We have been helping biopharmaceutical companies accelerate development and minimize risk for over 25 years. Our team has a broad base of experience in the industry, so whatever your needs are, we have the expertise and connections to help you hit your immediate goals quickly.
The Harmony Consulting Promise
We work with what you have
We propose solutions tailored for the resources you have, that will satisfy regulators without making extraneous investments.
We look at the big picture
We help you make decisions that will save you time and money now, AND in the future phases of development.
We do what you need, nothing more, nothing less
We don't pad our hours by charging you for services that you don't need.
A Pharmaceutical/Biotech consultant with 28 years of broad experience in development through commercial activities. Specialty in GxP manufacturing and operations. Expert in quality systems and regulatory affairs.
28 years of experience in biotech and Pharma
Expert in manufacturing and analytical development/validation for biologics and pharma
Authored regulatory submissions (IND,IDE, NDA, 501k, BLA, Fast Track, Orphan Drug, etc.)
Managed all technical operations for a biotech company including contracts negotiation and subcontractor management (>30 contractors and consultants).
Developed/validated >50 analytical methods in conformance with FDA guidelines, including ELISA, flow cytometry, PCR, endotoxin and many other method types.
Served as primary QA/QC contact in multiple FDA/EMA/PDMA inspections (pre-approval, routine, compliance).
Sourced and audited CMOs in the US and worldwide for biologics manufacturing and analytical development. Extensive network of relationships with different companies.
Developed and validated bioanalytical methods for GLP use in support of IND-enabling studies and human clinical trials.
Authored regulatory submissions (IND, IDE, NDA, 501k, BLA, Fast Track, Orphan Drug, etc.) for antibodies, pharma, device and cell therapy products.
Managed many GLP studies, including establishing IND-enabling pharm/tox studies, as well as efficacy studies. Expert in cost-effective vendor management for GLP studies.
Validated multiple biologic (monoclonal antibody and others) manufacturing processes in support of BLA submissions.
Performed compliance (483, Warning Letter) assessments and remediation
Established GMP manufacturing/quality systems for numerous companies, including SOPs, BPRs, lot release specifications and analytical methods.
Prepared SOPs and other documents for many pharmaceutical and biotech products.
Strong knowledge of GXP compliance as well as USP, EP, ICH and FDA guidelines
Professional Experience Highlights (Harmony Consulting)
President, Harmony Consulting, Inc: 2011 – present
Major Consulting Projects
Cell Therapy Project Manufacturing/Regulatory Affairs Management | 2016-present
Managed relationship with contract manufacturing organization (CMO) for manufacturing and analytical development/testing of multiple cell therapy biologic products in early clinical development. Sourced and managed other CMOs as required. Created quality system “from scratch” writing >50 batch records, specifications, and SOPs. Authored and submitted 2 INDs and other associated submissions. Regulatory point of contact for FDA.
Biologic Product Project Management | 2015-present
Served as primary contractor for Israeli company preparing Technical/Business proposals for BARDA contract for biologic product, leading to >$100M contract award in September 2015. Currently providing ongoing project management support, including technical support (analytical development) and FDA submissions.
Monoclonal Antibody Validation 2015
Prepared validation studies for a monoclonal antibody product in Phase 3 including writing development reports, gap analysis of manufacturing and testing procedures against current GMP/FDA requirements, writing of antibody manufacturing batch records, and writing validation protocols.
Medical Device Project Management – 2015-present
Project management for a >$40M BARDA contract.
Operations Management (VP Operations) | 2011-2017
Responsible for all GxP operations in a virtual company environment as VP Operations for a pharmaceutical company manufacturing medical countermeasures and oncology products. Created a GxP quality system “from scratch”, writing >100 SOPs. Responsible for vendor management, with over 10 CMO/CRO’s and over 20 consultants. Regulatory point of contact for FDA.
