This presentation covers the essential concept of ensuring all promotional communications are on label and the safe harbors established by FDA for disseminating off-label information compliantly.
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
This presentation was delivered to a webinar sponsored by Zinc Ahead on May 21, 2015, and provided an update about the current state of guidance from the FDA on the appropriate use of social media by prescription product manufacturers.
Quality Considerations in Due Diligence for Pharmaceutical TransactionsMichael Swit
The document discusses quality considerations in due diligence for pharmaceutical transactions. It outlines general considerations for due diligence structure and challenges. It emphasizes that quality matters because drugs made in non-compliant facilities can be considered adulterated by the FDA and result in criminal and civil penalties. The document provides examples of problems to look for, including manufacturing, pharmacovigilance, compliance history, FDA inspection history, and audits. It discusses techniques for probing issues, including reviewing FDA correspondence and litigation. Special considerations are outlined for different drug development stages. Helpful charts on diligence issues by stage and analyzing identified issues are presented.
This presentation covers the essential concept of ensuring all promotional communications are on label and the safe harbors established by FDA for disseminating off-label information compliantly.
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
This presentation was delivered to a webinar sponsored by Zinc Ahead on May 21, 2015, and provided an update about the current state of guidance from the FDA on the appropriate use of social media by prescription product manufacturers.
Quality Considerations in Due Diligence for Pharmaceutical TransactionsMichael Swit
The document discusses quality considerations in due diligence for pharmaceutical transactions. It outlines general considerations for due diligence structure and challenges. It emphasizes that quality matters because drugs made in non-compliant facilities can be considered adulterated by the FDA and result in criminal and civil penalties. The document provides examples of problems to look for, including manufacturing, pharmacovigilance, compliance history, FDA inspection history, and audits. It discusses techniques for probing issues, including reviewing FDA correspondence and litigation. Special considerations are outlined for different drug development stages. Helpful charts on diligence issues by stage and analyzing identified issues are presented.
The document outlines an agenda for a webinar on best practices for promotional content review. The webinar will cover what good promotional practices are, the importance of implementing them now, a four-step PACE process for content review, standard operating procedures for review, and a case study on tradeshow preparation. It includes slides on the key topics that will be discussed, such as establishing a cross-functional review committee and using categorization to ensure consistent application of review standards.
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
Regulatory Landscape for Approving Treatments
for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
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.
Regulatory strategy for medical device start-upsRina Nir
The document discusses regulatory considerations for medical device startups. It notes that the regulatory environment will significantly impact business plans by influencing budgets, timelines, staffing needs and more. Startups must thoroughly assess their regulatory situation and strategy to navigate the complex approval processes in both the US and EU. Later slides provide more details on specific regulatory pathways, standards, and trends to consider for medical device development.
The Other Agency: An introduction to Pharma MarketingDale Cooke
This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
This document contains forward-looking statements from Impax Laboratories regarding their financial projections, product pipeline and opportunities for growth. Some of the key points include:
- Impax expects revenue growth from the commercialization of their Parkinson's drug RYTARY, with projections of $275-350M in US sales by 2019.
- Their generics division has 30-48% potential for first-to-file or first-to-market opportunities among pending ANDAs, with expected product launches in 2015 addressing $1.6B in total market sales.
- Following the acquisition of CorePharma, Impax estimates their revenue mix will shift to 75-80% generics and 20-25% branded products, divers
Overcoming Regulatory, Clinical and Quality Challenges in Developing Combinat...Michael Swit
Webinar presented on May 19, 2011, sponsored by The Weinberg Group, focusing on:
* A Brief History of Combination Product Regulation
* Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
* The Request for Designation (RFD) Process
* GMPs
* Post-Market Safety Reporting
* How Many Applications to File?
* User Fees
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...Best Practices
Regulatory affairs group ensure that medical device companies comply with volatile regulatory environment pertaining to developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies for enhanced performance under stringent compliance norms. Also, optimal resourcing and staffing helps Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth.
Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure, activities, roles and responsibilities of Regulatory Affairs groups at medical device companies. The study also provides recent spend and staffing trends of regulatory affairs in medical device sector, including the use of outsourcing and off-shoring.
Medical device regulatory leaders can use this study to align their staff as per strategies of best in class companies for an increased performance delivery.
