Traumatic Miscarriage Precedes Birth of Baby Girl to Michelle Tang, Co-Founder & CEO of IMA ART Fertility

BEVERLY HILLS, CA, Jun 6, 2023 – (ACN Newswire) – Michelle's traumatic miscarriage and failed IVF treatment in Hong Kong inadvertently prepared her for leading IMA ART Fertility Beverly Hills. The Hong Kong experience honed Michelle's listening skills and to speak to clients with compassion and empathy.

Michelle and her husband were among the estimated 15% of couples who experience infertility. For several years, the couple tried to conceive naturally, ultimately turning to a disappointing Hong Kong IVF cycle. During their journey to parenthood, Michelle suffered a miscarriage, loss of a frozen embryo at a clinic in Hong Kong, and a failed embryo implantation. Her first-hand experience in Hong Kong demonstrated the decisive difference in reproductive healthcare standards between Hong Kong and California.

After the miscarriage, Michelle courageously turned adversity to strength, channelling her deep feelings of personal loss into connecting with, and helping others, through their own IVF and Surrogacy journeys. After arriving in Beverly Hills, Michelle sought the help of well known & highly respected Dr Thais Aliabadi. Within a few months of the first consultation, Michelle tested positive for pregnancy.

Dr Aliabadi provided experienced, skilled and compassionate obstetric care during Michelle's pregnancy and delivery. Miranda Ripper, Certified Registered Nurse Specialist in Labor & Delivery – a private nurse working along side Dr. Aliabadi – met Michelle and her husband at check-in and remained by her side through labor and delivery. Miranda's 25 years of clinical expertise in nursing, helped educate, guide, and support Michelle through labor and Dylan's birth.

The CDC's definition of infertility is not being able to get pregnant after 12 months of unprotected sex. Because fertility in women is known to decline steadily with age, some providers evaluate and treat women aged 35 years or older after 6 months of unprotected sex. In the United States, among heterosexual women aged 15 to 49 years with no prior births, about 1 in 5 (19%) are unable to get pregnant after one year of trying (infertility). Also, about 1 in 4 (26%) women in this group have difficulty getting pregnant or carrying a pregnancy to term (impaired fecundity).

IMA ART understands the process preceding the decision to ultimately seek professional fertility assistance needs time and patience. Michelle knows how stressful & physically draining infertility treatments can be. Patients receive personal treatment protocols addressing their unique needs. The company provides their clients with access to a privately curated network of world-class fertility specialists, reproductive lawyers, psychological assistance and exceptional concierge services. California IVF success rates make it the fertility capital of the world.

About the Company: IMA ART is a high-value bespoke professional advisory service providing luxury fertility & surrogacy concierge and solutions in Beverly Hills. The company offers an exclusive suite of discreet fertility options geared towards busy high net worth individuals. Learn more at www.imaartfertility.com.

Contact Information
Ron Sonnenberg
Co-Founder
ron@imaartfertility.com
(424)-284-1408

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Asensus Shares First Quarter Results and Future Plans

NEW YORK, Jun 1, 2023 – (ACN Newswire) – PCG Digital — Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery(TM), recently shared notable operating and financial results for Q1 2023 and significant plans moving forward.

The company reported 20% year-over-year growth in surgical procedures, with more than 900 procedures performed globally during the quarter, and it recently received FDA 510(k) clearance for an expanded indication to treat pediatric patients – in line with a growing commitment to meeting the needs of an underserved pediatric market and connect with key pediatric surgeons.

First quarter revenue was $1 million with cash, cash equivalents, short- and long-term investments, excluding restricted cash, of approximately $57.4 million at the close of the quarter.

Asensus also surpassed 10,000 procedures on its Senhance(R) Surgical System, including a new program launched in Japan – one of the company's fastest-growing regions. The Senhance Surgical System with digital laparoscopy advances minimally invasive surgery with robotic precision.

Asensus' Intelligent Surgical Unit(TM) (ISU(TM)) integrated with the Senhance System is the only real-time solution on the market today that provides surgeons with a suite of tools to use during surgical procedures, including eye tracking camera control, haptic feedback, digital measurement and digital tags. Eye tracking allows surgeons to seamlessly control the camera position without pausing a procedure, and digital tags enhance communication between the surgeon at the console and the OR team website to further engage and support a seamless operating room experience.

