions, it sends a powerful message to the younger generation¹³. This could potentially shift the needle in encouraging more young girls to pursue careers and take up leadership roles in biopharma. I was fortunate to have had good mentors and people who saw potential in me, even when I may not have put my hand up for those roles at the time. I tell young women today they must advocate for themselves and put their hands up when opportunities present themselves,” shares Seifert.

“In today’s world, gender diversity is a necessity for driving the biopharma industry forward. Companies that prioritize diversity and inclusion tend to have higher employee satisfaction, lower turnover, and stronger performance overall¹⁴. By creating a supportive environment for women to take on leadership positions, Pfizer ensures that we are attracting and retaining top talent,” says Ravi.

References:

1. Delivered by women, led by men: A gender and equity analysis of the global health and social workforce. 2019. Geneva: World Health Organization, (Human Resources for Health Observer Series No. 24). https://iris.who.int/bitstream/handle/10665/311322/9789241515467-eng.pdf Accessed 17 October 2024.

2. Milkovic, P. 2024. Women In Pharma – Are We There Yet? One Nucleus. https://onenucleus.com/women-pharma-are-we-there-yet   Accessed 17 October 2024.

3. Berlin, G., Robinson, N., & Sharma, M. 2023. Women in the healthcare industry: An update. McKinsey & Company. https://www.mckinsey.com/industries/healthcare/our-insights/women-in-healthcare-and-life-sciences-the-ongoing-stress-of-covid-19  Accessed 17 October 2024.

4. Tremmel, M., Wahl. I. 2023. Gender stereotypes in leadership: Analyzing the content and evaluation of stereotypes about typical, male, and female leaders. Front Psychol, 14:1034258. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9912935/

5. Sick and Tired: How the Lack of Women CEOs in Big Pharm Impacts Women’s Health. StoryMd. https://storymd.com/story/8dnXrlauZA-sick-and-tired-how-the-lack-of-women-ceos-in-big-pharm-impacts-women-s-health Accessed 17 October 2024.

6. Hunt, V., Prince, S., Dixon-Fyle, S., Yee, L. 2018. Delivering through diversity. Mckinsey and Company. https://www.insurance.ca.gov/diversity/41-ISDGBD/GBDExternal/upload/McKinseyDeliverDiv201801-2.pdf

7. Pfizer Statement on Results of Third Annual Pay Equity Study Among Colleagues Worldwide. Pfizer News. https://www.pfizer.com/news/announcements/pfizer-statement-results-third-annual-pay-equity-study-among-colleagues  Accessed 17 October 2024.

8. Scientific Workforce Diversity Seminar Series Proceedings: How Does Diversity Affect Innovation in Pharma; National Institutes of Health. https://diversity.nih.gov/sites/default/files/media-files/documents/September%202022%20SWDSS%20Proceedings.pdf Accessed 28 November 2024.

9. Delivering through Diversity. 2018. McKinsey & Company. https://www.insurance.ca.gov/diversity/41-ISDGBD/GBDExternal/upload/McKinseyDeliverDiv201801-2.pdf  Accessed 28 November 2024.

10. December 2022. ASEAN-USAID Inclusive Growth in ASEAN. Policy Brief Strengthening ASEAN Women’s Participation in STEM
https://asean.org/wp-content/uploads/2023/10/Policy-Brief-Strengthening-ASEAN-Womens-Participation-in-STEM-Endorsed.FINAL_.pdf Accessed 17 October 2024.

11. Rastogi, V., Meyer, M., Tan, M., Tasiaux, J. 2020. Boosting women in technology in Southeast Asia: Shifting from awareness to action on gender diversity. Boston Consulting Group. https://www.bcg.com/publications/2020/boosting-women-in-southeast-asia-tech-sector   Accessed 17 October 2024.

12. Garguilo, L. 2023. Women Rising in Biotech. Outsourced Pharma. https://www.outsourcedpharma.com/doc/viral-vectors-and-women-in-biotech-0001#:~:text=Less%20than%2010%25%20of%20CEOs,improved%20from%20previous%20years%5D.” Accessed 17 October 2024.

