Kinexum
Democratizing Life Science Product Development

Kinexum is an uncommon regulatory, clinical and product development strategic advisory firm. Founded in 2003, the firm has represented over 500 clients from around the globe in negotiations with and submissions to FDA (and other regulatory authorities in major ex-US markets), sell-side and buy-side due diligence for bankers and VCs, product development strategy, planning, timetables and budgeting, and other matters.

Founder and Executive Chairman Alexander (“Zan”) Fleming, M.D., is a former FDA senior medical reviewer who led the reviews that resulted in approval of metformin, and the first statin, insulin analogue, PPAR agonist and growth hormone for non-growth hormone deficiency conditions. From its original expertise in small molecules and peptides for diabetes and related metabolic diseases, Kinexum has grown to become a generalist, advising in most therapeutic areas (now including oncology, CNS, immunology, pulmonology and infectious diseases) and modalities (including small and large molecules, advanced therapies, medical devices and even botanical drugs), while maintaining a thought leader reputation in the cardiometabolic space (including type 1 and type 2 diabetes, obesity, cardiovascular and NASH/MASH) and chronic diseases (including neurodegenerative diseases and cancers). Its 58 MDs, PhDs and MD/PhDs cover disciplines from non-clinical and CMC to clinical, and enable clients to access decades of experience, expertise and judgment honed at FDA, large and emerging companies and academia.

The firm gets involved as early as lead nomination, when companies are considering first approaching a regulatory authority (for pre-submission meetings like Type C, pre-IND and Scientific Advice meetings), through translation from preclinical to clinical (including IND/IDE/CTA and end-of-phase meetings, protocol design and study reports and applications e.g. for orphan and breakthrough/fast track designations), through marketing approval (e.g. NDA/BLA/MAA/510(k)/de novo/PMA) and beyond (e.g. renegotiation of post-approval clinical trial commitments), and does its share of ‘rescue’ or ‘salvage,’ to help programs recover from setbacks.

“I’m from an emerging company operating background, not ex-FDA or Pharma. Having hired and fired hundreds of consultants, and knowing what management teams and boards like and dislike about consultants, we want to make Kinexum high-value, high-touch and quick and easy to work with. Our teams of seasoned medical product development experts approach each engagement as if it’s our program, and our money – what would we do, given the applicable objectives and constraints?” said Thomas Seoh, Kinexum CEO.

This client-centricity extends to curation and management of preclinical and clinical CROs and CDMOs and introductions to a quality product development ecosystem (including commercial assessment, market access, reimbursement, and other necessary components for successful development and commercialization) in order to ‘democratize’ the life science startup process and enable innovator clients to focus on their unique strengths and contributions.

Illustrative cases include: (i) helping combine a 510(k)-cleared delivery device with a generic chemotherapeutic via a pre-IND meeting, swiftly followed by an IND and orphan drug designation, to position the combination drug-device as a premium priced, higher value therapeutic; (ii) preparing due diligence reports and clinical development plans on multiple programs of an ex-US company that were transferred into a US affiliate, simultaneously with a fundraising; and (iii) guiding a startup to decide on priority disease indications for a pre-clinical program and preparing development plans, timelines and budgets, to support fundraising asks.

Another distinguishing feature is Kinexum’s robust pro bono activities, through its not-for-profit Kitalys Institute, which organizes an acclaimed annual conference on the prevention of chronic diseases and the extension of healthy longevity, with top FDA and NIH leaders, members of Congress and the UK parliament, worldclass researchers and clinicians in geroscience, metabolic, cardiovascular and neurodegenerative diseases and cancer, executives from industry and capital markets and other stakeholders.

Kinexum values creative, resourceful, evidence-based case building, not just populating submission fields with data received from the client. Informed by former FDA staff (including Division leadership and senior reviewers) and former executives from large and emerging companies, the firm seeks to deliver responsive, clear, focused, persuasive and tractable strategies, plans, reports and submissions for its clients.