Other key accomplishments include:

– Asensus received CE Mark approval for expanded machine vision capabilities on the ISU, which continues to notch praise throughout the industry.

– The ISU recently garnered two prestigious awards: It was named Best New Technology Solution in the MedTech Breakthrough awards' surgical category, where it faced competition from nearly 4,000 nominations across the globe, and Juniper Research Future Digital Awards for Excellence in Digital Health Innovation named Asensus the Best Medical Robotics Solution/Platinum Winner. Both awards are a strong testament to Asensus' commitment to innovation.

– Asensus signed a memorandum of understanding with KARL STORZ, a major player in the surgical device industry. The definitive agreements are progressing towards signing and will represent an important step in expanding commercial reach and development. Upon competition, this will bring the benefits of the ISU to KARL STORZ' extensive global customer base.

– As part of the company's aim to develop pediatric-specific real-world data, a peer-reviewed paper was published detailing the Senhance platform's usage in pediatric procedures. Senhance's unique combination of 3mm instrumentation with a 5mm camera scope combined with haptic feedback make it a unique robotic assisted laparoscopic solution for pediatric surgeries. The surgical team successfully performed surgeries on patients ranging from 4 months to 16 years old, including gallbladder removal, hernia repair, and other types of urological and GI procedures. These early results highlight the potential of the platform in the pediatric population and further validate its safety and effectiveness.

– To better support the pediatric market, Asensus hosted an event with several U.S. pediatric surgeons to gain a stronger understanding of their needs and a subsequent event with a group of key European pediatric surgeons to learn more about supporting further research.

Growth goals and future plans

– For the full year 2023, the Company continues to expect to initiate 10 – 12 new Senhance programs.

– During the second half of 2023, the Company expects to continue initiating integrated system testing for LUNA, the company's next-generation digital surgery platform. Through a combination of advanced minimally invasive instrumentation, the first ever digital interface between the surgeon and the console, and industry-leading clinical intelligence tools, the Company believes the LUNA System is poised to revolutionize the way surgery is performed.

"These are exciting times at Asensus," said Asensus President and CEO Anthony Fernando. "We have continued to push the boundaries of what's possible in robotic surgery, and we will keep pushing to deliver the tools and capabilities that surgeons need to deliver better, more consistent outcomes for their patients."

Disclaimer

This communication was produced by PCG Digital Holdings, LLC, an affiliate of PCG Advisory Inc., (together "PCG"). PCG is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security. PCG may be compensated by respective clients for publicizing information relating to its client's securities. See www.pcgadvisory.com/disclosures.

PCG Digital
info@pcgadvisory.com
646-863-6341

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

China Medical System: An Innovative Drug, ILUMETRI ‘Tildrakizumab Injection’ Approved for Marketing in China

SHENZHEN, CHINA, May 30, 2023 – (ACN Newswire) – On May 30, China Medical System Holdings Limited ("CMS" or the "Group") announced that on 26 May 2023, the New Drug Application (NDA) of Tildrakizumab Injection under the brand name of ILUMETRI has been approved by the National Medical Products Administration of China (NMPA). ILUMETRI is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

– CMS is pleased to announce the NDA of Tildrakizumab Injection under the brand name of ILUMETRI, a monoclonal antibody specifically targeting the p19 subunit of IL-23, has been approved in China. ILUMETRI is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
– The extended study of ILUMETRI's Phase III clinical trial in China, demonstrated that the primary efficacy assessment indicator PASI 75 response rate continued to increase over treatment time. The PASI 75 response rate reached a high level after 28 weeks of treatment with ILUMETRI and maintained at 91.3% at week 52, and ILUMETRI showed good long-term safety and tolerance.
– ILUMETRI only needs to be administered 4 times a year during maintenance treatment period, which may bring higher patient compliance.
– ILUMETRI will synergize with CMS Aesthetics' marketed products, Hirudoid, Aethoxysklerol and pipeline products, to solidify comprehensive competitiveness of CMS in the dermatology field.
– This is CMS's second innovative drug approved for marketing in China this year following the approval of Methotrexate Injection.

ILUMETRI is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMETRI has patents on composition and formulation in China.

