WO2024227635A1

WO2024227635A1 - Control system and methods for replicating delivery profiles of drug delivery devices

Info

Publication number: WO2024227635A1
Application number: PCT/EP2024/060733
Authority: WO
Inventors: Thomas Daniel JAMES; Stephen Allison PORTER; Martin Michael COYNE III; Christopher James FRANZESE; Mariano MUMPOWER; Mason WATTS; Florence Olivia STEVENSON; Lyndon Wild; Nils WEBER; Ola HALLSTRÖM
Original assignee: SHL Medical AG
Current assignee: SHL Medical AG
Priority date: 2023-05-04
Filing date: 2024-04-19
Publication date: 2024-11-07
Anticipated expiration: 2025-11-04

Abstract

The present disclosure provides a drug delivery device (100) The drug delivery device (100) includes a drive mechanism (102), a battery (104) configured to supply power to the drive mechanism (102), at least one memory storage element (106), at least one processor (108), and data storage (110) including program instructions (112) stored thereon that when executed by the at least one processor (108), cause the drug delivery device (100) to perform functions. The functions include (i) accessing (202) a drug delivery profile corresponding to a reference drug delivery device, (ii) replicating (204), via the at least one processor (108), a set of parameters associated with the drug delivery profile corresponding to the reference drug delivery device (100), and (iii) delivering (206) a medicament via the drug delivery device (100) according to the set of parameters.

Description

CONTROL SYSTEM AND METHODS FOR REPLICATING DELIVERY PROFILES OF DRUG DELIVERY DEVICES

TECHNICAL FIELD

The present disclosure generally relates to apparatus, systems, and methods for drug delivery devices, and more particularly to improved apparatus, systems, and methods to allow a first drug delivery device (a “replicating” device) to replicate a delivery profile associated with a second drug delivery device (the “reference” device).

BACKGROUND

Integration of a drug delivery device and candidate molecule follows a prescribed, stepwise process shown illustratively in Figure 1 for a biologic medication delivered subcutaneously (SC). For Figure 1, the launch device post-approval is an on-body injector (OBI) at launch.

Phase i and 2 studies are often conducted with a “proxy” device substituting for the expected launch device after approval, most commonly a flow-regulated or pressure- regulated pump. Common constant flow pumps include Alaris, Sapphire, and Crono designs. Pressure-regulated devices, such as Koru FreedomEdge or Freedom6o, may also be used. With either design, the volume and flow rate may be independently selected or controlled, which is advantageous for early clinical trials aimed at determining the final dose and delivery profile required for the pivotal Phase 3 trial.

Ideally, the final launch device would be used for the Phase 3 study. However, these devices may not be ready for Phase 3 study start. For instance, device customization timelines may extend past the desired start date for the Phase 3 trial. As a workaround, two devices may be used in the Phase 3 trial; initially, a proxy device continues, followed by the launch device later.

In such cases, a “bridging” study is used to demonstrate equivalence between the proxy device and the final launch device. Bridging studies are often clinical trials designed to allow comparison of pharmacokinetics (PK), pharmacodynamics (PD), or other clinical data to extrapolate results from one study arm to a second. In this case, bridging studies would be used to demonstrate that the PK/PD of the pump used in Phase 2 or the pump study arm in Phase 3 is equivalent to the PK/PD data of the final launch device (i.e., OBI). As they can require human clinical trials, bridging studies are costly and time consuming.

Additionally, the type of pump may differ between Phase 1, 2, and 3, as each type of pump may have a different delivery profile. There is some evidence that constant flow and constant pressure pumps have different SC deposition characteristics, which may impact PK and make different device types difficult to compare when transitioning between them in clinical development. Differences in SC deposition (or changes in PK) may raise questions from regulatory authorities during the approval process or introduce confounding variables in the clinical trial results.

Each drug delivery device has a specific delivery profile that is associated with the drive mechanism, fluidic path, startup behaviors, steady-state behaviors, physical orientation, medication properties, or other factors.

Figure 2 shows an illustrative example of a complete delivery profile for a representative device that may be used in early clinical trials or commercially approved molecules. For instance, the Koru Medical Freedom6o device is a constant pressure pump with mechanical (spring drive) and has a delivery profile shown below when tested with 6omL of water. Notably, the flow behavior may be different with biologic medications, which are often non-Newtonian in nature. The startup behavior is visible at the left side (e.g., o-i min), and steady state behavior is visible as time progresses (e.g., 2- 28 min). The fluidic path used in this example incorporates a reduced-diameter tubing segment (“F120”) that allows for a flow rate of approximately i2omL/h when tested in a lab setting.

In this example, the flow rate vs. time behavior could be replicated with the present invention although the underlying pump mechanism is different. To achieve this, the control system of the present invention would be configured for flow rate-regulation, and instructed to match the measured flow rate. Alternatively, the syringe pressure vs. dose remaining (curve not shown) could be replicated by the present invention, configured for pressure regulation, as desired by a pharmaceutical company. To the extent there are claims of drug efficacy or tolerability based on the delivery regulation method itself, syringe pressure would be the parameter to replicate on the Freedom6o, given its constant-pressure delivery mechanism.

While the example of Figure 2 shows a relatively fast startup and stable steady state performance, peristaltic pumps (e.g., the Alaris design) may produce flow rate variations that are essentially discontinuous flow. In these instances, startup and steady-state behaviors may also be of interest. Both flow rate accuracy and flow continuity may be of interest, depending on the medication to be delivered, route of administration, infusion time, and risk assessment. In this instance, flow rate accuracy and continuity are defined in the IEC 60601-2-24 standard, with illustrative data shown in Figure 3.

Flow rate during the first hour may be considered the “start-up” portion, which is generally disregarded, while the general stability of the steady-state is typically used to create the “trumpet” profile, as shown in Figure 4. Physical orientation and/or situation of the device, particularly of the drug container relative to the injection site, such as head height differences, may also affect the delivery characteristic of a given pump design.

As can be seen from the distinct differences in the two pump types illustrated in Figures 3-4, currently available pumps may not be easily interchanged and can require extensive recharacterization work, preventing efficient development effort and adding risk. Moreover, these different profiles, if used in a PK/PD, safety, dose finding, or early efficacy (e.g., Phase 2) study, may produce different pharmacologic effects that are not readily apparent, presenting a confounding factor that is ideally controlled during clinical development.

Thus, improved solutions are needed to allow delivery profiles and methods used in early studies to be replicated in later studies with a single device, avoiding the need for in-human bridging studies and reducing drug-device approvability risk. Additionally, improved solutions are needed to ensure equivalent PK/PD and overall pharmacologic effect when an approved medication’s delivery device is changed, as through life-cycle management (LCM) activities.

