FDASmart 60-Minute Webinars on Pharmaceutical
Emerging Regions Series:
     
A Former US FDA CMC Reviewer’s Perspective -
“Creating & Maintaining a cGMP Mindset in Today’s Global Pharmaceutical Industry”		   “Global Barriers and Opportunities for Bio-Manufacturing Outsourcing in Asia: Are China & India Ready?”
   
cGMP Date: January 14th-2011

Time: 11am EST

Cost: $ 459
Date: January 25th-2011

Time: 11am EST

Cost: Early Bird Rates-$ 399
Early bird Webinar EARLY BIRD PRICING at only $ 399.00 Ends Friday January 14th-2011, $ 459.00 thereafter!
Speaker: Speakers:
Tim Anderson - AquaMarine Group (former US FDA CMC Chemist/Reviewer– CDER)  Eric Chojnicki- Senior Director-SmartAnalyst (US)
  Hareesh CP - Head GBD- Lupin Limited (INDIA) 
   
On January 14th-2011 at 11am EST – on a 60-minute webinar with FDASmart Inc ,  listen to Tim Anderson  teach you just how to ACQUIRE AND BALANCE a cGMP mindset without overkill!

 On January 25th-2010 at 11am EST – come listen to two experts who will shed more light on the global challenges and opportunities to outsourcing biomanufacturing in Asia from two very different “looking-glass”, i.e. West and East ! 
   
Webinar Topic/Description: Webinar Topic/Description:
   
cGMP (Current Good Manufacturing Practice) is a set of guidelines from the US FDA and serves as the corner stone for assuring good manufacturing practice and quality assurance which is considered the best model emulated globally in the pharmaceutical industry.

We can all parrot out CFR 211 subsections and understand in varying degrees what is involved with an effective quality assurance and how to plan for its successful implementation but that is no longer enough.  

Imagine that the US FDA is standing right next to you at your manufacturing site, do you  feel:
  • Fear ?
  • Contempt?
  • Respect?
  • Ambivalence?

The answer you pick from above depends on the cGMP MINDSET at your company !

What is the cGMP Mindset?

Simple –it’s an ATTITUDE coupled with best practices which NOT ONLY ALLOWS you to follow your interpretation of the CFR 211 guidelines with your manufacturing processes but one that TRANSFORMS your organization such that cGMP becomes second nature to all-in other words—your staff “lives” and “breathes” cGMP every chance it gets.

How do you ACQUIRE AND BALANCE a cGMP mindset ?

Why bother? 


• SETTING THE TONE OF THE QUALITY ASSURANCE and even an FDA Audit BEGINS WITH YOU

• CONFIDENCE IN YOUR OPERATIONS and PROCESSES FORMS THE BASIS for a “We can handle anything that comes up” attitude

• Acquiring a cGMP mindset allows you to project TRANSPARENCY to the US FDA with confidence

• Maintaining a cGMP mindset allows you to create and maintain an envrironment where the is ZERO TOLERANCE for “SURPRISES”
A new era in the pharmaceutical industry has set in !


It’s no surprise that the pharmaceutical industry is not only becoming more global
BUT that the center of gravity is shifting towards Asia led by China and India & other emerging regions. India and China currently account for approximately 40-49% of the production of the g lobal API supply, but this will increase in the next 10 to 15 years to a staggering 80%!
 
For better or for worse, Western pharmaceutical companies can no longer afford to TRUST that cGMP standards practiced by your emerging regions API sourced vendors & outsourced manufacturing partners will suffice.
 
It’s one thing to know that they can do the job—the questions that goes begging is:
Will they do the job?
 

Mandating complete documentation of processes is one thing—making sure SOPS are  being practiced is another. Making sure  that cGMP is being practiced  at the right time in the right places demands the cGMP  mindset.


Tim Anderson is a CMC expert who   served with  the US Food and Drug Administration (US FDA), CDER  as a Review Chemist in 1992. In this capacity Tim  reviewed and granted approvals for Chemistry and Manufacturing Controls (CMC) submissions (ANDAs) at the Office of Generic Drugs.  