The results of the extended study of its Phase III clinical trial in China demonstrated that the primary efficacy assessment indicator PASI 75 response rate continued to increase over treatment time. The PASI 75 response rate reached a high level after 28 weeks of treatment with ILUMETRI and maintained at 91.3% at week 52, and ILUMETRI showed good long-term safety and tolerance. ILUMETRI only needs to be administered 4 times a year during maintenance treatment period, which may bring higher patient compliance.

Psoriasis is an autoimmune disease with complex causes, where IL-23 is regarded as one of the important driving factors of the pathogenesis of psoriasis. The incidence of psoriasis in China is about 0.47%, with the number of patients exceeding 7 million, of which more than 30% have developed into moderate-to-severe disease. ILUMETRI will provide moderate-to-severe plaque psoriasis patients with a safe and effective treatment option.

It took only 14 months from obtaining the approval for the drug clinical trial to submitting the NDA for ILUMETRI in China, with the enrollment of 220 subjects completed in only 2.5 months (which included the Spring Festival), highlighting CMS's highly efficient clinical development capabilities supported by its commercialization strength.

ILUMETRI is CMS's second innovative drug approved to be marketed in China in 2023, following the recent approval of Methotrexate Injection. CMS has invested in, and collaborated with, innovative companies globally over the last 5 years to jointly develop innovative products with academic value and differentiated advantages, in order to meet unmet clinical needs and enhance the accessibility of global innovative drugs for Chinese patients. Starting from 2023, CMS's innovation development is stepping into the harvest period.

ILUMETRI has been approved for marketing in the Hong Kong Special Administrative Region of China in April 2022. Tildrakizumab Injection has also been approved for marketing in the U.S., EU, Japan, UK, Switzerland, Canada, Australia and other countries/regions.

About CMS

CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet healthcare needs. In 2022, the Group recorded a turnover of RMB9,150 million; in the case that all medicines were directly sold by the Group, the turnover reached RMB10,498 million. Profit for the year reached RMB3,276 million.

CMS focuses on developing first- or best-in-class innovative products and has made the layout of 30 differentiated pipeline products with strong market potential. CMS deeply engages in specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to strengthen the competitiveness of its cardio-cerebrovascular/gastroenterology business, and independently operated dermatology and medical aesthetic business, and ophthalmology business, whilst enhancing the scale and efficiency. CMS also entered into the Southeast Asian market to create new opportunities to further enhance the sustainable development of the Group.

Media Contact
CMS Investor Relations
China Medical System Holdings Ltd.
Email: ir@cms.net.cn
Website: https://web.cms.net.cn/en/home/
Source: China Medical System Holdings Ltd.

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avance Clinical at ASCO & BIO 2023: Early Phase Oncology Trials Increasingly Elaborate and Demand More Patients

ADELAIDE, AUS & SAN DIEGO, May 30, 2023 – (ACN Newswire) – Avance Clinical, the leading award-winning Australian and North American CRO that offers ClinicReady and GlobalReady for early phase biotech companies to speed up the path to regulatory approval, says early phase oncology studies are increasingly more complex and demand more patients. Avance's ClinicReady and GlobalReady service platforms offer significant benefits to product development in oncology.

Avance Clinical's Chief Scientific Officer, Gabriel Kremmidiotis

According to Avance Clinical's Chief Scientific Officer Gabriel Kremmidiotis who is part of the Avance Clinical team attending ASCO:

"Recently, Phase I clinical trial designs in Oncology patients have become more elaborate and include elements of dose escalation, dose expansion and assessment of drug combinations. This, in addition to the increasing number of new emerging therapeutics, has increased the demand for fast progress through the early phases of development and a greater demand for access to patients."

"Utilizing Australia's regulatory environment and high-quality oncology experts, Avance Clinical is able to facilitate a fast project launch and seamless transition across different parts of modular oncology protocol designs. Studies start in Australia and, at appropriate stages, expand to the US as determined by patient accrual number requirements for each study."

"Retaining the majority of backend services (biostatistics, data management, pharmacokinetics and medical writing) in Australia ensures the highest degree of financial benefit for our clients through the Australian R&D tax incentive."