I delivered this presentation at the DTC National Conference in Washington DC. The presentation highlights the importance of mobile for people making decisions about their health and discusses how to present information about FDA-regulated products in this important channel.
Market Exclusivity Under the Waxman-Hatch ActMichael Swit
March 19, 2007 presentation to the San Diego County Bar Association IP Section, with a focus on:
•Orphan Drug Exclusivity (Seven Years)
•Five-Year Exclusivity
•Three-Year Exclusivity
•Pediatric Exclusivity (Six Months)
•180-Day Exclusivity
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Com...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.
The document provides an overview of careers in the biopharmaceutical industry. It describes the long process of developing new drugs, which involves identifying drug targets, designing and testing compounds, conducting preclinical and clinical trials, gaining regulatory approval, and post-launch monitoring. Many roles are needed across research, development, manufacturing, regulatory affairs, sales, and other functions. The average time to get a new drug to market is 14 years and over $1 billion.
The Trials and Tribulations of Combination Product Developmentsteverabin
Presented at the Sept. 7, 2010 Bio2Device group meeting, this talk focuses on the problems and solutions of combination product (primarly drug/medical device) development.
NAPM is a Section 21 Trade Association which was established in 1977. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. NAPM has a diverse membership comprising of 24 companies. Some of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
UCPMP guidelines pharma marketing code by http://www.dailyrounds.org/blog/ucp...Siddhartha Dash
Uniform code for pharmaceutical marketing Practices UCPMP Guidelines, Codes and Impact on Industry by DailyRounds.org (Largest network of doctors 200000+ & counting).
http://www.dailyrounds.org/blog/ucpmp-uniform-code-of-pharmaceuticals-marketing/
Compliant Promotion in an On-demand WorldDale Cooke
The Internet is now the premier source of healthcare information for physicians and consumers alike. Consequently, FDA-regulated companies have been leveraging it in various ways, but compliance has proven challenging and confusing for companies not accustomed to digital tactics.
* Recent FDA enforcement actions that command the attention of anyone considering digital communication tactics
* Trends in digital media consumption and their impact on advertising effectiveness
* FDA’s 2009 Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion
* FDA’s 2011 Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications
*Some red flags guaranteed to draw FDA’s ire
* The latest on FDA social media guidance
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
Drug Safety – An Overview of FDA Powers under FDAAAMichael Swit
Presentation to Conference on Marketing Applications jointly sponsored by San Diego Regulatory Affairs Network (SDRAN) and the Orange County Regulatory Affairs (OCRA) Discussion Group, in November 2009. Talk focused on the new powers granted FDA under the 2007 Food and Drug Administration Amendments Act (FDAAA).
The document discusses the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) in India. The UCPMP provides voluntary guidelines for ethical pharmaceutical marketing and promotion. It outlines restrictions on promotional claims, product comparisons, and interactions with healthcare professionals. The guidelines prohibit gifts, travel funds, cash payments, and other inducements that could improperly influence medical decisions. Adopting the ethical standards in the UCPMP is important for pharmaceutical companies to shift away from outdated marketing beliefs and practices.
This document provides information on medical devices used in equine medicine. It defines a medical device as an instrument or article that is used to diagnose, cure, mitigate, treat or prevent disease, and which does not achieve its purpose through chemical action or metabolism. For human medicine, devices are classified from Class I to III based on risk. While the FDA regulates human medical devices, there is no approval process for veterinary devices, though they cannot be misbranded or mislabeled. Practitioners can use veterinary devices for their intended purposes but should be aware they have not been evaluated for safety or efficacy if used as pharmaceuticals.
The document outlines an agenda for a webinar on best practices for promotional content review. The webinar will cover what good promotional practices are, the importance of implementing them now, a four-step PACE process for content review, standard operating procedures for review, and a case study on tradeshow preparation. It includes slides on the key topics that will be discussed, such as establishing a cross-functional review committee and using categorization to ensure consistent application of review standards.
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
Regulatory Landscape for Approving Treatments
for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
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.
