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 Expert  728603

Expert in Chemistry R&D and cGMP Manufacturing, Pharmaceutical Development

Available for your Consulting and Expert Witness Needs

Massachusetts (MA)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral analysis of starting materials, intermediates and product APIs; sourcing of optically active raw materials; understanding and exploitation of epimerization and racemization; resolution using chiral chromatography and fractional crystallization of diastereomeric salts.

stereoselective reaction




asymmetric synthesis


asymmetric induction


chiral synthesis


enantioselective catalysis




molecular chirality


racemic mixture resolution



Although Expert's industrial career has been concerned mostly with chemical and pharmaceutical development, he has also made significant contributions to discovery efforts at a number of organizations at which he was employed. Based on his postdoctoral studies, Expert has maintained an active interest in the area of prodrugs. One product that Expert worked on in his career that has been approved by the FDA is Fospropofol, a phosphate prodrug of the sedative propofol. He has also been an active participant on discovery projects while at Elixir Pharmaceuticals, assisting in the management of the outsourced work on the synthesis of compounds for testing and development of SAR, and as the leader of the new target sourcing effort while at PPD Dermatology. Expert has demonstrated the ability to identify new therapeutic targets in a given area, and to assess the chemical tractability of a given target. He was involved in a business development capacity while at PPD Dermatology, to identify and contact organizations and institutions deemed to be doing early discovery work in areas that were relevant to the establishment of a drug pipeline. Expert also had responsibility for the performance of due diligence on chemical matter and evaluation of the viability and merit of in-licensing, investment and partnering opportunities while employed at Elixir Pharmaceuticals, and Magen Biosciences/PPD Dermatology over the past five years.



chemotherapeutic drug


drug therapy

During the last five years, Expert's responsibilities have expanded to include all aspects of CMC development, including analytical method development and pharmaceutical development. He is proficient in leading efforts in preformulation, including salt screening and selection, polymorph screening, development of stability-indicating methods, forced degradation studies and physicochemical characterization of lead drug compounds. Expert's experience has extended to formulation development, including excipient compatibility studies, prototype generation and evaluation, and scale up to production scale. He has overseen the production of GLP suitable tox lots and GMP manufacture of Phase I supply for two NCEs, and has been involved in Phase III and registration lot manufacture for the commercialization of a type II diabetes drug that is already on the commercial market in Japan. This work involved significant strategic planning and management of a partnering relationship with the business and CMC functions of a major Japanese pharmaceutical company. It included auditing of API manufacturing facilities in Japan and preparation for a pre-approval inspection (PAI) by the FDA. Evaluation and interpretation of drug product stability data was also integral to this project. He has also worked on the development of a fixed dose combination for a tablet. Expert has direct experience in leading development efforts for drug products administered orally (tablets and capsules) and topically (creams and ointments). The above work resulted in the filing of two INDs, which were accepted by the FDA with no CMC questions. Expert was a key author on the CMC sections of both submissions. He was also a key author on the pre-NDA briefing book for the commercialization effort described. The FDA had no questions on the CMC section of this submission, even though it was a legacy product.

Expert had responsibility for the evaluation, selection and management of drug product vendors for the projects summarized above.


drug degradation


drug dosage form development


drug formulation


pharmaceutical analysis


pharmaceutical design


drug identification


drug development


drug screening


drug processing


pharmaceutical research and development


pharmaceutical manufacturing


pharmaceutical product shelf life testing


preclinical research

Expert's industrial career has been extensively involved in the solution of challenging problems in the area of chemical process development. He has worked in the laboratory on multistep syntheses of multiple classes of chemical compounds, including amino acids, carbohydrates, nucleosides and nucleotides, polyazamacrocycle chelating agents for MRI, peptidomimetics, heterocycles, alkaloids, ionophores, dyes, cannabinoids, organophosphorus compounds. His accomplishments have included development of novel practical synthetic routes to target compounds, development of scalable, robust processes for production and manufacture, process optimization, improvement of yield, stereochemical purity, API quality and operational simplicity and transfer of technology from R&D into kilo labs and then into pilot and multipurpose manufacturing plants. Expert has participated in and led multidisciplinary scientists charged with solving complex chemistry problems and delivering scientifically sound results in a timely and efficient manner.

