A Biotechnology and Pharmaceutical Primer - 200 Questions & Answers



The Biotechnology and Pharmaceutical industry is one of the most innovative sectors in healthcare. The industry is responsible for producing innovative life-saving and life-enhancing products for patients and consumers around the world. Though it is a fairly mature industry today, the growth over the last couple of decades has been staggering in terms of both the number of products produced and market cap of companies. 

The Biotechnology and Pharmaceutical Primer, prepared by experts offers a comprehensive list of over “200 questions and answers” covering all areas of the BioPharma value chain including discovery, development, manufacturing, distribution, marketing, life cycle management, performance monitoring, and business model optimization. This primer offers required foundation for you to effectively tackle technical aspects of your day-to-day work.  This book has been designed in such a way that experienced professionals could refresh their knowledge and newcomers could gain greater insights into all areas of BioPharma business. 

Preface



The biotechnology and pharmaceutical sector is one of the most complex and dynamic sectors in the healthcare industry and has been on the global forefront in offering innovative and highly effective cures to patients. This is primarily driven by a great appetite to find cures, exemplary encouragement of basic research, aggressive investments into risky research and development ventures, and is boosted by relatively attractive market economics and supporting policy environment. More importantly, the BioPharma sector has always been one of the most sought after job field, which employs highly educated scientific, medical, and business professionals, who are in turn responsible for complex activities in research, development and commercialization of BioPharma products.

This book, “Biotechnology and Pharmaceutical Primer”, offers a comprehensive list of over 200 questions and answers covering key areas of the BioPharma value chain including product discovery, development, manufacturing, distribution, marketing, life cycle management, and performance monitoring. Other critical strategic areas of BioPharma business including business models, investment opportunities and investment risks are also addressed in this book.  This primer should give you the required foundation to effectively tackle basic questions.

Biotechnology and Pharmaceutical Primer is a clear, concise, and comprehensive listing of basic questions and answers. This primer is structured into thirteen sections, with each section providing a brief overview followed by a list of key questions and answers. This primer provides room for notes at the end of each answer to allow you to capture additional research data points, your experiences, and other ideas laden with examples that will ultimately allow you to answer in your own discrete fashion.  

The entire collection of questions and answers has culminated from decades of experience in the industry. This primer is comprehensive; however, due to the complex nature of the industry we wholeheartedly encourage you to leverage the information in this book to build the required foundation and also do additional research in the areas of interest. The readers are encouraged to skim through all question sets to gain a broad understanding of the business issues commonly dealt with during day-to-day business operations. Whether you are an experienced professional in the BioPharma sector or a beginner, this primer will offer good insights. The Biotechnology and Pharmaceutical Primer will be an invaluable resource for finding answers for some of the most common questions in the industry.  

 

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List of Questions Answered



Section 1: BioPharma Sector Overview
1.1          What are Biopharmaceutical products (or medicines or drugs)?
1.2          What do prescription drugs account for in US healthcare expenditure?
1.3          What is a BioPharma Company’s intellectual property? How do they protect it?
1.4          Who are the key players in the BioPharma ecosystem?
1.5          What are the key drivers shaping the BioPharma industry today?
1.6          What are the key challenges faced by a BioPharma companies?
1.7          What are the key opportunities for BioPharma companies?  

Section 2: BioPharma Value Chain
2.1          What are the key elements of discovery and development of a drug?
2.2          Why is discovery and development of a product so complex?
2.3          What are the regulatory imperatives to successfully bring a product to market?
2.4          How does the FDA drug review and approval process work?
2.5          What is a BLA? Who has the regulatory responsibility for biologics?
2.6          What are the different categories of biologic products regulated by CDER?
2.7          How are drugs classified?
2.8          How attractive are the economics of BioPharma companies?
2.9          What are the typical discovery and development success rates?
2.10       What does it cost to develop a drug and why is it increasing?
2.11       Why R&D productivity continues to be a major challenge?
2.12       What do clinical trials cost?
2.13       What is the cost structure of a typical BioPharma company?
2.14       What are the key cost drivers for a BioPharma company?
2.15       What are the key economic decisions that companies have to contemplate with?
2.16       How best to maximize the financial investment into a product?  

Section 3: Product Discovery
3.1          What are the key steps in drug discovery?
3.2          What is drug design and what are the different types of drug design?
3.3          How is drug testing done? What is explored as part of clinical pharmacology?
3.4          What are the decision choices once the drug candidate is identified?
3.5          What’s a drug’s value proposition?
3.6          What are key elements of Drug Value Profile (DVP)?
 3.7         What are the DVP applications in a drug’s life cycle?
3.8          How does the IND review process work?
3.9          What are some of the considerations to make discovery process successful? 

