Early stage companies may not have the QA systems in place needed to meet GMP requirements. We work with you to develop a complete set of SOPs tailored to your company to ensure regulatory compliance as the project moves forward.

Finding the right manufacturing contract manufacturing organization (CMO) for the project is key. The process starts with obtaining proposals from the most suitable CMOs based on experience and reputation – pricing is not the only consideration.

Initial supplier qualification can be based on self-assessments by the CMOs but we ensure that Quality agreements are established and site audits are performed prior to GMP manufacture.

B4D has the experience to manage issues that inevitably arise along the way. We work with chemistry, manufacturing and analytical experts and quality consultants to oversee work conducted at CMOs. Our team provides cross-functional project management support using online collaboration tools for timelines and virtual meetings to keep on top of action items and minimize delays.

We establish virtual data rooms and tracking systems for the numerous project-associated controlled documents – including analytical protocols, reports, SOPs, specifications, certificates of analysis, tech transfer reports, master batch records for engineering and GMP runs, and stability protocols and reports. We also provide critical quality input and expert reviews into these documents as needed.

Our team will put in place company-specific administrative systems and SOPs that are needed to run a company efficiently. This includes establishing regular project and Senior management team meetings and reporting procedures to track both project progress and spending against approved budgets.

We provide management support for preclinical to clinical, chemistry and manufacturing, analytical, clinical, business development and licensing teams, whether in-house or external.

We have experience both as Board members and as management reporting to Boards and know what type of information they need to carry out their oversight function. We can prepare presentations for quarterly meetings along with written progress reports and develop Excel-based financial plans and budgets.

One of the challenges a start-up biotech company faces is to select the right contract research or manufacturing organizations (CROs/CMOs) for their specific project. There are so many to choose from and cost is not the only factor to consider. B4D has worked with many CROs/CMOs and can help you identify the most appropriate supplier for your project, obtain competitive bids, negotiate contracts and oversee work conducted at the company to ensure the project stays on track and on budget.

B4D can set up a virtual data room for your company, providing the ability to keep your information confidential but readily available to potential licensing partners and investors, as well as the appropriate company team members and consultants.

B4D will develop a licensing strategy that identifies the highest value inflection point for your project and optimal timing for out-licensing. We develop risk-adjusted project valuations and find deal comparables. Based on our industry experience we can advise on which potential partners to approach and the key data they will want to see.

Initial planning includes identifying potential partners through our industry network. Cost effective means such as licensing meetings can help build rapport with potential partners and anticipation for the product. Details about any licensing information can be broadcast in various ways, raising awareness without divulging confidential information. Once confidentiality agreements are in place, the selected partners are kept informed about milestone development events such as IND approvals and positive clinical data.

B4D has a network of financing contacts and can help identify appropriate sources of funding for your project – for example seed financing from non-dilutive government grants or equity-based venture capital financing. We monitor new funding opportunities and can match companies with sources most likely to succeed.

B4D has a network of financing contacts and can help identify appropriate sources of funding for your project – for example seed financing from non-dilutive government grants or equity-based venture capital financing. We monitor new funding opportunities and can match companies with sources most likely to succeed.

We work with you to ensure your financing and licensing presentations include the key elements investors need to make a decision. We know which partnering meetings yield the best results and can attend meetings and present for your company or as a part of your team.

The first step is to identify the most effective regulatory pathway based on your product and chosen indication. We will identify the major market countries where approval will be beneficial to your marketing or licensing strategy. We will identify any expedite programs or regulatory incentives that may apply and carve out the best regulatory pathway based on your product’s stage of development and current funding.

We will address which regulatory authority might be best to seek guidance from first and at what stage in the development process would be most beneficial for a Pre-IND or Pre-CTA meeting. We will also plan subsequent interactions with the select authority and when it would be most advantageous to approach multiple regulatory jurisdictions. Our team can work with you to approach the selected regulatory authority for consultation on your product development strategy early on. This usually takes the form of a Pre-IND or Pre-CTA meeting request.