chemical process troubleshooting


new chemical process research and development


chemical process development


new chemical process development


organic compound process development


chemical processing

In the course of his academic training and industrial career, Expert has enhanced and deepened his capabilities in his core technical area of synthetic organic chemistry. His primary expertise is in the area of chemical route selection for the multistep organic synthesis of small molecule drug candidates. He draws from his knowledge of synthesis and reaction mechanism to troubleshoot and solve problems in the synthesis of discovery scaffolds, development of chemical processes, introduction of stable and radioisotopes into molecules for bioanalytical applications. Expert is currently a regular reviewer for the ACS journal Organic Process Research and Development.

chemical synthesis


heterocyclic compound synthesis


organic chemical purification


organic chemical separation


organic synthesis


synthetic organic chemistry


organic reaction


process chemistry


addition reaction


chemical intermediate


chemical reaction


chemical transformation

For 11 of his 15 years in industry, Expert has worked at organizations for which chemical process R+D, production and manufacturing were at least partly, if not completely, virtual. As a consequence, he has acquired expertise in the selection, engagement and management of contract organizations devoted to custom synthesis, production and manufacturing of API for preclinical and clinical bulk drug supply. Expert has experience leading and managing work at every phase from late discovery through Phase III registration and validation lots. His hands-on experience in the laboratory at biotech pharmaceutical companies and as an employee at API vendors (Ricerca and SERES Laboratories) informs his ability to have the full perspective from both sides of the fence, and has made him an extremely effective leader and manager of outsourced chemistry efforts. Expert performed numerous manufacturing runs under cGMP at SERES laboratories, and was a project leader for the process development and manufacture of the initial clinical supply of a drug that is now FDA-approved while at Ricerca. He has a thorough understanding of the practical application of GMP to the manufacture of APIs and drug product. Expert is also an expert in the preparation and assembly of technology transfer packages for outsourced work, and has demonstrated repeated success in the timely and efficient implementation and execution of chemical technology transferred to API manufacturing vendors.

process optimization


active pharmaceutical ingredient


bulk pharmaceutical chemical manufacturing


Chemistry, Manufacturing and Controls


chemical process control


Current Good Manufacturing Practice


multi-step organic compound manufacturing


chemical production quality management


Good Manufacturing Practice


organic compound manufacturing troubleshooting


investigational drug

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Boston, Massachusetts;  Worcester, Massachusetts;  Springfield, Massachusetts;  Lowell, Massachusetts;  Cambridge, Massachusetts;  Brockton, Massachusetts;  New Bedford, Massachusetts;  Hartford, Connecticut;  Manchester, New Hampshire;  and Providence, Rhode Island.

Often requested
with this expert:

Clinical Pharmacology, Toxicology, Drug Development,...
Pharmaceutical and Biopharmaceutical Product Development,...
Pharmaceutical Manufacturing, Research and Development,...
Pharmaceutical Development & Validation

Year   Degree   Subject   Institution  
1992   PhD   Chemistry   University of Illinois, Chicago  
1987   BS   Biochemistry   University of Illinois, Chicago  

Work History:
Years   Employer   Title   Responsibilities

2008 to 2010


PPD Dermatology


Director, Chemistry


He was responsible for all aspects of chemistry in this organization, including R&D, CMC, management of outsourcing, support of biological research, new target sourcing and evaluation. Supervised two experienced PhD organic chemists.

2005 to 2008


Elixir Pharmaceuticals


Director, Pharmaceutics and Manufacturing


He was responsible for all CMC work (done virtually, using outsourcing) for internal discovery and in-licensed and partnered development projects. Included API, formulation development (oral), analytical method development and validation.

2001 to 2005


EPIX Pharmaceuticals


Senior Staff Scientist, Chemical R&D


He was the senior bench chemist in the process chemistry group. Performed discovery and process research. Managed all technology transfer and outsourcing activities for chemical process R+D and GMP manufacturing. Led a development team in process R+D for APIs.

2000 to 2001


Ricerca Biosciences


Senior Research Chemist / Project Leader


Project leader and lead bench chemist for a development effort to develop a process for a discovery compound, product a GLP tox lot and multi-kg manufacture of Phase I supply for parenteral administration. Transferred process to pilot plant for 20kg scale mfg run. Led R&D to devise commercial route to this API.

