FDA & regulatory
- FDA
- Food and Drug Administration. The U.S. agency that regulates drugs, biologics, and medical devices.
- CBER
- Center for Biologics Evaluation and Research. The FDA division overseeing biologics, cell and gene therapy, and exosome programs.
- IND
- Investigational New Drug application. Submitted to FDA before any new drug or biologic can be tested in humans.
- BLA
- Biologics License Application. The FDA submission that authorizes a biologic for marketing once trials are complete.
- 351(a)
- Section 351(a) of the Public Health Service Act. The full BLA pathway for new biologics like Wharton's jelly exosomes.
- 361
- Section 361 of the Public Health Service Act. A regulatory pathway for human cells and tissues that meet minimal-manipulation criteria.
- HCT/P
- Human Cells, Tissues, and Cellular and Tissue-Based Products. The FDA category for cell and tissue-based products under 21 CFR 1271.
- 21 CFR 1271
- Code of Federal Regulations Part 1271. Governs HCT/P registration, donor screening, and manufacturing.
- RMAT
- Regenerative Medicine Advanced Therapy designation. An FDA program that speeds approval of regenerative medicine candidates that address unmet need.
- cGMP
- Current Good Manufacturing Practice. FDA quality standards for drug and biologic manufacturing.
- CMC
- Chemistry, Manufacturing, and Controls. The section of an IND or BLA describing how the product is made and tested.
- Pre-IND
- A Type B meeting with FDA to align on clinical and CMC plans before submitting the IND application.
- INTERACT
- Initial Targeted Engagement for Regulatory Advice on CBER Products. An early FDA meeting type for novel biologics.
Clinical & cell therapy
- MSC
- Mesenchymal Stem Cell. A multipotent cell type used in regenerative therapies for inflammation and tissue repair.
- WJ-MSC
- Wharton's Jelly Mesenchymal Stem Cell. MSCs derived from umbilical cord tissue. Younger and more potent than bone-marrow MSCs.
- Exosome
- A small extracellular vesicle (30 to 150 nanometers) released by cells. Carries proteins, lipids, and nucleic acids that mediate cell-to-cell signaling.
- Discseel
- An outpatient procedure that injects fibrin sealant into spinal disc tears to repair annular damage without surgery.
- SOP
- Standard Operating Procedure. A documented method for performing a clinical or manufacturing step consistently.
- IRB
- Institutional Review Board. The committee that reviews and approves clinical research protocols to protect study subjects.
- IND-enabling
- Studies, especially preclinical safety and CMC work, that must be completed before submitting an IND to FDA.
Oncology & targeted therapy
- TOL
- Targeted Osmotic Lysis. A non-toxic cancer therapy that uses voltage-gated sodium channel modulation to selectively rupture tumor cells.
- VGSC
- Voltage-Gated Sodium Channel. A membrane protein over-expressed in many metastatic cancers, exploited by TOL therapy.
- VEGF
- Vascular Endothelial Growth Factor. A signaling protein that drives blood-vessel growth in tumors. The target of bevacizumab and related agents.
- Carboplatin
- A platinum-based chemotherapy drug used in cervical, ovarian, and lung cancers.
- Pembrolizumab
- A PD-1 inhibitor immunotherapy used in multiple solid tumors. Marketed as Keytruda.
- Bevacizumab
- A monoclonal antibody targeting VEGF. Marketed as Avastin.
- SCC
- Squamous Cell Carcinoma. A common cancer of skin, cervix, head and neck, and lung.
Investing & finance
- DCF
- Discounted Cash Flow. A valuation method that estimates the present value of future expected cash flows.
- LBO
- Leveraged Buyout. An acquisition financed mostly with debt secured against the target's assets and cash flow.
- Comps
- Comparable company analysis. Valuing a company by reference to public-market or transaction multiples of similar companies.
- IC
- Investment Committee. The deciding body that approves or rejects deals at a fund or family office.
