October Consortium Member Meeting Recap
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Recap of the October 10th, 2013 Avoca Quality Consortium Member Meeting, held in Princeton, New Jersey.

Recap of the October 10th, 2013 Avoca Quality Consortium Member Meeting, held in Princeton, New Jersey.

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    October Consortium Member Meeting Recap October Consortium Member Meeting Recap Document Transcript

    •     AVOCA’S FALL QUALITY CONSORTIUM MEMBER MEETING  “Progress  through  Collaboration”     October  10th,  2013   Princeton,  New  Jersey       A  group  of  55  Consortium  Members  gathered  at  the  fourth  Avoca  Quality  Consortium  Member’s   Meeting  in  Princeton,  New  Jersey  on  October  10th  to  discuss  the  acceleration  of  best  practices  and   industry  standards  in  order  to  achieve  proactive  quality  management.    The  following  companies  were   represented  at  the  session:       Alexion  Pharmaceuticals  Inc.  *  Amgen  *Astellas  Pharma  Global  Development,  Inc.   *AstraZeneca  *  Biogen  Idec,  Inc.  *  Cerexa,  Inc.  *  Chiltern  *  Covance,  Inc.     *  Cubist  Pharmaceuticals,  Inc.  *  Daiichi  Sankyo  Pharma  Development  *  Eli  Lilly  and  Company   *  Endocyte,  Inc.  *  F.  Hoffmann-­‐‑La  Roche  Ltd.  *  Genentech,  a  member  of  the  Roche  Group     *  Grünenthal  GmbH  *  Grünenthal  USA,  Inc.  *  ICON  Clinical  Research  *  INC  Research     *  inVentiv  Health  Clinical,  LLC  *  inVentiv  Health  Clinical  Labs,  Inc.     *  Janssen  Research  &  Development  LLC  *  Pfizer,  Inc.  *  PPD  *  PRA  International     *  Purdue  Pharma  L.P.  *  Quintiles  *  RPS,  Inc.  *  Sanofi  *  Seattle  Genetics,  Inc.     *  SynteractHCR,  Inc.  *  Theorem  Clinical  Research     The  core  themes  for  this  meeting  included:   • The  implementation  and  socialization  of  Consortium  guidelines,  tools,  and  metrics  within   Member  organizations  and  among  sourcing  partners   • Sharing  of  Member  information,  challenges,  and  the  desired  future  state  of  proactive  quality   management  and  closer  collaborations  between  Sponsors  and  CROs     • The  focus  for  the  Consortium  in  2014       Patricia  Leuchten,  Avoca’s  CEO  and  Founder  of  the  Consortium,  welcomed  Members  to  the  meeting  with   a  reminder  that  patients  and  our  pursuit  to  accelerate  the  development  of  life  saving  medicines  is  at  the   center  of  the  work  of  the  Quality  Consortium.    She  framed  the  Consortium  Companies’  common  goals  for   improving  quality,  increasing  efficiency,  and  lowering  costs  and  the  industry’s  common  challenges,   Page  1  of  4  
    • which  include  the  need  to  do  more  with  less.  “As  an  industry,  we  can  make  great  progress  through   collaboration,”  she  stated.     The  Consortium’s  Executive  Director,  Steve  Whittaker,  introduced  Avoca  team  members  who  have  been   working  on  authoring  the  guidelines  and  tools  for  effective  oversight  and  proactive  quality  management   that  will  be  hosted  on  the  Avoca  Quality  Consortium  Web  portal.    Janis  Hall,  an  Avoca  Consultant,   outlined  the  process  for  developing  the  guidelines  and  leading  practices  based  on  the  documentation  that   was  provided  to  Avoca  from  Member  organizations.    Many  Member  companies  contributed  information   and  tools.    Avoca  then  aggregated  and  assimilated  information  from  Member  companies  and  drew  upon   external  resources  as  well  to  develop  the  best  practices.     A  Quintiles  executive  asked  if  there  were  any  notable  industries  beyond  the  pharmaceutical  industry   from  where  we  could  borrow  key  elements  and  learnings.    Janis  Hall  noted  that  the  idea  of  “Quality  by   Design”  is  relatively  new  in  the  clinical  space,  as  it  was  borrowed  from  heavy  manufacturing  industries,   such  as  the  auto  industry.    Avoca  is  currently  authoring  best  practice  Quality  By  Design  guidelines  and   tools  that  will  be  hosted  under  the  Process  swim  lane.     At  the  core  of  the  October  Member  meeting  was  a  demonstration  of  the  web  portal  and  search  engine  that   Avoca  is  developing  that  will  host  all  the  tools  and  guidelines  under  the  eight  “swim  lanes”  that   comprise  proactive  quality  management:         Page  2  of  4  
