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5 Regulatory Submission Steps to Prep for Early Clinical Development

There are plenty of challenges associated with early clinical development for pharmaceutical drugs. There are timeline and budget concerns, along with market competition considerations. In the end, you want to advance your best candidate for regulatory submission. This requires careful assessment of efficacy and toxicity before you can start human trials. If you partner with a contract research organization, start the conversation early. You’ll want to discuss regulatory submissions at least six months prior to preclinical studies. Here are some steps to ensure your organization has a successful regulatory submission.

Prepare for Early Clinical Development by Planning Your IND in Advance

Long before early clinical development, you must first prepare for your Investigational New Drug application. You will need preclinical data to permit an assessment to determine if the drug is safe for human testing. The IND application must include animal pharmacology and toxicology studies, along with any previous human experience with the drug—most often foreign use. Also required is manufacturing information, including composition, manufacturer, and stability. Detail the controls used for producing both the drug substance and drug product. This ensures your organization can produce consistent batches of the drug. Finally, you need clinical protocols and investigator information in place. This requires detailed protocols for proposed early clinical studies, qualifications of clinical investigators. It also includes a commitment to get informed consent from potential study participants once research begins.

Be Proactive with Your Pivotal Toxicology Studies

You should be proactive and have a clinical strategy even before partnering with a CRO for preclinical studies, which can help ensure the data you collect is sufficient to support your IND. This also reduces the risk of start-up delays. There are several considerations to keep in mind here. First, a route of administration that mimics clinical use and identification of potential target organs for toxicity is essential. You should also have a plan for assessing the reversibility of toxicities. Consider standard and drug-specific endpoints. It’s also important to select your methods for analysis and bioanalysis.

Deciding Between Small Molecules and Biologics

Long before early clinical development, you will need to choose between small molecules and biologics for your drug candidate. This affects many aspects of the preclinical study, including species selection, dose selection, pivotal toxicology, and genetic toxicology. For example, it can affect which type of study is needed or the number of species you need to test.

Formulation, Test Article, and Bioanalysis Concerns

The proper formulation of drugs and vehicles can help with exposure to the test article. One method should be used for each vehicle. Consider the type of vehicle and solubility. You should also consider the consistency, characterization, and storage conditions. Conduct analyses that include concentration, homogeneity, and stability. This will allow you to prepare a material safety data sheet. You need validated bioanalysis methods for the quantitative evaluation of analytes and biomarkers in a given biological matrix.

Selecting a CRO Partner

Selecting the right CRO partner to help your organization with the IND submission is vital. You should ask questions, such as whether the CRO is GLP-compliant. Do they have a history of successful regulatory inspections? Do they have experience with your molecule type? What sort of resources do they have available? Similarly, do they have the ability to source resources they don’t have in-house? How responsive is the CRO? Choosing the right CRO can help streamline your IND submission process. Choosing an integrated CRO/CDMO means you get valuable guidance throughout the drug development process. They can help take your pharmaceutical drug from early clinical development to market.

About Altasciences

Are you looking for a drug development partner? Altasciences, a mid-sized contract research organization, is the partner with the expertise you need to make your next project a success. As an integrated CRO with pharmaceutical CDMO services, Altasciences offers partners more than 25 years of research experience for preclinical studies and clinical trials. This CRO uses an innovative, integrated approach that pharmaceutical and biotechnology companies can rely on. Altasciences also offers partners expertise in a wide range of study types and therapeutic indications. This includes a wealth of experience in first-in-human clinical trials and CNS clinical trials. Partners also gain access to essential resources, including experienced and highly trained staff, a recruiting database of over 400,000 potential participants, and over 580 beds for overnight studies. Choose this trusted CRO/CDMO for all your early clinical development needs.

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