Regulatory strategy for medical device start-upsRina Nir
The document discusses regulatory considerations for medical device startups. It notes that the regulatory environment will significantly impact business plans by influencing budgets, timelines, staffing needs and more. Startups must thoroughly assess their regulatory situation and strategy to navigate the complex approval processes in both the US and EU. Later slides provide more details on specific regulatory pathways, standards, and trends to consider for medical device development.
The Other Agency: An introduction to Pharma MarketingDale Cooke
This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
This document contains forward-looking statements from Impax Laboratories regarding their financial projections, product pipeline and opportunities for growth. Some of the key points include:
- Impax expects revenue growth from the commercialization of their Parkinson's drug RYTARY, with projections of $275-350M in US sales by 2019.
- Their generics division has 30-48% potential for first-to-file or first-to-market opportunities among pending ANDAs, with expected product launches in 2015 addressing $1.6B in total market sales.
- Following the acquisition of CorePharma, Impax estimates their revenue mix will shift to 75-80% generics and 20-25% branded products, divers
Overcoming Regulatory, Clinical and Quality Challenges in Developing Combinat...Michael Swit
Webinar presented on May 19, 2011, sponsored by The Weinberg Group, focusing on:
* A Brief History of Combination Product Regulation
* Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
* The Request for Designation (RFD) Process
* GMPs
* Post-Market Safety Reporting
* How Many Applications to File?
* User Fees
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...Best Practices
Regulatory affairs group ensure that medical device companies comply with volatile regulatory environment pertaining to developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies for enhanced performance under stringent compliance norms. Also, optimal resourcing and staffing helps Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth.
Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure, activities, roles and responsibilities of Regulatory Affairs groups at medical device companies. The study also provides recent spend and staffing trends of regulatory affairs in medical device sector, including the use of outsourcing and off-shoring.
Medical device regulatory leaders can use this study to align their staff as per strategies of best in class companies for an increased performance delivery.
I delivered this presentation at the DTC National Conference in Washington DC. The presentation highlights the importance of mobile for people making decisions about their health and discusses how to present information about FDA-regulated products in this important channel.
Market Exclusivity Under the Waxman-Hatch ActMichael Swit
March 19, 2007 presentation to the San Diego County Bar Association IP Section, with a focus on:
•Orphan Drug Exclusivity (Seven Years)
•Five-Year Exclusivity
•Three-Year Exclusivity
•Pediatric Exclusivity (Six Months)
•180-Day Exclusivity
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Com...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.
The document provides an overview of careers in the biopharmaceutical industry. It describes the long process of developing new drugs, which involves identifying drug targets, designing and testing compounds, conducting preclinical and clinical trials, gaining regulatory approval, and post-launch monitoring. Many roles are needed across research, development, manufacturing, regulatory affairs, sales, and other functions. The average time to get a new drug to market is 14 years and over $1 billion.
The Trials and Tribulations of Combination Product Developmentsteverabin
Presented at the Sept. 7, 2010 Bio2Device group meeting, this talk focuses on the problems and solutions of combination product (primarly drug/medical device) development.
NAPM is a Section 21 Trade Association which was established in 1977. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. NAPM has a diverse membership comprising of 24 companies. Some of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.
UCPMP guidelines pharma marketing code by http://www.dailyrounds.org/blog/ucp...Siddhartha Dash
Uniform code for pharmaceutical marketing Practices UCPMP Guidelines, Codes and Impact on Industry by DailyRounds.org (Largest network of doctors 200000+ & counting).
http://www.dailyrounds.org/blog/ucpmp-uniform-code-of-pharmaceuticals-marketing/
Compliant Promotion in an On-demand WorldDale Cooke
The Internet is now the premier source of healthcare information for physicians and consumers alike. Consequently, FDA-regulated companies have been leveraging it in various ways, but compliance has proven challenging and confusing for companies not accustomed to digital tactics.
* Recent FDA enforcement actions that command the attention of anyone considering digital communication tactics
* Trends in digital media consumption and their impact on advertising effectiveness
* FDA’s 2009 Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion
* FDA’s 2011 Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications
*Some red flags guaranteed to draw FDA’s ire
* The latest on FDA social media guidance
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
Drug Safety – An Overview of FDA Powers under FDAAAMichael Swit
Presentation to Conference on Marketing Applications jointly sponsored by San Diego Regulatory Affairs Network (SDRAN) and the Orange County Regulatory Affairs (OCRA) Discussion Group, in November 2009. Talk focused on the new powers granted FDA under the 2007 Food and Drug Administration Amendments Act (FDAAA).
