Scientific Insights that Accelerate Drug Development
New biologic development and approval of novel biological medications have significantly moved the needle for addressing unmet diseases. Scores of biologics scientists and developers have supported this modern-day marvel.
If you work at a biotechnology start-up, you’re probably excited about your compound assets, particularly if your development program has a single asset.
A new class of complex biologics has emerged in recent years.
Recently, artificial intelligence (AI) has been front and center of newspapers, trade journals, and social media.
This analysis evaluated the PK, exposure–response, and exposure–PDrelationships of tremelimumab in patients with uHCC and supported the clinical utility of the STRIDE regimen.
This blog highlights 3 key areas for integrating pharmacometrics and clinical pharmacology to add value to a drug development program.
This blog discusses 3 critical formulation questions your drug development program should consider.
This blog discusses the clinical pharmacology strategy, dose selection, and safety considerations for cell therapy development programs.
In this blog, we will review and reflect on the scientific and strategic parts of the FDA guidance. We will also reflect on this guidance from a European Union (EU) perspective.
In this blog, I will reflect on why this agency guidance is so important for new oncology therapeutics.
The ICH E11A draft Guideline on Paediatric Extrapolation was released on 4 April 2022 entering a public consultation phase. This guideline has several objectives. While aiming to harmonize methodologies and approaches for pediatric extrapolation in drug development, it balances access to pediatric indications and reduction of children’s exposure to experimental medications where warranted. The ICH E11A webpage outlines these considerations.
モデルを活かした医薬品開発（MIDD）は、密接に統合されたエコシステムのネットワークであり、不確実性を最小限に抑えながら、新薬候補をシームレスに位置づけることができます。
The new Clinical Pharmacology Considerations for Antibody-Drug Conjugates (ADC), Guidance for Industry, was issued by the US Food and Drug Administration (FDA) in February 2022. ADCs are targeted therapies that are designed to deliver cytotoxic payloads to cancer cells.
希少疾患における新たな治療薬の開発は、チャンスと複雑さの両方をもたらします。
Because of the small patient pool available in these indications, there are challenges in designing and conducting clinical trials and the data interpretation that follows, and the ultimate path to registration.
Bioequivalence is a commonly misunderstood term within biopharmaceutics. For starters, bioequivalence is a technical term baked in regulation.
Bioequivalence enables bridging safety and effectiveness of oral pharmaceutical dosage forms using pharmacokinetics.
Immunotherapy presents interesting and proximally viable therapeutic options in the growing…
Pandemics by nature are excellent fodders for disruptive innovation. They force you to think out of the box. The whole health care apparatus is on the COVID-19 frontlines with some more directly involved than others.
It is gratifying to see the continued uptake and adoption of tools for model-informed drug discovery and development since the early 2000s.
米国国立糖尿病・消化器・腎臓病研究所は、非アルコール性脂肪性肝疾患（NAFLD）を肝臓に過剰な脂肪が蓄積された状態とみなし、非アルコール性脂肪性肝炎（NASH）をNAFLDの一種としています。
抗体薬物複合体（ADC）は、腫瘍細胞を消滅させるユニークな方法であり、単独療法であれ併用療法であれ、腫瘍学において十分に利用されていない免疫治療薬の選択肢です。
The era of gene therapy may have started a couple of decades ago, but approvals of agents based on the platform have been relatively recent. In 2017, Spark Therapeutics, Inc. received FDA approval of voretigene neparvovec-rzyl (Luxturna™), a recombinant adeno-associated virus serotype 2 (AAV2) vector expressing the gene for human retinal pigment epithelium 65 kDa 5 protein (hRPE65), for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.
Alzheimer’s disease (AD) is one of the most common forms of neurodegenerative dementia in the United States. In fact, the Alzheimer’s Association predicts that by the year 2050, the number of people age 65 and older with Alzheimer’s dementia is expected to double to comprise 12.4 million patients.
by Rajesh Krishna and Abhijeeth Chandrasekaran
Written by Rajesh Krishna and James Bolognese
Strategic consulting within drug discovery and development is an exciting career choice for many. Unlike a biotechnology or pharmaceutical enterprise, where the assets one typically works on are within that ecosystem, consulting offers the possibility of working on many different innovation pipelines.
Global trials of therapeutic biologics have been historically absent from clinical
drug development.
従来の薬物作用機構は、リガンドと生物学的標的との可逆的で非共有結合的な相互作用に依存していました。On the other hand, a targeted covalent inhibitor (TCI) drug is designed to form a covalent bond between an electrophile on the ligand and a nucleophilic center in the target protein (Figure 1).
New therapeutics discovery and development for ocular diseases have been traditionally associated with a low probability of technical and regulatory success.
The safety of human participants in clinical trials, the intended patient population, and for the labeled indications at the point of introduction into the market is undoubtedly the paramount consideration of any drug hunting enterprise.