SUMMARY

The present invention is directed to improved apparatus, systems, and methods to allow a first drug delivery device (the “replicating” device) to replicate a delivery profile associated with a second drug delivery device (the “reference” device).

More particularly, the replicated delivery profile provides a specific known drug deposition, and corresponding physiologic, pharmacokinetic, or pharmacodynamic effect. Critically, the replicating device can reproduce within reasonable bounds the delivery profile associated with a wide array of different reference devices’ fluidic motivation methods. In essence, the present invention allows a single replicating device to “mimic” the delivery profile (and thus PK/PD and overall pharmacologic effect) of one or more reference devices.

In particular, in a first aspect, the present disclosure provides a drug delivery device. The drug delivery device includes a drive mechanism, a battery configured to supply power to the drive mechanism, at least one memory storage element, at least one processor, and data storage including program instructions stored thereon that when executed by the at least one processor, cause the drug delivery device to perform functions. The functions include (i) accessing a drug delivery profile corresponding to a reference drug delivery device, (ii) replicating, via the at least one processor, a set of parameters associated with the drug delivery profile corresponding to the reference drug delivery device, and (iii) delivering a medicament via the drug delivery device according to the set of parameters.

In another example, the accessed drug delivery profile can be a drug delivery profile stored in an information tag on a disposable drug cassette received within the drug delivery device instead of the corresponding to a reference drug delivery device as mentioned above. Alternatively, the accessed drug delivery profile can be both the drug delivery profile stored in an information tag on a disposable drug cassette received within the drug delivery device and the information of the corresponding to a reference drug delivery device.

In one example of the first aspect, the drug delivery profile corresponding to the reference drug delivery device comprises an indication that the reference drug delivery device is flow rate regulated or an indication that the reference drug delivery device is pressure regulated. In another example of the first aspect, the drug delivery profile corresponding to the reference drug delivery device comprises an indication that a delivery regulation method of the reference drug delivery device is constant or an indication a delivery regulation method of the reference drug delivery device is transient.

In another example of the first aspect, the drug delivery profile corresponding to the reference drug delivery device is a function of one or more of a) a time, b) a dispensed medicament, c) a remaining medicament, d) a user input, e) a startup behavior, f) a steady-state behavior, g) a flow accuracy bound, or h) a flow continuity behavior.

In another example of the first aspect, the drug delivery profile corresponding to the reference drug delivery device includes information relating to changes in one or more of a) a device orientation, b) a head height, or c) a local atmospheric pressure.

In another example of the first aspect, the drug delivery profile corresponding to the reference drug delivery device includes information relating to one or more of a) an occlusion of the fluid delivery line, b) a presence of air bubbles in the fluid delivery line, or c) an accidental or intentional removal of an administration needle from the patient.

In another example of the first aspect, the drug delivery profile corresponding to the reference drug delivery device includes one or more patient-device interface parameters selected from a group consisting of a needle gauge, a wall thickness, an exposed length, a location, and a number of cannulae.

In another example of the first aspect, the set of parameters associated with the drug delivery profile include a desired flow accuracy and or a flow continuity target.

In another example of the first aspect, the drug delivery profile corresponding to the reference drug delivery device is accessed wirelessly at a point of dispensing. In another example of the first aspect, the drug delivery profile corresponding to the reference drug delivery device is accessed wirelessly at a point of care.

In another example of the first aspect, the program instructions further cause the drug delivery device to apply one or more corrective factors to maintain the set of parameters associated with the drug delivery profile in response to a change in a parameter during administration of the medicament via the drug delivery device.

In another example of the first aspect, the medicament comprises a first medicament in a medication administration sequence, and the program instructions further cause the drug delivery device to: (i) access a second drug delivery profile corresponding to a second reference drug delivery device, (ii) replicate, via the at least one processor of the drug delivery device, a second set of parameters associated with the second drug delivery profile corresponding to the second reference drug delivery device, and (iii) deliver a second medicament via the drug delivery device according to the second set of parameters.

In another example of the first aspect, the program instructions further cause the drug delivery device to: (i) access a third drug delivery profile corresponding to a third reference drug delivery device, (ii) replicate, via the at least one processor of the drug delivery device, a third set of parameters associated with the third drug delivery profile corresponding to the third reference drug delivery device, and (iii) deliver a third medicament via the drug delivery device according to the third set of parameters.

In a second aspect, the present disclosure provides a method comprising (i) accessing a drug delivery profile corresponding to a reference drug delivery device, (ii) replicating, via the at least one processor of a drug delivery device, a set of parameters associated with the drug delivery profile corresponding to the reference drug delivery device, and (iii) delivering a medicament via the drug delivery device according to the set of parameters.

In one example of the second aspect, the drug delivery profile corresponding to the reference drug delivery device comprises an indication that the reference drug delivery device is flow rate regulated or an indication that the reference drug delivery device is pressure regulated.

In another example of the second aspect, the drug delivery profile corresponding to the reference drug delivery device comprises an indication that a delivery regulation method of the reference drug delivery device is constant or an indication a delivery regulation method of the reference drug delivery device is transient.

In another example of the second aspect, the drug delivery profile corresponding to the reference drug delivery device is a function of one or more of a) a time, b) a dispensed medicament, c) a remaining medicament, d) a user input, e) a startup behavior, f) a steady-state behavior, g) a flow accuracy bound, or h) a flow continuity behavior.

In another example of the second aspect, the drug delivery profile corresponding to the reference drug delivery device includes information relating to changes in one or more of a) a device orientation, b) a head height, or c) a local atmospheric pressure.

In another example of the second aspect, the drug delivery profile corresponding to the reference drug delivery device includes information relating to one or more of a) an occlusion of the fluid delivery line, b) a presence of air bubbles in the fluid delivery line, or c) an accidental or intentional removal of an administration needle from the patient.

In another example of the second aspect, the drug delivery profile corresponding to the reference drug delivery device includes one or more patient-device interface parameters selected from a group consisting of a needle gauge, a wall thickness, an exposed length, a location, and a number of cannulae.

In another example of the second aspect, the set of parameters associated with the drug delivery profile include a desired flow accuracy and or a flow continuity target.

In another example of the second aspect, the method further includes applying one or more corrective factors to maintain the set of parameters associated with the drug delivery profile in response to a change in a parameter during administration of the medicament via the drug delivery device.

In another example of the second aspect, the medicament comprises a first medicament in a medication administration sequence, the method further includes: (i) accessing a second drug delivery profile corresponding to a second reference drug delivery device, (iii) replicating, via the at least one processor of the drug delivery device, a second set of parameters associated with the second drug delivery profile corresponding to the second reference drug delivery device, and (iii) delivering a second medicament via the drug delivery device according to the second set of parameters.

