Jan Scicinski, PhD
Drug discovery and development scientist with a proven ability to successfully lead multi-disciplinary teams to achieve high quality results with a specialization in drug discovery, medicinal chemistry, CMC, and IND enabling studies
Skills
About
I am an experienced drug discovery and development scientist, executive, and problem solver with a successful track record in new pharmaceutical product discovery and development. A medicinal chemist, I have more than 35 years of experience in the pharmaceutical and biotech industries, in both start-up and large corporate environments (GSK, Nuada, ALZA, EpicentRx). I have experience in all aspects of drug discovery from high throughput screening, hit identification to lead selection and for development projects including CMC, IND-enabling activities, clinical trial operations and regulatory filings and communication. As a medicinal chemist, I have expertise in small molecule, peptide/peptidomimetic, PROTAC, and pro-drug programs. Over the course of my career in industry, I was involved in multiple disease areas and led multidisciplinary programs. Many of my recent projects were in the role of consultant, working with CROs and academics on start-up company projects, where I selected the CROs and led the chemistry and biology programs. These included early stage virtual or high throughput screening projects with extensive ‘analog-by-catalog’ stages that involved selecting and purchasing compounds from companies such as Mcule. I am a fellow of the Royal Society of Chemistry, with Chartered Chemist (CChem) status.
Work experience
Founder-CEO-Principal
Consulting business focused on providing rapid and effective solutions in Drug Discovery and Development:
Drug discovery/medicinal chemistry:
o Identification and management of drug discovery CROs.
o Design and execution of project strategies, from HTS, H2L, lead ID, and IND-enabling activities.
o Expertise in small molecule, peptide/peptidomimetic, PROTAC, and pro-drug programs.
o Identification of relevant biological assays in support of drug discovery.
o Established CDDVault database for client drug discovery projects for tracking and sharing data.
Full CMC support:
o Oversight of drug substance and product manufacturing campaigns.
o Applied extensive chemistry knowledge to drug substance synthetic route troubleshooting.
o CMC planning, and document review.
o CMC support for clinical trial operations.o Identified and managed GMP manufacturing CMOs.
o CMC writing for and regulatory filings, including IND and annual reports.
Sr Vice President and Chief Scientific Officer
Responsible for all aspects of lead optimization, preclinical development, including non-GMP and GMP synthesis, formulation, CMC and QA. Responsible for identifying and qualifying vendors for outsourcing of all CMC, and biological studies. Designed and implemented medicinal chemistry program for identification of next generation leads. Wrote Module 3 (CMC) for IND filing and contributed to drafting, finalizing, and submitting Phase 1 and Phase 2 clinical protocols, including a randomized Phase 2 protocol in subjects with colorectal cancer.
Assoc Director / Principal Scientist
Incorporated medicinal chemistry into ALZA’s research to combine med chem concepts with ALZA’s drug delivery technologies. Established a medicinal chemistry laboratory to support multidisciplinary programs. Formulated a strategy to initiate oncology drug discovery at ALZA. Investigated and proposed potential biological targets; prepared proposals on targets and strategies linked to specific delivery technologies. Identified and developed product concepts and medicinal chemistry strategies to develop products exploiting delivery of molecules to the lymphatic system.
Education
Cambridge University
Imperial College, London
Publications
Case STUDIES
Intracellular immune checkpoint small molecule discovery program
I worked with a virtual start-up company as project leader on the discovery of small molecule ligands for a novel intracellular immune checkpoint. I managed multidisciplinary international teams consisting of biotech team members, independent consultants, academic scientists, and CRO staff. I developed the discovery strategy, selected the CRO, and worked with them on high throughput screening, hit to lead and lead optimization. On a parallel project, following up different chemical leads, I identified consultants and CROs for a virtual screening campaign, and designed analogs for synthesis and purchase, defining and setting up the required assays at CROs to establish activity and selectivity data. The program involved multiple strategies, including the design, synthesis and testing of PROTACs against the target protein. I established and managed a CDDVault database to track, share and analyze the project data.
Identification of novel somatostatin agonists
The somatostatin program at GlaxoWellcome was a collaboration between GW and a Cambridge University-based pharmacology groups focused on identifying and characterizing new somatostatin agonists for the treatment of acromegaly, pain and other indications. Using ligand-based drug design principles, and new array synthesis techniques, I developed libraries of non-peptidic beta-turn mimetics that resulted in the identification of the first novel non-peptidic sst2 agonists.
Building drug discovery teams
Established and directed the drug discovery team at Nuada Pharmaceuticals, comprising of medicinal chemistry, chemoinformatics and biology resulting in successful collaborative research programs with large Pharma and the identification of preclinical candidates for internal diabetes anti-inflammatory and urinary incontinence programs.
