1st SMI Highly Potent Active Pharmaceutical Ingredients Conference 2017 London

  • Conference Call
  • SMi Group is hold­ing it’s 1st Highly Potent Active Phar­ma­ceu­ti­cal Ingre­di­ents Con­fer­ence on May 2223, 2017 in Lon­don, UK at the Copthorne Tara Hotel and is seek­ing your involvement.


    The global mar­ket for Highly Potent Active Phar­ma­ceu­ti­cal Ingre­di­ents is cur­rently on a growth fast track, largely dri­ven by its major use in oncol­ogy for can­cer treat­ment and more often in the form of ADCs. Over a quar­ter of drugs world­wide now con­tain HPA­PIs, as they have proven to be more effec­tive than other APIs.

    How­ever, work­ing with APIs high in potency and cyto­tox­i­c­ity comes with many reg­u­la­tions and require­ments, and presents phar­ma­ceu­ti­cal com­pa­nies with chal­lenges such as han­dling, con­tain­ment, cost and secu­rity questions.

    The inau­gural Highly Potent Active Phar­ma­ceu­ti­cal Ingre­di­ents con­fer­ence fea­tures key speak­ers of the indus­try pre­sent­ing chal­lenges, issues, inno­va­tion and new devel­op­ments in var­i­ous areas of HPAPI pro­duc­tion, devel­op­ment and manufacturing.

    Hear about new inno­v­a­tive con­tain­ment risk assess­ment tools and con­tain­ment strate­gies when han­dling HPAPI prod­ucts. Guid­ance for the eval­u­a­tion and man­age­ment of cross-​contamination will be addressed, as well as newest con­trol strate­gies and solu­tions. Phar­ma­ceu­ti­cal com­pa­nies will be pre­sent­ing their approaches to scale-​up processes and will be dis­cussing man­u­fac­tur­ing facil­ity designs and require­ments, also intro­duc­ing flex­i­ble facil­i­ties. Learn more about CMO selec­tion strate­gies and how to improve infor­ma­tion and tech­nol­ogy transfer.

    This con­fer­ence will cover many impor­tant and in-​demand aspects of the HPAPI indus­try, cre­at­ing a net­work­ing plat­form for indus­try pro­fes­sion­als and key play­ers to share their knowl­edge and find inno­v­a­tive new solutions.


    • Alessan­dro Briggo – Prin­ci­pal Sci­en­tist, Tox­i­col­ogy Project Leader, Roche
    • Alexan­der Flück­iger – Chief Occu­pa­tional Health Offi­cer, Roche
    • Aurore Perzyna – Head, Pro­duc­tion Plant, Oril Industries
    • Clau­dia Sehner – Prin­ci­pal Sci­en­tist, Occu­pa­tional Tox­i­col­ogy, Boehringer Ingelheim
    • Dean Cal­houn – Pres­i­dent /​CEO, Affy­gility Solutions
    • Eber­hard Ramisch – Global Head Pro­ject­man­age­ment Phar­ma­ceu­ti­cal Ingre­di­ents, Her­aeus GmbH & Co. KG
    • Fabio Zenobi – EHS Direc­tor, BSP Pharmaceuticals
    • Gre­gory Sow­ell – Prin­ci­pal Sci­en­tific Man­ager, Small Mol­e­cule Process Chem­istry, Genentech
    • Gwydion Churchill – Asso­ciate Direc­tor of Chem­istry, Antibi­otics Busi­ness Unit, AstraZeneca
    • Ildiko Ziegler – Dis­tin­guished Val­i­da­tion Expert, Gedeon Richter Plc.
    • Jack Brown – Senior Prin­ci­pal Sci­en­tist, Boehringer Ingel­heim Phar­ma­ceu­ti­cals, Inc.
    • James Evans – Vice Pres­i­dent CMC, NuCana Bio­Med Limited
    • Jason Hamm – Direc­tor — Chem­i­cal Devel­op­ment Oper­a­tions, Bristol-​Myers Squibb
    • Jhon Esco­bar – Oper­a­tions /​Sup­ply Chain Man­ager, Teva API
    • Michael Groan­ing – Direc­tor, Strate­gic Devel­op­ment, Endocyte
    • Richard Denk – Head Sales Con­tain­ment, SKAN AG
    • Robert Suss­man – Prin­ci­pal Tox­i­col­o­gist and Man­ag­ing Prin­ci­pal, East­ern Oper­a­tions, SafeBridge Con­sul­tants LLC
    • Shay Carmi – OPEX QC Work­stream Leader — Teva Tech Site, Teva API
    • Yaakov Machlav – Process Safety Man­ager, Teva Phar­ma­ceu­ti­cals Ltd