1998 to 2000




Process Chemist


He set up the first chemical process development laboratory at SUGEN. Responsible for the management of multiple outsourced manufacturing projects. Performed process R&D to optimize later-stage (Phase II and III) development candidates.

1995 to 1998


SERES Laboratories




Conception and development of new chemical processes for drug candidates, from mg to kg scale. Custom synthesis of discovery compounds. cGMP manufacture of APIs up to multi-kg scale. Writing of proposals based on client inquiries. Management of client relationships.

1992 to 1995


University of California San Diego, School of Medicine


Postdoctoral Fellow, Medicinal Chemistry


Synthesis of prodrugs of cytotoxic nucleotides. Synthesis of an isopolar, isosteric analog of 2-chlorodeoxyadenosine monophosphate to bypass the requirement for kinase activation of the nucleoside. Synthesis of a series of ionizable cannabinoid analogs for localization of their activity to peripheral tissues as antiinflammatory agents.

2010 to 2016


(Undisclosed Consulting Company)


Principal Consultant


Presently self employed in a sole proprietor chemistry practice. Provides expertise in chemical synthesis, chemical development, salt selection and solid state characterization, CMC development strategy, API manufacturing, preformulation and formulation development to start up and biotech pharmaceutical companies.

Career Accomplishments:

American Chemical Society, Organic Division; Northeast Section of the ACS;

Publications and Patents Summary

Expert has seven publications and two patents in synthetic organic chemistry.

Selected Publications and Publishers  
 - ACS/Organic Process Research and Development  
 - Thieme/Synthesis  
 - Journal of Heterocyclic Chemistry  
 - Dissertation Abstracts International. B: The Sciences and Engineering  
 - Thieme/Synthesis  

