Robert Blanks Email & Phone Number

Cambridge, Ma, Us

Waltham, Ma, Us

• Member of company’s executive leadership team • Oversee all regulatory activities for the company including submission of all INDs, CTAs and NDAs.• Plan and conduct FDA, EMA and PMDA meetings, address Health Authority questions.• Build quality system and team appropriate for virtual company model using multiple CROs and CMOs. Participate in PAIs.• Core team member in licensing deals and joint steering committees with strategic pharmaceutical partners.

Waltham, Ma, Us

Waltham, Ma, Us

Waltham, Ma, Us

Provide drug development assistance to Izumi Bioscience, an orphan drug focused biotech company, especially in areas of CMC and Regulatory.

Oversaw all manufacturing activities from production of active pharmaceutical ingredients to the formulation of all drug products including associated analytical development, specifications and stability protocols for all drug candidates.-Developed tablet formulation for integrin antagonist and provided clinical supplies for FIH study in four months.-Transferred technology from licensee to external CMO to produce extended release PLGA formulation of p38 inhibitor for intra-articular injection.-Reduced to practice extended release PLGA corticosteroid intra-articular formulation: led program from concept to clinical study material in one year. Wrote the CMC sections of all regulatory submission, including INDs and IMPDs. Met with regulatory health authorities in regard to CMC issues: FDA, MHRA, HC, and BfArM.Contracted and managed CMOs to ensure timely delivery of quality drug products. Ensured compliance with cGMPS and other applicable EU and US regulations for al clinical trial materials.

Responsible for all company quality activities including GMP, GCP and GLP for both development and commercial drug products. Write CMC sections of INDs, CTA and respond to health authorities CMC related questions. Responsible for CMC activities during partnering discussions and subsequent business partnerships. Directed all clinical supply activities for clinical trials.

Responsible for all CMC activities (manufacturing,regulatory, and analytical) for small virtual biotech company. In addition, oversaw all GXP activities.

Founded company to develop technologies from drug candidate through Proof of Concept to build value for sale. Partnered technologies with Esperion (bought by Pfizer), Millennium, and Transport Pharmaceuticals. Responsible for all mfg, quality and regulatory activities.

Responsible for building quality assurance group within the company. Key member of team that brought RenaGel (currently 700 million dollar product for Genzyme) from IND to commercialization. Directed CMC regulatory activities.

Waltham, Ma, Us

Bs, Biology

Ms, Chemistry