David Blum Email & Phone Number

Israel

Deeside, Flintshire, Gb

It takes grit to develop a great formulation. Why not give yourself a head-start and save valuable time working with the best. We use IP-free technology so as not to tie you into specific vendors and once you have taken possession of your product your use of it is royalty-free. We have successfully developed & delivered over 300 projects. We provide Contract Development & Manufacturing Services afforded in the US & UK for large & small molecules as well as live-biotherapeutics, for most dosage forms, and for all clinical phases. We are expert in enhancing the bioavailability of the active & modifying & targeting product release. We even have our own Phase I CPU and since joining SGS there ain't nothing we can't test.Come talk to us even before you decide on a preferred dosage form.• Promoting CDMO services• Seeking opportunities to grow business & revenue• Identifying metrics to drive client engagement, growth & retention• Leading & managing client on-boarding & maintenance• Building brand awareness to a growing portfolio of clients• Setting up, keeping track of, maintaining & updating Key Accounts• Attending to customer satisfaction

Amsterdam, Nl

• Laying down the foundations to develop a range of patented medical cannabis-based dosage forms with superior bio-availability properties and setting up the infrastructure to handle their subsequent full-scale manufacture. • Exhibiting at Cannabis conferences for Quay • Visiting growers, harvesters, extraction plants & packers • Collaborating with academia to develop suitable drug delivery systems • Engaging CDMOs for formulation development & up-scaling purposes • Engaging CROs in designing & executing preclinical studies & bio-analytical testing • Joining SMEs in developing clinical protocols • Deliberating with local & foreign Regulators & keeping abreast of evolving regulations • Engaging construction engineers to design a manufacturing facility • Following market developments & trends • Part-time employment in a pharmacy dispensing cannabis

Haifa, Israel, Il

• Pursued a course of action to demonstrate the potential of a novel platform of NCEs to disarm pathogens of disease-causing toxins & combat multidrug-resistant bacterial infections.• Presented company progress to local & foreign VCs and Government support mechanisms in efforts to secure investments and funding for continuing development. • Evaluated the results of derisking studies, PoC, efficacy, PK and off-target binding data, while engaging CDMOs & CROs in designing NCEs & developing drug-delivery systems in hit to lead optimization efforts.

• Reviewed & translated patient inserts (PILs) and MoH-generated position papers • Provided guidance with respect to PV reporting

Ness Ziona, Israel, Il

• Led efforts to first-ever GMP certification by MoH, EMA, ANVISA & Cofepris over clinical & commercial production, and built a Quality System that subsequently underwent PAI by FDA.• Oversaw QA over in-house and outsourced activities ensuring compliance to required standards.• Sourced, evaluated, subcontracted & audited, CMOs & CROs, supervising tech-transfer worldwide.• Released clinical & commercial batches worldwide, as well as "First-Batch" to the Israeli Market.• Submitted application dossiers to register novel therapy in Israel Drug Registry.• Submitted dossiers for reimbursement-evaluation to National Health Basket (NHB/Sal).• Established a unique post-approval patient registry.• Submitted spontaneous & periodic PV reports to MoH.• Supervised clinical distribution to sites worldwide.• Partook in structuring Phase III CT for Photodynamic Therapy in cancer patients.

• Set up an infrastructure for assembling & testing an IVDD.• Designed electronics & microbiology (BL-2 & BL-3) testing facilities.• Sourced & evaluated OEMs for product parts, and contractors for product assembly.• Drafted & established QSR (CFR-820) & provided support for the regulatory filing process.

• Sought out foreign cosmetics' manufacturers amenable to doing business in Israel.• Designed packaging and labelling suitable for the Israeli market.• Registered products in the Israel Cosmetics Registry.• Sold and distributed to Israeli wholesalers.

Rehovot, Il

• Obtained regulatory permits & licenses to run the facility.• Overhauled the QSR and drafted & approved manufacturing instructions.• Successfully led the company through ISO 13485 inspections.• Established EHS program & procured necessary equipment & systems.• Batch release

• Designed & oversaw construction of a manufacturing facility. • Recruited lead-staff for R&D, Production, QC, QA, Engineering, Purchasing & HR.• Drew up product development & manufacturing timelines• Led the team through development to delivery of a number of NCEs and formulations.• Negotiated & managed contract manufacturing activities.• Oversaw clinical labelling & distribution to sites worldwide.• Partook in due-diligence sessions. • Drafted Gantts for a multiplicity of projects being put through pre-clinical & clinical trials & monitored their progress over treatment of A-fib, Radiation exposure, IOP, & PARP inhibition.

• Involved in determining a course of action to demonstrate the efficacy of a number of NCEs in treating Epilepsy, Stroke, Alzheimer & Chronic Pain.• Participated in determining production needs & strategies.• Sourced, evaluated, subcontracted & audited CROs & CMOs, and supervised tech-transfer worldwide.• Oversaw QA over in-house and outsourced activities for production and pre-clinical (POC, Tox, ADME) operations.• Reviewed and/or authorized CMC, IND & IB files.

Hod Hasharon, Il

• Led efforts to obtain ISO & GMP certification on a routine basis• Developed continuous improvement, CAPA, risk mitigation, trend analysis, data integrity & staff training programs.• Authorized management reviews, PQRs, TQAs, protocols, reports, SOPs, specs, changes, validations, & investigations into OOTs, OOSs, deviations & deficiencies.• Audited suppliers, service providers & contract laboratories.• Authorized design of facility extension for production of solid dosage forms.• Presented company intentions to MHRA & FDA.

Us

• Led efforts to expand and revamp facilities as well as upgrade compliance & operations in readiness for first-ever FDA-PAI and MHRA inspections.• Managed up to 100 members of staff manufacturing; sterile, solid, semi-solid, liquid and cytotoxic final dosage forms.• Realized substantial cost savings by improving technology, optimizing methodology, increasing efficiency & reducing waste.• Specified, introduced & commissioned new technology.• Supervised tech transfer of newly developed ANDAs & POMs, from R&D to production.• Presented company intentions to FDA.

Tel-Aviv, Il

• Hands-on experience gained manufacturing sterile, solid, semi-solid, & liquid dosage forms.• Managed up to 30 employees in Jerusalem liquid & solid production final dosage form facility. • Pivotal in specifying & commissioning modern technology.• Participated in introducing the concept of GMP in readiness for production for the US market.• Instrumental in increasing efficiency & reducing costs in production & packaging.• Prepared departments for first-ever FDA-PAI & maintained them for subsequent FDA inspections.• Routed production & packaging procedures on an enterprise-grade process-planning program.

B Pharm

Mba