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 Fourth Drug Development Boot Camp - 2013

Overall Boot Camp Experience

"I learned what I came to Boot Camp to learn and more!"

"Anyone willing to have a big picture about drug development should participate in this boot camp!"

"It was a fantastic experience, very intense and challenging. I will understand the impact of this boot camp throughout the rest of my professional life, I'm sure. It's an amazing environment, given the competition that can exist between companies and everybody is in the same room to optimize the drug development process. Thank you for the impact that it will have on my everyday drug discovery work. Thank you."

"The positive scores don't do this course justice. It was eye opening."

"I had limited drug development experience (preclinical work on several compounds with focus on metabolic impact)…. Knew I would learn a great deal. The quality and scope of the panels was fantastic. They all really wanted to share and teach which came over in the sessions."

"Great job overall!"

Other Comments

"It was a fantastic experience, very intense and challenging. I will understand the impact of this boot camp throughout the rest of my professional life, I'm sure. It's an amazing environment, given the competition that can exist between companies and everybody is in the same room to optimize the drug development process. Thank you for the impact that it will have on my everyday drug discovery work. Thank  you."

"The Boot Camp was very well run and organized."

"I appreciated the Workshops especially on Day 2. Smaller Groups meeting for longer time to ensure that people don't opt out. Case studies are also higher impact than only lectures."

"Broadly speaking, I was humbled by the complexity of the drug development process! This course provided a framework to understand and assemble the resources to embark on the translation of discoveries at the bench to the bedside."

"This Boot Camp is very well organized. I especially like the small exercise/workshop after each session and the final workshop. I've learned a lot from them. Thank you!"

"We are a technology platform company that is using our proprietary process to produce nanoscale drug materials. Ass we have worked to become a drug delivery company, this conference has helped me to understand in detail what we have to do to attract pharma collaborators."

"This was a really amazing experience and I learned even more than I expected to. Itw as great to go from beginning to end for the whole development process and made perfect sense in how the boot camp was organized. Mixing in the workshops was also helpful and a good break from lectures."

Commercial Session

"Lewis did a fantastic job setting the big picture."

"Excellent overview."

"I thought this session was very useful and especially liked the philosophical insights regarding drug development."

"As a manufacturer with a process that we are migrating toward a pharma use, I have heard of all of these elements. This si the first time I had to really dig deeply in to gain understandong of how I will use these concepts daily or as I work to write my next business plan."

"Patent mistakes examples were very useful!"

"Margaret Sampson's mistakes were very informative."

Regulatory Affairs Session

"Very much enjoyed the "Top 10 Mistakes" section."

"Learnt lots on EMA --> enjoyed it very much."

"Going through mistakes was really excellent."

Preclinical Session

"I really enjoyed the PK/PD simulation workshop."

"Basic PK PD lecture was an outstanding review."

"Using the software program and learning about how to change dose, frequency and affect AUC, Cmax was great." 

"Liked understanding how to model for PK/PD."

"PK/PD were such a big "ahah" moment when I saw it spelled out this way. Perhaps it is an indictment of why engineers should not run pharma companies! Smiley face."

"Workshops were excellent!! Deborah did a fantastic job." 

"Modeling PK using the software program was very useful / helpful."

"I enjoyed being able to do hands-on PK. It will facilitate retention."

"Great PK/PD activity. Great breakout asthma session."

"Very helpful. Made many points I would not have thought of!"

Chemistry Manufacturing Controls

"The Biologics seession by Dr. Seshu Tyagararajan was the best in the entire boot camp!"

"IND CMC was very great detail. It was helpful."

"Got thorough understanding of the difference beteween biological and small molecule CMC."

"This was perhaps the most valuable section of the seminar for me. It really highlighted the work that we will have to do with our process and validation as we work our way up into beginning a first a drug devleopery company and then in the future moving tinto being a specialty pharma company."

"Great speaker (Tyajarajan)! Great workshop!"

Clinical Session

"Dr. Bello's summary was standout, thorough, amazing!"

"Dr. Akintunde Bello was a good presenter."

"Anti malarial example was really fun to be walked through."

"Malaria is interesting case study."

Day 2 Workshop Session

"Great group activiity. Lots of knowledge sharing. Multidisciplinary approach."

"By listening to other groups reporting back, it was a good overview of the wwhole drug development process (eg CMC, tox study)."

"Group work reinforced the fact that everyone has important ideas and the different backgrounds can be very complimentary."

Final Session

"Enjoyed Pravin's talk immensely."

"Benchmark discussion was very useful."

"Pravin Chaturvedi gave a great talk."

"Dr. Chaturvedi's talk was very inspiring."

"Last speaker Dr. Chaturvedi was phenomenal."

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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, 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.

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).
  • Scholarship Sponsors - can contact Dr. Speid at lspeid@sndtm.com.
   
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
$ 3,000.00  USD per participant if paid after 10/18/2014 
Register