The document discusses the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) in India. The UCPMP provides voluntary guidelines for ethical pharmaceutical marketing and promotion. It outlines restrictions on promotional claims, product comparisons, and interactions with healthcare professionals. The guidelines prohibit gifts, travel funds, cash payments, and other inducements that could improperly influence medical decisions. Adopting the ethical standards in the UCPMP is important for pharmaceutical companies to shift away from outdated marketing beliefs and practices.
This document provides information on medical devices used in equine medicine. It defines a medical device as an instrument or article that is used to diagnose, cure, mitigate, treat or prevent disease, and which does not achieve its purpose through chemical action or metabolism. For human medicine, devices are classified from Class I to III based on risk. While the FDA regulates human medical devices, there is no approval process for veterinary devices, though they cannot be misbranded or mislabeled. Practitioners can use veterinary devices for their intended purposes but should be aware they have not been evaluated for safety or efficacy if used as pharmaceuticals.
The document discusses issues related to drug promotion and marketing practices in India. Some key points:
- 11% of statements made by drug reps to clinicians have been found to be inaccurate, and only 25% of physicians are aware of incorrect information provided.
- Drug promotion aims to induce prescription and use of drugs and is defined broadly by WHO. In India, promotional materials are regulated by codes from DOP and OPPI.
- Promotional claims should be accurate, balanced, and substantiated by evidence. Superlatives like "safe" should be avoided. Overall, the accurate representation of drug benefits and risks is emphasized.
The document discusses issues related to drug promotion and marketing practices in India. It notes that 11% of statements made by medical representatives about drugs have been found to be inaccurate. Few physicians are aware of incorrect information provided. Drug promotion is defined as any activity aimed at inducing prescription or use of drugs. Regulations and codes like the IFPMA and OPPI codes aim to ensure promotional materials are truthful, accurate and not misleading. However, commercial pressures sometimes lead companies to use less ethical practices like exaggerating drug effectiveness or downplaying risks to influence prescribing. Strong regulation and compliance with codes is needed to improve standards of drug promotion in India.
This voluntary code establishes marketing practices for the Indian pharmaceutical industry. It prohibits promoting products without authorization and requires all promotional materials and claims to be truthful, accurate, and capable of substantiation. Medical representatives must maintain high ethical standards. Free drug samples are only permitted for qualified professionals and in limited quantities. No gifts, benefits, or entertainment may be provided to healthcare professionals. Companies can provide reasonable assistance for bona fide medical education events in India.
The document discusses the marketing and regulation of over-the-counter (OTC) drugs, including the differences between OTC and prescription drugs, the OTC drug review process conducted by the FDA, and the role of pharmacists in counseling patients on the safe and effective use of OTC medications. Key points covered include the benefits and risks of OTC drug use, the FDA approval pathways for OTC products, and best practices for pharmacist counseling on OTC selections and their appropriate use.
This document discusses distribution records and the Hatch-Waxman Act. It defines distribution records as written data related to the distribution of drug products from manufacturers to distributors. It notes distribution records should include information like product name, strength, recipient details, and quantities. The document also summarizes the key aspects of the Hatch-Waxman Act, including that it established the Abbreviated New Drug Application process for generics and aimed to balance interests of brand and generic drug companies as well as consumers.
The document discusses pharmaceutical marketing practices in India and the development of a Uniform Code of Pharmaceutical Marketing Practices (UCPMP). It notes that while the UCPMP aims to standardize ethical practices, some remain skeptical of its effectiveness without strict enforcement. Concerns have been raised about the influence of pharmaceutical company promotions on doctor prescribing habits. The UCPMP framework outlines principles for ethical product promotion, prohibiting gifts to influence prescribing, and requiring transparency around expenditures.
The document discusses Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Supplemental New Drug Applications (SNDAs). It provides details on the purpose and requirements of each application type, including necessary contents, guidelines, and the laws and regulations that govern the FDA drug approval process.
