Tag: Novotech Health Holdings Pte Ltd

Novotech, the leading Asia Pacific centred biotech CRO with extensive experience in vaccine trials, is convening an expert panel webinar covering the evolving landscape in vaccine development.

Register here https://webinars.endpts.com/keeping-pace-with-the-evolving-global-landscape-in-vaccine-development/

Between 2017 and 2021, there were close to 1,400 industry-sponsored single country vaccine based clinical trials globally, with the Asia Pacific involved in over 45% of the trials. Download our latest data report here: Vaccines – Asia Pacific Clinical Trial Landscape. https://novotech-cro.com/whitepapers/vaccines-asia-pacific-clinical-trial-landscape

The webinar, Keeping pace with the evolving global landscape in vaccine development, will hear from a panel of life science experts on the latest advancements and innovative modalities paving the way in the global vaccine development space including:

• The COVID-19 impact on drug development and the regulatory landscape.
• Key factors contributing to Asia Pacific being recognised as the hub for vaccine development and opportunities for biotech’s to leverage.
• Key considerations for pre-clinical and clinical planning to accelerate vaccine development, supporting a robust global strategy.

Date/Time: March 09 11:00 am – 12:00 pm EST
Register here https://webinars.endpts.com/keeping-pace-with-the-evolving-global-landscape-in-vaccine-development/

Panelists:
SUSHANT SAHASTRABUDDHE
ASSOCIATE DIRECTOR GENERAL, INTERNATIONAL VACCINE INSTITUTE (IVI)
Dr. Sushant Sahastrabuddhe, Associate Director General at the International Vaccine Institute (IVI), joined in July 2010, leading the clinical trials of IVI’s typhoid vaccine and process to achieve its licensure, the global clinical development of and licensure of SK bioscience’s COVID-19 vaccines and Phase 1 and 2 trials of Bharat Biotech’s Chikungunya vaccine. As a vaccine enthusiast with more than 17 years of experience in multiple countries across diverse projects, he continues to lead collaborative efforts with companies and partners in Korea, India and globally to get these vaccines through early- to late-stages of their clinical development. Dr. Sahastrabuddhe is also the Associate Editor for Vaccines for tropical diseases and associated with Yonsei University as Research Professor and with Universite Claude Bernanrd, Lyon France as Research Fellow. In 2021, Dr. Sahastrabuddhe was named an ‘Honorary Citizen of Seoul’ for his contributions to the joint efforts with Korean companies and international partners to develop vaccines against COVID-19 and other diseases.

PAUL GRIFFIN
ASSOCIATE PROFESSOR, INFECTIOUS DISEASES PHYSICIAN, MICROBIOLOGIST, UNIVERSITY OF QUEENSLAND
An Infectious Diseases Physician and Microbiologist, Dr. Paul Griffin was appointed as the Director of Infectious Diseases at Mater Health Services in 2013 and continues an appointment as an Associate Professor of Medicine at the University of Queensland Medical School. Additionally, Dr. Griffin chairs the Advanced Training Committee in Infectious Diseases with the Royal Australasian College of Physicians, the committee that oversees the training of Infectious Diseases specialists in Australia.
Previously, Dr. Griffin was the Principal Investigator (PI) and Medical Director at Nucleus Network, a contract research organization specializing in infectious diseases trials, which included a PI role on in excess of 125 clinical trials predominantly in Infectious Diseases including novel vaccines and COVID-19 vaccines. With fellowships in Infectious Diseases from the Royal Australasian College of Physicians, in Clinical Microbiology from the Royal College of Pathologists of Australasia and from the Australasian College of Tropical Medicine, Dr. Griffin has an active interest in vaccine education and advocacy and has become a trusted media authority and spokesperson across the nation during the COVID-19 pandemic.

