SlideShare ist ein Scribd-Unternehmen logo
1 von 2
Downloaden Sie, um offline zu lesen
What the Future of the Pharma Industry Holds
Interview with: B o r i s R e z n i k ,
Chairman, BioRASI LLC
Maximizing the probability of clinical
trial success is key, as pharmaceutical
companies are increasingly pressured to
reduce the time and cost of clinical
development, without compromising on
quality, says Boris Reznik, Chairman,
bioRASI LLC.
A contract research organization (CRO)
joining the marcus evans Evolution
Summit 2013, in Palm Beach, Florida,
May 8-10, as a solutions provider,
bioRASI LLC’s Reznik highlights the
latest trends in the industry.
What trends do you see in the
pharmaceutical industry globally?
The growth of emerging consumer
markets worldwide is prompting
pharmaceutical companies to take
deliberate steps for adhering to
regulatory requirements of not only the
US Food and Drug Administration (FDA)
and the European Medicines Agency
(EMA) but also other jurisdictions even if
rollout to those markets is not
immediately planned. For example,
including Russia into pivotal trial
geographies assures eligibility of the
drug for future registering there.
The industry is also experiencing
mounting pressure to reduce overall
costs of bringing new drugs to market.
With clinical development being one of
the most expensive components of this
process, the accepted paradigm of
outsourcing specialized services to CROs
continues to climb. CROs are now
accountable for maximizing the
probability of trial success and
maintaining high service levels while
minimizing both the time and cost of
development. This trend is causing the
pharma industry to re-evaluate their
exclusive relationships with multi-billion
dollar CROs and in certain cases to shift
alignment to small and mid-size CROs
who might be better at fulfilling the
entire spectrum of these requirements.
Additionally, sponsors are increasingly
looking to CROs to provide a scientific
angle, not only in development of
protocols or clinical trial designs, but
also in running them with the aim of
optimization. Agile CROs are responding
to this challenge by augmenting their
professional talent pool with MDs and
PhDs trained in particular areas of
specialty.
Leading CROs are progressing beyond
mere global presence to fully integrating
their geographic capabilities, the best
worldwide medical facilities, supply chain
management and e-clinical technologies.
Strong partnerships between pharma
companies and CROs optimize the
fulfillment of global regulatory
requirements eliminating the necessity
to duplicate trials.
Another trend is associated with an
increasing number of expiring
blockbuster drug patents. This is
opening up new areas of opportunities
for pharma and biotech companies.
Building upon existing successful small
molecule drugs, companies are
delivering to the market both generic
drugs and enhanced 505(b)(2) versions.
Similarly, biologics going off patent
create tremendous opportunities with
follow-on biologics, from biosimilars to
bio-betters and soon to inter-
changeables. Pharma companies are
searching for CROs that have
demonstrated experience in these areas
to avoid pitfalls that have been known to
derail biosimilar development. Not
surprising, companies are eager to
pursue simultaneous approvals from
FDA, EMA and other jurisdictions for
costly biosimilar drug developments.
In the wake of this trend some CROs are
emerging as experts in follow-on
biologics. The concept of inter-
changeability presents even greater
potential; biosimilars would require a
direct-to-physician sales force, which is
expensive. Interchangeable biosimilars,
however, can be sold directly to major
distributors and pharmacy chains,
because they can be substituted at those
levels, providing a far more cost-
e ffe c tive s trate gy f or ma rke t
penetration.
How can pharmaceutical companies
achieve the highest probability of
success?
Trial success requires a close partnership
between the sponsor and CRO in
advance of project design. With
collective focus on optimization, they can
determine the relative importance to be
placed on crucial trial variables. Focusing
on factors as if they are independent
leads to unintended consequences, for
example increasing the number of
patients naturally increases the trial
power, but also increases costs and
time. Since all program requirements
are in fact interconnected, solutions
must be developed with simultaneous
multidimensional considerations in mind.
This demands using a more scientific
approach when designing studies and
leads to a higher probably of success.
For example, selecting precise endpoints
measurements and reducing trial-
induced variability provides for a study
with a given number of patients having
higher power, or for the same trial
power but with fewer patients. This is
where novel principal investigator (PI)
interactive training reduces intra- and
inter-rater variability. Taking that a step
further, you can apply similar techniques
for training study subjects to minimize
inter- and intra-subject variability.
These types of scientifically designed,
and more importantly validated
methods, are exactly what the industry
leaders use.
Any final comments?
Billions of dollars have been needlessly
wasted on trials that have failed to reach
success or need to be repeated for
approvals in different jurisdictions. The
industry is moving toward leveraging
appropriate expertise, normally
associated with CROs, in the areas of
trial design and conduct to increase the
overall probability of success and
eliminate rerunning the studies.
Many
billions
of dollars
have been
wasted
on trials
The Pharma Network – marcus
evans Summits group delivers
peer-to-peer information on
strategic matters, professional
t r e n d s a n d b r e a k t h r o u g h
innovations.
Please note that the Summit is a
closed business event and the
number of participants strictly
limited.
About the Evolution Summit 2013
This unique forum will take place at The Ritz-Carlton, Palm Beach, Florida, May
8-10, 2013. Offering much more than any conference, exhibition or trade show, this
exclusive meeting will bring together esteemed industry thought leaders and
solution providers to a highly focused and interactive networking event. The
Summit includes presentations on improving trial performance, establishing
strategic alliances, site selection and e-recruitment.
www.evolutionsummit.com
Contact
Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits
Division
Tel: + 357 22 849 313
Email: press@marcusevanscy.com
For more information please send an email to info@marcusevanscy.com
All rights reserved. The above content may be republished or reproduced. Kindly
inform us by sending an email to press@marcusevanscy.com
About BioRASI LLC
As a full service global CRO, bioRASI delivers “Clinical Research Optimized”. bioRASI provides expertise in the design and execution
of large complex clinical trials, supporting Specialty, Innovative and Biopharmaceutical companies bioRASI accelerates drug
development by optimally leveraging global resources and proficiency across a broad range of therapeutic indications, maximizing
quality, service levels, regulatory and industry acceptance, while minimizing time and cost.
www.biorasi.com
About marcus evans Summits
marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss
strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to
individually tailor their schedules of keynote presentations, think tanks, seminars and one-on-one business meetings.
For more information, please visit: www.marcusevans.com
Upcoming Events
Discovery Summit (Europe) - www.discovery-summit.com
Evolution Summit (Europe) - www.evolution-summit.com
To view the web version of this interview, please click here: www.evolutionsummit.com/BorisReznik

