IPPCR 2016: Concepts in Pharmaceutical Development Project Management

MY NAME IS CHRIS BREDER FROM THE FDA DIVISION OF PRODUCTS. THIS IS MY FIFTH YEAR GIVING THIS LECTURE. I THOUGHT IF I CHANGED THE COVER SLIDE I’D GET A BIGGER AUDIENCE HERE, SO WE’LL SEE IF ANYONE ELSE WALKS IN OR IF WE GET SOLD OUT HERE. SO — AND I’M SURE YOU ALL THINK IT’S SORT OF STRANGE GOING TO A LECTURE ON PROJECT MANAGEMENT. THERE ISN’T GOING TO BE MIAS, NO RESTRIKES ENZYMES, NO GENE SEQUENCES, AND ALSO LOT ARE PROBABLY WONDERING WHY AM I SPENDING MY VALUABLE TIME TO LISTEN TO A LECTURE ON PROJECT MANAGEMENT. I HOPE I CONVINCE YOU BEFORE THE END THIS IS PROBABLY THE RELEVANT LECTURE FOR YOUR CAREER. EVEN IN SCIENCE, EVERYBODY BECOMES A MANAGER. AND REALLY, IF YOU’RE ON A TEAM AT ALL, YOU’RE SORT OF A PROJECT MANAGER WITHIN THAT FOR YOURSELF. SO I HOPE EVERY ONE GETS SOMETHING OUT OF THIS LECTURE. SINCE I’M FROM THE FDA, OF COURSE, WE DISCLAIM EVERYTHING WE’RE ABOUT TO SAY AND IT DOESN’T REPRESENT THE FDA IN ANY WAY. SO IT’S A MATTER OF INTRODUCTION, AND I PREVENT THIS JUST SO YOU KNOW THAT THE LECTURE YOU’RE GOING TO GET IS NOT JUST THE VIEWPOINT OF SOMEONE FROM THE FDA. I’VE SPENT MORE YEARS IN INDUSTRY THAN I HAVE AT THE AGENCY, AND I ALSO AM IN ACADEMIA, I TEACH ALSO AT HOPKINS. SO I THINK YOU’LL GET A VERY WELL-ROUNDED PERSPECTIVE HERE, HAVING NOT ONLY A REGULATORY PERSPECTIVE, BUT A BUSINESS PERSPECTIVE AS WELL. SO BY TEND OF THIS LECTURE, IT’S REALLY SPLIT INTO TWO HALFS. THE FIRST HALF REALLY TALKS ABOUT WHAT PROJECT MANAGERS DO. I WOULD INVITE YOU TO THINK ABOUT YOURSELF AND YOUR SUPERVISOR OR BOSS, AND THINK ABOUT WEATHER THEY HAVE THESE CHARACTERISTICS. AND THEN THE SECOND HALF I’LL PRESENT SOMETHING ABOUT TOOLS USED IN PROJECT MANAGEMENT. AND I DO THAT BECAUSE IN ONE OF MY POSITIONS WHERE I WAS MANAGING PEOPLE AND PROJECTS, I REALIZED THAT THE — THERE WERE CERTAIN TOOLS I HAD THAT REALLY MADE THE PROJECT, MADE IT MUCH EASIER AND ALLOWED ME TO BE VERY EFFECTIVE, SO IT’S BECOME AN INTEREST OF MINE. SO JUST A SHOW OF HANDS. WHO HERE HAS A POSITION — I’M TALKING TO THOUSANDS ON THE STREAM AS WELL. WHO HERE HAS WORKED IN THE PHARMACEUTICAL INDUSTRY? ANYONE? SO NOT A LOT OF PEOPLE. SO THAT’S WHY I ALWAYS START THIS AT A VERY BASIC LEVEL BUT I THINK THAT ONCE YOU SEE WHAT I’M PRESENTING, IT’S NOT SO MYSTERIOUS, WHAT GOES ON IN PHARMACEUTICAL INDUSTRY. WHO HERE HAS A BOSS? DOES ANYONE HAVE A BOSS OR SUPERVISOR? HOW MANY OF YOU HAVE EVER HAD A BAD BOSS? VERY IMPORTANT, THEN, TO UNDERSTAND ABOUT MANAGING, MANAGING PROJECTS. I’M SURE IF YOU’RE IN A LAB, YOU WORK ON PROJECTS. PROJECTS IN EVERY INDUSTRY. SO MAYBE IF YOUR BOSS ISN’T THAT GOOD YOU CAN TEACH THEM A LITTLE SOMETHING ABOUT HOW TO MANAGE THINGS. SO FIRST, I WANT TO SHOW YOU A LITTLE PEEK UNDER THE HOOD OF WHAT HAPPENS IN THE PHARMACEUTICAL INDUSTRY, FOR THOSE WHO HAVEN’T WORKED IN ONE BEFORE. SO THIS IS MY PERSPECTIVE ON THE PHARMACEUTICAL DEVELOPMENT. IT’S LIKE A WHEEL CONTINUOUSLY MOVING. WHAT ENERGIZES THE WHEEL ARE UNMET MEDICAL NEEDS FROM PATIENTS AND INNOVATION IN THE R AND D SECTOR, AS WELL AS MARKET POTENTIAL. HERE YOU HAVE THE SCIENTIST AND THE BUSINESS FOLKS, IF THERE WAS NO OTHER CONSTRAINTS, THEY WOULD BE WORKING TOGETHER TRYING TO DEVELOP THINGS AND — BUT THEIR ARE CONSTRAINTS IN THE INDUSTRY. THE FIRST IS RESOURCE LIMITATIONS. ESPECIALLY IF YOU’RE IN A VERY SMALL COMPANY, LET’S SAY YOU GOT YOUR FIRST SEED AMOUNT OF MONEY. IT’S ABOUT 40 MILLION DOLLARS. THAT SOUNDS LIKE A LOT, BUT IT’S REALLY NOT, AND THAT CAN REALLY TAILOR WHAT SORT OF ACTIVITIES YOU’RE GOING TO DO. AND THEN ANOTHER CONEXTRA POINT YOU HAVE TO LIVE WITH ARE — CONSTRAINT YOU HAVE TO LIVE WITH ARE REGULATORY CONSTRAINTS. NO ONE LIKES TO BE CONSTRAINS BUT IF YOU CONSIDER THE TRIAL THAT JUST HAPPENED REASONABLY WHERE 90 PEOPLE WENT IN THE TRIAL AND ONE PERSON CAME OUT FAIRLY BRAIN DEAD, THE FRENCH TRIAL IN THE NEWS, THAT’S WHY WE HAVE REGULATIONS. THINGS LIKE THAT MAY NOT HAPPEN SO FREQUENTLY. SO IT’S REALLY A VERY DYNAMIC TENSION BETWEEN THE INNOVATION THAT GOES ON AND BOTH THE RESOURCES AND THE REGULATORY CONSTRAINTS. LEFT TO ITS OWN DEVICES IT WOULD JUST SPIN WITHOUT FRICTION, BUT YOU DEFINITELY NEED TO DEAL WITH THESE OTHER REALITIES. SO WHAT IS A PHARMACEUTICAL PROJECT TEAM LOOK LIKE? IN THE SIMPLIST REINCARNATION, THE DRUG IS THE CENTER OF THE DEEM. EVERYTHING FOCUS — TEAM. EVERYTHING FOCUSES AROUND THE PROJECT. THEN YOU HAVE CERTAIN SPECIALIZATIONS. SOME PEOPLE ARE NOPE AS THE CLINICAL — KNOWN AS THE CLINICAL FOLKS, MDs OR SOMETIMES FARM Ds. THEN YOU HAVE PEOPLE WHO SPECIALIZE IN REGULATORY ISSUES, YOU HAVE CHEMISTS WHO — THE BUCKET THEY’RE IN IS CALLED CMC, MANUFACTURING AND CONTROLS. AND THEN WHAT’S KNOWN AS NON CLINICAL, NO, SIR ARE PHARMACOLOGISTS, TOXICOLOGISTS, IT’S NOT JUST 4 PEOPLE ON A TEAM
