Pharma IQ’s 2011
Clinical Event Series
Information Pack
IQPC is pleased to announce the launch of the 2011 clinical
event series providing high-level platforms to initiate and
cement new business relationships across the clinical space.
Specifically tailored events featuring senior experts from
across the biotech and pharma industry include:

• Optimising Clinical Development in Oncology
• Global Clinical Outsourcing Forum
• Clinical Data Standardisation and Management
• Phase I Clinical Development
• Clinical Trial Supply
• Optimising Clinical Development in CNS
• Successful Comparator Sourcing and Development
• Clinical Investigations and Evaluations for Medical Devices
• Bioavailability and Bioequivalence
• Innovation in Clinical Design, Analysis and Reporting



 A golden opportunity to share knowledge,
 concerns, solutions and promising developments
 Bristol Myers Squibb
Featured speakers on our clinical event panels include:
• Tomas Skacel, International Medical Director, Amgen                  • Benedikte Akra, Medical Science Manager – Oncology, Bristol
• Ridwaan Jhetam, Global Clinical Operations Head: Oncology              Myers Squibb
  Senior Director, Johnson and Johnson                                 • Christiane Langer, Group Medical Director, Oncology Clinical
• Mike Burgess, European Head of Oncology Clinical Research and          Research Europe, Bristol Myers Squibb
  Early Development, Roche                                             • Susanne Kihlblom, Strategic Sourcing Leader, AstraZeneca R&D
• Grégory Coraux, Sourcing and Vendor Management, Merck                • Richard Pompe, Global Procurement Director, Mylan
  Serono                                                               • Anish Desai, Head R&D, Medical Director, Bayer Schering
• Michael Herschel, Director Clinical Research, GlaxoSmithKline          Pharma India
• Michael Zaiac, Assistant Vice President, Medical Affairs EMEA,       • Monika Kouba, Clinical Research Director CEE and Subregional
  Transplant, Oncology and GI, Wyeth                                     Head Clinical Operations Central Eastern Europe and Middle East,
• Thore Nederman, Head of Clinical Development, Active Biotech           Schering-Plough
• Antonio Llamas, Regional Head of Operations Spain & Portugal,        • Pasi Piitulainen, Global Clinical Development Affairs Director,
  Wyeth Research                                                         Actelion
• Anne Maria Ylisaari, Head of In-and-Outsourcing, Orion Pharma        • Pia Sauer, Outsourcing and Contract Manager, Clinical
• Estrella Garcia, Head of Global Clinical Operations and Strategic      Development, Genmab
  Resourcing, Almirall                                                 • Uwe Schneider, Global Head of Sourcing Management and Head
• Giorgio Massimini, Administrative Head of Oncology , Europe,           of Development Office, Grünenthal
  Roche                                                                • Nursah Omeroglu, Clinical Research Manager, Sanofi-Aventis
• Jai Balkissoon, Senior Medical Director, Director of Oncology,       • Christian Hucke, Clinical Development Manager, Affimed
  Oxigene                                                              • Esther Garcia Gil, Global Clinical Leader R&D, Respiratory
• Shanna Stopatschinskaja, Global Medical Director Oncology,             Therapeutic Area, Almirall
  Schering Plough                                                      • Sheila Weir, Head, Project Management, Newron Pharmaceuticals

  2011 Clinical Series Events
  Clinical Trial Supply Europe
  26-27th January 2011, Rotterdam
  www.clinicalsupplyeurope.com
  With the latest statistics showing that an estimated 70% of clinical trials fail to complete on
  time, clinical supply departments are under increased pressure to streamline processes and
  cut time wherever possible. In response to industry demand, Pharma IQ’s Clinical Trial
  Supply Europe conference will bring together senior industry experts from across the globe
  to discuss innovative approaches to planning, packaging, distribution, comparator sourcing
  and much more in three days of interactive presentations and discussions.                          Excellent.