By analyzing both market approvals and the development landscape for your chosen indication, our team will use the most recent regulatory precedents in developing a regulatory strategy that has proven success while incorporating any unique advantages that may be inherent in your product.

Our team can write the documents that are required for the submission of the Pre-IND or Pre-CTA meeting requests as well as the IND and CTA submissions themselves. We will work with you to create the dossiers necessary for regulatory submission and ensure that all supporting documentation such as preclinical reports, CMC documents, investigator brochures and protocols meet regulatory quality standards.

As the development of your product progresses, we will ensure that regulatory milestones are aligned with the completion of significant development milestones. This will ensure that the regulatory authorities are kept current on your development’s progress and will make sure to take advantage of all available avenues of dialogue with the authorities.

The first step is to identify the target indication based on the assumed mechanism of action of your product and then select the appropriate preclinical disease models. B4D will ascertain which disease models are favoured by both clinical experts and regulatory authorities and work with academic experts or CROs to conduct these experiments in validated models. B4D will assist in the design of the protocols ensuring that each study is maximized to provide information on effects on biomarkers, clinical indicators, safety, pharmacokinetics and dosing. While there is not a requirement for conduct under GLP at this stage, B4D will assure GLP-like conduct of these studies and the issuance of IND quality final reports.

Based on the type of product and the selected indication, B4D will work with toxicology experts with the required experience to develop a nonclinical program of studies to support the FIH clinical trial. Where possible, study elements will be combined to maximize the information obtained from a single study. B4D will identify qualified CROs to conduct these studies under GLP and can organize audits of the selected facilities. B4D will also map out the nonclinical requirements at each stage of clinical development to ensure you are prepared for each step in your regulatory filing without incurring large financial commitments in the early stages of clinical development.

In designing the first study B4D will consider both the competitive and regulatory landscape and include not only evaluations of safety and dose-finding but endpoints which provide proof of concept for target engagement. This provides the necessary information for determining the design and sample size of subsequent studies as well as support fundraising efforts. B4D will assemble a Clinical Advisory Board (CAB) consisting of clinical experts in the indicated therapeutic area to develop this novel FIH protocol. B4D will refine the protocol by engaging regulatory authorities in Pre-IND/CTA meetings prior to filing the IND/CTA.

Following regulatory approval, B4D can assist in all or select aspects of clinical operations to ensure the conduct of the clinical study adheres to the principles of Good Clinical Practice (GCP). B4D can identify qualified vendors through an RFP process and ensure the CRO selected is the best qualified for the study. Having previously worked in the therapeutic area, B4D can identify clinical trial sites through our network and work with the CRO on management of the sites throughout the conduct of the study. B4D also has preferred data management groups for all aspects of statistical analysis and data collection and management of clinical trial information. We also work with pharmacovigilance groups for the management and reporting of SAEs that may arise during the study. Throughout the process, B4D will use online management tools to ensure development milestones are met so that costly delays are not incurred at this vital stage of the product development process.

In addition to protocol writing, at the completion of the clinical trial and following the analysis of the data, B4D can produce the Final Study Report and also assist in the writing and submission of publications to targeted journals based on the study results.

B4D’s Strategic Development Plan summarizes the current stage of your program and outlines the regulatory pathway, clinical and product development timelines and cost estimates to approval in the selected indication. B4D consultants review all available data on your product and assess the competitive landscape and clinical/regulatory environment to help you better understand the commercial potential of your product and the challenges that lie ahead.

The plan includes appropriate therapeutic area information and summarizes completed and planned preclinical, clinical and drug manufacturing/QA activities. It includes sufficient detail to facilitate project management to the next major milestone. Information on market size and competitive landscape is also included along with financial plans and budget to support valuation modeling which is useful for both investors and potential licensees.

Product development and commercialization is a long and expensive process with many steps and plenty of opportunities to make the wrong decision. In addition to a great plan you need an experienced team to successfully implement the plan. B4D has the experience to manage the project and troubleshoot issues that inevitably arise along the way.