— I SHOU
LD MENTION THE BUSINESS PEOPLE ARE ON THIS TEAM, TOO. SOMETIMES THE SCIENTISTS WOULD LIKE TO KEEP THEM IN A LITTLE CAGE BUT THEY CAN BE VERY PRESENT ON THIS TEAM. SO AT THE FIRST LEVEL YOU CAN SEE THEY’RE ACTUALLY ARE A LOT OF SUBTEAMS WITHIN THOSE TEAMS. I DON’T KNOW IF YOU EVER — ANYONE HEARD OF THE SHAMPOO PERK. ANYONE REMEMBER — I TOLD TWO PEOPLE, THEY TOLD TWO PEOPLE. PRETTY SOON JUST THE CLINICAL TEAM ALONE IS HUGE. I WAS ON ONE DRUG DEVELOPMENT TEAM IN A MEETING THAT HAD SEVERAL HUNDRED PEOPLE IN THAT MEETING FROM THAT TEAM. SO THESE TEAMS CAN BE VERY BIG. AND AS — EVEN WITH SMALL TEAMS, YOU GET A LOT OF VERY SMART PEOPLE TOGETHER. EVERY ONE WANTS TO DO THINGS THEIR WAY. IT CAN BE VERY DIFFICULT TO MANAGE THAT. THE TEAM STRUCTURE IS SOMETHING KNOWN AS A MATRIX TEAM. AND A MATRIX TEAM IS ONE WHERE, FOR EXAMPLE, YOUR DIRECT SUPERVISOR REALLY DOESN’T DEDIRECT YOUR DAY TO DAY ACTIVITIES. IT’S EITHER A PROJECT MANAGER OR A TEAM LEADER. YOU GO BACK AND REPORT TO YOUR DIRECT SUPERVISOR BUT THE — YOU KNOW, THE PERSON THAT GIVES YOU YOUR SCHEDULE IS TYPICALLY SOMEONE ELSE, WHO DOESN’T REALLY HAVE DIRECT CONTROL OVER YOU. AND THE EXPRESSION IS THAT PERSON NEEDS TO LEAD YOU BY ANONYMOUS BECAUSE THEY DON’T REALLY HAVE A — LEAD YOU NEW INFLUENCE BECAUSE THEY DON’T REALLY HAVE DIRECT CONTROL OVER YOUR PERFORMANCE. THEY MAY GIVE THEIR OPINION. SO YOU’RE BEGINNING TO SEE HERE THAT THE SHIP IS CONTROLLED BY SOMEONE WHO IS NOT REALLY ALLOWED TO GRAB THE STEERING WHEEL. IT ALL NEEDS TO BE INFLUENCE AND THEIR BUSINESS AND BEHAVIORAL SKILLS THAT WILL LEAD THIS MASSIVE ARMY IN THE DEVELOPMENT PROJECT. SO AS I MENTIONED, YOU’RE GOING TO HAVE LOTS OF PEOPLE ON THIS TEAM. LOTS OF IDEAS. AND CHANGE IS GOING TO HAPPEN VERY FREQUENTLY. MOST DRUG DEVELOPMENT PROJECTS GO ANYWHERE FROM 5-15 YEARS. SO MANY THINGS CHANGE. THE PEOPLE CHANGE, USUALLY THE PEOPLE YOU GO ON A TEAM TO START WITH ARE NOT THE SAME AS THE PEOPLE WHO ARE GOING TO MAKE IT TO THE END. ONE THING ABOUT VERY SMART PEOPLE, THEY HAVE A LOT OF IDEAS. JUST LIKE YOUR MICROSOFT PLATFORM IN EXCEL, SOMETIMES YOU’LL GET CHANGE JUST FOR THE SAKE OF CHANGE. SO THERE IS GOING TO BE A LOT OF STRESS IN THE TEAM. YOU NEED SOMEONE TO MANAGE ALL OF THAT, WHAT’S GOING ON. AND IF THAT WASN’T HARD ENOUGH YOU HAVE MANY INTERNAL FORCES IN A PROJECT TEAM. I’M SURE YOU KNOW ALSO FROM YOUR LAB, YOU HAVE BEHAVIORAL RELATIONSHIPS. THAT’S THE TEAM I PUT UP TOP. AND TIME IS A FACTOR. YOU’RE ON A DEADLINE. MAYBE YOUR PROJECT FELL OUT OF FAVOR WITH THE MANAGEMENT. SO FO NO REASON AT ALL THAT COULD BE CUT OFF BECAUSE IT MAY NOT MAKE AS MUCH AS THE OTHER PERSON’S TEAM AND YOU HAVE NO CONTROL OVER THAT. AND THEN IS EXTERNAL FORCES. OTHER COMPANIES, ACTIVISTS, GROUPS NOW. IF YOU LISTEN TO THE NEWS, ACTIVIST GROUPS ARE VERY INVOLVED IN PHARMACEUTICAL DEVELOPMENT. THERE IS REIMBURSEMENT ISSUES. CONGRESS — I HAD A BOSS THAT GOT COMMONED IN FRONT OF CONGRESS ABOUT A DRUG WE WERE WORKING ON. IT’S NOT A PLEASANT EXPERIENCE. THE AGENCY IS IN YOUR FACE AND OTHER COMPANIES, OF COURSE, SO A LOT OF EXTERNAL FORCES, A LOT OF INTERNAL FORCES. SO THERE IS A LOT OF PIECES MOVING ON A TEAM AND A LOT OF PEOPLE, SO YOU NEED SOMEONE TO REALLY KEEP ORDER OF ALL THAT. I’VE AN EXPRESSION THAT I SAY ABOUT TEAMS, MORE BEHAVIORAL DISORDERS HAVE KILLED DRUGS THAN TOXICOLOGY ISSUES. I TEACH A COURSE AT HOPKINS THAT HAS A SIMULATED DRUG DEVELOPMENT EXPERIENCE. TYPICALLY THE TEAM HAS DOES THE WORK IS THE ONE HA — THAT DOES THE WORST IS THE ONE WITH THE MOST BEHAVIORAL ISSUES. THE TEAM THAT DIDN’T APPEAR TO HAVE SUCH A GREAT BACKGROUND OR ALL THE SELF-PROCLAIMED JOANIOUSS BUT THEY CAN GET ALONG, THEY SEEM TO DO BEST IN THE COURSE. SO IT’S REALLY THE MASTERY OF ALL THESE SOFT SKILLS THAT ARE VERY CRITICAL. SO NOW THAT I’VE SORT OF INTRODUCED YOU TO WHAT PHARMACEUTICAL PROJECT MANAGERS DO, WE’LL TALK A