Regulatory affairs professionals ensure public health by controlling the safety and efficacy of products. They keep track of changing legislation and advise their company on legal and scientific requirements. They collect and evaluate scientific data, present registration documents to regulatory agencies, and obtain marketing authorization for products. A good regulatory affairs professional helps maximize resources and serves as the first point of contact between a company and government authorities.
The document provides an overview of Japan's regulatory system for pharmaceutical products. It discusses the classification of medical products, the required licenses to manufacture and market products, and the roles of the Ministry of Health and Pharmaceuticals and Medical Devices Agency. It also summarizes regulations around clinical trials, marketing approval, pricing, manufacturing, advertising, packaging, patents, trademarks, and product liability.
In late 2011, the FDA released a document addressing how the pharmaceutical industry can and should respond to requests about off-label drug usage. This POV provides more information about the guidance document, highlights the key issues, and offers use cases to consider in the digital realm.
On numerous occasions, we have seen companies’ websites and products boasting with an FDA approved stamp on it. While the FDA is responsible for protecting public health by regulating drugs, medical devices, tobacco, food, cosmetics, and radiation-emitting products; it does not approve all products in the categories above...
The document discusses the process of drug development and approval, including the role of generic drugs. It covers the following key points:
1. There are 5 stages of drug development from discovery to post-marketing trials. Generic drugs can enter after patents and exclusivity expire through an abbreviated approval process requiring only proof of bioequivalence rather than full clinical trials.
2. The Hatch-Waxman Act of 1984 aimed to balance incentives for innovation with increased generic competition. It established provisions for patent term extensions and periods of marketing exclusivity for innovators as well as an abbreviated approval pathway for generics.
3. Generics must file an ANDA demonstrating bioequivalence to the reference drug and can
IND (Investigational New Drug) industrial perspectiveAYESHA NAZEER
Describing the Industry's/sponsor's/drug manufacturers' perspective of the Investigational New Drug Application (IND) program based on the survey conducted by the Office Of Inspector General (OIG).
Pharmaceutical Industry - Business Perspectives for IT TeamsSatheesh Kadiam
The document provides an overview of the pharmaceutical industry and drug development process. It discusses how the industry is highly regulated and the various stages of drug development from target discovery through clinical trials and regulatory approval. It also outlines the major areas of pharmaceutical manufacturing including biochemical and chemical API production, bulk manufacturing, and packaging. Regulatory compliance and good manufacturing practices are essential throughout the manufacturing process.
Best Practice Document on Handling of Market Complaints.pdfTom Aspinall
Market complaints in the pharmaceutical industry refer to issues raised by consumers or regulatory bodies regarding product quality, safety, or marketing practices. These complaints are crucial for maintaining industry standards, ensuring patient safety, and regulatory compliance.
The document discusses the Investigational New Drug (IND) application process. An IND application is required for a pharmaceutical company to conduct clinical trials of an unapproved drug and ship the drug across state lines. The IND application contains information on preclinical animal and toxicology studies, clinical trial protocols, manufacturing details, and the qualifications of investigators. It must be approved by the FDA before clinical trials can begin.
This document discusses the role and importance of regulatory affairs professionals in the pharmaceutical industry. It notes that regulatory affairs professionals ensure companies comply with relevant laws and regulations, advise on regulatory strategies and requirements, and facilitate the approval and marketing of drugs by communicating with regulatory agencies. Their work is important for developing innovative products and accelerating time to market while ensuring safety, efficacy and compliance.
Letter of comment to DOC Titanium Sponge Working GroupDickson Consulting
Robert J. Dickson submitted comments to the U.S. Department of Commerce's Bureau of Industry and Security's Titanium Sponge Working Group. He has over 20 years of experience in the titanium industry as the CFO of Dynamet Incorporated. In his comments, he recommends that the working group comprehensively review financial and regulatory filings of major titanium companies, make efforts to incentivize and support titanium processing in the U.S., retain intellectual developments in the U.S., support growth of the U.S. employment base, use tariffs when necessary, consider stockpiling titanium ingots, establish relations with non-U.S. titanium producers, and plan for reliance on foreign supply chains in
This poem celebrates the new Covid-19 vaccine and hopes that it will allow life to return to normal. It expresses excitement that the suffering, fear, isolation, and risk of infection and death from the virus may soon end now that the vaccine is available. It hopes people will stop wearing masks and be able to hug friends again as the pandemic nightmare comes to an end. The poem encourages building a better life as the vaccine brings an end to the fear and strife of the past year.
