The document discusses early asset development and commercialization, and partnering arrangements. It introduces Cello Health and their services in market research, strategic consulting and scientific communications. It then discusses evaluating potential partners based on their capabilities and how they match a company's needs, as well as considering different types of partnering arrangements like licensing, acquisitions, joint ventures and more. Managing the value of early assets across development is also emphasized.
Speakers:
Paul Chipperton, Vice President, Business Development & Marketing, matREGEN
Nina Chagnon, Director of Business Development, MaRS Discovery District
For more information and the webcast link: http://www.marsdd.com/Events/Event-Calendar/BioEntrepreneurship/2007/business-models-12192007.html
How does the licensing process differ for in-licensing and out-licensing comp...daisyrmuzzio
PHARMA & BIOTECH LICENSING & PARTNERING:
Filling the Pipeline & Growing Market Share Through Strategic Deal-Making-- March 2-3- San Diego California
This is part of the MaRS BioEntrepreneurship series.
Speaker: Lynne Zydowsky, Ph.D., Managing Principal Zydowsky Consultants
* Explore the development of regulated drugs and devices
* Understand where and how value is generated in the pharmaceuticals industry
* Appreciate the interplay between science and business in a biotech company
To download a copy of the audio for this presentation, please go to:
http://www.marsdd.com/bioent/oct16
For the event blog and Q+A, please see:
http://blog.marsdd.com/2006/10/17/bringing-together-art-and-science/
Speakers:
Paul Chipperton, Vice President, Business Development & Marketing, matREGEN
Nina Chagnon, Director of Business Development, MaRS Discovery District
For more information and the webcast link: http://www.marsdd.com/Events/Event-Calendar/BioEntrepreneurship/2007/business-models-12192007.html
How does the licensing process differ for in-licensing and out-licensing comp...daisyrmuzzio
PHARMA & BIOTECH LICENSING & PARTNERING:
Filling the Pipeline & Growing Market Share Through Strategic Deal-Making-- March 2-3- San Diego California
This is part of the MaRS BioEntrepreneurship series.
Speaker: Lynne Zydowsky, Ph.D., Managing Principal Zydowsky Consultants
* Explore the development of regulated drugs and devices
* Understand where and how value is generated in the pharmaceuticals industry
* Appreciate the interplay between science and business in a biotech company
To download a copy of the audio for this presentation, please go to:
http://www.marsdd.com/bioent/oct16
For the event blog and Q+A, please see:
http://blog.marsdd.com/2006/10/17/bringing-together-art-and-science/
Performing Competitive Intelligence in a Pharmaceutical CompanyAnthony Russell
Workshop presented in the Competitive Intelligence and Pricing course as part of the University of Southern California Master of Science in Healthcare Decision Analysis program. Presented on Nov 4, 2018 at USC. The workshop gives an overview of what competitive intelligence is and how it is done in pharmaceutical companies. The workshop includes a couple of non-pharmaceutical exercises to help students learn how to write key intelligence questions and to work through a market simulation exercise. The workshop ends with a discussion on the various career pathways available within the competitive intelligence field.
Future Pharma Trends - Long-term opportunities tempered by short-term challengesscottosur
An overview of the key trends shaping the pharmaceutical industry today, and those that are set to play a central role in the future, as companies transition towards a new business model: Pharma 2.0.
Provides key strategies and trends shaping the future of the pharmaceutical industry. Examines the impact of the Obama administration on US healthcare, and the implications for Pharma. Assesses the implications of the current economic and financial situation on healthcare. Analyzes key growth drivers and resistors set to shape Pharma\'s future.
Contact me at sosur@datamonitor.com to learn more!
This presentation was made in Pharmasource Munich 2012 and covers the aspects of Pharma API and Intermediate sourcing. The presentation covers the following sub topics
1. How the changing structure of the Pharma industry is affecting ingredients sourcing
2. Are India and China still the places to go ( and for how long) – does the Cost - Benefit stack –up?
3. Supplier Innovation and Potential gains
4. Analyzing the Asian Pharma market –
a generics hub with a competitive skill base
i may be contacted at gurmeetsingh144@hotmail.com
Building a Business Case for New Product Planning in a Small Company EnvironmentAnthony Russell
Presented at the 2nd New Product Planning Summit by ExL Events in Boston (Dec 8, 2017). An overview of why commercial strategy is needed early in product development. As pressures continue to mount in drug development (crowded markets, payer and access issues, etc.), it is becoming critical to focus on the early stages of drug development. Working early with research and development teams to evaluate the commercial viability of programs will benefit companies of all sizes to maximize their portfolio of therapeutic candidates.
