Drug Development Skills are Difficult to Acquire
The pharmaceutical industry has its fair share of Ph.D.s, and MDs, and yet qualifications do not translate into understanding of the drug development process. In fact, Nobel Laureate scientists find the drug development process bewildering.
As drug development costs increase, the process of drug development is becoming more and more complex. Those involved with the process of developing new therapeutics (drugs, devices, combination products and diagnostics) must understand the process and be able to navigate it with great skill. These skills are difficult to acquire.
The second Boot Camp at Harvard University was Co-chaired by Dr. Michal Preminger, Executive Director, Harvard University Office of Technology Development. It provided a unique opportunity for participants to obtain a hands-on insight into the drug development process from drug discovery (designation of a lead) to registration. The major aspects of development were considered in detail. Because most people in the industry work in silos, even those with many years of drug development experience benefited.
Some Participant Feedback from the Fifth Drug Development Boot Camp - 2014
Participants for the 2014 Drug Development Boot Camp came from Canada, Germany, India, Israel, Japan, The Netherlands, Spain, UK, and USA.
Overall Boot Camp Experience
"Thanks! Great experience. Case studies were excellent. Thought provoking and helpful in terms of absorbing and applying new information."
"The division into 3 groups - company, academia and special forces was a great idea to collaborate and share ideas."
"Overall program organization was superb - location, adherence to time for each session and food."
"Thanks for organizing. It was a great experience!"
"Thank you for organizing this fantastic event!"
"Great training course! The Drug Development Boot Camp immersed me into the drug development process and I came out much more knowledgeable."
"I appreciate the addition of this topic - gives the program a good starting point."
"Nice starting panel. Overall health economics considerations are key to success! Gallagher presentation was excellent."
"Paul Gallagher was very interesting/impressive. I did notice that the Gilead QOLY> threshold he specified in the presentation indicating undervalued but I didn't raise my hand against the majority!"
"It was interesting to see the "checklists" that Tony and Paul used for decision making. It is important to consider these checklists as early as possible during a new project."
Regulatory Affairs Session
"The seven mistakes were really good to know."
"The Seven Mistakes to avoid were helpful - importance of the Target Product Profile."
"My take away - Develop a Target Product Profile and a regulatory strategy as early as possible. From Dr. L Speid. I thought all the Seven mistakes were helpful."
"Very useful information - a good overview of the program. The 7 mistakes outlined was the best part of the day - importance of Target Product Profile and maintaining relationship with FDA is typically first heard but not written and discussed - this presentation actually talked about it."
"Regulatory strategy is key! Loved Seven mistakes - presented well with additional insights."
"Loved to understand more of validated animal models. Proof of concept, mechanism, pharmacology would be good."
"Deborah did a fabulous job managing the whole session. Great speakers and content."
"The purpose of systems pharmacology modeling by -- Dr. J Burke."
"I now appreciate the incredible amount of skill needed to properly accomplish this task/goal."
"Informative and illustrative - an important part of the program."
"I learnt that animal models not always predictive - Excellent - Dr. Slipetz"
"The asthma section was great for pointing out that bridges can be built from human data, and these bridges can often be useful model systems."
"Loved session on toxicology - very informative."
"I learned about clearance, NOAEL, and MABEL. Great session!"
"One of the most important and eye opening sessions -> good presentations and a good snapshot of the tox program."
Chemistry Manufacturing Controls
"Very well run session, engaged speakers."
"I learned a lot about the CMC related elements of the CTD. Great presentations!"
"Emphasis on timelines was appreciated! Good presentation by Seshu."
"Templin lecture was great. Workshops also productive."
"Regional expectations were also valuable info."
"Excellent summary of CMC in particular on biologics."
"I'm from Japan and there are several pharmaceutical companies specialized for natural products. They could not successfully go into the market other than Japan so far. Now I can see the reason. Maybe Napo Pharma is the way to go into the US market."
"The case study narrative of the novel anti-diarrhoeal drug was informative on many levels. Another good session!"
"Excellent! Very good workshops. Adaptive design pluses and minuses. Well elucidated session."
"Very interesting case studies!"
"Very interesting and informative. Great insights into kind of considerations going into the strategy."
"Fixed versus adaptive design was very interesting and useful."
Day 2 Workshop Session
"Great case studies. Makes you think and fantastic to then see how it went in reality."
"Great exercise with recap of "What Really Happened"
"Great session on economics of R&D in pharma."
"The analysis of success rate is impressive."
"As a non scientist, I have a new respect for the drug development process."
"Amazing. Talk from Pravin! Best talk of the Boot Camp."
"It was a treat to participate or simply "WOW". "
"Better understanding of registration strategy worldwide."
Why Drug Development Boot Camp?
Dr. Speid is a global regulatory affairs and drug development expert. After watching many of her client companies make expensive and avoidable mistakes, she decided to help as many as possible avoid making the same mistakes over and over again.
Who Should Attend?
What Will You Learn?
This is not an entry level program. It is intensive and intended for those involved with R&D of new drugs. If you make drug development decisions on a daily basis, the Boot Camp is for you. A minimum of 5 years of relevant drug research or drug development experience is required in order to be accepted onto the Drug Development Boot Camp because of the depth and intensity of the program.
This is a unique opportunity to be totally immersed in drug development for two days and to mix with a Faculty that has proven themselves by bringing drugs to market, or that has contributed to this success. For this reason, the number of spaces is limited.
Those who do not attend the Drug Development Boot Camp or a similar program are at risk of the following:
I have been in the pharmaceutical industry for many years and have a lot of experience. I don't need to attend the Boot Camp!
If only the many years that people have been in the industry would translate into experience, we would not have the current attrition rate in the pharmaceutical industry. Sadly many years in the industry do not denote experience or expertise. Likewise, attendance at many conferences and even courses, will not necessarily improve one's drug development experience level. You need the Drug Development Boot Camp. The unique total immersion, open and interactive atmosphere, promotes hands-on learning, and is like nothing else available.
We regret that no Scholarships are available for the 2015 Drug Development Boot Camp
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