Now is the time to evaluate solar and wind generated powerDickson Consulting
The document discusses the benefits of solar panels and wind turbines for businesses. It notes that political changes and concerns over climate change may result in new legislation that provides subsidies and reduces costs for renewable energy projects. The document recommends that CEOs, COOs, and CFOs evaluate utilizing solar panels or wind turbines at their facilities, as now is a good time to begin planning such projects. It outlines factors to consider in deciding if solar or wind projects are suitable, as well as providing example plans for executing a renewable energy project.
Titanium sponge is a porous form of titanium produced in the first stage of processing titanium ore into alloys. Titanium alloys are used across many industries like aerospace, medical, and sports equipment due to their strength and corrosion resistance. The United States imports over 60% of its titanium sponge needs and only has one facility capable of processing titanium ore into sponge, making stockpiling difficult since sponge degrades over time.
This document discusses the process of taking a company public through a special purpose acquisition company (SPAC). It outlines the key steps and roles of the SPAC sponsors in launching the initial public offering, identifying an acquisition target, and completing the business combination to bring the target public. The document also provides an overview of the services offered by Dickson Consulting to support companies throughout the SPAC process.
The document provides a response to the SEC's proposal to grant an exemption allowing natural persons called "Finders" to connect investors with small businesses needing capital without registering as brokers. The response recommends: (1) eliminating the two proposed tiers of Finders and having one tier with comprehensive regulations; (2) expanding the definition of Finders to include professional service providers; and (3) requiring Finders to register online with the SEC and confirm understanding and intent to comply with regulations. The response then answers each of the SEC's 45 questions, providing further recommendations to improve the proposed exemption.
This document is a letter submitted in response to a proposed rule from the Centers for Medicare & Medicaid Services regarding Medicare coverage of innovative medical devices designated as breakthrough by the FDA. The letter applauds the proposed rule, which would provide national Medicare coverage starting on the date of FDA market authorization for 4 years. This would help start-up medical device companies commercialize their products after FDA approval and avoid the "Valley of Death" period between approval and reimbursement when patients may go untreated and companies may fail financially. The letter urges CMS to finalize and implement the proposed rule, arguing it would benefit both patients and the medical device industry. It is signed by current and former executives, investors, and advisors in start-up medical
McCracken Alliance Partners (MAP) is a partnership of experienced CFOs and finance executives that provides a range of financial leadership services to companies. This includes interim or full-time CFOs, board membership, mergers and acquisitions advisory roles, and special projects. Founder Bob Dickson is a partner at MAP and Dickson Consulting. The presentation summarizes MAP's services and partnerships with other professional services firms that help support clients' needs. It also discusses how the COVID-19 pandemic has changed work environments and increased the ability to provide services virtually from anywhere.
The document discusses the challenges facing chief financial officers in closing the 2020 financial year due to the COVID-19 pandemic. It notes that staff may be working remotely, disruptions occurred, and systems/controls changed. Business conditions also changed as supply chains were disrupted and strategies changed. As a result, the CFO faces more issues than ever in the 2020 financial closing. The presentation then outlines the role of the CFO and some potential issues they may face in the closing.
Creating a M&A advisory board can help companies achieve their objectives of acquiring other companies or selling their own company. M&A transactions are complex, risky, and expensive, so having independent advisors with M&A expertise can increase the likelihood of success. A M&A advisory board can provide advice and expertise to assist the board of directors and management in their strategic objectives. Setting up an effective M&A advisory board requires defining its mandate, selecting qualified members, and managing the board to maximize its contributions.
Now is the Time for CEO's, COO's and CFO's to Evaluate the Use of Solar PanelsDickson Consulting
- Bob Dickson, founder of Dickson Consulting and partner at McCracken Alliance Partners, is presenting on evaluating the use of solar panels for CEOs, COOs, and CFOs.
- Political changes under the Biden administration may result in increased funding for clean energy projects like solar, making them more economically feasible. Additionally, reducing or eliminating tariffs on solar imports could lower costs.
