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Pfizer Class Presentation
- 2. We will become the world's most valued company to patients, customers, colleagues, investors, business partners, and the communities where we work and live. We dedicate ourselves to humanity's quest for longer, healthier, happier lives through innovation in pharmaceutical, consumer, and animal health products. Our Mission Our Purpose
- 3. O ur Values are a declaration of our core beliefs and the defining features of a culture that breeds achievement. The Pfizer Values provide the direction necessary for making the Pfizer Vision a reality. They are guiding principles for day-to-day decision-making and reflect the enduring character of Pfizer and its people. They appear in order as follows: INTEGRITY We demand of ourselves and others the highest ethical standards, and our products and processes will be of the highest quality. The Pfizer name is a source of pride to us and should inspire trust in all whom we come in contact. RESPECT FOR PEOPLE We recognize that people are the cornerstone of Pfizer's success. We come from many different countries and cultures, speak many languages, and value this diversity as a source of strength. We are proud of Pfizer's history of treating employees with respect and dignity, and we are committed to building upon this tradition. CUSTOMER FOCUS We are deeply committed to meeting the needs of our customers, and we constantly focus on customer satisfaction. We take genuine interest in the welfare of our customers, both internal and external. COMMUNITY We play an active role in making every country and community in which we operate a better place to live and work, knowing that the ongoing vitality of our host nations and local communities has a direct impact on the long-term health of our business. V A L U E S
- 4. INNOVATION Innovation is the key to improving health, sustaining Pfizer’s growth, and enhancing our contribution to society. The quest for innovative solutions should invigorate all of our core businesses and the Pfizer community worldwide. TEAMWORK We know that to be a successful company we must work together, frequently transcending organizational and geographic boundaries to meet the changing needs of customers. PERFORMANCE We strive for continuous improvement in our performance, measuring results carefully, and ensuring that integrity and respect for people are never compromised. When we commit to doing something, we will do it in the best, most timely way possible. Then we will try to think of ways to do it better the next time. LEADERSHIP We believe that leaders lead by establishing clarity of purpose, a shared sense of goals, and commitment to excellence. Leaders demonstrate courage, pursuing actions based on a well-defined sense of what is right and a view to long-term success. Leaders empower those around them by sharing knowledge and rewarding outstanding individual effort. We encourage leadership at all levels of the organization and are dedicated to providing opportunities for leaders to grow and develop. QUALITY Since 1849, the Pfizer name has been synonymous with the trust and reliability inherent in the word Quality. Quality is ingrained in the work of our colleagues and all our Values. We are dedicated to the delivery of quality healthcare around the world. Our business practices and processes are designed to achieve quality results that exceed the expectations of patients, customers, colleagues, investors, business partners and regulators. We have a relentless passion for Quality in everything we do.
- 5. Ethical Clinical Trials Employee Business Conduct Policies Compliance with Local, State and Country Laws Uniform Standards of Performance Surrounding the Global Environment, Health and Safety Highest possible standards of laboratory animal care and use Highest ethical standards on providing information about our medical research and medicines. Treat suppliers with dignity and respect, comply with laws and regulations, ensure sound financial practices, and actively encourage diversity. Commitment to Employees Safety of Medicines
- 8. Community and Social Responsibility
- 11. MOTIVATION
- 13. FUTURE 2006 and Onward to the
- 16. The Condensed Explanation of Drug Development