Weitere ähnliche Inhalte

Mehr von Life Sciences Network marcus evans

Optimizing Clinical Trial Operations - Alexander Fetkovsky, SanaClis
Optimizing Clinical Trial Operations - Alexander Fetkovsky, SanaClisOptimizing Clinical Trial Operations - Alexander Fetkovsky, SanaClis
Optimizing Clinical Trial Operations - Alexander Fetkovsky, SanaClisLife Sciences Network marcus evans
 
How Sponsors and Vendors Can Form a True Partnership-Kristine Koontz, GSK
How Sponsors and Vendors Can Form a True Partnership-Kristine Koontz, GSKHow Sponsors and Vendors Can Form a True Partnership-Kristine Koontz, GSK
How Sponsors and Vendors Can Form a True Partnership-Kristine Koontz, GSKLife Sciences Network marcus evans
 
Technological Crossroads: Navigating the Intersection between Recruitment, Re...
Technological Crossroads: Navigating the Intersection between Recruitment, Re...Technological Crossroads: Navigating the Intersection between Recruitment, Re...
Technological Crossroads: Navigating the Intersection between Recruitment, Re...Life Sciences Network marcus evans
 
Beyond the Hype: Practical Approaches for Implementing Machine Learning and A...
Beyond the Hype: Practical Approaches for Implementing Machine Learning and A...Beyond the Hype: Practical Approaches for Implementing Machine Learning and A...
Beyond the Hype: Practical Approaches for Implementing Machine Learning and A...Life Sciences Network marcus evans
 
Keeping up with ICH E6(R2): Risk-Based Monitoring (RBM) Redefined
Keeping up with ICH E6(R2): Risk-Based Monitoring (RBM) RedefinedKeeping up with ICH E6(R2): Risk-Based Monitoring (RBM) Redefined
Keeping up with ICH E6(R2): Risk-Based Monitoring (RBM) RedefinedLife Sciences Network marcus evans
 
