What is the training program called the Drug Development Boot Camp®?
Someone from the SAS said, "They train you to do certain things, and then you have to do them tired." The Drug Development Boot Camp is a little like that. Come prepared to work very hard. If you want to sit back, fall asleep, and drop in and out of lectures for two days, Drug Development Boot CampTM is not for you." - Dr. Lorna Speid, Founder and Co-chair.
The 2017 Drug Development Boot CampTM will be held on the 15th to 16th November.
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. At the same time that the process is becoming more complex, researchers and developers are becoming more specialized. The challenge is there is a need to gain a thorough understanding of other areas of research and development in order to be effective in their own areas.
Prospective participants are interviewed in order to find out their aspirations and goals in taking the Boot Camp. They are also given reading materials so that they can prepare for the Boot Camp. They will take a survey so that the Faculty can gain an understanding of the audience before they attend.
Some Participant Feedback from the Seventh Drug Development Boot Camp®held in 2016
Participants for the 2016 Drug Development Boot CampTM came from Switzerland, Australia and the USA.
Overall Boot Camp Experience
"Great immersion series. Comprehensive picture of drug development program."
"As a business development professional in the pharmaceutical sector, Drug Development Boot Camp was an essential primer To enhance my understnding of the entire development spectrum."
"Thank you for the opportunity to attend. The workshops and presentations were very informative and challenging. The exposure to multiple areas of pharma will support my decisions with a strong overall comprehension of drug development."
"Great course. Loved the Workshops."
"I liked the reimbursement section. The BRICS discussion and marketing case - this was brief and something I didn't know)."
"Excellent overview of global market access requirements."
"Provided an excellent understanding of the overall drug development process."
"Enjoyed this session."
"Excellent section. Perspectives from multiple key functions."
"This was a very insightful discussion. I found it very useful."
"It was interesting to understand the reimbursement point of view."
Global and Strategic Regulatory Affairs Session
"7 Mistakes - will print for my desk."
"Learnt about the benefits of pulling together full packages versus rolling submissions - fast track may not be best approach."
"7 Mistakes - recognition that I have inherited programs that have experienced each of the 7 things you shouldn't do."
"I was not previously aware of the impact and areas that regulatory affairs touches on in the drug development process."
"This was a very informative session."
"7 Mistakes talk was very helpful."
"I can see many times where these things were not done with my programs."
"I did not previouslyrealize the importance of having a TPP."
Preclinical Efficacy Session
"Really liked the PK/PD session."
"The bathtub model was a very lay, but effective way of visualizing PK/PD."
"The modeling in the workshop was valuable."
"Dr. Martin's bathtub analogy makes PK/PD understandable! Lots of material and felt a bit rushed. I could have used mor etime to review this."
"Finally understood PK/PD."
"Excellent workshop case study."
"It was a great idea to build the App to allow us to play around."
"I enjoyed the modeling session. It was fun!"
"PKPD talk was good - first time I understand it."
"Using the software was great way to visualize the space between efficacy and harm with dosing strategy."
"Iain Martin's "bathtub" analogy to describe PK/PD helped me understand the concept."
"Excellent overview of toxicology across the development life cycle."
"Very useful!. Dr. Boley made tox seem so much simpler!"
"Great overview by Scott!!!"
"Workshop was good too."
"Workshop was excellent."
"Very informative; well organized. Scott conveyed the goals of what he wanted us to take away very clearly."
"Fascinating talk. Made many things clear. I feel this will help me greatly in my work."
"The calculation of human doses of a drug based on the equivalence charts was interesting to me."
Chemistry Manufacturing Controls Session
"The CMC and manufacturing sections provided a great overview of the process and its complexity."
"Very balanced (depth/breath) view of CMC with in development life cycles."
"I liked the fishbone risk assessment tool!"
"Small Molecules versus biologics - great overview!"
"Great session as well!"
"Nice examples. Learnt a lot."
"Loved Seshu's and Mike's talks - very engaging."
"This was a good session. Very well done by Seshu."
"I really appreciated Dr. Tyagarajan's enthusiasm for her field!"
"CMC - excellent section. Very clear. Not enough time for 1st speaker."
"Excellent talk on CMC manufacturing."
"Biologics session presentation was very crisp and clear."
"Biologics and talks and workshops great."
"I learnt a new concept of correlation between safety assessment CMC today it is really helpful in deciding drug candidates."
"I liked the discussion on the manufacture of biologics and the parallels with small molecule manufacture."
"Would be nice to add labeling differences domestic vs global US vs EU or Rest of World."
"Clinical - I particularly liked this session regarding biomarker use in trials for patient stratification."
"Possibly due to technical difficulties, but it felt quite dull and that we did not cover all the material he intended to."
"Good statistical overview."
"Many advantages to using adaptive clinical designs. I hadn't realized that this kind of flexibility was possible."
"I learnt how to do clinical trial design. It definitely increased my knowledge in this area."
"It was nice to receive a clear description of the various adaptive designs as presented by Dr Chang."
Day 2 Afternoon Workshop Session
"This session was great. I liked that I was able to move to a different group and to be exposed to different ways of problem solving."
"Rather a great opportunity to learn and improve."
"The Workshops in general were great because they enabled immediate "hands-on" of information from talks - this brought a "real-world" component which I thought was quite valuable. "
"Really interesting to work on a different area than previous experience."
"I appreciated the fact that Faculty were going from table to table."
"Really appreciated the opportunity to work on a real case."
"The ....... workshop was great - right amount of time. Good scope, effective way to pull together the concepts."
"Final Workshop was best - going deeper was appreciated."
"Found the sessions very helpful to think and answer questions."
"It was extremely useful to be tasked with in depth challenge outside my area of expertise. I really enjoyed this."
"Really key to do this section. Putting learning to work through cases is valuable."
Final Session: Sending Out the Special Forces!
"Great talk comparing first in class and later in class drug success rate to market (patent filing)."
"Interesting sessions! I learnt a lot!"
"....I was surprised to see we've gotten less efficient with drug development over the past decase. How to improve? More people need to go through boot camp as many folks have a siloed uncreative view of how to develop drugs. Its a small world but many folk are making similar mistakes. Education is the key to overcome this."
"Liked all the discussion of how to approach partner, work with big pharma."
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 an extremely intensive training program. It is 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 CampTM 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 CampTM. The unique total immersion, open and interactive atmosphere, promotes hands-on learning, and is like nothing else available.
Scholarship Competition for SMEs
Scholarship Applicants must be able to demonstrate an R&D spend of at least 3 million USD between 2015 and 2017 (April 2017). The competition is open to SMEs. We regret that it does not include academia or government employees. Applicants may apply from firms in the US and Europe.
The application form is found at the following Link
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You will be asked to write two detailed essays. Applicants who only fill in their contact information will be automatically disqualified.
Opening date: 1st of January 2017
Closing Date: 30 May 2017
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