Dear all,
I have tried putting down my view-points on benefits of Project Management system in Pharmaceutical Industry...
Please let me know what do you think.
Regards,
Megha Thakkar
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
Role of Business Development in Pharmaceuticals (Generic Product Business)Muhammad Ali Jehangir
Role of Business Development in Pharmaceuticals (Generic Product Business)
For New Updated Slide Deck: https://www.slideshare.net/alijehangir/business-development-licensing-overview-150008616
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
Pharmaceutical Portfolio & Product Life Cycle Managementsbryant89
As product pipelines become thinner, and pressure to get the most out of dwindling resources increases, pharmaceutical portfolio and product lifecycle management becomes an imperative part of a company’s approach to maximizing ROI. Not only must managers carefully strategize in relation to the product’s strengths against competitors and also in such a way to compliment the overall company portfolio, but they must also balance the crucial factors of regulatory change in patent protection, risk mitigation, effective R&D resource allocation in order to achieve an integrated approach to effective portfolio and PLCM.
Now in its 6th year, SMi Groups Pharmaceutical Portfolio & Product Life-Cycle Management is a well established meeting ground for such managers and directors who are faced with the task of managing the pipeline in a way that acknowledges the above mentioned factors and more. In the close up environment that our conferences provide, you can expect to discuss with some of the leading professionals in the field the best way to approach this difficult task. In a showcase of effective approaches from many of the largest pharmaceutical companies, you can be sure to learn much of value to yourself, and to your organization.
Role of Business Development in Pharmaceuticals (Generic Product Business)Muhammad Ali Jehangir
Role of Business Development in Pharmaceuticals (Generic Product Business)
For New Updated Slide Deck: https://www.slideshare.net/alijehangir/business-development-licensing-overview-150008616
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
Pharmaceutical Portfolio & Product Life Cycle Managementsbryant89
As product pipelines become thinner, and pressure to get the most out of dwindling resources increases, pharmaceutical portfolio and product lifecycle management becomes an imperative part of a company’s approach to maximizing ROI. Not only must managers carefully strategize in relation to the product’s strengths against competitors and also in such a way to compliment the overall company portfolio, but they must also balance the crucial factors of regulatory change in patent protection, risk mitigation, effective R&D resource allocation in order to achieve an integrated approach to effective portfolio and PLCM.
Now in its 6th year, SMi Groups Pharmaceutical Portfolio & Product Life-Cycle Management is a well established meeting ground for such managers and directors who are faced with the task of managing the pipeline in a way that acknowledges the above mentioned factors and more. In the close up environment that our conferences provide, you can expect to discuss with some of the leading professionals in the field the best way to approach this difficult task. In a showcase of effective approaches from many of the largest pharmaceutical companies, you can be sure to learn much of value to yourself, and to your organization.
Dear Students
We can help you to write total dissertation/project report.
Our 9 step method of project writing:-
Step 1) Helping you in Selection of topic.
Step 2) Group discussion / conference call with in team of professors.
Step 3) Helping you in Preparation of Synopsis/ proposal & sent to project guide
Information Management In Pharmaceutical IndustryFrank Wang
Pharmaceutical Industry Information Management Opportunities and Challenges in Research, Development, Clinical, Sales, Marketing, Managed Markets, Manufacturing, Supply Chain and Distribution
This presentation explores some of the underlying issues responsible for declining pharma R&D productivity, and provides a new, fully integrated approach to reverse this trend by navigating R&D projects and portfolios through the risk-return landscape in real time.
A case study demonstrates how this system can be used in practice to improve the risk-return profile of a Phase 2 development project according to risk appetite.
This presentation focuses on R&D in the pharmaceutical industry, however the approach can be used to manage and optimize the risk-return profile of any business asset at any stage of its lifecycle, at any level, in any industry.
This study is designed to help brand and marketing leaders identify winning lifecycle management (LCM) strategies they can use to extend the commercial life of bio-pharmaceutical products. The study examines ROI and future viability of 20 different LCM strategies. In addition, the research provides insights into which strategies will survive as they are faced with a changing pharmaceutical environment.
A presentation I made at a large pharmaceutical industry conference in 2007. Initial speaker (to the 5.5 minute mark) is the chair of the session, Eric Towler. The session was focused on the Evolving Role of Project Management in Drug Development, and my portion was focused on Resource Planning and Management.
