Category: Clinical Trials

AcuraBio Appoints Talented Senior Executives to Drive Global Growth Program

AcuraBio (formerly Luina Bio), a leading Australian biopharmaceutical CDMO, recently acquired by biotech investor Dr. Glenn Haifer and Ampersand Capital Partners, announced today new senior executive hires to support global growth plans. International biopharma executive Guillaume Herry has been appointed as CEO, while HR executive Joanne Reichardt has been appointed Head of People & Culture.

AcuraBio CEO Guillaume Herry

AcuraBio brings two decades of experience in innovative therapeutics for customers in the biotech, pharmaceutical, and animal health industries. The CDMO provides recombinant proteins, vaccines, and complex live biotherapeutic products to customers on the leading edge in emerging therapeutics.

Dr. Haifer stated “These senior executive appointments are key to shaping the company as we move forward with our growth plans. AcuraBio will immediately benefit from Guillaume Herry’s experience with companies in the US, Europe and Australia designing and implementing growth strategies. He brings over 15 years of international operational and strategic consulting experience across the biopharmaceutical and medical device industries.”

Mr. Herry said: “I’m excited to be part of this new phase of growth and to be working with Glenn and the Ampersand team. I look forward to leveraging the business’ deep technical experience to grow the company and expand the service offering.”

Mr. Herry holds an MBA from the Australian Graduate School of Management at University of New South Wales Business School (Australia), a Master’s Degree in Engineering for Health and Drugs (Biotechnology, Health and Management) from the University Joseph Fourier in Grenoble (France) and a Master’s Degree in Entrepreneurship in Life Sciences & Technologies from the University Paris-Sud X (France).

Regarding the appointment of Joanne Reichardt as Head of People & Culture, Dr. Haifer added “Ms. Reichardt’s appointment reflects a significant step in supporting our growth mission as we aim to create a robust culture. Ms. Reichardt brings over 20 years of HR experience and proven leadership expertise in successfully delivering critical people and culture strategies to support changing and growing businesses.”

Ms. Reichardt holds a Bachelor of Business (Strategic HR & Marketing) from the University of Southern Queensland and is a CAHRI member of the Australian Human Resources Institute.

Ms. Reichardt she was excited to be joining AcuraBio. “I look forward to working closely with the team to advance people processes and systems, with a focus on attracting and retaining the industry’s top talent to strengthen AcuraBio’s position as the most experienced biopharmaceutical CDMO. My goal is to enhance our people & culture offering, with a view to becoming industry Employer of Choice.”

About AcuraBio
AcuraBio Pty Ltd is one of Australia’s most experienced biopharmaceutical CDMOs, offering trusted, client-focused services to both domestic and international clients for the past 20 years. AcuraBio offers significant quality, cost, and IP assurances for biopharma companies around the world. World-class researchers and proven facilities, a streamlined regulatory framework, generous tax incentives, and government funding make Australia a prime location for biotech research. AcuraBio has the following operating licenses: TGA (Australian FDA equivalent) license for the manufacture of human therapeutic APIs from biological and synthetic sources, APVMA (veterinary equivalent of the TGA) license for manufacture of sterile immunobiological products, OGTR license to produce products from genetically modified organisms, and a DAF facility license for import and use of biologic materials. Additional information about AcuraBio is available at www.acurabio.com.

About Ampersand Capital Partners
Founded in 1988, Ampersand is a middle market private equity firm with more than $3 billion of assets under management dedicated to growth-oriented investments in the healthcare sector. With offices in Boston and Amsterdam, Ampersand leverages its unique blend of private equity and operating experience in seeking to build value and drive strong long-term performance alongside its portfolio company management teams. Ampersand has helped build numerous market-leading companies across each of the firm’s core healthcare sectors. Additional information about Ampersand is available at www.ampersandcapital.com

The Biotech Landscape Webinar: Market Trends, Priorities, Predictions, and Pathways to FDA Approval

Novotech, the leading Asia Pacific biotech specialist CRO, and Endpoints News present a webinar for biotechs considering the clinical research opportunities in Asia Pacific and the regulatory pathways to achieving FDA approval.

Novotech has operations across Asia Pacific and the US offering a unique and unparalleled suite of CRO services for early to late phase biotech clinical research.

