Benjamin Isaacs, Phd Email & Phone Number

United States

"From a small Acorn grows a big Oak" - Business Consulting & Development to help companies grow by applying business growth and product life cycle experiences from 25+Years in corporate development and growth.Goal-oriented, professional with 25+ yrs of innovative biopharma product/device development and quality aseptic manufacturing experience coupled with corporate program management/product development & business process improvement experience. Creative, results-oriented, and adept at communicating effectively, managing projects & programs, building and nurturing cross-functional team leaderships and relationships that includes clients, vendors and multi-disciplinary team members. Proven leader with a record of strategic integration including creative marketing and sales execution impacting the bottom line.• In-depth knowledge and experiences in both Human and Veterinary Pharma.• Biologics/Monoclonal antibodies (Synagis® and Humira®), enzymes, New Chemical Entities, Generics.• Strategic Alliances - Forged a strategic partnership with Abbott for Fill Finish for sterile products that I had built, validated, commissioned, and operated aseptic fill and finish (including GMP Lyo capability).• Worked in big and small pharma (worldwide) as well with USG’s DoD and DHHS.• Business Development – built BD teams and new assets, opportunities into the organization.• Corporate Development - Did all Marketing and Sales to put my CDMO on the Human Pharma map as founder and CEO.• Pharmaceutical Product/Device Dev (Implants & Particles and autoinjectors for nerve gas antidote) R&D including Process, Human & Veterinary Pharmaceuticals - Pre-Clinical to Commercialization.• CMC activities to support regulatory submissions for both sterile and non-sterile dosage forms.• Worked with private Pharma companies (human and veterinary) as well as USG on specific DOD and DHHS programs.

Lawrence, Kansas Area

o Strategic and Tactical Growth of the US business - Organic growth – improved in-house capabilities and infrastructure. Quantum growth -Evaluated M&A opportunities in drug delivery and manufacturing for board approval.o Drove Pharmaceutical strategies to meet financial targets -Implemented cost-effective target product definitions and development (oral dosage forms, including flavored chews, Transdermal dosage forms, topicals, controlled release (microspheres), and sterile bio erodible systems for expedient veterinary regulatory approvals for clients.

Alachua, Fl

Scientific and pharma development consulting that included CMC leadership of several cross-functional teams (internal, external and DOD & DHHS/BARDA) to drive products towards IND, BLA and ANDA.o Managed Programs with USG departments in addressing-o FDA Critical Drug Shortages with attendant product portfolio assessmentso API (China and India) vendor selection and qualificationo CMC documentation for regulatory submissionso DHHS/BARDA Program Management including budgetso Technology Transfer from R&D to cGMP manufacturing at a CMO including a pandemic FLU vaccineo Sterile Aseptic product, process & assay development & manufacture of anti-nerve gas agent(s) and auto-injector delivery systems

Andover, Ma

Transformed an innovative Contract Research Organization (CRO) focused on formulation of biologicals and new Chemical entities in to a profitable Contract Development and Manufacturing Organization (CDMO) by offering CGMP, FDA-inspected (no 483s) quality Aseptic Fill and Finish manufacturing for a global client base.The many aspects of this transformation and growth included -o Coined, trademarked and effectively deployed "We Formulate Solutions®" to launch Formatech as a CRO, with great success. o Raised company profile by innovative accomplishments (Synagis® for MedImmune, now Astra-Zeneca) and other innovations.o Built an aseptic Fill-Finish operations in Andover, MA to meet a global need. o Forged a 3-yr strategic alliance with Hospira (previously, Abbott's One-2-One) on sterile (aseptic) products manufacturing as a testament to company's quality systems and market place niche summarized as - "Develop-Characterize-Manufacture" ®.o Established a successful Preferred Manufacturing partnership (25% plant capacity commitment) with a major Massachusetts Biopharma giant.o Developed and served a global clientele base for product development and manufacturing services.o 2 FDA inspections (no 483s) and MHRA certification to allow clinical products to EU territories.o Biological process developmento Sterile Aseptic product and process developmento Biological and NCE Formulation and Dosage Form Development for IND and BLAso Built, validated and commissioned a CGMP sterile fill and finish plant in Andover, MAo Managed and grew this CGMP manufacturing operations to account for ~80% of total company annual revenues by serving a worldwide client base.