Biology • Year 12 • Module 6 • Lesson 10
Future Directions and Potential Benefits for Society
Build HSC Band 5–6 extended-response technique. Both tasks require a scenario plus a real data figure plus a multi-criteria evaluation that separates feasibility from fairness and grounds prediction in evidence.
1. CRISPR therapy for sickle cell — global access scenario (Band 5–6)
7 marks Band 5–6
Scenario. In 2023, Casgevy (exagamglogene autotemcel) became the first FDA-approved CRISPR-based therapy. It treats sickle cell disease and transfusion-dependent beta-thalassaemia by editing the BCL11A regulatory enhancer in a patient's own haematopoietic stem cells ex vivo, re-activating fetal haemoglobin, and re-infusing the modified cells. Published list price: ~US$2.2 million per patient. Treatment requires high-dose conditioning chemotherapy, several weeks of inpatient care, specialised centres, and 15-year safety follow-up. Sickle cell disease is most prevalent in sub-Saharan Africa, the Middle East and India, and among diaspora communities in higher-income countries. The figure below shows the geographic distribution of new sickle cell births (2021 estimate) versus the published distribution of accredited CRISPR / cell-therapy treatment centres (2024).
Q1. Analyse and evaluate, using the lesson's framework, whether Casgevy can presently be described as a realistic social benefit. In your response you must:
- Define future direction and contrast it with guaranteed benefit using lesson terminology.
- Use at least two specific numbers from the figure.
- Evaluate Casgevy on all three lesson criteria: need, feasibility and fairness.
- Reach a justified evidence-based judgement rather than a hype or absolute claim.
2. Gene drives in malaria vectors — release decision (Band 5–6)
8 marks Band 5–6
Scenario. A CRISPR-based gene drive in the mosquito Anopheles gambiae (engineered to disrupt the doublesex female-fertility gene) crashed laboratory cage populations to zero within 7–11 generations. Field release has not yet been authorised. Researchers argue release could save lives at scale; ecologists, regulators and local communities raise concerns about ecological knock-on effects, cross-border spread, and lack of recallability. The graph below shows the time-course of cage populations under three conditions: (i) wild-type, (ii) low-frequency drive release (~1% of starting population are drive-carriers), (iii) high-frequency drive release (~10%).
Q2. A national regulator must advise whether to authorise the first open-air field trial of the An. gambiae gene drive in a malaria-endemic region. Analyse and evaluate the proposal. In your response you must:
- Identify which lesson directions (gene editing, synthetic biology, precision breeding, disease screening) are combined in a gene drive.
- Use the data trend from the figure to support a claim about technical feasibility.
- Explain why feasibility in cages is not yet equivalent to a defensible future direction, drawing explicitly on the lesson's distinction between current capability and realistic future direction.
- Apply need, feasibility and fairness, with a specific point under each.
- Reach a recommendation that is consistent with evidence-based prediction.
Q1 — Sample Band 6 response (7 marks), annotated
A future direction in biotechnology is an emerging area showing increasing biological precision — for example, gene editing — that may deliver social benefit if it proves safe, scalable, regulated and fairly accessible. A guaranteed benefit, by contrast, would require that all four of those conditions are already met in the populations that need the technology. The two are not the same. [1 — definition + distinction]
Casgevy is a CRISPR-based gene-editing therapy, so by the lesson's Card 1 classification it sits squarely inside the emerging "future direction" category. It clearly addresses a real need: sickle cell disease causes severe pain, organ damage and reduced life expectancy, and the figure shows roughly 290,000 new sickle-cell births per year in sub-Saharan Africa alone, with a further ~45,000 in India and South Asia. [1 — need with figure cited]
On feasibility, Casgevy has passed FDA and MHRA approval, so the underlying science works in a regulated trial setting. However, the treatment requires ex vivo editing of haematopoietic stem cells, high-dose conditioning chemotherapy, weeks of inpatient care, and 15-year safety follow-up — feasibility in the regulatory sense is not the same as feasibility at population scale. [1 — feasibility with mechanism + caveat]
The decisive constraint is fairness. The figure shows 0 accredited treatment centres in sub-Saharan Africa against 38 in North America, even though sub-Saharan Africa carries the overwhelming majority of new sickle-cell births. [1 — fairness with figure cited] A list price of US$2.2 million per patient is approximately 27 years of median US household income (US$2.2m ÷ US$80,000) and far further beyond average incomes in the regions of highest disease burden, so even before infrastructure constraints are considered, the cost essentially excludes the populations the therapy was designed to help. [1 — quantitative reasoning, fairness deepened]
Within the lesson's framework, Casgevy is therefore a strong example of a future direction in gene editing whose biological feasibility is established but whose social benefit is currently bottlenecked by access. It is not yet a guaranteed benefit — to call it one would be hype. [1 — evidence-based judgement, rejects hype]
To convert Casgevy from a future direction into a realistic broad social benefit, the binding work is not further DNA-editing precision but the fairness side of the framework: technology transfer, regional manufacturing, cheaper conditioning protocols, and reimbursement / subsidy mechanisms in malaria-endemic and sickle-cell-endemic regions. Until those move, the lesson's evaluative language — "may benefit", "has potential to", "if accessible" — remains the only defensible framing. [1 — explicit lesson language + forward-looking judgement]
Marking criteria.