In another example of the second aspect, the method further includes (i) accessing a third drug delivery profile corresponding to a third reference drug delivery device, (ii) replicating, via the at least one processor of the drug delivery device, a third set of parameters associated with the third drug delivery profile corresponding to the third reference drug delivery device, and (iii) delivering a third medicament via the drug delivery device according to the third set of parameters.

These as well as other aspects, advantages, and alternatives, will become apparent to those of ordinary skill in the art by reading the following detailed description, with reference where appropriate to the accompanying drawings. BRIEF DESCRIPTION OF THE FIGURES

Figure 1 illustrates a stepwise process for traditional integration of a drug delivery device and candidate molecule, according to an example embodiment.

Figure 2 illustrates an illustrative example of a complete delivery profile for a representative device that may be used in early clinical trials or commercially approved molecules, according to an example embodiment.

Figure 3 illustrates a chart showing instantaneous flow error and thus, continuity of a drug delivery device, according to an example embodiment.

Figure 4 illustrates a chart showing the flow error rate of a drug delivery device over a range of observation windows in the form of a trumpet curve, according to an example embodiment.

Figure 5 illustrates a simplified block diagram of a medication delivery device, according to an example embodiment.

Figure 6 is a block diagram of a method for providing feedback for a rechargeable medication delivery device, according to an example embodiment.

DETAILED DESCRIPTION

Example methods and systems are described herein. It should be understood that the words “example,” “exemplary,” and “illustrative” are used herein to mean "serving as an example, instance, or illustration." Any embodiment or feature described herein as being an “example,” being “exemplary,” or being “illustrative” is not necessarily to be construed as preferred or advantageous over other embodiments or features. The example embodiments described herein are not meant to be limiting. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein.

Furthermore, the particular arrangements shown in the Figures should not be viewed as limiting. It should be understood that other embodiments may include more or less of each element shown in a given Figure. Further, some of the illustrated elements may be combined or omitted. Yet further, an example embodiment may include elements that are not illustrated in the Figures.

In Figure 6, referred to above, the blocks may represent operations and/or portions thereof and lines connecting the various blocks do not imply any particular order or dependency of the operations or portions thereof. It will be understood that not all dependencies among the various disclosed operations are necessarily represented. Figure 6 and the accompanying disclosure describing the operations of the method(s) set forth herein should not be interpreted as necessarily determining a sequence in which the operations are to be performed. Rather, although one illustrative order is indicated, it is to be understood that the sequence of the operations may be modified when appropriate. Accordingly, certain operations may be performed in a different order or simultaneously. Additionally, those skilled in the art will appreciate that not all operations described need be performed.

Unless otherwise indicated, the terms “first,” “second,” etc. are used herein merely as labels, and are not intended to impose ordinal, positional, or hierarchical requirements on the items to which these terms refer. Moreover, reference to, e.g., a “second” item does not require or preclude the existence of, e.g., a “first” or lower-numbered item, and/or, e.g., a “third” or higher-numbered item.

Reference herein to “one embodiment” or “one example” means that one or more feature, structure, or characteristic described in connection with the example is included in at least one implementation. The phrases “one embodiment” or “one example” in various places in the specification may or may not be referring to the same example.

As used herein, apparatus, element and method “configured to” perform a specified function is indeed capable of performing the specified function without any alteration, rather than merely having potential to perform the specified function after further modification. In other words, the apparatus, element, and method “configured to” perform a specified function is specifically selected, created, implemented, utilized, programmed, and/or designed for the purpose of performing the specified function. As used herein, “configured to” refers to existing characteristics of an apparatus, element, and method which enable the apparatus, element, and method to perform the specified function without further modification. For purposes of this disclosure, an apparatus, element, and method described as being “configured to” perform a particular function can additionally or alternatively be described as being “adapted to” and/or as being “operative to” perform that function.

Systems and methods of the present invention allow for determination of factors associated with use of a reference drug delivery device that affect flow of medication to a patient and deposition therein.

These factors are then used to provide a replicating device with a control system to mimic these parameters, and thus delivery to a patient, allowing the deposition and pharmacologic effect of the drug delivered with the reference device to be replicated with a different fluidic drive system. In a preferred embodiment, the present invention is implemented in the control system of a pneumatically-driven drug delivery system. One significant and unique advantage of the pressure drive concept is the ability to “match” drug deposition characteristics to an existing device that is either pressure-regulated or rate-regulated. As described later, the present invention may alternatively be implemented in the motor controller of an electromechanical device.

Crucially, the new device that is tasked with delivery profile “replication” must be capable of producing actively controlled flow-regulated injections (as required to replicate delivery profiles produced by syringe pumps or peristaltic pumps), and additionally be capable of producing actively controlled pressure-regulated injections (as required to replicate delivery profiles commonly produced by spring- or elastomer-driven systems). Preferably, the new device control system can additionally replicate transient profiles that vary with either time or dose delivered, such as a bolus-infusion profile or a spring-driven device that provides transient (non-constant) delivery pressure. The control system herein advantageously provides a single architecture usable from initial human clinical trials through commercial launch after drug approval. In some preferred embodiments, the control system is configured to replicate the control method(s) of a pressure or force-regulated fluid pump, for example, the Koru Freedom 6o/Freedom Edge, or Enable enFuse. In other embodiments, the control system is configured to replicate the control methods of a motor-driven drive, for example, West SmartDose, Eitan Medical Sorrel, Cane Medical Crono, or Phillips- Medisize Aria. The present method is not limited to a subset of devices - if the delivery profile can be characterized as described below, the present invention may be implemented in the pressure-driven system.

With reference to the figures, Figure 5 illustrates a simplified block diagram of a drug delivery device 100, according to an example embodiment. As shown in Figure 1, the drug delivery device 100 a drive mechanism 102 and a battery 104 configured to supply power to the drive mechanism 102. The drive mechanism 102 may comprise a motor, a fluid pump, or a pneumatic pressure-driven system, as non-limiting examples.

The drug delivery device 100 further includes at least one memory storage element 106. The at least one memory storage element 106 can include any type of memory now known or later developed including but not limited to volatile memory (such as RAM), non-volatile memory (such as ROM, flash memory, etc.) or any combination thereof. The drug delivery device 100 also includes at least one processor 108 and data storage no including program instructions 112 stored thereon that when executed by the at least one processor 108, cause the drug delivery device 100 to perform functions. Although various components of the drug delivery device 100 are shown as distributed components, it should be understood that any of such components maybe physically integrated and/or distributed according to the desired configuration of the system. Depending on the desired configuration, the at least one processor 108 can be any type of processor including, but not limited to, a microprocessor, a microcontroller, a digital signal processor, or any combination thereof.