LITTLE BIT ABOUT THEIR JOB. FIRST OF ALL, PROJECT MANAGEMENT IS DEFINED AS WHAT YOU SEE ON THE SLIDE HERE. YOU’RE EXPECTED THE MEET OR EXCEED THE NEEDS OR EXPECTATIONS, THE STAKEHOLDERS. WHO DO YOU THINK THAT STAKEHOLDERS ARE FOR PHARMACEUTICAL PROJECTS? ANY THOUGHTS ON THAT? WHO COULD BE STAKEHOLDERS? INVESTORS, RIGHT. THEY CAN BE KIND OF DEMANDING, I WOULD THINK. WHO ELSE? I SORT OF EDUCATIONED THEM BEFORE. MENTIONED THEM BEFORE. [INAUDIBLE] >> PATIENTS. RIGHT. ACTIVIST GROUPS. PATIENTS PARENTS, IF YOU WORK IN A PAEDIATRIC AREA. ALSO — RIGHT, SO INVESTORS. THE COMPANY. LOTS OF STAKEHOLDERS. SO PROJECT MANAGEMENT TEACHES YOU THE SKILLS, HOW TO RECOGNIZE ALL THESE STAKEHOLDERS AND WHAT THEIR NEEDS ARE. THIS IS A TRIVIA QUESTION I ASK THAT NO ONE GETS RIGHT. 27,400,000. WHAT DO YOU THINK THAT REPRESENTS? THAT IS THE DAILY CASH PROFIT FROM THE DRUG LIPITOR. 10 BILLION A YEAR IF I DID MY DIVISION RIGHT. SO ACTUALLY, THE GUY THAT USED TO TEACH THIS COURSE BEFORE ME WHO IS ONE OF MY MENTORS SAID — AND HE ONLY USED A MILLION DOLLARS. HE GOES IF YOU COST YOUR COMPANY A MILLION DOLLARS BECAUSE YOU DELAYED SOMETHING BY ONE TIME, DO YOU THINK YOU’LL STILL HAVE A JOB? NOPE. SO WHEN THE DRUG MAKES 27 MILLION, THE PRESSURE IS EVEN HIGHER. THAT’S WHY YOU NEED VERY GOOD MANAGEMENT. EACH DRUG — WELL, I DON’T THINK EVERY DRUG COSTS ABOUT 900 MILLION TO DEVELOP SOME OF THE MORE COMPLICATED ONES CAN GET UP THERE. THERE IS ALSO WHAT THEY CALL OPPORTUNITY COSTS. THAT IS THE TIME AND MONEY YOU SPEND ON THIS DRUG YOU DON’T SPEND ON THE OTHER DRUG. AND AS WAS MENTIONED THE PATIENTS ARE WAITING. PATIENTS REALLY KNOW WHAT’S GOING ON THESE DAYS IN TERMS OF PHARMACEUTICAL DEVELOPMENT. SO IT REALLY BEHOOVES THE COMPANY TO MANAGE WELL. THIS JUST I CAN’T CARELY DEMONSTRATES IT. — GRAPHICALLY DEMONSTRATES IT. I THINK YOU CAN TELL I LIKE MANAGES. STOCK PLUMMETS, MONEY GOES DOWN THE DRAIN. PATIENTS ARE LEFT WAITING. IF YOU DO OIF YOU MANAGE GOOD, YOU KEEP THINGS ORGANIZED, ET CETERA. YOU’LL HAVE HIGHER WHAT THEY CALL NET PRESENT VALUES. YOU’LL BE ABLE TO GET MORE PRODUCTS OUT. ONE OF THE GOALS OF THE TEAM IS NOT SO MUCH DEVELOPING THE DRUG BUT KILLING THE BAD DRUGS. THAT’S AS IMPORTANT AS LETTING THE WINNERS WIN. AND ALSO, I SHOULD PROBABLY STRIKE THIS FROM THE SLIDE SINCE I’M FROM THE AGENCY. I THINK A MORE ORGANIZED PROGRAM MAY TEND TO GET A FASTER REGULATORY REVIEW. BUT I’M SURE THERE IS NO GUARANTEE OF THAT. THE SITUATION IS ACTUALLY BECOMING INCREASINGLY DIFFICULT OVER THE YEARS. IN THIS SLIDE IT SHOWS THE DRUG INDID YOU RECALL, A BETA BLOCKER. WHEN IT WAS DEVELOPED IN 1968, IT WAS TEN YEARS BEFORE THE COMPETITOR CAME. TH VIED IS ONLY AS DATA FROM — THIS SLIDE IS ONLY DATA FROM 1992. IT SHOWS YOUR COMPETITORS THERE ARE GOING TO BE ON YOUR HEELS IN LESS THAN A YEAR. IN FACT I WOULD SAY IN THE LATE 90s, MOST DRUGS LIKE — THE ANTIPSYCHOTIC DRUG FIELD, ALL THOSE DRUGS WERE DEVELOPED AT ABOUT THE SAME TIME. SO EVERY ONE IS REALLY NECK AND NECK. SO WHAT DOES THE PROJECT MANAGER DO? SO SOME HISTORICAL NOTES. WHEN THE JOB DESCRIPTION FIRST CAME OUT, THE PROJECT MANAGER WAS GENERALLY JUST SOMEONE WHO TOOK NOTES, SAT THERE IN THE ROOM, DIDN’T COMMENT TOO MUCH. AS THEY STARTED TO TRACK RESOURCES, MONEY AND PEOPLE, THEY — INFORMATION IS POWER. AND THEY BECAME MORE AND MORE IMPORTANT TO THE DEVELOPMENT EXERCISE TO THE POINT NOW, IF YOU LOOK AT THE VERY TOP WHERE THEIR KEY MEMBERS IN DECIDING WHAT THE PORTFOLIO OF THE COMPANY LOOKS LIKE, AND OFTEN INVOLVED IN A CORPORATE VENTURE, EXERCISES. SO THEY’VE REALLY BECOME AN ACTIVE PART, NOT ONLY OF THE DRUG DEVELOPMENT TEAM BUT OF THE EXECUTIVE MANAGEMENT OF COMPANIES. STILL MOST OF THEM IN THEIR PROJECT MANAGEMENT ROLES HAVE TO DO BOTH PROJECT ANALYST DUTIES, IN OTHER WORDS, THEY NEED TO KEEP TRACK AND KEEP ORGANIZED. THINGS LIKE TIMELINES AND BUDGETS. BUT ALSO IN MANY ORGANIZATIONS THEY’RE SEEN AS PROJECT LEADERS OR VOICES TO THE UPPER MANAGEMENT. I WORKED IN ONE COMPANY WHERE — THE FAMILY THAT OOPED THE COMPANY — OOPED THE COMPANY, ON THE 9th FLOOR, THE ONLY OTHER PEOPLE ON THE 9th NOR WERE HEADS OF PROJECT MANAGEMENT FOR THE MAJOR PROJECTS. THAT’S THE RECOGNITION THAT THOSE PEOPLE ARE THE EYES AND EARS FOR THE EXECUTIVE BOARD. REALLY WHAT, THEY DO IS A COMBINATION OF BUSINESS. YOU NEED TO BE A MASTER OF BUSINESS AS WELL AS INTERPERMANENT SKILLS. INTERPERSONAL