- 17. Translational Research Lifecycle in Drug Development Lead Development Candidate Biomarker Idea! Does it work in animals? It sure does!!! Discovery selects the best candidate Generate human data from method study Validation in humans! POM! Phase I & IIA Clinical Trials THE DRUG WORKS!!!! LET’S INVEST OUR RESOURCES! Biomarker Plan Clinical Plan Discovery – Fix Problem!! YES NO Proof of Concept ! START HERE Cross-line Biomarker Team (EM, Discovery, Biomarker Lab, Clinical Technology, Safety, PK/PD, etc.) Biomarker Study Team (EM,CRS, PK/PD, biostatistics, etc.) Clinical team creates plan Translational experts work with Discovery Project Team Looks good for patients, maybe a product for Pfizer! Validates the outcome biomarker used in Phase IIA Oops-Needs a Tweak Cross-functional Development Team
- 18. Strategy and Governance Idea FIP Approval Development Research Cross-TA Within-TA TA Strategy & Priority Resource Management TA Strategy & Priority Governance Pharmaceutical Strategy Group (PSG) Therapeutic Area Steering Committee (TASC) CAN Research Portfolio Team (RPT) Development Portfolio Review (DPR) Research TA Review Committee (RTARC) Within Development TA Discovery Leadership Team (DL) TA Leadership Team (TALT ) TM Head member TA TM Lead member
- 19. TA-TRC and RTARC Alignment: Advice, Governance and Execution Idea FIP Approval Within TA TA Strategy & Priority Governance CAN TA Leadership Team (TALT ) Commercial Development LOE Research Execution TA Commercial Leadership Team Discovery Project Team Research Candidate Management Team Development Team Commercial Team TA Development Head + TALT Review Committee TA Technical Review Committee Technical/ Advisory Research Lines TA TM Lead membership
- 20. PRESIDENT GLOBAL R&D CEO PFIZER, INC. SR. VICE PRESIDENT PGRD SR. VICE PRESIDENT DEVELOPMENT REPORTING RELATIONSHIPS FOR TRANSLATIONAL MEDICINE
- 21. VICE PRESIDENT GLOBAL TRANSLATIONAL MEDICINE A.K.A. THE GANG OF FOUR MASTERS OF DIPLOMACY CREATIVITY EXCITEMENT GENERATION ! ADMINISTRATIVE LEAD MANAGER ADMIN ASST MANPOWER
- 24. My Role Within TM GTRBF OCT 31-NOV 2
- 25. Immuno Suppression KIDNEY GRAFT SUCCESS! One Measure of Success…… Reduction in NK Cells= BIOMARKER
- 26. … .But TM takes the BIOMARKER view YES POM!!! DISCONTINUE INVESTMENT IN COMPOUND NO NK Cells= BIOMARKER NK Cells= BIOMARKER Reduction Found???
- 27. Phase 2 Survival Pharmacology can be safely expressed in humans – Proof of Mechanism Pharmacology leads to efficacy in the target population – Proof of Concept
- 28. How do we handle problems??
- 29. A BIG wrench in the works…….
- 30. And then the not-so-big problems
- 31. SAE’s Good Clinical Practices SOPs REGULATORY AUDITS EMPLOYEE TRAINING EHS CAN GUIDELINES ANNUAL YBM IDPs NDA FILINGS PLANNING
- 32. COMPLIANCE WITH VALUES POM ACCURATE CLINICAL DATA Pfizer Quarterly Corporate Performance—Fourth-Quarter 2006 PERFORMANCE TO GOALS CONTROL ROI P U B L I C E D U C A T I O N
- 33. QUESTIONS
Editor's Notes
- Our mission and our purpose statements indicate Pfizer’s belief that we are the #1 drug maker in the world with a duty as the industry leader to provide value in all measures.
- Pfizer places a great deal of importance upon compliance to its stated values. Employees are encouraged to learn the values and conduct themselves - within and outside of Pfizer walls – with these values in mind.
- Criteria for awards and promotions include demonstration of the Pfizer values. I’d like to draw attention in particular to our value of innovation. Pfizer leadership encourages innovation at all employee levels and rewards us for improving our products, our environment, our colleagues and ourselves. The Annual Achievement Award, PGRD’s highest achievement award, is presently annually to colleagues whose innovative ideas make important contributions to Pfizer and drug development.
- Decision-making at Pfizer is guided by our values and the needs of our stakeholders. Written policies and procedures provide the maps and our values are the compass to decision-making. We strive for integrity to underpin all our business activities and relationships. Prime example was the case of Torcetrapib when researchers saw a rise in blood pressure in some patients. Pfizer senior leaders ordered the immediate discontinuation of Torcetrapib drug trials, despite an investment of $800 MILLION .
- Pfizer is dedicated to the development of all employees to improve themselves as well as the company. Employees at every level and position are encouraged to “Find a Way to Lead”. In our current atmosphere, the leader behavior of “manage change” is of particular importance. Anticipate strategically Take initiative Plan for better ways to operate Empower people to act Train change agents Seek better practices
- Diversity of its people and diversity of thought are actively encouraged at Pfizer. Membership in affinity groups is promoted as a means to celebrate differences and educate others outside the groups. Various events are held throughout the year which celebrate diversity and inclusion.
