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The Development of Live Biotherapeutics

Sep 24 2013 8:30AM - Sep 24 2013 5:00PM | Hilton Washington DC 1750 Rockville Pike, Rockville, MD 20852 USA

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Overview 

Opportunities and Challenges in the Development of Live Biotherapeutics

A Live Biotherapeutic is a biological product that:

  1. contains live microorganisms, such as bacteria or yeast, that are naturally occurring, recombinant, or clonally selected;
  2. is applicable to the prevention, treatment, or cure of a disease or condition of human beings; and
  3. is not an immunogen-specific vaccine. 

While often sharing common origins with probiotics, Live Biotherapeutics are distinct in that they are products developed as therapeutic agents with defined clinical benefit claims.  As the characterization of the human microbiome and its link to human health has become better understood, the use of Live Biotherapeutic products in clinical application has shown great promise for reducing infection, stimulating innate immune responses, and modulating gastrointestinal metabolism.

A better understanding of the unique challenges of this therapeutic class will enable more translational research to move forward into new therapeutics. 

Who Should Attend 

  • Translational clinicians involved in utilizing probiotics for clinical applications
  • Regulators and product developers interested in clarifying regulatory requirements for Live Biotherapeutics
  • Sponsors considering the development of commercial Live Biotherapeutics

Learning Objectives 

At the conclusion of this meeting, participants should be able to:

  • Identify the key considerations for turning clinical research into therapeutic potential
  • Discuss the attributes of Live Biotherapeutics that are unique in the development of biological products
  • Formulate a list of priority topics and action plans further evaluation

Special Offers 

MEMBERS SAVE $100
EARLY BIRD REGISTRATION ENDS 9/3

GROUP DISCOUNT AVAILABLE!
BUY 3 AND GET 1 FREE!!!

Hotel & Travel 

The conference will be held at the Hilton Washington D.C./Rockville
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until Monday, August 26, 2013, or until room block is filled). Attendees can call +1.212.532.1660 or in the USA at 1.800.221.3531 for reservations. When calling, please select option 1 for “Hotel Reservations," inform the phone agent that it is a DIA event, and provide them with the date and title of the meeting. Please Note: In order to receive the reduced room rate, hotel reservations must be made as noted above and not directly with the hotel.


Standard Room Rate $224

Hotel Address: 1750 Rockville Pike, Rockville, MD 20852

The most convenient airport is Washington Dulles International Airport – IAD or Ronald Reagan Washington National Airport - DCA and attendees should make both airline and hotel reservations as early as possible.

Contact Information 

Registration Questions
Marilyn Ginsberg, Customer Service Associate
Phone +1.215.442.6135
Fax +1-215.442.6199
Marilyn.Ginsberg@diahome.org

Agenda and Event Details
Melissa Matta, Content Lead
Phone +1.215.442.6158
Fax +1 215.442.6199
Melissa.Matta@diahome.org

Event Logistics
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1-215.442.6199
Ellen.Diegel@diahome.org

Program Committee 

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Agenda  

Day 1 Tuesday, September 24, 2013

  • 8:30AM - 8:45AM

    Welcome and Opening Remarks

    Speaker(s):

    • Norman W. Baylor, PhD
      President and CEO
      Biologics Consulting Group, Inc., United States
  • 8:45AM - 9:45AM

    Translational Research of Live Biotherapeutics


    Session Chair(s):

    • Ryan Ranallo, PhD
      Program Officer, Enteric & Hepatic Diseases Branch
      NIH, United States

    The advances of next generation sequencing have broadened our understanding of microbial ecology and the host-microbe relationship. This combined with the rapid accessibility of bioinformatic and omics based tools is providing a new opportunity to design novel live biotherapeutic (LBP) applications to predict and manipulate microbial community structure and function so as to promote a healthy microbial ecosystem at the level of a single organism, community or the larger host-microbe interface. The improved probability of success with LBP applications requires the integration of genomic standards, translatability of bioinformatic pipelines, and the acceleration of lead optimization processes. This will translate into safer and more effective clinical applications for the prevention and treatment of disease.