- Now is the time for companies to establish cross-functional teams to evaluate installing solar panels, considering factors like available roof space, energy consumption needs, and geographic suitability. Advisory boards including financial experts can help develop and oversee solar projects.
MAP provides professional services to support venture capital and private equity firms, including serving on advisory boards, managing the office of the CFO, addressing capital formation issues, and supporting M&A transactions. Bob Dickson is a partner at MAP who has experience as CFO of companies that were sold, such as CardiacAssist which was sold for $250 million. MAP works with a network of CFO advisors across the US to provide local and national services and links clients to technical expertise.
The document discusses the role and responsibilities of an audit committee. It provides an overview of how an audit committee should provide oversight of an organization's financial reporting and internal controls. This includes coordinating with leadership, developing an audit committee charter, overseeing external financial reporting and the external audit, monitoring internal controls and risk management, and reporting to the full board of directors. The document also describes services that McCracken Alliance Partners (MAP) can provide to assist audit committees, such as performing reviews, providing temporary audit committee members, and advising audit committees.
Dickson Consulting provides professional services to support merger and acquisition activity. Founder Bob Dickson has over 40 years of experience as a CFO for both smaller and publicly traded companies. Dickson Consulting's services include serving on an M&A advisory board, managing the office of the CFO, addressing capital formation issues, supporting transaction execution, providing investment banking for exits, searching for acquisition candidates, and providing HR and risk management advisory services. The document discusses these services and provides examples of Dickson Consulting's experience. It also provides information on working with a community of professional partners including legal counsel, investment bankers, and firms that specialize in acquisition searches.
This document discusses financial statements and how they relate to entrepreneurial businesses. It provides definitions for key financial terms like assets, liabilities, equity, income statement, balance sheet, and cash flow statement. It explains the purpose and components of various financial statements. The document also discusses financial analysis metrics for evaluating a company's profitability, solvency, and efficiency.
This document provides an overview of a 401(k) plan education presentation by Dickson Consulting. It includes sections on investor considerations, background on 401(k) plans, investing overview, types of mutual funds, and additional information. The presentation covers topics like risk tolerance assessments, asset allocation strategies, and guidelines for conservative to aggressive investment approaches. It aims to promote understanding of 401(k) plans and the investing process without providing specific investment advice.
The document provides an overview of financial reporting for entrepreneurs. It discusses key financial statements including the balance sheet, income statement, and statement of cash flows. It aims to help entrepreneurs better understand and explain financial statements to demonstrate the growth and strength of their business to various stakeholders. The presentation covers accounting principles, forms of business organizations, and components of the major financial statements.
This document provides tips for entrepreneurial companies during an economic slowdown. It recommends preparing detailed short-term forecasts, strengthening the balance sheet by improving financial ratios and having more cash, cutting costs and reducing burn rates, focusing on revenue generation and variable costs, shifting to equity-based compensation, slowing down payables and accelerating receivables, turning inventories, and exploring funding alternatives. Maintaining strong financial management is key to weathering an economic downturn.
Brian Fitzsimmons on the Business Strategy and Content Flywheel of Barstool S...Neil Horowitz
On episode 272 of the Digital and Social Media Sports Podcast, Neil chatted with Brian Fitzsimmons, Director of Licensing and Business Development for Barstool Sports.
What follows is a collection of snippets from the podcast. To hear the full interview and more, check out the podcast on all podcast platforms and at www.dsmsports.net
The Genesis of BriansClub.cm Famous Dark WEb PlatformSabaaSudozai
BriansClub.cm, a famous platform on the dark web, has become one of the most infamous carding marketplaces, specializing in the sale of stolen credit card data.
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Zodiac Signs and Food Preferences_ What Your Sign Says About Your Tastemy Pandit
Know what your zodiac sign says about your taste in food! Explore how the 12 zodiac signs influence your culinary preferences with insights from MyPandit. Dive into astrology and flavors!
The APCO Geopolitical Radar - Q3 2024 The Global Operating Environment for Bu...APCO
The Radar reflects input from APCO’s teams located around the world. It distils a host of interconnected events and trends into insights to inform operational and strategic decisions. Issues covered in this edition include:
Building Your Employer Brand with Social MediaLuanWise
Presented at The Global HR Summit, 6th June 2024
In this keynote, Luan Wise will provide invaluable insights to elevate your employer brand on social media platforms including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok. You'll learn how compelling content can authentically showcase your company culture, values, and employee experiences to support your talent acquisition and retention objectives. Additionally, you'll understand the power of employee advocacy to amplify reach and engagement – helping to position your organization as an employer of choice in today's competitive talent landscape.
