Alliance4U - The collaboration initiative to move drug candidates forward

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1 - The collaboration initiative to move drug candidates forward

2 Introduction What are we offering? How? Why apply? Terms

3 Background For grant applications and to attract venture capital start-up companies increasingly have to support their product potential by essential documentation such as Target Product Profile, risk/gap analysis and drug development strategy (plan). For many of these companies building a product value proposition is a challenge and budget for generating such documentation is often lacking or limited. The Alliance4U initiative will help you to break this circle and build your value story by bridging financial and other business challenges. It may improve your success rate to obtain grants and to attract venture capital. If successful, Kinesis is looking forward to collaborate with you on the next step, the further development of your drug candidate.

4 What are we offering? Three types of incentives: Target Product Profile. The ideal version of what the company would like to claim in its marketed drug label. Includes defining the design goals for a product, overall intented drug development program/studies. Such TPP can be used in dialogue with authorities. Gap analysis. Includes technical assessment of early stage projects (review of available data), identification of gaps and important risks by experts from CMC, non-clinical, clinical and regulatory department. Drug Development Plan. Includes the minimal required non-clinical and clinical studies, drug formulation requirements, regulatory requirements, timelines, risks and costs that are associated with the development of the product up to a certain milestone. Source Image: creative nano

5 How? Application process Contact us ( ) or apply via Pharma.com) / website (www.kinesis-pharma.com) End submission deadline: March 1, 2015 (earlier received applications will be attended upon receival) Submission of proposal by applicant via website or Evaluation by Alliance4U committee and Kinesis senior experts weeks Fund/Investment decision by Kinesis Investment approval letter is sent out Project Start Yes No Information is provided immediately to applicant Source Image: open evaluation

6 How? Application Information: 1. Company information a. Name, legal entity, number of employees b. Drug development knowledge within company (CMC, Preclinical, Clinical, Regulatory, Quality Assurance) c. Grants obtained (title, period, no financials). Grant applications pending/planned. d. Existing partnerships and/or collaborations 2. Compound and Target background information a. Small molecule, biologic, gene therapy, cell therapy, oligonucleotide, antibody drug conjugate, other b. Drug target / Mechanism of action, pharmacology/efficacy data c. Therapeutica area (indication /orphan disease) d. Stage of development e. Information on drug substance and on drug product (formulation) f. Product summaries, any summary or presentation available that can be shared 3. Studies and other information a. Overview all experimental data/list of studies done b. Information on drugability (potency, PK, bioavailability, solubility etc) c. Information on translation of animal data to the human situation (e.g. biomarker) d. Information about interaction with regulatory authorities e. Other relevant findings / information Please, be concise. In total not more than 3 to 5 pages

7 Why apply Bridging financial and other business challenges Benefit from collaboration wrt costs, time and experience in drug development Improve success rate of grant applications and attracting venture capital Access to experienced professionals with regulatory and industry experience. Easy application process and fast decision process of 2-4 weeks Start of project within 2 weeks after approval of application! Speed up drug development process Consistent high quality of work supported by in-house QA unit and GLP endorsement We all benefit from a collaborative partnership!

8 Terms A complete Terms&Condition document is request. Application Terms highlights: 1. Kinesis decides in which projects will be participated/invested. Any startup, spin-off or biotech company not exceeding ten (10) employees is eligible to participate the Alliance4U initiative. 2. Both Recipient and Kinesis intend to continue the collaboration after finalization of the Alliance4U incentive. The Target Product Profile, Gap Analysis or Drug Development Plan is provided by Kinesis free of charge service. 3. Kinesis will be invited to support Recipient s drug development program(s) to compensate for the investment made by Kinesis. In case of discontinuation of the collaboration Kinesis expenses are to be paid by Recipient.

9 Questions? Perry Verzaal Director Business Development Phone Phone Direct Mobile Fax Thank for your attention! 9

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