Tim has developed a set of  discipline and check-list to assist  you  with  CREATING AND MAINTIANING  a  cGMP mindset that only a former US FDA insider can.
 
On this 60 minute webinar you will learn:
▪ Two things  that you and your management should know regarding your SOPs

▪  How to conduct a self-assessment as your starting ground

▪  The four missions in your path to ACQUIRING AND MAINTAINING a BALANCED cGMP

▪ Knowing when to “TURN it ON ” or “TURN it OFF ”
( you do not want to go overboard!), i.e.  learn how to “adjust the aperture” so that you know exactly when to NARROW THE FOCUS or WHEN  TO TAKE ON THE BROADER VIEW
 
Speakers Background:
 
Tim Anderson: - AquaMarine Group (former US FDA CMC  Chemist/Reviewer– CDER)

Tim Anderson has 28 years in the pharmaceutical/consumer products industries.  He  brings diversified academic and scientific credentials: 

▪8 years in formulary and analytical R&D,
▪8 years in pharmaceutical Quality Control/Quality Assurance,

▪18+ years in pharmaceutical Regulatory Affairs, the latter which embodies tenure at FDA as a Review Chemist

▪Post-FDA – Tim held various positions include serving as division Vice-President, Regulatory Affairs (Creighton Pharmaceuticals, Sandoz).

▪The AquaMarine Group, Inc.  formed by Tim brings seasoned, diversified skills sets to client projects, reducing overall costs of pharmaceutical and consumer sector regulatory compliance: maintaining/improving the client's profit margin, while remaining comfortably within expectations of global regulatory health authorities
Cost: $ 459 per person
More than 100 biotechnology drugs have been approved since 1997 and  TODAY, at least seven of the top biotechnology drugs bring in more than US $1 billion annually.

Biomanufacturing is a complex, labor-intensive, highly sophisticated & expensive process - hence outsourcing biomanufacturing poses even more challenges to the industry.

The contract biomanufacturing market is expected to continue its growth at an annual rate of 10-15% until at least 2011. The proportion of biologics in new drug approvals has risen by over 30% during the last decade, and with the current pipeline containing more than 500 protein and 150 peptide developmental drugs, this trend is set to continue.

Globalization in the biopharma sector could effectively shift once again the manufacture of biopharmaceuticals and jobs overseas, so companies will need to plan strategies to address outsourcing to foreign countries. Time and language differences, long travel distances, variations in experience level, conflicts regarding intellectual property and process compatibility issues are major barriers to overcome before manufacturing jobs move overseas. In the preclinical and early clinical phases,  it is believed that companies are reluctant to move overseas due to the evolving nature of the manufacturing process, and the benefits of being closer to where the development is occurring.

Biologic-based drugs are increasingly part of the product-development strategies of pharmaceutical companies. The very nature of biologics such as monoclonal antibodies (mAbs), recombinant proteins, or vaccines require specialized manufacturing conditions compared with the chemical synthesis of small molecules.

Biosimilar regulatory pathways are more complex, will not be as well defined as small molecules and generics-we all agree.  Will the same drivers for outsourcing manufacturing of small molecule pharmaceuticals & APIs  to China and India be the SAME drivers that will dominate  biomanufacturing biosimilars for example?

Many experts anticipate that Biomanufacturing outsourcing  to Asia  today will mostly  magnify  the  outsourcing challenges and gain little beyond cheaper labor or manufacturing costs?

Why?
Bio-manufacturing
 
On this 60 minute webinar you will learn:
» How drivers for outsourcing manufacturing in Asia of small molecule APIs/Generics and Ethical Drugs are DIFFERENT from drivers for Biopharma manufacturing outsourcing

» Why the same robust growth has still not occurred for bio-manufacturing in Asia (India/China)

» Discover initiatives underway in Asia (India/China) that will help address challenges and create even better opportunities for biopharma  manufacturing outsourcing in Asia

» Business, Legal, Regulatory & scientific challenges to outsourcing biopharma manufacturing in India/China

» Hear examples of successful cases where Western biopharma manufacturing outsourced to India actually worked  & why !