Turning Sponsor/CRO Relationships into Partnerships for Success
Turning Sponsor/CRO Relationships into Partnerships for SuccessTurning Sponsor/CRO Relationships into Partnerships for Success
Turning Sponsor/CRO Relationships into Partnerships for SuccessLife Sciences Network marcus evans
 
Evolving Risk-Based Monitoring to Improve Clinical Studies-Dunya Botetzayas, ...
Evolving Risk-Based Monitoring to Improve Clinical Studies-Dunya Botetzayas, ...Evolving Risk-Based Monitoring to Improve Clinical Studies-Dunya Botetzayas, ...
Evolving Risk-Based Monitoring to Improve Clinical Studies-Dunya Botetzayas, ...Life Sciences Network marcus evans
 
Discovering Key Regulatory Reforms to Enable Accelerated Drug Development and...
Discovering Key Regulatory Reforms to Enable Accelerated Drug Development and...Discovering Key Regulatory Reforms to Enable Accelerated Drug Development and...
Discovering Key Regulatory Reforms to Enable Accelerated Drug Development and...Life Sciences Network marcus evans
 
The Patient’s Perspective: Finding a Cure to Rare Genetic Diseases - Dr Nicol...
The Patient’s Perspective: Finding a Cure to Rare Genetic Diseases - Dr Nicol...The Patient’s Perspective: Finding a Cure to Rare Genetic Diseases - Dr Nicol...
The Patient’s Perspective: Finding a Cure to Rare Genetic Diseases - Dr Nicol...Life Sciences Network marcus evans
 
Targeting Ras and MDS: Rigosertib Taking Aim at Important Targets-Steven Fruc...
Targeting Ras and MDS: Rigosertib Taking Aim at Important Targets-Steven Fruc...Targeting Ras and MDS: Rigosertib Taking Aim at Important Targets-Steven Fruc...
Targeting Ras and MDS: Rigosertib Taking Aim at Important Targets-Steven Fruc...Life Sciences Network marcus evans
 
Individualizing Patient Care through Precision Medicine: Shaping the Industry...
Individualizing Patient Care through Precision Medicine: Shaping the Industry...Individualizing Patient Care through Precision Medicine: Shaping the Industry...
Individualizing Patient Care through Precision Medicine: Shaping the Industry...Life Sciences Network marcus evans
 
Collaboration between Industry and Academia – An Opportunity to Drive Efficie...
Collaboration between Industry and Academia – An Opportunity to Drive Efficie...Collaboration between Industry and Academia – An Opportunity to Drive Efficie...
Collaboration between Industry and Academia – An Opportunity to Drive Efficie...Life Sciences Network marcus evans
 
Considering the End before the Beginning: Choosing the Correct Endpoints - An...
Considering the End before the Beginning: Choosing the Correct Endpoints - An...Considering the End before the Beginning: Choosing the Correct Endpoints - An...
Considering the End before the Beginning: Choosing the Correct Endpoints - An...Life Sciences Network marcus evans
 
Pushing the Innovation Envelope: Strategies for Boosting Productivity and ROI...
Pushing the Innovation Envelope: Strategies for Boosting Productivity and ROI...Pushing the Innovation Envelope: Strategies for Boosting Productivity and ROI...
Pushing the Innovation Envelope: Strategies for Boosting Productivity and ROI...Life Sciences Network marcus evans
 
Biomarkers to Diagnostics – The Essential Tool Box for Drug Development - Joh...
Biomarkers to Diagnostics – The Essential Tool Box for Drug Development - Joh...Biomarkers to Diagnostics – The Essential Tool Box for Drug Development - Joh...
Biomarkers to Diagnostics – The Essential Tool Box for Drug Development - Joh...Life Sciences Network marcus evans
 
Strategies for Maximizing Pediatric Studies: Orphan Indications - Deborah Lee...
Strategies for Maximizing Pediatric Studies: Orphan Indications - Deborah Lee...Strategies for Maximizing Pediatric Studies: Orphan Indications - Deborah Lee...
Strategies for Maximizing Pediatric Studies: Orphan Indications - Deborah Lee...Life Sciences Network marcus evans
 
Forming Powerful Partnerships to Drill Down into the Areas of Expertise of Ea...
Forming Powerful Partnerships to Drill Down into the Areas of Expertise of Ea...Forming Powerful Partnerships to Drill Down into the Areas of Expertise of Ea...
Forming Powerful Partnerships to Drill Down into the Areas of Expertise of Ea...Life Sciences Network marcus evans
 