    • The  web  portal  also  includes  other  Consortium  documents  such  as  the  modularized  Quality  Agreement   template.     This  technology  platform  is  easy  to  navigate  and  permits  Members  to  actively  use  the  different  swim   lanes  to  identify,  locate,  and  then  download  specific  guidelines  and  tools.    The  portal  enables  Members  to   extract  the  components  and  sections  of  documents  that  they  need  for  their  respective  organizations.     Members  were  given  a  roadmap  and  exercise  to  practice  with  the  tool  to  ensure  they  felt  comfortable   navigating  and  accessing  different  documents.    A  Purdue  Pharma  Executive  said,  “I  like  the  idea  of   having  many  opportunities  to  select  the  right  tools.    One  size  doesn’t  fit  all.    But  we  do  need  to  know  how   to  consistently  do  things  and  this  type  of  standardization  is  exciting  and  important.”     The  portal  has  embedded  a  “Social  Center”  that  functions  similarly  to  LinkedIn,  Salesforce  Chatter,  and   Facebook,  where  Members  can  upload  profile  information  and  interact  with  other  Consortium  Members.     “Nothing  we  are  doing  in  this  space  is  static.    Regulations  change.    Pressures  on  the  industry,  knowledge,   experiences  change.    Is  there  a  mechanism  in  place  to  make  sure  best  practices  are  updated?”  an   AstraZeneca  executive  asked.     Avoca  is  constantly  updating  its  documents,  and  none  of  the  tools  are  static.    For  example,  one  of  the  2012   deliverables  was  a  Quality  Agreement  template,  which  has  since  been  revised  and  updated  based  on   ongoing  feedback.    Members  have  the  ability  to  set  alerts  through  the  portal  so  that  they  are  notified   when  content  has  been  added,  changed,  or  updated.     Following  the  demo  and  practice  of  the  IT  solution,  which  will  “go  live”  with  three  of  its  swim  lanes  on   November  15th,  Members  discussed  the  concept  of  “socialization”,  a  term  that  refers  to  a  company’s   ability  to  successfully  ensure  best  practices  become  incorporated  into  the  cultural  norm  of  Member   organizations  and  their  partnerships.    It  includes  the  ability  to  address  major  barriers  that  prevent   successful  implementation  of  change  initiatives  and  its  impact  on  best  practices.     Steve  Jacobs,  President  of  Global  BioPharm  Solutions  LLC,  spoke  about  influencing  organizational   change  for  large  and  complex  organizations  using  socialization.    He  spoke  about  the  tangible  skills  in   change  management  as  well  as  human  skills  that  can  be  applied.    Jacobs  recommended  starting  with  the   “why”.    Companies  and  people  need  to  be  able  to  clearly  articulate  why  they  do  what  they  do.    Why   should  anyone  care?    What  is  the  purpose,  cause,  or  belief?     “If  you  can’t  get  your  folks  to  understand  the  why,  you  need  to  modify  and  adapt  your  change  plan  or   adjust  it  or  it  will  fail,”  he  said.     Jacobs  also  highlighted  the  5  C’s  as  the  core  of  being  able  to  build  and  maintain  trust:    Consistency,   Commitment,  Competency,  Communication,  and  Character.    He  mentioned  the  importance  of  identifying   and  expressing  appreciation  to  people  for  the  important  contributions  they  make  to  the  company’s   challenges.    He  stressed  the  value  of  employee  engagement  and  lessons  learned  meetings;  where  you  can   instill  mental  discipline  by  using  after-­‐‑action  reviews  to  promote  learning,  frank  discussion  of   performance,  and  a  continuous  improvement  mindset.    “It  is  important  for  lessons  learned  to  be  posted   and  shared  with  the  larger  group  or  company.    They  also  help  when  there  is  turnover.”     A  panel  with  executives  from  Cerexa,  Amgen,  and  Quintiles  shared  their  respective  experiences  with   socialization  of  the  quality  agreement  and  quality  best  practices.   Page  3  of  4  