Avance Clinical CEO, Yvonne Lungershausen, Chief Scientific Officer Gabriel Kremmidiotis, and Head of Scientific and Regulatory Affairs Jorgen Mould are featured in a new Global Health video on Reuters news service about the importance of quality clinical trials as part of the drug development process.

The Global Health program brings together 100 leaders and executives from various sectors of the Private and Public Healthcare Industry.

Avance Clinical CEO, Yvonne Lungershausen and Executive VP North American Operations John Mann attended the Global Health Summit and Yvonne was a leading panelist.

Avance Clinical is at the cutting edge of clinical trial technology and has recently been ranked as the world leader in decentralised clinical trials (DCT) technology adoption by GlobalData and Clinical Trial Arena in the CRO sector.

The report found 46% of Avance Clinical's trials incorporated some elements of DCT technologies in 2022 including telemedicine, remote monitoring, and digital data collection. The DCT report also noted that Avance Clinical's staff training in the latest technologies was a key factor in the ranking. See the full report here. https://www.clinicaltrialsarena.com/features/year-in-review-dct-2022/

Avance Clinical's unique GlobalReady offering enables biotechs that have completed early-phase trials in Australia to rapidly and seamlessly transition to the US in preparation for FDA approvals, all with the one CRO and dedicated teams across both regions, which reduces time and cost and delivers quality data.

There are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which demonstrates Australian data acceptability with the FDA and other major regulatory authorities. More than 40 biotech clients are now taking advantage of Avance Clinical's GlobalReady program.

This seamless GlobalReady journey is designed so biotechs can:
– Take advantage of the Australian early-phase clinical trial landscape (No IND and 43.5% tax rebate)
– Transition or expand into North America for later phases – without changing CROs (retain study knowledge and processes/team)
– Seamlessly operationalize global dose-escalation and dose-expansion trials across the two regions
– Harness significant speed and cost advantages
– Be assured of quality data – transferable and readily acceptable by the FDA and other regulatory authorities

Book a meeting with Avance Clinical at ASCO https://www.avancecro.com/event/asco-2023-chicago-il/
Book a meeting with Avance Clinical at BIO Booth #2884 https://www.avancecro.com/event/4602/

Find out more:
Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/
For more information about the benefits of running your next study with Avance Clinical
contact us: enquiries@avancecro.com

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and North American CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company's clients are biotechs in their drug development phases that need fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past three years, has been providing CRO services in the region for more than 24 years.

Pre-clinical through to Phase I and Beyond
Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia. With experience across more than 110 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable for FDA and EMA review.

Technology
Avance Clinical uses state-of-the-art technology and gold-standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, Zelta, Veeva and Medrio are just some of Avance's technology partners.
www.avancecro.com

Media Contact:
Avance Clinical
Kate Thompson
media@avancecro.com

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Codify Self-Care for Advancement of Universal Health Coverage, Says United for Self-Care Coalition at WHA76

GENEVE, CH, May 25, 2023 – (ACN Newswire) – On the occasion of the 76th World Health Assembly, the United for Self-Care Coalition hosted a side event highlighting the need to embed self-care into the healthcare continuum, particularly in the context of managing the burden of non-communicable diseases (NCDs), strengthening primary health care (PHC) and advancing universal health coverage (UHC).

The event, which was held on Wednesday 24 May entitled "Self-Care: A Foundational Component of Health System Sustainability," brought together policymakers, healthcare providers, academics and patient advocates to discuss strategies for integrating self-care into national health systems and advancing health equity.

Speakers from a range of organizations provided a rich debate, including representatives from the World Health Organization (WHO), the International Pharmaceutical Federation (FIP), the Self-Care Trailblazer Group, Imperial College London Self-Care Academic Research Unit (SCARU) and the International Alliance of Patient Organisations (IAPO). Speakers highlighted the potential benefits of self-care, including improved health outcomes, increased access to healthcare services, stronger health systems and reduced healthcare costs.

The event also featured the official launch of the United for Self-Care Coalition, which is a global group of like-minded organisations unified by one common goal: to achieve UHC through codifying recognition of the value of self-care within the WHO to spearhead the development of a WHO Resolution on Self-Care and/or inclusion of self-care as a meaningful component of progress. The Coalition will work collaboratively to raise awareness of the importance of self-care, promotes evidence-based interventions, and advocates for policies and strategies that support the integration of self-care as a core component of people-centred care and PHC.

