Picture of Global Clinical Trials: Preferred CRO Partnerships

Global Clinical Trials: Preferred CRO Partnerships


October 1-2, 2012
Philadelphia, PA
United States

Bookmark and Share
Untitled Document
Conference Details:
In the past 15 years, the number of new drug applications on pharmaceuticals in the United States has decreased by half, yet R&D spending has tripled. Pharmaceutical companies have resorted to outsourcing clinical research in order to contain costs.

Our conference will look at how pharmaceutical companies choose a CRO partner based upon their strategy, how sponsor/vendor partnerships have evolved to improve clinical research outcomes, how the quality of a study can be assessed and how sponsors can maintain networks in order to remain in control of the study.

More and more, clinical trials undertaken by pharmaceutical, biotech, and medical device companies are designed as international in scope, which drastically increases the number of risks, liabilities, and legal/regulatory exposures that are inherent to conducting trials. This has affected how companies collaborate with each other in order to sustain profit margins.

Opal Events is pleased to announce the Global Clinical Trials: Preferred CRO Partnerships conference this coming October, which will focus on sponsor/CRO strategic partnerships for collaborative research and development. Issues addressed will allow attendees to:
  • Explore the difference in strategy and scale of CROs
  • Look at how sponsor/vendor partnerships have evolved so that the incentives of both parties are aligned
  • Analyze how to establish networks in order to supervise the quality of the clinical study and overcome the challenges faced by sponsors and CROs
Our Distinguished Speaking Faculty Includes:
Makarand Jawadekar, PhD, Former Director, Portfolio Management and Performance, PFIZER
Stella Stergiopoulos, Senior Project Manager, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
Madhu Anant, Senior Director, Regulatory Affairs, VALEANT PHARMACEUTICALS
Mark Milberg, MCRI Global Clinical Operations Contract Management Leader, MEDTRONIC
Dave Conway, Senior Director, Clinical Operations, HALOZYME THERAPEUTICS
Some the Topics to be Covered:
  • Differentiating Vendors' Strategy: Not all CROs are Created Equal
  • Preferred Partnerships: Sponsor and Provider Perspectives on Risk Sharing
  • Full Service Provider vs Functional Integrated Sourcing Model
  • Structuring Win-Win Contracts with Aligned Incentives
  • Assessing a CRO's Value Proposition
  • Protocol Building, Proposal Processes and Bidding
  • Maintaining Networks to Supervise CRO's Onsite Performance
Who Will Attend:

This event has been researched and developed specifically for executives from Pharmaceutical Companies, Medical Device Companies and Contract Research Organizations.

The conference will also appeal to Principal investigators and Physician Groups/Practitioners.

Specifically for C-Level Executives and Vice Presidents, Directors, and Managers of:

  • Clinical Quality Assurance/QA
  • Clinical Oversight
  • Vendor Management
  • Clinical Affairs
  • Clinical Outsourcing/Contracts
  • Compliance/Global Compliance
  • Drug Safety & Risk
  • Management/Operations
  • Good Clinical Practice/GCP
  • Global QA/Compliance
  • Regulatory Affairs
  • Clinical Budgeting
  • Global Clinical Operations
  • Legal Counsel
  • R & D Operation
  • Outsourcing
  • Purchasing/Procurement
  • Strategic Sourcing
  • Network Management
  • Provider Relation
Hotel Info:
Crowne Plaza Phildelphia Hotel
1800 Market Street
Philadelphia, PA 19103

We are pleased to announce that the Opal room block is open and we are accepting reservations. Please click on the ONLINE HOTEL RESERVATION link to book your room. The hotel will not accept individual call-ins.
Online Hotel Reservations
  • Rooms are available only to those participants who are registered conference attendees.
  • Rooms will not be guaranteed without a credit card.
  • Rooms are allocated on a first come first serve basis. Room types/rates are subject to availability.
  • The name on the form will be the name of the guest room.
Conference Registration Prices:
Early Bird Rate
(Expires 8/15/12)
Standard Rate
Service Providers and CRO's
$795
$995
Pharmaceutical and Medical Device Companies, Academia, Government, Physician Groups, Hospitals, Non-Profit
First 100 free, after $495

Register Now!

Group Discounts:
Register 3 people and receive 10% off ***
Register 4 people and receive 15% off ***
Register 5 people or more and receive 20% off ***

If you'd like to be invoiced, please submit your contact details on the registration page and select "Please invoice me" at the bottom of the page.

If you are interested in sponsorship, exhibiting, or speaking opportunities, please call 212-532-9898 or email information@opalevents.org
* TERMS & CONDITIONS
Subject to approval. To qualify you must be currently employed by a non-vendor company. Eligibility will be verified by conference producer. Opal reserves the right to allocate places and to refuse applications.

***Registrations must be made online on the same date. Discount will be applied after all registrants have been received.