BABAJI YADAV
SENIOR CONSULTANT, NOVOTECH DRUG DEVELOPMENT CONSULTING
Babaji Yadav is a Senior Consultant with over eight years of academic experience in pre-clinical oncology drug development and eight years of industry experience in drug development. Babaji has a strong background in pharmaceutical sciences with a Ph.D. in Pharmacology and Toxicology from the University of Otago, New Zealand. Previously he has worked as a Research Project Manager to oversee IND-enabling toxicology studies for lead oncology drugs and, prior to joining Novotech, was a Clinical Project Manager for early-phase oncology trials. Babaji is a UK Registered Toxicologist and at Novotech he is focused on providing technical toxicology advice and product development strategies to facilitate the entry of client’s compounds into clinical trials. Babaji has experience in small molecules, combination products, and biologicals including vaccines, proteins, monoclonal antibodies, and advanced cell and gene therapies.

JENNIFER ARELLANO
DIRECTOR OF CLINICAL SERVICES (PHILIPPINES), NOVOTECH
Jennifer Arellano is the Director of Clinical Services in the Philippines with over 25 years of technical and leadership experience in managing clinical trial operations for sponsors and CROs. With a Bachelor of Industrial Pharmacy from the University of the Philippines and a Pharmacist license, Jennifer’s research operations experience includes monitoring, auditing, project leadership, feasibility, study start-up, driving inspection readiness and hosting regulatory inspection, client engagement and business development, learning & development and organization SOP development/review. Jennifer has contributed to the transformation of the Philippine clinical research industry – bringing improvement to the local clinical research regulations and practices and is the founding President of a non-profit organization, the Philippine Clinical Research Professionals Inc, with more than 400 members from pharmaceutical and CROs, and has more recently, volunteered pro-bono services during the Covid-19 pandemic to provide trial management consultancy to the Philippine DOH-funded trials such as WHO Solidarity COVID-19 Treatment and Vaccine trials, Avigan COVID-19 treatment trial, and Philippine Heart Association funded cardiovascular outcome study.

Novotech has recently acquired EastHORN, a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent. The acquisition is part of Novotech’s global expansion program in Europe and the US.

Novotech has recently been benchmarked as a top 10 CRO among the world’s leading CROs, is the recipient of the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence award and the Asia-Pacific Contract Research Organization Company of the Year Award, and has signed 45 Leading Site Partnership agreements over the last 3 years.

Novotech offers biotechs a unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials.

About Novotech (Novotech-CRO.com)
Novotech is internationally recognized as the leading Asia Pacific centred biotech Contract Research Organization (CRO) with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 2,700 staff working across offices in 20 geographies. 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, the leading Asia Pacific centred biotech CRO, has published a new global report on Phase 1 trial activity including current metrics on fast growth regions and therapeutic areas. The data analysis found that Asia Pacific has been the fastest-growing region for Phase 1 trials in the last ten years, reaching a share of 58% in 2022, with China leading the Phase I trials globally.

According to the report, titled “Phase I Global Clinical Trial Landscape – Focus on Asia Pacific”, in 2022 Asia Pacific accounted for a 58% share of the approximately 3,600 Phase I trials initiated globally in 2022. The report found that Asia Pacific has been the fastest growing region for Phase 1 trials in the last ten years with a 10Y CAGR of 18%. Between 2018 and 2022, the region has had consistent performance and has been maintaining its majority share since 2018, with a peak of 61% share achieved in the year 2021. Mainland China, Australia, South Korea, Japan and India were the top five Asian locations, and together contribute over 50% of the global phase I trials.

One of the key reasons why Asia Pacific is in demand is that it has the shortest patient enrolment duration and fastest recruitment rate. Asia Pacific region has a much wider patient base which expedites the patient time recruitment process and shortens the trial duration enabling initiation and completion of trials.

The report found that Asia Pacific also leads phase I trials across the top therapeutic areas. Oncology, infectious disease, CNS, cardiovascular and metabolic disorders are the top therapeutic areas of Phase I trials across the top Asian locations of China, Australia, South Korea, Japan and India. Of all the five locations put together, China occupies the major share (>80%) of phase I trials in all the top therapeutic areas considered together.

