Fierce Biotech Week

Attendees, exhibitors & solutions

Who this event is for

Industry trends

Key trends shaping this market and its wider industry.

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Frequently asked

Glossary

1

Biologics

Medicines produced from living systems, such as antibodies, proteins, vaccines, and cell-based products. They are typically more complex to characterise and manufacture than small-molecule drugs.

2

Biosimilar

A follow-on biologic designed to be highly similar to an approved reference product, with no clinically meaningful differences in safety or efficacy. Approval pathways vary by regulator.

3

CMC

Chemistry, Manufacturing, and Controls: the technical and regulatory work that defines how a product is made, tested, and controlled. CMC data support IND filings, clinical supply, and marketing applications.

4

IND

Investigational New Drug application submitted to the U.S. FDA before testing an unapproved drug in humans. It summarises preclinical data, manufacturing information, and the proposed clinical protocol.

5

CDMO

Contract Development and Manufacturing Organization: an outsourced partner that develops processes and manufactures drug substances or drug products for biotech and pharma clients.

6

CRO

Contract Research Organization: a service provider that runs or supports clinical trials, data management, biostatistics, monitoring, and related activities for sponsors.

7

GMP

Good Manufacturing Practice: the quality system and regulatory requirements used to ensure that medicinal products are consistently produced and controlled to appropriate quality standards.

8

Biomarker

A measurable biological indicator, such as a gene variant, protein level, or imaging feature, used to diagnose disease, select patients, or monitor response to treatment.

9

Translational medicine

The work of moving findings from laboratory and preclinical research into human studies, and using clinical insights to refine drug targets and development plans.

10

Cell and gene therapy

Therapeutic approaches that modify cells or genetic material to treat disease. They often require specialised manufacturing, potency assays, and long-term patient follow-up.

11

mRNA therapeutics

Treatments or vaccines that deliver messenger RNA to cells so they produce a desired protein or immune response. Manufacturing and lipid nanoparticle delivery are central development challenges.

12

Monoclonal antibody

A lab-made antibody that binds a specific target. Monoclonal antibodies are used across oncology, immunology, infectious disease, and other therapeutic areas.

13

Clinical trial phases

Sequential stages of human testing: Phase I assesses safety and dosing, Phase II explores efficacy and dose range, Phase III confirms benefit in larger populations, and Phase IV monitors approved products.

14

Orphan drug designation

A regulatory status for therapies targeting rare diseases, often providing incentives such as market exclusivity or fee reductions. Eligibility and benefits vary by jurisdiction.

15

Licensing and co-development

Deal structures in which a company grants rights to an asset or partners to share development costs, risks, and rewards. Terms usually cover territory, stage, milestones, and royalties.

16

Due diligence

The structured review of scientific, clinical, manufacturing, regulatory, and commercial information that precedes an investment, licensing, or acquisition decision.

17

Assay

A laboratory test used to measure a biological or chemical effect, such as target binding, potency, or biomarker concentration. Assay validation is important for reproducible development data.

18

Bioprocess

The manufacturing process for biological products, including cell culture, fermentation, purification, and formulation. Scale-up and reproducibility are key concerns.

19

Precision medicine

An approach that tailors prevention or treatment to individual patient characteristics, often using biomarkers, genomics, or other molecular data.

20

Real-world evidence

Clinical evidence derived from routine care, registries, claims, or patient-reported data rather than controlled trials. Regulators increasingly consider it alongside trial data.