CRTH2 Antagonists for the Treatment of Asthma and Allergic Rhinoconjunctivitis
CRTH2 Antagonists for the Treatment of Asthma and Allergic RhinoconjunctivitisCRTH2 Antagonists for the Treatment of Asthma and Allergic Rhinoconjunctivitis
CRTH2 Antagonists for the Treatment of Asthma and Allergic RhinoconjunctivitisLife Sciences Network marcus evans
 

Mehr von Life Sciences Network marcus evans (20)

Optimizing Clinical Trial Operations - Alexander Fetkovsky, SanaClis
Optimizing Clinical Trial Operations - Alexander Fetkovsky, SanaClisOptimizing Clinical Trial Operations - Alexander Fetkovsky, SanaClis
Optimizing Clinical Trial Operations - Alexander Fetkovsky, SanaClis
 
How Sponsors and Vendors Can Form a True Partnership-Kristine Koontz, GSK
How Sponsors and Vendors Can Form a True Partnership-Kristine Koontz, GSKHow Sponsors and Vendors Can Form a True Partnership-Kristine Koontz, GSK
How Sponsors and Vendors Can Form a True Partnership-Kristine Koontz, GSK
 
Technological Crossroads: Navigating the Intersection between Recruitment, Re...
Technological Crossroads: Navigating the Intersection between Recruitment, Re...Technological Crossroads: Navigating the Intersection between Recruitment, Re...
Technological Crossroads: Navigating the Intersection between Recruitment, Re...
 
Beyond the Hype: Practical Approaches for Implementing Machine Learning and A...
Beyond the Hype: Practical Approaches for Implementing Machine Learning and A...Beyond the Hype: Practical Approaches for Implementing Machine Learning and A...
Beyond the Hype: Practical Approaches for Implementing Machine Learning and A...
 
Keeping up with ICH E6(R2): Risk-Based Monitoring (RBM) Redefined
Keeping up with ICH E6(R2): Risk-Based Monitoring (RBM) RedefinedKeeping up with ICH E6(R2): Risk-Based Monitoring (RBM) Redefined
Keeping up with ICH E6(R2): Risk-Based Monitoring (RBM) Redefined
 
Turning Sponsor/CRO Relationships into Partnerships for Success
Turning Sponsor/CRO Relationships into Partnerships for SuccessTurning Sponsor/CRO Relationships into Partnerships for Success
Turning Sponsor/CRO Relationships into Partnerships for Success
 
Evolving Risk-Based Monitoring to Improve Clinical Studies-Dunya Botetzayas, ...
Evolving Risk-Based Monitoring to Improve Clinical Studies-Dunya Botetzayas, ...Evolving Risk-Based Monitoring to Improve Clinical Studies-Dunya Botetzayas, ...
Evolving Risk-Based Monitoring to Improve Clinical Studies-Dunya Botetzayas, ...
 
Discovering Key Regulatory Reforms to Enable Accelerated Drug Development and...
Discovering Key Regulatory Reforms to Enable Accelerated Drug Development and...Discovering Key Regulatory Reforms to Enable Accelerated Drug Development and...
Discovering Key Regulatory Reforms to Enable Accelerated Drug Development and...
 
The Patient’s Perspective: Finding a Cure to Rare Genetic Diseases - Dr Nicol...
The Patient’s Perspective: Finding a Cure to Rare Genetic Diseases - Dr Nicol...The Patient’s Perspective: Finding a Cure to Rare Genetic Diseases - Dr Nicol...
The Patient’s Perspective: Finding a Cure to Rare Genetic Diseases - Dr Nicol...
 
Targeting Ras and MDS: Rigosertib Taking Aim at Important Targets-Steven Fruc...
Targeting Ras and MDS: Rigosertib Taking Aim at Important Targets-Steven Fruc...Targeting Ras and MDS: Rigosertib Taking Aim at Important Targets-Steven Fruc...
Targeting Ras and MDS: Rigosertib Taking Aim at Important Targets-Steven Fruc...
 
Individualizing Patient Care through Precision Medicine: Shaping the Industry...
Individualizing Patient Care through Precision Medicine: Shaping the Industry...Individualizing Patient Care through Precision Medicine: Shaping the Industry...
Individualizing Patient Care through Precision Medicine: Shaping the Industry...
 