View “Phase I Global Clinical Trial Landscape – Focus on Asia Pacific”, the new report, on this link: https://tinyurl.com/novotech-global-report

See the report for Phase 1 location and therapeutic area analysis including:
– IMMUNOMODULATORY THERAPY
– IMMUNO-ONCOLOGY
– ADOPTIVE CELL THERAPY
– ALLOGENIC, AUTOLOGOUS, STEM CELL AND REGENERATIVE MEDICINE
– DNA AND RNA
– VACCINES
– MULTI-SPECIFIC MONOCLONAL ANTIBODY
– MICROBIOME

Cell & Gene
The latest data also shows Asia Pacific is the fastest-growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies, with China leading in the region. The region already accounts for over a third of cell & gene therapy trial activity and shows a nearly 50% faster growth rate in cell & gene therapy trials compared to ROW between 2016 and 2021. China shows a 15% faster growth rate than the ROW. After oncology, the majority of cell & gene trials are in infectious diseases, CNS, and cardiovascular diseases. In addition, the Asia Pacific is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022.

European expansion – global footprint
Novotech offers a unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials. Novotech recently acquired EastHORN, a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent. The acquisition is part of Novotech’s global expansion program in Europe and the US.

Award recognition
Novotech has recently been benchmarked as a top 10 CRO among the world’s leading CROs, has been awarded the Asia-Pacific Cell & Gene Therapy Clinical Trials Excellence award and selected for the Asia-Pacific Contract Research Organization Company of the Year Award. The company has signed 45 Leading Site Partnership agreements over the last 3 years.

View “Phase I Global Clinical Trial Landscape – Focus on Asia Pacific”, the new report, on this link: https://tinyurl.com/novotech-global-report

About Novotech (Novotech-CRO.com)
Novotech is internationally recognized as the leading Asia Pacific centred biotech Contract Research Organization (CRO) with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 2700 staff working across offices in 20 geographies. 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, the leading Asia Pacific focused biotech specialist CRO and recipient of the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence award, said the number of cell & gene therapy trials in the region was growing 50% faster than ROW. The majority of trials are in oncology, specifically for blood cancers, viral infections, and solid tumors.

Novotech, which has extensive experience in cell & gene therapy clinical trials, is sponsoring the 6th Annual Cell And Gene Therapy Innovation Summit in Berlin, Germany (15-16 February 2023).

The company recently acquired EastHORN, a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent. The acquisition is part of Novotech’s global expansion program in Europe and the US.

The acquisition means biotech clients can access Novotech’s unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials.

The latest data shows Asia Pacific is the fastest-growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies, with China leading in the region.

The region already accounts for over a third of cell & gene therapy trial activity and shows a nearly 50% faster growth rate in cell & gene therapy trials compared to ROW between 2016 and 2021. China shows a 15% faster growth rate than the ROW. After oncology, the majority of cell & gene trials are in infectious diseases, CNS, and cardiovascular diseases.

In addition, the Asia Pacific is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022.

Novotech CEO Dr. John Moller said: “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 been benchmarked as a top 10 CRO among the world’s leading CROs, selected for the Asia-Pacific Contract Research Organization Company of the Year Award, and has signed 45 Leading Site Partnership agreements over the last 3 years.

Download our latest data report:
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-CRO.com)
Novotech is internationally recognized as the leading Asia Pacific centred biotech Contract Research Organization (CRO) with global execution capabilities.

Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 2,700 staff working across offices in 20 geographies. For more information visit https://novotech-cro.com/contact

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

Novotech announced today the acquisition of EastHORN, a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent. The acquisition is part of Novotech’s global expansion program. EastHORN was established in 2004 and has over 250 employees.

The acquisition means biotech clients can access Novotech’s unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials.

