Definitions
Patent Assignee & Patent Applicant
Applicants- Applicants are the individuals or entities who filed the patent application
RRN, Clinical Trials, Grants, Publications, and Patents. (maybe: Crunchbase and News)
What is an ontology and why are they helpful for researchers?
Ontologies are a "controlled vocabulary." A specific way of describing a subject. Ontologies help people find relevant information, identify relationships, limits complexity of variations in terminology, and organizes data using industry accepted semantics.
For medical device companies, what are the 5 most common pathways to market?
Most exempt from premarket submission (Class I)
510(k) - Premarket notification (Class II)
• Special Controls - E.g., meeting FDA-recognized performance standards, postmarket surveillance, patient registries
Premarket Application (PMA) (Class III)
• Life-supporting, life-sustaining or important in preventing impairment of human health
De Novo
• Device “types” that have never been marketed in the U.S., but whose safety profile and technology are now reasonably well understood
Humanitarian Device Exemption (HDE)
• Devices for orphan diseases
• Intended to benefit patients in diagnosis and/or treatment of disease or condition affecting or manifested in fewer than 4,000 patients per year in the United States
What industries do we have clients within?
Pharma, Med Device, Biotech, Agriculture, CPG, Performance Materials/Aerospace, Nutrition/Nutraceuticals/Health, Chemicals, Higher Education, Consulting
List all of our data sources for Clinical Trials
Clinicaltrials.gov, EU-CTR, UMIN-CTR, ANZCTR, CRIS, TCTR
What is a patent family?
A patent family is "a set of patents taken in various countries to protect a single invention." In other words, a patent family is "the same invention disclosed by a common inventor and patented in more than one country."
What is Elastic Search? What is indexing? How are they related?
- Elastic Search: a search and analytics engine (used for indexing). Data is ingested in its original form and then it goes through a normalization process (so it’s usable by us in our platform) and then it is indexed.
- Indexing: a process of storing data optimized for fast information retrieval. An index is a collection of documents related to one another.
What is a Product Code? What sort of users (titles/depts) use them most frequently? Name 1 client who uses them.
- Classification product codes are a method of internally classifying and tracking medical devices. CDRH and a subset of CBER regulated medical device product codes consist of a 3 letter combination which associates a device's type with a product classification designated for the application.
- Surveillance, MedSci, Regulatory, Product Development
- Olympus, AstraZeneca, Cepheid
Name at least 3 of our clients for each industry: pharma, biotech, and medical device.
Pharma: Alexion, Zentiva, Merck Group, AstraZeneca, Abbvie
Med Device: Danaher (& opcos), Thermo Fisher, WL Gore, ConvaTec, 3M, Olympus
Biotech: Resilience, Aditxt, Chinook Therapeutics
List all Patent data sources
USPTO, WIPO, EPO
A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA).
What is federated search?
Federated search is a technique used to search multiple data sources at once. With federated search, you can retrieve information from many different content locations with just one query and one search interface.
What is a Patent CPC symbol?
- Cooperative Patent Classification (CPC) is a bilateral classification system jointly developed by the United States Patent and Trademark Office (USPTO) and the European Patent Office (EPO). CPC is jointly managed and maintained by both offices and is available for public search for classification.
- There are about 280,000 CPC codes.
What is basic research and what is applied research?
- Basic research is aimed at a fuller, more complete understanding of the fundamental aspects of a concept or phenomenon. This understanding is generally the first step in R&D. These activities provide a basis of information without directed applications toward products, policies, or operational processes.
- Applied research entails the activities used to gain knowledge with a specific goal in mind. The activities may be to determine and develop new products, policies, or operational processes. While basic research is time-consuming, applied research is painstaking and more costly because of its detailed and complex nature.
What are the two main avenues for FDA medical device approvals and what is the main difference between the two?
The two main avenues for the FDA to allow medical devices to be marketed in the U.S. are known as Premarket Approval (PMA), which requires clinical and laboratory studies and a detailed process to determine safety and effectiveness. On the other hand, 510(k) does not require any of that.