Collaboration between Industry and Academia – An Opportunity to Drive Efficie...
Collaboration between Industry and Academia – An Opportunity to Drive Efficie...Collaboration between Industry and Academia – An Opportunity to Drive Efficie...
Collaboration between Industry and Academia – An Opportunity to Drive Efficie...
 
Considering the End before the Beginning: Choosing the Correct Endpoints - An...
Considering the End before the Beginning: Choosing the Correct Endpoints - An...Considering the End before the Beginning: Choosing the Correct Endpoints - An...
Considering the End before the Beginning: Choosing the Correct Endpoints - An...
 
Pushing the Innovation Envelope: Strategies for Boosting Productivity and ROI...
Pushing the Innovation Envelope: Strategies for Boosting Productivity and ROI...Pushing the Innovation Envelope: Strategies for Boosting Productivity and ROI...
Pushing the Innovation Envelope: Strategies for Boosting Productivity and ROI...
 
Biomarkers to Diagnostics – The Essential Tool Box for Drug Development - Joh...
Biomarkers to Diagnostics – The Essential Tool Box for Drug Development - Joh...Biomarkers to Diagnostics – The Essential Tool Box for Drug Development - Joh...
Biomarkers to Diagnostics – The Essential Tool Box for Drug Development - Joh...
 
Business Development Activities Interview - Clinart MENA
Business Development Activities Interview - Clinart MENABusiness Development Activities Interview - Clinart MENA
Business Development Activities Interview - Clinart MENA
 
Strategies for Maximizing Pediatric Studies: Orphan Indications - Deborah Lee...
Strategies for Maximizing Pediatric Studies: Orphan Indications - Deborah Lee...Strategies for Maximizing Pediatric Studies: Orphan Indications - Deborah Lee...
Strategies for Maximizing Pediatric Studies: Orphan Indications - Deborah Lee...
 
Where marcus evans fits in our business development mix
Where marcus evans fits in our business development mixWhere marcus evans fits in our business development mix
Where marcus evans fits in our business development mix
 
Forming Powerful Partnerships to Drill Down into the Areas of Expertise of Ea...
Forming Powerful Partnerships to Drill Down into the Areas of Expertise of Ea...Forming Powerful Partnerships to Drill Down into the Areas of Expertise of Ea...
Forming Powerful Partnerships to Drill Down into the Areas of Expertise of Ea...
 
CRTH2 Antagonists for the Treatment of Asthma and Allergic Rhinoconjunctivitis
CRTH2 Antagonists for the Treatment of Asthma and Allergic RhinoconjunctivitisCRTH2 Antagonists for the Treatment of Asthma and Allergic Rhinoconjunctivitis
CRTH2 Antagonists for the Treatment of Asthma and Allergic Rhinoconjunctivitis
 

Kürzlich hochgeladen

The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003
The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003
The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003believeminhh
 
Trauma Training Service for First Responders
Trauma Training Service for First RespondersTrauma Training Service for First Responders
Trauma Training Service for First RespondersBPOQe
 
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdfTalent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdfCharles Cotter, PhD
 
Borderless Access - Global Panel book-unlock 2024
Borderless Access - Global Panel book-unlock 2024Borderless Access - Global Panel book-unlock 2024
Borderless Access - Global Panel book-unlock 2024Borderless Access
 
Michael Vidyakin: Introduction to PMO (UA)
Michael Vidyakin: Introduction to PMO (UA)Michael Vidyakin: Introduction to PMO (UA)
Michael Vidyakin: Introduction to PMO (UA)Lviv Startup Club
 
AMAZON SELLER VIRTUAL ASSISTANT PRODUCT RESEARCH .pdf
AMAZON SELLER VIRTUAL ASSISTANT PRODUCT RESEARCH .pdfAMAZON SELLER VIRTUAL ASSISTANT PRODUCT RESEARCH .pdf
AMAZON SELLER VIRTUAL ASSISTANT PRODUCT RESEARCH .pdfJohnCarloValencia4
 
UNLEASHING THE POWER OF PROGRAMMATIC ADVERTISING
UNLEASHING THE POWER OF PROGRAMMATIC ADVERTISINGUNLEASHING THE POWER OF PROGRAMMATIC ADVERTISING
UNLEASHING THE POWER OF PROGRAMMATIC ADVERTISINGlokeshwarmaha
 