For additional context, see related blog post at http://hermosatech.com
FDA on Prefilled Syringes and Combination Products (Lana Shiu,MD)Sun Kim
Audio at http://QbDWorks.com
(Courtesy of Dr. Lana Shiu of FDA)
I met Dr. Lana Shiu after her presentation at the PDA conference. She gladly agreed to share her talk with our QbDWorks community.
What Dr. Shiu covers:
Why FDA is focusing on Combination Products Now
Why this applies to all of us
Case study of failed combination product (prefilled syringe)
Background of Combination Products governed by FDA
Product Development Considerations
Human Factors Considerations
FDA Application Submission Guidelines
Lessons Learned
Key Steps to Successful Application
At the end of this article are links to the FDA guidelines:
Guidance Documents (finalized 2013)
Drug or Biologic using Injectors/Prefilled Syringes Assembled into Injectors
TetraQ - Integrated Preclinical Drug Development Solutions Presentationguest55305
TetraQ is a leading Australian preclinical contract research organization focused on providing a broad range of integrated preclinical drug development solutions in the disciplines of ADME, Bioanalytics, Efficacy, Toxicology and Pharmaceutics. TetraQ’s Toxicology, ADME and Bioanalytics laboratories are GLP recognised and in collaboration with NATA, TetraQ’s ADME team pioneered ISO17025-2005 (R&D) research & development accreditation becoming the first laboratory in Australia to obtain this accreditation in 2005.
Each of our world-class facilities is equipped with state-of-the-art instrumentation including LC-MS/MS, HPLC & ELISA. Essentially, TetraQ is a one-stop-shop for early stage drug development and we are recognized as world leaders in bioanalytical method development & sample analysis of drugs / metabolites in biological fluids with both human and animal samples.
Safety is the prime attention of regulatory bodies as it is the critical factor which can destroy even the humankind. Quality system like GLP has a lot tom play in the field of safety
assessments to reach its goal. There are various toxicity studies for assessing the degree of its toxicity. Academic research and peer reviewed journals has their own pitfalls as they could not
monitor or inspect the studies which has been conducted. This presentation speak about the Importance of safety assessment, various studies to evaluate the safety and Importance of GLP in safety assessment.
Biomarkers to Diagnostics – The Essential Tool Box for Drug Development - Presentation delivered by Johan Luthman, Vice President, Neuroscience Clinical Development, Eisai Pharmaceuticals at the marcus evans Evolution Summit Fall 2015 in Las Vegas
Drug Discovery path
Pharma R & D –overview
Discovery & Development
Preclinical research
Clinical Trial
NDA and FDA Approval
Post marketing data
References
Introduction
History
How are new drug discovered?
Bioinformatics in drug discovery
Tools for drug discovery
Successful drug
Software for drug discovery
Conclusion
References
2. PHARMACEUTICAL R&D
• Pharmaceutical R&D is the process of discovering,
p g,
developing, and bringing to market new ethical drug
products.
• Manufacturers in the pharmaceuticals industry turn out
goods in five distinct areas;
goods in five distinct areas;
Ethical products
p
Biotechnology products
Generic products
Diagnostics products
Diagnostics products
Medical products
Megha Thakkar, PMP®
3. WHY ARE NEW DRUGS NEEDED?
• Unmet medical need
Unmet medical need
• New diseases (BSE; AIDS, Alzheimer’s; obesity)
• Low efficacy (Dementia, Cancer)
Low efficacy (Dementia Cancer)
• Side effects (Antidepressants, Antipsychotics)
• Downstream health costs; (Alzheimer’s; Spinal
D t h lth t (Al h i ’ S i l
injury)
• Cost of therapy; (Viagra, Interleukins)
C f h (Vi I l ki )
• Costs to individual/country; (Depression)
• Sustain industrial activity
• Patent expiry
Megha Thakkar, PMP®
6. DRUG DISCOVERY/DEVELOPMENT PROCESS
Discovery /
Refinement
R fi t
Safety & toxicity in
Lessons & animals;
development formulation
development
Post registration Volunteer studies;
monitoring patient studies
Marketing Regulatory process
Megha Thakkar, PMP®
7. FROM BENCH TO BEDSIDE
• A medicine progresses ‘from bench to bedside’ over
A medicine progresses from bench to bedside over
a period of many years —from initial development in
the laboratory, through clinical testing, licensing,
the laboratory, through clinical testing, licensing,
promotion to doctor and patient, and final
prescription.
