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.
Archives: FAQs
Investor/Licensing Pitch
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.
Implementing Licensing & Financing Plan
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.
Securing Investors
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.
Identifying Licensing Partners
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.
Licensing Strategy
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.
Meeting Regulatory Milestones
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.
Dossier Evaluation
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.
Competitive Intelligence
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.
Interactions with Regulatory Authorities
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.