"The United for Self-Care Coalition is proud to have hosted this important side event at the World Health Assembly," said Judy Stenmark, Director General of the Global Self-Care Federation. "The time to act is now. We believe that self-care is a critical component for the advancement of UHC, and we are committed to working with policymakers, healthcare providers, patients and academic partners to promote its integration into the healthcare continuum."

For more information about the United for Self-Care Coalition and details on how to join, please visit https://www.unitedforselfcare.org

Contact Information
Catherine Laverty
claverty@selfcarefederation.org

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

ZAGENO Secures $33M Funding to Revolutionize Life Science Research Procurement

Cambridge, MA, May 25, 2023 – (ACN Newswire) – ZAGENO, the leading online marketplace for life science research products, announces the completion of a $33 million funding round. General Catalyst, the largest public pension fund in the United States, Grazia Equity, OakRidge Management Group, and a German investment house led this round, joined by existing investors Capnamic Ventures and HighSage Ventures.

This funding propels ZAGENO's expansion in the United States and Europe, significantly enhancing the accessibility and affordability of life science research products. ZAGENO simplifies product discovery, experiment planning, and seamless purchasing from thousands of suppliers. The marketplace revolutionizes the scientific workflow, saving time and product costs. With a wide selection of quality products and verified suppliers, scientists benefit from competitive pricing fostered by the marketplace's transparency and supplier choice.

"We're thrilled to welcome new investors, including one of America's most powerful shareholder bodies and global leader in the investment industry and a prominent German investment house, while enjoying continued support from General Catalyst and existing investors," said Florian Wegener, CEO of ZAGENO. "This funding empowers scientists to focus on scientific value creation."

ZAGENO's online marketplace offers a vast selection of products and services, including laboratory equipment, consumables, chemicals, antibodies, and customized solutions. By providing scientists access to a network of verified suppliers, the ZAGENO platform enables informed purchasing decisions.

"ZAGENO is transforming the scientific research industry with its groundbreaking platform," said Larry Bohn, Managing Partner at General Catalyst. "We proudly support their journey."

"With this funding, ZAGENO is positioned to deliver even greater value to scientists worldwide," emphasized Joe von Rickenbach, Chairman of the Board of ZAGENO. "Their innovative platform drives unmatched efficiency and cost savings."

ZAGENO is primed for rapid growth and pioneering innovation in the scientific research industry with this new funding.

To learn more about ZAGENO, please visit www.zageno.com.

About ZAGENO

ZAGENO is a marketplace for life science research products. By revolutionizing how scientists discover, procure, and manage life science research products, ZAGENO supports researchers pursuing breakthroughs that improve our lives. With an extensive catalog, advanced search functionality, transparent pricing, and dedicated customer support, ZAGENO simplifies the research workflow and enables scientists to focus on groundbreaking discoveries. ZAGENO is a global company with offices in Cambridge, San Francisco, Berlin, and Bangalore. For more information, visit www.zageno.com.

About General Catalyst

General Catalyst is a venture capital firm that invests in powerful, positive change that endures – for our entrepreneurs, our investors, our people, and society. We support founders with a long-term view who challenge the status quo, partnering with them from seed to growth stage and beyond to build companies that withstand the test of time. With offices in San Francisco, Palo Alto, New York City, London, and Boston, the firm has helped support the growth of businesses such as: Airbnb, Deliveroo, Guild, Gusto, Hubspot, Illumio, Lemonade, Livongo, Oscar, Samsara, Snap, Stripe, and Warby Parker. For more: www.generalcatalyst.com.

Contact Information
Stephanie Harold
pr@zageno.com
+1 (857) 477-8479

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avance Clinical Joins Global Heath Summit Campaign for Faster Access to Life-Changing and Life-Saving Therapies

ADELAIDE, AUS & SAN DIEGO, May 25, 2023 – (ACN Newswire) – Avance Clinical the leading award-winning Australian and North American CRO that offers the programs ClinicReady and GlobalReady for early phase biotech companies to speed up the path to regulatory approval, has been invited to join the Global Health Summit campaign which will be featured on Reuters.