SKILLS. I’LL TALK MORE ABOUT THESE IN DETAIL, THESE ARE THE SKILLS THAT YOU NEED ON THE JOB. MOST PROJECT MANAGERS AREN’T THE TOPIC EXPERTS ON A TEAM. SOMETIMESTHE CLINICAL LEADERS IS ALSO THE PROJECT MANAGER ON SOME TEAMS, BUT REALLY, THE PROJECT MANAGER’S JOB IS TO FACILITATE THINGS. FACILITATING DECISIONS. EVEN THOUGH THEY’RE NOT THE TOPIC EXPERTS, THE ONES WITH A LOT OF EXPERIENCE, YOU’D NEVER KNOW THEY DIDN’T HAVE A DEGREE IN PHARMACOKINETICS, OR ANY PART OF CLINICAL RESEARCH BECAUSE THEY HAVE DEEP BACKGROUND AND THEY SEE WHERE ALL THESE THINGS FIT WITH EACH OTHER. AS I MENTIONED NUMEROUS TIMES, BEING ABLE TO INTERAGENT WITH HUMANS IS VERY IMPORTANT, KNOWING WHAT IT MEANS TO BE A LEADER. HOW TO KEEP YOUR TEAM WORKING TOGETHER IS VERY IMPORTANT. KNOWING HOW TO COMMUNICATE IS ABSOLUTELY ESSENTIAL, NOT ALWAYS JUST AGREEING WITH SOMEONE, BUT KNOWING HOW TO SORT OF NAG THEM JUST ENOUGH TO GET THE BEST JOB DONE. A LITTLE COMMUNICATION JOKE. AND THEN TOOLS, WHICH WE’LL TALK ABOUT AT SOME DEPTH. MOST PROJECT MANAGERS, ESPECIALLY THE ONES WHO HAVE THIS LICENSE CALLED PMP, LIKE A TEST, THAT THEY TAKE ARE VERY GOOD AT THESE TOOLS. I CAN THE ONE THAT MOST PEOPLE ARE THE WEAKEST ON IS PROBABLY THE ONE YOU’RE THE WEAKEST ON IN YOUR EVERY DAY LIFE, AND THAT’S BUDGETS. BUDGETS ARE VERY DIFFICULT. THEY’RE HARDER IN THE PHARMACEUTICAL INDUSTRY. EVERY TIME THERE IS A CHANGE YOU MAY HAVE TO DO A FIVE YEAR BUDGETED. SO A PROJECT GETS KILLED, REDO THE BUDGETED. THINKING OF MERGING WITH SOMEONE, REDO THE BUDGET. IT’S VERY CHALLENGING. SO — I THINK THE TAKE HOME MESSAGE IS REALLY THAT THE SO-CALLED SOFT PARTS OF PROJECT MANAGEMENT CAN BE THE MOST IMPORTANT. YOUR INNER PERSONAL SKILLS. IT’S NOT ALWAYS THE MOST SORT OF BRILLIANT BY THE BOOK PERSON WHO IS GOING TO DO VERY WELL. IT’S REALLY SOMEONE WHO IS VERY ORGANIZED. WHO REALLY HAS SENSIBILITY ABOUT PEOPLE THAT’S GOING TO DO VERY, VERY WELL IN THIS JOB. SO NOW I’LL STOP FOR A SECOND. ARE THERE ANY QUESTIONS? THAT’S THE FIRST HALF OF WHAT WE’LL TALK ABOUT. THAT’S SORT OF THE SOFT BEHAVIORAL PART. ANY QUESTIONS ABOUT THAT OR THE JOB? I HAVE TO SAY THAT EITHER PROJECT MANAGEMENT OR A REGULATORY PERSON SEEMS TO BE THE MOST COMMON THING THAT PEOPLE COMING OUT OF COLLEGE OR WITH SOME LEVEL OF SCIENTIFIC BACKGROUND, THOSE ARE THE ENTRY SORT OF JOBS FOR MOST PEOPLE THAT I SEE IN THE PHARMACEUTICAL INDUSTRY. SO IT’S SOMETHING WORTH CONSIDERING, PROJECT MANAGERS CAN ACTUALLY RISE VERY WELL IN A COMPANY. I’VE SEEN THEM GO UP TO CHIEF OPERATING OFFICER FROM YOUR JOE AVERAGE PROJECT MANAGER BECAUSE THEY’RE EXCEPTIONAL WITH PEOPLE AND THEY REALLY KNOW HOW TO GET JOBS DONE. SO — ALL RIGHT. NOW, TOOLS. AS I MENTIONED BEFORE, I INCLUDE THIS IN THE LECTURE JUST FOR MY OWN EXPERIENCE BECAUSE I NOTICED IN MYSELF THAT THERE WERE CERTAIN TOOLS THAT REALLY HELPED YOU BE ORGANIZED AND REALLY PROPELLED THE PROJECTS FORWARD. SO I’D LIKE TO SHARE SOME OF THAT WITH YOU. THE MOST — OH, AND EVEN FOR THOSE WHO ARE NOT ON A TEAM, YOU ACTUALLY ARE ON A TEAM. YOU CAN USE THESE TOOLS FOR YOURSELF. YOU DON’T NEED TO BE ON SOMETHING CALLED A PROJECT TEAM. BECAUSE ALMOST EVERY PROJECT THAT YOU DO FOR YOURSELF, IT’S THIS LEVEL OF ORGANIZATION THAT PEOPLE TEND TO NOTICE AND MAY REALLY, YOU KNOW, PROPEL YOUR OWN CAREER. SO FOR MY PURPOSES, ONE OF THE MOST USEFUL TOOL I FOUND WAS SOMETHING AS SIMPLE AS THE TEAM MEETING MINUTES. AND WHAT THEY ARE IS A VERY, VERY WELL ORGANIZED PROGRESS REVIEW. THEY’RE THE BASIS OF COMMUNICATING WITH SENIOR MANAGEMENT WHO AS YOU MIGHT SUSPECT IS QUITE INTENTIONALLY DEFICIENT. SO THE MORE YOU CAN BOIL THINGS DOWN, THE MORE SIMPLE THINGS ARE, THE BETTER THEY’RE LOOKED AT. THEY’RE A GOOD PLACE TO DOCUMENT WHAT THEY CALL ACCOUNTABILITIES AND RESPONSIBILITY. MOSTPLE HAVE A HARD TIME TELL SOMEONE THEY HAVE TO DO SOMETHING OR YOU ARE DEFINITIVELY RESPONSIBLE FOR SOMETHING. BUT WHEN IT IS WRITTEN DOWN AND EVERY ONE IN THE COMPANY SEES THAT IT MAKES IT EASIER. ALSO IT’S A GOOD WAY TO DRIVE THE AGENDA OF A MEETING. SOMETHING — MANY MEETINGS GO ON WITH NO AGENDA. YOU CAN SORT OF SEE THEM FLOATING AROUND LIKE THAT WITH NO REAL DIRECTION. BUT THE TEAM MEETING MINUTES SORT OF STARTS WITH THE AGENDA AND EVERYTHING ELSE GETS FILLED IN AS YOU HAVE THE MEETING. JUST FOR A TEMPLATE, THERE IS A CONCEPT KNOWN AS ISSUES WHICH SEEMS LIKE A SIMPLE