  2nd annual Optimising Clinical Development in Oncology
                                                                                                     Very interesting
  (Co-located with Clinical Development in CNS)
  22-23 March 2011, Berlin/London
                                                                                                     networking
  www.oncologysummit.co.uk
  With the oncology market now valued at $55 billion, pharma and biotech manufacturers are           MSF Supply
  under pressure to find innovative ways of speeding development times in order to claim
  their share of this lucrative area. However, oncology poses unique patient recruitment, trial
  design and operational challenges – issues that can waste invaluable resource and slow
  regulatory approval. Through a series of interactive presentations and discussions, Pharma
  IQ’s Optimising Clinical Development in Oncology conference provides a unique platform for
  manufacturers to discuss practical, proven ideas to save time and money and ensure that
  companies have the knowledge they need to take their drugs to market fast.

  Optimising Clinical Development in CNS
  (Co-located with Clinical Development in Oncology)
  22-23 March 2011, Berlin/London
  As the second largest therapeutic segment but with the fastest growth rate, the global CNS
  market is forecast to expand to US$63.9 billion in 2010. Much like oncology however, several
  challenges remain when it comes to conducting clinical trials within this therapy area
  compounded by the recent FDA suicidality regulation that has left pharma companies
  needing further clarification. Optimising Clinical Development in CNS provides a good
  opportunity to discuss all the key challenges in an interactive event forum.
Successful Comparator Sourcing and Development
April 2011, Venue TBC
In response to an ever increasing number of global comparator clinical trials, it is
important for any company to ensure that comparator drugs are available for all trials.
However, with this task being fraught with challenges such as thee inability to obtain the
right documentation, lack of supply chain security and an increasing number of
counterfeits, as well as the high quality level of product needed, the opportunities for
success becoming harder to find. Pharma IQ's Successful Comparator Sourcing and                 Overall very
Development Conference will bring together senior thought leaders to address the                knowledgeable. Very
numerous challenges faced by comparator professionals, offering a platform for in-depth
discussion to enable the birth of innovative answers to these key challenges                    valuable, good high level
                                                                                                summary of real life
2nd annual Global Clinical Outsourcing Forum
May 2011, Munich                                                                                process excellence”
www.globalclinicaloutsourcing.com
Over the past few years outsourcing has become vastly popular among biotech and pharma          Schering Plough
companies with an estimated third of all R&D budgets now being spent on CROs. As
rewarding as this practice can be, there are still multiple challenges to be faced when it
comes to outsourcing, particularly when it comes to choosing an outsourcing strategy,           “The conference was
selecting a CRO, project managing the trial and ensuring that the company achieves the          “perfect” in my
desired outcome in the desired timeline. This conference is focused on effectively
managing strategic and tactical outsourcing partners to maximise the efficiency of global       personal opinion. From
trials and speed time to market for new drugs. Case studies from industry key players as        last year I have received
well as interactive sessions will offer attendees a unique opportunity to interact and
exchange ideas with fellow experts facing similar challenges, assess the industry trends,       2 orders that started
maximise alliance opportunities and take advantage of the practical experience shared by        during the meeting. I
the most knowledgeable experts in the business.                                                 hope we can at least
2nd annual Clinical Data Standardisation and Management                                         repeat this number
June 2011, London                                                                               based on this
www.clinicaldataevent.com
In a climate where streamlining processes and maximising resources is paramount,
                                                                                                conference. I don’t have
ensuring an efficient and effective approach to data management is integral to running a        a total overview yet, but
trial on time and on budget. However, key challenges remain. With changes to CDISC              I think we have picked
standards and the CDASH initiatives in place, implementing these initiatives at a company
level can be approached in a number of ways – some which are more successful than               up about 10 leads and
others. Covering key areas such as effective approaches to standardisation, outsourcing the     at least 30 great
data management function, best practice approaches to data warehouses, enhancing
efficiency and reducing costs and effective data migration methods, Pharma IQ’s Clinical        contact”
Data Standardisation and Management event will provide a wealth of pharma and biotech
manufacturer case studies to ensure delegates take away practical techniques that they          Avantium Technologies
can apply to their business.

