Resume of Paul M. Kleinman, M.A.
** **** *** ***. *** Mateo, CA 94402
Tel. 510-***-****
Experience and Qualifications Summary
• Biologics and Drugs CMC regulatory strategies and submissions from early
development through early and late clinical trials to market applications and post
approval life cycle.
• Experienced general regulatory affairs for early clinical trial development.
• Extensive experience in FDA-ICH submission management/planning and writing
sections of 20 INDs (both CMC and all sections) and 7 BLAs/NDAs.
• Strong innovative track record while working in matrix organization.
• Excellent grasp interpreting and applying FDA/ICH policies/guidelines to sponsor’s
product-specific attributes and design.
• Successful regulatory negotiator with FDA, strong track record identifying reviewers’
concerns and meeting regulatory expectations; experienced in EU submissions.
• Experienced developing and delivering high level regulatory presentations to internal
and external stakeholders/audiences.
• Experienced in working with consultants and contract manufacturer organizations.
• M.A., Cell/Molecular Biology; RAC certified 1997.
Work History Summary:
March 2013 – Present
• CMC Regulatory Services ( San Mateo CA): Owner and Principal Consultant
Working with clients to develop CMC regulatory strategies and submissions for
IND and Market applications (BLA/NDA).
Nov 2012 – Feb 2013
• Pharmacyclics (Sunnyvale, CA): Associate Director, Regulatory Affairs: Headed
CMC regulatory affairs for NDA campaign of 1st of kind oncology small molecule,
liaising with Big Pharmaceutical partner.
Nov 2010 - June 2012:
• Aesculap Biologics (Breinigsville, PA): Sr. Manager, Regulatory Affairs: Headed
regulatory strategy and development for Biologics-Device Combination Product for
Phase 3 IND, managed preparation of successful comparability amendment,
liaised with EU combination product development.
(Left company for family matters in CA).
August 2005 - June 2010:
• CMC Regulatory Services (Alameda CA): Owner and Principal Consultant:
Recruited clients, prepared and defended responses to RFPs and worked with clients to
develop regulatory strategies and implement them, including preparation of INDs and
market applications as well as liaising with FDA.
. Examples of Projects:
• BioMarin Pharmaceuticals (Novato, CA): Prior Approval Supplements to CBER.
• Wyeth Pharmaceuticals (Rouses Point, NY): International CMC Regulatory
Dossiers with recommendations for global harmony.
Resume of Paul Kleinman, M.A.
• Pfizer Inc. (Morris Plains, NJ): Reviewed CMC legacy market applications with
recommendations for compliance to FDA commitments.
• Pepgen Corp (Alameda, CA): Acting RA/QA manager, helped develop regulatory
strategy for pivotal trial production scale up; prepared a Quality System compliance
plan for GMP documents.
• Institute for One World Health (San Francisco, CA): Worked on successful NDA
including clinical trials sections; designed GXP SOP documentation system.
• SanBio Inc. (Mountain View, CA): Acting RA Director for stem cell/gene therapy
Company; co-led pre-IND campaign and preparation of the Pre-IND briefing
dossier.
Oct 2004 - Aug 2005:
• ICON Plc Development (Redwood City, CA): Director, Regulatory Affairs:
Worked with clients to plan and implement pre-IND, IND, NDA and post approval
strategies and submissions. Authored CMC section of combination product NDA for
rHInsulin implantable pump; planned and outlined NDA supplement for Mfg. site addition.
Nov 1998 - Oct 2004:
• CMC Regulatory Services (Oakland, CA): Owner and Principal Consultant:
Examples of projects:
• Cell Genesys (South San Francisco, CA): Acted as regulatory manager for early
IND oncology immunotherapy.
• Pharmaceutical Training Institute Course Instructor: Created course content
Complying with SUPAC Requirements and taught 2 day course at various venues.
• Ribi ImmunoChem (Hamilton, Montana): CMC regulatory data evaluation and BLA
preparation for Melacine (allogeneic cellular therapeutic vaccine:
• Coulter Pharmaceutical (Palo Alto, CA): CMC submission plan for BLA for Bexxar
(tositumomab-Iodine 131 immunoconjugate) for Non-Hodgkin’s Lymphoma
• Chiron (Emeryville, CA): Created annotated CTD templates for IND data collection.
Reviewed and authored cGCP and cGMP SOPs; wrote Module 2 Quality Overall
Summary for rDNA protein therapeutic; wrote CMC section for “Quantiplex”
branched DNA diagnostic.
• Sugen, Inc. (South San Francisco, CA): Developed strategy and prepared the
CMC section of NDA for tyrosine VEGF kinase inhibitor vs. colon cancer; created
and led team for gap analysis and data preparation for NDA; managed German
API and US DP contract manufacturers’ regulatory compliance for NDA and DMF
documentation.
Mar 1991 - Nov 1998:
• Biopharmaceutical Writers Service (Oakland, CA): Owner:
Provided biopharmaceutical companies with regulatory writing, editing and review
services for CMC and Clinical sections of INDs, BLAs and biological PMA;
Prepared QA/GMP SOPs and batch records.
Sept 1987- Feb 1991:
• Cetus Corp (Emeryville, CA): FTE Technical Writer:
Resume of Paul Kleinman, M.A.
Became the primary CMC writer for Betaseron PLA, prepared CMC sections of
INDS, wrote original PCR Thermal Cycler Operator's Manual. CMC. IND CMC
preparation for MAb-Tumor Necrosis Factor conjugates.
Education
• 1987 M.A, Cell/Molecular Biology, San Francisco State University. Thesis
research at Lawrence Berkeley National Laboratory in Dr. Richard Schwarz’ lab.
• 1983 B.A. Genetics, U.C. Berkeley (GPA 3.3, Biology GRE top 1%)
Professional Affiliations
• Bay Area Bioscience Forum
.
Publications and Presentations
• Ascorbate Can Act as an Inducer of the Collagen Pathway Because Most Steps
are Tightly Coupled. Annals New York Academy of Science, Vol 498. 172-185, 1987.
• The Role of Ribosome Distribution in Regulating Ascorbate Induced Procollagen
Synthesis in Primary Avian Tendon Cells. Master’s Thesis, San Francisco State
University, 1987.
• Key Elements in Preparing a Quality CMC Submission (RAPS FOCUS, July 1999
Issue).
• The NDA/BLA Process: An Evolving Landscape for FDA Regulation. Presented at
Health Industries Regulatory Approval Workshop, Univ. of Calgary, Calgary, Alberta,
Canada, May 10-11, 1999.
• Complying With SUPAC Requirements. Sponsored by Pharmaceutical Training
Institute, Created course content, 15 hours class time; taught at various venues, 2002.
• From IND to the Common Technical Document (CTD) Quality Module: Changing the
Scope of CMC Documentation. Presented at DIA meeting on Global CMC Challenges,
Feb 4-6, 2002, DIA Annual Meeting, June 2002 and other venues.
• New Regulatory Requirements and Challenges for Clinical Trial Sponsors.
Presented at BioScience Forum Clinical Trial Symposium, Jan 8 2003.
• Draft Guidance Potency Tests for Cellular and Gene Therapy Products - CBER has
Raised the Bar. CMCRegulatory.com, News and Views, September 2009
References Available Upon Request