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Reflections on Chirality in the Pharmaceutical Industry: Past, Present and Future Dr. Christopher J. Welch, Distinguished Scientist Process Research & Development Merck Research Laboratories, USA

 Presentations  Comments Off on Reflections on Chirality in the Pharmaceutical Industry: Past, Present and Future Dr. Christopher J. Welch, Distinguished Scientist Process Research & Development Merck Research Laboratories, USA
Dec 262016
 

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New Technologies, Postdoc Program, Science Lead, Analytical Chemistry at Merck

Reflections on Chirality in the Pharmaceutical Industry: Past, Present and Future
Dr. Christopher J. Welch, Distinguished Scientist
Process Research & Development Merck Research Laboratories, USA

 

A PRESENTATION
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At Chiral India 2016, New horizons in Drug development, Harnessing the power of Chirality .Organised by chemical weekly at Holiday inn international, Mumbai, India, Nov 8 2016

Christopher J. Welch

Science Lead for Analytical Chemistry
Merck Research Laboratories
Christopher J. Welch is Science Lead for Analytical Chemistry within the Process and Analytical Chemistry area at Merck Research Laboratories in Rahway, NJ.  Chris leads the New Technologies Review and Licensing Committee (NT-RLC), the organization that oversees identification, acquisition and evaluation of new technologies of potential value to Merck Research Laboratories.  Chris also leads the MRL Postdoctoral Research Fellows Program.  He received his BS degrees in Chemistry and Biochemistry from the University of Illinois at Urbana-Champaign in 1982 and a Ph.D. degree in Organic Chemistry (also U of I) in 1992. Dr. Welch has worked in a variety of fields within the chemical industry, including discovery synthesis of agrochemicals (Velsicol-Sandoz), development of reagents for improved immunodiagnostic assays (Abbott Laboratories), and development and commercialization of chromatographic stationary phases, reagents and enantioselective catalysts within a small chemical business environment (Regis Technologies).  Since joining Merck in 1999, he has focused on developing and applying improved methods and equipment for purification, synthesis and analysis of pharmaceuticals and intermediates.  Dr. Welch has authored more than 230 scientific publications and patents.  He is co-founder of the journal, Enantiomer, a current or past member of the editorial advisory boards for the journals, Chirality, Organic & Biomolecular Chemistry, Journal of the Korean Chemical Society, Chemistry World, Chemical & Engineering News and ACS Central Science.  Chris is past chair of the ACS Division of Organic Chemistry (ORGN), a member of the Executive Committee for the International Symposia on Chirality, a member of the ACS steering committee for Pacifichem and a member of the PittCon Program Resource Team.  Honors and awards include the NJCG Award for Excellence in Chromatography (2004), the PACS Activated Carbon Hall of Fame award (2007), MRL Presidents Award for Environmental Achievement (2009), Microsoft Life Science Innovation Award (2010), Fellow of the American Chemical Society (2010), Fellow of the American Association for the Advancement of Science, AAAS (2013), the Chirality Medal (2015) and the University of Nebraska Industrial Advisory Board Award (2016).

Experience

 

Distinguished Scientist, Process & Analytical Chemistry

Merck & Co., Inc.

– Present (17 years 8 months)Rahway, NJ

Current responsibilities:
Scientific Lead, Analytical Chemistry
co-chair, New Technologies Review & Licensing Committee (NT-RLC)
co-chair, Merck Research Laboratories Postdoctoral Research Fellows Committee

Previous Positions at Merck:
Science Lead, Global Analytical Chemistry 8/10 – 8/12
Distinguished Senior Investigator, Process Research 7/07 – 8/10
Associate Director. Process Research 1/06 – 6/07
Senior Research Fellow, Process Research 6/03 – 12/05
Research Fellow, Process Research 5/99 – 6/03

 

 

Director of Research

Regis Technologies

– (6 years 11 months)Morton Grove, IL (Chicago area)

– New product development and commercialization (chromatography columns, reagents, enantioselective catalysts)
– Scientific evaluation of custom organic synthesis business
– Set up contract synthesis/preparative chromatographic separation business – first of kind

Honors & Awards

Fellow

American Association for the Advancement of Science (AAAS)

Fellow

American Chemical Society (ACS)

Chirality Medal 2015

Presidential Green Chemistry Award

US Environmental Protection Agency

– for precompetitive collaboration between Merck, Pfizer, Eli Lilly and University of Wisconsin on Aerobic Oxidation Methods for Pharmaceutical Synthesis – co-awardees: Shannon Stahl and Thatcher Root (U. Wisconsin), Joel Hawkins (Pfizer) and Joe Martinelli (Lilly)