In particular, the functions include (i) accessing a drug delivery profile corresponding to a reference drug delivery device, (ii) replicating, via the at least one processor 108, a set of parameters associated with the drug delivery profile corresponding to the reference drug delivery device, and (iii) delivering a medicament via the drug delivery device 100 according to the set of parameters.

In one example, the drug delivery profile corresponding to the reference drug delivery device comprises an indication that the reference drug delivery device is flow rate regulated or an indication that the reference drug delivery device is pressure regulated. In another example, the drug delivery profile corresponding to the reference drug delivery device comprises an indication that a delivery regulation method of the reference drug delivery device is constant or an indication a delivery regulation method of the reference drug delivery device is transient. In another example, the drug delivery profile corresponding to the reference drug delivery device is a function of one or more of a) a time, b) a dispensed medicament, c) a remaining medicament, d) a user input, e) a startup behavior, f) a steady-state behavior, g) a flow accuracy bound, or h) a flow continuity behavior.

In another example, the drug delivery profile corresponding to the reference drug delivery device includes information relating to changes in one or more of a) a device orientation, b) a head height, or c) a local atmospheric pressure. In another example, the drug delivery profile corresponding to the reference drug delivery device includes information relating to one or more of a) an occlusion of the fluid delivery line, b) a presence of air bubbles in the fluid delivery line, or c) an accidental or intentional removal of an administration needle from the patient. In another example, the drug delivery profile corresponding to the reference drug delivery device includes one or more patientdevice interface parameters selected from a group consisting of a needle gauge, a wall thickness, an exposed length, a location, and a number of cannulae.

In another example, the set of parameters associated with the drug delivery profile include a desired flow accuracy and or a flow continuity target. Such an arrangement ensures that the set of parameters associated with the delivery profile of the first reference drug delivery device are replicated in the delivery device too within reasonable boundaries, based on the accuracy burden(s), clinical requirements, and performance of the reference device. In one example, replicating the set of parameters associated with the drug delivery profile corresponding to the reference drug delivery device includes replicating the response of the first drug reference delivery device to line occlusion, air bubble detection, and/or needle removal in the drug delivery device too.

In one example, the drug delivery device too is used to detect and/or respond to line occlusion, air bubble detection, or needle removal during administration of a medication to a patient, in a manner that replicates the behavior of the reference drug delivery device.

In one example, the drug delivery device too is used to detect a parameter change altering the delivery profile of the reference drug delivery device. In one such example, the program instructions 116 further cause the drug delivery device 100 to apply one or more corrective factors to maintain the set of parameters associated with the drug delivery profile in response to a change in a parameter during administration of the medicament via the drug delivery device 100. In one example, the drug delivery device too further includes a communication interface 114 configured to receive information from an external device 101 using a communication link 116, such as a wired or wireless connection. Such information may include the drug delivery profile corresponding to the reference drug delivery device. The external device 101 may be any type of device that can receive data and display information corresponding to or associated with the data. For example, the external device 101 maybe a mobile phone, a tablet, or a personal computer as examples.

The communication interface 122 and external device 101 may contain hardware to enable a communication link therebetween, such as processors, transmitters, receivers, antennas, etc., as discussed above. In one example, the communication link between the communication interface 114 and the external device is a wired connection. In another example, the communication link between the communication interface 114 and the external device 101 is a wireless connection such as radio frequency identification (RFID), near-field communication (NFC), Bluetooth, Bluetooth low energy (BLE), Ultra wide band (UWB), wireless fidelity (Wi-Fi), cellular communication, and infrared (IR), as nonlimiting examples.

In one example, the drug delivery device 100 is pre-configured at the point of dispensing to deliver medication to a patient according to the replicated profile of the reference drug delivery device using near field communication methods and an encoding “token” provided by the drug manufacturer, device manufacturer, HCP, prescribing facility, or dispensing facility. In another example, the drug delivery device 100 is preconfigured at the point of care to deliver medication to a patient according to the replicated profile of the reference drug delivery device using near field communication methods and an encoding “token” provided by the drug manufacturer, device manufacturer, HCP, prescribing facility, or dispensing facility.

In another example, the drug delivery device too is pre-configured at either the point of dispensing or at the point of care using other means of system configuration, such as via a companion software application or software system which may communicate via cable (hard-wired), Bluetooth, Wi-Fi, cellular network, near-field communication, or other means. In yet another example, the drug delivery device too is pre-configured remotely by the drug manufacturer, device manufacturer, HCP, prescribing facility, or dispensing facility such as via a companion software application or software system which may communicate via cable (hard-wired), Bluetooth, Wi-Fi, cellular network, near-field communication, or other means. As such, the drug delivery device too may be configured during manufacturing with the memory of several "pre-loaded" delivery profiles of applicable reference devices.

In one example, the medicament comprises a first medicament in a medication administration sequence. In such an example, the program instructions 116 further include (i) accessing a second drug delivery profile corresponding to a second reference drug delivery device, (ii) replicating, via the at least one processor of the drug delivery device, a second set of parameters associated with the second drug delivery profile corresponding to the second reference drug delivery device, and (iii) delivering a second medicament via the drug delivery device according to the second set of parameters. In another example, the the program instructions 116 further include (i) accessing a third drug delivery profile corresponding to a third reference drug delivery device, (ii) replicating, via the at least one processor of the drug delivery device, a third set of parameters associated with the third drug delivery profile corresponding to the third reference drug delivery device, and (iii) delivering a third medicament via the drug delivery device according to the third set of parameters.

Figure 6 is a block diagram of an example method 200, according to an example embodiment. Method 300 shown in Figure 6 presents an embodiment of a method that could be used by the drug delivery device 100 as described in Figure 5, as examples. Method 200 may include one or more operations, functions, or actions as illustrated by one or more of blocks 202-206. Although the blocks are illustrated in a sequential order, these blocks may also be performed in parallel, and/or in a different order than those described herein. Also, the various blocks may be combined into fewer blocks, divided into additional blocks, and/or removed based upon the desired implementation.

In addition, for the method 200 and other processes and methods disclosed herein, the block diagram shows functionality and operation of one possible implementation of present embodiments. In this regard, each block may represent a module, a segment, or a portion of program code, which includes one or more instructions executable by a processor or computing device for implementing specific logical functions or steps in the process. The program code maybe stored on any type of computer readable medium, for example, such as a storage device including a disk or hard drive. The computer readable medium may include non-transitory computer readable medium, for example, such as computer- readable media that stores data for short periods of time like register memory, processor cache and Random Access Memory (RAM). The computer readable medium may also include non-transitory media, such as secondary or persistent long term storage, like read only memory (ROM), optical or magnetic disks, compact-disc read only memory (CD-ROM), for example. The computer readable media may also be any other volatile or non-volatile storage systems. The computer readable medium may be considered a computer readable storage medium, for example, or a tangible storage device.

