Archives: Speakers

• Over 20 years of experience in Biologics CMC, both in large biopharma and startup biotech companies, providing operational and strategic leadership for process development, analytical development, manufacturing, and supply chain for clinical and commercial
• Broad experience in selecting, partnering and managing the external service providers (CDMO and CRO) for tech transfer, process characterization, scale up/out, cGMP manufacturing, process validation (DS/DP PPQ), as well as analytical transfer, method validation, QC for release and stability, extended characterization (PTM, MAM, HCP by Proteomic MS, HOS, PS20/80 Degradation, Charge Variant Characterization, Cell-Based Assay), and comparability study
• Deep understanding of regulatory requirements: FDA guidance, USP Pharmacopeia, Ph Eur, EMA, and ICH guidelines
• Experience in co-authoring and reviewing CMC sections (Quality Module 3 DS and DP) for IND/IMPD
• Strong expertise in GMP best practices (used to practice GMP at Catalent Biopharma Solutions for 5 years), applying “GMP principle” to non-GMP data integrity (good documentation practice and data verification) for global regulatory filings
• Chairing specification committee on patient-centric specification setting and justification for in-process and final product QC release/stability
• Experience in responding to the regulatory queries from health authorities worldwide

Senior manager with over 25 years experience in clinical research and the CRO industry and proven abilities in clinical project management, strategic business development, and FSP alliance leadership.

Specialties: Strategic CRO Business Development, Alliance/FSP Leadership, Clinical Project Management & Planning, Budget & Expense Control,Team Leadership & Consensus-Building, Contract & Price Negotiation,Project Resourcing, Financial & Resource Forecasting, 
Staff Development & Motivation, Line Management, Operations Process Improvement

I contribute to protocol development, protocol medical writing, conceptual development per FDA guidance, background research, QC/QA, compilation of TMF, and briefing and supporting documents. I am experienced in writing/reviewing ICFs, CSRs, NTF/MTF, IRB material, data tables, data spreadsheets, and briefing documents. I am responsible for the development and execution of clinical study plans and budget analysis. I am skilled in MS Office, SAS and SPSS, EDC, public speaking, and team building.

I am a clinical research operations specialist with two decades of experience with CRO’s, startups, research sites, and small consulting firms. I am creative, efficient, effective, and a problem solver. I am able to identify with the challenges of research from many different perspectives.

Dr. Peter Heifetz is President and CEO of OrPro Therapeutics Inc., a Johnson & Johnson San Diego JLABS alumni company developing a novel biologic drug platform based on human thioredoxin for the treatment of multiple indications associated with inflammatory and oxidative stress. Dr. Heifetz has over 30 years of academic and industry experience in drug discovery and development with a primary focus on gene, protein and metabolic engineering technologies. Prior to founding OrPro, Dr. Heifetz held positions as a senior scientist and group leader at Novartis (NYSE: NVS), research director at the Novartis Research Foundation, head of biopharma and consumer health R&D at Syngenta (NYSE:SYT), fellow at Diversa Corporation (NASDAQ:DVSA), and was chief scientific officer at private biotechnology companies ERA Biotechnology (Barcelona) and Rincon Pharmaceuticals (San Diego). Dr. Heifetz studied at Duke University with degrees in genetics (PhD), mechanical/biochemical engineering (MS) and biology (BS) and was a National Institutes of Health graduate research trainee with interdisciplinary research support from the Department of Energy. Dr. Heifetz also earned an executive certificate in innovation management from the Kenan-Flagler School of Business at the University of North Carolina at Chapel Hill.

Kieran is an AI and Data Ethics Manager at NatWest. He has 17 years experience working at the bank, primarily in a Risk and Control role where he has supported with the safe implementation of changes to key digital services such as online and mobile banking, as well as the AI chatbot Cora. Over the past year he has been working in the newly formed AI and Data Ethics team who support to ensure the banks development and deployment of AI is aligned with the banks AI and Data Ethics Code of Conduct, as well as enhancing the internal policies, processes and governance to be compliant with AI related regulations, such as the EU AI Act

Simon is a manager in the AI and Data Ethics team at NatWest Group. He has spent just short of a decade in the financial services industry, covering various roles from customer engagement to financial crime policy. He is primarily responsible for responding to new and emerging AI regulation, guidance and industry best practice with a focus on the implementation of the EU AI Act

Claire graduated with an MEng in Chemical Engineering and went on to complete a PhD on the topic of heterogeneous catalysis for Biodiesel production. She then spent 13 years working in various process development roles at AstraZeneca including specialisations in filtration and continuous processing. From there, Claire moved to CPI’s Medicines Manufacturing Innovation Centre where she is now the Oligonucleotides Grand Challenge Lead, managing a portfolio of projects including Grand Challenge 3 – Sustainable and Scalable Oligonucleotide Manufacturing.