WORD. BUT IN THIS CASE, ISSUES ARE VERY SPECIFIC THINGS. THESE ARE THINGS THAT WILL CAUSE A DELAY OR COST YOU MORE MONEY. SOMETHING THAT’S REALLY GOING TO WORRY YOUR BOSS. ALL THOSE GO IN TO — JUST LIKE A DRUG LABEL, A BLACK BOX UP TOP. YOU REALLY NEED TO PUT IT IN PEOPLE’S FACE. ANYTHING THAT IMPACTS WHAT THEY CALL A GO NO GO DECISION. WHICH ASK YOU GET TO SALT AND PEPPER — WHICH IS YOU GET TO A CERTAIN POINT IN A PROJECT. IF IT’S THIS LEVEL YOU’LL GO AHEAD. THAT LEVEL YOU’LL STOP. ANYTHING THAT EFFECTS THAT POINT GOES IN THAT BOX. ALSO, TIMELINES. THAT MAKES A LOT OF SENSE. FINANCES, IF YOU CAN BOIL IT DOWN, THAT’S GOOD TO PUT IN. AND THEN SPECIFICALLY FOR THE — MAYBE NOT EVEN SPECIFICALLY. FOR THE PHARMACEUTICAL INDUSTRY, AS YOU CAN SEE FROM THE FIRST SLIDES I PUT UP, THERE ARE A LOT OF DEPARTMENTS AND SO IT’S GOOD TO BREAK THINGS DOWN AT THE VERY END BY DEPARTMENT SO PEOPLE CAN GO TO THEIR OWN AREA AND SEE WHAT’S IMPORTANT. ALL RIGHT. THE NEXT ONE IS SOMETHING KNOWN AS A TARGET PRODUCT PROFILE. HAS ANYONE HERE HEARD OF A TARGET PRODUCT PROFILE? SO IT’S FUNNY, I WORKED IN ONE COMPANY WHERE I GOT THE SAME SORT OF RESPONSE. THEY GOT A NEW HEAD OF DEVELOPMENT. NO ONE HAD EVER HEARD OF A TARGET PRODUCT PRO FILL. THAT PERSON WASN’T THE MOST ARTICULATE SO IT TOOK ALMOST A YEAR TO UNDERSTAND WHAT IT IS. NOW WHEN I TEACH CLINICAL DEVELOPMENT, I ALWAYS PUT THIS IN. IT’S A VERY IMPORTANT TOOL, NOT JUST THE PHARMACEUTICAL INDUSTRY BUT IT TURNS OUT IN ALL OF INDUSTRY, EVEN THE WORLD HEALTH ORGANIZATION USES THEM, FOR EXAMPLE, WHEN THEY’RE THINKING ABOUT EVACUATION PROGRAMS. THEY — VACCINE PROGRAMS. WHEN THEY WANTED TO DEVELOP A NEW VACCINE, THEY FIGURE OUT WHAT IMPROVEMENTS THEY WANT. YOU’LL SEE IN A SECOND HOW ALL THAT GETS SORTED OUT ON A TPP. AND ACTUALLY, IT’S ALMOST BETTER TO SEE IT. THEN WE’LL COME BACK TO THE ALL — I’LL EXPLAIN WHAT I WROTE DOWN HERE. UNTIL YOU SEE IT, IT’S HARD TO IMAGINE WHAT IT IS. ACTUALLY SKIP THIS. SO THIS, ON THE SCREEN, IS AN EXAMPLE OF A TARGET PRODUCT PROFILE. AND ALL THIS IS MADE UP. SO THE DRUGS THAT I WANT TO DEVELOP IS CALLED THE BRAND NAME WE’LL CALL IT AWAKENAL. IT’S FOR SLEEPING AND THIS IS ONE OF MY COURSE NUMBERS AT HOPKINS. SO THAT’S ONE THING TO KNOW. THE GOLD STANDARD FOR THAT PARTICULAR INDICATION IS THIS DRUG — SEE IF I HAVE A — I DON’T THINK I HAVE A MOUSE THAT’S WORKING. THE DRUG IN THE COLUMN DON’T SNOOZENAL. IF IT WAS HEAD ACHE, I COULD BE DEVELOPING IN A PROXEN, THE GOLD STANDARD MIGHT BE ASPIRIN. THE GOLD STANDARD COULD BE PER MARKET PERSPECTIVE, WHO SELLS THE MOST, OR FROM A TECHNOLOGY PERSPECTIVE OR PERFORMANCE PERSPECTIVE. THAT’S REALLY A CONVERSATION BETWEEN YOU AND YOUR BUSINESS FOLKS. THE LEFT MOST COLUMN IN THE PROFILE ARE WHAT I CALL ATTRIBUTES. THOSE ARE THINGS THAT YOU CAN PLAN FOR, THEY’RE CHARACTERISTICS OF A DRUG. SO THE FREQUENCY OF A DRUG IS IMPORTANT IN TERMS OF ITS APPEAL FOR PATIENTS. DRUG, YOU NEED TO TAKE 4 TIMES A DAY. NOT AS ATTRACTIVE AS WHEN YOU TAKE ONCE A DAY. THERE IS SOMETHING KNOWN AS A FOOD EFFECT. IF YOU EAT A HAMBURGOIR THE DRUG, SOME DRUG CONCENTRATIONS GO WAY UP. THE SIZE IS IMPORTANT. SOME PILLS, ESPECIALLY ANTIBODY ANTIBY ETICS, VERYBY HARD TO SWALLOW. ESPECIALLY IF YOU’RE ELDERLY. THERE ARE INTELLECTUAL PROPERTY ASPECTS YOU COULD TALK ABOUT. YOU COULD DO IT MANY WAYS TO MAKE THE DRUG BUT ONE WAY HAS A TYPE OF BODY THAT HAS AN INTELLECTUAL PROPERTY ADVANTAGE. SO THAT MIGHT BE SOMETHING YOU WANT TO BELLED IN. YOU ALSO PUT IN EXPECTED EFFICACY PARAMETERS AS WELL AS SAFETY PARAMETERS. NOW, THE DIFFERENCE HERE BETWEEN SAFETY AND TOLERABILITY IS SAFETY IS THINGS THAT GIVES RISE TO WARNINGS OR PRECAUTIONS MOVE AND TOLERABILITY ARE MORE THE SIDEFECTION THAT PEOPLE DECIDE ON THEIR OWN. MAKE THEM WANT TO TAKE A DRUG OR NOT. I ACTUALLY, IN YOUR SLIDE DECK, I THINK YOU CAN SEE A NUMBER OF FLAGS HERE. WHAT I DO WITH THESE FLAGS IS I POINT OUT HOW EACH OF THESE ATTRIBUTES — IF YOU’RE TRYING TO DEVELOP A COMPETITOR FOR THE GOLD STANDARD, HOW YOU COULD IMPROVE ON EACH OF THESE. NOW, THERE ARE DIFFERENT COLUMNS ALSO IN THE TPP. AND TO START WITH, THE BASE CASE IS WHAT YOU REALISTICALLY BELIEVE THE DRUG WILL PERFORM LIKE AND IT’S VERY HARD TO PREDICT THESE THINGS. PEOPLE WHO ARE VERY I DON’T SAID TO DOING IT — I DON’T SAID TO DOING IT COME UP WITH PROGRAMMERS OR METRICS THAT ARE PRETTY