13. KPMG Women’s Leadership Study – Moving Women Forward into Leadership Roles. 2015. https://assets.kpmg.com/content/dam/kpmg/ph/pdf/ThoughtLeadershipPublications/KPMGWomensLeadershipStudy.pdf   Accessed 17 October 2024.

14. Why are diversity and inclusion critical in the workplace? 2022. Penn LPS Online, University of Pennsylvania. https://lpsonline.sas.upenn.edu/features/why-are-diversity-and-inclusion-critical-workplace  Accessed 17 October 2024.

15. Smith, S. G., Sinkford, J. C. 2022. Gender equality in the 21st century: Overcoming barriers to women’s leadership in global health. Journal of Dental Education, 86(9): 1144-1173. https://onlinelibrary.wiley.com/doi/full/10.1002/jdd.13059

Pfizer

The post Women Leaders in Biopharma: The Way Forward appeared first on Pharma Advancement.

In the fast-paced world of pharmaceuticals, effective partnerships between CMOs and pharmaceutical companies are crucial for swiftly producing life-saving drugs. As the global CMO market continues to grow, it’s imperative for pharmaceutical companies to strategically select and collaborate with the right partners to optimise operations, minimise costs, and drive innovation.

Pharma Contract Manufacturing 2025 will provide a platform for sharing best practice, building relationships and addressing common challenges collectively. From partner selection and cost management to digital transformation and sustainability, we will explore practical solutions and real-world case studies to help you build and sustain successful partnerships in today’s uncertain environment. Join us in Berlin at the Mercure Hotel from the 26-27^th March 2025.

Hear from our 28 speakers who are leading roundtables, debates and collaborative discussions and network with our attendees as we tackle the current challenges facing the pharma industry.

The 2025 speaker lineup includes:

• Ingrid Lux, Director, Quality Disposition Oncology and External Supply Small Molecule Europe, Takeda

• Maik Talarczyk, Head, PMO ESO, Sandoz

• Philip Coetzee, Director CMO Management, Daiichi Sankyo

• Lucas Lucero Lopez, Associate Director, Vendor Management, AstraZeneca

• Maria Palha, Associate Director, External Manufacturing Operations, UCB

• Mohamed Fayez Monir, Head of Third Party Manufacturing, Boehringer Ingelheim

Key topics will include:

• Embracing Sustainability: Exploring sustainable practices and reducing environmental impact.

• Discussing Business Strategies: Particularly looking at pricing and contract negotiations.

• Navigating Regulatory Changes: Understanding the implications of new regulations and developing compliance strategies.

• Building Resilient Supply Chains: Mitigating risks and ensuring continuity of operations in a volatile environment.

• Leveraging Digital Transformation: Harnessing technology to improve efficiency, quality, and innovation.

The full event agenda is available here for you to browse and use our code: PARTNER15 for 15% off your ticket.

Event venue: Mercure Hotel MOA Berlin , Stephanstraße 41 , 10559 Berlin, Germany

The post Pharma Contract Manufacturing 2025 appeared first on Pharma Advancement.

Modern medicine, informed by molecular technologies and the completion of the human genome, has delivered a biological therapy revolution, with highly effective and specific monoclonal antibody treatments that provide symptomatic relief from many cancers, autoimmune and other chronic disorders. However, for conditions resistant to treatment and with complex and disputed causes, cell replacement therapies emergent from regenerative medicine research provide attractive palliative or curative options, improvements in cost and therefore accessibility. This fully depends on the promise of small molecule inhibitors playing a starring role.