Suresh Gopalan - AstraZeneca Business Strategy Evaluation/Recommendations (Ap...Suresh Gopalan
This is an evaluation/recommendations on the business strategy of AstraZeneca (in April 2013) that I prepared for Foundations of Business Strategy course @Coursera. The report was highly appreciated by an executive in AstraZeneca for insightful content and accuracy. Did not have time for finishing touches - misunderstanding of timezone deadline. I would like to draw your attention especially to Exhibit 5.
A workshop presentation for Medical Affairs Strategic Summit West held in San Diego on September 23, 2019. The workshop covered the following learning objectives:
* Understand the factors involved in selecting and prioritizing indications
* Understand the importance of strategic market segmentation
* Understand how Medical Affairs can be involved in the process of new product planning
Success Factors and Failure Points in Cardiovascular Product Launches Report ...Best Practices
Biopharmaceutical companies invest large amount of resources to develop and launch new products for cardiovascular therapeutic areas. However, the complexity of a new cardiovascular product launch is compounded by the many pitfalls that are part of the market-entry landscape.
Best Practices ®, LLC undertook this research to showcase current and future risk levels for various pitfalls across critical launch fronts that can derail a new cardiovascular product. Pharmaceutical launch executives can use this study to better understand the potential pitfalls and stumbling blocks that they'll have to navigate as part of a new cardiovascular product entering the market.
Study Overview–- This study explores the executive insights, best practices and lessons learned to avoid common pitfalls while launching a new cardiovascular product into market.
About the Benchmark Class - Forty four executives from 38 leading companies including Abbott, Amgen, Baxter, Bayer, Eisai, GlaxoSmithKline, Merck, Novartis, and Roche participated in this study. Majority of the respondents were at vice president or director level.
Section 1: Study Background -- Reviews the study background, the research approach, methodology, participant demographics, the benchmark class and key findings.
Section 2: Topical chapters -- Outlines valuable insights and findings from the study that includes pitfalls & stumbling blocks, lessons learned and best practices and future changes. Pitfalls chapter reviews current and future risk levels for these cardiovascular launch factors: product shaping, market shaping, physician, patient, payer, internal and regulatory.
Market Access - Getting ready for Personalized Medicine!executiveinsight
A presentation outlining the potential gains, pitfalls and strategies needed to realize the value in Personalized Medicine (Companion Diagnostics, Therapies).
The value of early asset development and commercializationCello Health
Worldwide pharmaceutical R&D spend is increasing each year, and the competition for a share of that investment is becoming fiercer. Companies need to demonstrate the potential value of their asset in commercial as well as scientific and clinical terms.
The slides in this deck define and identify value from a financial, clinical and commercial perspective while also exploring how to derive value for patients.
Performing Competitive Intelligence in a Pharmaceutical CompanyAnthony Russell
Workshop presented in the Competitive Intelligence and Pricing course as part of the University of Southern California Master of Science in Healthcare Decision Analysis program. Presented on Nov 4, 2018 at USC. The workshop gives an overview of what competitive intelligence is and how it is done in pharmaceutical companies. The workshop includes a couple of non-pharmaceutical exercises to help students learn how to write key intelligence questions and to work through a market simulation exercise. The workshop ends with a discussion on the various career pathways available within the competitive intelligence field.
Future Pharma Trends - Long-term opportunities tempered by short-term challengesscottosur
An overview of the key trends shaping the pharmaceutical industry today, and those that are set to play a central role in the future, as companies transition towards a new business model: Pharma 2.0.
Provides key strategies and trends shaping the future of the pharmaceutical industry. Examines the impact of the Obama administration on US healthcare, and the implications for Pharma. Assesses the implications of the current economic and financial situation on healthcare. Analyzes key growth drivers and resistors set to shape Pharma\'s future.
Contact me at sosur@datamonitor.com to learn more!
This presentation was made in Pharmasource Munich 2012 and covers the aspects of Pharma API and Intermediate sourcing. The presentation covers the following sub topics
1. How the changing structure of the Pharma industry is affecting ingredients sourcing
2. Are India and China still the places to go ( and for how long) – does the Cost - Benefit stack –up?
3. Supplier Innovation and Potential gains
4. Analyzing the Asian Pharma market –
a generics hub with a competitive skill base
i may be contacted at gurmeetsingh144@hotmail.com
Building a Business Case for New Product Planning in a Small Company EnvironmentAnthony Russell
Presented at the 2nd New Product Planning Summit by ExL Events in Boston (Dec 8, 2017). An overview of why commercial strategy is needed early in product development. As pressures continue to mount in drug development (crowded markets, payer and access issues, etc.), it is becoming critical to focus on the early stages of drug development. Working early with research and development teams to evaluate the commercial viability of programs will benefit companies of all sizes to maximize their portfolio of therapeutic candidates.
Suresh Gopalan - AstraZeneca Business Strategy Evaluation/Recommendations (Ap...Suresh Gopalan
This is an evaluation/recommendations on the business strategy of AstraZeneca (in April 2013) that I prepared for Foundations of Business Strategy course @Coursera. The report was highly appreciated by an executive in AstraZeneca for insightful content and accuracy. Did not have time for finishing touches - misunderstanding of timezone deadline. I would like to draw your attention especially to Exhibit 5.
