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Vaccine development process is safe, claims of the contrary are baseless

All of our lives have been drastically impacted by the ongoing coronavirus pandemic — and we know all of us are eager to return to the way things were before the pandemic began. However, that simply won’t be possible without a safe, effective vaccine. Fortunately, due to the strength of American innovation and unprecedented public-private partnerships, a COVID-19 vaccine is on the horizon. We, as the top Republican on the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee and a physician on the Energy and Commerce Health Subcommittee, have been closely following our nation’s progress — and we are confident that we will have a safe, effective vaccine soon.

On July 21, 2020, the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee held a hearing on vaccine development. The subcommittee heard from AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer. All five companies are working on various vaccines and therapeutics for COVID-19 and have received federal funding. Moderna, Pfizer, AstraZeneca, and Johnson & Johnson are all now conducting “phase 3” clinical trials for their COVID-19 vaccine candidates, which is the last stage of testing prior to regulatory approval. AstraZeneca and Johnson & Johnson both recently paused their studies to examine an illness in one of the participants. This is standard protocol, and should give us even more confidence that vaccine companies are following standard safety procedures in their trials — not rushing through the process.

Currently, the Trump administration is working with many pharmaceutical companies to assist in two ways: To advance research and development and to ensure that when a COVID-19 vaccine is approved for safety and efficacy, it is ready to be shipped and distributed across the United States. 

Through “Operation Warp Speed” and the “Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)” partnership, the federal government is doing everything it can to ensure that the private companies developing a vaccine have the resources they need. This assistance is also helping companies to begin establishing manufacturing capability and to initiate the purchasing of necessary raw materials including glass vials for packaging and needles and syringes for the administration of the vaccines. These programs are also facilitating the condensing of the regulatory timeline. For example, the government is currently providing financial support to a number of companies to allow for simultaneous development and production of a vaccine before it receives final approval from the Food and Drug Administration (FDA). Usually, companies will not begin to invest in producing a vaccine or treatment until it has first completed testing and received regulatory approval. We need to ensure that any COVID-19 vaccine is available as soon as it receives the final approval from the FDA.

All five companies assured the subcommittee that any vaccine they produce will meet all safety standards set by the FDA. They also vowed to be transparent about the testing and development process so there are no questions about safety or efficacy.

Many who are working closely on vaccine development are cautiously optimistic that we will

How Can Pharma Companies Simplify the Five-Phase Drug Development Process? Infiniti’s Experts Highlight the Need for Product Research Solutions

The increasing competition of the pharmaceutical industry has encouraged companies to invest in innovation and drug development. However, the drug development process is challenging, and without appropriate guidance, developers can face various roadblocks. What is the solution? Infiniti’s product research solutions enable companies to identify, evaluate, and strategize for potential roadblocks through the process. Additionally, our product research experts provide drug developers with crucial insights regarding target customers, regulatory requirements, and competitors’ strategies through the process. This further provides companies with a strategic advantage and enables them to successfully develop and launch a new drug and monitor their success efficiently. To leverage Infiniti’s product research solutions for comprehensive insights regarding the drug development process and an effective strategy, request a free proposal.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201008005908/en/

Five Phases of the Drug Development Process (Graphic: Business Wire)

With constant technological and pharmaceutical advancements, the pharmaceutical industry is continually becoming more competitive and challenging. Pharmaceutical companies need to focus on innovation and stay ahead of the curve to acquire and maintain market share successfully. Therefore, many pharma companies and researchers have shifted focus on drug development. The drug development process is long drawn and includes multiple phases. It is a five-phase process in the United States and acquiring regulatory approval from the Food and Drug Administration (FDA) is extremely challenging. Therefore, Infiniti’s experts decided to simplify the five-phase drug development process and discuss the value of product research solutions during every stage of the process in their recent article.

Gain comprehensive insights into the five phases of the drug development process and the value of product research solutions by reading the complete article here.

“Although the drug development process becomes easier with more available resources, workforce, and a better understanding of the regulatory requirements, many major pharma companies may still struggle to complete the process without experts’ guidance,” says a pharmaceutical industry expert at Infiniti Research.

Infiniti’s product research experts discussed the following five phases of the drug development process:

  • Discovery and development of a particular compound that elicits a desirable effect on the druggable target for any disease and developing a drug candidate

  • Preclinical research involves testing of the drug candidate on an animal species with similar genetic makeup as humans and gaining an understanding of the dosage and toxicity levels

  • Designing a clinical trial, developing a protocol, and submitting an IND application is part of the third phase of the drug development process

  • The relevant information procured from the preclinical and clinical research is submitted to the FDA for review, and it is either approved, delayed, or referred to an advisory committee for further review

  • The fifth phase involves surveillance of the drug after it has been approved, manufactured, and marketed. This aims to analyze the long-term efficacy and safety of the drug and involves various inspections by FDA representatives

To learn how Infiniti Research helps pharma companies strategize for each phase efficiently, and overcome potential bottlenecks with product research

Insilico Medicine to present at Leveraging Intelligent Tech for Drug Development

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IMAGE: Leveraging intelligent tech for drug development.
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Credit: Insilico Medicine

Wednesday, September 30, 2020 – Insilico Medicine, a global leader in artificial intelligence for drug discovery and development, will present its latest results in modern and next-generation AI for drug discovery and productive longevity at the Live Leveraging Intelligent Tech for Drug Development Forum on September 30, 2020.

AI, automation and data integration are condensing the timeline from discovery to development and solving biological problems. On September 30th, leaders from biotech and pharma will discuss specific examples of how these technological advancements are reshaping the drug development landscape.

While technology continues to revolutionize biotech, pharmaceutical companies are investing heavily in modernizing internally to embrace and embed these innovations throughout their organizational structure and culture. On the clinical trial front, not only are sponsors pressed to have remote and decentralized designs for their trial models due to the ongoing COVID19 pandemic, but regulators have openly expressed their willingness to consider creative new ideas for trial design, including wearable technology for remote data capture. Meanwhile in the workforce, competition is fierce to recruit and maintain the best talent and to understand how the role of the scientist is evolving to embrace the future of tech-enabled biopharma.

“We are thrilled to have CEO Alex Zhavoronkov address stakeholders at the upcoming digital forum on Leveraging Intelligent Tech for Drug Development on September 30th, hosted by Unite Life Sciences. Insilco Medicine’s work in the use of AI in drug discovery for Sars-CoV-2 and the ongoing COVID19 Global Pandemic offers remarkable insight to participants in the forum, which convenes senior decision makers, investors, and innovators in pharma, biotech and venture capital to examine real-case scenarios for accelerating drug discovery and modernizing clinical trials with data & automation. Unite Life Sciences is the dedicated life science division of IQPC US. Their digital content & forums provide a platform to drive stakeholder engagement, collaboration, and transformational change in biopharma.” said Nicole Hayes, Managing Director, Unite Life Sciences.

“I am very happy to present at Leveraging Intelligent Tech for Drug Development – a great event to gain insight on how industry can successfully align innovation in science, design, regulatory process and patient-centricity.” said Alex Zhavoronkov, Ph.D., Founder and CEO of Insilico Medicine.

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About Insilico Medicine


Since 2014 Insilico Medicine is focusing on generative models, reinforcement learning (RL), and other modern machine learning techniques for the generation of new molecular structures with the specified parameters, generation of synthetic biological data, target identification, and prediction of clinical trials outcomes. Recently, Insilico Medicine secured $37 million in series B funding. Since its inception, Insilico Medicine raised over $52 million, published over 100 peer-reviewed papers, applied for over 25 patents, and received multiple industry awards. Website http://insilico.com/

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