The basic paradigm of cell replacement therapy proceeds as follows: 1) identify a stem or progenitor cell type with adequate renewal and plasticity properties; 2) define conditions to purify it or train its differentiation to an organ-specific cell type; and 3) optimize transplantation, engraftment, survival and function. The long-standing epitome of this strategy is heterologous transplantation of bone marrow-derived hematopoietic stem cells to treat leukemias. It is a fraught and invasive procedure for donor and patient, and one-to-one matching inevitably raises issues of immunogenicity and scalability. However, its success as a therapy argues that the general approach can be modified and scaled to suit any disorder driven by loss or compromise of a defined cell type. Hence, research laboratories have vastly improved their understanding of differentiation and the narrowing of specificity, from progenitors to organ-like systems. Investigators have refined generation of putative therapeutic cell types in murine and human models of homeostasis and disease, from hematopoietic lineages to cardiomyocytes to pancreatic beta cells. The concomitant ability to reprogram seemingly mature and fate-restricted cells back to a stem-like state has aided the cause by providing potentially unlimited source material.

The serious ethical quandaries and restrictive regulations that arose with the dawn of the 21^st century around use of human stem cell lines were made quaint by discoveries reported in 2006 by the Yamanaka group¹, and the rise of somatic cell reprogramming that began with the OSKM four-factor approach. Mature fibroblasts can be converted to induced pluripotent stem cells (iPSCs), restoring the ability to differentiate to all three germ layers and their derivatives, using retroviral delivery of key transcription and regulatory factors (OCT4, SOX2, KLF4, c-Myc). This discovery did not just bypass ethical and procedural dilemmas. It also prompted seismic shifts in multiple fields of biomedical science, notably regenerative medicine, which added to its cell replacement therapy paradigm the prospect of superficially obtaining cell samples from patients and using them to create patient-specific iPSCs. Differentiating and expanding them ex vivo can validate in principle an inexhaustible well for safe autologous transplantation, addressing concerns over immunogenicity, sourcing and scale.

But as the window opened to a tireless source of progenitor cells, the particular nature of reprogramming introduced its own narrowing apertures of scale, safety and medical applicability. First, it is a reproducible but fickle process, with a typical conversion efficiency of only between 0.1 – 1 percent. Second, the induction of gene expression by exogenous viral constructs carries risks of infection, integration, mutability and tumorigenicity. However, other research groups utilized reprogramming’s mechanistic principles to begin replacing gene constructs with small molecule inhibitors (SMIs) in various contexts. Substitution with SMIs introduces a higher degree of control and predictability, with the ability to finely control dosage and timing, vastly reduce costs through chemical synthesis reactions in comparison to biological production workflows, and impart a degree of reversibility and plasticity via periodic treatment and removal of cell-permeable compounds.

Mechanistically, iPSC reprogramming modulates activity of Wnt and transforming growth factor-beta (TGF-β) signaling pathways, which are both important regulators of developmental patterning. It also promotes chromatin accessibility through epigenetic modification, and cellular metabolism via autophagy, unlocking cells’ receptivity to new instructions. Therefore, investigators screened chemical cocktails to impart these combined functions and achieve a level of stemness equivalent to OSKM. In 2013 Hou and colleagues replaced the SKM portion of OSKM with VC6T in mice^2,4, consisting of SMIs for glycogen synthase kinase (CHIR99021), TGF-β (616452) and histone deacetylase and demethylase (valproic acid and tranylcypromine). They followed this discovery by identifying inhibitors to substitute for OCT4 expression, and enhance efficiency, in part by targeting retinoic acid signaling (Table 1). In 2022, Guan et al achieved SMI-mediated reprogramming in human cells by additionally targeting inflammatory responses through inhibition of the janus kinase (JNK) pathway^3,4.

What, then, is the best path forward for using SMIs to translate encouraging research results into medically actionable procedures? What degree of multipotency is adequate, or excessive, for a starting cell type? What disease state may have a good chance of becoming a standard bearer for a new paradigm of precision and regenerative medicine?

The answers remain to be debated and agreed upon for several years to come, but research into neurodegeneration and Parkinson’s disease may provide a great example from which to start. Parkinson’s disease (PD) is a neuromuscular degenerative disorder characterized by rigidity and tremor associated with the progressive loss of dopaminergic (DA) neurons in the substantia nigra region of the midbrain. Although deep brain stimulation and administration of levodopa can restore some function, patients eventually become refractory to amelioration. Consequently, the prospect of therapeutically replacing the lost cell type is an attractive option in the menu of potential long-term care or cure solutions.

