Who We Help
Our Value Proposition: aktaPD® is an open-architecture business consortium and international Life Science industry partner to private, academic, and government clients. aktaPD experts help to facilitate the development of meaningful products, including new chemical entities (NCEs), biosimilars, biologicals, cell therapies, beneficial bacteria, foods, diagnostics, medical tools, and devices.
Our Successes Include:
Placed executive level interim experts for over 50 clients
Played a key role in smooth acquisition by a Fortune 500 company
Helped raise $50M in venture capital
Helped several companies acquire millions in IPO funding
Assisted several companies’ conversions to E6 Compliance Regulations
Jump-started a difficult and complex first-in-human protocol for a neurological indication
Organized, designed, implemented, and followed through submission completion pre-INDs / INDs / BLAs for numerous clients
Engineered successful pre-IND meeting for a novel anti-cancer agent
Revised an entire development program for a unique product, facilitated site and subject enrollment, worked with FDA and DSMB to significantly accelerate enrollment goals, and helped raise capital--all of which increased the company’s valuation
Helped develop European Phase1b/2 clinical trials for a new molecular entity for rare neuro-inflammatory indications
Designed aggressive development plan, timelines, and cost analysis, from preclinical to POC, for several therapeutic areas, including orphan indications
Oversaw governance of five CROs, four data management outsourced providers, 22 vendors, and 63 in-house contractors, and performed simultaneous clinical trial management for two mid-sized companies
Achieved annual cost savings on clinical trial execution of 27.25%
Evaluated vendor experience and work product, resulting in cost savings and added value for privately-held company
Designed and implemented a virtual vendor management / procurement model
Took over medical supervision for an on-going international metastatic cancer program
Commercialized and branded implantation devices
Supported the expert selection of an RNA inhibitor platform technology’s first indications
Supervised the successful preclinical evaluation of a potential immunogenic compound
Helped guide a successful Complete Clinical Hold response for a rare disease indication
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