REASONABLE. FOR MY SAKE, THE MOST IMPORTANT COLUMN IS’ ONE THAT SAYS LOCASE. THE LOW CASE IS THE COLUMN SUCH THAT WHEN THE DRUGS PERFORMANCE FALLS BELOW THAT LINER, YOU’RE WILLING TO KILL THE WHOLE PROJECT. REMEMBER, I SAID IT’S IMPORTANT TO KNOW HOW TO WEED OUT THE LOSERS? ET CETERA? WELL, THIS IS THE FIRST PLACE WHERE YOU SORT OF MAKE A CONTRACT WITH THE COMPANIES MANAGEMENT THAT YOU’RE GOING TO DO EVERYTHING YOU CAN TO DEVELOP THIS DRUG ONCE IT CROSSES BELOW THAT LINE, THE DRUG HAS TO BE KILLED. EVEN THOUGH IT’S SORT OF YOUR DRUG, IT’S ACTUALLY BETTER TORE YOU TO KILL SOMETHING THAT ISN’T WHAT YOU WANT THAN TO KEEP PUMPING MONEY AND RESOURCES INTO SOMETHING THAT IS NOT GOING TO BE SUCCESSFUL MOVE SO FOR EXAMPLE, THE LOCASE HERE IS BID, TWICE A DAY. THAT ISN’T SO HARD. FOOD EFFECT, I DON’T WANT A DRUG WITH ANY FOOD EFFECT AT ALL. IF IT TURNS OUT THAT THE MAXIMAL CONCENTRATION OF THE DRUG IS INCREASED, AFTER A HIGH FAT MEAL, I NEED TO THINK, YOU KNOW, IF EFFICACY GAIN I’M GETTING GOOD ENOUGH SUCH THAT I’VE CROSSED OVER THE GO NO GO, DOES THAT SORT OF CANCEL IT OUT? IT’S NOT SO BLACK AND WHITE AS ANY TIME YOU CROSS OVER, THE DRUG GETS KILLED. IF IT CURES PANCREATIC CANCER YOU’RE NOT GOING TO CARE IF THE DRUG CONCENTRATION GOES UP A LITTLE. IF THE EFFICACY IS JUST BOUTS WHAT YOU EXPECTED, BUT IT’S VERY LOW ON OTHER KEY PROGRAMMERS, FOR EXAMPLE, TOLERABILITY OR SAFETY, YOU MIGHT KILL THE DRUG AT THAT POINT. THIS IS WHAT A TARGET PRODUCT PROFILE IS. IT’S THE THING YOU CREATE, VERY SIMPLE. ONE PAGE BEFORE YOU COME UP WITH A — WHAT IT WOULD BE, THE CLINICAL DEVELOPMENT PLAN CAN THEN THAT ULTIMATELY TRANSLATES INTO THE LABELING FOR THE DRUG. EVERYTHING YOU WANT IN THE LABELING SHOULD BE FACTORS THAT ARE PRESENT IN YOUR TARGET PRODUCT PROFILE, BECAUSE IF YOU DIDN’T THINK OF IT BACK THEN YOU’RE NOT GOING TO DO A TRIAL TO GET THE DATA TO SUPPORT IT IN YOUR LABELING. NOW ONE HAVE QUESTIONS ON TARGET PRODUCT PROFILE? >> [INAUDIBLE QUESTION] >> I THINK YOU NEED A MIC. CAN YOU SAY THAT A LITTLE LOUDER? >> [INAUDIBLE QUESTION] THAT’S A GREAT QUESTION. LET’S SAY — HERE IS WHAT THE FLOW — I GIVE A LECTURE ABOUT DEVELOPMENT PROGRAMS. THE FIRST THING THAT HAPPENS IN A COMPANY IS HUNDREDS OF MOLECULES GET SEN THATS ISED, THEN YOU HAVE DIFFERENT CRITERIA. ONE OF THOSE GETS THROWN OVER THE FENCE TO GET INTO HUMANS. ONCE THAT DRUG IS SYNTHESIZED, YOU CAN’T DO ANYTHING ABOUT IT. ALL YOU CAN DO IS STEADY IT, RIGHT? IF YOU THINK ABOUT THIS BEFOREHAND, YOU CAN SAY, FOR EXAMPLE, I DON’T WANT A PSYCHOTIC THAT HAS SO MUCH WEIGHT GAIN ISSUE, AND BACK THEN, THE THEORY WAS THAT THAT WAS TIED TO HISTORY MEAN BINDING. — HISTOMEAN BINDING. IF YOU KNOW THAT YOU CAN DO RECEPTOR BINDING ASSAYS AS YOUR SCREENING. SO THE ANSWER TO YOUR QUESTION IS BEFORE YOU PULL OUT A DRAWER OF CHEMICALS, THE BEST SITUATION I’VE EVER BEEN IN, THE CLINICAL PERSON, THE BUSINESS PERSON, THE NON CLINICAL, AND THE CHEMISTRY PERSON GET TOGETHER AND DO THIS. THAT SORT OF THING LEADS TO LIKE A FIRST RATE PROJECT BASE YOU THOUGHT ABOUT WHAT YOU WANTED, YOU KNOW, AS MUCH AS THERE IS A POSSIBILITY TO CONTROL THINGS WITH THE CHEMISTRY AND TYPE OF MOLECULE, THAT’S YOUR BEST CHANCE. ONCE YOU HAVE A MOLECULE YOU’RE STUCK WITH IT. ALL YOU CAN DO IS CHARACTERIZE IT THEN. THAT’S A GREAT QUESTION. ANY OTHER QUESTIONS? ALL RIGHT. EDUCATION NOW THAT WE TALKED ABOUT — SO LET’S GO BACK FOR A SECOND. JUST TO WHAT IT IS. THE BUSINESS PEOPLE TAKE ALL THESE FACTORS FOR EACH OF THE CASES, LOW, BASE CASE AND HIGH. THEY’LL FIGURE OUT WHAT THE VALUE OF A DRUG WOULD BE BASED ON THOSE DIFFERENT SCENARIOS. AS I MENTIONED, THIS ALSO FORMS THE BASIS OF THE GO NO GO CRITERIA, AND ALSO, AS I MENTIONED, THIS WILL BE THE BASIS OF THE CLINICAL DEVELOPMENT PLAN AND THE LABEL, DRUG LABELING, THAT SHEET OF PAPER THAT HAS 2 POINT FONT ON THAT YOU’VE SEEN WITH ALL THE INFORMATION ABOUT THE DRUG. PERHAPS MOST IMPORTANTLY, THE MAJORITY BULLET IS THAT IT’S A CONTRACT BETWEEN YOU, THE DEVELOPMENT TEAM, AND THE MANAGEMENT OF THE COMPANY ABOUT WHAT THEY WANT OHAVE YOU EVER DONE SOMETHING FOR SOMEONE, AND THEY SAID I DIDN’T EXACTLY WANT IT LIKE, THAT I WANT IT LIKE. THAT HAS THAT EVER HAPPENED TO YOU? I’M ALSO ANNOYING SCOUTS ADVISOR. I WAS ON — EAGLE SCOUT INDIVIDUALSER, I WAS ON A PLANNING TREE PROJECT. THE GUY THAT SIGNED IT WHO SAID HE WANTED 12 TREES, SAID