Initially, at block 202, the method 200 includes accessing a drug delivery profile corresponding to a reference drug delivery device. At block 204, the method 200 includes replicating, via the at least one processor 108 of a drug delivery device 100, a set of parameters associated with the drug delivery profile corresponding to the reference drug delivery device. At block 206, the method 200 includes delivering a medicament via the drug delivery device 100 according to the set of parameters.

In another example, the drug delivery profile corresponding to the reference drug delivery device includes information relating to changes in one or more of a) a device orientation, b) a head height, or c) a local atmospheric pressure. In another example, the drug delivery profile corresponding to the reference drug delivery device includes information relating to one or more of a) an occlusion of the fluid delivery line, b) a presence of air bubbles in the fluid delivery line, or c) an accidental or intentional removal of an administration needle from the patient. In another example, the drug delivery profile corresponding to the reference drug delivery device includes one or more patientdevice interface parameters selected from a group consisting of a needle gauge, a wall thickness, an exposed length, a location, and a number of cannulae. In another example, the set of parameters associated with the drug delivery profile include a desired flow accuracy and or a flow continuity target.

In one example, the method 200 further includes applying one or more corrective factors to maintain the set of parameters associated with the drug delivery profile in response to a change in a parameter during administration of the medicament via the drug delivery device 100.

In one example, the method 200 further includes performing on-bench comparative validation testing to identify the drug delivery device 100 is reasonably equivalent to the reference drug deliveiy device on the replicated parameters. In another example, the method 200 further includes performing human clinical trial testing to compare the replicating delivery device to the reference drug deliveiy device based on one or more pharmacokinetic parameters such as bioavailability, C max, Ctrough, Caverage, Tmax, Tmin, and/or area under the concentration-time curve (AUC).

In one example, the medicament comprises a first medicament in a medication administration sequence. In such an example, the method 200 may further include (i) accessing a second drug delivery profile corresponding to a second reference drug delivery device, (ii) replicating, via the at least one processor of the drug delivery device, a second set of parameters associated with the second drug delivery profile corresponding to the second reference drug delivery device, and (iii) delivering a second medicament via the drug delivery device according to the second set of parameters. In another example, the method 200 further includes (i) accessing a third drug delivery profile corresponding to a third reference drug delivery device, (ii) replicating, via the at least one processor of the drug delivery device, a third set of parameters associated with the third drug delivery profile corresponding to the third reference drug delivery device, and (iii) delivering a third medicament via the drug delivery device according to the third set of parameters.

Various Examples will now be described in additional detail. The Examples are representative in nature and are no way exhaustive or limiting.

Example 1; Replication of Single Device

The simplest case is replication of a single drug delivery device 100 by the at least one processor, allowing a second (replicating) drug delivery device 100 to replicate a delivery profile associated with a first (reference) drug delivery device. This approach to developing, implementing, and verifying the replicating drug delivery device 100 is described in relation to Figures 5-6 above.

Example 2; Use in Clinical Trial for Elimination of Bridging Studies

This provides immense flexibility to bridge between devices (either clinical trial to commercial, or between devices as part of life cycle management activities). The concept may facilitate much simpler bioequivalence studies to demonstrate SC drug deposition, PK/PD, safety, or efficacy equivalence between devices (“bridging”). This maybe done by programming a pneumatically-driven controller to replicate the profile of a desired prior device.

Some embodiments of the present invention are directed to use of the replicating device’s control system(s) to deliver one or more investigational medicines during a clinical trial. More particularly, the control system(s) may be implemented in a novel replicating delivery device to provide the same underlying drug deposition, PK/PD, and overall pharmacologic effect as a prior rate-regulated or pressure-regulated reference delivery device either used in a prior human clinical trial or anticipated for use in a future human clinical trial.

Some embodiments of the present invention are directed to eliminate the need for in-human bioequivalence (“bridging”) studies to demonstrate SC drug deposition equivalence between a prior and new drug delivery device. More particularly, rather than relying on human clinical trials, the drug delivery profile for a prior device is determined through mechanical (lab-bench) testing, programmed into the drive controller of the new device, and then replicated by the new device during medication delivery to a patient. Put another way, the only “bridging” required is verification that the delivery profile is indeed replicated, which is a bench-top test.

Example a: Replication of Multiple Different Devices for Multiple Medications

Examples i and 2 above focus on a single medication delivered by a single reference device, and mimicry of the delivery profile by the replicating device. However, not all patients are candidates to receive therapy with a single device. Some patients require complex, ongoing treatment to manage their conditions. Such treatments may include individual medications or multi-medication regimens given by one or more routes of administration. Each of these may be given with a different medication delivery device. Medication regimens may also change during the course of therapy, as with oncology regimens.

The present invention may be applied to deliver a medication regimen where multiple reference devices are present by sequentially applying the methods of Embodiment #1, and then independently changing modes of the pneumatic drive system for each, replicating each reference device in turn; examples are shown in Table 1. It may be seen that three different device drive mechanisms are used by the reference devices, but the pneumatic-driven system may replicate these devices with a single underlying drive system, and in the same device, simply by varying the controller behavior as each medication is sequenced.

Table i

In applying the concept of Example 1 to Example 3, it may be seen that each of these devices may have different optional behaviors included. For instance, it is unlikely to include occlusion detection with the replicating system during administration of Medication 1.

However, in the case of Medication 3, it may be advantageous not only replicate the delivery profile and behavior, but also to include occlusion detection or needle dislodgement detection (whether partial or complete dislodgement), even if this functionality is not present in the reference device. Put another way, replication need not be a facsimile - the replicated behavior and performance maybe better than that in one or more reference devices. Similarly, the drug delivery device of the disclosure can be a two-parts drug delivery system including a drive unit to be paired with a disposable drug cassette. The drive unit comprises the drive mechanism, the battery, the memory, the processor, the data storage as mentioned above. The drug cassette comprises a drug held in a container, e.g., a flexible bag, the drug cassette comprises an infusion set, e.g., RFID tag.

In this example, to deliver the drug, the two units are combined to form a complete infusion system. Drug is infused by drive mechanism, e.g., pumping air. The infusion is controlled by the drive unit using. Important parameters are cassette and ambient pressure, volume/mass of air pumped, temperature, fluid flow, dispensed volume over time. The system can handle a sequence of cassettes to be mounted in specific order (under supervision by the drive unit). Each cassette is associated with sequence information as well as the cassette specific infusion parameters. Sequence information and configurable parameters of how to perform the infusion may be a) stored on the cassette rfid tag, read by drive unit when cassette is mounted; b) pre-defined in drive unit memory; and/or c) downloaded via wireless connection from a back-end system.