» Strategies for biopharmaceutical outsourcing you can use without making same costly mistakes in India & China
 
Speakers Background:
 
Dr.
Dr. Eric Chojnicki –Senior Director-Life Sciences –New York (US)

In his current position, Dr. Chojnicki ‘s main responsibilities are to provide leadership on SmartAnalyst’s projects to assist Western pharma clients in the formulation of development strategies and strategic decision analysis including for emerging regions.
He also assists with the development of project scope requirements for SmartAnalyst’s client.

SmartAnalyst is a global consulting company that empowers clients in Life Science and Consumer Healthcare to make successful business decisions. The company has headquarters in New York with offices in London and Gurgaon (New Delhi), India.

Prior to joining SmartAnalyst Dr. Chojnicki was the Director of Project Management at Progenics Pharmaceuticals. During his 20 year career he has held line-management and cross-functional management positions at companies such as Tanox (Genentech), Bristol-Myers Squibb, Amgen, Inc. and others.

Most recently he was actively involved in the development of two monoclonal antibody HIV entry inhibitors (CCR5 and CD4 targeted) and has lead development efforts for small molecules, protein based, peptide, live cell, gene based therapeutics and vaccines. Dr. Chojnicki holds a PMP certification from the Project Management Institute and certification as a Six Sigma Black Belt form Villanova University
 
Haresh
Hareesh CP – Head- Global Business Development-Lupin Limited- Biotechnology Division –Pune (India)

Hareesh CP’s current role at Lupin is to Head up the Global Business Development & Licensing activites at a global level and he is part of the startegic team that guides investements in technologies, products and investments within the Biotech space.
• In his current capacity, he is involved with:
 In-licensing of cutting edge technologies for recombinant proteins and monoclonal anti bodies

• Monitoring & evaluating the biopharmaceutical markets for potential
co-development novel projects with promising potential

Prior to joining Lupin, Hareesh CP  headed up the global development of the CRAMS business at Intas Biopharmaceuticals Ltd. (IBPL). 

At Intas-Hareesh CP was actively engaged with:

• India’s first EU Approved EU GMP certified plant for Biologics manufacturing

• Working  on evaluating partners for early stage active pipeline of recombinants and partnering subsequently with companies on process development, scale up and manufacture.
  • Successfully winning  two full development projects (both novels, from clone to
clinical manufacture) from Western clients -1 EU and 1 US and about closing the 3rd

Hareesh CP has more than 11 years of experience in the Asian biotech industry. Hareesh CP started his career with Astra Zeneca as a product manager followed by Cadila Pharmaceuticals as Business Development Manager from 1998 to 2004.

  At Zenotech Laboratories Ltd (Acquired by Ranbaxy), Hareesh CP handled Business Development- CRAMS. Hareesh CP successfully developed International business from North America, Latin America, Central America, South Africa, central Europe and Eastern Europe in the Biotech industry.

He attended at the Government College of Pharmacy – Bangalore and earned his MBA from IES, Mumbai.
   
  Who Should Attend?
   
 

VPs,  Heads & Directors, Business Development Managers, Project Leaders  of leading biopharmaceuticals & biotechnology companies whose responsibilities include:
   
  • Biopharma Manufacturing
• Biopharma Outsourcing
• Process Development
• External Biopharma partnering
• Upstream Processing
• Downstream Processing
• Technical Services/Operations
• Process Excellence
• Quality
• Tech Transfer
• Validation  
   
  SAVE  by REGISTERING EARLY !   
Click Below to Register
  Webinar EARLY BIRD PRICING at only $ 399.00 Ends Friday January 14th-2011, $ 459.00 thereafter!
Register
 
For more information contact Ram Balani at 516-515-9642 or email at rbalani@fdasmart.com
   
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