    • Sarah  Carter,  Executive  Director,  Planning  and  Platform  Services,  Amgen,  stated  that  it  requires,  “a  shift   in  the  employee’s  mentality  -­‐‑  shifting  away  from  something  else  requiring  their  attention  during  the  busy   day  job  and  role.    You  have  to  get  them  to  understand  the  reason  behind  the  change  and  make  it  easier   compared  to  what  they  currently  do.    They  have  to  know,  ‘What’s  in  it  for  me?’    If  you  can’t  explain  this,   then  you  won’t  get  buy-­‐‑in.    Management  is  at  the  strategy  level  and  often  does  not  take  the  time  to   explain  ‘the  why’  and  ‘what  is  in  it  for  me’  to  everybody.    Getting  them  to  understand  the  importance  of   an  initiative  and  why  it  is  important  is  essential.”     Tony  Owen,  Vice  President  Clinical  Quality  Assurance,  Quintiles,  supported  that  notion,  stating,  “A  lot   of  quality  initiatives  are  driven  from  the  top,  and  often  there  is  a  gap  between  management  and   operations  on  what  they  need.”     “Ownership  is  a  key  motivator.    One  of  the  tactics  in  our  group  is  helping  staff  understand  how  the   quality  initiatives  will  help  them  do  what  they  need  to  do,”  said  Denise  Sharp,  Associate  Director,   Pediatric  Program,  Cerexa.    “People  need  to  understand  how  quality  management  would  impact  their   work  and  how  it  is  explained  to  CRO  partners.    They  need  to  understand  how  it  will  help  Cerexa  as  a   company  and  how  it  will  help  the  end  product.”     One  Consortium  Member  made  the  suggestion  for  Avoca  to  tie  the  documents  and  tools  in  the  web  portal   to  actual  success  measures  or  have  people  comment  on  whether  a  document  or  tool  has  led  to  success.     Avoca  and  Pfizer  presented  a  joint  session  on  a  Quality  Metrics  Case  Study.    David  Nickerson,  Senior   Director,  Quality  and  Risk  Management  Lead,  Clinical  Quality  Management,  Pfizer,  and  Dr.  Denise   Calaprice-­‐‑Whitty,  Senior  Consultant,  The  Avoca  Group,  co-­‐‑presented.     “There  were  so  many  metrics,  so  little  time,”  Nickerson  stated.    “There  are  many  different  roles  related  to   reviewing  the  data  such  as  the  process  owners,  operational  partners/CROs,  study  teams,  governance   committees,  etc.,  so  we  felt  we  needed  to  reach  out  to  Avoca  to  do  an  external  review  of  our  metrics,   metric  processes,  and  approach.”     Denise  Calaprice-­‐‑Whitty  provided  background  information  on  how  Avoca’s  Quality  Metrics  were   derived,  including  perspectives  based  on  additional  research.    She  and  Dave  Nickerson  introduced  a   Quality  Metrics  framework  for  consideration  by  the  Consortium  Members  and  engaged  the  attendees  in  a   discussion  regarding  best  practice  approaches  to  developing  robust  metrics  programs.    Key  concepts   include  a  proposed  taxonomy  that  is  tied  to  outcomes  and  an  approach  for  grouping  metrics  for  the  correct   audience  and  intended  goal  for  the  use  of  the  metric.     Patty  Leuchten  then  closed  the  meeting  with  a  review  of  the  Pulse  Survey  Results  that  focused  on  2014   initiatives.    This  survey  was  sent  to  staff  at  all  Consortium  Member  companies  prior  to  the  October   meeting.    The  polling  tool  was  used  to  obtain  on-­‐‑site  interest  from  Consortium  Members  on  potential   2014  topics.     Recommendations  that  were  made  by  attendees  at  both  the  May  2013  Quality  Summit  and  at  this  October   Working  Session  will  be  incorporated  into  the  2014  plans  that  will  be  presented  on  November  15,  2014  at   an  Executive  Meeting  for  Consortium  Members.     Members  will  be  notified  of  our  2014  Quality  Consortium  Initiatives  after  the  November  Executive   Meeting.   Page  4  of  4