2nd annual Innovation in Phase 1 Clinical Development
September 2011, Munich
www.phase1clinicaldevelopment.com
With the emphasis on speeding the go/no-go decision and saving clinical development costs
later down the line, annual spend on Phase 1 trials is up by 12.5% and a total of 40% of all
development projects are now in this stage. Increased spend has led to increased
innovation and companies are approaching trial design and exploratory development in
new ways in order to speed the process along. Pharma IQ’s Phase 1 Clinical Development
event will bring together key regulators and manufacturers to address core issues such as
regulatory requirements, changes to the ICH guidelines, microdosing studies and patient
recruitment amongst others, in order to aid manufacturers in their quest to reduce cost
and achieve a go/no-go decision faster.

2nd annual Clinical Investigations and Evaluations for Medical Devices
October 2011, Berlin, Germany
www.clinicalmedicaldevice.com
With the recent amendments to the Medical Device Directive (2007/47/EC), it is essential that
the medical device industry adapts their evaluations and investigations strategy to
maintain complete compliance. Pharma IQ’s Clinical Evaluations and Investigations for
Medical Devices Conference will bring together regulators, notified bodies, medical device
professionals and CRO’s all tasked with the same remit; medical device evaluations and
trials. This conference will offer attendees the opportunity to discuss the key challenges
currently being faced as well as possible solutions and also gain immediate clarification
over how best to implement the guidelines from the regulatory bodies represented.
2nd annual Bioequivalence and Bioavailability
October 2011, Munich, Germany
www.bioequivalenceevent.com
Bioequivalence and bioavailability are an essential part of regulatory approval process for
generic and innovator companies and with the arrival of new EMA guidelines (on 1st August
2010) and the expanding scope of the generics market, it is now a crucial time to explore
the impact of these guidelines and the changes they are bringing. The guidelines permit
                                                                                              Overall very
increased flexibility regarding study design, as well as providing recommendations on BCS-    knowledgeable. Very
based biowaivers and new approaches to study requirements for different dosage forms.         valuable, good high level
The conference is bringing together several of the drafting committee to address these
changes to help optimise your bioequivalence studies.                                         summary of real life
                                                                                              process excellence”
Innovation in Clinical Design, Analysis and Reporting
November 2011, London
www.clinicalreporting.co.uk                                                                   Schering Plough
The world of clinical trials is evolving. More trials are taking place than ever before and
the last 18 months have seen a flood of regulation in the biostatistics arena, with the       “The conference was
EMA laying down new rules on missing data and the FDA publishing new guidelines on
adaptive trials. Getting your design, analysis and reporting right to cut time and costs      “perfect” in my
has never been more important.Pharma IQ’s Innovation in Clinical Design, Analysis and         personal opinion. From
Reporting conference will help to open up this area to debate, facilitate discussion
between like-minded professionals within the field, presenting industry professionals         last year I have received
with a forum for learning new developments and the networking potential to forge              2 orders that started
lasting business relationships.                                                               during the meeting. I
                                                                                              hope we can at least
                                                                                              repeat this number
                                                                                              based on this
                                                                                              conference. I don’t have
                                                                                              a total overview yet, but
                                                                                              I think we have picked
                                                                                              up about 10 leads and
                                                                                              at least 30 great
About Pharma IQ                                                                               contact”

Pharma IQ has been rated again and again as the most effective business                       Avantium Technologies
development event partner!
Pharma IQ is a division of IQPC. Founded in 1973, IQPC now has offices in major cities
across six continents, giving Pharma IQ a truly global reach. The international
research base ensures Pharma IQ is uniquely positioned to put together our leading
events, tackling the issues important to you and bringing tangible benefits to your
organisation. As an organisation, we have educated and trained over two million
executives at over 40,000 conferences and training courses worldwide.