The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...
The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...
The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...Brian Solis
 
Building Your Personal Brand on LinkedIn - Expert Planet- 2024
 Building Your Personal Brand on LinkedIn - Expert Planet-  2024 Building Your Personal Brand on LinkedIn - Expert Planet-  2024
Building Your Personal Brand on LinkedIn - Expert Planet- 2024Stephan Koning
 
Live-Streaming in the Music Industry Webinar
Live-Streaming in the Music Industry WebinarLive-Streaming in the Music Industry Webinar
Live-Streaming in the Music Industry WebinarNathanielSchmuck
 
PDT 88 - 4 million seed - Seed - Protecto.pdf
PDT 88 - 4 million seed - Seed - Protecto.pdfPDT 88 - 4 million seed - Seed - Protecto.pdf
PDT 88 - 4 million seed - Seed - Protecto.pdfHajeJanKamps
 
To Create Your Own Wig Online To Create Your Own Wig Online
To Create Your Own Wig Online  To Create Your Own Wig OnlineTo Create Your Own Wig Online  To Create Your Own Wig Online
To Create Your Own Wig Online To Create Your Own Wig Onlinelng ths
 
HELENE HECKROTTE'S PROFESSIONAL PORTFOLIO.pptx
HELENE HECKROTTE'S PROFESSIONAL PORTFOLIO.pptxHELENE HECKROTTE'S PROFESSIONAL PORTFOLIO.pptx
HELENE HECKROTTE'S PROFESSIONAL PORTFOLIO.pptxHelene Heckrotte
 
Scrum Events & How to run them effectively
Scrum Events & How to run them effectivelyScrum Events & How to run them effectively
Scrum Events & How to run them effectivelyMarianna Nakou
 
A flour, rice and Suji company in Jhang.
A flour, rice and Suji company in Jhang.A flour, rice and Suji company in Jhang.
A flour, rice and Suji company in Jhang.mcshagufta46
 
MoneyBridge Pitch Deck - Investor Presentation
MoneyBridge Pitch Deck - Investor PresentationMoneyBridge Pitch Deck - Investor Presentation
MoneyBridge Pitch Deck - Investor Presentationbaron83
 
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)tazeenaila12
 
Borderless Access - Global Panel book-unlock 2024
Borderless Access - Global Panel book-unlock 2024Borderless Access - Global Panel book-unlock 2024
Borderless Access - Global Panel book-unlock 2024Borderless Access
 
BCE24 | Virtual Brand Ambassadors: Making Brands Personal - John Meulemans
BCE24 | Virtual Brand Ambassadors: Making Brands Personal - John MeulemansBCE24 | Virtual Brand Ambassadors: Making Brands Personal - John Meulemans
BCE24 | Virtual Brand Ambassadors: Making Brands Personal - John MeulemansBBPMedia1
 

Kürzlich hochgeladen (20)

The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003
The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003
The Vietnam Believer Newsletter_MARCH 25, 2024_EN_Vol. 003
 
Trauma Training Service for First Responders
Trauma Training Service for First RespondersTrauma Training Service for First Responders
Trauma Training Service for First Responders
 
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdfTalent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
 
Borderless Access - Global Panel book-unlock 2024
Borderless Access - Global Panel book-unlock 2024Borderless Access - Global Panel book-unlock 2024
Borderless Access - Global Panel book-unlock 2024
 
Michael Vidyakin: Introduction to PMO (UA)
Michael Vidyakin: Introduction to PMO (UA)Michael Vidyakin: Introduction to PMO (UA)
Michael Vidyakin: Introduction to PMO (UA)
 
AMAZON SELLER VIRTUAL ASSISTANT PRODUCT RESEARCH .pdf
AMAZON SELLER VIRTUAL ASSISTANT PRODUCT RESEARCH .pdfAMAZON SELLER VIRTUAL ASSISTANT PRODUCT RESEARCH .pdf
AMAZON SELLER VIRTUAL ASSISTANT PRODUCT RESEARCH .pdf
 
UNLEASHING THE POWER OF PROGRAMMATIC ADVERTISING
UNLEASHING THE POWER OF PROGRAMMATIC ADVERTISINGUNLEASHING THE POWER OF PROGRAMMATIC ADVERTISING
UNLEASHING THE POWER OF PROGRAMMATIC ADVERTISING
 
The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...
The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...
The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...
 