The webinar features regulatory affairs and investment leaders from North America and Asia Pacific who will discuss:

  • why biotech companies are increasingly exploring clinical opportunities in Asia Pacific to generate diverse, globally accepted clinical trial data
  • what actionable strategies can be implemented to leverage Asia Pacific’s recruitment potential to accelerate your clinical development
  • how Phase 1 data from Australia is acceptable to the FDA and can be used to launch global drug development programs
  • deep insight into processes for designing and delivering a robust clinical program
  • biotech challenges and opportunities in the post-COVID environment with a focus on global investments and drug pipelines

Register for the webinar here https://webinars.endpts.com/the-biotech-landscape-market-trends-priorities-predictions-and-pathways-to-fda-approval/
October 18, 2022
1:00 pm – 2:00 pm EDT

The industry leaders presenting include:

  • Yi Larson, Chief Financial Officer of LianBio. Formerly Executive Vice President and Chief Financial Officer at Turning Point Therapeutics, Inc., and Goldman Sachs & Co. LLC, Managing Director of Healthcare Investment Banking
  • Kasey Kime, Director of Regulatory Affairs for Novotech’s in-house consulting group, BioDesk
  • Dr. Jeanne M. Novak, President and CEO of CBR International Corp., a full-service product, clinical, and regulatory strategy group
  • Dr. Fred Cohen, a Co-Founder and Chairman of Monograph Capital Partners. He is also a Co-Founder and Senior Managing Director at Vida Ventures.

Novotech has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership and flexibility. Consistent investment in advanced training and technology systems combine to deliver a specialist full-service biotech CRO solution.

Novotech has recently been benchmarked as a top 10 CRO among the world’s leading CROs, is a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.

About Novotech
Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact

Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Novotech India Recognised as “Best Workplaces for Women 2022” by Global Work Standards Authority

Novotech, the leading Asia Pacific biotech specialist CRO, has again received Best Workplace certification by the leading workplace culture organization Great Place to Work Institute. Novotech’s India team has received a Best Workplaces for Women 2022 recognition and listed in the Top 75 organisations in India recognised for excelling people practices, responsiveness to feedback and a culture of openness and diversity. Novotech also holds Great Place to Workplace recognition in Australia and Korea.

To identify India’s Best Workplaces for Women 2022, Great Place to Work India studied 1122 organizations that had:

  • Women employees constituting at least 10% of their workforce
  • Women employees sharing at least 70% positive feedback on the Great Place to Work Trust Index Organizations that excelled in gender parity in representation

According to Great Place to Work India: “We have observed that the Best Workplaces have gone above and beyond to create and sustain aspirational organizations. We congratulate Novotech for being a role-model in India by fostering an equal and equitable workplace culture.”

Novotech CEO Dr. John Moller said: “As a leading employer of women in India we are extremely pleased to be ranked among the top companies in India as a Best Workplaces for Women 2022. This is especially important for retaining and attracting top talent. This recognition demonstrates the importance of culture, diversity and work life balance as we strive to be one of the leading employers so we can deliver our world-class CRO services across India.”

Novotech’s Chief People Officer Angela Edwardson said: “We are delighted that Novotech India has been recognized as a leading employer for women. This is a real credit to our workplace culture and leadership that drives all our Asia Pacific and North American teams. Novotech attracts a high proportion of talented female employees, so we are extremely proud to have our workplace recognized using the criteria from the Great Place to Work Institute’s Trust Index and the Gender Parity in Experience & Representation. Our continued focus on building a leading workplace means team members can balance their personal responsibilities with work during all stages of life.”

According to Yooni Kim, Vice President, Global Clinical Services Novotech: “Employees are the most valuable assets of a company. Novotech is dedicated to improving our working environment and enhance employee health and wellbeing. We are more than grateful to receive this recognition.”

Sridevi Gubbala, Manager Centralized Document Management Novotech said: “Novotech is a great place to work. It’s wonderful to have flexibility at work because it helps me balance my work and personal life.”

Vandana Jaising, Manager Project Support joined Novotech after an extended career break and said: “Women should consider coming back, even if it is has been a while. Before joining Novotech I took an eight-year career break, and now I’m glad Novotech had the confidence in me to say ‘YES! You can do it!'”

Novotech has operations across Asia Pacific and the US offering a unique and unparalleled suite of CRO services for early to late phase biotech clinical research.

Novotech has recently been benchmarked as a top 10 CRO among the world’s leading CROs, is a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.