The European arm, based in our London office, has grown an enviable reputation
for quality and now widely recognised as a market leader in specialist
pharmaceutical conferences.

Pharma IQ works closely with a number of industry organisations to deliver
cutting edge conferences that showcase the latest requirements, emerging
technologies and practical solutions in the area. The international speakers and
audiences at each event ensure that the need for communication between the
pharmaceutical community. With ample opportunity for networking, these events
represent an unparalleled platform to gather information, meet key customers and
develop business.

Pharma IQ - Clinical Series 2011

  • 1.
    Pharma IQ’s 2011 ClinicalEvent Series Information Pack IQPC is pleased to announce the launch of the 2011 clinical event series providing high-level platforms to initiate and cement new business relationships across the clinical space. Specifically tailored events featuring senior experts from across the biotech and pharma industry include: • Optimising Clinical Development in Oncology • Global Clinical Outsourcing Forum • Clinical Data Standardisation and Management • Phase I Clinical Development • Clinical Trial Supply • Optimising Clinical Development in CNS • Successful Comparator Sourcing and Development • Clinical Investigations and Evaluations for Medical Devices • Bioavailability and Bioequivalence • Innovation in Clinical Design, Analysis and Reporting A golden opportunity to share knowledge, concerns, solutions and promising developments Bristol Myers Squibb
  • 2.
    Featured speakers onour clinical event panels include: • Tomas Skacel, International Medical Director, Amgen • Benedikte Akra, Medical Science Manager – Oncology, Bristol • Ridwaan Jhetam, Global Clinical Operations Head: Oncology Myers Squibb Senior Director, Johnson and Johnson • Christiane Langer, Group Medical Director, Oncology Clinical • Mike Burgess, European Head of Oncology Clinical Research and Research Europe, Bristol Myers Squibb Early Development, Roche • Susanne Kihlblom, Strategic Sourcing Leader, AstraZeneca R&D • Grégory Coraux, Sourcing and Vendor Management, Merck • Richard Pompe, Global Procurement Director, Mylan Serono • Anish Desai, Head R&D, Medical Director, Bayer Schering • Michael Herschel, Director Clinical Research, GlaxoSmithKline Pharma India • Michael Zaiac, Assistant Vice President, Medical Affairs EMEA, • Monika Kouba, Clinical Research Director CEE and Subregional Transplant, Oncology and GI, Wyeth Head Clinical Operations Central Eastern Europe and Middle East, • Thore Nederman, Head of Clinical Development, Active Biotech Schering-Plough • Antonio Llamas, Regional Head of Operations Spain & Portugal, • Pasi Piitulainen, Global Clinical Development Affairs Director, Wyeth Research Actelion • Anne Maria Ylisaari, Head of In-and-Outsourcing, Orion Pharma • Pia Sauer, Outsourcing and Contract Manager, Clinical • Estrella Garcia, Head of Global Clinical Operations and Strategic Development, Genmab Resourcing, Almirall • Uwe Schneider, Global Head of Sourcing Management and Head • Giorgio Massimini, Administrative Head of Oncology , Europe, of Development Office, Grünenthal Roche • Nursah Omeroglu, Clinical Research Manager, Sanofi-Aventis • Jai Balkissoon, Senior Medical Director, Director of Oncology, • Christian Hucke, Clinical Development Manager, Affimed Oxigene • Esther Garcia Gil, Global Clinical Leader R&D, Respiratory • Shanna Stopatschinskaja, Global Medical Director Oncology, Therapeutic Area, Almirall Schering Plough • Sheila Weir, Head, Project Management, Newron Pharmaceuticals 2011 Clinical Series Events Clinical Trial Supply Europe 26-27th January 2011, Rotterdam www.clinicalsupplyeurope.com With the latest statistics showing that an estimated 70% of clinical trials fail to complete on time, clinical supply departments are under increased pressure to streamline processes and cut time wherever possible. In response to industry demand, Pharma IQ’s Clinical Trial Supply Europe conference will bring together senior industry experts from across the globe to discuss innovative approaches to planning, packaging, distribution, comparator sourcing and much more in three days of interactive presentations and discussions. Excellent. 