Les Eric Johnson
CEO - Optimum Development Technologies, Inc
COO – Shock Therapeutics Biotech, Inc
CMC and FDA Submissions Lead – CSSi LifeSciences
Head of Quality and CMC – Acurx Pharmaceuticals
Over 35 years of international Quality Assurance (QA), Quality Control (QC), Operations, Regulatory, Quality Management Systems, Chemistry, Manufacturing and Controls (CMC), Analytical Development and Validation, and Process Development and Validation. Proven industry expert in biologics, pharmaceuticals, vaccines, advanced cell therapies, medical devices and combinatorial drugs. Solid history of developing and managing complex, worldwide projects. Specializes in in-person and on-site Contract Manufacturing Organization (CMO) and Laboratory management. Develops the best possible sponsor/vendor partnerships to ensure on-time and on-budget delivery of products of the highest possible quality. Led several IND, NDA and BLA submission teams and written CMC sections for 20+ products. International auditing and qualifying of manufacturers, laboratories and suppliers. Manages and trains clients on Quality Management, deviation and CAPA investigations, risk mitigations, root cause analysis and proof of effectiveness. Provide valuable financial services through due diligence assessments and process/cost modeling of real products, projects and sites for investors, acquisitions, mergers and contracting purposes. Develops, optimizes and manages effective business and regulatory strategies, as well as product development, and commercialization plans. Provides expert advice to start-up and transitioning companies including well developed cost modeling, budgeting, risk analysis and risk mitigation, contract templates and building/training full quality management systems.
Founder and General Manager of Optimum Development Technologies, Inc.
Executive assignments through Optimum Development Technologies, Inc.:
• COO to Shock Therapeutics Biologics, Inc., a new therapeutics company developing a treatment to prevent and reverse the effects of shock after severe injury/trauma/infection. Responsible for all corporate strategies, fund raising, regulatory (Early FDA advice and IND) relationships with partners and service providers, product development and quality management systems.
• CMC and FDA Submissions Lead for CSSi Lifesciences, a company providing expert consulting for clients in project management, product development, clinical studies and regulatory submissions. Responsible for CMC and product development for various clients working on a wide range of biologic and pharmaceutical products
• Head of Quality and CMC for Acurx Pharmaceuticals, a company developing polypeptide-based antibiotics to treat a range of resistant or untreated pathogenic infections. Led IND teams for 2 products and wrote all CMC sections for INDs and NDAs.
• Previous CEO of Rasio Therapeutics, a company developing novel technologies to quickly design highly directed anti-cancer drugs based on 3-dimensional molecular mapping. Built new company, managed technology development and set partnerships. Initiated fundraising and drafted IND for first products.
Other projects through Optimum Development Technologies, Inc.:
• Providing executive consulting services with a real-world perspective and a great propensity (and desire) to get my hands dirty.
• Strong experience of real-time and in-person task management and issue resolution. Available 24 hours a day, 7 days a week to receive data, resolve deviations and make decisions. This is currently utilized for major manufacturing project in India.
• Success through use of excellent teaching, coaching and consensus-building skills, and application of high-value financial, operational, quality management and assessment tools.
• Provide global quality compliance and qualification audits, mock-inspections. Manage all types of deviations and CAPAs.
• Manage IND, NDA and BLA teams and make presentations to appropriate agencies.
• Write entire CMC sections for a wide range of products, submitted to several agencies.
• Manage grant applications and build relationships with government agencies, venture capital groups, corporate venture groups and private investors.
• Build and manage entire Quality Management Systems that are appropriate for the stage of development.
• Assisting with initiative to bring high-quality, critical medicines to areas of Central and Southern Africa. Setting up raw materials, Drug Substance and Drug Product manufacturing and testing. Applied process and cost modeling to predict price of drugs and negotiate bids. Project currently awaiting USAID/USDOD approvals.
• Head of CMC and Product Development for a new company being spun out of Johns Hopkins University’s Neuro-oncology group to develop a very promising new cancer therapeutic.
• Assisting Johns Hopkins spinoff working on an advanced HPV VLP vaccine
• Providing CMC, Quality and Business Development consulting to a Venture Capital/Project Management group with 10 current products in their portfolio.
• Providing Executive Business and CMC/Quality/Regulatory consulting through CloudAdvisors.com
2012 - 2017
Senior Technical Adviser in CMC and Operations – RRD International and Head of CMC and Quality - ClearPath Development
• Highest level advisory role in RRD's partner programs.
◦ Business development activities related to RRD direct partnerships with pharma and biopharma companies, including new technology discovery and development
◦ Lead role on RRD projects providing project management, quality management, drug development, process development, financial, regulatory and CMC expertise to Partner companies and joint development teams.