Megha Thakkar, PMP®
8. THE R&D BUSINESS PROCESSES IN THE PHARMA INDUSTRY
R&D B
• Identifying active ingredients
Medical chemistry
Here, natural substances or known chemical substances are
systematically modified to increase their effectiveness,
reduce their side‐effects, or increase their therapeutic value in
treating diseases. The medical chemistry and pharmacology areas
work closely together.
Screening
A large number of substances are investigated in one or more tests
in order to identify a new active molecule
i d t id tif ti l l
Rational drug design
The idea behind this method is to tailor‐make a molecule that will
h d b h d h h d l k l l h ll
interact with known and well‐researched biological systems in the
desired way.
Megha Thakkar, PMP®
9. THE R&D BUSINESS PROCESSES IN
R&D B
THE PHARMA INDUSTRY
• Development
Development
When a research substance demonstrates a desired
pharmacological effect, and a decision is made to
pharmacological effect and a decision is made to
pass it on to development.
Preformulation
The first step is to determine the substances chemical and
p
physical properties. Procedures must be found to produce
sufficient quantities of the substance with the required purity
for the subsequent development steps.
for the s bseq ent de elopment steps
Megha Thakkar, PMP®
10. THE R&D BUSINESS PROCESSES IN
R&D B
THE PHARMA INDUSTRY
Pharmacokinetics
The effects of the substance on living organisms are
investigated with the help of animal experiments. These make
it possible to effectively assess toxicological data and to obtain
bl ff l l ld d b
information about the effects of the substance on the human
body.y
Toxicology
Both animal and non‐animal tests are used to assess whether
a substance is safe for use by humans. These include studies
on acute toxicity, chronic toxicity, mutagenicity, fertility, and
on ac te to icit chronic to icit m tagenicit fertilit and
carcinogenicity.
Megha Thakkar, PMP®
11. THE R&D BUSINESS PROCESSES IN
R&D B
THE PHARMA INDUSTRY
• Pharmaceutical and chemical development
Pharmaceutical and chemical development
Pharmaceutical and chemical development
The active‐ingredient synthesis developed in the laboratory is
g y p y
then scaled up for production, and the final formulation of the
new product is developed. If the scale up is too large to
accomplish straight away, an interim step is included. This
accomplish straight away an interim step is included This
interim step can be used to produce clinical samples before
the final scale‐up prior to market launch.
Megha Thakkar, PMP®
12. THE R&D BUSINESS PROCESSES IN
R&D B
THE PHARMA INDUSTRY
• Clinical trials
Clinical trials
Once the pharmacokinetic and toxicological
investigations have provided the necessary
investigations have provided the necessary
information about whether a substance is effective
and safe for use by humans, a risk/benefit analysis is
and safe for use by humans a risk/benefit analysis is
carried out and a decision is then made about
whether to use the substance on humans.
whether to use the substance on humans
The central objective is to achieve an improvement
The central objective is to achieve an improvement
in the treatment of disease.
Megha Thakkar, PMP®
13. THE R&D BUSINESS PROCESSES IN
R&D B
THE PHARMA INDUSTRY
Phase I
The new substance is administered to healthy, volunteer test
subjects or to selected patients with particular indications,
such as cancer or Aids. This first clinical study provides
h d h f l l d d
information about the substances pharmacological effects,
side‐effects, pharmacokinetics, bio‐availability, and drug
,p , y, g
interaction. Based on these results, which take about 8 ‐ 18
months to gather, the initial dosage and dosage interval for
patients are determined. At the end of Phase I, a decision is
ti t d t i d At th d f Ph I d ii i
made about whether to continue or terminate the clinical
trials for the substance.
Megha Thakkar, PMP®
14. THE R&D BUSINESS PROCESSES IN
R&D B
THE PHARMA INDUSTRY
Phase II
This phase involves patients with target indications, and aims
to gather data on pharmacological effects, therapeutic effects,
correct dosage, and pharmacokinetics, and information about
d d h k d f b
chronic application. In this phase too, a decision is made about
whether to continue or terminate the study. This second phase
y p
usually lasts between 18 and 36 months.
