Expert Details
Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization
ID: 726016
New Jersey, USA
He has over 15 years experience in the commercialization of products, sterile and nonsterile, ranging from liquids to complex systems such as suspensions and emulsions, liposomes, microspheres and drug device combination products. Ensuring that the science is well understood prior to scale up so that the process at the point of commercialization is lean and robust and most importantly, in control.
He has completed the process development and validation of well over a dozen products ranging in complexity and has never received a negative impact regulatory observation, eg. FD 483. He has a reputation for troubleshooting and deriving compliant resolution options.
He has been in the injectable drug industry for most of his career. Starting with sterile powder processes, including aseptic milling and blending prior to filling. He has worked with every conceivable injectable drug process from liquids through to controlled release using microspheres, liposomes, emulsions, nanoparticles, suspensions to complex solvent systems.
Improved process for oral suspension in late stage development, original process time was 4 days; process was neither scalable nor robust. Resultant process was scalable and robust with a total processing time of 6 hours. Saved the company $ 32MM.Used Process Excellence approach to reduce the variability associated with the elution test for a drug/device combination medical device. Saved the company $7.8 MM He wrote the technical description for the regulatory submission of a new start up contract Parenteral facility. The document was well received by the reviewing authority.Successfully used Process Excellence approach to data mine and analysis to resolve an outstanding FDA observation without performing further processing and lab work. Saved the company $ 1.4 MMDeveloped the cleaning program (policy through implementation plan) for a multi-use contract aseptic manufacturing facility specifically designed for cytotoxic and ultra potent compounds.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1992 | Degree: Ph.D. | Subject: Pharmaceutics | Institution: University of Missouri |
| Year: 1987 | Degree: B.S. | Subject: Pharmacy | Institution: Drake University |
| Year: 1984 | Degree: B.A. | Subject: Chemistry and Biology | Institution: Drake Unversity |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2008 to Present | Employer: Undisclosed | Title: Principal Consultant | Department: |
Responsibilities:Available as an independent contract technical resource for the Biotech, Pharmaceutical and Medical Device (with specific emphasis on drug/device combination products) industries. |
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| Years | Employer | Title | Department |
| Years: 2005 to 2008 | Employer: (Undisclosed) | Title: Sr. Research Fellow/Exec. Director Process Engineering | Department: Worldwide Operations |
Responsibilities:Responsibilities included providing base business support as a Subject Matter Expert (SME) for drug/device combination products, by leading or supporting directly the product improvement of commercial products, as well as process optimizations for the operational sites in the manufacturing of a wide variety of medical device products. Prepared project plans and involved with design review, PMA submissions and PAI readiness. |
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| Years | Employer | Title | Department |
| Years: 2001 to 2005 | Employer: Schering-Plough | Title: Director, Pharmaceutical Technology Transfer | Department: Global Technical Services |
Responsibilities:Responsibilities included leading and directing technology transfer through the scale-up and validation of sterile and non-sterile liquid and semisolid pharmaceutical products. Preparing technology transfer, strategy plans, and GAP analysis for project transfers between development and operations or from one operating Site to another. Served as the Technical Operations representative member on the project team, the CMC sub-team, and the technology transfer team to insure that the final process was commercially feasible and efficient. |
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| Years | Employer | Title | Department |
| Years: 1999 to 2001 | Employer: Purdue Pharma, LLP | Title: Asst Director, Parenteral Technology Transfer | Department: Parenteral Formulations |
Responsibilities:Responsibilities included leading and directing the technology transfer group through the scale-up and validation of parenteral products. Also involved with equipment acquisitions, the writing and reviewing of equipment specifications and related SOPs. Prepared and executed protocols for process and equipment validations (e.g. IQOQPQ). Involved in the optimization of complex processes for the manufacture of injectable controlled release formulations. Involved in the development of the CMC section for NDA and BLA submission and with preapproval inspections. |