About Novotech
Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact

Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Novotech Selected as Scrip Awards Finalist for Best Full-Service CRO

Novotech, the leading Asia Pacific biotech specialist CRO, joins a prestigious group of global CROs as a finalist in the Scrip Award for Best Full-Service CRO. This year the Award has been split into two categories to separate the full-service providers from the smaller CROs.

According to the Scrip Award organizers: “The Award for the Best CRO acknowledges the critical role that CROs play in drug development. Outsourcing is vital as the pharmaceutical industry seeks to benefit more and more from these specialist companies’ experience in handling all aspects of clinical trials and other research. Today, the role of the CRO has gone beyond the traditional model of service-level agreements, to offer bespoke clinical trial and other strategies; and CROs are increasingly engaged in risk-sharing partnerships, or acting as a single-source developer, while also remaining committed to core strengths.”

The award judges are senior executives from biopharma and investment firms, and clinical research leaders.

Novotech CEO Dr. John Moller said he was extremely pleased that Novotech has been selected as a finalist and thanked the global Novotech team for their hard work and commitment to a truly customer focused approach to accelerate clinical development.

“This level of recognition is a credit to the team and shows our Asia Pacific centered, global operations are setting new standards for biotech CRO partnerships. Our deep experience, exceptional site and investigator relationships – which also translates to patient access – our project management approach focused on problem-solving, ownership and flexibility, and our investments in data and technology combine to deliver the full service, customer focused solutions that biotechs need.”

Novotech has operations across Asia Pacific and the US offering a unique and unparalleled suite of CRO services for early to late phase biotech clinical research.

Novotech has recently been benchmarked as a top 10 CRO among the world’s leading CROs and has also been selected for the Gene & Cell Therapy Excellence Award. The company also has more than 50 Leading Site Partnership agreements and hundreds of long-term site relationships across the Asia Pacific region.

About Novotech
Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact

Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Avance Clinical Wins International Health Award for Biotech CRO Services

Avance Clinical, the leading Australian-based biotech CRO with US operations has won the South Australian Premier’s Export Awards – International Health category. The award recognises excellence in clinical services exports.

Avance Clinical CEO Yvonne Lungershausen

The Premier of South Australia Peter Malinauskas, and Minister for Trade and Investment Nick Champion, presented the Premier’s Export Awards to Avance Clinical CEO Yvonne Lungershausen at the awards industry event today. This follows Avance Clinical’s selection as finalist for the Informa Pharma Intelligence Awards 2022 Best Contract Research Organization in APAC. Avance Clinical, which is backed by global private equity firm The Riverside Company, recently acquired a leading CRO in North America to expand services and offer their biotech clients US sites for later phase studies.

CEO Yvonne Lungershausen said Avance Clinical is now the leading Australian-based biotech CRO with US operations. “We are honoured to be selected for the award. We are a major employer with more than 220 staff and we bring significant biotech clinical research business into South Australia and Australia. Clinical research is a high-value export that keeps our medical, research, and biopharma sectors at the forefront of international knowledge and innovation. The majority of our clients are from North America, the EU, and Asia so we really are an internationally-focused organisation. Avance Clinical has a global reputation for agile clinical solutions to support accelerated clinical development for our international biotech clients and we are very proud of our growth and success in recent years.”

The company provides global regulatory standard clinical research services across all phases to the international biopharma industry. Avance Clinical is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) for vaccines and GMO therapies clinical trials.

“We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biopharma clients require in this fast-moving, competitive and high-stakes sector,” said Lungershausen.

Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Find out more:
– Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/
– Read more about Avance Clinical’s cell and gene therapy capabilities here www.avancecro.com/avance-clinical-featured-in-endpoints-news-on-cell-gene-therapy-capabilities/
– 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 CRO delivering quality clinical trials, with globally accepted data, in Australia and New Zealand 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 two 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.

Media Contacts:
Avance Clinical
Chris Thompson
media@avancecro.com

Novotech Presented with Cell & Gene Excellence Award 2022 at 6th Cell & Gene Therapy World Asia Conference

Novotech, the leading Asia Pacific biotech specialist CRO, has been awarded the Cell & Gene Therapy Clinical Trials award at the 6th Cell & Gene Therapy World Asia 2022 conference.