Building Your Personal Brand on LinkedIn - Expert Planet- 2024
 Building Your Personal Brand on LinkedIn - Expert Planet-  2024 Building Your Personal Brand on LinkedIn - Expert Planet-  2024
Building Your Personal Brand on LinkedIn - Expert Planet- 2024
 
Live-Streaming in the Music Industry Webinar
Live-Streaming in the Music Industry WebinarLive-Streaming in the Music Industry Webinar
Live-Streaming in the Music Industry Webinar
 
Investment Opportunity for Thailand's Automotive & EV Industries
Investment Opportunity for Thailand's Automotive & EV IndustriesInvestment Opportunity for Thailand's Automotive & EV Industries
Investment Opportunity for Thailand's Automotive & EV Industries
 
PDT 88 - 4 million seed - Seed - Protecto.pdf
PDT 88 - 4 million seed - Seed - Protecto.pdfPDT 88 - 4 million seed - Seed - Protecto.pdf
PDT 88 - 4 million seed - Seed - Protecto.pdf
 
To Create Your Own Wig Online To Create Your Own Wig Online
To Create Your Own Wig Online  To Create Your Own Wig OnlineTo Create Your Own Wig Online  To Create Your Own Wig Online
To Create Your Own Wig Online To Create Your Own Wig Online
 
HELENE HECKROTTE'S PROFESSIONAL PORTFOLIO.pptx
HELENE HECKROTTE'S PROFESSIONAL PORTFOLIO.pptxHELENE HECKROTTE'S PROFESSIONAL PORTFOLIO.pptx
HELENE HECKROTTE'S PROFESSIONAL PORTFOLIO.pptx
 
Scrum Events & How to run them effectively
Scrum Events & How to run them effectivelyScrum Events & How to run them effectively
Scrum Events & How to run them effectively
 
A flour, rice and Suji company in Jhang.
A flour, rice and Suji company in Jhang.A flour, rice and Suji company in Jhang.
A flour, rice and Suji company in Jhang.
 
MoneyBridge Pitch Deck - Investor Presentation
MoneyBridge Pitch Deck - Investor PresentationMoneyBridge Pitch Deck - Investor Presentation
MoneyBridge Pitch Deck - Investor Presentation
 
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
 
Borderless Access - Global Panel book-unlock 2024
Borderless Access - Global Panel book-unlock 2024Borderless Access - Global Panel book-unlock 2024
Borderless Access - Global Panel book-unlock 2024
 
BCE24 | Virtual Brand Ambassadors: Making Brands Personal - John Meulemans
BCE24 | Virtual Brand Ambassadors: Making Brands Personal - John MeulemansBCE24 | Virtual Brand Ambassadors: Making Brands Personal - John Meulemans
BCE24 | Virtual Brand Ambassadors: Making Brands Personal - John Meulemans
 