Avance Clinical CEO, Yvonne Lungershausen, Chief Scientific Officer Gabriel Kremmidiotis, and Head of Scientific and Regulatory Affairs Jorgen Mould are interviewed in a new Global Health video featured on Reuters news service about the importance of quality clinical trials as part of the drug development process.

The campaign is a collection of interviews and video documentaries, highlighting international business leaders and healthcare specialists from various industries. The series will showcase organisations spearheading specific health initiatives, developing ground-breaking medicine and complex health technologies, and taking on the challenges of both physical and mental health globally.

The Global Health program launches at the upcoming Global Health Summit on 25-27 May 2023 at the prestigious Intercontinental Hotel in Geneva, bringing together 100 leaders and executives from various sectors of the Private and Public Healthcare Industry.

The event will feature round table discussions where participants will discuss strategies, share knowledge and expertise, and identify opportunities for collaboration. This will be complemented by keynote speeches and panel discussions that will explore the latest trends and emerging issues in the healthcare industry.

Avance Clinical CEO, Yvonne Lungershausen and Executive VP North American Operations John Mann will be attending the Global Health Summit and Yvonne will be a leading panelist. Avance Clinical is at the cutting edge of clinical trial technology and has recently been ranked as the world leader in DCT technology adoption by GlobalData and Clinical Trial Arena in the CRO sector.

The report found 46% of Avance Clinical's trials incorporated some elements of DCT technologies in 2022 including telemedicine, remote monitoring, and digital data collection. The DCT report also noted that Avance Clinical's staff training in the latest technologies was a key factor in the ranking. See the full report here. https://www.clinicaltrialsarena.com/features/year-in-review-dct-2022/

Avance Clinical's unique clinical offering GlobalReady enables biotechs that have completed early to mid-phases in Australia to rapidly and seamlessly transition to the US in preparation for FDA approvals, all with the one CRO and dedicated teams across both regions, which reduces time and cost and delivers quality data.

There are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which demonstrates Australian data acceptability with the FDA and other major regulatory authorities.

More than 40 biotech clients are now taking advantage of Avance Clinical's GlobalReady program.

This seamless GlobalReady journey is designed so biotechs can:
– Take advantage of the Australian early-phase clinical trial landscape (No IND and 43.5% tax rebate)
– Transition or expand into North America for later phases – without changing CROs (retain study knowledge and processes/team)
– Seamlessly operationalize global dose-escalation and dose-expansion trials across the two regions
– Harness significant speed and cost advantages
– Be assured of quality data – transferable and readily acceptable by the FDA and other regulatory authorities

Find out more:
– Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/
– Learn about the ClinicReady model here https://www.avancecro.com/about-clinicready/
– Learn about the GlobalReady model here https://www.avancecro.com/avance-clinical-north-america-operations/
or more information about the benefits of running your next study with Avance Clinical
contact us: enquiries@avancecro.com

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and US CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company's clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past three years, has been providing CRO services in the region for more than 24 years.

Pre-clinical through to Phase 1 and 2
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology
Avance Clinical uses state-of-the-art technology and gold-standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM Watson and Medrio are just some of the technology partners.
www.avancecro.com

Media Contact:
Avance Clinical
Kate Thompson
media@avancecro.com

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Northway Biotech Set to Launch Advanced Microbial and Mammalian GMP Facilities in Massachusetts

WALTHAM, MA, May 25, 2023 – (ACN Newswire) – Northway Biotech, a biopharmaceutical contract development and manufacturing organization (CDMO), established in 2004, with an EMA and FDA-compliant, state-of-the-art cGMP manufacturing site in Vilnius, Lithuania, announced the completion of its expansion project for cGMP manufacturing facilities in Waltham, Massachusetts. This significant accomplishment further solidifies Northway Biotech's standing as an influential player in the global biopharmaceutical landscape.

Northway Biotech Set to Launch Advanced Microbial and Mammalian GMP Facilities in Massachusetts

This recent growth is an extension of the successful launch of Northway Biotech's process and analytical development laboratories in Waltham (Greater Boston area) in 2020. The expanded facility now includes state-of-the-art cGMP suites, marking a significant milestone in the company's journey. The newly established cutting-edge biomanufacturing suites host a microbial fermentation train with up to 450 liters of volume capacity, and a mammalian production train with the ability to handle volumes of up to 2,000 liters. Northway Biotech has further established a specialized, fully automated fill and finish line to accommodate its clients' varied needs, supporting high-throughput filling into vials, syringes, and cartridges.