Novotech has extensive experience in cell & gene therapy clinical trials across Asia Pacific. The Asia Pacific accounts for over a third of cell & gene therapy trial activity with China being the leading location in APAC. In addition, APAC has nearly a 50% faster growth rate in cell & gene therapy trials than ROW. Blood cancers (ALL, NHL, DLBCL, lymphomas), solid tumors, viral infections, liver and gastrointestinal tract cancers are the top indications in China-based cell & gene therapy trials between 2016 and 2021.

Watch our recent Endpoints News webinar for more information:
EVOLUTION OF CELL & GENE THERAPY IN CHINA: THE CASE FOR UNIVERSAL CAR-T
https://novotech-cro.com/webinars/evolution-cell-gene-therapy-china-case-universal-car-t

The award was presented to Novotech during the 6th Cell & Gene Therapy World Asia 2022 conference (14th – 15th September) at the Sheraton Towers, Singapore.

Novotech CEO Dr. John Moller said, “We are extremely pleased our team has been recognized with this prestigious award at the 6th Cell & Gene Therapy World Asia 2022 conference. Cell & gene therapy is driving recent innovations in biotech and it is an honour to be recognized as the CRO at the forefront in Asia-Pacific supporting this vital clinical research. Cell & gene therapy research typically presents another level of complexity and regulatory processes which means an experienced CRO partner is vital. Our deep experience, exceptional site and investigator relationships – which also translates to patent access – our project management approach focused on problem-solving, ownership and flexibility, and our investments in data and technology combine to deliver the service biotechs need in this specialist sector for success.”

Novotech has recently also been benchmarked as a top 10 CRO among the world’s leading CROs, and has signed 45 Leading Site Partnership agreements over the last 3 years.

Download our latest data reports here:
EVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5
https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5

About Novotech
Novotech is the leading Asia-Pacific centered, globally capable, biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact

Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Indonesian pharmaceutical Bio Farma ready to produce IndoVac Covid-19 vaccines

  • Global markets in sight for shariah-compliant IndoVac vaccine brand

PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a new milestone in the manufacturing of IndoVac, a Covid-19 vaccine brand it has developed since November 2021.

IndoVac Covid-19 vaccine in production at PT Bio Farma’s facilities near Bandung, Indonesia (Image: PT Bio Farma)

Honesti Baasyir, the President Director of PT Bio Farma, said the company collaborated with Baylor College of Medicine, a private, independent health sciences centre in Houston, Texas to develop IndoVac, a recombinant protein subunit vaccine produced from yeast.

PT Bio Farma has completed Phase 1 and Phase 2 clinical trials and is currently in the Phase 3 stage to produce the primary series vaccines or two vaccine doses for everyone aged 18 years and older.

“IndoVac uses vaccine technology platforms which are compatible with the equipment and facilities within our factories. The technology platforms for protein recombinant vaccines also offer other benefits: they can be adapted to the new strains of Covid-19. Results from Phase 1 and Phase 2 clinical trials showed that IndoVac offers quality safety and efficacy, not less competitive than other Covid-19 vaccines. Now we are completing a report to wrap up Phase 3.”

Honesti said, Bio Farma has had intense communication with the Indonesian Food and Drug Administration (BPOM) since July 2022 to provide the necessary data, so that BPOM can release the Emergency Use Authorization (EUA) permit for IndoVac’s primary series vaccines in the near term.

The EUA, released by a country’s regulatory agency, is a permit for medical supplies (including vaccines) and medications during a public health emergency. In Indonesia, BPOM plays the key role as a regulatory gatekeeper of medicines and vaccines used in the country.

BPOM’s head Penny K. Lukito, during a hearing with Commission IX at the Indonesian House of Representatives, has said that the regulator expects to release the EUA for IndoVac’s primary series vaccines in mid-September 2022.

Shariah Compliance
Bio Farma also has processed the Halal (or Shariah compliant) certification for IndoVac’s primary series vaccines to provide comfort to Indonesian Muslim consumers. The vaccines have passed an audit from The Indonesian Ulema Council Food and Drug Analysis Agency (LPPOM MUI), which reviews the halal aspect of a product.

The certificate from the Halal Certification Agency (BPJPH) under the Religious Affairs Ministry is expected to be released in the near term after BPOM release the EUA for IndoVac.

After securing all the necessary permits, Bio Farma is ready to move on to the next stage, which is producing IndoVac’s primary series vaccines massively. At the first stage, Bio Farma plans to produce a maximum of 20 million doses of primary series vaccines, before this can be further increased to 40 million doses in 2023, as the company expands its production facilities.

