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 Expert  726978

Expert in Pharma/Biotech Development, Life-Cycle Management, 505(b)(2), Chemical Development, CRO Services


Available for your Consulting and Expert Witness Needs

Illinois (IL)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Expert is a Pharmaceutical development leader with ~25 years drug development and manufacturing experience with large Pharma, large Biotech, and a highly successful small start-up. Managed large groups (from three different countries), teams and budgets. Played critical roles in several major products launches including Fosinopril, Taxol and Entecavir. He is one of the very rare scientists with certain attributes: experience with large molecules (biologics), and small molecules and specific role as director of outsourcing. Lately he has been providing independent scientific advisory and consulting services to a diverse array of Pharma companies in many areas including drug delivery, development (Chemical, pre-clinical/non-clinical), CMC components, API manufacturing, CRO services, Due diligence to investment firms, Life cycle management, and regulatory strategies.

Specifically, At a pharmaceutical start-up, he served as VP-R&D / Chief Scientific Officer (CSO) and was responsible for building an R&D organization, leadership capabilities and providing strategy and direction for the company's drug discovery and development programs including pre-clinical/non-clinical development, pipeline advancement, and API manufacturing and facilitating regulatory filings. While at the start up-firm, he filed a US IND and successfully completed a Phase I clinical study, and early stage manufacturing of two projects under his stewardship.

While at Abbott, Expert not only modernized the analytical labs with facility, but brought instrumentation (~1 million dollar annual capital budget) and technology to address diagnostic-life science reagent development issues, quality issues, FDA concerns, and sustained growth. He played a crucial role in the FDA-post-consent decree development of reagents for Abbott diagnostic products for a globally compliant product development quality management system including introducing reagents stability studies, analytical specifications, and performance and acceptance criteria.

Over the years at BMS, he was involved with a multitude of drug development projects. This involved the discovery and development of synthetic routes, demonstration of these routes in the lab followed by its implementation in the Kilo-lab and pilot plant to prepare APIs for pre-clinical and clinical studies leading to regulatory IND and NDA filings. They not only addressed all the API issues, but issues such as pre-formulation, Final Form, particle issue and characterization, analytical issues and all other CMC disciplines. His department was responsible on a routine basis to provide data regarding process, procedures, characterization and structural proof, impurity identification, specification setting, analytical standards etc. for INDs, NDA/SNDA (as required) and for regulatory updates.

At BMS, he was credited for shortening the development timelines from lead drug candidate identification to first dose in man by making the drug candidates (APIs) available with a sense of urgency and coordinating the activities of various developmental divisions. This brought prestige and recognition to BMS from Wall Street and from its peers in industry.

Expert was also director of outsourcing at BMS. A newly created department, he set the direction and strategy for the process R&D outsourcing. They had ~$15 million worth of annual outsourcing (at that time) including APIs, advanced intermediates and contract R&D.

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active pharmaceutical ingredient

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asymmetric synthesis

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bulk drug

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chemical intermediate

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chemical pilot plant development

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chemical process analysis

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chemical process control

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chiral separation

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chiral synthesis

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drug analysis

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drug bioavailability

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drug clinical trial

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drug degradation

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drug delivery

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drug development

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Drug Enforcement Agency-restricted chemical

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drug formulation

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drug processing

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drug product approval

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drug regulation

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drug stability

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generic drug manufacturing

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investigational drug

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investigational drug procedures

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peptide synthesis

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pharmaceutical industry

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pharmaceutical manufacturing

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pharmaceutical drug

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pharmaceutical product development

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pharmaceutical research

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pharmaceutical research and development

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pharmaceutical technology

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pilot plant scale-up

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prodrug

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research and development management

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research and development organization

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research and development planning

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pharmaceutical life cycle management


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Chicago, Illinois;  Rockford, Illinois;  Aurora, Illinois;  Naperville, Illinois;  Joliet, Illinois;  Elgin, Illinois;  South Bend, Indiana;  Gary, Indiana;  Milwaukee, Wisconsin;  and Madison, Wisconsin.

Education:
Year   Degree   Subject   Institution  
1977   Ph.D.   Organic Chemistry   IISc  

Work History:
Years   Employer   Department   Title   Responsibilities

2014 to

 

(Undisclosed)

 

Pharmaceutical Division

 

President

 

A VC backed pharmaceutical company based on drug delivery technologies.

2013 to 2014

 

Meridian-Labs

 

Manufacturing and CMC

 

Technical Development

 

Provide strategy and direction for development, manufacturing and IP for drug candidates ML061 and ML141, injectable drugs based on Docetaxel and a novel drug delivery technology and 505(b)(2) path.

2011 to 2014

 

Lat Pharma LLC

 


 

Chief Scientific Officer

 

Provide strategy and direction for development, manufacturing and intellectual property (IP) for Terlipressin Peptide based drug candidates using novel drug delivery technology for Ascites and liver cirrhosis.