2nd annual Optimising Clinical Development in Oncology Very interesting (Co-located with Clinical Development in CNS) 22-23 March 2011, Berlin/London networking www.oncologysummit.co.uk With the oncology market now valued at $55 billion, pharma and biotech manufacturers are MSF Supply under pressure to find innovative ways of speeding development times in order to claim their share of this lucrative area. However, oncology poses unique patient recruitment, trial design and operational challenges – issues that can waste invaluable resource and slow regulatory approval. Through a series of interactive presentations and discussions, Pharma IQ’s Optimising Clinical Development in Oncology conference provides a unique platform for manufacturers to discuss practical, proven ideas to save time and money and ensure that companies have the knowledge they need to take their drugs to market fast. Optimising Clinical Development in CNS (Co-located with Clinical Development in Oncology) 22-23 March 2011, Berlin/London As the second largest therapeutic segment but with the fastest growth rate, the global CNS market is forecast to expand to US$63.9 billion in 2010. Much like oncology however, several challenges remain when it comes to conducting clinical trials within this therapy area compounded by the recent FDA suicidality regulation that has left pharma companies needing further clarification. Optimising Clinical Development in CNS provides a good opportunity to discuss all the key challenges in an interactive event forum.
  • 3.
    Successful Comparator Sourcingand Development April 2011, Venue TBC In response to an ever increasing number of global comparator clinical trials, it is important for any company to ensure that comparator drugs are available for all trials. However, with this task being fraught with challenges such as thee inability to obtain the right documentation, lack of supply chain security and an increasing number of counterfeits, as well as the high quality level of product needed, the opportunities for success becoming harder to find. Pharma IQ's Successful Comparator Sourcing and Overall very Development Conference will bring together senior thought leaders to address the knowledgeable. Very numerous challenges faced by comparator professionals, offering a platform for in-depth discussion to enable the birth of innovative answers to these key challenges valuable, good high level summary of real life 2nd annual Global Clinical Outsourcing Forum May 2011, Munich process excellence” www.globalclinicaloutsourcing.com Over the past few years outsourcing has become vastly popular among biotech and pharma Schering Plough companies with an estimated third of all R&D budgets now being spent on CROs. As rewarding as this practice can be, there are still multiple challenges to be faced when it comes to outsourcing, particularly when it comes to choosing an outsourcing strategy, “The conference was selecting a CRO, project managing the trial and ensuring that the company achieves the “perfect” in my desired outcome in the desired timeline. This conference is focused on effectively managing strategic and tactical outsourcing partners to maximise the efficiency of global personal opinion. From trials and speed time to market for new drugs. Case studies from industry key players as last year I have received well as interactive sessions will offer attendees a unique opportunity to interact and exchange ideas with fellow experts facing similar challenges, assess the industry trends, 2 orders that started maximise alliance opportunities and take advantage of the practical experience shared by during the meeting. I the most knowledgeable experts in the business. hope we can at least 2nd annual Clinical Data Standardisation and Management repeat this number June 2011, London based on this www.clinicaldataevent.com In a climate where streamlining processes and maximising resources is paramount, conference. I don’t have ensuring an efficient and effective approach to data management is integral to running a a total overview yet, but trial on time and on budget. However, key challenges remain. With changes to CDISC I think we have picked standards and the CDASH initiatives in place, implementing these initiatives at a company level can be approached in a number of ways – some which are more successful than up about 10 leads and others. Covering key areas such as effective approaches to standardisation, outsourcing the at least 30 great data management function, best practice approaches to data warehouses, enhancing efficiency and reducing costs and effective data migration methods, Pharma IQ’s Clinical contact” Data Standardisation and Management event will provide a wealth of pharma and biotech manufacturer case studies to ensure delegates take away practical techniques that they Avantium Technologies can apply to their business. 