Prof. Vladas Algirdas Bumelis, CEO of Northway Biotech, shared his insights regarding this accomplishment, stating, "The addition of GMP suites in our US site represents a transformative step for our organization, enabling us to provide comprehensive end-to-end solutions from our second site now. We are poised to transition current process development projects into the cGMP manufacturing phase in a timely manner, in line with our clients' committed schedules. Additionally, our longstanding US partners who have engaged with our Lithuanian site can now also take advantage of the geographical convenience of our modern facilities located in the Greater Boston Area. With our fully functional and technologically advanced manufacturing site at our disposal, Northway Biotech is perfectly positioned to take on manufacturing projects aimed at both clinical and commercial supply."

To commemorate this significant expansion and express gratitude to its valued partners and industry leaders, Northway Biotech will be hosting a grand opening event for its cGMP suites on June 8. This event promises to be an occasion of celebration and networking, providing an opportunity for attendees to witness firsthand the state-of-the-art facilities and engage in meaningful discussions within the biotech community.

About Northway Biotech – https://www.northwaybiotech.com

Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced, professional team executes projects at any stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company's wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development and commercial manufacturing. Northway Biotech is a privately-owned company founded in 2004 and located in Vilnius, Lithuania; London, United Kingdom; and Waltham, Massachusetts, United States.

For Further Information, Contact:
Prof. Vladas Algirdas Bumelis
CEO and Chairman of the Board
Northway Biotech
vladas.bumelis@northwaybiotech.com

Contact Information
Vladas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

New Access Accelerated Global Collective Report Charts Path Forward in Fight Against Noncommunicable Diseases

GENEVE, CH, May 24, 2023 – (ACN Newswire) – Access Accelerated, a pioneering collective of leading biopharmaceutical and life science companies dedicated to confronting the growing global noncommunicable disease (NCD) crisis, announced the release of a six-year report: Key Lessons in Advancing Access to NCD Care: Collaboration, Connectivity, Community.

This milestone report highlights the initiative's outcomes, impact, and collective learnings between 2017 and 2022 and serves as a retrospective, a showcase for the initiative's success stories and challenges, and a much-needed vision for the future.

Michael Fredrich, Lead Access to Medicine Non-Communicable Diseases at Bayer Pharmaceuticals and Chair of the Access Accelerated Board, commented, "With the 2030 deadline for the UN Sustainable Development Goals approaching fast, which include Universal Health Coverage, it's more important than ever that we make the most out of our resources and approach this fight strategically. This report gives us the opportunity to critically evaluate our past and use key learnings for the future. It is essential that we share insights and learn from our collective efforts. Much work lies ahead, but this report serves as a valuable foundation for effectively addressing NCDs."

This initiative's impact has already been felt widely. Access Accelerated and its strategic partners – the City Cancer Challenge Foundation, NCD Alliance, PATH, the World Bank and the World Heart Federation – have helped improve access to NCD screening, diagnosis, and treatment around the world, reaching over 700 million people through 54 partner projects in 37 countries and catalyzing $US1.6 billion in investment in 2022 alone. By the end of phase 2 (2020-2022), this number totalled $US3.7 billion. In the same period, Access Accelerated partner projects contributed to policy change in 35 countries and 13 projects were scaled to national level, moving away from pilot phase to locally embedded projects.

Six years since its founding, the initiative has accumulated a wealth of hard-won knowledge and experience. The report highlights those learnings, including the crucial role of open, transparent communication in measuring intangible impact of partnerships, the ways flexible long-term funding can open the way for locally embedded solutions, and why community- and patient-centric approaches are essential to sustainability. By capturing impacts beyond hard numbers, the report demonstrates the importance of local engagement, trust, and social capital in improving NCD outcomes over time.

