Main Conference Day 1: Tuesday, September 28, 2010

7:45 Registration & Coffee

8:35 Chairperson’s Welcome & Opening Remarks

8:45 Opening Keynote: Creating A Diversified Anti- Infective Drug Portfolio That Includes Antiviral Therapeutics

The global market for anti-infective drugs, is steadily growing and projected to increase by over 50% by the year 2015, to total US$100 billion. Manufacturers have shifted aim, launching Research and Development programs combating drug-resistant pathogens, a major driver of new market opportunities. Some of the initial draws to competing in the anti-fungal and anti-bacterial space are diminished due to an ever increasing generic drug opportunity and comparatively shorter treatment regimens. However, antiviral therapeutics such as MedImmune’s Synagis have produced significant gains in recent years ($1.1 Billion in 2009), and the market continues to carry expanding populations with chronic infections who are looking for innovative alternatives. The continually evolving market needs are producing significant opportunities for commercialization of new, better solutions. Topics to be discussed include:

  • Segmenting the market to determine the most effective launch plan
  • Regulatory hurdles to expect
  • Leveraging Key Opinion Leaders
  • Post-Market surveillance

George Kemble, PhD
Vice President, Research & Development
MedImmune

9:30 New Ways To Address A Growing Resistance Problem

In 2009 we saw an increase in reported cases of resistance against neuraminidase inhibitors such as Tamiflu and Peramivir. This attention to a growing problem has left doctors and patients asking the question of what might be available in upcoming flu seasons to address the H1N1 virus. Fludase (DAS181) is an innovative, recombinant drug in development for the treatment and prevention of influenza. There are currently several potential solutions in the pipeline. Topics to be discussed include:

  • The rise of resistance
  • Host-targeted vs. pathogen-targeted drugs, and the potential implication for resistance
  • New drug candidates to be aware of

David Wurtman, MD, MBA
Vice President, Corporate Development, NexBio
Incorporated

10:15 Morning Networking And Refreshment Break

11:00 Biologically Inspired Technology

Small molecule compounds and polymers that mimic the activity of proteins are being tested for use in various capacities. Biomimetic pipeline candidates in Phase 2 clinical trials include a broad spectrum antibiotic, PMX-30063. Current programs will be followed by other candidates directed at uniquely treating serious medical conditions. Topics to be discussed include:

  • Explanation of the technology and application possibilities
  • Current outcomes data for PMX-30063
  • Future disease targets to ponder

Bozena Korczak
Vice President, Drug Development
Polymedix Incorporated

11:45 Nanotechnology On A Commercial Scale

NanoViricides is using nanoscale materials and processes licensed from TheraCour Pharma, Inc. The company’s novel class of drug candidates is designed to specifically attack enveloped virus particles and dismantle them. Applications include treatment for H5N1 bird flu, seasonal influenza, HIV, Epidemic Kerato-Conjunctivitis, hepatitis C, rabies, dengue fever, and Ebola virus. Topics to be discussed include:

  • Nanotechnology applications
  • Current outcomes data
  • How nanoscale pays big dividends in regard to outcomes

Dr. Randy Barton
Chief Scientific Officer
NanoViricides Incorporated

12:30 Networking Luncheon

1:30 Case Study: A New Class Of Antiviral Agent Against An Elusive Virus

Hepatitis C is on the list of NIAID emerging and re-emerging diseases under the category of “Group I Pathogen,” newly recognized in the past two decades. Several companies specialize in the development of both traditional and novel therapeutics for the treatment of Hepatitis C (HCV). Some firms are focused on the use of nucleic acid therapeutics, with initial trial results of great promise. A novel approach to antiviral drug discovery introduces us to SB 9200, a new class of antiviral agent for the treatment of Hepatitis C. Topics to be discussed include:

  • Reasons to center focus and funding on Hepatitis C
  • Mechanism of action for new therapies
  • Predictions for the future

Radhakrishnan P. Iyer, PhD
Chief Scientific Officer
Spring Bank Pharmaceuticals

2:00 A Focus On “Exotic” Threats: Viral Hemorrhagic Fevers

Viral hemorrhagic fevers are a diverse group of animal and human illnesses caused by five individual families of RNA viruses. These viruses have bioterrorism potential, and thus there is need for development efforts beyond treatment of naturally occurring infections. U.S. Government agencies have centered attention on the development of solutions regarding bioterrorist threats surrounding viral hemorrhagic fevers. Topics to be discussed include:

  • The spectrum of viral hemorrhagic fevers
  • State-of-the-art treatments
  • The future of government investment in biosecurity

Gene Olinger
Scientist
Army Medical Research Institute of Infectious Diseases

2:45 Afternoon Networking And Refreshment Break

3:30 Case Study: Viral Encephalitides Touch A Market Nerve

Outbreaks of encephalitis have populated the news throughout the past several years. In fact, detection of disease in encephalitis carriers has initiated aggressive spring and summer mosquito control programs in many parts of the United States. Articles on viral encephalitides have been noted by major publishing houses as some of the “hottest articles” in the pharmaceutical science space for good reason. As a result of all of this excitement, companies such as Genomed have been studying viral infection and developing therapeutic solutions to treat encephalitis for over a decade. Topics to be discussed include:

  • Understanding the issues
  • Regional trends in human cases to be aware of—opportunities await
  • Pain points for the future

Dr. David Moskowitz
President, Chief Executive Officer
Genomed Incorporated

4:15 Cytomegalovirus: Risks For A Successful Transplant

Cytomegalovirus (CMV) is among the most important infectious causes of significant morbidity and mortality in transplant patients. Approximately 60 percent of all at-risk allogeneic stem cell (bone marrow) transplant patients will show evidence of CMV infection in the first 100 days post transplant. Potent and selective, antiviral drugs are in development, with a unique mechanisms of action. Topics to be discussed include:

  • New classes of drugs
  • Trial outcomes
  • Next Steps

Prof. Helga Rübsamen-Schaeff
Chief Executive Officer
AiCuris GmbH & Co. KG

5:00 Multi-Drug Resistance As A Driver In The Development Of New Drugs

The development of drug resistance limits the effectiveness of many anti-infectives. The changing face of the disease, emergence of more resistant strains and changes in patterns of infection all add to the risks assumed by a pharmaceutical company investing in the development of an antiviral therapeutic. Managing risks is an important part of survival in heavily competitive spaces. Only the fit firms with compelling cases for drug effectiveness survive. Topics to be discussed include:

  • Major patterns of drug resistance
  • Risks associated with multi-drug resistant pathogens
  • Techniques used to maximize effectiveness of therapeutics against resistance

Ursula Theuretzbacher
President
Center for Anti-Infective Agents and Biotechnology

5:45 End Of Conference Day 2