In 2024, the company may further increase the volume to 100 million doses per year, depending on the demands and needs in the markets. Honesti said after the company has secured all the necessary permits, then IndoVac’s primary series vaccines “can be massively used by people aged 18 and above.”

Booster Vaccine and Vaccine for Children
At the same time, Bio Farma also started clinical trials for its booster vaccine on September 1, 2022. “We have secured approval for a clinical trial (PPUK) from BPOM for IndoVac booster vaccine,” Honesti said. Next, Bio Farma plans to conduct clinical trials for children after it secures PPUK from BPOM.

Bio Farma conducted clinical trials for its booster vaccine at Hasan Sadikin General Hospital (Faculty of Medicine of Padjajaran University, Bandung) and Dr. I.G.N.G Ngoerah General Hospital in Bali (Children’s Health Sciences Department, Udayana University). Trials involved 900 subjects aged 8 and above to test IndoVac’s booster vaccines.

BPOM requires vaccine manufacturers to conduct clinical trials to decide if a vaccine is safe and can boost immunity against Covid-19, and to determine whether the vaccine offers good efficacy to help protect the subjects from heavy symptoms and risks of fatalities due to Covid-19 infection.

All Covid-19 vaccines made by Bio Farma, including the primary series, booster vaccines and vaccines for children, will be labelled IndoVac. Bio Farma started the process of registering IndoVac as a brand name for Covid-19 vaccines at the Directorate General of Intellectual Property (DGIP) of the Ministry of Law and Human Rights on July 29.

President Joko Widodo gave the IndoVac name to the vaccine. “We are in the process of securing it. Should no-one object at this level, we will proceed to the next stage until we secure an IndoVac trade licence and patent from the ministry, as a product of Bio Farma,” Honesti said.

For Bio Farma, it is not the first time embarking on clinical trials. The company has conducted more than 30 clinical trials in Indonesia. This includes the Phase 3 clinical trials for the Covid-19 vaccine. Bio Farma also has experience in conducting clinical trials overseas for Pentabio and Novel Oral Polio Vaccine type 2 (nOPV2).

Made-in-Indonesia Vaccines
Honesti Basyir said IndoVac is special as one of the few made-in-Indonesia vaccine products. The vaccines (which include the primary series vaccines, the booster vaccines and vaccines for children) are developed and manufactured for nation’s children. Bio Farma handles the manufacturing process from upstream to downstream.

The local contents of IndoVac’s primary series vaccines, according to Bio Farma, will be around 80%. “This is a step closer to achieving independence in the health sector. With such a high proportion of local content, we expect to help reduce the nation’s dependency on imported vaccines. This will also impact foreign exchange reserves,” Honesti said.

In the long term, Bio Farma hopes to capture the export market with IndoVac vaccines. “We will not only produce them (the three types of vaccines) to meet domestic needs but also target the supply of global markets,” he said.

“We registered for Emergency Use Listing (EUL) with the World Health Organization (for primary series), so this vaccine can be used in other countries through the Covax Facility (multilateral procurement). Through its Covid-19 vaccines, Bio Farma expects to contribute to the health industry, not just in Indonesia, but also to the world.”

Bio Farma’s Success in Polio Vaccine

Honesti said apart from manufacturing Covid-19 primary series vaccines, which is currently waiting for the results of Phase 3 clinical trials and the EUA, Bio Farma has previously proven that it can secure the EUA from BPOM and the EUL from the WHO for its novel Oral Polio Vaccine type 2 (nOPV2).

The EUL, which is released by the WHO, is a procedure for assessing and listing vaccines during public health emergencies by non-vaccine-producing countries. As Indonesia hasn’t had any polio outbreaks since 2014, it never used nOPV2. The Bio Farma-manufactured vaccine was used by countries in Africa, Europe and the Middle East.

Among the countries that have used Bio Farma’s nOPV2’s vaccine are Algeria, Cameroon, the Democratic Republic of Congo, Djibouti, Ethiopia, Gambia, Ghana, Nigeria, Senegal, and Uganda. In Europe, the vaccine was used in Ukraine and in the Middle East, it was used in Israel, Egypt, Somalia and Yemen.

