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Atlantic Bio Sci, LLC

A biotechnology company

Presenter: Sandra Saouaf, PhD, Founder and President

 

Monday, February 10, 2014

Embassy Suites, Chesterbrook, Pennsylvania (directions)

 

About

 

Atlantic Bio Sci is a biotechnology company dedicated to developing therapeutics to fulfill unmet medical needs in autoimmune disease. The company's lead compound, ABS11, is a small molecule in mid-late stage of preclinical development as an oral therapeutic for autoimmune diseases including type 1 diabetes, rheumatoid arthritis, juvenile rheumatoid arthritis, psoriasis, multiple sclerosis, systemic lupus erythematosus, Sjôgren's syndrome and inflammatory bowel diseases including Crohn's disease and ulcerative colitis. These serious chronic autoimmune diseases lack sufficient treatment options.

 

Twenty to fifty million people in the US and 8-20% of the world population suffer from autoimmune disease. No disease modifying drugs are FDA approved for type 1 diabetes or primary progressive multiple sclerosis. Current treatments for rheumatoid arthritis, psoriasis, lupus and inflammatory bowel diseases are expensive biologic therapeutics with significant undesirable side effects that must be administered by injection. These therapeutics include Humira (Abbott), Orencia (BMS), Enbrel (Pfizer, Amgen), and Remicade (J&J). Effective oral therapeutics are highly sought by autoimmune disease patients and by the pharmaceutical industry as evidenced by Abbott Labs recent $1.35B investment in Galapagos' promising early stage oral compound targeting rheumatoid arthritis.

 

The company is a Delaware LLC founded September 5, 2012. The founder and president of Atlantic Bio Sci is Sandra J. Saouaf, PhD, an immunologist and entrepreneur. The vice president of intellectual property and head of chemical development is Roxanne Spencer, PhD, a registered US patent agent and organic chemist. Advisory board members include Mark I. Greene, MD, PhD, FRCP; John Eckman, Professor of Medical Science, Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, PA with others to be added.

 

Preclinical studies of the ABS11 compound active ingredient have been completed in an animal model of rheumatoid arthritis. Disease severity was decreased by over 90% in animals treated with the compound. The mechanism of action of the compound has been conclusively determined. Additional preclinical studies have been performed in animal studies of type 1 diabetes and multiple sclerosis with similar results obtained. Toxicology testing revealed no issues with the compound active ingredient. An accelerated FDA approval process is anticipated for the ABS11 compound.

 

 

 

3 Major Issues

 

  1. When partnering with a pharmaceutical company during the preclinical stage or licensing intellectual property to pharma during the preclinical stage, are there adequate protections that can be put in place to ensure timely development of the compound by the pharma company for the clinical indication? Are these protections effective in practice?   Does partnering with pharma at a later stage of development provide better protection to ensure timely development of the compound by pharma for the clinical indication?
  2. Other than financial, what are the pros and cons of developing an oral therapeutic using NIH resources versus using private equity sources or a pharmaceutical strategic relationship? Consider this question for both the preclinical and clinical stages of development.
  3. What number of patients would FDA require in a phase I/II clinical study in a rare disease indication with a total of 30,000 patients affected by the disease?  Similarly, the number of patients for a phase III study?  What is the cost estimate for this phase I/II study and for the phase III study? 

 

Program:

 

6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)

8:00 - Sandra Saouaf, PhD, Founder and President, will deliver the Company's "Elevator"
Pitch to the Group

8:20 - A Panel will address 3 Major Issues for the Company

9:00 - Open discussion: members and guests

 

 

Available Media

Please note: All information obtained here is the property of those presenting and should not be copied or duplicated without written consent.

 

Slides

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Audio

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Video

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Webcast

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Contact Info:

 

 

 

Our Sponsors

EisnerAmperIdeas x Innovation Network i2nNew Jersey Institute of TechnologyScience Center

 

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Questions or Coments?

Contact: Peter van der Kam,

peter@rxpcci.com | (610) 296-8086

 

 

 

Good Company! Good Drink! Good Food! Good Program! Good Fun!

 

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Meetings Held at Embassy Suites - Valley Forge

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