Industrial Advisory Board (IAB) Award

University of Nebraska Department of Chemistry

Inaugural IAB award from U. Nebraska recognizing excellence in scientific research in an industry setting

Christopher J Welch

Organizations

American Chemical Society, Division of Organic Chemistry (ORGN)

Councilor and Chair

–

Pacifichem

Member of Steering Committee for Pacifichem 2020

Starting

 

Chirality (Journal)

member, editorial board

Starting

Chemical & Engineering News

member, editorial advisory board

Starting

Chemistry Today (RSC)

member, editorial advisory board

Starting

 

Journal of the Korean Chemical Society

member, international advisory board

Starting

Pittcon

Member, Pittcon Program Committee Resource Team

Starting

ACS Central Science

Member of Editorial Advisory Board

Starting

 

American Chemical Society

Member, Committee on Science (ComSci

Starting

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Publications

2014 publications, part 1

Use of a Miniature Mass Spectrometer to Support Pharmaceutical Process Research Investigations, Org. Proc. R&D 18, 103-108, 2014.

Chromatographic Separation and Assignment of Absolute Configuration of Hydroxywarfarin Isomers, Chirality 26, 95-101, 2014.

Chromatographic Resolution of Closely Related Species in Pharmaceutical Chemistry: Dehalogenation Impurities and Mixtures of Halogen…more

 

2014 publications – part 2

 

Precompetitive Collaboration on Enabling Technologies for the Pharmaceutical Industry, Org. Proc. R&D 18, 481–487, 2014.

Imine-based Chiroptical Sensing Approach for Analysis of Chiral Amines: From Method Design to Synthetic Application, Chem. Sci. 5, 2855-2861, 2014.

Advances in Achiral Stationary Phases for SFC, Amer. Pharm. Rev., April 2014, 36-41.

Liquid Chromatography Methods for…more

2013 Publications

Evaluation of core–shell particle columns for ion-pair reversed-phase liquid chromatography analysis of oligonucleotides, J. Pharm. Biomed. Anal. 72, 25–32, 2013.

Pharmaceutical Industry Practices on Genotoxic Impurities, in Pharmaceutical Industry Practices on Genotoxic Impurities, ed Heewoon Lee, Taylor & Francis, 2013.

Rapid Analysis of Residual Palladium in Pharmaceutical…more

2012 Publications
2012

A Simple Parallel Gas Chromatography Column Screening System, Wes Schafer, Simon E. Hamilton, Zainab Pirzada and Christopher J. Welch, Chirality, 24,1–4, 2012.

Rapid catalyst identification for the synthesis of the pyrimidinone core of HIV integrase inhibitors, A. Bellomo, N. Celebi-Olcum, X. Bu, N. Rivera, R.T. Ruck, C.J. Welch, K.N. Houk, S.D. Dreher, Angew. Chem. Int. Ed., 51 (2012) 1-5
…more

2011 Publications

Application of Ion Mobility Spectrometry in Drug Substance Development, H. Gao, X. Jia, R. Xiang, X. Gong, C. Welch, Analytical Methods, 3, 1828-1837, 2011.

Analytical Method Volume Intensity Index:A Green Chemistry Metric for HPLC Methodology in the Pharmaceutical Industry, R. Hartman, R. Helmy, M. Al-Sayah, C. Welch, Green Chemistry 13, 934-939, 2011.

Does an Axial Propeller Shape on a…more

2010 Publications

High-throughput metal screening in pharmaceutical samples by ICP-MS with automated flow injection using a modified HPLC configuration, Tu, Wang, Welch, J. Pharm. Biomed. Anal., 51, 90-95, 2010.

Systematic Evaluation of New Chiral Stationary Phases for Supercritical Fluid Chromatography Using a Standard Racemate Library, Pirzada, Personick, Biba, Gong, Zhou, Schafer, Welch, J. Chromaogr.A,…more

Adsorbent Screening for Metal Impurity Removal in Pharmaceutical Process(Link)

Organic Process Research & Development

February 23, 2005

A microtube screening approach affords simple and convenient assessment of the selective adsorption of metal impurities by a variety of different process adsorbents. This approach is helpful in identifying rapid solutions to metal impurity problems in pharmaceutical process research. Several examples illustrating the utility of the approach are presented.
Online Analysis of Flowing Streams Using Microflow HPLC
Journal of Pharmaceutical and Biomedical An

Response to Comment on “Cocktail Chromatography: Enabling the Migration of HPLC to Nonlaboratory Environments”(Link)

ACS Sustainable Chem. Eng. 2015, 3 (9), 1897.

