Dan Fishelovitch

Head of CMC @ GHF- Golden Heart Flower

About

I am a passionate CMC expert, expereinced in all drug development stages, CMC R&D, Quality, and Regulatory wise, that is driven by saving lives and improving patients quality-of-life. I have over 18 years of experience in the pharmaceutical industry working in several companies in R&D and CMC managerial roles. The below are my main fields of expertise:• Formulation development - OSD: IR, DR, ER, oral solutions, injectables, lyophilized products, eye drops, Drug-Device combination products, ATMPs• Process development: design, characterization, scale-up, optimization, validation, QbD concept implementation • Granulation, capsulation, tablet compression, beads and tablet coating • Clean rooms, aseptic manufacturing, sterile filtration, terminal sterilization• GMP manufacturing & QMS• Small molecules, peptides & proteins, cell-based ATMPs• CRO/CMO/CDMO selection and management for DS and DP• CMC RA writing: CTA, IND, SA, MAA, NDA, BLA• Actively support regulatory filing of clinical trial applications and other regulatory submissions and consultations (EMEA, FDA, and locals such as PEI, BfArM, MHRA, Israel MOH)• Project management: budget, timelines and risks• Chain supply managementI am open to providing services

Country

City

Israel

Industry

Pharmaceuticals

Skill

Research and Development (R&D), Pharmaceutical Industry, Life Sciences, Pharmaceutics, Biotechnology, Chemistry, Formulation, GMP

Experience

Head of CMC

GHF- Golden Heart Flower

2022-12 - Present · 3 yrs 10 mos

Founder

DFarma consulting

2021-9 - Present · 5 yrs 1 mo

Head of CMC

Enlivex

2019-6 - 2021-11 · 2 yrs 6 mos

Rehovot Area, Israel

• Part of Enlivex management team • Management of all CMC teams including Production, Development, QC, and procurement (in charge of 20 employees) • Formulation and manufacturing process development of cell therapies • GMP manufacturing and release for clinical use • Assess risks related to the quality, timelines and budget • Actively support regulatory filing of clinical trial applications (CTA, IMPD, IND) and other regulatory submissions and consultations (EMEA, FDA, PEI, Israel MOH) • Clinical chain supply management

CMC director

Mitoconix Bio

2017-12 - 2019-6 · 1 yr 7 mos

Israel

• Part of Mitoconix management team • Leading all CMC activities related to peptide synthesis development and scaleup, formulation and DP manufacturing process development and scaleup • Support in preclinical (in-vitro and in-vivo) studies and clinical manufacturing and supply • Leading all drug-device combination activities for use of a medical delivery system in preclinical and clinical studies • Regulatory support in clinical applications (IMPD/IND) and meetings with competent authorities (FDA, EMEA, Israel MOH) • Project management (budget, timelines, risks)

Head of CMC

NeuroDerm Ltd.

2017-6 - 2017-12 · 7 mos

• Heading the department in all its activities (in charge of 4 employees) • Clinical manufacturing and supply • Translating R&D projects into products • Support in the development of drug-devices combinations (pump delivery systems for SC administration), • Regulatory support in clinical applications (IMPD/IND) and filing (NDA)

Senior Project Manager

NeuroDerm Ltd.

2015-8 - 2017-12 · 2 yrs 5 mos

• Leading a cross‐functional multidisciplinary project team to develop, execute, and deliver on time an integrated product development plan that allows for a product to meet its Target Product Profile (TPP) • Project management (budget, timelines and risks) • Leading the preparation of documents for regulatory meetings with competent authorities in EU countries (NSAs)

CMC manager

NeuroDerm Ltd.

2014-5 - 2017-12 · 3 yrs 8 mos

NeuroDerm

• Sterile finished products development • Working with CMOs/CDMOs/CROs for DS and DP development • Drug-device combination products (PFS, syringe pumps) • Extractables & Leachables studies

CMC project leader

Teva Pharmaceuticals

2008 - 2014 · 6 yrs

• Oral and sterile NCE drug products development • Formulation development: oral solid dosage forms (solutions, capsules and tablets) and steriles (injections, eye-drops, lyophilized products) • Process Development and scaleup (granulation, capsulation, tablet compression, tablet coating, aseptic filtration and lyophilization) • Writing of regulatory documents for global submissions (CTAs, INDs, MAAs, NDAs) • Leader of Quality by Design (QbD) concepts implementation globaly • Working with CMOs/CDMOs/CROs.