Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market)

Why Should You Attend:

The unique market positioning opportunity of a Paragraph IV Application in the US Market allows global Generic Product Manufacturers to develop useful Drug Products (even those with high barriers to entry e.g. transdermals) to offer significant value to patients prior to Branded Patent Expiration on providing a Certification of Non-Infringement and an automatic 30 month stay prior to approval.

This 60-minute webinar will help you understand the rationale for Generic Drug Product Development via an ANDA Filing and the potential added value of a Paragraph IV Application, exclusive to the US Market. The mechanism of a Paragraph IV Filing will be discussed using case studies to demonstrate the creation of value prior to Patent Expiration as a unique opportunity exclusive to the US Market.

Areas Covered in the Webinar:

• Strategic Planning for an ANDA vs Paragraph IV
• Efficient Implementation and Communication with the FDA.
• Content and Format of ANDA’s
• Plan for FDA-Sponsor Meetings
• FDA Expectations and CMC Data including Bioavailability/Bioequivalence
• Outline of Paragraph IV Applications and Case Studies

Who Will Benefit:

This topic applies to personnel/ companies in the pharma/biopharma industries. The employees who will benefit most include:

• Senior management
• Regulatory affairs
• Quality Assurance
• CMC and Clinical Development
• Documentation
• Scientists, R&D
• Product Development

Instructor Profile:

Dr. Aditya Das, is a CMC and Regulatory Consultant serving the Pharmaceutical Industry. He coordinates the interface between client needs and external services/capabilities to facilitate strategic positioning for optimal product development and Global Registration. Services provided to clients in response to specific requests include regulatory input (chemistry, manufacturing and control sections); risk analysis; cost estimates; process design; and combination (drug/device) product development. He performed similar roles at AAIPharma Services Corp, Cardinal Health (now dba Catalent Pharma Solutions) and at MDS Pharma Services. Due diligence activities include Technology Evaluation/Outlicensing and Inlicensing for Combination Products, for Mergers and Acquisitions and for Strategic Joint Venture Opportunities.

Dr. Das has been involved in biopharmaceutical product development for more than 20 years related to parenteral (pulmonary, transdermal and intravenous) and oral drug delivery therapeutic strategies-he has been directly involved in the filing of 14 IND’s and 1 CTD/NDA (for Inhaleable Insulin ("Exubera"). These efforts were directed to both single drug and combination products used for the treatment of infectious, allergic, genetic, neurological and metabolic diseases. As a senior scientist at Alexza MDC, Dr. Das was involved in the design and development of a novel thermal aerosol inhaler including all aspects of design control implementation; coordination of IND filings (CMC sections); product selection analysis; in-vitro toxicology screening assays; pulmonary delivery space opportunities; intellectual property line extensions; and examination of disease areas suited to rapid onset therapeutics. Alexza's ADASUVE® (loxapine) Inhalation Powder for the Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I Disorder in Adults was approved in Dec 2012.

Dr. Das earned his Ph.D. in chemical engineering at West Virginia University and the National Institute for Occupational Safety and Health where he studied the effects of inhaleable inorganic dusts and the associated etiology of silicosis. He earned an M.S. degree in chemical engineering from Carnegie Mellon University and a B.S. degree in chemical engineering from the University of New Hampshire. Dr. Das also earned an MBA (Strategy) degree from the University of California at Irvine. Dr. Das is the holder of five (5) US patents and author of 11 peer-reviewed publications.

Topic Background:

Generic Drug Development has direct effects on cost reductions and the importation of medicines as required due to supply shortages and is a growing trend in the US Market (and globally) where a number of Branded Pharmaceutical Companies under revenue pressures are seeking to establish Authorized Generics.

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