A certain treatment could mean that multiple cassettes are mounted. The “cassette sequence” has certain parameters related to the drug; the order of cassettes included in the sequence and if there is a required time delay between cassettes. A “cassette sequence” is defined as the overlying system sequence in a multi-cassette scenario. An “infusion sequence” is defined as the sequence related to a single cassette infusion; pressure-, volume-, flow calculations, detecting events from start to finish, per cassette. In a multi-cassette scenario, there would be one cassette sequence and multiple infusion sequences (one per cassette in the sequence). The most basic representation of parameters needed, to be supplied with every cassette. For example, a first cassette is configured to be delivered before a second cassette. The first cassette is configured to be delivered with the flowrate of iml/minute. The second cassette is configured to be delivered with the flowrate of 2ml/minute. Alternatively, or additionally, the multiple drugs information from multiple cassettes respectively are shown in Table 2.

Table 2

Furthermore, the underlying mechanism is based on a mathematical function that could represent the desired behavior. The array decimals are coefficients to that function. In some cases, the setpoint can be tailored to the needs by having varying number of decimals involved, still using the same mathematical function. For example, the order polynomial function:

Having this mechanism will allow a simple static setpoint as well as a dynamic setpoint changing over time according to a desired shape. The difference will be the number of significant values (polynomial coefficients) supplied. Some examples shown in Tables 3-7.

Table 3

Table 4

Table 5

Table 6: Example Cassette 1

Table 7: Example Cassette 2 In this example as shown in Tables 6-7, the two cassettes operate in a, by the control system, strict sequence; Start with cassette 1 then cassette 2 with a 10 minute delay in between. For Cassette 1, the operation of the drug delivery device can be set as:

1: Start pumping with 80% power until 200 mbar is reached

2: Use “flow-via-pressure” control, 1 ml/min, until 40 ml has been dispensed.

For Cassette 2, the operation of the drug delivery device can be set as:

1: Use pressure control as method, start the pump and set 225 mbar as a fixed target. Stop at when 225 mbar is reached.

2: Use pressure control with a varying setpoint as a function of time using all the coefficient supplied (5: th order poly). Continue until 40 ml has been dispensed.

3: Use pressure control with varying setpoint as a function of time using two coefficients (linear function). Stop after 60 seconds.

Example 4: Transition of On-Market Products to Pneumatically-

Driven System

There is often a need to transition a medication delivery device to an alternative delivery device. This can take place in the case of:

• Device supply shortages, where medication delivery is required, the medication is available, and the devices (or components, such as tubing) is not available due to backorder, recall, or other issues;

• Single-medication life-cycle management, where an older device in a reference commercial presentation is to be transitioned to a newer device (e.g., pneumatic system); • Multi-medication life-cycle management, in a reference commercial presentation is to be transitioned to a newer device (e.g., pneumatic system) in order to accommodate changes to competitive landscape or therapy regimen to include multiple medications for improved efficacy and/or competitiveness.

In the case of a supply shortage or single-medication life-cycle management, it becomes advantageous to have the ability to mimic key injection parameters in a replicating device with the intention of avoiding the burden of a bridging study. This allows device equivalency to be assessed via benchtop testing instead of in a costly trial. The replicating, or mimicking, device can then be brought to market in place of the original, no longer available device. Put another way, the replicating device of Embodiment #3 may be used to provide continuity of drug delivery if desired, providing an inherent dual-sourcing strategy even though the underlying drive principle is different from the reference.

Therapy regimens may evolve over time to include multiple medications, as is common in oncology. However, single-medication devices are not readily changed to multi-drug configurations, and new delivery devices may be needed. It is advantageous in these cases to replicate the previously single drug delivery profile to avoid new characterization work, and also use the pneumatically-driven system to deliver the additional (new) medications in the regimen. The latter new medications need not use the replication features described previously if this feature is not required. Thus, Example 4 may include either a) fully replicated behavior for all medications or b) combinations of replicated and non-replicated medications in a regimen. It will be obvious that each medication may have a different device replicate if desired as well, allowing multiple medications to each be delivered as they were in a single-medication configuration previously.

Example 5; Proactive use for device selection

As described previously, during Phase 1 and 2 studies, “proxy” devices are often used as a stand-in for the eventual combination product device not yet being sufficiently mature to a) put in front of patients due to incomplete verification and/or approval, b) supply the clinical trials in the appropriate volumes. Furthermore, the trial sponsor may in fact be considering two or more commercial device candidates which offer unique and exclusive benefits over each other. It is foreseeable that these devices under consideration for commercial presentation have different drive mechanisms.

For example, there may be one syringe-pump-driven device with connectivity advantages, and another elastomeric pump with attractive usability affordances. One or both of those candidates may be unavailable during Phase 1 and 2 (e.g., due to long customization timelines for a drug-device combination product), but the sponsor maybe interested in assessing the PK of one delivery method against the other (flow rate regulation against pressure regulation), all other factors (peripheral feature-sets, commercial drivers, etc.) held equal. In this setting, the mimicking device would be used in Phase 1 and/or 2, to study the delivery profiles and PK of the two (or more) candidate delivery systems’ drive methods.

Notably, all other device factors (form, use experience, filling burden) could be identical between the two arms of the study. This way, relative efficacy and outcomes attributable to the drive methods themselves can be assessed truly independently to more effectively down-select from the candidate devices to the commercial single device. Of course, this down-selection may consider the peripheral attributes inherent to the candidate devices such as usability, patient or HCP preference, cost, distribution methods and infrastructure, or device availability timelines.

Example 6; Use for Delivery Profile Optimization

Since delivery devices used in a clinical trial have a “fixed” delivery profile based on the underlying pump principle of operation, the delivery profile is rarely tested or optimized during clinical development. However, the present invention may be used if desired to explore and ultimately select the optimal delivery profile for a desired candidate molecule by:

1. Performing initial human clinical trials or in silico PK/PD modeling to determine an initial or hypothetical human PK/PD response to a candidate medication

2. Determining a set of candidate delivery profiles for the medication, based on the modeling data

3. Configuring the controller to deliver a candidate medication according to one or more candidate delivery profiles

4. Administering the candidate medication according to a candidate delivery profile

5. Measuring the PK/PD parameters (e.g., Cmax, Ctrough, Caverage, Tmax, Tmin, AUC, receptor binding, EC50, LC50, therapeutic window) of interest before, during, or after administration

6. Selecting the optimal delivery profile based on optimal PK/PD profile, or minimized side effects (e.g., pain, injection site reaction, infusion reaction) 7. Configuring a pump or injector for use in a product presentation in future clinical trial(s) or commercial presentation(s).