- IC memo
- The written brief presented to the Investment Committee for a deal decision.
- LP
- Limited Partner. The investor in a fund. Provides capital but does not run the fund.
- GP
- General Partner. The fund manager who makes investment decisions and earns carried interest.
- Carry
- Carried interest. The share of profits paid to the GP after returning capital to LPs above the hurdle rate.
- ROIC
- Return on Invested Capital. A profitability metric that measures how well a company converts capital into earnings.
- EBITDA
- Earnings Before Interest, Taxes, Depreciation, and Amortization. A proxy for operating cash flow used in valuation.
- WACC
- Weighted Average Cost of Capital. The blended rate of return required by all of a company's capital providers.
Healthcare compliance & legal
- HIPAA
- Health Insurance Portability and Accountability Act. The U.S. federal law governing protected health information.
- AKS
- Anti-Kickback Statute. A federal law that criminalizes offering or receiving anything of value to induce referrals of federally-reimbursed services.
- Stark
- The federal physician self-referral law. Restricts physicians from referring Medicare patients to entities with which the physician has a financial relationship.
- OIG
- Office of Inspector General. The HHS agency that audits, investigates, and excludes individuals or entities from federal healthcare programs.
- LEIE
- List of Excluded Individuals/Entities. The OIG's public database of parties barred from participating in federal healthcare programs.
- HHS
- U.S. Department of Health and Human Services. The federal department that oversees the FDA, CDC, CMS, and OIG.
- CMS
- Centers for Medicare and Medicaid Services. The HHS agency that runs Medicare and Medicaid.
- CON
- Certificate of Need. A state-level approval required to build or expand certain healthcare facilities.
- ASC
- Ambulatory Surgical Center. An outpatient surgical facility, regulated separately from hospitals.
- LOP
- Letter of Protection. A document by which a personal injury plaintiff's attorney guarantees payment to a treating provider out of settlement proceeds.
- PI
- Personal Injury. A civil claim for damages arising from negligence or intentional harm.
Litigation & legal Latin
- et al.
- Latin "et alii" — "and others." Used in case captions to abbreviate a list of additional parties. Hillman v. Ringleader Digital et al. means the case names Ringleader Digital and other co-defendants.
- v.
- Latin "versus" — "against." Separates plaintiff from defendant in case names. Levine et al. v. Google, Inc.
- Pro se
- Latin "for himself." A party who represents themselves in court without an attorney.
- Plaintiff
- The party who brings a civil lawsuit. The one seeking relief from the court.
- Defendant
- The party against whom a civil or criminal action is brought.
- Class action
- A lawsuit filed by a representative plaintiff on behalf of a larger group with shared claims against the same defendants.
- Discovery
- The formal pre-trial process where each side requests documents, depositions, and admissions from the other.
- Deposition
- Sworn out-of-court testimony recorded by a court reporter. Used to preserve testimony and probe witness accounts.
- Subpoena
- A court order compelling a person to testify or produce documents.
- Summary judgment
- A pre-trial ruling that decides a claim on the law alone, without a jury, when no material facts are disputed.
- Stipulation
- An agreement between opposing parties about facts or procedure, removing the need to prove those points at trial.
- Estoppel
- A legal doctrine preventing a party from contradicting a position they previously took.
- Restitution
- Court-ordered repayment to victims for losses caused by the defendant.
- Supervised release
- Federal post-imprisonment monitoring, separate from probation. Replaces parole in the federal system.
- Probation
- Court-ordered supervision served in lieu of incarceration, with conditions the defendant must follow.
- Voir dire
- French "to speak the truth." The jury-selection process where attorneys question potential jurors for bias.
- Prima facie
- Latin "at first sight." A claim supported by sufficient evidence to proceed to trial absent contrary evidence.
- Daubert
- A standard from Daubert v. Merrell Dow governing the admissibility of expert testimony in federal court.
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