 

ACS Sustainable Chem. Eng. 2015, 3 (9), 1897.
Education

University of Illinois at Urbana-Champaign

The University of Chicago

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FUELING INNOVATION
Welch helped launch Merck’s new postdoctoral research fellowship program.

P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent.

Happy New Year's Eve from Google! 
 
 
 
 
/////////Reflections on Chirality in the Pharmaceutical Industry, Past, Present and Future
Dr. Christopher J. Welch, Distinguished Scientist, Process Research & Development,  Merck Research Laboratories, USA, presentation
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Scaling up from mg to Kgs – Making your First GMP Batch

 companies, CONFERENCE  Comments Off on Scaling up from mg to Kgs – Making your First GMP Batch
Aug 032016
 

STR1

Scaling up from mg to Kgs – Making your First GMP Batch 

6th – 7th October 2016, Clearwater, USA

“the course was very informative and it allowed me to see the big picture from discovery stage to pilot plant” 
Genentech

Course Outline:

  • Introduction
  • Making the first 100g non-GMP Batch
  • Non-GMP vs GMP preparation
  • Physical version and form
  • Process safety and raw materials supply
  • Scaling into fixed vessels
  • Technology transfer
  • Genotoxic impurities
  • Case studies and Review

Who should attend:

  • Project managers
  • Project leaders
  • Bench chemists
  • New starters
  • MedChem Support teams

This course aims to provide attendees with a good understanding of the issues involved taking development candidates to the first in human trials.

Click here to Download the Course Brochure

Presented by Dr John Knight, JKonsult Ltd

John Knight

Managing Director at JKONSULT Ltd

STR1
Click here to Download the Course Brochure

“Brilliant Course, learn lots of tips and tricks”
Vertex
“First incursion into Chemical Development has been very, very educational. John’s way of explaining the material has been wonderful.”
Almirall

“Very clear and interesting sessions with a lot of relevant examples and not only theory.” 
Oribase Pharma
LINK
LITERATURE FROM INTERNET ON HIS TOPIC
//////////Scaling up,  mg to Kgs, Making,  First GMP Batch, SCIENTIFIC UPDATE,  JOHN KNIGHT, Clearwater, USA
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EMA reviews Medicines manufactured at U.S. Company

 regulatory  Comments Off on EMA reviews Medicines manufactured at U.S. Company
Jul 142016
 

Following the issuance of two Non-Compliance Reports for two sites of the US based company, EMA has started a review of medicines manufactured by Pharmaceutics International Inc., USA.

The European Medicines Agency (EMA) has started a review of medicines manufactured by Pharmaceutics International Inc., USA. This follows the issuance of two Non-Compliance Reports for two sites of the US based company after an inspection in February 2016 conducted by the MHRA (the medicines regulatory agency in the United Kingdom) which highlighted several shortcomings in relation to good manufacturing practice (GMP).

Pharmaceutics International Inc. manufactures the centrally authorised medicine Ammonaps (sodium phenylbutyrate) and is also the registered manufacturing site for some other medicines that have been authorised through national procedures in the European Union (EU).

This inspection which was a follow-up to an inspection in June 2015 aimed to assess whether corrective measures agreed previously had been appropriately implemented. It found that shortcomings remained, which included insufficient measures to reduce the risk that traces of one medicine could be transferred to another (cross-contamination), as well as problems with the way data were generated and checked and deficiencies in the systems for ensuring medicines’ quality (quality assurance).

EMA’s Committee for Medicinal Products for Human Use (CHMP) will now review the impact of the inspection findings on the products’ overall benefits and risks and make a recommendation as to whether any changes are needed to their marketing authorisations.

There is no evidence that patients have been put at risk by this issue. However, as a precautionary measure, medicines from this site will no longer be supplied to the EU unless they are considered to be ‘critical’ to public health. Criticality will be assessed by national medicines regulatory agencies for their territories, taking into account alternatives and any impact of shortages on patients. In case where a medicine manufactured at this site is considered not critical in a member state it will no longer be supplied in this member state and any medicine remaining on the market will be recalled.

