Harvard University Speid and Associates
Harvard University Speid and Associates
Drugs To Market
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What is the training program called the Drug Development Boot CampTM?

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

 

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 2016 Boot Camp will be the seventh Drug Development Boot Camp. 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 Sixth Drug Development Boot CampTM - 2015

Participants for the 2015 Drug Development Boot CampTM came from Canada, Germany, Israel, Belgium, The Netherlands, Spain, and the USA.

Overall Boot Camp Experience

"I think the breadth and depth of the camp was excellent."

 

 "Janis Fraser - Excellent talk which taught me that should try to patent anything (might not work though). "

 

Commercial Session

"Helped me better understand how pharma selects candidates. Ironically uses the SAME financial models we use to select products to develop. Was GREAT!"

"This session made me realize that it's very valuable to think about the target product profile very early and that the commercial assessment should be considered earlier."

 

"Thrilled by Paul Gallagher."

 

"Great"

 

Tony Sarraino's talk was fantastic

Global and Strategic Regulatory Affairs Session

"All talks were great - especially on a topic such as this which can be DRY!"

"Good overview of modules needed for IND and CTA packages. Important to have a good regulatory strategy at an early stage of the process."

 

"The slide that showed a side by side comparison was helpful."

 

"I liked Lorna's examples of Tegenero/U Penn cases of mistakes."

 

"Seven Mistakes to Avoid with IND/CTAs was concise and fantastic takeaway points."

 

"The mistakes session (7 Mistakes) was great"

 

Preclinical Efficacy Session

"This was an interesting session - Lots presented in short time."

"Great PK/PD session. Very helpful to use the PK/PD models."

 

"Iain M. was charismatic and engaging. I liked his slides. Some didn't make sense (picture of bath) but overall I liked his method of explanation."

 

"Nice workshop / case study: easyt to understand for a not subject matter expert."

"I gained an appreciation for PK/PD modeling and its impact and effectiveness."

 

"Great workshop! Hands-on Matlabs software was very informative"

 

"Very informative. The conversion chart between species very useful!"

 

"I did like John Burke's session a lot."

 

Toxicology Session

"Scott was GREAT!"

"I learned the comprehensive nature of toxicology considerations companies go through, including how drugs are assessed if being in-licensed."

 

"Allometric scaling is not as complex as I thought it was."

 

"Understanding that nonclinical safety studies objective and scope allows me to better understand the design of the safety studies in my current projects."

 

"Great session! Learned lot about small molecules vs biopharmaceuticals Workshop was very informative."

 

"That was a good session."

 

"Scott Boley was the best speaker. He brought us from the basic to complex. Very good and helpful tox information."

Chemistry Manufacturing Controls Session

"Better understanding of tech transfer and how we can modify our messages and products to address the needs of pharma."

"Really well presented."

 

"Eye opening session due to my lack of expertise and also importance of the process and non-clinical toxicology."

 

"Seshu spoke easily about her topic. I didn't understand all of her presentation but it was good - easier to relate to what she was saying than some other presentations and logical presentation."

 

"Like the presentation of highlights of both small molecules and biologics."

 

"One REALLY has to plan early. I now understand my CMC colleagues a lot better."

 

"It was a good session."

 

Clinical Session

"I enjoyed the clinical design information, especially the augmented design."

"Great case study and workshop"

 

"Benefits of adaptive design. Great discussion after the Workshop."


" Excellent and would like longer session in future
"

 

"Adaptive design was very informative."

 

Day 2 Workshop Session

"Great experience!"

"Good example of team work as we had good discussion."

 

"Good to see what really happened to the drug in the case study."

 

"Great workshop. Enjoyed working in group as a team."

 

"Experience of other attendees was very high."

 

Final Session: Sending Out the Special Forces!

"Great talks; very inspiring!"

"Fantastic talk about how important innovation is."

 

"The whole session was incredibly interesting!"

 

"Pravin Chaturvedi, Ph.D. Best presenter and most motivating sessions."

 

 

___________________________________________________

Why Drug Development Boot CampTM?

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

Scholarship Applicants must be able to demonstrate an R&D spend of at least 3 million USD between 2014 and 2016 (April 2016). 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

 

https://www.surveymonkey.com/r/CC8PGQB

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Opening date: 1st of March 2016

Closing Date: 30 May 2016

   
Harvard University Office of Technology Development and Speid and Associates
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Drug Development
Boot Camp
November 16-17, 2016
The Harvard Club • Boston, MA

Cost
$ 2,900.00  USD per participant if paid before 10/17/2016 
Register