A workshop presentation for Medical Affairs Strategic Summit West held in San Diego on September 23, 2019. The workshop covered the following learning objectives:
* Understand the factors involved in selecting and prioritizing indications
* Understand the importance of strategic market segmentation
* Understand how Medical Affairs can be involved in the process of new product planning
Success Factors and Failure Points in Cardiovascular Product Launches Report ...Best Practices
Biopharmaceutical companies invest large amount of resources to develop and launch new products for cardiovascular therapeutic areas. However, the complexity of a new cardiovascular product launch is compounded by the many pitfalls that are part of the market-entry landscape.
Best Practices ®, LLC undertook this research to showcase current and future risk levels for various pitfalls across critical launch fronts that can derail a new cardiovascular product. Pharmaceutical launch executives can use this study to better understand the potential pitfalls and stumbling blocks that they'll have to navigate as part of a new cardiovascular product entering the market.
Study Overview–- This study explores the executive insights, best practices and lessons learned to avoid common pitfalls while launching a new cardiovascular product into market.
About the Benchmark Class - Forty four executives from 38 leading companies including Abbott, Amgen, Baxter, Bayer, Eisai, GlaxoSmithKline, Merck, Novartis, and Roche participated in this study. Majority of the respondents were at vice president or director level.
Section 1: Study Background -- Reviews the study background, the research approach, methodology, participant demographics, the benchmark class and key findings.
Section 2: Topical chapters -- Outlines valuable insights and findings from the study that includes pitfalls & stumbling blocks, lessons learned and best practices and future changes. Pitfalls chapter reviews current and future risk levels for these cardiovascular launch factors: product shaping, market shaping, physician, patient, payer, internal and regulatory.
Market Access - Getting ready for Personalized Medicine!executiveinsight
A presentation outlining the potential gains, pitfalls and strategies needed to realize the value in Personalized Medicine (Companion Diagnostics, Therapies).
The value of early asset development and commercializationCello Health
Worldwide pharmaceutical R&D spend is increasing each year, and the competition for a share of that investment is becoming fiercer. Companies need to demonstrate the potential value of their asset in commercial as well as scientific and clinical terms.
The slides in this deck define and identify value from a financial, clinical and commercial perspective while also exploring how to derive value for patients.
The importance of getting a Biotechnology launch right the first time and the difficulty of recovering from a slow sales trajectory suggest that there is a need to evolve the go-to-market approach to ensure launch success. Successfully bringing a product to market has been increasingly difficult as the U.S. Healthcare Market has evolved since implementation of the Affordable Care Act. Pricing has become more controlled - and value based - as healthcare costs have increased to an unsustainable level. Customers realize there is little product differentiation and the traditional Field Sales representative based go-to-market models are struggling to effectively communicate the value proposition to more demanding and informed customers and stakeholders. The results of our pre-launch survey are provided here along with recommendations for what Biotechnology companies can do to improve launch readiness.
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
On February 23, 2015, the MIT Enterprise Forum of Philadelphia hosted a forum on raising money for early-stage life science and healthcare companies. In a discussion hosted by moderator Steve Bowman of Busclarity, panelists Jim Stuber and Bernard Rudnick addressed the subject from the point of view of founder and funder, respectively, with input on IP issues from Baker Hostetler's Jeffrey Rosedale.
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
Genetic Technologies Limited is a diversified molecular diagnostics company developing tools for the prediction and assessment of chronic disease risk to help physicians proactively manage patient health. The Company’s lead products, ‘GeneType for Breast Cancer’ and ‘GeneType for Colorectal Cancer’, are clinically validated risk assessment tests that are first in their class. The Company signed a multi-year distribution agreement for its COVID-19 Risk Test and remains on track to launch its revolutionary Multi-Test, covering up to 70% of mortalities and morbidities, including major oncological, metabolic, and degenerative diseases. Genetic Technologies recent acquisition of EasyDNA has significantly accelerated the Company’s commercialization strategy, providing established revenue streams and direct-to-consumer marketing channels that include 70 websites in 40 countries. Listed on the ASX in 2000 and NASDAQ in 2005, Genetic Technologies has been a leader in the development and commercialization of genetic risk assessment technology for 20 years.
Analysis of drivers that cause restricted access to funding for smaller biotech companies.
A detailed reviewed of the steps
venture capitalists and companies are
taking — models such as fail-fast R&D, asset-centric funding and more.
Proposal of a model that
could radically change R&D by taking a
much more holistic approach to drug
development, sharing information to
learn in real time across the cycle of care
and fundamentally changing how risk
and reward are allocated.
Similar to Early asset development and commercialization: Partnering for success (20)
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.