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 Third Drug Development Boot Camp (with Harvard University OTD) - 2012

Overall Boot Camp Experience

"This was a wonderful Boot Camp. Great talks and it was very well organized."

"Very good overview of drug development process with the associated regulatory components. I enjoyed the case studies and workshop components. Organization etc was great!  Faculty very knowledgeable and approachable! Great selection of participants."

"Take home reference binder and suggested readings were extremely valuable. Great networking opportunities. Last workshop case study was fantastic and informative."

"I learnt what I came to Boot Camp to learn, and more!"

"This was an excellent primer to the complete drug development process"

"Faculty and experts from every corner of drug development are really a good opportunity to increase our knowledge and personal networking."

"Perfect!"

"Working on the small cases and questions within and after the lectures is most useful - really reinforces concepts." 

"I learned so much in less than 36 hours about the basic process of drug development. All the Faculty are very accessible and friendly to talk to. All are inspired."

"I am impressed by how much was covered and how much I learned in a 2 day intensive boot camp. I have a better understanding of patenting, licensing and registration of drugs during the development process. Lectures were helpful to cover gaps in knowledge and study cases were extremely relevant."

Commercial Session

"I really enjoyed this session of talks as it sets the backdrop for what was to come in the next few sessions. The speakers did a very good job."

Regulatory Affairs Session

"For Day 1 - found this section most interesting. Presenter was engaging with audience." 

The 10 Mistakes lecture was very useful. 

"I liked how Dr. Speid highlights all the potential pitfalls concisely so people who are inexperienced (like myself) would know what to watch out for when filing an IND/CTA in the future." 

Preclinical Session

"Excellent overview! Very helpful and good exercises." 

"Excellent! I felt that I learned a lot."

"The contrast with small molecule vs biologics was very useful."

Chemistry Manufacturing Controls

"Best presentaton on QbD I've heard."

"Very good."

"Very clear and concise overview of the CMC pathway - something I'm not very well acquainted with. I've learnt a lot from it."

"Excellent!"

Clinical Session

"I really liked Bello's talk but I also liked to see case studies of trials that failed and trials that succeeded."


"Excellent speakers "

"Excellent!"

Day 2 Workshop Session

"Case studies were excellent. Good spotlight on how different organizations view liabilities." 

"This was really useful in allowing application of the concepts learned in the lessons. Really appreciated being able to consult Faculty."

"Excellent learning opportunity  - Good way to solidify learning experience."

"This was the best part."

"Excellent! I felt that this gave mea  better sense of some of the issues that are faced."

"Excellent - nice integration/ small comment - define ex vivo in the case. Can be two types of assays."

Some Participant Feedback from the Second Drug Development Boot Camp (with Harvard University OTD) - 2011

"This was a great overview of drug development that will benefit me a long time to come. "

"I liked the short workshops after each session - it helps to understand and remember the material."

"Very well designed and integrated workshop - it takes you from ignorance to knowledge on traversed  path of preclinical work to clinical reality."

"Excellent."

"Overall very good."

"Great sessions. Very good content and competent and experienced speakers. "

Cornell University Drug Development Boot Camp Participant Feedback (September 2010)

"A superb bootcamp on drug development; it was great that we were given the lecture materials in a binder."

"Process time line for applications etc. both in America, as well as European market was informative."

"The conference was worth every minute and every "admission dollar" spent."

"The speakers were great."

"Great experience! I learned quite a bit. Thanks for the great opportunity."

"This was a very useful presentation. I very much appreciated that the specialists in their fields made time to share their knowledge with us."

"I very much enjoyed the experience overall and felt that I learned quite a bit in a short period of time."

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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
  • 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
  • Harvard 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 executive level individuals who make drug development decisions on a daily basis. A minimum of 5 years of relevant 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.

Three Categories of Scholarships May be Available in a strict competitive process

If you fall into any of the following categories, contact Dr. Lorna Speid to receive applications for the Scholarships. We are also looking for Sponsors for these scholarships. 

  • Biotechnology companies conducting novel drug development (tuition to be paid)
  • Hospital institutions involved in pediatric research and development of  new medicines (tuition and other expenses to be paid)
  • Chinese, Israeli and European biotechnology companies that are involved with the development of new chemical entities (tuition and other expenses up to a set amount would be paid).
  • Update - no sponsors have come forward. Please contact Dr. Speid for information on how to individually seek sponsors for an individual scholarship.
   
Harvard University Office of Technology Development and Speid and Associates
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Drug Development
Boot Camp
November 19-20, 2014
The Harvard Club • Boston, MA

Cost
$2,150 USD per participant if paid before 04/15/2014 
Register