Megha Thakkar, PMP®
15. THE R&D BUSINESS PROCESSES IN
R&D B
THE PHARMA INDUSTRY
Phase III
Patients with the target indication receive the preparation
under normal medical conditions. The number of patients
involved ranges from 200 to 4,000. Based on this broad scope
l d f d h b d
of application, the compound is tested for its efficacy and side‐
effects on people of different ages, sex, lifestyle, and ethnic
p p g , , y ,
origin (various countries). The nature and frequency of side‐
effects are recorded, interaction with other medicaments is
observed, and a comparison is made with standard therapy.
b d d i i d ith t d d th
This phase, lasting between 20 and 46 months, leads to a
decision about whether to apply for regulatory approval or
pp y g y pp
whether to terminate the project.
Megha Thakkar, PMP®
16. THE R&D BUSINESS PROCESSES IN
R&D B
THE PHARMA INDUSTRY
Phase IV
Phase IV begins when the compound has been approved. It
involves clarifying the side‐effects noted in relatively large
numbers of patients, investigating interactions with other
b f h h
drugs, and examining the long‐term effects. New areas of
application may also be identified for a compound during this
pp y p g
phase.
Megha Thakkar, PMP®
17. THE R&D BUSINESS PROCESSES IN
R&D B
THE PHARMA INDUSTRY
• Regulatory approval
g y pp
Application:
Once Phases 1 to 3 of the clinical trial for a new substance have been
completed successfully, the company can apply for regulatory
completed successfully the company can apply for regulatory
approval.
Documentation:
The documents required for the application are prepared on an
Th d t i d f th li ti d
ongoing basis throughout the development process, which means
that only the results of Phase 3 need to be added at this stage.
Submission:
S b i i
When the application documents are complete, they are sent to the
responsible authority. The application process can take anything
from 9 to 26 months, depending on the authority concerned and the
f h d d h h d d h
quality of the application documents.
Megha Thakkar, PMP®
18. THE R&D BUSINESS PROCESSES IN
R&D B
THE PHARMA INDUSTRY
• Market launch
Introduction to Market:
Once regulatory approval has been issued, the next goal is to bring
the new compound to market as quickly as possible. With this goal in
mind, companies begin manufacturing the compound and preparing
their marketing activities before they actually receive approval, so
that market launch can begin the instant approval arrives.
• Post‐launch
Analysis of New drug formations:
y g
Once the new compound is on the market, another series of steps
begins. These include Phase IV of clinical testing, developing new
forms in which to administer the drug, and marketing. And, if this
has not already happened, the compound is now scaled up for
h t l d h d th di l d f
production in a normal manufacturing environment.
Megha Thakkar, PMP®
19. ADMINISTRATION
• Project management embraces the entire project
Project management embraces the entire project
procedure, from active‐ingredient discovery to
compound development. It plans the entire R&D
compound development. It plans the entire R&D
process, monitors execution, and evaluates the
results. At the same time, it plans dates, defines
results. At the same time, it plans dates, defines
milestones and resources, and sets the budget.
Megha Thakkar, PMP®
20. WHY PHARMACEUTICAL PROJECT MANAGEMENT
• The course of drug development is unpredictable and
g p p
therefore it is critical to have realistic expectations for
any given project.
• There are inherent difficulties in running a drug
development successfully and the larger the project the
development successfully and the larger the project the
more numerous potential problems can be.
• Accounting for the factors that can stand in the way of a
project’s success and being able to take an objective
view of the strategies required is a demanding, but
necessary task.
Megha Thakkar, PMP®
22. PROJECT MANAGEMENT
• Project management is a complex undertaking, with
many stages and processes. It should follow the full
business lifecycle, from definition and justification of the
project, through to delivering demonstrable benefits for
project, through to delivering demonstrable benefits for
the business.
•P j
Project management is the obedience of planning,
i h b di f l i
organizing, and managing resources to bring about the
successful completion of specific project goals and
p p p j g
objectives.
• Project management is bringing cross functional team
Project management is bringing cross‐functional team
members together to achieve a common goal.
Megha Thakkar, PMP®
23. WHAT COMPANIES WANT FROM PROJECT MANAGEMENT
• Cost‐effective planning, execution and monitoring of
p g, g
projects
• Optimized business processes and resources; fewer
routine activities;
• Faster project procedures
• Also they want to be able to compare various
different projects in order to identify at a glance
which ones to press ahead with.
