Web Series Sessions

Upcoming Events

COVID-19: Architecture of a Pandemic

September 23, 2020, 1 PM Eastern

While clearly the COVID-19 pandemic has caused international apprehension, there has been concern about the global morbidity and mortality associated with slowing and halting science and treatments for other medical conditions. In this webinar, Dr. Ben Locwin, International COVID-19 Advisor, Science & Public Health Task Force Member, will explore why we cannot mortgage our future for the current pandemic because we will have future pandemics, and the lessons we learn now will help us infrastructurally to be better-prepared so that we don’t re-commit these widespread ‘errors of thinking.

Speaker:

  • Dr. Ben Locwin, International COVID-19 Advisor, Science & Public Health Task Force Member

Sponsored by

DPT-session3

Maintaining Critical Drug Supply During the Pandemic

September 23, 2020, 2 PM Eastern

Prior to 2020, historically low-cost manufacturing, with just-in-time production and logistics, was key to staying competitive. In a time of crisis, however, the consequences of this model have become all too apparent. The leadership team at Dr. Reddy’s rose to the challenge by adapting quickly, decisively and without hesitation. Identifying opportunities for improvement in supply and building new digital infrastructure helped the company deliver on their promises to customers and established a framework for the new normal. Vanessa Brill and Vin Colicchio will discuss the challenges and solutions of maintaining drug supply during the COVID crisis, and how the pandemic has changed their company’s business model.

Speakers:

  • Vanessa Brill, Vice President and Regional General Counsel, the Americas, Dr. Reddy’s Laboratories
  • Vincent Colicchio, Vice President, Supply Chain and External Manufacturing, Dr. Reddy’s Laboratories

Sponsored by

DPT-session3

Understanding Your CDMO: A Legal Perspective on Quality Agreements

September 24, 2020, 1 PM Eastern

CDMOs are becoming increasingly assertive in their negotiation of contracts with pharmaceutical companies. This trend may be the result of the rise of the CDMO model, as well as the influx of private equity into this market segment. Regardless of the reason, pharmaceutical companies should now expect CDMOs to be more aggressive in contractually protecting themselves.

Speakers:

  • Stephen Sayre, Member, Dykema
  • Susan Fyan, Senior Legal Counsel, Perrigo Company

Sponsored by

cmic-session2

Contract Manufacturing Opportunity: COVID Catalyst for Supply Chain Conversion

September 24, 2020, 2 PM Eastern

2020 has brought COVID to most of the world and disruption across industries. The pharmaceutical industry didn’t escape impact with supply chains disconnected, trials halted, and drug shortages caused by spikes in demand for drugs thought to provide some hope for COVID relief. While COVID has been a supply-side disruption, recovery through the summer has been swift. At the same time, COVID has been a demand side catalyst. Engagement of capacity for vaccine manufacture…at risk…has been astonishing. In this exclusive session, Dave Windley, managing director of Jeffries LLC, will look at growth trends and impacts of COVID on contract manufacturing players.

Speaker:

  • Dave Windley, Managing Director, Jefferies LLC

Sponsored by

pfizer-session3

FDA Regulations and Inspections Amid COVID-19

September 30, 2020, 1 PM Eastern

Ricki Chase of Lachman Consultants is an expert in Food and Drug Law, Compliance Law, and Current Good Manufacturing Practices. She will provide an overview of how FDA has responded to the COVID-19 pandemic in both regulatory and compliance oversight of regulated industry. Topics covered will include:

  • Application of little used authorities;
  • Managing applications and approvals; and
  • Ensuring compliance without on-site access to industry sites.

Speaker:

  • Ricki Chase, Executive Director, Lachman Consultant Services, Inc.

Sponsored by

bora-session3

Impact of Covid-19 on Bioprocessing Facilities and Suppliers

September 30, 2020, 2 PM Eastern

Over the past 15 years, outsourcing of biologics has continued to increase steadily at a rate of around 4% annually. This is already accelerating, at least in the near-term, as the current Covid-19 crisis changes the dynamics of bioprocessing. According to BioPlan Associates, 65% of biotherapeutic facilities use contract development and manufacturing organization (CDMO) services for at least some of their bioprocessing. In addition, 70% of biopharma decision-makers expect to do more outsourcing, and 60% will change their supply chain strategies as a long-term result of the Covid-19 pandemic. In this webinar, BioPlan’s Eric Langer will explore how the landscape for both supply chain managers and contract manufacturers will evolve as a result.

Speaker:

  • Eric Langer, President and Managing Partner, BioPlan Associates, Inc.

Sponsored by

adare-session3

Oral Solid Dose Quality and Production

October 1 , 2020, 1 PM Eastern

Quality can cripple production for all the wrong reasons. Don’t let it happen to you. Over the past decade, quality advancement in technology and capability has far exceeded the rate at which the production team has excelled. The result has had devastating effects on productivity. Aren’t we a team? Don’t we work together and share the same goal? The objective of this presentation is not at all what you’re thinking. We are all part of the quality team, and we are all a part of production; we need to establish better principles to accelerate beyond survival and succeed at performance in production. Quality can help us get there.

