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Gain Cutting Edge Perspective from Experts on Clinical Trial Strategy and Management
Here is how Navitas Life Sciences Defines Key Aspects on Building a resilient Future
Recent publications include powerful insights from our team of experts at Navitas Life Sciences, with ideas gained from vast experience, and a pulse on the latest in clinical trial management. The result? a cutting-edge perspective, supported by the deep domain experience of our experts. Such insights have been leveraged to promote ideas and solutions to cope with the ever-evolving clinical trial ecosystem, with the aim of boosting clinical trial operations and supporting efficient market reach of life saving medicines.
Here are a few recent articles published by experts at Navitas Life Sciences that highlight the perspectives of key opinion leaders:
1. Key trends in Biologics and Biosimilars Market in 2021
Dr. Ayaaz Hussain Khan, Managing Director, Global Head-Generics, Navitas Life Sciences, provides key trends that will drive global growth in the biosimilar and biologics market in the article titled “BIOLOGICS AND BIOSIMILARS MARKET: Key trends in 2021” published in Issue 44 of Pharma Focus Asia.
“The Global Biosimilars Market is estimated to reach US$240 billion by 2030, with the Indian market at US$35 billion. The considerable increase in reference products, with the USFDA adding 90 molecules and India approving 70 biosimilars, promises to usher in further growth.
The Biopharma industry seems keen on investing in the biosimilar market with a focus on improving healthcare and health care costs for diseases of interest like COVID-19, cancer, immunologic diseases, and diabetes.
This is evident in the projected growth of the oncology biosimilar market at 17 per cent CAGR, and the growing demand and importance of monoclonal antibodies such as tocilizumab, sarilumab, and itolizumab for testing on COVID-19 patients.”
Dr. Ayaaz Hussain Khan
Managing Director,
Global Head-Generics,
Navitas Life Sciences
BIOLOGICS AND BIOSIMILARS MARKET: Key trends in 2021
Pharma Focus Asia- Issue 44, September 2021
2. Defining effective Solutions for Clinical Trial Management Beyond COVID-19
Ms. Sowmya Kaur, Executive Vice President, Navitas Clinical Research and Head of Clinical – APAC for Navitas Life Sciences, explores 5 landmark solutions that were woven into the existing clinical trial fabric, with agility and innovation, to strengthen processes and make it relevant to current needs and beyond, in the article titled “Overcoming the challenges of COVID-19” published in Applied Clinical Trials Magazine Volume 30, July/August, 2021.
“There were considerable, dynamic changes to clinical trial management during the start of the COVID-19 pandemic to cope with the movement restrictions and the risk of infection. Logistical challenges were rapidly solved using technological prowess and digital tools, forcing the pharmaceutical industry to view clinical trial operations in a new light”
Ms. Sowmya Kaur,
Managing Director,
Executive Vice President,
Navitas Clinical Research and Head of Clinical – APAC
Navitas Life Sciences
Overcoming the challenges of COVID-19
Applied Clinical Trials Magazine Volume 30, July/August, 2021
3. Insights for First-time-Right Submissions
Mr. Balaji A, Manager of Regulatory Operations, Navitas Life Sciences, explores the quest for First-Time-Right Submissions to the Health Authorities (HA) by pharmaceutical companies, in his article titled “Electronic Automation and Process Optimization for First-Time-Right Submissions” published in Express Pharma magazine, Volume 16, July, 2021.
“We know that the publishing process is complex, with pharmaceutical companies using various publishing tools to both compile and publish documents in eCTD, NeeS, and paper formats as specified by the HAs.
In our experience, some 70%+ of small to medium companies are still following a manual process to process and add documents to the Document Management System (DMS) and, subsequently to the Publishing tool. This is not only time consuming, but it also expends additional efforts both pre and post publishing.”
Mr. Balaji A,
Manager of Regulatory Operations,
Navitas Life Sciences
Electronic Automation and Process Optimization for First-Time-Right Submissions
Express Pharma magazine, Volume 16, July, 2021
4. Empowering Clinical Trial Design with Innovation
Ms. Sowmya Kaur, Executive VP, Navitas Clinical Research and Head of Clinical – APAC, Navitas Life Sciences and Dr. Atul Gupta, Associate Vice President Medical Monitoring, Navitas Life Sciences explore new age ideas in the article titled “Innovative Trial Designs”, published in issue 43 of Pharma Focus Asia.