Remediation Project: Medical Device Company | 2014-2016
Responsible for technical writing, auditing, and general document creation for device company with multiple FDA Warning Letters to remediate their quality and operational systems.
Other Project Summaries: 2011-2018
From 2011, acted as head of Quality for 4 different companies as a consultant, implementing QA program. Transferred QA to in-house personnel when systems were active. Provided general Quality consulting for many different companies.
Built quality systems for companies manufacturing:
Sterile parenteral products (biologics and small molecule),
Cell therapy products, and
Drug/device combination products.
Responsible for all QA functions for GxP operations, including lot release, audits, change control, deviation management, validation, etc.
Assisted with FDA submissions (pre-IND, IND, EOP2, etc.)
Managed commissioning, qualification, and validation for pharmaceutical equipment.
Managed computer system qualification and validation.
Prepared grant applications for: NIH, DOD, DARPA, NAIAD, and other federal agencies for companies worldwide.
Professional Experience (Other)
Dendreon Corporation, Sr. Manager, Quality Control, 2010-2011
Managed daily QC operations for a commercial active immunotherapy company.
• Successfully managed QC start-up of a new commercial AIT facility
• Conducted technology transfer (TT) of Quality Control methods; assisted in TT of manufacturing processes.
• Led activities for new staff, including EDMS and LIMS implementations for new site
• Oversaw QC activities for analytical method, lab equipment, and manufacturing process validation
Spectrum Pharmaceuticals, Sr. Manager, Global Quality Control / Quality Assurance, 2008-2010
Responsible for worldwide QA/QC & Validation for a global commercial biotechnology company with 2 commercial and 8 clinical products.
• Established QA/QC systems for the company, including lot release, vendor qualification analytical method validation, equipment validation, and process validation.
• Led team that acquired and transferred a radiolabeled monoclonal antibody to the company. Sourced contract manufacturers for antibody production.
• Saved company $2M yearly through alternate supplier qualification.
Biogen IDEC, Manager, Equipment and Process Validation, 2003-2004
Responsible for equipment, utility and process validation for a new $300M biotech production facility in Oceanside, CA.
• Was a member of the facility design team from initial stages to finalization of design.
• Worked with contractors to establish Validation Master Plan (VMP), and validation procedures (IQ/OQ/PQ/FAT/CQ).
• Established lab equipment validation plan for new facility
• Established specifications for new equipment and utilities
• Interviewed and hired multiple validation contracting firms.
Biogen IDEC, Manager, QC Analytical Methods Validation 1999-2003
Responsible for the validation of analytical methods for the company. Promoted 2003.
• Managed the validation of over 25 different analytical methods, including bioassays, HPLC, ELISA, q-PCR, micro and others.
• Transferred analytical methods from R&D to Quality Control in tech transfer (TT) project,
• Validated laboratory equipment for all QC labs (IQ/OQ/PQ).
• Created and implemented 21 CFR Part 11 computer validation program
Medeva Pharmaceuticals, Manager QC/Validation, 1998-1999
Responsible for validation (equipment, process, cleaning, computer) for an oral solid-dosage company.
• Developed and executed a Validation Master Plan (VMP).
• Commissioned and validated new manufacturing equipment, computers and utilities (CQ/IQ/OQ/PQ). Validated existing equipment and utilities.
• Validated four manufacturing processes (PQ), according to FDA guidelines and using Statistical Process Control (SPC) techniques.
• Led QA/QC/Validation technology transfer (TT) process of all products to new facility.
• Served as QC Manager as part of company remediation. Responsible for all OOS investigations and product release.
• Supervised a staff of 20 plus contract groups.
Peregrine Pharmaceuticals, Director, QA Validation / Project Manager, 1997-1998
Supervised the design of a $30MM GMP pilot plant facility for a monoclonal antibody. Supervised a staff of 6 plus contractors.
• Managed technology transfer (TT) and scale-up of monoclonal antibody product.
• Established a VMP and commissioning and validation schedule (CQ/IQ/OQ/PQ execution).