2nd annual Innovation in Phase 1 Clinical Development September 2011, Munich www.phase1clinicaldevelopment.com With the emphasis on speeding the go/no-go decision and saving clinical development costs later down the line, annual spend on Phase 1 trials is up by 12.5% and a total of 40% of all development projects are now in this stage. Increased spend has led to increased innovation and companies are approaching trial design and exploratory development in new ways in order to speed the process along. Pharma IQ’s Phase 1 Clinical Development event will bring together key regulators and manufacturers to address core issues such as regulatory requirements, changes to the ICH guidelines, microdosing studies and patient recruitment amongst others, in order to aid manufacturers in their quest to reduce cost and achieve a go/no-go decision faster. 2nd annual Clinical Investigations and Evaluations for Medical Devices October 2011, Berlin, Germany www.clinicalmedicaldevice.com With the recent amendments to the Medical Device Directive (2007/47/EC), it is essential that the medical device industry adapts their evaluations and investigations strategy to maintain complete compliance. Pharma IQ’s Clinical Evaluations and Investigations for Medical Devices Conference will bring together regulators, notified bodies, medical device professionals and CRO’s all tasked with the same remit; medical device evaluations and trials. This conference will offer attendees the opportunity to discuss the key challenges currently being faced as well as possible solutions and also gain immediate clarification over how best to implement the guidelines from the regulatory bodies represented.
  • 4.
    2nd annual Bioequivalenceand Bioavailability October 2011, Munich, Germany www.bioequivalenceevent.com Bioequivalence and bioavailability are an essential part of regulatory approval process for generic and innovator companies and with the arrival of new EMA guidelines (on 1st August 2010) and the expanding scope of the generics market, it is now a crucial time to explore the impact of these guidelines and the changes they are bringing. The guidelines permit Overall very increased flexibility regarding study design, as well as providing recommendations on BCS- knowledgeable. Very based biowaivers and new approaches to study requirements for different dosage forms. valuable, good high level The conference is bringing together several of the drafting committee to address these changes to help optimise your bioequivalence studies. summary of real life process excellence” Innovation in Clinical Design, Analysis and Reporting November 2011, London www.clinicalreporting.co.uk Schering Plough The world of clinical trials is evolving. More trials are taking place than ever before and the last 18 months have seen a flood of regulation in the biostatistics arena, with the “The conference was EMA laying down new rules on missing data and the FDA publishing new guidelines on adaptive trials. Getting your design, analysis and reporting right to cut time and costs “perfect” in my has never been more important.Pharma IQ’s Innovation in Clinical Design, Analysis and personal opinion. From Reporting conference will help to open up this area to debate, facilitate discussion between like-minded professionals within the field, presenting industry professionals last year I have received with a forum for learning new developments and the networking potential to forge 2 orders that started lasting business relationships. during the meeting. I hope we can at least repeat this number based on this conference. I don’t have a total overview yet, but I think we have picked up about 10 leads and at least 30 great About Pharma IQ contact” Pharma IQ has been rated again and again as the most effective business Avantium Technologies development event partner! Pharma IQ is a division of IQPC. Founded in 1973, IQPC now has offices in major cities across six continents, giving Pharma IQ a truly global reach. The international research base ensures Pharma IQ is uniquely positioned to put together our leading events, tackling the issues important to you and bringing tangible benefits to your organisation. As an organisation, we have educated and trained over two million executives at over 40,000 conferences and training courses worldwide. The European arm, based in our London office, has grown an enviable reputation for quality and now widely recognised as a market leader in specialist pharmaceutical conferences. Pharma IQ works closely with a number of industry organisations to deliver cutting edge conferences that showcase the latest requirements, emerging technologies and practical solutions in the area. The international speakers and audiences at each event ensure that the need for communication between the pharmaceutical community. With ample opportunity for networking, these events represent an unparalleled platform to gather information, meet key customers and develop business.