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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.

The Drug Development Boot CampTM was founded by Dr. Lorna Speid. The 2017 Boot Camp will be the eighth Drug Development Boot CampTM. The Boot Camp is a very intensive training program designed for those that have relevant experience in research and development of New Chemical and New Biological Entities. This is a very challenging program because of the content, but also because of the amount that must be accomplished in two full days. Participants that complete the Boot Camp can be proud of their accomplishment and the Certificate of Completion that they have earned. 

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."

 

Commercial Session

"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"

"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."

 

"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."

 

 

Toxicology Session

"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."

 

"Excellent session."

 

"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."

 

 

Clinical Session

"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."

 

"Nice workshop."

 

"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?

  • Large Pharma / Large Biotech - whole project teams can, and have been trained
  • Small Medium and Virtual Biotech companies - CEOs, CFOs, COOs, officers, executives
  • Executives involved with the drug development process
  • Small and virtual company executives
  • Drug researchers and laboratory-based scientists and senior scientists
  • Large pharma professionals involved in silos of drug development, but who want to understand the whole process.
  • NIH/NCI, FDA, BPharm, MHRA, and professionals from major regulatory authorities
  • Regulatory affairs professionals, clinical research professionals, senior research scientists, toxicologists
  • Clinical investigators who would like to gain an understanding of drug development, or improve their understanding of the drug development process
  • Harvard University Investigators - contact Office of Technology Development for information on how to register for the Drug Development Boot Camp

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:

  • Wasting huge sums of investors' money on patent prosecution which will ultimately be useless, lead to costly litigation and prevent the asset from finding an appropriate exit.
  • Spend many years and huge sums of money developing a drug or drugs that the market does not want, and will not pay for.
  • Make costly mistakes throughout the development process, which will ultimately cost the company, one's reputation and may even lead to safety problems in those administered the company's products.
  • Experience a lack of direction from the top management team because of a failure to take the time to receive real training in drug development.
  • Clinical hold situations which are extremely costly.
  • Failure to design a clinical program/clinical programs which could lead to registration of the drug.
  • A US-centric approach, rather than a global approach to drug development.  This will lead to many problems later in development.
  • End up with a "good drug bad development syndrome".
  • Face expensive CRO and consulting bills, with no additional assurance of success.
  • Be forced to rely on the input from CROs.   There is a likelihood that you will be assigned the E Team by the CRO because of inability to tell the difference between an A Team and an E Team.
  • Inability to take the drug to the market in the timeframe promised to investors, analysts, the Board of Directors and patient groups.
  • Inability to manage the expectations of the Board of Directors.
  • Ineffective decision making mechanisms.
  • Inability to raise funds or to find an appropriate exit.
  • Inability to work effectively wtih major health authorities.
  • Loss of company, job and reputation.

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

One scholarship place is available in a competitive process. The scholarship granted will cover registration and all fees, including the Boot Camp training. Travel, visas, hotels, etc are not included in the scholarship.

 

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 in the US and Europe.  We regret that it does not include academia or government employees.

 

The application form is found at the following Link

 

https://www.surveymonkey.com/r/PS5FQ7C

 

[copy link into a browser]

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 February 2017

Closing Date: 31 May 2017

   
Harvard University Office of Technology Development and Speid and Associates
Additional Informationsee flyerProgram BrochureRegister & PayHotelsSponsors

Drug Development
Boot Camp®
November 15-16, 2017
The Harvard Club • Boston, MA

Cost
$ 3,250.00  USD per participant if paid before 10/17/2017 
Register