Speaker:

  • Michael Tousey, CEO and Technical Director, Techceuticals

Sponsored by

fec-home

Keys to Success in Accelerating Early to Mid-Phase Drug Development

October 1 , 2020, 2 PM Eastern

2018 saw the first year where the number of drugs entering development came from emerging pharma compared to large pharma. As these companies rely heavily on outsourcing, they turn to their providers not only for resource needs, but also for expertise to guide them through the minefield of early development. As bio-enhancement of NCEs is often a critical driver for successful transition through preclinical studies, it is essential that the CRO/CDMO selected has the right knowledge to support this stage of work.

Speaker:

  • Dr. Mark Saunders, Founder of P2C Pharma & Strategic Advisor at Fluid Pharma

Sponsored by

Catalent logo

Data Integrity Trends in Remote Inspection Findings

October 7, 2020, 1 PM Eastern

With remote inspections here to stay in the inspection toolkit, learn how remote inspections have impacted data integrity findings to date. What are the “hidden triggers” lurking in your SOPs and work instructions that tell an investigator/inspector that “here lie data integrity issues”? Does FDA have the right to log into your systems directly? How can you better prepare your people—and your customers—to handle remote data integrity scrutiny?

Speaker:

  • John Avellanet, Managing Director and Principal, Cerulean Associates

Achieve DSCSA Serialized Interoperability Required by 2023

October 8, 2020, 1 PM Eastern

In this exclusive web event, Peter Sturtevant, senior director of community engagement – pharmaceuticals for GS1 US, will explore how to meet Drug Supply Chain Security Act (DSCSA) interoperability by applying GS1 Standards of Identify, Capture, and Share. The pharmaceutical industry is preparing to meet the requirements of DSCSA Serialized Interoperability by applying GS1 Standards between supply chain trading partners.

Speaker:

  • Peter Sturtevant, Senior Director, Community Engagement – Pharmaceuticals, GS1 US

Sponsored by

abbvie145x27

Upcoming Sessions

COVID-19: Architecture of a Pandemic

September 23, 2020, 1 PM Eastern Time

While clearly the COVID-19 pandemic has caused international apprehension, there has been concern about the global morbidity and mortality associated with slowing and halting science and treatments for other medical conditions. In this webinar, Dr. Ben Locwin, International COVID-19 Advisor, Science & Public Health Task Force Member, will explore why we cannot mortgage our future for the current pandemic because we will have future pandemics, and the lessons we learn now will help us infrastructurally to be better-prepared so that we don’t re-commit these widespread ‘errors of thinking.’

Speaker:

  • Dr. Ben Locwin, International COVID-19 Advisor, Science & Public Health Task Force Member

Sponsored by

DPT_Mylan_Logo72dpi-150

09/23/2020 1:00 pm

Sponsor :

Maintaining Critical Drug Supply During the Pandemic

September 23, 2020, 2 PM Eastern

Prior to 2020, historically low-cost manufacturing, with just-in-time production and logistics, was key to staying competitive. In a time of crisis, however, the consequences of this model have become all too apparent. The leadership team at Dr. Reddy’s rose to the challenge by adapting quickly, decisively and without hesitation. Identifying opportunities for improvement in supply and building new digital infrastructure helped the company deliver on their promises to customers and established a framework for the new normal. Vanessa Brill and Vin Colicchio will discuss the challenges and solutions of maintaining drug supply during the COVID crisis, and how the pandemic has changed their company’s business model.

Speakers:

  • Vanessa Brill, Vice President and Regional General Counsel, the Americas, Dr. Reddy’s Laboratories
  • Vincent Colicchio, Vice President, Supply Chain and External Manufacturing, Dr. Reddy’s Laboratories

Sponsored by

DPT_Mylan_Logo72dpi-150

09/23/2020 2:00 pm

Sponsor :

Understanding Your CDMO: A Legal Perspective on Quality Agreements

September 24, 2020, 1 PM Eastern

CDMOs are becoming increasingly assertive in their negotiation of contracts with pharmaceutical companies. This trend may be the result of the rise of the CDMO model, as well as the influx of private equity into this market segment. Regardless of the reason, pharmaceutical companies should now exxpect CDMOs to be more aggressive in contractually protecting themselves.

Speakers:

  • Stephen Sayre, Member, Dykema
  • Susan Fyan, Senior Legal Counsel, Perrigo Company

Sponsored by

CMIC-Group-Logo_web-200

09/24/2020 1:00 pm

Sponsor :

Contract Manufacturing Opportunity: COVID Catalyst for Supply Chain Conversion

September 24, 2020, 2 PM Eastern

2020 has brought COVID to most of the world and disruption across industries. The pharmaceutical industry didn’t escape impact with supply chains disconnected, trials halted, and drug shortages caused by spikes in demand for drugs thought to provide some hope for COVID relief. While COVID has been a supply-side disruption, recovery through the summer has been swift. At the same time, COVID has been a demand side catalyst. Engagement of capacity for vaccine manufacture…at risk…has been astonishing. In this exclusive session, Dave Windley, managing director of Jeffries LLC, will look at growth trends and impacts of COVID on contract manufacturing players.