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| Years | Employer | Title | Department |
| Years: 1997 to 1999 | Employer: Novartis Pharmaceuticals, Inc. | Title: Res Fellow II/Asst Director, Process R & D, Liquids | Department: Pharmaceutical and Analytical Development |
Responsibilities:Responsibilities included leading and directing a group through the early development, scale-up and validation of liquid pharmaceutical commercial processes (oral liquids and sterile products). Worked with multidisciplinary groups to assess the feasibility of new chemical entities. Involved with the identification of new technologies, equipment acquisitions, and the writing and reviewing of equipment specifications and related SOPs. Prepared and executed protocols for process and equipment validations (e.g. IQOQPQ). Involved in the development of the CMC section for NDA and BLA submission and with preapproval inspections. |
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| Years | Employer | Title | Department |
| Years: 1996 to 1997 | Employer: Hoffmann-LaRoche | Title: Pharmaceutical Process Investigator | Department: |
Responsibilities:Responsibilities included the scale-up and validation of sterile pharmaceutical commercial processes. Also involved with equipment acquisitions, the writing and reviewing of equipment specifications and related SOPs. Prepared and executed protocols for process and equipment validations (e.g. IQOQPQ). Involved in the development of the CMC section for NDA and BLA submission and with preapproval inspections. |
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| Years | Employer | Title | Department |
| Years: 1992 to 1996 | Employer: Johnson & Johnson | Title: Sr. Scientist/Scientist | Department: Pharmaceutical Product Development/Technical Services |
Responsibilities:Responsibilities included the scale-up and validation of sterile pharmaceutical commercial processes. Also involved with the set-up, design, and validation of parenteral manufacturing facilities in the US and Europe. Involved in the development of the CMC section for NDA, BLA, and dossier submissions and with preapproval inspections. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2001 to 2004 | Country / Region: Singapore | Summary: He coordinated and was the technical subject matter expert for the technology transfer, regulatory filing and eventual site inspection for a greenfield biotechnology robotic lyophilization facility used to manufacture a protein lyo formulation within a two chamber syringe cartridge. |
| Years: 2004 to 2005 | Country / Region: Germany | Summary: He led functioned as the site subject matter expert for the scale up of a cytotoxic lyophilized Parenteral product being transferred from the research site in the US to the contract manufacturing facility in northern Germany. |
| Years: 2001 to 2005 | Country / Region: Ireland | Summary: He functioned as a product subject matter expert and expert in steam in place validation for this biotech facility both for the SIP validation Technical Support issues within the biofermentators and for the manufacture of the liquid filled and lyophilized vial products. |
Career Accomplishments
| Associations / Societies |
|---|
| American Chemical Society (ACS) American Association of Pharmaceutical Scientist (AAPS) Parenteral Drug Association (PDA) International Society of Pharmaceutical Engineers (ISPE) New Jersey Pharmaceutical Association of Science and Technology (NJPhAST) |
| Licenses / Certifications |
|---|
| MO Licence RPh. |
| Professional Appointments |
|---|
| Invited to participate in the ISPE Examination Development Committee for the development of certification examination questions for the CPIP (Certified Pharmaceutical Industry Professional) program. Referee for manuscripts submitted for publication in Pharmaceutical Research (AAPS) (2003 – 2005) Vice Chair, Chair-Elect, Chair and Past Chair, Pharmaceutical Technology (PT) Section of American Association of Pharmaceutical Scientist (AAPS) (2001-2005). Arden House Conference 2000, “Technical Transfer of Pharmaceutical Products from the Laboratory to Commercial Production”, Planning Committee Chair (1999-2000) Chairman of the Paperscreening Committee, Pharmaceutical Technology (PT) Section (AAPS) (1998) President, Pharmaceutical Sciences Graduate Student Association (PSGSA) (1989-1991). Voting Member, Graduate Programs & Admission Committee, School of Pharmacy (1989-1991). Vice President, Pharmaceutical Sciences Graduate Student Association (PSGSA) (1987-1989). |
| Awards / Recognition |
|---|