Registration price reflects $100 online discount
Media Partner
Bvents.com
Untitled Document
Conference Day One
7:15 am
Continental Breakfast & Registration
8:00 am
Opal Events' Opening Remarks

8:05 am
Chair's Welcome and Audience Demographics

Makarand Jawadekar, PhD, Former Director, Portfolio Management and Performance, PFIZER
8:15 am
Keynote Address
9:00 am
PREFERRED PARTNERSHIPS: SPONSOR AND PROVIDER PERSPECTIVES ON RISK SHARING
  • Evaluate the current pattern in CRO/pharma relationships - does sharing risk optimize profit?
  • How has the shift from the FSP model impacted quality and timeliness?
10:00 am
Morning Refreshment & Networking Break in the Exhibitors'Hall
Talk with your peers, enjoy some light refreshments – all while learning about new and exciting services and technologies from our exhibitors.

10:15 am
DIFFERENTIATING VENDORS' STRATEGY: NOT ALL CROs ARE CREATED EQUAL
  • Different strengths, different focus: size, structure and regulatory emphasis
  • Choosing providers with therapeutic specialties
  • Determine which strategy best complements your company's approach to bioresearch
11:00 am
SELECTING FULL SERVICE VS FUNCTIONAL OUTSOURCING
  • Identify whether you should outsource the entire process or just certain parts or the study - to the same CRO or a combination of vendors
  • Evaluate Data Management, Biostatistics, and Regulatory Writing outsourcing perspectives
Stella Stergiopoulos, Senior Project Manager, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
Solomon Babani, Vice President, Alliance Management, CELTIC THERAPEUTICS DEVELOPMENT (pending)
11:45 am
MANAGING CLINICAL TRIALS UNDER REGULATORY EXPECTATIONS
  • More than just the theory, learn what the FDA expects from a clinical study and strategies to best collaborate with the agency
  • Look at the greatest challenges faced by the FDA and by study directors
Madhu Anant, Senior Director, Regulatory Affairs, VALEANT PHARMACEUTICALS
12:30 pm
Luncheon
1:30 pm
DEVELOPING KEY METRICS FOR ASSESSING THE QUALITY OF A CLINICAL STUDY
  • How can you determine whether your vendor conducted a successful trial?
  • How can you evaluate whether a CRO performed better than you expected or if could have done better on your own or with another vendor?
  • Active discussion: What is important to you in vendor qualification and vendor oversight?
Mark Milberg, MCRI Global Clinical Operations Contract Management Leader, MEDTRONIC
2:15 pm
STRUCTURING WIN-WIN CONTRACTS WITH ALIGNED INCENTIVES

Allan M. Cohen, Esq., CPA, Director of Legal Services, CELTIC THERAPEUTICS DEVELOPMENT (pending)
3:00 pm
Afternoon Refreshment & Networking Break in the Exhibitors' Hall
3:30 pm
CENTRALIZING STUDY DESIGN AND TRANSLATION
  • Does incorporating design and translation into the budget early decrease costs in the end?
  • How having a centralized structure vs leaving translation up to end sites can affect quality of results
  • Does your collected data reflect the qualitative and quantitative variables in your study's design?
4:15 pm
COMPARING LOCAL VS GLOBAL VENDORS
  • Look at how CROs collaborate with each other internationally depending on their size and therapeutic specialty
  • Determine how these vendor partnership's impact vendor/sponsor relationships
Dave Conway, Senior Director, Clinical Operations, HALOZYME THERAPEUTICS
5:00 pm
ASSESSING A CRO's VALUE PROPOSITION
  • What can a pharmaceutical company expect from a CRO's proposal?
  • How much can a CRO promise? What is realistic?
  • How should sponsors compare vendor proposals?
6:00 pm
Day One Closing Remarks and Cocktail Reception in the Exhibitors' Hall
Conference Day Two
8:00 am
Continental Breakfast & Registration
8:45 am
Chair's Welcome & Day One Re-Cap
9:00 am
Keynote Address
9:30 am
Keynote Panel
10:15 am
MAINTAINING NETWORKS TO SUPERVISE A CRO's ONSITE PERFORMANCE
  • How a sponsor can remain in control while the CRO does the ground work
11:00 am
Refreshment & Networking Break in the Exhibitors' Hall
11:15 am
PROTOCOL BUILDING, PROPOSAL PROCESSES AND BIDDING
  • Evaluate how CRO proposals and bidding impact the cost of the study
12:00 pm
EXPANDING INTO EMERGING MARKETS – SUCCESS AND LESSONS LEARNED
  • Weighing advantages in recruiting patients and reducing costs against challenges in conducting research abroad
  • Determine how other countries' regulations impact study design and implementation, including study phases permitted
12:45 pm
Luncheon
1:00 pm
Closing Remarks and Debriefing
Service Providers and CRO's
Regular Price: $995.00
Price: $795.00
:
Pharmaceutical and Medical Device Companies, Academia, Government, Physician Groups, Hospitals, Non-Profit
First 100 Free
Regular Price: $495.00
Price: $0.00
:
Pending Registrations
No Registrations Pending
    register now
    Healthcare
    life sciences
    emerging technology
    Finance Events
    Sponsor
    Request More Information
    Join Our Mailing List