• Coordinated the activities for the submission of an IND
Peregrine Pharmaceuticals, Manager, Validation/QC, 1996-1997
Developed and validated analytical methods for a monoclonal antibody product in Phase III clinical trials. Promoted 1997.
• Validated over 20 analytical methods, including SEC, ELISA, bioassays, and microbiological methods.
• Created validation policy for the company, including writing of a Validation Master Plan (VMP), analytical methods and computer validation activities.
• Validated analytical equipment and computer systems (IQ/OQ/PQ).
• Developed and implemented Cleaning Validation program.
Peregrine Pharmaceuticals, Supervisor, QC, 1994-1996
Supervised the testing and release of finished product, in-process, and raw materials, using ELISA, HPLC, LC, and bioassay methodologies. Promoted 1996.
Gensia Pharmaceuticals (now Teva), Quality Control Chemist, 1993-1994
Used HPLC, GC, FTIR, and wet chemistry methods to test finished product and raw materials.
MacDonald-Stephens Laboratories, Chemist, 1992-1993
Used HPLC, ICP, GFAA to test environmental samples.
· University of Phoenix, 1998-2000, BS Business/Information Systems
· UCLA, 1988-1993, Major: Biology
A Pharmaceutical/Biotech consultant with 15 years of broad experience in development through commercial activities. Specializes in GxP compliance, document management, legal affairs, contract review and due diligence, and business development.
15 years of experience in biotech/pharma
10 years of experience in legal contract review and negotiation
Expert in documentation systems, agreements and contracts
Wrote and reviewed >1000 SOPs, batch records and technical reports for different companies. Legal/Contracts:
Authored and reviewed agreements for pharma/biotech:
- Supply agreements
- Quality agreements
- Partnership contracts
Reviewed FDA submissions (pre-IND, IND, EOP2, etc.)
Established documentation systems “from scratch” for pharma/biotech comapnies Prepared successful grant applications for: NIH, DOD, DARPA, NAIAD, and other federal agencies for companies worldwide. Conducted RA/QA gap analyses for companies GxP system and submission.
Professional Experience Highlights (Harmony Consulting)
CEO, Harmony Consulting, Inc: 2011 – present
Performed technical writing and contract management to multiple companies.
Project Summaries: 2011-2018
• Established documentation systems for >10 companies.
• Obtained and managed >$300M of funding for different clients.
• Authored and reviewed legal agreements from a GxP perspective for clients. .
• Built quality systems for companies manufacturing:
o Sterile parenteral products (biologics and small molecule),
o Cell therapy products, and
o Drug/device combination products.
• Responsible for all QA functions for GxP operations, including lot release, audits, change control, deviation management, validation, etc.
• Assisted with FDA submissions (pre-IND, IND, EOP2, etc.)
• Managed commissioning, qualification, and validation for pharmaceutical equipment.
• Managed computer system qualification and validation.
• Prepared grant applications for: NIH, DOD, DARPA, NAIAD, and other federal agencies for companies worldwide.
Professional Experience (Other)
www.invitationinabottle.com, CEO, 2003-2011
Founded a successful Internet-based invitation company, with peak sales of $350,000/year and 2,000 unique website visitors per month. Fulfilled approximately 10,000 orders and sent out over 1,000,000 invitations. Sold company for 3X sales in 2008.
Wet Seal, Inc., Legal Assistant, 1996-1998
Managed corporate filings, copyright/trademark disputes, and financial reporting and served as a liaison to outside counsel for the corporate headquarters of a successful women’s clothing retailer.
Realty World, In-House Paralegal. 1994-1996
Managed legal operations for a real estate franchise company.
Tom Norminton, Attorney at Law- Paralegal 1989 - 1994
Coordinated legal activities for a busy corporate law office, including research, contract review, court filings, and many other functions.
• Oregon State University 2017-2018, Psychology
• UCLA, 1989-1993, Political Science