Section 4: Product Development
4.1          What are the different phases in clinical trials?
4.2          What are the different types of clinical trials?
4.3          What is the difference between Evidence-based vs. Value-based medicines?
4.4          What’s Value Based Study (VBS) design?
4.5          What are the key process steps in undertaking clinical trials?
4.6          Why are some clinical trials terminated early?
4.7          How companies make Phase II/III “Go/No-Go” decisions?
4.8          What are the requirements around evidence generation for a drug?
4.9          What are the NDA/approval related activities?
4.10       What is a Biologics License Application (BLA)?
4.11       What is a Package Insert?
4.12       What are some of the post-approval considerations for a drug?
 4.13      How do you ensure successful product clinical development? 

Section 5: Product Manufacturing
5.1          How does the product manufacturing process work?
5.2          How does product manufacturing scale-up work?
5.3          What are the key steps involved in product manufacturing?
5.4          How are biologics manufactured?
5.5          What are the life cycle phases in product manufacturing?
5.6          How product is developed (Phase I) from a manufacturing perspective?
5.7          What are the different approaches to product development?
5.8          How does the Technology Transfer (Phase II) work?
5.9          How is Commercial Manufacturing done (Phase III)?
5.10       What is quality risk management?
5.11       How is product packaging and labeling done?
5.12       How is product storage and distribution handled?
5.13       What is the process used to discontinue a product?
5.14       What is Process Analytical Technology (PAT) framework?
5.15       How does FDA review product quality issues?
 5.16      Who at FDA reviews product manufacturing related activities?
5.17       How do you ensure that manufacturing process is well executed? 

Section 6: Product Distribution
6.1          What does the distribution landscape entail?
6.2          What are the different distribution models?
6.3          How BioPharma companies work with distributors?
6.4          What is the role of pharmacies?
6.5          How does the pharmacy prescription fulfillment process work?
6.6          What is the role of Group Purchasing Organizations (GPOs)?
6.7          What is a chargeback?
6.8          What are the key regulations governing a product distribution?
6.9          How is information managed in product distribution?
6.10       What are the key developments in distribution environment?
6.11       What are the distribution imperatives for BioPharma companies?
6.12       What are the key considerations for new products from a distribution perspective?
6.13       How do you ensure successful product distribution? 

Section 7: Product Marketing
7.1          What are the roles of target stakeholders?
7.2          How do target stakeholders make decisions?
7.3          What are the positioning imperatives to effectively position the product?
7.4          How product value proposition is customized for each stakeholder group?
7.5          How are product value proposition messages developed?
7.6          How product value proposition is communicated to target stakeholders?
7.7          What communication channels are used to target stakeholders?
7.8          How product marketing success is monitored and measured? 

Section 7A: Product Value Proposition
7A.1       What are the three components of a product’s value proposition?
 7A.2      What are the attributes of a product’s clinical value? How are they measured?
7A.3       What are the attributes of a product’s economic and strategic value? How are they measured?
7A.4       What is the Value over Cost imperative for a product?
7A.5       What does product value proposition mean to each stakeholder group?
7A.6       How stakeholder preferences around a product are assessed?
7A.7       How to ensure that the product value proposition is differentiated?
7A.8       How a product value proposition is communicated to stakeholders? 

Section 7B: Product Pricing  
7B.1       What are the demand and supply drivers affecting pricing?
7B.2       What are the common pricing strategies?
7B.3       What are the positive and negative drivers that impact pricing decisions?
7B.4       What is Value-Based Pricing (VBP)? How is it developed?
7B.5       What is the price elasticity for each stakeholder?
7B.6       How does pricing work in private vs. public sectors? 

Section 7C: Product Demand Forecasting   
7C.1       What are forecasting applications in a product life cycle?
7C.2       What is a Patient Treatment Flow (PTF) model? How is it used to estimate a product’s potential?
7C.3       How potential opportunities are uncovered using the PTF model?
7C.4       What are the factors that could affect a product’s potential?
7C.5       How to assess the impact of uncertainties?                                                                                                                                                                                               

Section 7D: Provider Positioning      
7D.1      What are the different provider segments and care settings?
7D.2      What role do primary care physicians and specialists play?
7D.3      Who are Key Opinion Leaders?
 7D.4     How do physicians make decisions along the treatment continuum?
7D.5      What role do Nurse Practitioners play?
7D.6      How do Nurse Practitioners make decisions along the treatment continuum?
7D.7      What role do Pharmacists play?
7D.8      How do Pharmacists make decisions along the treatment continuum?
7D.9      What is the best way to position a product among providers?
7D.10    How to customize the product value proposition for providers?
7D.11    How to measure the impact of value messages?
7D.12    How to communicate the product value proposition to providers?
7D.13    How is promotional channel response evaluated?
7D.14    What are the common communication tools and tactics used to target providers?
7D.15    How to monitor and measure the effectiveness of provider positioning efforts? 