“The median investment to bring a new drug to market is estimated at $985 million, which is expected to rise further in the current COVID-19 era. To improve efficiency of clinical trials, lower costs and enhance data quality while ensuring patient access to new treatments, the drug development industry is pursuing new seamless approaches to clinical trial design.
The innovative approach to contemporary clinical trial designs like integrated trials, basket trials, therapeutic repurposing during the trial etc. will not only optimize the cost and speed but will inspire both investigators and pharmaceutical companies for cutting-edge scientific discoveries.”
Ms. Sowmya Kaur,
Executive VP,
Navitas Clinical Research and
Head of Clinical – APAC
Navitas Life Sciences
Dr. Atul Gupta,
Associate Vice President
Medical Monitoring,
Navitas Life Sciences
Innovative Trial Designs
Pharma Focus Asia, Issue 43, June 2021
5. Focusing on Accelerated Drug Approvals from a Regulatory Perspective
Mr. Velkumar Kuzhandhaipandian, Manager, Regulatory Operations, explores the 11 most common mistakes while applying for drug approval and what applicants can do to prevent them from occurring in the article titled “Regulatory Support for Accelerated Drug Approvals” and published in Published by BioSpectrum, 15 July, 2021.
“In the process of product registration, one of the main concerns for the pharmaceutical industry across the globe is to keep their dossier updated with current regulation for quicker approval of new product registration and product license maintenance.
Marketing Authorization Holders (MAHs) have a responsibility to submit the dossier as per the current regulatory requirements, where regulatory intelligence and competitive regulatory strategy play a key role in achieving the rapid approval of products in a specific country.”
Velkumar Kuzhandhaipandian,
Manager, Regulatory Operations,
Navitas Life Sciences
Regulatory Support for Accelerated Drug Approvals
BioSpectrum, 15 July, 2021
6. A closer look at Labelling
Ms. Tris Nockles, Labeling Networks Lead, Navitas Life Sciences explores how labeling teams are responding and positioning themselves to lead into the future, to not just survive, but to thrive in an environment where they are constantly required to do more with less. In this article titled “Future Ready Labeling – How to Thrive and Survive” and published in Express Pharma Volume 16, May, 2021, our expert discusses five trends that are critical to the future success of labeling.
“Labeling continues to grow in terms of delivering value for patients, prescribers, and industry. Demands on labeling are continuing to expand exponentially with the COVID-19 pandemic only adding another level of complexity.
As the public’s interest in drugs, treatments, and medications increases, now more than ever, labeling is playing a critical role in public health and must be well managed and future ready.”
Tris Nockles,
Labeling Networks Lead,
Navitas Life Sciences
Future Ready Labeling – How to Thrive and Survive
Express Pharma Volume 16, May, 2021
7. Technological Innovations in Clinical Data Management
Mr. Shrishaila Patil, Vice President of Statistical Programming, Navitas Data Sciences, explores latest technological innovations in the article titled “The 7 key technology enablers in new age Clinical Data Management” published in the BioSpectrum India, Volume 19, July, 2021.
“Advances in technology coupled with the complexity of clinical trials and the acceleration of decentralized trials necessitate the need to move away from the traditional towards more advanced Clinical data science processes.”
Mr. Shrishaila Patil,
Vice President Statistical Programming,
Navitas Data Sciences,
a part of Navitas Life Sciences
The 7 key technology enablers in new age Clinical Data Management
BioSpectrum India, Volume 19, July, 2021
Pharmaceutical companies have their own map of growth, but this risks becoming outdated soon if they do not follow the changing patterns and trends. Experts at Navitas Life Sciences help pharmaceutical companies, small to large, rethink their strategies and evolve successfully to aid in relevant growth. Partnering with Navitas Life Sciences can help to unlock new facets of growth through innovation in clinical trial management.
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