Consulting Services:
Selected Consulting Examples:
  • Devised and executed CMC strategy for the development of a drug candidate for topical treatment of inflammatory skin disease, including: API scale up, production and GMP mfr, topical formulation development, ointment drug product production for GLP tox studies and GMP ointment drug product for Phase I clinical trials, synthesis of 14C-radiolabeled API for in vivo PK/ADME studies, development of analytical methods for drug substance and drug product, and drafting, editing and finalization of relevant sections of the CMC section of the IND for this candidate. IND was accepted by FDA with no CMC questions.
  • Functional project leader for an in-licensed small molecule candidate for the treatment of metabolic disease. Created and refined a detailed plan for the development of this candidate. Staffed and led a virtual development team composed of experts in areas other than API - formulation, toxicology, PK/ADME, quality, regulatory, analytical. Had responsibility for coordination and execution of all preclinical development activities, including direct responsibility for all CMC activities. Led production of >10kg API suitable for GLP tox studies, manufacture of 800g GMP API and 10,000 dry-filled capsules for Phase I clinical supply. Wrote API process CMC section of IND and made significant contributions to drug product, analytical and characterization sections of IND. IND was accepted by FDA with no CMC questions.
  • Led CMC activities related to an effort to commercialize an in-licensed type II diabetes drug that was approved for use in Japan. Key author and reviewer of pre-NDA briefing book CMC section. Key author of successful request for biowaiver based on SUPAC guidance for in vitro dissolution testing. Led and managed the manufacture of Phase III clinical supply, registration lots and analytical method validation. Established and strengthened the relationship between CMC functions at the client company and the Japanese licensor. Led and managed the development of a fixed dosage combination tablet for this drug with another well known type II diabetes drug.
  • Led and managed the CMC development effort for a discovery candidate for the treatment of metabolic disease. Provided scientific direction, leadership and management to the synthesis and scale up of the API, resulting in the production of >1kg of API suitable for GLP studies within < 5 months of candidate nomination. Managed and led two salt screening studies to give a water soluble API. Identified issues relevant to the formulation development of this candidate, including physicochemical properties and stability.
  • Leader, new target sourcing team. Established a process for researching and evaluating new approaches to topical small molecule therapies for dermatologic diseases in order to build a dermatology pipeline. Identified biological mechanisms of action relevant to dermatologic diseases and determined tractability based on natural product and medicinal chemistry hits in the literature. Sought scientific collaborators and partners in industry and at academic and research institutions.
Recent Client Requests:
  • Expert oral dosage pharmaceutical tablet formulation excipient compatibility API degradation pathways phase III trials CMC pharmaceutical formulation development expert for consulting on oral dosage tablet formulation development.
  • Expert in Pharmaceutical Manufacturing, Research and Development, Education & Training expert,Generic pharmaceutical products.
  • Chlorhexadrine expert for consulting on chlorhexidine product launch.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
Successfully completed first expert assignment in March, 2016. Wrote draft report that was used to successfully negotiate a settlement that was favorable to the client. Case cannot be disclosed because the report was not finalized and I did not testify, so I am still confidentially retained, and my work is not a matter of public record.
Recent Litigation Client Requests:
  • Expert in validity of RX patent claims.
  • Expert for consulting on anti-aging cream false claims
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
1999 to 1999   Dresden, Germany   Expert was sent to an API vendor in Germany while employed at SUGEN to conduct process R&D to optimize the process for a Phase III registration manufacturing campaign. He found a means of isolating a late intermediate in the process in very pure form, resulting in API product with improved quality. The results obtained in the laboratory by Expert were converted to operating instuctions, and the technology developed was transferred into the multipurpose manufacturing plant to manufacture feasibility and then registration lots of this API.
2005 to 2008   Nagoya, Fukui, Tokyo, Nagano, Japan   While employed at Elixir Pharmaceuticals, Expert traveled three times to Japan, to establish a working relationship with the CMC group at Kissei Pharmaceuticals, from whom Elixir had in-licensed a type II diabetes drug approved in Japan for commercialization in the US and the EU. Work included obtaining essential technical information pertaining to drug development, performing due diligence quality audits of contract API mfg organizations and providing progress reports on development of a dosage form of the drug suitable for Western hemisphere patient populations. Negotiation of supply schedules and agreements for the API with Kissei was also performed.
2007 to 2007   Chiplun, India   Expert traveled to India to perform a quality audit of a generic manufacturing plant run by USV that produced a generic active ingredient that was intended to be used in a fixed dosage combination tablet that Elixir was developing with the Kissei drug. The objective was to qualify USV as a reliable, low cost supplier of this generic API for development and commercialization of this combination drug.
2005 to 2007   Hyderabad, India   Visits to chemistry vendors to manage work
2007 to 2007   India   Visited chemistry vendors, participated in a quality audit of a generic API manufacturer
2013 to 2013   Netherlands   Visited solid state vendor that had done work for my client to discuss next owrk to be done
2014 to 2014   Yokohama, Japan   Visited a big pharma to provide a training course in the development of molecules for the treatment of inflammatory dermatological disease
2014 to 2014   Brussels, Belgium   Visited sterile product manufacturer to perform quality audit and to discuss issue fo particulates in dosage form manufactured for my client
2014 to 2014   Biasca, Switzerland   Visited API manufacturer to discuss process validation work on behalf of my client
2015 to 2015   Clonmel, Ireland   Participated in quality audit of solid dosage drug product manufacturer for my client
2015 to 2015   Biasca,. Switzerland   Visited API vendor for technical discussions and quality audit of facility
2015 to 2015   Madrid, Spain   Technical visit to evaluate sterile dosage form manufacturer for client

Language Skills:
Foreign Language   Description
Spanish   Expert is proficient in conversational spanish. He pursued a double major in Spanish literature and biochemistry while an udergraduate at the University of Illinois, Chicago. He did not complete the degree in Spanish literature, but he did complete coursework at an advanced level that required the reading of works of literature in Spanish, the writing of multiple term papers, exams and final exams in Spanish, and classroom participation that was completely in Spanish. Expert has also translated patents and manufacturing batch records from Spanish to English.

Additional Skills and Services:
Supplier and Vendor Location and Selection

Expert in the identification, evaluation, selection, engagement and management of vendors for organic synthesis, API process development and manufacture, radiosynthesis, analytical development, formulation development and manufacture, solid-state chemistry, quality assurance, regulatory.

Other Skills and Services

Chemical and Pharmaceutical development professional with unique understanding of how technical and logistical functions work together in drug discovery and development. Efffective liaison within CMC subdisciplines and between CMC and adjacent functions, e.g., discovery, PK/ADME, toxicology, clinical, finance. Add value beyond significant contributions in core area of expertise due to strong relationships with representatives of all other disciplines. Very effective at moving entire project forward, due to hands on experience and understanding of how all CMC functions are integrated in a successful drug development effort.


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