Section 7E: Payer Positioning
7E.1       Who pays for prescription drugs?
7E.2       What is Medicare?
7E.3       What is Medicaid?
7E.4       What’s the role of managed care organizations?
7E.5       How do payers make decisions around product coverage?
7E.6       What are the typical coverage restrictions payers put in place?
7E.7       How does the payer decision-making process around product coverage work?
7E.8       What’s the role of Pharmacy Benefit Managers (PBMs)?
7E.9       How do PBM’s intervene to influence product selection and utilization?
7E.10     How do BioPharma companies work with payers to create value?
7E.11     How best to position a product among payers?
7E.12     How to customize a product’s value proposition to payers?
7E.13     How to communicate a product value proposition to payers?
7E.14     How best to monitor the effectiveness of payer positioning efforts? 

Section 7F: Patient Positioning         
7F.1       What are the challenges that patients face as they seek treatment?
7F.2       How do patients make decisions around treatment continuum?
7F.3       How a product value proposition is customized for patients?
7F.4       How to capture the lifetime value of a patient?
7F.5       How to communicate value proposition to patients?
7F.6       What is the role of advocacy and public relations in patient communications?
7F.7       How to monitor the effectiveness of patient positioning efforts? 

Section 7G: Policy Maker Positioning            
7G.1      Who are the policy makers?
7G.2      What is Patient Protection and Affordable Care Act (PPACA)?
7G.3      How is PPACA affecting BioPharma companies?
7G.4      What’s the decision making process of the policy makers?
7G.5      How best to position the product among policy makers?
7G.6      How do you customize the product value proposition for policy makers?
7G.7      How do you communicate the value proposition to policy makers?
7G.8      How do you measure the effectiveness of policy maker positioning efforts? 

Section 8: Product Life Cycle Management
8.1          What are typical Life Cycle Management strategies?
8.2          What are some of the key advantages and considerations for LCM strategies?
8.3          How is evidence generated to support LCM strategies?
8.4          What are authorized generics?
8.5          What’s generic intrusion? What are the settlement choices?
8.6          What are Rx-to-OTC switching strategies?
8.7          How to invest into LCM opportunities? 

Section 9: Product Valuation and Economics
9.1          What are the key valuation levers for a product?
9.2          What are the revenue and cost drivers in product valuation?
9.3          How best to develop a valuation model?
9.4          What are the key uncertainties in product valuation?
9.5          How does the valuation change during a product’s life cycle? 

Section 10: Product Performance Monitoring
10.1       What is a product strategic roadmap?
10.2       How should companies approach global development and commercialization?
10.3       Which areas must be monitored closely assess a product’s performance?
10.4       What are the key financial performance measures?
10.5       What are the key performance measures to ensure successful product discovery?
10.6       What are the key performance measures to ensure successful product development?
10.7       What are the key performance measures to ensure successful manufacturing and distribution?
10.8       What are the key performance measures to ensure successful commercialization? 

Section 11: BioPharma Business Model
11.1       What are the different types of business models?
11.2       What are the strategic choices under Traditional business model?
11.3       What are the strategic choices under a Focused business model?
11.4       What are the strategic choices under a Networked business model?
11.5       What are the strategic choices under a virtual business model?
11.6       What is horizontal vs. vertical integration?
11.7       What does “Focus vs. Diversification” offer to a BioPharma Company?
11.8       Should a BioPharma Company pursue Diagnostic/Device integration?
11.9       Should a BioPharma provide value-add service offerings?
11.10    How could technology create value for BioPharma companies?
11.11    Why do BioPharma companies license products and pursue partnerships?
11.12    How to ensure competitiveness of a BioPharma company?
11.13    Why should BioPharma companies strive for continuous innovation?
11.14    How could a BioPharma company ensure organizational alignment? 

Section 12. BioPharma Investment Opportunities                
12.1       What are some of the consideration before investing into BioPharma companies?
12.2       How do you identify attractive investment opportunities in the BioPharma industry?
12.3       What are the most commonly found investment transactions?
12.4       What is an example for an attractive market opportunity with unmet needs?
12.5       What is an example for an attractive evolving market opportunity?
12.6       What is an example of a chronic disease with continued unmet medical needs?
12.7       How are companies targeting rare diseases?
12.8       What do companies focused on technology platforms do?
12.9       What do intellectual property (IP) asset management companies do?
12.10    What are some of the opportunities in the biologics and biotech space?
12.11    What are the funding sources for BioPharma companies? 

Section 13. BioPharma Investment Risks
13.1       What are the key risks faced by a BioPharma Company?
13.2       What are the risks associated with intellectual property?
13.3       What are the common risks in discovery and development?
13.4       What are the common risks in manufacturing and distribution?
13.5       What are the common risks in commercialization?
13.6       What are the common financial risks faced by BioPharma companies?
13.7       How best to assess a BioPharma Company’s risks?

 

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