2008 to 2014

 

Pharmaceutical Consultant

 


 

Independent Consultant

 

Provided development, manufacturing, supply chain, API, CMC, IP, QC-QA, FDA PAT and QbD, Tech Transfer and regulatory strategies to Genta and LAT Pharma and Pharmasset. Product discovery, development, manufacturing, regulatory and 505(b)(2) strategies in the areas of Taxoids and Gallium metal based (both oncology) and peptide based therapeutics have resulted in the creation of ten patents (filed US-and foreign) for the consulting companies. Direct, lead and manage drug development and manufacturing teams at various CRO-CMO companies in US and abroad (Europe, Asia) for Genta, LAT Pharma, and Meridian-Labs. Direct, lead and manage Mock-FDA-cGMP-PAI QC-QA-CMC audit of a foreign (Asia) based API manufacturer for Pharmasset (Gilead). Provided Due Diligence to Ganic Pharmaceuticals/Warburg Pincus to acquire Pharma Companies and/or Pharma Products. This involved three separate segments of different Pharma companies. Provided CMC-API strategy including QC/QA/Analytical to become FDA-NDA ready to a brand drug candidate to BioCryst including development and manufacturing options.

2010 to 2012

 

Genta Pharmaceuticals

 


 

Acting Head of Technical Development & Manufacturing

 

Provide strategy and direction for drug development, CMC, manufacturing, IP, life cycle management and 505(b)(2) strategies in the areas of Tesetaxel and Oral Gallium programs. Reported to the CEO and Chairman.

2006 to 2007

 

New River Pharma

 


 

Chief scientific officer/VP-R&D

 

Provided strategy and direction for NRPH's drug discovery, delivery, development, and manufacturing programs by building and hiring an R&D organization and leadership capabilities. Addressed and oversaw Facility and DEA issues. Reported to the CEO and Chairman. NRPH was acquired in 2007 and the Virginia facility was closed.

2001 to 2005

 

Abbott Laboratories

 


 

Director

 

Direct Core Chemistry R&D (Organic, Analytical/Bio-Analytical, and Biologics Analytical, outsourcing, and Mass Spec Technology) and oversee Chemistry issues for Abbott's global immunodiagnostic assays development. Direct a staff of 40. Manage a $6 million operating budget and $1 million capital budget.

1982 to 2001

 

Bristol-Myers Squibb

 


 

Director

 

Responsible for a staff of approximately 50 professionals and the Chemical Process Research Department operations for New Brunswick, NJ and the Chemical Process Research Deptartment, Candiac, Canada.

Responsible for providing strategy and building a formal worldwide outsourcing group and managing outsourcing activities for Process R&D involving $15 million annual outsourcing of APIs, Intermediates, contract R&D, and FTEs.


Career Accomplishments:
Associations/Societies

American Chemical society

Awards/Recognition

Led teams to six BMS Pharmaceutical Research Institute President's Awards recognizing project teams for development of: BR96-Dox Conjugate (anti-tumor), Paclitaxel (anti-tumor), Mitomycin (anti-tumor), Squalene Synthase Inhibitor (Cardiovascular), BMS- 207147 antifungal (Infectious disease), and lead drug candidate identification to First-in-Man timelines. Led Abbott ADD Chemistry department Mass Spec Technology teams and individuals received Abbott Technical Advisory Board (TAB) Awards 2003 and 2005 in recognition of development accomplishments.


Publications:
Publications and Patents Summary

Patents: 74 either in use or used to make valuable products for BMS, Abbott, and NRPH Publications: 44 in peer reviewed journals Chaired conferences/Talks given: 25


Consulting Services:
Selected Consulting Examples:
  • Three of Expert's recent consulting activities were in the CMC-disciplines, development and manufacturing area. One was a NASDAQ listed small molecules Pharma, and the other two were due diligence for a major Wall Street investment firm in the M&A area involving multiple products including biologics projects. Again he was helping with the CMC package of development and manufacturing.
  • Scientific advisor and a consultant to a drug delivery based pharma start-up
Recent Client Requests:
  • Expert for consulting on Pharmaceutical for Food Product.
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:
Recent Litigation Client Requests:
  • Expert in prodrugs, small peptides and amino acids for pharmaceutical breach of contract litigation.
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:
Country / Region   Summary
India   Audit of a Pharma companies many facilities and giving seminars

Language Skills:
Foreign Language  
English  
indian languages  

Market Research:
He is a Pharma development leader with ~25 years drug development and manufacturing experience with large Pharma (BMS), large Biotech (Abbott), and a highly successful small start-up (New River Pharma). Managed large groups (from three different countries), teams and budgets. Played critical roles in several major products launches (BMS and Abbott) including Fosinopril, Taxol and Entecavir. I am one of the very rare scientists with certain attributes: experience with large molecules (biologics), and small molecules and specific role as director of outsourcing.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Supplier and Vendor Location and Selection

This activity was specific to his role as Director Outsourcing, Worldwide Process R&D, BRISTOL-MYERS SQUIBB. Successfully outsourced several drug candidate APIs, advanced intermediates, and contract research for several key projects. $15 million annual outsourcing at that time

Other Skills and Services

Expert has been providing independent scientific advisory and consulting services to a diverse array of Pharma companies in many areas including drug delivery, development (Chemical, pre-clinical/non-clinical), CMC components, API manufacturing, CRO services, Due diligence to investment firms, Life cycle management, and regulatory strategies.


 

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