I DIDN’T WANT THERE. I WANTED THEM OVER THERE. THIS PROFILE, WHEN YOU’RE TALKING ABOUT $900 MILLION, IT’S GOOD TO KNOW WHERE THE TREES SHOULD GO. SO IT’S A CONTRACT WITH YOU AND THE COMPANY. I SHOULD MENTION I JUST FLEW BY IT. LET ME SEE IF I CAN GET IT. THIS IS A GUIDANCE FOR INDUSTRY FROM THE FDA ON TARGET PRODUCT PROFILES, ALMOST A DIFFERENT THING. THE TARGET PRODUCT PROFILE YOU PRESENT TO THE AGENCY BUT IT HAS A LOT OF SIMILARITIES. THERE, LIKE THE OTHER SITUATION, YOU SAY BASICALLY WHAT YOU WANT IN YOUR LABELING AND WHAT YOU’RE GOING TO DO TO STUDY IT. AND THEN THE AGENCY KIND OF COMMENTS ON WHETHER IT’S CREDIBLE TO GET A LABELING LIKE THAT. AND EXACTLY WHAT YOU WOULD NEED TO DO TO ACHIEVE THAT. ENOUGH ON TPPs. YOU MIGHT HAVE SEEN ON ONE OF THE SLIDES, I HAD THE PHRASE DRAFT LABEL. SO THE GUY WHO USED TO TEACH THIS COURSE BEFORE, HE WAS ACTUALLY VICE-PRESIDENT OF PROJECT MANAGEMENT FOR THE TEAM THAT DEVELOPED CELOBBY WRECKS. HIS TEACHES WAS THAT THE DRUG COMPANY DOESN’T MAKE A DRUG. THEY MAKE THE PRODUCT LABELING. THE PRODUCT LABELING ALLOWS YOU TO DO ADVERTISING, WE ALL WISH THEY DIDN’T. ESPECIALLY WHEN YOU GO HOME FOR DENIER. AND IT INSTRUCTIONS THE PHYSICIANS ON HOW TO GIVE THE DRUG. AND TELLS PEOPLE ABOUT WHAT THEIR CONCERNS NEED TO BE T PROJECT LABELING IS EXTREMELY IMPORTANT. ONE THING PEOPLE DO IS BEFORE THE FINAL LABEL, THEY MOCK UP A DRAFT LABEL. THAT’S BASED ON THE ATRIABUSE AND THE TPP, CLINICAL DEVELOPMENT PLANNED AS WELL AS THE DATA CONTINUOUSLY COMING IN. YOU’RE ALWAYS UPDATING THE DRAFT LABEL AS THE DRUG GETS DEVELOPED. THE DRAFT LABEL IS A TOOL FOR THE DEVELOPMENT OF DRUGS, VERY DYNAMIC DOCUMENT. THIS IS JUST SOME DETAIL ON WHAT GOES INTO LABELING. AS I MENTIONED, REALLY, THE BASIS FOR ADVERTISING CLAIMS. IT’S THE INFORMATION FOR DOCTORS AND CONSUMERS. AND AS I MENTIONED, IF YOU WANT TO TALK ABOUT IT AT ALL, IT NEEDS TO BE IN YOUR LABEL WHICH MEANS YOU NEED TO STUDY IT. A LOT OF PEOPLE THINK SOMETHING IS SELF-EVIDENT. THEY DON’T NEED TO STUDY IT, THEY WRIGHT THE IN THE LABEL. THERE IS NO NEED TO — IT’S SELF EVIDENCE. SOMETIMES YOU GET THINGS IN YOUR LABEL THAT YOU DIDN’T STUDY. THESE THINGS ARE CALLED CLASS LABELING. FOR EXAMPLE, THE WARNING ABOUT SUICIDE FOR ANTI-DEPRESSANTS IS A CLASS LABELING. SO PRETTY MUCH IF YOU DEVELOP ANY ANTI-DEPRESENT IT WILL GET THAT CLASS LABELING. OR THE WARNING FOR DIABETES WITH ANTI PSYCHOTIC DRUGS. EVEN IF YOUR DRUG LOOKS VERY GOOD FROM A BLOOD GLUCOSE OR INCIDENCE OF DIABETES, YOU’RE LIKELY TO GET THAT LABELING. SO — ANOTHER TOOL, VERY IMPORTANT, I MENTIONED THIS EARLIER, STRATEGIC DEVELOPMENT PLAN. STRATEGIC DEVELOPMENT PLAN IS AT A CORPORATE LEVEL. THE CLINICAL DEVELOPMENT PLAN IS A COMPONENT OF THAT. STRATEGIC DEVELOPMENT PLAN HAS AN EXECUTIVE SUMMARY, OF COURSE, BECAUSE YOU WANT YOUR ATTENTION — INTENTIONALLY DEPRIVED MANAGEMENT TO BE ABLE TO SWALLOW THIS. EVEN IN THIS, THIS IS FROM A BOOK I’M GOING TO SHOW YOU AT THE VERY END, PROBABLY THE BEST THING TO READ IF YOU’RENISTED IN PROJECT MANAGEMENT. SECOND THING THEY PUT IN WAS THE TARGET PRODUCT PROFILE, THE BUSINESS STRATEGY, THE CLINICAL STRATEGY, REGULATORY. EVERY DIVISION MAKES UP THEIR OWN PLAN. THE CHEMISTS. AND THEN THE SCIENCE AND THEN AT THE VERY END, THE BUDGET STUFF GOES INTO THIS. IT’S FROM THIS BOOK I’M GOING TO TALK ABOUT AT THE END IN CASE YOU’RE INTERESTED. SOMETHING KNOWN AS A GANNT CHART. HAS ANYONE HERE EVER SEEN A GANNT CHARTA YOU KNOW WHAT THIS GUY’S NAME IS HERE? IT’S ACTUALLY MR. GANNT. HE’S FROM MARYLAND. A BID OF PRIDE HERE FOR THE HOMETOWN PERSON. GANNT CHARTS — IT’S HARD TO SEE BECAUSE IT’S SMALL. THE ACTUAL DEFINITION IS IT’S A TOOL USED FOR SHOWING THE RELATIONSHIP OF RESOURCES, SO WHAT ARE YOUR RESOURCES OF THE MOST OBVIOUS FROM HERE IS TIME IS A RESOURCES. MOST PEOPLE DON’T THINK OF THAT. IT’S PROBABLY YOUR MOST VALUABLE RESOURCE. THE OTHER RESOURCE YOU HAVE IS MONEY, AND PEOPLE. SO YOU CAN USE YOUR GANNT CHART TO SHOW WHERE YOU HEED TO ALLOCATE MONEY AND PEOPLE, AND WHAT THE RELATIONSHIP OF ALL THE PROJECTS IS. ALL RIGHT. EACH OF THE MAJOR PHASES IS ONE OF THESE BLACK BARS, AND THEN THE PROJECTS THAT GO ON WITHIN THAT ARE THESE HATCHED BARS, AND YOU CAN SEE THESE ARROWS THAT SHOW ONCE YOU FINISH ONE, WHICH PROJECT STARTS NEXT. AND ON THE LEFT YOU CAN SEE ALL THE PROJECTS LISTED OUT AND THEIR DURATION. ALL RIGHT. VERY