Example 7: Use for Biosimilar Life Cycle Management

Embodiments #3 & 4 discuss examples of life cycle strategies that are likely to be conducted by the innovator of a molecule. However, biosimilar medications (medications which are near copies of an original biologic made by a different manufacturer) may also be used with the present invention. To be called a biosimilar drug, a biological drug must have no clinically meaningful differences in terms of safety, purity, and potency (i.e., effectiveness) when compared to an innovator product. The present invention may be used with biosimilar medications in two ways.

First, the present invention may be used to replicate the delivery device characteristics of the innovator product as part of an overall determination that the product is safe and effective. For instance, the innovator product maybe cleared for use with the Koru Freedom6o system, and the present invention maybe used to replicate the Freedom6o’s delivery profile for the biosimilar. The present invention may be used in clinical trials and/or the commercial product as desired.

Secondly, the present invention may be used to support filing and approval as an interchangeable biosimilar, a higher regulatory standard than simple biosimilarity. Interchangeability refers to approval whereby the biosimilar may be substituted for the reference product without the intervention of the prescribing health care provider. To achieve this designation, a biosimilar manufacturer must demonstrate that the risk in terms of safety or diminished efficacy of alternating or switching between the interchangeable biosimilar and the innovator product is not greater than the risk of using the reference product without such alternation or switch. This typically requires a switching study, where patients are crossed over between innovator and biosimilar products to surface any difference that could affect safety and efficacy (e.g., in this instance, a different delivery profile that could alter drug deposition and PK/PD). The present invention may be used to implement complete replication of the innovator delivery device.

Example 8; Use with Motor-Driven Systems

While much of the core disclosure focuses on the implementation of device mimicry in the context of a pneumatically-driven replicating device, this need not be the case in all instances. This is particularly true when volumes are small, and can be delivered with a handheld device, such as an electromechanical autoinjector. These devices typically have a powerful electric motor and controller circuit that may be programmed to vary the flow-rate regulated delivery profile. While prior art devices are focused on providing an approximately autoinjector-like (e.g., average flow rate) delivery profile, nothing precludes these devices from being programmed similarly to the controller of a pneumatically-driven system with the proper feedback elements implemented. Motor position feedback can allow for displacement- or rate-regulated system feedback and corresponding closed-loop control, while implementing a force or pressure sensor allows for syringe pressure feedback, and in turn, closed-loop pressure control, which would enable the replicating device to mimic the spring decay behavior seen in mechanical autoinjectors common in the art.

In this instance, the method of Example 1 maybe adapted to the electronic motor controller. The desired characteristics of the reference device may be determined as previously described; the controller of the electromechanical device would then be configured with these profiles for delivery replication. Depending on the characteristics of the motor controller and motor, optional aspects of Example 1 may be implemented. For instance, current draw of the motor may be monitored as a correlate of syringe pressure to identify an occlusion, or a force sensor may be included to identify changes in backpressure corresponding to an occlusion or needle dislodgement.

Example 9; Use for Reducing Facility Stocking Burden

The present invention is largely focused on replicating the profile of a drug delivery device presented in a drug-device combination product, for the benefit of device LCM, clinical trials, and delivery optimization. However, as the pneumatically-driven system can replicate the dispense behavior or profile within reason of most (if not all) known SC delivery devices, it opens the possibility for the system to act as a device “generic,” configurable to replicate any delivery device of interest. Via this capability, it may be possible to establish “interchangeability” with specific devices, much in the way many infusion pumps are considered “interchangeable.” With this disposition, the present invention could be “swapped in” in place of the original combination product device, provided the reference device profile has been previously verified on the replicating device, and provided the delivery container is compatible with the delivery device or accessible by pharmacy to allow for pharmacy transfer to a compatible container. In this way, dispensing facilities may be able to substantially reduce or eliminate the storage burden of several different types of devices that individually correspond to only a small number or even a single drug.

When the device of the present invention is dispensed, the dispensing facility can select from a list, or otherwise configure, which reference device the replicating device should mimic for the subsequent dispense, dispenses, or until the next time its delivery mode is configured.

It will be appreciated that other arrangements are possible as well, including some arrangements that involve more or fewer steps than those described above, or steps in a different order than those described above.

While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. All embodiments within and between different aspects of the devices and methods can be combined unless the context clearly dictates otherwise. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the claims.

Other aspects of the invention are defined in the following clauses.

1. A drug delivery device (too), comprising: a drive mechanism (102); a battery (104) configured to supply power to the drive mechanism (102); at least one memory storage element (106); at least one processor (108); and data storage (no) including program instructions (112) stored thereon that when executed by the at least one processor (108), cause the drug delivery device (100) to: access (202) a drug delivery profile corresponding to a reference drug delivery device; replicate (204), via the at least one processor (108), a set of parameters associated with the drug delivery profile corresponding to the reference drug delivery device (100); and deliver (206) a medicament via the drug delivery device (100) according to the set of parameters.

2. The drug delivery device (100) of clause 1, wherein the drug delivery profile corresponding to the reference drug delivery device (100) comprises an indication that the reference drug delivery device (100) is flow rate regulated or an indication that the reference drug delivery device is pressure regulated.

3. The drug delivery device (100) of any one of clauses 1-2, wherein the drug delivery profile corresponding to the reference drug delivery device comprises an indication that a delivery regulation method of the reference drug delivery device is constant or an indication a delivery regulation method of the reference drug delivery device is transient.

4. The drug delivery device (100) of any one of clauses 1-3, wherein the drug delivery profile corresponding to the reference drug delivery device is a function of one or more of a) a time, b) a dispensed medicament, c) a remaining medicament, d) a user input, e) a startup behavior, f) a steady-state behavior, g) a flow accuracy bound, or h) a flow continuity behavior.

5. The drug delivery device (100) of any one of clauses 1-4, wherein the drug delivery profile corresponding to the reference drug delivery device includes information relating to changes in one or more of a) a device orientation, b) a head height, or c) a local atmospheric pressure.

6. The drug delivery device (100) of any one of clauses 1-5, wherein the drug delivery profile corresponding to the reference drug delivery device includes information relating to one or more of a) an occlusion of the fluid delivery line, b) a presence of air bubbles in the fluid delivery line, or c) an accidental or intentional removal of an administration needle from the patient.