    Con­fer­ence Topics

    • Basic under­stand­ing of occu­pa­tional health risk assess­ments: haz­ard and exposure
    • Case study 1: steroid hor­monal API production
    • Case study 2: man­u­fac­tur­ing par­enteral cyto­toxic products
    • Cat­e­gories of con­cern” (cyto­tox­ics, hor­mones, steroids) are often referred to, but rarely defined for APIs requir­ing seg­re­ga­tion or ded­i­ca­tion in manufacturing
    • Chal­lenges with HPA­PIs are very unique, in that there is typ­i­cally lim­ited data on.
    • Char­ac­ter­is­tics of these cat­e­gories are dis­cussed to iden­tify and pri­or­i­tize com­pounds requir­ing spe­cial attention
    • Com­plex­ity of cross con­t­a­m­i­na­tion risk and tech­ni­cal mea­sures at pro­duc­tion areas
    • Com­pli­ance with worker health reg­u­la­tions in an envi­ron­ment where no-​one complies
    • Con­tain­ment from the PDE/​OEL to Life Cycle
    • Con­tain­ment Risk Man­age­ment of HP drug sub­stance throught FMECA
    • Con­trol­ling air­borne con­cen­tra­tions and the con­t­a­m­i­na­tion of prod­uct con­tact sur­faces to val­ues derived from quan­ti­ta­tive risk assess­ments is more appro­pri­ate, regard­less of spe­cific cat­e­gor­i­cal designations
    • Cri­te­ria for select­ing an exter­nal ven­dor for the man­u­fac­ture of HPAPI’s
    • Devel­op­ment of robust process uti­liz­ing plant data systems
    • Doc­u­mented con­tain­ment capa­bil­i­ties: hav­ing the data and being able to explain them
    • Effec­tively scal­ing up potent APIs from clin­i­cal to man­u­fac­tur­ing scale
    • Engi­neer­ing con­trols uti­lized in API plants for HPAPI’s
    • Full overview on Containment
    • Gen­eral SHE aspects: no undue risk for the project
    • Impor­tant to con­sider to design a Con­tain­ment Facility
    • Indus­try move­ment is toward estab­lish­ing compound-​specific health-​based lim­its and per­form­ing risk assess­ments to deter­mine whether seg­re­ga­tion and/​or ded­i­ca­tion may be required
    • Mis­un­der­stand­ings and high risk approaches can lead to delays and sub­stan­tial cost increase
    • Out­sourc­ing of novel com­plex cyto­toxic com­po­nents is challenging
    • Out­sourc­ing: a SME Pharma Perspective
    • Project-​specific tech trans­fer: com­pe­tent and respon­sive part­ners wanted
    • Smart Case stud­ies to avoid obsta­cles and early pitfalls
    • There is typ­i­cally lim­ited process data as well. How do you under­stand the processes and their characteristics?
    • This would include process safety data (calorime­try, tox­i­co­log­i­cal data for intermediates)
    • Tox­i­co­log­i­cal con­cerns in „cross con­t­a­m­i­na­tion” guidelines
    • Will dis­cuss approaches to both and upside and down sides for each)


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