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Study Group: Generic Pharmaceuticals Regulation Experts: Healthcare Consultants

Council Members in this Study Group: 45

This study group may include physicians, care providers, and researchers specializing in internal medicine, cardiology, oncology, dermatology, emergency medicine, family medicine, neurology, obstetrics-gynecology, psychiatry, radiology, nursing, optometry, genetics, and mental health. It may also include experts knowledgeable on diagnostic labs, disease management, medical devices, long term care, surgery centers, health management, pharma, and biotechnology, among others.

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Leading Experts in this Study Group

Eric Gruff, Principal, E4 ConsultingEric Gruff

Principal
E4 Consulting
What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Eric Gruff, PhD, MBA, BS, is Founder of E4 Consulting, which specializes in pharmaceutical development, regulatory affairs, and project and portfolio management. Dr. Gruff has over 17 years of experience in the pharmaceutical and biotech sector, including...

Evan Siegel

Adjunct Professor
THE UNIVERSITY OF QUEENSLAND
What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Evan Siegel, M Phil, Ph D, is the President and Chief Executive Officer of Ground Zero Pharmaceuticals, a regulatory affairs and product development consulting firm in California, since June 1999. Dr. Siegel is also an Adjunct Professor at the University...

David Zimmerman, President/Owner, Doctors of Pharmacy, Inc.David Zimmerman

President/Owner
Doctors of Pharmacy, Inc.
What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

David Zimmerman, PharmD, FASCP, is the President and an Independent Consultant of Doctors of Pharmacy. Dr. Zimmerman formerly served as the Director of Clinical Affairs at Employee Health Insurance Management, a pharmacy benefit manager. He has over 30...

Michael Sosnowik

President
MSS Consultants, LLC
What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Michael Sosnowik, PD, Pharmacist and former C-Level executive in pharma distribution, is the President of MSS Consultants, an independent consulting firm to pharmaceutical manufacturers, distributors as well as managed care providers, in New York, since...

Jim Farley, President, Cardinal Consulting and TrainingJim Farley

President
Cardinal Consulting and Training
What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Jim Farley is an Independent Consultant and Owner of Cardinal Consulting and Training. Formerly, Mr. Farley served as the Director of the Science Branch of Philadelphia District FDA. He has over 30 years of experience in pharmaceutical and pharmaceutical...

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GLG NewsSM Analyses by this Study Group's Leading Experts(?)

Opinions and analyses expressed in GLG News are solely those of the author. See the Terms of Use for details.

Thriving in a time of adversity - Sun Pharma pounces on shortage by getting approval on Oxycodone

April 13, 2009

Sun Pharma gets USFDA's nod to market painkillers | www.hindu.com

Sun Pharma can greatly benefit from the nationwide shortage of Oxycodone Immediate Release Tablet, by getting approval from the FDA on their own generic. With recent recalls from different manufacturers, and the shortage of a comparable product Morphine Sulphate, the FDA currently estimates that return to normal supply levels of Oxycodone may occur in approximately 2 months, during which time Sun Pharma can capitalize on the shortage by securing longer term contracts with wholesalers.

Aurobindo Pharma's Escitalopram will be a big mover ... when it comes out in 2011

March 5, 2009

Aurobindo Pharma receives tentative approval for Escitalopram | www.indiainfoline.com

Forest's Lexapro commands a $2.5+ billion USD market share, just in the US.  Due to such a high volume of the brand product, Aurobindo's tentative approval on Lexapro's generic Escitalopram will be a great opportunity - primarily if they can procure a 6 month period of exclusivity from the FDA.  Additionally, despite being a brand name product, Lexapro holds an 8%+ year over year increase in the past 3 years.  Hence, the market for the drug in September of 2011 when the patent runs out will be closer to a $3 billion market.                

Teva's Generic Imitrex commands market of Sumatriptan

February 26, 2009

Teva Announces Approval and Launch of Generic Imitrex(R) Tablets | www.pipelinereview.com

With the 180 day exclusivity, Teva is already commanding the market of the generic Imitrex - Sumatriptan oral tablets.  Teva maintains an AB rating of the generic that will render most insurance companies to push brand name Imitrex by GlaxoSmithKline to a non-formulary tier, skyrocketing the generic's sales.  Already, different wholesalers are reporting a backorder on Teva's generics.  Additionally, Teva's pricing point is very favorable to itself, despite Dr Reddy's prior entrance.

Acquisitions of Indian Pharma on the extended horizon by Brand name pharma

February 23, 2009

Pharma cos on lookout for Indian drug firms | economictimes.indiatimes.com

Acquisitions of various Indian generic pharmaceuticals is likely on the horizon for brand name manufacturers.  However, this is not an immediate concern.  I would see more consolidations in the US and other Western markets first. 

Sun Pharma - much stronger with acquisitions including Taro

February 17, 2009

As valuations dip, Sun Pharma is in M&A mode | economictimes.indiatimes.com

Sun Pharma is attempting to gain market share in the world largest market - the US market.  Sun Pharma is clearly expanding it product base with venturing into topical (dermatological) and pediatric segments, and with vertical integration as with raw materials suppliers.  Sequentially, I would see SunPharma to be a leader in the US market within this decade, unless other Indian manufacturers encroach in this market.                     

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Members in this Study Group include these company types:

  • Consultancy, Pharma-Focused
  • Individual/Small Consultancy
  • Consultancy, Healthcare-Focused
  • Academic Institution*
  • Pharmaceuticals Manufacturer
  • Healthcare Management

Members in this Study Group often have these job titles:

  • President
  • Consultant
  • Owner
  • Principal
  • Professor
  • Managing Director
  • Director
  • Chief Executive Officer

GLG Live Meetings with this Study Group's Leading Experts (?)

October 26, 2006 | Palo Alto

GLGi: New Drug Application Process

GLG Webcasts & Teleconferences

Leading Experts in Generic Pharmaceuticals Regulation Experts: Healthcare Consultants have not participated in any GLG webcasts.

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