3 Simple Steps To Buy Verified Payoneer Account In 2024SEOSMMEARTH
Buy Verified Payoneer Account: Quick and Secure Way to Receive Payments
Buy Verified Payoneer Account With 100% secure documents, [ USA, UK, CA ]. Are you looking for a reliable and safe way to receive payments online? Then you need buy verified Payoneer account ! Payoneer is a global payment platform that allows businesses and individuals to send and receive money in over 200 countries.
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Top mailing list providers in the USA.pptxJeremyPeirce1
Discover the top mailing list providers in the USA, offering targeted lists, segmentation, and analytics to optimize your marketing campaigns and drive engagement.
Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.AnnySerafinaLove
This letter, written by Kellen Harkins, Course Director at Full Sail University, commends Anny Love's exemplary performance in the Video Sharing Platforms class. It highlights her dedication, willingness to challenge herself, and exceptional skills in production, editing, and marketing across various video platforms like YouTube, TikTok, and Instagram.
Industrial Tech SW: Category Renewal and CreationChristian Dahlen
Every industrial revolution has created a new set of categories and a new set of players.
Multiple new technologies have emerged, but Samsara and C3.ai are only two companies which have gone public so far.
Manufacturing startups constitute the largest pipeline share of unicorns and IPO candidates in the SF Bay Area, and software startups dominate in Germany.
Digital Marketing with a Focus on Sustainabilitysssourabhsharma
Digital Marketing best practices including influencer marketing, content creators, and omnichannel marketing for Sustainable Brands at the Sustainable Cosmetics Summit 2024 in New York
Part 2 Deep Dive: Navigating the 2024 Slowdownjeffkluth1
Introduction
The global retail industry has weathered numerous storms, with the financial crisis of 2008 serving as a poignant reminder of the sector's resilience and adaptability. However, as we navigate the complex landscape of 2024, retailers face a unique set of challenges that demand innovative strategies and a fundamental shift in mindset. This white paper contrasts the impact of the 2008 recession on the retail sector with the current headwinds retailers are grappling with, while offering a comprehensive roadmap for success in this new paradigm.
How to Implement a Strategy: Transform Your Strategy with BSC Designer's Comp...Aleksey Savkin
The Strategy Implementation System offers a structured approach to translating stakeholder needs into actionable strategies using high-level and low-level scorecards. It involves stakeholder analysis, strategy decomposition, adoption of strategic frameworks like Balanced Scorecard or OKR, and alignment of goals, initiatives, and KPIs.
Key Components:
- Stakeholder Analysis
- Strategy Decomposition
- Adoption of Business Frameworks
- Goal Setting
- Initiatives and Action Plans
- KPIs and Performance Metrics
- Learning and Adaptation
- Alignment and Cascading of Scorecards
Benefits:
- Systematic strategy formulation and execution.
- Framework flexibility and automation.
- Enhanced alignment and strategic focus across the organization.
HOW TO START UP A COMPANY A STEP-BY-STEP GUIDE.pdf46adnanshahzad
How to Start Up a Company: A Step-by-Step Guide Starting a company is an exciting adventure that combines creativity, strategy, and hard work. It can seem overwhelming at first, but with the right guidance, anyone can transform a great idea into a successful business. Let's dive into how to start up a company, from the initial spark of an idea to securing funding and launching your startup.
Introduction
Have you ever dreamed of turning your innovative idea into a thriving business? Starting a company involves numerous steps and decisions, but don't worry—we're here to help. Whether you're exploring how to start a startup company or wondering how to start up a small business, this guide will walk you through the process, step by step.
How to Implement a Real Estate CRM SoftwareSalesTown
To implement a CRM for real estate, set clear goals, choose a CRM with key real estate features, and customize it to your needs. Migrate your data, train your team, and use automation to save time. Monitor performance, ensure data security, and use the CRM to enhance marketing. Regularly check its effectiveness to improve your business.