7. The drug delivery device (100) of any one of clauses 1-6, wherein the drug delivery profile corresponding to the reference drug delivery device includes one or more patient-device interface parameters selected from a group consisting of a needle gauge, a wall thickness, an exposed length, a location, and a number of cannulae.

8. The drug delivery device (100) of any one of clauses 1-7, wherein the set of parameters associated with the drug delivery profile include a desired flow accuracy and or a flow continuity target.

9. The drug delivery device (100) of any one of clauses 1-8, wherein the drug delivery profile corresponding to the reference drug delivery device is accessed wirelessly at a point of dispensing.

10. The drug delivery device (100) of any one of clauses 1-8, wherein the drug delivery profile corresponding to the reference drug delivery device (100) is accessed wirelessly at a point of care.

11. The drug delivery device (100) of any one of clauses 1-10, wherein the program instructions (112) further cause the drug delivery device to: apply one or more corrective factors to maintain the set of parameters associated with the drug delivery profile in response to a change in a parameter during administration of the medicament via the drug delivery device.

12. The drug delivery device (100) of any one of clauses 1-11, wherein the medicament comprises a first medicament in a medication administration sequence, and wherein the program instructions (112) further cause the drug delivery device (100) to: access (202) a second drug delivery profile corresponding to a second reference drug delivery device; replicate (204), via the at least one processor of the drug delivery device, a second set of parameters associated with the second drug delivery profile corresponding to the second reference drug delivery device; and deliver (206) a second medicament via the drug delivery device (100) according to the second set of parameters.

13. The drug delivery device (100) of clause 12, wherein the program instructions (112) further cause the drug delivery device (100) to: access (202) a third drug delivery profile corresponding to a third reference drug delivery device; replicate (204), via the at least one processor of the drug delivery device, a third set of parameters associated with the third drug delivery profile corresponding to the third reference drug delivery device; and deliver (206) a third medicament via the drug delivery device (100) according to the third set of parameters.

14. A method (200) comprising: accessing (202) a drug delivery profile corresponding to a reference drug delivery device; replicating (204), via the at least one processor of a drug delivery device, a set of parameters associated with the drug delivery profile corresponding to the reference drug delivery device; and delivering (206) a medicament via the drug delivery device according to the set of parameters. 15- The method (200) of clause 14, wherein the drug delivery profile corresponding to the reference drug delivery device (100) comprises an indication that the reference drug delivery device is flow rate regulated or an indication that the reference drug delivery device is pressure regulated.

Claims

1. A drug delivery device (ioo), comprising: a drive mechanism (102); a battery (104) configured to supply power to the drive mechanism (102); at least one memory storage element (106); at least one processor (108); and data storage (no) including program instructions (112) stored thereon that when executed by the at least one processor (108), cause the drug delivery device (100) to: access (202): a drug delivery profile corresponding to a reference drug delivery device; and/or a drug delivery profile stored in an information tag on a disposable drug cassette received within the drug delivery device; replicate (204), via the at least one processor (108), a set of parameters associated with the accessed drug delivery profile; and deliver (206) a medicament via the drug delivery device (100) according to the set of parameters.

2. The drug delivery device (100) of claim 1, wherein the accessed drug delivery profile corresponding to the reference drug delivery device (100) comprises an indication that the reference drug delivery device (100) is flow rate regulated or an indication that the reference drug delivery device is pressure regulated.

3. The drug delivery device (100) of any one of claims 1-2, wherein the drug delivery profile corresponding to the reference drug delivery device comprises an indication that a delivery regulation method of the reference drug delivery device is constant or an indication a delivery regulation method of the reference drug delivery device is transient.

4. The drug delivery device (100) of any one of claims 1-3, wherein the accessed drug delivery profile is a function of one or more of a) a time, b) a dispensed medicament, c) a remaining medicament, d) a user input, e) a startup behavior, f) a steady-state behavior, g) a flow accuracy bound, or h) a flow continuity behavior.

5. The drug delivery device (100) of any one of claims 1-4, wherein the accessed drug delivery profile includes information relating to changes in one or more of a) a device orientation, b) a head height, or c) a local atmospheric pressure.

6. The drug delivery device (100) of any one of claims 1-5, wherein the accessed drug delivery profile includes information relating to one or more of a) an occlusion of the fluid delivery line, b) a presence of air bubbles in the fluid delivery line, or c) an accidental or intentional removal of an administration needle from the patient.

7. The drug delivery device (100) of any one of claims 1-6, wherein the drug delivery profile corresponding to the reference drug delivery device includes one or more patient-device interface parameters selected from a group consisting of a needle gauge, a wall thickness, an exposed length, a location, and a number of cannulae.

8. The drug delivery device (100) of any one of claims 1-7, wherein the set of parameters associated with the accessed drug delivery profile include a desired flow accuracy and or a flow continuity target.

9. The drug delivery device (100) of any one of claims 1-8, wherein the accessed drug delivery profile is accessed wirelessly at a point of dispensing.

10. The drug delivery device (100) of any one of claims 1-8, wherein the accessed drug delivery profile is accessed wirelessly at a point of care.

11. The drug delivery device (100) of any one of claims 1-10, wherein the program instructions (112) further cause the drug delivery device to: apply one or more corrective factors to maintain the set of parameters associated with the drug delivery profile in response to a change in a parameter during administration of the medicament via the drug delivery device.

12. The drug delivery device (100) of any one of claims 1-11, wherein the medicament comprises a first medicament in a medication administration sequence, and wherein the program instructions (112) further cause the drug delivery device (100) to: access (202) a second drug delivery profile corresponding to a second reference drug delivery device; replicate (204), via the at least one processor of the drug delivery device, a second set of parameters associated with the second drug delivery profile corresponding to the second reference drug delivery device; and deliver (206) a second medicament via the drug delivery device (100) according to the second set of parameters.

13. The drug delivery device (100) of claim 12, wherein the program instructions (112) further cause the drug delivery device (100) to: access (202) a third drug delivery profile corresponding to a third reference drug delivery device; replicate (204), via the at least one processor of the drug delivery device, a third set of parameters associated with the third drug delivery profile corresponding to the third reference drug delivery device; and deliver (206) a third medicament via the drug delivery device (100) according to the third set of parameters.

14. A method (200) comprising: accessing (202) a drug delivery profile corresponding to a reference drug delivery device; replicating (204), via the at least one processor of a drug delivery device, a set of parameters associated with the drug delivery profile corresponding to the reference drug delivery device; and delivering (206) a medicament via the drug delivery device according to the set of parameters. 15- The method (200) of claim 14, wherein the drug delivery profile corresponding to the reference drug delivery device (100) comprises an indication that the reference drug delivery device is flow rate regulated or an indication that the reference drug delivery device is pressure regulated.