Speaker:

  • Dave Windley, Managing Director, Jefferies LLC

Sponsored by

Pfizer_CentreOne_Logo-200

09/24/2020 2:00 pm

Sponsor :

FDA Regulations and Inspections Amid COVID-19

September 30, 2020, 1 PM Eastern

Ricki Chase of Lachman Consultants is an expert in Food and Drug Law, Compliance Law, and Current Good Manufacturing Practices. She will provide an overview of how FDA has responded to the COVID-19 pandemic in both regulatory and compliance oversight of regulated industry. Topics covered will include:

  • Application of little used authorities;
  • Managing applications and approvals; and
  • Ensuring compliance without on-site access to industry sites.

Speaker:

  • Ricki Chase, Executive Director, Lachman Consultant Services, Inc.

Sponsored by

bora220

09/30/2020 1:00 pm

Sponsor :

Impact of Covid-19 on Bioprocessing Facilities and Suppliers

September 30, 2020, 2 PM Eastern

Over the past 15 years, outsourcing of biologics has continued to increase steadily at a rate of around 4% annually. This is already accelerating, at least in the near-term, as the current Covid-19 crisis changes the dynamics of bioprocessing. According to BioPlan Associates, 65% of biotherapeutic facilities use contract development and manufacturing organization (CDMO) services for at least some of their bioprocessing. In addition, 70% of biopharma decision-makers expect to do more outsourcing, and 60% will change their supply chain strategies as a long-term result of the Covid-19 pandemic. In this webinar, BioPlan’s Eric Langer will explore how the landscape for both supply chain managers and contract manufacturers will evolve as a result.

Speaker:

  • Eric Langer, President and Managing Partner, BioPlan Associates, Inc.

Sponsored by

adareimage

09/30/2020 2:00 pm

Sponsor :

Data Integrity Trends in Remote Inspection Findings

October 7, 2020, 1 PM Eastern
With remote inspections here to stay in the inspection toolkit, learn how remote inspections have impacted data integrity findings to date. What are the “hidden triggers” lurking in your SOPs and work instructions that tell an investigator/inspector that “here lie data integrity issues”? Does FDA have the right to log into your systems directly? How can you better prepare your people—and your customers—to handle remote data integrity scrutiny?

Speaker:

  • John Avellanet, Managing Director and Principal, Cerulean Associates

10/07/2020 1:00 pm

Sponsor :

Achieve DSCSA Serialized Interoperability Required by 2023

October 8, 2020, 1 PM Eastern

In this exclusive web event, Peter Sturtevant, senior director of community engagement – pharmaceuticals for GS1 US, will explore how to meet Drug Supply Chain Security Act (DSCSA) interoperability by applying GS1 Standards of Identify, Capture, and Share. The pharmaceutical industry is preparing to meet the requirements of DSCSA Serialized Interoperability by applying GS1 Standards between supply chain trading partners.

Speaker:

Peter Sturtevant, Senior Director, Community Engagement – Pharmaceuticals, GS1 US

Sponsored by

annvie-session3

10/08/2020 1:00 pm

Sponsor :

Oral Solid Dose Quality and Production

October 1, 2020, 1 PM Eastern

Quality can cripple production for all the wrong reasons. Don’t let it happen to you. Over the past decade, quality advancement in technology and capability has far exceeded the rate at which the production team has excelled. The result has had devastating effects on productivity. Aren’t we a team? Don’t we work together and share the same goal? The objective of this presentation is not at all what you’re thinking. We are all part of the quality team, and we are all a part of production; we need to establish better principles to accelerate beyond survival and succeed at performance in production. Quality can help us get there.

Speaker:

  • Michael Tousey, CEO and Technical Director, Techceuticals

Sponsored by

FEC-session

10/01/2020 1:00 pm

Sponsor :

Keys to Success in Accelerating Early to Mid-Phase Drug Development

October 1, 2020, 2 PM Eastern

2018 saw the first year where the number of drugs entering development came from emerging pharma compared to large pharma. As these companies rely heavily on outsourcing, they turn to their providers not only for resource needs, but also for expertise to guide them through the minefield of early development. As bio-enhancement of NCEs is often a critical driver for successful transition through preclinical studies, it is essential that the CRO/CDMO selected has the right knowledge to support this stage of work. This presentation will focus on the following key aspects:

  • The concept of rapid early development of poorly soluble drugs
  • Scale-up considerations for bioavailability enhancing technologies
  • A consultant perspective on selecting CDMO for the right partnership for drug development
  • How a CDMO can offer advantages in terms of scalability, speed to market, access to technical expertise and potential cost efficiencies?

Speaker:

  • Dr. Mark Saunders, Founder of P2C Pharma & Strategic Advisor at Fluid Pharma

Sponsored by

Catalent logo

10/01/2020 2:00 pm

Sponsor :

Catalent logo

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