Novotech CEO Dr. John Moller said: “This acquisition is a strategic move to further expand our CRO operations and provide biotech clients with in-country expertise across Asia-Pacific, North America, and Europe to deliver their global drug development programs. EastHORN and Novotech have been working together for many years and we share a culture of clinical excellence in biotech drug development. EastHORN which is retaining its brand, is now a Novotech company and will be integrated into our systems and processes so clients benefit from working with one CRO globally. Clients can now access our exceptional European infrastructure, local knowledge, site relationships and access to diverse patient populations.”

EastHORN Executive Chairman Iain Gordon said: “I first started working on clinical projects with Novotech 15 years ago and have always been impressed by the quality of their services and their client-focused approach. EastHORN has been working closely with Novotech for over a decade now and have many friends within the Novotech team. This is a natural next step for our group and my colleagues and I are excited to become part of Novotech’s global operations to support biotech clients’ clinical programs. In particular, we can now offer our clients access to Novotech’s team of experts across Asia-Pacific and the US including project management, regulatory, clinical, medical and biometrics, while our team’s European expertise can advance clinical development in Europe for Novotech clients. We work with similar-sized biotechs and small to mid-size pharma companies and have experience across the same therapeutic areas, so this is an excellent cultural and strategic fit.”

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 combines to deliver an exceptional full-service biotech CRO solution.

Novotech has recently been recognised with significant CRO awards including the Asia-Pacific Biotech CRO of the Year by Frost & Sullivan, benchmarked as a top 10 CRO among the world’s leading CROs, 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 centred biotech CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. Novotech is well-positioned to serve biotech clients conducting clinical trials in Asia-Pacific, the US, and Europe. 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

• Expands Drug Development and FDA Regulatory Expertise

Novotech, the leading Asia Pacific-centered biotech CRO today announced the acquisition of CBR International, a global product development, clinical oversight and strategic regulatory operations group.

CBR was founded in 2002 as a consultancy company focused on assisting biotechnology and pharma companies navigate FDA requirements from early-stage development through to approval. CBR adds a group of experts to Novotech to provide US and global regulatory, scientific, quality, and clinical development services. CBR’s specific regulatory expertise and services include long-range Regulatory Strategy and Writing, FDA Representation, eSubmissions, and Scientific Affairs to support requirements for cGMP commercial product development.

The acquisition will further strengthen Novotech’s capabilities in regulatory strategy and US FDA interactions and submissions including IND, IDE, NDA, BLA, Fast-Track, Break-through, and Orphan Drug Applications.

Novotech CEO Dr. John Moller said: “CBR will provide decades of FDA regulatory experience for our biotech clients. They have experience across all product types and are highly regarded for their IND expertise having managed approximately 80 INDs through all phases of development. This acquisition, together with Novotech’s existing regulatory affairs capability, creates a large global group of experts in toxicology, drug development, and global regulatory submissions support. This regulatory expertise benefits our US, European, and Asia Pacific biotech clients as they progress through the US clinical environment and navigate often complex FDA requirements.”

CEO and Founder of CBR, Dr. Jeanne Novak said: “We are extremely pleased to be joining a company the size and calibre of Novotech which brings global demand for our regulatory expertise. The US is an important region for global biotech and pharma companies as part of their clinical program development. We have the experience and track-record of directly supporting US approvals for over 10 programs. Navigating novel product development and achieving multiple approvals has built our expertise to support the complex development needs of clients worldwide which will now support Novotech clients. We look forward to working with Novotech clients to support their drug development programs in the US and globally. We are excited to continue working with our clients and bringing Novotech expanded services to our colleagues.”

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 combines to deliver a specialist full-service biotech CRO solution.

Novotech has recently been recognised with significant CRO awards including the Asia-Pacific Biotech CRO of the Year by Frost & Sullivan, benchmarked as a top 10 CRO among the world’s leading CROs, 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 centered biotech CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. Novotech is well-positioned to serve biotech clients conducting clinical trials in Asia-Pacific the US, and Europe. 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, the Asia Pacific centered biotech specialist CRO is proud to be Gold Sponsor at Biotech Showcase 2023. Novotech CEO Dr. John Moller and experts from the Novotech US and Asia Pacific teams will be attending the conference.