Neural induction of multipotent cells borrows from some of the same pathways as reprogramming, and so some of the same classes of SMIs can be repurposed to promote ectoderm and its differentiation at the expense of mesoderm and endoderm lineages. Although iPSCs are highly valued in research fields for their pluripotency, it is simultaneously a mark against them in their capability to form teratomas. However, recent research has shown induction of early and mature neural lineages from several other types of progenitor cells, restoring function in neurotoxin-mediated PD mouse models. These include induction from mesenchymal (MSCs) and spermatogonial stem cells (SSCs), with conversion efficiencies of anywhere between 20 and 90 percent^5,6. Additional work has optimized relatively simple SMI-based protocols for direct transdifferentiation of mature somatic cells such as fibroblasts to neural stem and progenitor cells or even neurons that express markers of DA maturation^5,7. Some key SMIs that have been used in induction, conversion and differentiation are noted in Table 1.

Table 1. A partial list of common small molecules used in reprogramming, neural induction, and conversion to dopaminergic neurons in cell culture.

Of these cell types, SSCs may have the best combination of renewability, plasticity, safety, and sensitivity to the supportive niche within the eventual transplant, and therefore perhaps the highest capacity to properly engraft and promote new synapse formation and physiological function. The obvious caveat here is that although men are approximately twice as susceptible to PD as women, a sex-specific cell type is intrinsically not the most universal candidate.

Regardless, in the end the simplest path to conversion and expansion/maintenance with the highest efficiency should win the day for the best cell source and procedure, especially if cells remain viable and functional post-transplant. Additional work needs to be done to modify baseline culture conditions that currently require recombinant growth factors, cytokines, and neurotrophic factors such as FGF8 and GDNF. Finally, if a disease like PD is to serve as a bellwether, then the complexities of its etiology must also be taken into consideration. Restoration of DA neurons may not be adequate to overcome other aspects of its progression or epidemiology, such as neuronal transmission of misfolded alpha-synuclein protein aggregates, neurotoxicity and inflammation, and the difficulty of achieving early diagnoses when intervention is more likely to be effective.

References

1. Takahashi K, Yamanaka S. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell 126(4): 663 (2006).
2. Hou P et al. Pluripotent stem cells induced from mouse somatic cells by small-molecule compounds. Science 341(6146): 651 (2013).
3. Guan J et al. Chemical reprogramming of human somatic cells to pluripotent stem cells. Nature 605: 325 (2022).
4. Kim Y et al. Small-molecule-mediated reprogramming: a silver lining for regenerative medicine. Exp Mol Med. 52(2): 213 (2020).
5. Alexanian A et al. Dopaminergic progenitors generated by small molecule approach survived, integrated and promoted functional recovery in (6-OHDA) mouse model of Parkinson’s disease. J Neurol Sci. 465: 123188 (2024).
6. Yang H et al. Generation of functional dopaminergic neurons from human spermatogonial stem cells to rescue parkinsonian phenotypes. Stem Cell Res Ther. 10(1): 195 (2019).
7. Sorraska N et al. Rapid induction of dopaminergic neuron-like cells from human fibroblasts by autophagy activation with only 2 small molecules. 3 Biotech 14(4): 115 (2024).

Author:

Brandoch Cook,
Enzo Life Sciences
Brandoch Cook, Ph.D, Enzo Life Sciences .

Enzo Life Sciences

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“These technologies are designed to be less intrusive and are significantly more accurate than current industry standards,” said Gregg Rouse, President of AKM’s United States business unit. “What sets these components apart is a focus on privacy thanks to our mmWave radar, which presents a new way of monitoring through electromagnetic waves instead of cameras. Our sensors don’t know what you look like, just how you’re doing. AKM’s technology captures essential health indicators as anonymous data points. This allows AI systems to enhance care and safety without infringing on personal privacy and allows users to feel independent.”