What the Future of the Pharma Industry Holds - Boris Reznik, BioRASI LLC

  • 1. What the Future of the Pharma Industry Holds Interview with: B o r i s R e z n i k , Chairman, BioRASI LLC Maximizing the probability of clinical trial success is key, as pharmaceutical companies are increasingly pressured to reduce the time and cost of clinical development, without compromising on quality, says Boris Reznik, Chairman, bioRASI LLC. A contract research organization (CRO) joining the marcus evans Evolution Summit 2013, in Palm Beach, Florida, May 8-10, as a solutions provider, bioRASI LLC’s Reznik highlights the latest trends in the industry. What trends do you see in the pharmaceutical industry globally? The growth of emerging consumer markets worldwide is prompting pharmaceutical companies to take deliberate steps for adhering to regulatory requirements of not only the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) but also other jurisdictions even if rollout to those markets is not immediately planned. For example, including Russia into pivotal trial geographies assures eligibility of the drug for future registering there. The industry is also experiencing mounting pressure to reduce overall costs of bringing new drugs to market. With clinical development being one of the most expensive components of this process, the accepted paradigm of outsourcing specialized services to CROs continues to climb. CROs are now accountable for maximizing the probability of trial success and maintaining high service levels while minimizing both the time and cost of development. This trend is causing the pharma industry to re-evaluate their exclusive relationships with multi-billion dollar CROs and in certain cases to shift alignment to small and mid-size CROs who might be better at fulfilling the entire spectrum of these requirements. Additionally, sponsors are increasingly looking to CROs to provide a scientific angle, not only in development of protocols or clinical trial designs, but also in running them with the aim of optimization. Agile CROs are responding to this challenge by augmenting their professional talent pool with MDs and PhDs trained in particular areas of specialty. Leading CROs are progressing beyond mere global presence to fully integrating their geographic capabilities, the best worldwide medical facilities, supply chain management and e-clinical technologies. Strong partnerships between pharma companies and CROs optimize the fulfillment of global regulatory requirements eliminating the necessity to duplicate trials. Another trend is associated with an increasing number of expiring blockbuster drug patents. This is opening up new areas of opportunities for pharma and biotech companies. Building upon existing successful small molecule drugs, companies are delivering to the market both generic drugs and enhanced 505(b)(2) versions. Similarly, biologics going off patent create tremendous opportunities with follow-on biologics, from biosimilars to bio-betters and soon to inter- changeables. Pharma companies are searching for CROs that have demonstrated experience in these areas to avoid pitfalls that have been known to derail biosimilar development. Not surprising, companies are eager to pursue simultaneous approvals from FDA, EMA and other jurisdictions for costly biosimilar drug developments. In the wake of this trend some CROs are emerging as experts in follow-on biologics. The concept of inter- changeability presents even greater potential; biosimilars would require a direct-to-physician sales force, which is expensive. Interchangeable biosimilars, however, can be sold directly to major distributors and pharmacy chains, because they can be substituted at those levels, providing a far more cost- e ffe c tive s trate gy f or ma rke t penetration. How can pharmaceutical companies achieve the highest probability of success? Trial success requires a close partnership between the sponsor and CRO in advance of project design. With collective focus on optimization, they can determine the relative importance to be placed on crucial trial variables. Focusing on factors as if they are independent leads to unintended consequences, for example increasing the number of patients naturally increases the trial power, but also increases costs and time. Since all program requirements are in fact interconnected, solutions must be developed with simultaneous multidimensional considerations in mind. This demands using a more scientific approach when designing studies and leads to a higher probably of success. For example, selecting precise endpoints measurements and reducing trial- induced variability provides for a study with a given number of patients having higher power, or for the same trial power but with fewer patients. This is where novel principal investigator (PI) interactive training reduces intra- and inter-rater variability. Taking that a step further, you can apply similar techniques for training study subjects to minimize inter- and intra-subject variability. These types of scientifically designed, and more importantly validated methods, are exactly what the industry leaders use. Any final comments? Billions of dollars have been needlessly wasted on trials that have failed to reach success or need to be repeated for approvals in different jurisdictions. The industry is moving toward leveraging appropriate expertise, normally associated with CROs, in the areas of trial design and conduct to increase the overall probability of success and eliminate rerunning the studies. Many billions of dollars have been wasted on trials
  • 2. The Pharma Network – marcus evans Summits group delivers peer-to-peer information on strategic matters, professional t r e n d s a n d b r e a k t h r o u g h innovations. Please note that the Summit is a closed business event and the number of participants strictly limited. About the Evolution Summit 2013 This unique forum will take place at The Ritz-Carlton, Palm Beach, Florida, May 8-10, 2013. Offering much more than any conference, exhibition or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The Summit includes presentations on improving trial performance, establishing strategic alliances, site selection and e-recruitment. www.evolutionsummit.com Contact Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division Tel: + 357 22 849 313 Email: press@marcusevanscy.com For more information please send an email to info@marcusevanscy.com All rights reserved. The above content may be republished or reproduced. Kindly inform us by sending an email to press@marcusevanscy.com About BioRASI LLC As a full service global CRO, bioRASI delivers “Clinical Research Optimized”. bioRASI provides expertise in the design and execution of large complex clinical trials, supporting Specialty, Innovative and Biopharmaceutical companies bioRASI accelerates drug development by optimally leveraging global resources and proficiency across a broad range of therapeutic indications, maximizing quality, service levels, regulatory and industry acceptance, while minimizing time and cost. www.biorasi.com About marcus evans Summits marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and one-on-one business meetings. For more information, please visit: www.marcusevans.com Upcoming Events Discovery Summit (Europe) - www.discovery-summit.com Evolution Summit (Europe) - www.evolution-summit.com To view the web version of this interview, please click here: www.evolutionsummit.com/BorisReznik