◦ Head of Quality and CMC for ClearPath Vaccines Corporation, a subsidiary of RRD. Conducted qualification, pre-IND and Pre-NDA multi-national audits of service and material providers for several of the projects in our portfolio.
◦ Provided process and project financial modeling and risk analysis to allow accurate calculation of the current and potential value and cost of projects
◦ Used modeling tools to terminate major project before main financial commitment. Product was shown to fall well short of delivery cost target with optimistic projections.
◦ Built and maintained complete Quality Management Systems for ClearPath and several partners. Designed these systems to be compliant with all applicable regulations and to be cost effective through application of best business practices and risk avoidance.
◦ Took lead role in the writing and submission of several documents to the FDA and other regulatory agencies, including INDs, NDAs, Annual Reports, White Papers and Audit Responses
◦ Lead teams to conduct scientific investigations, resolve deviation and develop proper corrective and preventive actions
2008 - 2012
Senior Consultant in CMC and Operations - Salamandra LLC
• Interim Corporate Officer for Operations, Regulatory and Quality for a cellular vaccine sponsor. Involved manufacturing sites on 4 continents and suppliers from over 12 countries. Phase 3 studies being approved for start by TGA, EMA and FDA for over 2000 patients.
• Led IND, BLA and NDA teams as well as writing entire CMC sections for numerous client submissions.
• Help clients locate and qualify for funding through government and industry sources.
• Assess, build and repair quality management systems for Salamandra and several clients, including Unither Virology, Prima Bio, US Army research facilities and several DOD/CDC/BARDA/JVAP contractors.
• Work with early-development and established cellular therapy companies to ensure their quality compliance, set their regulatory strategy and optimize their processes and product economics
• Provide specific guidance to several vaccine manufacturing clients, including BSL-3/GMP plant and laboratory design. Assess and optimize client quality, manufacturing and operational systems providing gap, risk and cost analysis.
• Broker and manage supply agreements, contract manufacturing and contract testing services for clients
• Provide due diligence services in support of acquisitions and mergers.
• Lead business development efforts, significantly increasing client base and revenue. Create community outreach program including mentoring programs with UMD, UMUC and UMBC, and charity fund raising and food drives.
2007 - 2008
Vice President of Product Operations – Celsis (formerly In Vitro Technologies)
• Initial role of managing acquisition and transition of In Vitro by Celsis. Extended contract to run the very complex products division
• Worked directly with US, EU and Asian Sales/Marketing to set short and long-term production and quality goals, establish marketing strategies, customer satisfaction, supply agreements and new product opportunities
• Built quality management system and re-designed manufacturing operations to improve product quality, ensure delivery and optimize profitability
• Set regulatory strategy and invited FDA to audit processes and to establish regulations for human tissue products industry
• Developed and launched 2 new cellular product lines, increasing market share and profits
• Managed all Division finances, established operating budget process, operational excellence system and performance metrics
• Created interactive Master Database from 8 years of processing data covering over 3 million product samples in storage. Used system to set product prices, manage complex product formulations, significantly improve productivity, strategically use high-value raw materials (human tissues) and improve profits.
• Increased profits 2-fold per year
2006 – 2007
Senior Director of Commercial Operation, Planning and Logistics – Cambrex Bio
• Initial role of preparing division for sale or merger. Extended contract to manage division through acquisition and transition by Lonza.
• Responsible for all commercial aspects of operations: project management, client relations, customer service, sales management and support, manufacturing, quality, scheduling, corporate reporting, R&D, QC and QA
• Established R&D groups as profit centers for company, instead of value-added services.
• Wrote CMC sections for several client IND and BLA submissions
• Renegotiated agreements to align better with actual and modeled costs. Negotiated new contracts (up to $75 million) based on accurate cost and process modeling.
2004 – 2006
Senior Director of Manufacturing and Operations – Progenitor Cell Therapies
• Initial role to correct operational and financial deficiencies to make company profitable to attract buyers. Extended to renegotiate existing contracts, establish quality testing and consulting services as profit centers and manage build out of new facilities.
• Brought Manufacturing and Quality Control Operations for cellular therapies into GTP compliance for east-coast and west-coast facilities. Hosted first FDA inspection of cellular products manufacturer and trained field inspectors.
• Managed all client relationships and business development - doubling number of clients under contract and delivering products for 8 clinical trials
• Lead Consultant to several clients moving into clinical or commercial phases, including setting regulatory strategies and writing submissions
• Managed all QC method, process and facility validations
2002 – 2004
Vice President of Technical Operations – Biosynexus
• Initial role to bring company into GMP and GLP compliance and to set products in development onto clinical trial pathway. Extended contract to manage product manufacturing within strict budget and tight timeline.