Interactive AgeTech Demonstrations

AKM will showcase several live demonstrations at booth 54418 in the Venetian Expo & Convention Center. One such demo is the fall detection system, which recognizes people’s falls, presence, and movement. The system does all this without the use of cameras to offer life-saving monitoring without compromising privacy or independence. This solution uses AKM’s antenna-in-module (AiM) technology, which combines antennas and AKM’s  AK5816 60 GHz mmWave radar transceiver into one unit. Its design provides an easy-to-use, ready-made solution with extremely low noise performance compared to the conventional approach, where antennas are integrated into the device package. A battery-free smart diaper will also be on display. This diaper features a reusable component that enhances elderly and infant care by detecting the presence of liquid, even with a few drops on the electrode. This moisture generates a tiny amount of voltage (~300 mV), which is then amplified by AKM’s AP4470L ultra-low-power boost converter to power the product without batteries or complex electronics. The technology can then wirelessly send data to caregivers using AKM’s AK1595A Bluetooth® Low Energy transmitter, thereby reducing the discomfort associated with prolonged wetness.

AKM will also demonstrate a wristband-based thermometer featuring the AK9757P. This minuscule infrared temperature sensor, measuring just 1.6 x 1.76 mm, integrates seamlessly into wearables such as hearing aids, earbuds, and smartwatches, enabling continuous, non-invasive health monitoring with negligible impact on battery life. It can measure temperature accurately within ±0.2°C even in the presence of a small air gap, allowing for early health issue detection and more personalized care.  Other cutting-edge technologies on display during the convention, will include mmWave radar-based vital sign monitoring (breathing rate, heat rate, heat rate variation, and heartbeat sound), muscle activity monitoring (electromyography) enabled by an analog-front-end IC, and smart home solutions to enhance security and detect air quality.

The Growing Need for Innovative Healthcare Technology

AKM’s innovations represent a significant leap forward in AgeTech and provide invaluable support to caregivers, family members, and patients. By offering real-time, accurate, and AI-ready data, AKM’s technologies can alleviate the stress and uncertainty associated with remote caregiving. Family members can have peace of mind knowing their loved ones are safely monitored. At the same time, professional caregivers can optimize their time and resources, focusing on providing personalized care where it’s needed most. As the population of Americans 65 and older nearly doubled to approximately 55 million from 2000 to 2020, the need for such innovative solutions is increasingly urgent. Learn more about how AKM’s technology produces quality data to power the next generation of AgeTech. The AKM media kit includes photos of the technologies.

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On this point the fair’s director, Esther Cano, underscores that “this change in location is a response to both our exhibitors’ and our visitors’ needs”. Cano and her technical team have begun preparations for this next edition and are aiming to further boost Nutraceuticals Europe Summit & Expo as the leading platform for presenting the latest advances in research in this field and launching them onto the market.

With that aim in mind, the fair will again be featuring its space dedicated to training, scientific innovation and analyzing trends, the ‘Seminar Theatre’. The Theatre is also a hub where high-level internationally recognised speakers will not just be talking about the latest market news but will also be addressing issues relating to innovation in nutraceutical ingredients, new areas of research and nutritional product development and trends in the health and wellness market.

As to the commercial exhibition itself, Nutraceuticals Europe Summit & Expo is seeking to surpass the results the last edition of the fair achieved, when it brought together 113 exhibitors, 13% more than in 2023. 40% of exhibitors were foreign companies, hailing from Argentina, Belgium, China, Colombia, Denmark, France, Germany, Great Britain, Holland, India, Italy, the Netherlands, Poland, Portugal Singapore and Switzerland. This most recent fair also saw a significant increase in the number of professionals attending: 21.25% more than attended the previous edition. According to Cano, “we have some very ambitious targets, we are committed to exceeding them and to making Nutraceuticals Europe Summit & Expo an even more successful experience than in previous years”.

5^th and 6^th March 2025, Hall 1, Ifema, Madrid.

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