Meetings can be scheduled via the PartneringOne portal. https://informaconnect.com/biotech-showcase/partnering/

Novotech will share the Asia Pacific advantages for expedited clinical trials, where biotechs have access to Novotech’s vast patient populations, strong local regulatory knowledge, extensive site and KOL networks, and reputation for data quality.

Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions in Asia Pacific delivering exclusive benefits for sponsors.

The latest industry research publication by GlobalData and Novotech found almost 50% of new trials globally have sites in Asia Pacific. According to the new publication titled “State of the Global Biotech Landscape: Where the Opportunities Lie”, demand for Asia Pacific trial sites is strong with almost half of the more than 27,000 clinical trials initiated in 2021 having sites in Asia Pacific. The data shows almost 12,900 of the new trials had sites in Asia Pacific.

Download the report here https://novotech-cro.com/whitepapers/state-global-biotech-landscape-where-opportunities-lie

The report also noted that the Asia Pacific region, which has more than 6,772 trial sites each with access to an average of 2,136 million people, has considerable underutilized capacity presenting an opportunity for growth in multinational trials in the region.

Novotech this month was awarded the Frost & Sullivan Company of the Year Award 2022 for Best Practices in the Asia-Pacific contract research organization industry. Novotech has been a recipient of the Frost & Sullivan Asia Pacific Best Practices awards since 2006.

Frost & Sullivan said: “Our approach involves the deployment of best practices and strategic analytics across a value chain. Against this backdrop, Frost & Sullivan recognizes Novotech for its valuable achievement. Novotech addresses the global drug development market’s unmet needs with a strong leadership focus that incorporates client-centric strategies with best-practice implementation. From feasibility assessments to regulatory submission support, data management, medical monitoring, and project management, the company provides a 360-degree approach to drug development for its biotech clients.”

Novotech also recently produced a new publication for biotechs considering China for their clinical research, and the relevant processes required for global regulatory approvals. The report details regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful US FDA approval pathway. Novotech provides the relevant regulatory knowledge and drug development pathways specifically designed to support the US FDA approval process, avoiding delays and additional costs.

Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approval

Novotech has also 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.

About Novotech – https://novotech-cro.com
Novotech is internationally recognized as the leading Asia Pacific centred contract research organization (CRO) with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services. It has accumulated experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia, the US and globally. Novotech has over 2500 staff working across our offices in 13 geographies. 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, the Asia Pacific centered biotech specialist CRO said the latest industry research publication by GlobalData and Novotech found almost 50% of new trials had sites in Asia Pacific.

According to the new publication titled “State of the Global Biotech Landscape: Where the Opportunities Lie”, demand for Asia Pacific trial sites is strong with almost half of the more than 27,000 clinical trials initiated in 2021 having sites in Asia Pacific. The data shows almost 12,900 of the new trials had sites in Asia Pacific.

Download the report here https://novotech-cro.com/whitepapers/state-global-biotech-landscape-where-opportunities-lie

The report also noted that the Asia Pacific region, which has more than 6,772 trial sites each with access to an average of 2,136 million people, has considerable underutilized capacity presenting an opportunity for growth in multinational trials in the region.

In addition, analysis of trial growth trends found that Asia Pacific has also seen high phase-level growth over the 5-year analysis period to 2022.
– Phases I and II were dominated by Asia Pacific, which served as a trial location in 57% and 49% of trials, respectively.
– US and EU remained stable at approximately 20% at phases I through III.
– RoW representation is low in phases I and II but on par with the US and EU in phase III.

Novotech this month was awarded the Frost & Sullivan Company of the Year Award 2022 for Best Practices in the Asia-Pacific contract research organization industry. Novotech has been a recipient of the Frost & Sullivan Asia Pacific Best Practices awards since 2006. Frost & Sullivan identifies companies that consistently develop growth strategies based on a visionary understanding of the future, and effectively address new challenges and opportunities.