According to Dr. Juan Pablo Uribe, World Bank's Global Director for Health, Nutrition & Population and Director of the Global Financing Facility, the report demonstrates the importance of rigorous monitoring and reporting. "Learning from our successes and challenges is absolutely necessary if we are going to shape more efficient and effective initiatives that can respond to the growing NCD burden on countries around the world. That's why we're excited to have the insights offered by this report to inform future initiatives and are grateful to the partnership with Access Accelerated which has led to meaningful action in creating sustainable change."

Visit www.accessaccelerated.org to download the report.

About Access Accelerated

Founded in 2017, Access Accelerated is an unprecedented industry-led collective of life science companies united by the belief that no person should die from a preventable and treatable disease. Through the power of collaboration and a proven framework for cooperation, Access Accelerated brings together stakeholders across the private, public and social sectors, including implementers, decision-makers and financiers, in a shared mission of advancing action against the escalating challenge of NCDs in low- and middle-income countries and underserved communities.

Contact Information
Thuy Khuc-Bilon
Communications Manager
info@accessaccelerated.org
+41 79 473 0341

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Food Fortification a Major Focus at the World Health Assembly

Geneva, Switzerland, May 22, 2023 – (ACN Newswire) – The crucial topics of micronutrient deficiencies and Large Scale Food Fortification (LSFF) will be discussed at a side event at the 76th World Health Assembly (WHA) in Geneva on Tuesday, 23 May 2023, hosted by the governments of Colombia, Ecuador and Malaysia. At the side event, The Global Alliance for Improved Nutrition and partners will help unpack the pivotal resolution that calls on WHA Member States to scale up food fortification programs globally, particularly in countries where micronutrient deficiencies are prevalent.

The public can follow the updates on the Food Fortification resolution here.

Half of all preschool-aged children and 2/3rds of all women of reproductive age worldwide suffer from at least one micronutrient deficiency, also known as "hidden hunger". These deficiencies cause a range of health problems, from impaired cognitive development in children to increased risk of infections and conditions such as anemia and blindness.

Lawrence Haddad, executive director of the GAIN and a speaker at the event, said, "At GAIN, we have spent the past 20 years supporting food fortification in over 40 low and middle-income countries. Unfortunately, the prevalence of malnutrition is growing globally due to simultaneous climate and food crises exacerbated by the COVID-19 pandemic and Russia's war on Ukraine. More investment in food fortification can help to provide an important nutrition safety net as we seek to build nutritious food systems that are more resilient in the face of global shocks."

Food fortification has been identified as a cost-effective and sustainable strategy to combat hidden hunger and improve public health. According to the WHO, fortification of staple foods can improve micronutrient status in populations and reduce the incidence of associated diseases, particularly in low- and middle-income countries where access to diverse diets and supplements is limited. Eighty-four countries could benefit from establishing new mandatory fortification programs, and most existing programs must be strengthened to reach more people with adequately fortified food.

"Food fortification is among the solutions that we are urgently pursuing to combat rising levels of malnutrition in African Union countries," said Ambassador Josefa Sacko, Commissioner for Rural Economy and Agriculture at the African Union and member of the Scaling Up Nutrition Movement's Lead Group. "We welcome this important resolution of the World Health Assembly as food fortification is also on the front burner at the African Union."

The proposed WHA resolution has united the health policy, disability rights, and nutrition sectors. Over 70 global, regional, and national organizations have endorsed the resolution and are actively working to support its passage. "The World Health Organization is pleased to stand alongside Member States of the WHA and the wide coalition of stakeholders that has come together to support accelerated action on food fortification to combat micronutrient deficiency and its impacts," said Dr. Francesco Branca, Director of the Department of Nutrition and Food Safety at WHO. "Governments need to design effective food fortification programs aimed to reach all people in need and engage civil society and the private sector for effective implementation."

The Masters of Ceremony for the side event are Saskia Osendarp, Executive Director of the Micronutrient Forum, and Gail Rosseau, George Washington School of Medicine & Health Sciences and G4 Alliance. In addition to Lawrence Haddad, speakers will include representatives from supportive member states, food fortification experts and representatives from the disability rights, child rights, and health policy communities.

Registration for the event is open here. https://pr.report/F6yaLNnj

Contact Information:
Edwin Shankar
Media Relations
edwin.shankar@leidar.com

Copyright 2023 ACN Newswire. All rights reserved. http://www.acnnewswire.com