    Speaker(s):

    • Commensal, Pathogen Definitions & Human Microbiome
      Speaker Invited
      United States
    • Products Based on Food, Food Additives, and Dietary Supplements
      FDA Speaker Invited
      United States
  • 10:15AM - 11:15AM

    Translational Research of Live Biotherapeutics (continued)


    Session Chair(s):

    • Ryan Ranallo, PhD
      Program Officer, Enteric & Hepatic Diseases Branch
      NIH, United States

    The advances of next generation sequencing have broadened our understanding of microbial ecology and the host-microbe relationship. This combined with the rapid accessibility of bioinformatic and omics based tools is providing a new opportunity to design novel live biotherapeutic (LBP) applications to predict and manipulate microbial community structure and function so as to promote a healthy microbial ecosystem at the level of a single organism, community or the larger host-microbe interface. The improved probability of success with LBP applications requires the integration of genomic standards, translatability of bioinformatic pipelines, and the acceleration of lead optimization processes. This will translate into safer and more effective clinical applications for the prevention and treatment of disease.

    Speaker(s):

    • Preclinical Safety/Risk Assessment
      David Pepperl, PhD
      Senior Consultant
      Biologics Consulting Group, Inc., United States
    • Panel Discussion
      Panelist Invited
      United States
  • 11:15AM - 12:05PM

    Product Definition and Characterization


    Session Chair(s):

    • Ann Sutton, MPH
      Senior Consultant
      The Biologics Consulting Group Inc., United States

    Selection of strains to be included in an LBT should consider source histories to support safety assessment. Establishing methods for strain-specific identity testing will support product control and clinical development. Final identity and potency testing as viable count for products that consist of 2 or more strains may pose challenges. Assurance of purity requires sensitive in-process control and release testing for detection of extraneous contaminants.

    Speaker(s):

    • Strain Selection for Product Design
      Industry Speaker Invited
      United States
    • Manufacturing Issues in Working with Live Products
      John Aunins
      Executive Vice President, CMC
      Ventures/Seres Health, United States
  • 1:05PM - 2:15PM

    Product Definition and Characterization (continued)


    Session Chair(s):

    • Ann Sutton, MPH
      Senior Consultant
      The Biologics Consulting Group Inc., United States

    Product Definition and Characterization (continued)

    Speaker(s):

    • Quality Control for Potency and Purity
      Marian McKee
      Principal Scientist, Development Services/Microbiology Biologics Testing
      BioReliance, United States
    • Chemistry, Manufacturing and Controls (CMC) Expectations for Phase I
      FDA Speaker Invited
      United States
    • Panel Discussion
      Panelist Invited
      United States
  • 2:45PM - 4:45PM

    Planning for Regulatory and Commercial Success


    Session Chair(s):

    • Julienne M. Vaillancourt, MPH,RPh
      Sr. Regulatory Reviewer/Project Mgr., Div. of Vaccines & Related Prod. Appln.
      CBER FDA, United States
    • Trent A. Carrier
      Chief Business Officer
      Biologics Consulting Group, Inc, United States

    To foster regulatory and market success, clinical development of a live biotherapeutic (LBP) should focus on demonstrating safety and efficacy in the intended population for use while adhering to principles of good clinical practice (GCP) and human subject protection (HSP). Clinical trials to evaluate LBPs will vary in design, depending on the product, phase of development, and proposed indication. Clinical strategy should be outlined early in product development based on interactions with clinicians, feedback from the FDA and an understanding of key commercial factors.

    Speaker(s):

    • Clinical Trial Design: A Regulatory Perspective
      FDA Speaker Invited
      United States
    • Case Study: Results of LBP Phase 1 Studies in Healthy Adults
      Speaker Invited
      United States
    • Key Factors for Market Success
      Speaker Invited
      United States
    • Panel Discussion
      Panelist Invited
      United States
  • 4:45PM - 5:00PM

    Closing Remarks

Registration Fees 

Member

Member Government Individual
$300.00
Charitable Nonprofit/Academia Member Individual
$415.00
Member Individual
$725.00
Member Individual (As of 09/04/2013)
$825.00

Non-Member

NonMember Government Individual
$475.00
Charitable Nonprofit/Academia Nonmember Individual
$590.00
NonMember Individual
$1000.00
Group Discounts

Printable Registration Form

Group Discount

Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions.

To take advantage of this offer, please make a copy of the registration form for EACH of the four registrants and include the names of all other group registrants in the Group Discount section. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.

Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia.


Register Online

CANCELLATION POLICY: All cancellations must be received in writing two weeks before
the start of the event. Administrative fee that will be withheld from refund amount:

  • Member or Nonmember = $200
  • Government or Academia or Nonprofit (Member or Nonmember) = $100
  • Tutorial (if applicable) = $50

Cancellations must be in writing and be received two weeks before the start of the event. Registrants who do not cancel two weeks before the start of the event and do not attend the event will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel and airline reservations. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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