Frost & Sullivan said: “Our approach involves the deployment of best practices and strategic analytics across a value chain. Against this backdrop, Frost & Sullivan recognizes Novotech for its valuable achievement. Novotech addresses the global drug development market’s unmet needs with a strong leadership focus that incorporates client-centric strategies with best-practice implementation. From feasibility assessments to regulatory submission support, data management, medical monitoring, and project management, the company provides a 360-degree approach to drug development for its biotech clients.”

In response to the Company of the Year Award announcement, Novotech CEO Dr. John Moller said this award is a credit to our entire global team which has decades of biotech drug development experience. “Our global clients benefit from access to our expert teams in Asia Pacific, which is the fastest-growing clinical trial region, due to its vast patient populations and sophisticated medical research infrastructure. Our consistent investment in advanced training and technology systems combine to deliver a specialist full-service biotech CRO solution.”

Novotech also recently produced a new publication for biotechs considering China for their clinical research, and the relevant processes required for global regulatory approvals. The report details regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful US FDA approval pathway. Novotech provides the relevant regulatory knowledge and drug development pathways specifically designed to support the US FDA approval process, avoiding delays and additional costs.

Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approval

Novotech has also 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 delivering exclusive benefits for sponsors.

About Novotech – https://novotech-cro.com
Novotech is internationally recognized as the leading Asia Pacific centred contract research organization (CRO) with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services. It has accumulated experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia, the US and globally. Novotech has over 2500 staff working across our offices in 13 geographies. For more information visit https://novotech-cro.com/contact

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

Novotech, the leading Asia Pacific biotech specialist CRO, has been awarded the Frost & Sullivan Company of the Year Award 2022 for Best Practices in the Asia-Pacific contract research organization industry. Novotech has been a recipient of the Frost & Sullivan Asia Pacific Best Practices awards since 2006.

Frost & Sullivan identifies companies that consistently develop growth strategies based on a visionary understanding of the future, and effectively address new challenges and opportunities.

Frost & Sullivan said: “Our approach involves the deployment of best practices and strategic analytics across a value chain. Against this backdrop, Frost & Sullivan recognizes Novotech for its valuable achievement. Novotech addresses the global drug development market’s unmet needs with a strong leadership focus that incorporates client-centric strategies with best-practice implementation. From feasibility assessments to regulatory submission support, data management, medical monitoring, and project management, the company provides a 360-degree approach to drug development for its biotech clients.”

In response to the Company of the Year Award announcement, Novotech CEO Dr. John Moller said this award is a credit to our entire global team which has decades of biotech drug development experience.

“Every day our team supports biotech companies in their drug development programs with unparalleled regulatory knowledge, vast site and investigator networks, technology-driven clinical data management, and a project management approach focused on problem-solving, ownership, and flexibility. Our global clients benefit from access to our expert teams in Asia Pacific, which is the fastest-growing clinical trial region, due to its vast patient populations and sophisticated medical research infrastructure. Our consistent investment in advanced training and technology systems combine to deliver a specialist full-service biotech CRO solution.”

Novotech regularly produces expert reports on East-West strategies. A new publication is now available for international biotechs considering China for their clinical research, as well as China biotechs conducting research in China, and the relevant processes required for global regulatory approvals.

The report details regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful US FDA approval pathway. Novotech can provide the relevant regulatory knowledge and drug development pathways specifically designed to support the US FDA approval process, avoiding delays and additional costs.

Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approval

Novotech has also 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 delivering 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, the leading Asia Pacific biotech specialist CRO, is sponsoring BioCentury-BayHelix East-West Summit 2022, and Novotech’s Chief Commercial Officer Barry Murphy is Session Chair for the expert panel on How to Build and Finance an East-West MRCT Strategy Workshop at the Summit (14-16 November 2022).

Novotech is sponsoring the Networking Reception and Dinner.