| Selected as Subject Matter Expert (SME) by International Soc. Pharm Eng. (ISPE: 2007) Sr. Research Fellow – Johnson & Johnson Corporate Office of Science and Technology (2007) Team Excellence Award – Cordis Corp (2005) President’s Award Schering-Plough Research Institute (2003) Leadership Awards – AAPS (2000 & 2003) Member of RHO CHI Marion Laboratories Fellowship in Pharmaceutical Technology (1989-1990) Chancellor’s Award, University of Missouri-Kansas City (1988-1991) Marion Laboratories Summer Graduate Research Internship (1989) NPC Research Intensive Internship - Sandoz Research Institute (1986) |
| Medical / Professional |
|---|
| Marion Laboratories Summer Graduate Research Internship (1989) NPC Research Intensive Internship - Sandoz Research Institute (1986) |
| Publications and Patents Summary |
|---|
| He has 14 externally presented publications and presentation. He has had numerous publications and presentation within the organizations that he has served that have been used for over a dozen successful product regulatory filing and approvals. |
Additional Experience
| Expert Witness Experience |
|---|
| I provided expert testimony in the form of a deposition during a lawsuit between two companies. The buyer alleged deception on the part of the seller of a Parenteral manufacturing facility. Testimony given was with respect to my cGMP inspection of the specific Parenteral facility. |
| Training / Seminars |
|---|
| I developed a 4 part training module to provide a basic pharmaceutical science understanding within Cordis, a Medical Device Company whose engineers lacked even the basic understanding of chemistry. The training was to facilitate and drive for future success within the development of drug/device combination products. |
| Vendor Selection |
|---|
| I have extensive experience with equipment and vendor selection. I have been involved with due diligence and cGMP quality audits. I had in my past been frequently requested by QA site auditors to participate in site quality audits as their pharmaceutical subject matter expert. |
| Marketing Experience |
|---|
| I have been fortunate to be involved with and had insight for what is hot in the industry. Most recently, I was involved with the design and development of the latest in drug /device combination products. I also have published, been invited to speak and have become a subject expert in the field of terminal sterilization of biologic and protein based drug products. I am involved with professional organizations and provide input into technical papers, presentation and provide opinion papers for the available trade publications. |
| Other Relevant Experience |
|---|
| I am well versed in editing or writing technical documentation that is concise and succinct with an effective presentation of the pertinent data. My documentation is frequently used either in its entirety in the regulatory filing of as a standalone report reviewed during an inspection. I am also Black Belt Certified (J&J) in Process Excellence, six sigma approach which further strengthens my ability to effectively analyze data and draw a practical and meaningful conclusion. |
Language Skills
| Language | Proficiency |
|---|---|
| Turkish | He is able to read technical documentation and provide explanation and translation into English for either technical support for facilities in Turkey. Or function towards a due diligence for in-licensing of research from universities in Turkey by providing a mediation service. |
Fields of Expertise
aseptic pharmaceutical process validation, commercialization, design for manufacturability, pharmaceutical product development, Current Good Manufacturing Practice, Good Manufacturing Practice, injectable drug, injectable pharmaceutical product, parenteral drug delivery, protein drug delivery, abbreviated new drug application, overall cycle time, pharmaceutical filtration, bulk packaging material, pharmaceutical liquid, generic drug manufacturing, contract manufacturing, drug release polymer, drug product approval, Food and Drug Administration compliance, bulk mixing, drug formulation, Food and Drug Administration validation, drug degradation, pharmaceutical filter, drug processing, cream, pharmaceutical design, disinfectant Food and Drug Administration regulation, rapid product development, design for cost, drug stability, drug development, pharmaceutical industry, product development cycle time, pharmaceutical engineering, device product development, new product development, drug dosage form development, drug delivery, Food and Drug Administration, pharmaceutical dissolution, new drug, new product development management, controlled-release drug delivery, design process, Food and Drug Administration regulation, drug regulation, transdermal drug delivery, nonaseptic pharmaceutical process validation, new drug application, dosage form, bulk pharmaceutical chemical manufacturing