• Brought two products (antibiotic and vaccine) up to Phase 2 clinical trials
• Set manufacturing, quality, regulatory, and acquisition strategies.
• Developed and directed staff in the areas of Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs, Validation (process and QC methods), Process Development and Project Management.
• Designed and operated aseptic filling systems for semi-solid product formulations. Supervised and audited contract fill/finish operations for vaccine product.
• Led all regulatory submissions (INDs, BLAs, supplements and amendments) related to
CMC and testing. Hosted agency audits resulting in no citations and prepared for pre-approval inspections.
• Negotiated sale of these products to two major biopharmaceutical companies
2001 – 2002
Senior Consultant in Process and Operations – Biologics Consulting Group
• Initial role to manage major project with GATES Foundation to establish international development and manufacturing consortium for a MenA vaccine (continuation of project from Baxter)
• Provided quality (QA and QC), CMC, technical and operational consulting services to clients.
• Developed and executed validation master plans and regulatory strategy for projects in US, EU and India
• Performed more than 20 GLP, GMP and Due Diligence audits for merger-acquisitions and investors
• Wrote and presented courses on Process Validation, QSIT/PAT and emerging FDA quality initiatives
2000 – 2001
Plant Manager and Director of Vaccine Manufacturing – Baxter Bioscience
• Initial role to direct site out of FDA non-compliance status. Extended contract to manage through acquisition by Baxter and re-license of facility by FDA.
• Plant Managers position reporting to CSO of Immuno Corporation, then to VP of Baxter International Production
• Responsibility for all Vaccine (MenC and Pertusis) Manufacturing, Engineering, Regulatory (CMC and Quality), Quality, Facilities, Housekeeping, Environmental Health and Safety, Production Planning and Maintenance - 8 departments with approximately 200 people.
• Took over plant with record number of 483 citations and warning letters negotiated with agency, set and executed action plan, resolved all deviations, made process changes and brought plant back on line in 6 months at full capacity with measurable profit margins
• Won Annual Baxter Quality Achievement Award
• Assisted Baxter Corporate Acquisitions team with the assessment of several potential companies and did full due diligence and helped with negotiating three acquisitions by Baxter
• Member of corporate committees including Baxter Quality Awards Council (Malcolm Baldridge), Manufacturing Quality Council, Global Readiness Committee, SITE Council, etc.
1997 – 2000
Director of Bioprocessing – Protein Polymer Technologies
• Senior staff position with leading edge company specializing in the design, development and application of silk-elastin block co-polymer materials for use as tissue replacements, medical adhesives and drug delivery.
• Responsible for design and build-out and FDA inspection of manufacturing facility. Submitted pre-IDE, IDE, IDE supplements and amendments for FDA approval.
1993 – 1997
Senior Development Scientist/Engineer – Bayer Pharmaceuticals
• Led Quality Review Group to study process statistics, resolve deviations, determine process changes and optimize employee training in areas of bioprocessing and aseptic fill/finish. Conducted HAZOP, DDA and COG studies for site.
• Bayer Quality Improvement Award for 1997. Transferred Quality Systems and inspection experience to 2 other Bayer sites preventing numerous inspection citations and improvement of quality across company’s bio-divisions.
• Planned and executed installation and validation work on $160MM production facility. Plant Engineer for the development facility - responsible for over $14MM of architectural changes.
1987 – 1993
Manager of Purification Systems – Berlex Biosciences (spun from Cetus)
• Managed group responsible for all downstream process development and pre-clinical manufacturing of human and animal therapeutics
• Designed and operated USDA facility to produce recombinant fractional vaccines for veterinary use
• Member of several patent, IND, ELA and PLA teams (ß-interferon)
1982 – 1987
Manufacturing Supervisor – Cetus Corporation
• Supervised all GMP production, formulation and aseptic filling in Biotech's first licensed facility
• Designed and installed all process equipment including automated fill/finish line
• Hosted first FDA inspections for recombinant biologics
1981 BS, Chemistry, Hayward State University, Hayward, CA
1977 - 1978 Oceanography Major, Long Beach State University, Long Beach, CA
OTHER EDUCATIONAL EXPERIENCE:
Continued Education through University of California Extension and MIT Biochemical Engineering (etc.)
International Society for Pharmaceutical Engineering (ISPE)
Maryland Tech Council
India Biotechnology Chamber of Commerce Who’s Who - Biotechnology
20 years experience as baseball coach at various levels including high school.