Source: EMA Press Release

Pharmaceutics International Inc., USA

/////////// EMA,  Medicines,  manufactured, U.S. Company, Pharmaceutics International Inc., USA

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Illegal Drugs in Dietary Supplements

 drugs  Comments Off on Illegal Drugs in Dietary Supplements
May 132016
 

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Illegal Drugs in Dietary Supplements

Forbidden stimulant oxilofrine found in various dietary supplements sold in the USA

Read more

http://www.chemistryviews.org/details/news/9278771/Illegal_Drugs_in_Dietary_Supplements.html

 

 

Oxilofrine (also known as methylsynephrine, hydroxyephrine, oxyephrine, and 4-HMP) is a stimulant drug[1] and is anamphetamine chemically related to ephedrine and to synephrine.

Oxilofrine is currently a WADA prohibited substance when used in competition.[2] It is an ingredient found in some dietary supplements.

Publicized cases

  • In 2009, Brazilian/American cyclist Flávia Oliveira was suspended for 2 years after taking a supplement known as “HyperDrive 3.0+” which contained methylsynephrine, a chemical equivalent of Oxilofrine, among other substances. [3] Her sentence was eventually reduced to 18 months after an appeal as there was enough evidence that she had unknowingly consumed said substance as the old label did not list methylsynephrine.[4]
  • On July 14, 2013, Jamaican runners Asafa Powell and Sherone Simpson tested positive for Oxilofrine prior to the 2013 World Athletics Championships. [5] Powell, however, maintained that he did not take any banned supplements knowingly or willfully.[6]Powell voluntarily withdrew as a result of the test. On 10 April 2014, both athletes received an 18-month suspension from competing, which was set to expire in December that year.[7] However, after appealing to the Court of Arbitration for Sport (CAS), both athletes’ suspensions were lifted on 14 July 2014.[8]
  • On July 16, 2015, Boston Red Sox pitching prospect Michael Kopech was suspended without pay for 50 games after testing positive for Oxilofrine, which is a banned substance under the Minor League Drug Prevention and Treatment Program. Kopech denied knowingly taking the substance.[9]

 

 

 

 

References

  1.  Fourcroy, Jean L. (2008). Pharmacology, doping and sports: a scientific guide for athletes, coaches, physicians, scientists and administrators. Taylor & Francis. ISBN 978-0-415-42845-3.
  2.  http://list.wada-ama.org/prohibited-in-competition/prohibited-substances/
  3.  Charles Pelkey (2010-04-13). “Oliveira suspended for two years”. Velonews.
  4.  Charles Pelkey (2011-02-24). “Court of Arbitration for Sport reduces Flavia Oliveira suspension”. Velonews.
  5.  Reuters. “Jamaicans Powell, Simpson test positive – SuperSport – Athletics”. SuperSport. Retrieved 2013-07-15.
  6.  “Jamaican Sprinter Asafa Powell slapped 18-month ban for doping”. IANS. news.biharprabha.com. Retrieved 10 April 2014.
  7.  “Asafa Powell banned for 18 months for doping”. BBC Sport. 10 April 2014. Archived from the original on 9 May 2014.
  8.  Drayton, John (14 July 2014). “Asafa Powell and Sherone Simpson given green light to return to action after sprinters have doping bans reduced to six months”. Mail Online. Retrieved14 July 2014.
  9.  Danny Wild (16 July 2015). “Red Sox No. 10 prospect Kopech suspended”. MiLB.com. Retrieved 8 March 2016
Oxilofrine
Oxilofrin Structural Formulae V.1.svg
Systematic (IUPAC) name
(1S*,2R*)-(±)-4-(1-Hydroxy-2-methylamino-propyl)phenol
Legal status
Legal status
  • Uncontrolled
Identifiers
CAS Number 365-26-4 
ATC code none
PubChem CID 9701
ChemSpider 9320 Yes
UNII F49638UBDR Yes
KEGG D08314 Yes
ChEMBL CHEMBL30400 Yes
Chemical data
Formula C10H15NO2
Molar mass 181.23 g/mol

////Illegal Drugs, Dietary Supplements, Forbidden stimulant , oxilofrine, dietary supplements ,  USA, Oxilofrine

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Comparative Study of Dossier Compilation & Submission Process of Drug Product in USA, Europe & India. by DeveshDRA

 regulatory  Comments Off on Comparative Study of Dossier Compilation & Submission Process of Drug Product in USA, Europe & India. by DeveshDRA
Jul 102013
 

Comparative Study of Dossier Compilation & Submission Process of Drug Product in USA, Europe & India.

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