discovery and dev of antiviral antibodies
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key elements of a development plan
-right target -right tissue -right safety -right patient -right commercial
Key elements of a target product profile (TPP)
-efficacy -safety -dosing/formulation
step 1 in pre clinical
identify an opportunity
step 2 in pre clinical:
identify a solution
step 2 in pre clinical: identify a solution
• Identify the target • Understand the mechanism of action/impact on host • Antibody must meet key components of the TPP * Potency * Mechanism * Ability to manufacture
MoA-based Discovery
Incorporate ACE2-blocking into the pipeline: * Donor selection * B cell sorting * mAb screening
Aims of Nonclinical Safety Studies
• Predict likelihood of toxicity in humans • Identify target organs for toxicity • Investigate reversibility of any toxic effects • Recommend an appropriate starting dose for Phase I studies • Identify safety parameters for clinical monitoring • Provide information on mechanism of action • Investigate fate of the molecule
what is the purpose of transition to the clinical phase
Purpose: Communicate to health authorities the pre-clinical data supporting first in human studies
what are the key sections of the clinical phase
• Animal Pharmacology • Toxicology • Manufacturing information (composition, stability, controls) • Clinical protocols
clinical protocols are focused on what
This is primarily focused on the initial-phase trials, although it is an opportunity to gain feedback on plans for the complete clinical development plan
Traditional antibody manufacturing requires massive (…..) tanks to produce sufficient drug substance.
10K liter
Cells produce the antibody, which is harvested, …
filteres, purified and frozen
Operations (the manufacturing group) is also responsible for:
• Testing stability and determining shelf-life of both frozen and non-frozen drug substance • Producing drug product (the final packaged form) • Delivery and supply to global markets
what are the clinical phase
-1: is it safe -2: does it work -3: does it work better than the normal drugs -4: how is it going
Regulators play an essential role in ensuring that…
a non-biased party reviews the benefit/risk of any product
Communication with health authorities begins even before…
the IND (pre-IND meeting)
what are the key meetings/touch points of the pre ind meeting
• Pre-IND • Post Phase 1 • Post Phase 2 • Pre-BLA (US)/Pre-MAA (EU/RoW
Commercial and Medical teams input into the TPP from the start of the program, and work in parallel with the R&D organization to:
• Educate on un-met medical need • Curate external experts who provide guidance on target patient populations, lead ad-boards, etc. • Work with scientific societies to ensure recommendations • Access – build the reimbursement/supply/operational systems to bring the medicine to patients
life cycle management
• New indications (treatment, prevention, post exposure) • New formulations (pre-filled syringe, nebulizer, oral)