New Drug Development: What To Do Internally & What To Outsource

Technology startups in pharmaceutical production have numerous challenges in bringing a new drug to market. Often, these startups are the brainchild of a scientist who decides to monetize a new medical discovery.

Such a person has considerable intellectual capital, but such a person cannot bring a pharmaceutical product to market singlehandedly. They say it takes a village to raise a child. It also takes a team to bring a new drug to market.

The most important element of this R&D step is to understand that your therapeutic or technology is solving a real problem that the market will embrace. Without this marketability your technology may be stuck in a laboratory.

This article will help you to learn how to manage the complex ecosystem of regulatory, scientific, and technical needs for any drug to get to market or be licensed to a larger company. Our experts have helped hundreds of companies through the FDA challenges.

Phases Of Drug Development

Scientific know-how may not translate into knowledge of accepted norms of pharmaceutical development practice. Obtaining a patent on a new API is just the starting-point of discovery.

R & D Studies

R&D studies need to take place to identify optimal dosage.

Additionally, studies need to take place to characterize dissolution, formulation, stability, impurity profiles, efficacy, toxicity, etc.

These are studies only at the Pre-Clinical stage – all of which need to be conducted under strict GLP conditions, using qualified equipment in controlled environments while observing data integrity, and with trained scientists who cross-check each other’s work.

Development Procedures

Procedures need to be developed for assuring the reliability of the results of the pre-clinical studies to ensure that the product is ready for clinicals.

Establishing Ownership

Startup companies need to have ownership over their technology and how it is used, so preclinical development can and should be done internally. Small startups, however, have a knowledge gap, so outsourcing some activities may ensure faster development because it prevents the need to repeat poorly-executed studies.

Pre-Clinical Outsourcing

Pre-clinical outsourcing may involve hiring laboratory assistants, performance of animal studies, technical writers for the numerous SOPs to be developed, validation experts for qualifying the laboratory instruments/equipment, and auditors to ensure that procedures are followed and laboratory staff understand and adopt GLP principles.

Drug Performance

Next on the pharmaceutical journey is the development and implementation of clinical protocols and clinical studies to determine how the new drug performs in a human population.

Submission For IND

Part of this process involves submission for an Investigational New Drug (IND), which requires assembly of an Investigational Review Board (IRB) a body whose function is to ensure that clinical protocols are followed and that the clinical protocol meets Informed Consent requirements, in a way that prevents violation of patient rights.

Testing

This will include identifying Study Directors and clinical sites, ensuring that the studies encompass a variety of demographic and genetic subgroups, and if study subjects are compensated for their participation in the study, that their participation and compensation is not tethered to the success or failure of the drug trial.

Stay Off Disbarment List

It is particularly important that study directors recruited for the study are competent and understand the principles for ethical drug trials. The FDA has a rather lengthy “Debarment List” of clinical study investigators who failed to adhere to clinical trial requirements.

At the clinical phase, the activities that might be outsourced may include submission of the IND application, design of the clinical study, and hiring of clinical study monitoring staff. Due to the double-blind, placebo-controlled study requirements, direct clinical interaction with the patients has restrictions, and some of these activities may need to be outsourced purely to prevent conflicts of interest.

Production

While each of the three phases of clinical trials ensue, the bench-scale, and later, pilot-scale versions of the pharmaceutical products need to be brought to full production-scale.

Automation

Steps that may have been manually-performed will need to be automated, which means that validations will be needed to ensure consistent performance of the equipment within the stated process requirements.

Validation

QA and QC requirements will need to be developed and laboratory equipment and test methods for quality release will need to be validated.

Depending on the nature of the product, from simple (topical ointment) to complex (intravenous biologics) each step of the manufacturing and testing process needs to be validated to ensure that the product, as manufactured, is safe and effective, and therefore suitable for its intended use. This step does involve considerable business risk for the company. If the clinical trials fail, the money invested in developing manufacturing and test methods is wasted.

Project Management Is Crucial

So during the drug manufacturing and scale-up phase, it is essential to have a great project manager on your team, and the best type of project manager is one who is familiar with pharmaceutical projects. Often these types of individuals are from the outside, as they have years of experience with numerous pharmaceutical development projects.

Consultants For Drug Production

Other consultants include chemists for developing laboratory methods, chemical engineers for designing scale-up equipment, development of packaging systems and track-and-trace compliance.

Importantly, all these systems require validation, and validation consultants are needed to ensure the equipment, facilities, utilities and computerized systems involved in the manufacturing and quality control have undergone documented testing to assure these systems are suitable.

Other outsourced staff may involve technical writers who develop procedures and processes for operating all these systems in a manner that complies with FDA or other applicable regulations in the various countries where the pharmaceutical is intended to be marketed.

How To Market A New Drug

Finally, in the realm of pharmaceutical development, regulatory affairs constitutes the final requirement that allows that fully-developed pharmaceutical product to be marketed in the chosen location for its sale.

Earlier, the IND application for Investigational New Drug was discussed, but the data collected during clinical trials, as well as the final manufacturing and test methods, and validation data must be compiled into a dossier that is presented to the regulatory authorities in the defined locales where the drug product is intended for sale.

Regulatory Expertise Is Key

The process can be drawn out, especially for a novel new drug that carries significant risks. Regulatory expertise is often outsourced to identify the best strategy for marketing a new drug and will consider the country’s requirements for sales and marketing, the potential for sales volume and profitability, as well as the speed at which the regulating body is likely to approve.

Post-Market Analysis

In addition to the initial clearance of the new drug, are the regulatory processes for ongoing monitoring, which may be prescribed as a condition for initial clearance of a drug for marketing. Post-market surveillance and annual reporting are requirements and depending on the perceived risk profile of certain drugs, a regulatory may conditionally permit marketing authorization, with the understanding that ongoing studies and market surveillance be provided at agreed intervals to permit ongoing sales of a drug product.

Retaining Consultants

Consultants are often retained for writing the procedures that define this process, and for implementation of these procedures, including the post-market surveillance reporting.

Consultants in the pharmaceutical development process are essential to successful and quick market launch for a pharmaceutical product. Their expertise fills in knowledge gaps that could prove costly for a pharmaceutical company in both speed to market and reputational risk.

Ready To Develop A New Drug?

Yes, development of a pharmaceutical drug is a journey. Like many journeys, the path is often not straightforward, but encounters hills, valleys, and sometimes, detours.

Compliance Team is your roadmap to success, which minimizes these mishaps, to help you reach your destination using a more direct route. Let our pipeline of pharmaceutical consultants provide you with the know how to successfully bring you through the various stages of your development.