In the manufacturing of nOPV2 vaccine, Bio Farma collaborated with world-class research institutions like Bill and Melinda Gates Foundation (BMGF), PATH and the WHO. Bio Farma has become the main supplier for the polio vaccine in the world. The company currently contributes 67 percent to the global supply of polio vaccines. It distributes the vaccines via bilateral or multilateral means (through UNICEF).

Apart from producing polio vaccines, Bio Farma’s Laboratories have secured international acknowledgement as the reference labs to check samples of polioviruses. The world was previously waiting for two countries, Afghanistan and Pakistan, to combat polio diseases, before a ‘world-free polio’ can be declared. However, during the wait, polio outbreaks occurred in Africa and the Middle East.

The nOPV2 vaccine became an important product to prevent further spread of the polio disease. Bio Farma’s success in producing and exporting nOPV2 vaccine means that the Indonesian state-owned company has contributed to the world’s health sector, apart from providing the necessary polio vaccine for domestic use at home in Indonesia.

Media Contact:
R. Rifa Herdian
PT Bio Farma (Persero)
Corporate Secretary & Investor Relations
Tel: +62-81-2542-8844
Email: rifaherdian@biofarma.co.id

Avance Clinical Announces North American CRO Acquisition to Expand Later Phase Services for Biotechs

Avance Clinical, the Australian CRO for biotechs, has expanded into North America with the acquisition of CRO partner company C3 Research Associates, enabling biotech clients a seamless journey from early phase to later phase studies. Avance Clinical has backing from private equity group Riverside Company for their global expansion program.

Watch the video here: https://www.avancecro.com/avance-clinical-north-america-operations/

Avance Clinical is the largest and most established full-service Australian and New Zealand CRO with a proven track-record of data acceptance by the FDA and all other major regulatory bodies.

The combined Avance Clinical Australia, New Zealand, and North American operations deliver a unique GlobalReady drug development model for biotechs.

Avance Clinical’s CEO Yvonne Lungershausen said: “Avance Clinical has been working with C3 Research Associates in recent years and they share a similar culture and focus on customer service and clinical excellence. This strong relationship made C3 Research Associates a natural acquisition choice for Avance Clinical’s expansion plans into North America. The due diligence process has taken more than 6 months and we are excited to now welcome our US team and offer the GlobalReady model for our clients.

“This acquisition gives our biotech clients conducting their early phase studies in Australia and New Zealand a seamless journey into the US to continue their clinical development programs, retaining the same high-quality CRO, which reduces time and cost and delivers quality FDA-accepted data. This GlobalReady model is designed to extend biotechs’ investments so they can achieve greater clinical development milestones with reduced spend, all with the assurance of FDA accepted data.

“In addition, the attractive 43.5% rebate on clinical spend in Australia, offers our clients the opportunity to utilize our North American operations expertise and team, whilst maintaining services in Australia to maximise their rebate potential.

“We often point to the fact that there are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which again demonstrates Australian data acceptability with the FDA and other major regulatory authorities.

“We will be making significant investments in our US operations including growing the team to more than 120 people and leveraging their deep industry experience across a broad range of therapeutic areas, in particular oncology.

Clients can be assured the world-class best practice technologies, systems and processes will be integrated across all regions.”

This seamless GlobalReady journey is designed for success whereby 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 operationalise 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

The Avance Clinical team offers exceptional study approval and success rates which can be attributed to its deep scientific expertise, advanced data technologies, knowledge of the Australian, New Zealand and North American regulatory environment, and its extensive relationships with sites and KOLs.

The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which allows it to manage pre-clinical and clinical trials for vaccines and GMO therapies.

Avance Clinical’s has achieved high growth and industry-leading repeat business rates with its focus on gold standard technology paired with solution-orientated clinical experts. This is the mix that biopharma clients clearly require in this fast-moving, competitive and high-stakes sector.

Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Learn about the Australian Advantage here: https://www.avancecro.com/the-australian-advantage/
Meet the North American leadership team here: https://www.avancecro.com/avance-clinical-north-america-operations/
For more information about the benefits of running your next study with Avance Clinical contact us https://www.avancecro.com/contact-us/

About Avance Clinical
Avance Clinical is the largest premium full-service Australian CRO with operations across Australia, New Zealand and North America delivering quality clinical trials with globally accepted data 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 two years, has been providing CRO services in the region for 24 years.

Pre-clinical to Later Phase
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to later phase 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.