What is embedded metadata? What is an example for how a Nebula user (NO FOUNDATION) use this to identify subject matter experts?
- Embedded metadata: metadata that is maintained and stored within the object it describes; the opposite of stand-alone metadata
- File metadata: Author filter
What are the common types of drug and biologic applications?
- Investigational New Drug Application (IND)
- New Drug Application (NDA)
- Biologic License Application (BLA)
- Abbreviated New Drug Application (ANDA)
- Over-the-Counter (OTC) Application
What is the difference between drug discovery and drug development?
Double Jeopardy Bonus Question: How was chemotherapy first discovered?
- Drug Discovery can be done in many ways and will be largely dependent upon the application of the final drug for therapeutics purposes. It can include the discovery and design of small and large molecules which can be to support the release of new tablets, capsules and biopharmaceuticals for therapeutic purposes. Drug discovery in modern Biotechnology takes a focus on manipulating the metabolic pathway(s) related to the relevant disease / pathogen. Traditional drugs have been discovered by isolating key active ingredients from existing drugs or potentially by a chance discovery.
- Drug Development takes the science from drug discovery and turns this into the suitable, ethical and safe medication. Within this stage it is essential that development experts can establish the correct formulation, dosage form and ensure that it safely passes all forms of pre clinical testing and clinical trials. Due to the impact of drugs to human safety this stage of R&D can take many years to do successfully and the cost to do so is great. This is why drug development is primarily done by large pharmaceutical, biotechnology companies or a specific part by small or dedicated CMO / CROs.
- During World War II, it was discovered that people exposed to nitrogen mustard developed significantly reduced white blood cell counts. This finding led researchers to investigate whether mustard agents could be used to halt the growth of rapidly dividing cells such as cancer cells.
What is the definition for drug repurposing/repositioning?
Drug repositioning involves the investigation of existing drugs for new therapeutic purposes.
2 part question:
- What does TF-IDF stand for and what is it?
- How do we rank relevance?
- TF-IDF (term frequency–inverse document frequency): measurement of the relevancy of word to a document within a wider collection of documents.
- The relevance score for a document is based on the importance of terms and concepts in the document. The importance of a term is proportional to its frequency, but offset by the number of documents that contain that term.
Define each AI technique listed below and provide an example for how a user can benefit from the feature or why they might care about it:
-OCR
-Image Recognition
-Document Cracking
-Audio Transcription
- OCR (Optical character recognition): the process of converting scanned documents, or photographs, into machine-encoded, and therefore readable, text. i.e. someone can search words in an image.
- Image Recognition: a set of methods for detecting and analyzing images to enable the automation of a specific task. It is a technology that is capable of identifying places, people, objects and many other types of elements within an image, and drawing conclusions from them by analyzing them.
- Document Cracking: Document cracking is the process of extracting or creating text content from non-text sources during indexing.
- Audio Transcription: the process of creating text from video/audio files that can then be searched and analyzed.
What is a FDA Pharm Class and what are the active moieties?
FDA Pharm Classes include a pharmacologic class associated with an approved indication of an active moiety that the FDA has determined to be scientifically valid and clinically meaningful. Active moieties include Mechanism of Action (MOA), Physiologic Effect (PE) and Chemical Structure (CS)
Name at least 5 general tasks ResoluteAI supports, and briefly explain what each task is.
Technology scouting
Regulatory submissions
Product roadmap and horizon planning
Competitive intelligence gathering
Adverse event reporting
Key interest area monitoring and trend analysis
KOL discovery and mapping
Patent strength analysis, freedom to operate, and white space analysis
Accelerate onboarding for research associates to new projects
Knowledge transfer and data integration after acquisition or loss of key personnel
Discover opportunities for drug repurposing and new intended use for devices
Identify strategic M&A, tech transfer, co-development, and partnership opportunities
Simplify data architecture while reducing data and labor costs
Search the unsearchable (unstructured data)