- Community-PFE leadership is dedicated to assist not only the communities in which we have offices, but also the world community in general. To this end, management not only leads by example, but also encourages all employees to participate in any effort that will improve the lives of others. American Heart Walk Habitat for Humanity United Way – Pfizer allows colleagues a day with pay to volunteer at a United Way initiative and also is a large contributor each year through the United Way Campaign. Pfizer Helpful Answers materials detail the help that is available for patients without prescription drug SMART – Science and Math Are Really Terrific – reaches out regularly to area students and teachers to encourage learning about math and science. The SAMJAM committee will hold its 18th annual event Welcomes more than 3000 local middle school students to experience math and science first-hand with Pfizer colleagues on campus. Some of the other programs in which Pfizer colleagues are involved are A Moveable Feast; Boy Scouts; CT Brain Injury Association; Breast Cancer Foundation fundraisers; Public school mentoring programs; Holiday Helpers; Make a Wish Foundation; Red Cross Blood Drives; Shoreline Soup Kitchens.
- Communication through Pfizer is promoted via various methods which include company-wide emails, voice mail, site plasma screens, town hall meetings, networking events, Our daily online newspaper – The Pipeline Continued next slide……………..
- Weekly Site Announcements Department Web Sites The PGRD Portal, which provides links to many sources of information
- Unlike what has to be done with this fellow, Pfizer uses a variety of means to motivate its employees. Some of these methods include: Providing a comfortable work environment Promoting and rewarding teamwork Openly communicating with employees – both the good and the bad Conducting surveys to determine where management needs to improve Everyone, regardless of position must create goals and conduct regular discussion with their management Child care centers Fitness centers Flexible work arrangements Mandatory individual development plans Frequent communication directly from patients about how our medicines improve and save lives.
- 1849 Charles Pfizer & Company opens as a fine-chemicals business in the Williamsburg section of Brooklyn, New York. That buildings served as office, laboratory, factory, and warehouse. The company's first product is santonin — a palatable antiparasitic which is an immediate success. 1880 - Citric Acid - Pfizer began producing citric acid in using imported raw citrus. Used in processing of pharmaceutical salts such as citrate of magnesia, a popular laxative, paper making, dissolving iron oxides, and as a flavoring for foods and in soft drinks. Pfizer becomes America's leading producer of citric acid. Coca-Cola, Dr. Pepper, and Pepsi-Cola make citric acid Pfizer's biggest product in the next century. 1936 - Doctor Richard Pasternack develops a fermentation-free method for producing ascorbic acid, vitamin C. After building a new plant and initiating a 24-hour-a-day, seven-day-a-week production schedule, Pfizer becomes the world's leading producer of vitamin C. 1944 - Using deep-tank fermentation, Pfizer mass-produces penicillin and becomes the world's largest producer of the "miracle drug." Most of the penicillin that goes ashore with Allied forces on D-Day is made by Pfizer. 1967 – 1998 Pfizer develops and markets a number of important drugs for infectious diseases, diabetes, depression, hypertension and probably its most famous drug, Viagra.
- Today, Pfizer is a company with over 100,000 employees worldwide. In addition to full-time employees, we have part time, flexible arrangement employees as well as contracted employees, consultants, domestic outside companies (travel arrangements, HR benefits assistants) off-shore outside companies (accounts payable and some desktop support). Exubera – Inhaled insulin Chantix – Smoking cessation Sutent - Oncology
- Highest level management – Balanced portfolio (level of funding appropriate for each Tas particular need – i.e. some Tas may have more unprecedented indications. Risk mitigation Stages : New and risky – novel compound for unprecediented indication i.e. AD modification versus just treating AD symptoms. Standard Pursue aggresively At TA level Very project specific and not tuned in to risk.
- With risk in mind, we come to my department – Translational Medicine
- Take a step backward and here is the short version of drug development
- And this is a “bit” more complicated pictorial of the part TM plays in drug development. As you will see a little further on, my department is basically involved with drug development from Discovery through to Phase 2. So we are basically an “Early Development” Group.
- I’LL BEGIN BY TALKING A LITTLE ABOUT OUR GOVERNANCE STRUCTURE AT THE HIGHER LEVELS OF THE ORGANIZATION.
- AND THEN DRILL DOWN TO THE THERAPEUTIC AREA GOVERNANCE.
- And then to a simplified version of Translational Medicine’s reporting relationships. Things are fairly straightforward until we get down to the Sr. Vice President of Development. Then they get interesting…..
- Why? You ask, Do you have to be the masters of Diplomacy, Creativity and Excitement Generation?
- Because only a manager, and I report directly to my boss. We have a matrixed reporting structure with everyone else. The challenge with this system is that the TM leads have supervisors to whom they directly report – and their priorities may come ahead of TM priorities.