State-of-the-art 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 and Medrio are just some of the technology partners.

Media Contacts:
Avance Clinical
Chris Thompson
media@avancecro.com

Novotech at ESMO Congress 2022 – New Data Shows 100% Oncology Trials Growth in APAC

  • Meet the team at Booth #409

Novotech, the leading Asia Pacific biotech specialist CRO, will attend ESMO Congress 2022 with new data showing Asia Pacific has seen a 100% growth in oncology trials during 2017 to 2021 and contributes to more than a third of the global clinical development of immune-oncology drugs.

Novotech has experienced CRO operations across APAC and the US offering a unique and unparalleled suite of services for early to late phase biotech clinical research.

The clinical data compiled by GlobalData for Novoteoch also found that: “By the end of 2021 40% of active immuno-oncology clinical trials involved at least one location in the Asia-Pacific region, with majority of trials conducted in China, followed by Australia, South Korea, Japan and Taiwan. In the APAC region, the proportion of oncology trials doubled during 2017-2021. In China, the growth in oncology trials was associated with a significant increase in cancer incidence, development of innovative products by domestic companies, focus on immune-oncology, and leadership in cell therapy.”

Download the Reports Here:
IMMUNO-ONCOLOGY – ASIA PACIFIC – CLINICAL TRIAL LANDSCAPE https://novotech-cro.com/whitepapers/immuno-oncology-asia-pacific-clinical-trial-landscape
EVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5 https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5

According to Yooni Kim, Vice President, Global Clinical Services Novotech: “Asia-Pacific offers a compelling solution for expedited clinical trials with its vast patient populations, less competitive clinical trial landscape, and world-class KOLs, in addition, regulatory reforms have accelerated approval processes. Novotech’s service delivery model is tailored to the needs of biotech clients. Our local teams have exceptional site and investigator access, our project management approach emphasizes problem-solving, ownership and flexibility, and our investments in data and technology ensure clients have real-time access to trial performance.”

Novotech has recently been benchmarked as a top 10 CRO among the world’s leading CROs, and has signed 45 Leading Site Partnership agreements over the last 3 years.

About Novotech
Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact

Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

APAC Attracts 50% of Global Clinical Trials According to New GlobalData Report

Novotech, the leading Asia Pacific biotech specialist CRO has released new market data in a report now available titled “Evolution of Clinical Trials in the Asia Pacific Region”. The report was prepared by GlobalData and confirms that “the Asia-Pacific (APAC) region was the largest contributor to the global clinical trial landscape from 2017 to 2021, accounting for more than 50% of conducted trials during the analysis period.”

Download report here https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5

In addition, the GlobalData research found that all phases of clinical trials in the region registered higher growth than both the US and the EU5.

The region registered significantly higher growth than the US and the EU5 across all analysed therapeutic areas, including CNS diseases, cardiovascular diseases, gastrointestinal diseases, and infectious diseases, the latter of which witnessed the highest growth. There was also 100% growth in oncology trials during the same period.

GlobalData analysis of this strong growth has been linked to a range of factors, including:

  • site availability, particularly for oncology trials, when compared to the US and Europe
  • lower operating costs
  • the pharmacogenomic profile of Asian populations as a key factor that requires Phase I data in local populations.

“Add to the mix the ease of regulatory compliance as well as the high standards required, and overseas drugmakers have never been keener to access this burgeoning market,” according to GlobalData. “Recent streamlining of drug approval by the government, guided by the National Health Commission (NHC) and National Medical Products Administration (NMPA), has also resulted in a more efficient and clear-cut drug approval system based on global standards.”

According to Yooni Kim, Vice President, Global Clinical Services Novotech: “Asia-Pacific offers a compelling solution for expedited clinical trials with its vast patient populations, less competitive clinical trial landscape, and world-class KOLs, in addition, regulatory reforms have accelerated approval processes. Novotech’s service delivery model is tailored to the needs of biotech clients. Our local teams have exceptional site and investigator access, our project management approach emphasizes problem-solving, ownership and flexibility, and our investments in data and technology ensure clients have real-time access to trial performance. In addition, experienced CRO operations across APAC and the US offer a unique and unparalleled suite of services for early to late phase biotech clinical research.”

Novotech has recently been benchmarked as a top 10 CRO among the world’s leading CROs, and has signed 45 Leading Site Partnership agreements over the last 3 years.

About Novotech
Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact

Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427