GOOD TO WRITE DOWN ALL THESE THINGS. IT’S LIKE MAKING A LIST FOR YOURSELF. IT FORCES A LITTLE REALITY INTO THE SITUATION. THE PHRASE I LIKE IS THAT IT ALLOWS RECOGNITION OF CRITICAL INNER DEPENDENCIES. IT DOESN’T HELP TO GET TO THE POINT WHERE YOU’RE READY TO START THE CLINICAL TRIALS IF YOU HAVE NO MONEY TO BUY THE SCALED UP DRUG, SO YOU BETTER HAVE $15 MILLION BEFORE THE PHASE 3, OTHERWISE, THE CLINICAL FOLKS ARE JUST GOING TO SIT THERE. ANOTHER PHRASE THAT’S TIED INTO ALL THIS IS SOMETHING KNOWN AS CRITICAL PATHS. WHAT CRITICAL PATH IS, IS IT’S THE SERIES OF PROJECTS THAT ARE REALLY DEFYING THE TIMELINE. OKAY? THINGS CAN’T GET DONE UNTIL PROJECT A GETS FINISHED. YOU CAN DO ALL THESE OTHER THINGS DURING THAT. THOSE ARE CALLED OFF THE CRITICAL PATH. BUT EVERYTHING IS WAITING ON A TO FINISH, THEN A NEW THING PECULIARS UP THE POSITION OF — PICKS UP THE POSITION OF THE RATE LIMITING STEP. THAT’S KNOWN AS CRITICAL PATHS. THIS JUST SHOWS ON A LARGER VIEW, THE LIGHT GRAY THINGS ARE ON THE CRITICAL PATH. WHEREAS THE OPEN BOXES ARE NOT. AND YOU CAN SEE THAT THE LIGHT GRAY THINGS LINE UP, YOU KNOW, END TO END, REALLY, DEFINING THE TIMELINE OF THE PROJECT. AND BELIEVE ME, YOUR MANAGEMENT, YOU KNOW, IF YOU SLOW DOWN ONE OF THE OPEN BOX THINGS, IT’S NOT GOOD. IF YOU SLOW DOWN A CRITICAL PATH ITEM, THAT’S VERY PAD. SO YOU NEVER WANT — FIRST OF ALL, YOU NEVER WANT TO BE ON THE CRITICAL PATH. ONCE YOU’RE ON IT YOU NEVER WANT TO DELAY YOUR PROJECT. PROBABLY THE ONLY CRITICAL PATH CARTOON ON THE INTERNET RIGHT HERE. THEN THE LAST TOOL I’LL TALK ABOUT IS ONE FOR RISK MANAGEMENT. WHEN YOU’RE IN PROJECT MANAGEMENT YOU’RE CONSTANTLY THINKING BROUGHT IF I CONTINUE WITH THIS, AM I WASTING MONEY? WHAT’S THE LIKELIHOOD OF SUCCEEDING? WHAT AM I GIVING UP BY GOING AHEAD HERE? IT’S CALLED TECHNICAL PROBABILITY OF SUCCESS. AND THIS DEMOCRAT SHOWS FOR EACH OF THE PHASES OF A DRUG DEVELOPMENT, PRECLINICAL, PHASE ONE TWO, THREE, WHAT THE PROBABILITY OF SUCCESS IS. WHAT THE COST IS, THIS NET PRESENT — OR WHAT THE VALUE OF THE ASSET IS AT THAT TIME. AND THEN WHAT THE CUMULATIVE PROBABILITY OF SUCCESS TO GET TO THE VERY END IS. AND SO PEOPLE VERY GOOD AT PROJECT MANAGEMENT ALONG WITH THE REST OF THE TEAM, ESPECIALLY PEOPLE WHO HAVE DONE THIS A LOT, CAN PRETTY MUCH FIGURE OUT THOSE
— THE PE
RCENT OF SUCCESS OR FAILURE, GETTING TO EACH STEP. AND IT HELPS PLANNING A PORTFOLIO TO KNOW WHAT THE LIKELIHOOD OF SUCCEEDING IS. THERE IS A WHOLE SCIENCE IN HOW THIS IS DONE. ALL RIGHT. SO I’M JUST ABOUT FINISHED. THIS IS THE BOOK I MENTIONED TO YOU. IF ANYONE IS REALLY INTERESTED IN PROJECT MANAGEMENT, THIS IS KENNEDY’S PHARMACEUTICAL PROJECT MANAGEMENT. THERE IS A WHOLE SERIES OF BOOKS THAT HAVE THIS RED COVER ON IN MOST LIBRARIES. THIS IS ACTUALLY THE — THERE ARE TWO ADDITIONS TO THIS BOOK. THIS IS THE FIRST EDITION, IT REALLY DIFFERS FROM THE SECOND. YOU CAN TELL HE WAS SORT OF WRITING THIS THERE THE HEART. I’VE POINTED SOME STATEMENTS OUT THAT FOR SOMEONE WHO HAS DONE THIS REALLY SORT OF HIT HOME, YOU CAN REALLY TELL THAT KENNEDY HAS BEEN IN THE TRENCHES DOING PHARMACEUTICAL PROJECT MANAGEMENT WHICH MAKES IT VERY ENJOYABLE TO READ. YOU CAN ACTUALLY BUY THE FIRST EDITION SEPARATE PER THE SECOND ONE — FROM THE SECOND ONE. SO THAT’S WHAT I WOULD RECOMMEND. IN SUMMARY, I THINK YOU GOT FROM THE INITIAL SLIDES THAT CLINICAL DEVELOPMENT IS VERY COMPLEX, BOTH THE SCIENCE OF IT AND THE BEHAVIORAL ASPECTS. THE CLINICAL DEVELOPMENT PROJECT MANAGER PLAYS A VERY PICTURAL ROLE IN THAT — PIVOTAL ROLE IN THAT JOB. THEY HAVE VARIOUS TOOLS AT THEIR DISPOSAL FOR ORGANIZING AND FOR COMMUNICATION. ONE THING I DIDN’T REALLY STRESS IS THAT BEYOND HAVING THE TITLE OF PROJECT MANAGER, REALLY, THE PROJECT LEADER OF A PROJECT, I FOUND, IS ANYONE WHO REALLY TAKES THE REIGNS. IT’S THE NAME OF THIS PAINTING RIGHT HERE. I’VE SEEN TEAMS WHERE THE PROJECT MANAGER WAS AN MD, I ACTUALLY HAD ONE WHERE THE PROJECTED MANAGER WAS THE MEDICAL WRITING. THAT PERSON HAD — WRITER. THAT PERSON HAD SEEN SO MANY PROJECTS GO TRY THEY HAD THE CLEAREST HEAD AS TO WHAT SHOULD BE GOING ON WHEN. IT REALLY IS WHOEVER TAKES THE REIGNS AND MOVES THE PROJECT FORWARD. 0 WITH THAT, I’LL CONCLUDED AND TAKE ANY QUESTIONS. I’LL CONCLUDED AND TAKE ANY QUESTIONS. OR NOT. ALL RIGHT. STAY DRY. [APPLAUSE]

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