Megha Thakkar, PMP®
24. PROJECT MANAGEMENT IS ABOUT 6 “C”
6 “C”
• Concept
• Clarity
• Consensus
• Commitment
• Control
C t l
• Confirmation
Megha Thakkar, PMP®
25. 6 “C” OF PROJECT MANAGEMENT
6 “C”
• Concept ‐ High level ideas about the project
p g p j
Project proposal
A brief about scope of project
• Clarity ‐ Requirements elicitation, and analysis. Defining
the requirements and then documenting them or
q g
implementing them into a system that can track changes
and act as a control point.
Project Execution plan
l
System to draw a road map of the Project execution
Project status update
j p
System to track and communicate project status which includes
variance system and assignable route‐causes systems
Megha Thakkar, PMP®
26. 6 “C” OF PROJECT MANAGEMENT
6 “C”
• Consensus ‐ Socialization and approvals.
Consensus Socialization and approvals.
Project kick off meeting + Project status update meeting
One on one discussion on each challenges phased to avail a
g p
quick and reliable solution
• Commitment ‐ Addressing requirements in the
solution design and allocating resources to build the
solution.
Pre formulation/Formulation development
Guided by experts to avail a non‐infringement development
Megha Thakkar, PMP®
27. 6 “C” OF PROJECT MANAGEMENT
6 “C”
• Control ‐ Control process applied to requirements;
Control Control process applied to requirements;
understanding the impact of changes (and possibly
making sure the developers stay focused on the
making sure the developers stay focused on the
requirements while building the solution.)
Analytical development
Analytical development
• Confirmation – Confirming designs in testing and
Confirmation Confirming designs in testing and
implementation.
Tech transfer
Tech transfer
Megha Thakkar, PMP®
28. OPERATIVE STRUCTURES
• Project definition : to describe project goals in general
Project definition : to describe project goals in general
terms.
• Work breakdown structure : The WBS is the hierarchical
model of the tasks to be performed in the project. It
p p j
provides a clear overview of the project by:
Forming the basis for organizing and coordinating the project
Showing the work, time and costs involved in the project.
The WBS also forms the basis for subsequent planning steps,
such as planning dates and costs, and allocating the budget.
such as planning dates and costs and allocating the budget
Megha Thakkar, PMP®
29. OPERATIVE STRUCTURES
• Network : The main components of a network are
p
activities and relationships. Through the activities in
a network, you can represent the people, capacities,
dates, materials, production resources/tools, and
services that you need for the various tasks in your
project. Depending on the task concerned, you can
j t D di th t k d
create different types of activity:
Internally processed activities
Externally processed activities
yp
General costs activities
Megha Thakkar, PMP®
30. OPERATIVE STRUCTURES
• Milestones : Milestones are events of particular
Milestones : Milestones are events of particular
significance in a project or that trigger predefined
functions. You can assign milestones to both
functions. You can assign milestones to both
activities and WBS elements. In the Project System,
milestones are used:
milestones are used:
To trigger predefined milestone functions, such as
gg p ,
workflows
To carry out progress analyses
To determine dates in the billing plan for sales orders
Megha Thakkar, PMP®
31. NEEDS FROM A PROJECT MANAGER
HARD SKILL SOFT SKILL
• Science • Leadership
• Drug Development • Matrix Management
Understanding • Energy
E
• Line Function Comprehension • Drive
• Tools • Passion
Planning • Influencing
Risk • Negotiation
Financial • Communication
C i i
• Facilitation
• Proactive
• Strategic Thinking
Megha Thakkar, PMP®
32. PROJECT MANAGEMENT IN PHARMA
RESEARCH & DEVELOPMENT
• Bring 3 E’s to Project:
Efficient, Economic , Elite
• One of the main factors to influence the success of a
pharmaceuticals company is its efficiency in bringing new products
to market.
• The faster market maturity is gained for a product, the greater the
market lead.
• The success rate for developing new compounds is about 1:6,000.
In other words, of 6,000 newly synthesized substances, only one
will meet the requirements for a new product in terms of its
effectiveness and safety for use in drugs.
Megha Thakkar, PMP®