- 1 mark — Defines future direction and contrasts it with guaranteed benefit using lesson terminology ("may", "could", "if feasible / accessible").
- 1 mark — Identifies Casgevy correctly as a gene-editing (CRISPR) therapy and explicitly addresses need using at least one figure from the chart.
- 1 mark — Evaluates feasibility, noting both regulatory approval AND remaining barriers (ex vivo workflow, conditioning, follow-up).
- 1 mark — Cites a second specific figure from the chart in service of the fairness analysis (e.g. 0 centres in sub-Saharan Africa vs 38 in North America).
- 1 mark — Deepens the fairness analysis with quantitative reasoning about cost relative to median income.
- 1 mark — Reaches an evidence-based judgement that explicitly rejects hype (does NOT call Casgevy a guaranteed cure for sickle cell globally).
- 1 mark — Closes with a forward-looking statement using lesson language (e.g. "may benefit", "has potential to") and names what would have to change for fairness to be satisfied.
Q2 — Sample Band 6 response (8 marks), annotated
A gene drive is simultaneously an example of gene editing (CRISPR cuts the wild allele) and of synthetic biology (a deliberately designed inheritance system that copies itself onto the homologous chromosome, breaking ordinary 50/50 inheritance). Both directions from Card 1 are combined. [1 — directions identified and combined]
The figure provides strong evidence of technical feasibility in cages. The wild-type control population is stable at roughly 600 adult mosquitoes across all 12 generations. A 1% release of drive-carriers drives the cage population from ~600 to 0 by approximately generation 11, and a 10% release crashes the population to 0 by approximately generation 7 — a faster and steeper extinction trajectory than even most insecticide programs have shown. [1 — uses the data trend to support a feasibility claim]
However, "works in cages" is not the same as "is a defensible future direction". The lesson's Card 3 distinguishes current capability (proven function under controlled conditions) from realistic future direction (a prediction grounded in feasibility, safety, regulation, access and acceptance). The cage results establish the first half of that equation, not the second. [1 — current vs future distinction made explicit]
Need is genuine and substantial. Malaria causes ~600,000 deaths per year, predominantly children under five in sub-Saharan Africa, and progress has stalled because of insecticide and antimalarial resistance — so the population-health case for a new tool is strong. [1 — need with specific figure]
Feasibility, beyond cages, has three open questions: (a) whether the drive remains effective when released into a wild population with much greater genetic diversity than a cage; (b) whether resistant alleles emerge as Anopheles populations become smaller and selection on the cut site intensifies; (c) whether the drive can be recalled — currently it cannot easily be reversed once released, and it can spread across national borders without the consent of neighbouring countries. [1 — feasibility extended beyond the figure]
Fairness is the most ethically loaded of the three. Decisions affect African communities most directly, and meaningful consent — not only national but at the community level — is essential. Fairness also includes who carries the ecological risk if eliminating An. gambiae has knock-on effects on predators (e.g. bats, fish) or releases an ecological niche for other vector species. The lesson's framework therefore requires governance arrangements before release, not after. [1 — fairness deepened with named ecological + governance issues]
Bringing the three together: cage data establish biological feasibility; need is real and unmet; but feasibility-at-field-scale and fairness-of-governance remain unresolved. [1 — explicit integration of all three criteria]
Recommendation. I would not authorise an immediate open-air release. The lesson's evaluative language supports a staged path: continued contained trials in large semi-field enclosures; parallel work on a "reversal drive" or self-limiting variant that addresses recallability; multilateral cross-border governance agreed before release; and explicit community consent in any first-release region. On those conditions, gene drives may become a realistic future direction for malaria control. Until those conditions are met, the defensible HSC-level claim is "potential benefit with significant feasibility and fairness conditions still to satisfy" — not "guaranteed solution". [1 — recommendation consistent with evidence-based prediction, uses precise lesson language]
Marking criteria.
- 1 mark — Correctly identifies that a gene drive combines gene editing and synthetic biology as defined in Card 1.
- 1 mark — Uses the data trend from the figure (wild-type stable; 1% release crashes by ~gen 11; 10% release crashes by ~gen 7) to support a claim about technical feasibility.
- 1 mark — Explicitly distinguishes current capability from realistic future direction (Card 3) and applies that distinction here.
- 1 mark — Addresses need with a specific quantitative anchor (e.g. ~600,000 malaria deaths per year; insecticide resistance).
- 1 mark — Extends feasibility beyond the cage data — identifies at least one of: wild-population diversity, resistance alleles, lack of recallability, cross-border spread.
- 1 mark — Addresses fairness with at least one of: community consent, cross-border governance, ecological knock-on risk distribution.
- 1 mark — Integrates all three criteria into a single evaluative position rather than treating them as separate paragraphs.
- 1 mark — Reaches a recommendation consistent with evidence-based prediction (e.g. "not yet" + named conditions, OR "yes with X, Y, Z conditions") and uses precise lesson language ("may", "has potential to", "if feasibility and fairness conditions are met"). A simple "yes" or "no" without conditions does not score this mark.