Harvard University Speid and Associates
Harvard University Speid and Associates
Drugs To Market
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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 Drug Development Boot Camp was founded by Dr. Lorna Speid. The first Boot Camp was held at Cornell University in September (9 - 10), 2010, and was a great success. Dr. Alan Paau, Vice Provost for Technology Transfer & Economic Development, Cornell University, was the Co-chair of the firstDrug Development Boot Camp. 

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."

Commercial Session

"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."



Preclinical Session

"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."

"Good workshop."

Chemistry Manufacturing Controls

"Very well run session, engaged speakers."

"Very good!"

"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."


Clinical Session

"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"

Final Session

"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?

  • CEOs, CFOs, COOs of biotech companies
  • Executives involved with the drug development process
  • Small and virtual company executives
  • Large pharma professionals involved with drug development, but who want to understand the whole process.
  • Large pharma professionals that work within silos.
  • 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 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:

  • 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 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


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

Drug Development
Boot Camp
November 17-18, 2015
The Harvard Club • Boston, MA

$ 3,400.00  USD per participant if paid after 10/18/2015