- And yet, the responsibility is huge! Our department can quite possibly make some of the most important contributions to Pfizer, directly affecting its future successes as well as reducing costs.
- I play an important part in TM communication to all sites and in getting the different sites and TA’s to communicate with one another. In my role, part of my job is to help ensure that redundancies are decreased and synergies are increased across our global sites. Enabling Times TM TV Show TM Web Site
- So what exactly do we DO in TM? We help Pfizer make good business decisions through the use of biomarkers. Pfizer measures success in a number of ways, depending upon the phase of discovery and or development of the compound in question. Here we are looking at a Discovery compound we would like to develop to prevent organ rejection in kidney transplant patients. We find that injestion of the compound reduces the number of natural killer cells (autoimmune cells) in the body, thereby suppressing immunity and preventing organ rejection. Obviously, this is a success…..in monkeys….
- However, the results found in animal models do not always TRANSLATE to the same response in humans. TM takes the biomarker view and conducts validation studies by which the number of NK cells are counted in healthy volunteers over a period of time to determine the normal variability in the subjects. In this manner, TM scientists and clinicians are validating whether or not there is a great deal of variability in the NK cells on a regular basis without the compound. The compound is then given to the healthy volunteers and more tests are conducted to determine the amount of NK cells present in the body. Without validating this biomarker, we could not accurately determine whether or not a reduction in NK cells was caused by the compound or by the natural changes in the body. Once the biomarker data are compared and contrasted, a determination can be made as to whether or not we have found PROOF OF MECHANISM with this compound. POM is the determinant of success and it is the decision maker about whether or not investment in the compound should be considered. This testing and decision making is made prior to Phase 2. In the past, many drugs were not “killed” (cessation of investment) until well into Phase 2, where a substantial $ investment is required. Determination of POM is imperative to avoid serious financial loss in Phase 2, 3 and 4 trials.
- Why is this so important??? Because of every 10 compounds developed in Discovery EIGHT fail. Imagine the Mercedes Benz manufacturer who makes 10 shiny new Mercedes sports cars. Now imagine that he takes 8 of those 10 sports cars from the factory and pushes them over a bridge. How much money do you think those remaining 2 would cost to manufacture? Most importantly, how much money do you think the consumer would have to pay for 1 of those 2 cars?
- Any wrench in the works – small or large – must be handled. Size of the wrench, of course, determines the course of action. Major – A recent example encountered by my manager was that a $7.25M project being run at Corporate (early development project using a marketed compound as a comparator). Major problem -coordinating across divs with different processes – required creativity. Took 8 months to get resolution The appropriate stakeholders had to be identified. Numerous telecons with multiple divisions and lines and face-to-face meetings were held. As is the normal course of action within Pfizer, the stakeholders (Finance, Regulatory, Marketing and TM) had to come to a consensus. After consensus was achieved, the proposed solution was then brought to the Research governing body for approval.
- Minor problems, on the other hand, are handled with less fanfare. Procedures are in place that can address the issue in many cases. Conferring with colleagues, via telecon, face to face or email resolves many issues. Regardless of the issue, there is never a reason to “Go It Alone” at Pfizer. Management encourages teamwork and that value transcends throughout the organization. There is always someone who has the answer or is willing to help.
- In TM, for standard issues, we have clearly delineated processes, which we communicate via email, face to face and on our web site. For the out of the ordinary issues, we handle them on a case-by-case basis using whatever needs to be accomplished. We are also expected to use Pfizer SOPs and our policies and procedures to assist us in resolving issues.
- As I mentioned earlier, in TM, POM is the controlling factor of our “go / no-go” decisions. It is our most important control. Also, we have measurements which we use to evaluate proposed studies and determine their possible Return on Investment. Another important control is the statistical data we receive from Discovery and from on-going clinical trials. These data must be comply with the highest standards of accuracy in order to enable prompt, ethical, safe, and financially secure decisions. Unfortunately, we find ourselves in an increasingly hostile environment due to the cost of drugs. Pfizer regularly conducts public education sessions, and public outreach programs. These programs assist patients to understand the challenges of drug discovery and development while also assisting those in need to obtain needed medications. These actions are necessary to improve customer perceptions and understanding. To summarize Pfizer, TM and my part in it all, I feel that I work for a wonderful company filled with people who genuinely care about making the world a better place for everyone. In addition, Pfizer has provided me with many opportunities that I would not have had elsewhere. I am proud to say I work there. Thank you for your attention.