Workshop details:
Global Development Workshop: How to Build and Finance an East-West MRCT Strategy
November 15, 2022
2:30 PM – (PACIFIC TIME ZONE)
BioCentury-BayHelix East-West Summit 2022
https://conferences.biocentury.com/china-healthcare-summit/schedule

Panelists are:

• PATRICIA KEEGAN, M.D.: Chief Medical Officer, Junshi Biosciences
• KE LIU, M.D., PH.D.: Chief Development Officer, Marengo Therapeutics
• ROGER LUO, PH.D.: Chief Development Officer, Overland Pharmaceuticals
• PEONY YU, M.D.: Chief Medical Officer, Apollomics Inc.

Novotech has significant real-world experience in East-West MRCT strategy after more than 2 decades managing clinical research programs for biotechs across Asia Pacific and the US.

Commenting on Novotech’s experience, Chief Commercial Officer Barry Murphy said the right drug development pathway supports investor attraction and a successful clinical program.

“Local regulatory knowledge and expertise will accelerate early clinical programs, while a global perspective with a focus on US FDA and NMPA requirements, will support key market approvals. Strategies for an East-West MRCT include:

• Companies should engage with the US FDA and NMPA early to confirm guidance on their clinical roadmap.
• Biopharma companies should take advantage of China’s revised regulatory framework around acceptance of foreign clinical trials data for drug approval, making it easier for foreign companies to enter the Chinese market.
• For biopharma companies looking to enter China, China’s pharmaceutical market has advantages such as conducting first-in-human trials (FIH) and utilization of overseas clinical trial data for clinical trial application (CTA) filing, leveraging expedited clinical development pathways for accelerating the approval process; implementation of the Marketing Authorization Holder (MAH) system, favourable government policies to enhance domestic and global innovation encourages foreign direct investments (FDIs) in R&D that benefit the overseas companies.

Novotech regularly produces expert reports on East-West strategies. A new publication is now available for international biotechs considering China for their clinical research, as well as China biotechs conducting research in China.

The report details regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful US FDA approval pathway. Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approval

Novotech, with experienced clinical teams in China and the US, can provide the relevant regulatory knowledge and drug development pathways specifically designed to support the US FDA and NMPA approval process, avoiding delays and additional costs.

Novotech has operations across the Asia Pacific and the US offering a unique and unparalleled suite of CRO services for early to late-phase biotech clinical research. The company 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
communications@novotech-cro.com

Novotech, the leading Asia Pacific biotech specialist CRO, and GlobalData have published the latest China biotech landscape analysis with expert guidance on pathways to USFDA approval for biotechs conducting research in China.

Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approval

The report was prepared for international biotechs considering China for their clinical research, as well as China biotechs conducting research in China, and the relevant processes required for USFDA approvals.

Novotech’s Vice President, Global Head of Clinical Services Dr. Yooni Kim said: “China presents exceptional clinical opportunities with vast populations and word-class research facilities and KOLs. This concise analysis of the pathway to USFDA approval expertly informs clinical stage biotechs about the China research benefits and how to manage any challenges. The report details the regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful USFDA approval pathway. Novotech, with experienced clinical teams in China and the US, can provide the relevant regulatory knowledge and drug development pathways specifically designed to support the USFDA approval process, avoiding delays and additional costs.”

The key learnings from the report are:

• Companies should engage with the USFDA early and formally to confirm guidance on their clinical roadmap.
• China’s clinical development regulations are aligned with the USFDA regulations and present significant benefits for biopharma companies.
• Biopharma companies should take advantage of China’s revised regulatory framework around acceptance of foreign clinical trials data for drug approval, making it easier for foreign companies to enter the Chinese market.
• For biopharma companies looking to enter China, China’s pharmaceutical market has advantages such as conducting first-in-human trials (FIH) and utilization of overseas clinical trial data for clinical trial application (CTA) filing, leveraging expedited clinical development pathways for accelerating the approval process; implementation of the Marketing Authorization Holder (MAH) system, favorable government policies to enhance domestic and global innovation encourages foreign direct investments (FDIs) in R&D that benefit the overseas companies.
• Chinese biotech companies can enter developed markets in the US and Europe through strategic partnerships or by setting-up their own operations in these markets.

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